nitinol and Constriction--Pathologic

Primary nitinol stenting (PNS) and drug-coated balloon (DCB) angioplasty are two of the most common endovascular interventions for femoropopliteal atherosclerotic disease. Although many prospective randomized controlled trials have compared PNS or DCB with plain balloon angioplasty (POBA), no studies have directly compared PNS against DCB therapy. The purpose of this network meta-analysis is to determine whether there is a significant difference in outcomes between PNS and DCB.. The primary outcome measure was binary restenosis, the secondary outcome measures were target lesion revascularization (TLR) and change in the ankle-brachial index (ABI). Outcomes were evaluated at 6, 12, and 24 months. A literature review identified all randomized controlled trials published before March 2020 that compared DCB with POBA or PNS with POBA in the treatment of native atherosclerotic lesions of the femoropopliteal artery. Studies were excluded if they contained in-stent stenosis or tibial artery disease that could not be delineated out in a subgroup analysis. Network meta-analysis was performed using the network and mvmeta commands in STATA 14.. Twenty-seven publications covering 19 trials were identified; 8 trials compared PNS with POBA and 11 trials compared DCB with POBA. The odds of freedom from binary restenosis for patients treated with DCB compared with PNS at 6 months was 1.19 (95% confidence interval [CI], 0.63-2.22), at 12 months was 1.67 (95% CI, 1.04-2.68), and at 24 months was 1.36 (95% CI, 0.78-2.37). The odds of freedom from TLR for patients treated with DCB compared with PNS at 6 months was 0.66 (95% CI, 0.12-3.80), at 12 months was 1.89 (95% CI, 1.04-3.45), and at 24 months was 1.68 (95% CI, 0.82-3.44). The mean increase in ABI for patients treated with PNS compared with DCB at 6 months was 0.06 higher (95% CI, -0.03 to 0.15), at 12 months was 0.05 higher (95% CI, 0.00-0.09), and at 24 months was 0.07 higher (95% CI, -0.01 to 0.14).. Both DCB and PNS demonstrated a lower rate of binary restenosis compared with POBA at the 6-, 12-, and 24-month timepoints. When comparing DCB with PNS through network meta-analysis, DCB had a statistically lower rate of a binary restenosis and TLR at the 12-month timepoint. This network meta-analysis demonstrates that both DCB and PNS are superior to POBA, and that PNS is a satisfactory substitute for DCB when paclitaxel is not desirable.

Topics: Alloys; Angioplasty, Balloon; Ankle Brachial Index; Coated Materials, Biocompatible; Constriction, Pathologic; Femoral Artery; Humans; Network Meta-Analysis; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices

Topics: Alloys; Angioplasty, Balloon; Constriction, Pathologic; Device Approval; Drug-Eluting Stents; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Stents; Treatment Outcome; Vascular Patency

Esophageal cancer is a very deadly disease, killing more than 15,000 people in the United States annually. Almost 400,000 new cases happen in the worldwide every year. More than 50% esophageal cancer patients are diagnosed at an advanced stage when they need an esophageal stent to open the blocked esophagus for feeding and drinking. Esophageal stents have evolved in stages over the years. Current clinically used stents commonly include stainless steel or nitinol self-expandable metallic stent (SEMS) and self-expandable plastic stent (SEPS). There are many choices of different types of stents and sizes, with fierce competition among manufacturers. However, current stent technology, whether uncovered, partially covered, fully covered SEMS or SEPS, has their own advantages to solve the dysphagia, stricture, and fistula problems, but they also cause some clinical complications. The ideal stent remains elusive. New 3D printing technique may bring new promising potential to manufacturing personalized esophageal stents. Drug-eluting stents could be the new avenue to do more than just pry open a stricture or cover a defect in the esophageal lumen, a possibility of proving local anticancer therapy simultaneously. Additionally, the lack of esophageal cancer animal models also hinders the progress of stent development. This paper reviews these topics for a comprehensive understanding of this field. In a conclusion, the ultimate goal of the future esophageal stent would have multifunction to treat the underlying conditions and restore esophageal function to near normal.

Topics: Alloys; Animals; Constriction, Pathologic; Deglutition Disorders; Drug-Eluting Stents; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Esophagus; Fistula; Humans; Models, Animal; Palliative Care; Plastics; Printing, Three-Dimensional; Stainless Steel; Stents

Treatment of superficial femoral artery (SFA) lesions remains challenging. We conducted a network meta-analysis of randomized controlled trials aiming to explore the efficacy of treatment modalities for SFA "de novo" lesions.. Eleven treatments for SFA occlusive disease were recognized. We used primary patency and binary restenosis at 12-month follow-up as proxies of efficacy for the treatment of SFA lesions.. A total of 33 studies (66 study arms; 4659 patients) were deemed eligible. In terms of primary patency, odds ratios (ORs) with 95% confidence intervals (CIs) were statistically significantly higher in drug-eluting stent (DES; OR, 10.05; 95% CI, 3.22-31.39), femoropopliteal bypass surgery (BPS; OR, 7.15; 95% CI, 2.27-22.51), covered stent (CS; OR, 3.56; 95% CI, 1.33-9.53), and nitinol stent (NS; OR, 2.83; 95% CI, 1.42-5.51) compared with balloon angioplasty (BA). The rank order from higher to lower primary patency in the multidimensional scaling was DES, BPS, NS, CS, drug-coated balloon, percutaneous transluminal angioplasty with brachytherapy, stainless steel stent, cryoplasty (CR), and BA. Combination therapy of NS with CR and drug-coated balloon were the two most effective treatments, followed by NS, CS, percutaneous transluminal angioplasty with brachytherapy, cutting balloon, stainless steel stent, BA, and CR in terms of multidimensional scaling values for binary restenosis.. DES has shown encouraging results in terms of primary patency for SFA lesions, whereas BPS still maintains its role as a principal intervention. On the contrary, BA and CR appear to be less effective treatment options.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Brachytherapy; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cryotherapy; Drug-Eluting Stents; Endovascular Procedures; Femoral Artery; Humans; Network Meta-Analysis; Odds Ratio; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency; Vascular Surgical Procedures

Amassed evidence from several randomized controlled trials and high quality meta-analyses clearly support the primary use of paclitaxel-coated balloons (PCB) in the superficial femoral artery over traditional plain balloon angioplasty or primary bare nitinol stenting with significantly lower vascular restenosis, less need for repeat procedures, improved quality of life and potential cost savings for the healthcare system. Stents may be reserved for bail-out in case of a suboptimal dilatation result, and for selected more complex lesions, or in case of critical limb ischemia in order to eliminate vessel recoil and maximize immediate hemodynamic gain. Debulking atherectomy remains unproven, but holds a lot of promise in particular in combination with PCBs, in order to improve compliance of the vessel wall by plaque removal, allow for a better angioplasty result and optimize drug transfer and bioavailability. The present overview summarizes and discusses current evidence about femoropopliteal PCB angioplasty compared to the historical standard of plain old balloon angioplasty and bare nitinol stents. Available evidence is appraised in the context of clinically meaningful results, relevant unresolved issues are highlighted, and future trends are discussed.

Topics: Alloys; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Cost-Benefit Analysis; Female; Femoral Artery; Health Care Costs; Humans; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Stents; Treatment Outcome; Vascular Access Devices

In the femoropopliteal segment, endovascular revascularization techniques have gained the role as a first line treatment strategy. Nitinol stent placement has improved the short- and mid-term primary patency rates in most lesion types and is therefore widely applied. Stenting has several shortcomings as in-stent restenosis, stent fractures and foreign material being left behind in the vessel. The concept of atherectomy is plaque debulking. This results in a potential reduction of inflation pressure requirements in angioplasty. Stent placement and consecutive in-stent restenosis may be avoided. In this non systematic literature review, the performance of different atherectomy techniques, such as direct atherectomy, orbital atherectomy, laser debulking and rotational atherectomy in the treatment of complex femoropopliteal lesions, including long lesions, moderately to heavily calcified lesions as well as occlusions and in-stent restenosis, has been analyzed.

Topics: Alloys; Atherectomy; Constriction, Pathologic; Equipment Failure; Femoral Artery; Graft Occlusion, Vascular; Humans; Inguinal Canal; Lasers, Excimer; Peripheral Vascular Diseases; Popliteal Artery; Severity of Illness Index; Stents; Treatment Outcome; Vascular Calcification; Vascular Patency

The efficacy and safety of primary stenting for superficial femoral artery (SFA) disease have been benchmarked against historically derived performance goals. However, contemporary evidence evaluating SFA stenting is accumulating. The objective of this systematic review and meta-analysis was to quantitatively assess outcomes after primary SFA stenting with nitinol stents in contemporary practice, to compare these rates with commonly used efficacy and safety goals, and to discuss the clinical and regulatory implications of these findings.. We searched MEDLINE, the US Food and Drug Administration (FDA) website, reference lists of qualifying articles, and conference proceedings until October 2012. Studies prospectively assessing primary nitinol stenting for diseased SFA were sought. Data from 11 prospective clinical trials were included. The twelve-month primary patency (PP) rate was reported in five trials. The meta-analytic 12-month PP rate was 71.6% (95% confidence interval [CI] 66.4-76.7%). The meta-analytic rate of 30-day freedom from a composite of death, target limb amputation, and reintervention was 99.9% (95% CI 100.0-90.0%).. Contemporary nitinol-based bare-metal stents performed well in controlled settings. Occurrence of the 1-month composite safety endpoint was extremely uncommon.

Topics: Alloys; Constriction, Pathologic; Endovascular Procedures; Femoral Artery; Humans; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Treatment Outcome; Vascular Patency

Several randomized controlled trials (RCTs) have shown the superiority of some of these technologies over balloon angioplasty, but direct comparisons between these treatment options are lacking. The authors conducted a network meta-analysis of RCTs comparing bare nitinol stents, covered nitinol stents, paclitaxel- or sirolimus-eluting stents (PES or SES), and paclitaxel-coated balloons (PCB) with plain balloon angioplasty or with each other in the femoropopliteal artery (PROSPERO registry: CRD42013004845).. Sixteen RCTs comprising 2532 patients with 4227 person-years of follow-up were analyzed on an intention-to-treat basis. Bayesian random effects Poisson and binomial models were used for mixed treatment comparisons (WinBUGS). Clinical heterogeneity was accounted for by incorporating a meta-regression model on trial-specific baseline risk. End points included technical success, vascular restenosis, target lesion revascularization, and major amputations. Pairwise odds ratios and rate ratios (ORs and RRs) of absolute treatment effects were calculated, and the probabilities of each treatment being best are reported. Summary estimates are reported as the posterior median and associated credible intervals (CrIs) that serve the same purpose as confidence intervals in the context of the Bayesian framework. Extensive sensitivity, meta-regression, and network consistency analyses were performed to evaluate heterogeneity.. Technical success was highest with covered stents (pooled OR, 13.6; 95% CrI, 3.3-31.1, probability best 82%) followed by uncovered stents (pooled OR, 7.0; 95% CrI, 2.6-129, probability best 18%) when compared with balloon angioplasty (reference treatment). Vascular restenosis was lowest with PES (RR, 0.43; 95% CrI, 0.16-1.18, probability best 45%) followed by PCB (RR, 0.43; 95% CrI, 0.26-0.67, probability best 42%). Target lesion revascularization was lowest with PCB (RR, 0.36; 95% CrI, 0.23-0.55, probability best 56%) followed by PES (RR, 0.42; 95% CrI, 0.16-1.06, probability best 33%). Major amputations were rare in all treatment and control groups (pooled amputation rate of 0.7 events per 100 person-years).. Immediate technical success is better with the use of covered stents, whereas paclitaxel-eluting stents and paclitaxel-coated balloons offer the best long-term results in the femoropopliteal artery.

Topics: Alloys; Amputation, Surgical; Angioplasty, Balloon; Bayes Theorem; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Equipment Design; Femoral Artery; Humans; Limb Salvage; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Sirolimus; Stents; Treatment Outcome; Vascular Access Devices

The aim of this paper was to evaluate the efficacy of a novel 4-F compatible self-expanding Nitinol stent for the treatment of long femoro-popliteal obstructions.. This retrospective analysis includes patients with femoro-popliteal obstructions ≥ 120 mm in length, treated with a novel Nitinol stent (Pulsar-18) between February 2010 and December 2011. Patients were categorized as either intermittent claudication (IC) or critical limb ischemia (CLI). Primary endpoint was primary patency, secondary endpoints were target lesion revascularization (TLR).. A total of 31 patients (IC: N=18 and CLI: N=13) were included in the present series. Mean age was 73.3 ± 10.1 years and 71% (22/31) of the patients were male. Primary intervention was performed in 77.4% (24/31) of the patients and re-do revascularization in the remaining. Mean lesion length of femoro-popliteal obstructions was 163.5 ± 32.5 mm. Technical success was obtained in all patients. Mean follow-up duration was 316 ± 198 days. Primary patency rates were 83.3% in IC and 80.0% in CLI patients at 6 months and 64.1% and 54.9% at 12 months, respectively (P=0.84). Target lesion revascularization occurred in 5.6% of IC and 20.0% of CLI patients at 6 months and in 14.1% and 36.0% at 12 months, respectively (P=0.43).. Endovascular stenting of long femoro-popliteal lesions using the Pulsar-18 stent provides acceptable results with patency and restenosis rates comparable with data from literature for stenting of long femoro-popliteal obstructions.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Catheters; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Male; Middle Aged; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

To determine the efficacy and safety of balloon angioplasty (BA) with optional stenting vs. routine stenting with current open cell nitinol stents for femoropopliteal occlusive disease by analyzing the overall results from all available randomized controlled trials.. A bibliographic search of electronic medical databases (MEDLINE, Embase, ISI Web of Knowledge, and the Cochrane Central Register of Controlled Trials) was conducted to identify relevant articles from 1960 to July 2011. Of the 701 published articles retrieved, 17 clinical trials randomized patients with symptomatic femoropopliteal occlusive disease to either primary BA or primary stenting. Of these, 4 RCTs involved the use of currently employed high flexibility nitinol stents. Thirteen other trials that employed obsolete, steel, or coated stents were excluded. The technical success rate, the target lesion revascularization (TLR) rate, and the binary restenosis rate at 12 months were primary efficacy endpoints; mortality was the primary safety endpoint. The results are reported as the odds ratio (OR) with 2-tailed 95% confidence intervals (95% CI).. The study population was made up of 627 patients (416 men; mean age 67±10 years) and 665 lesions (361 assigned to the primary stenting and 304 to BA). The mean length of the treated lesion was similar in both groups (74.6±45.7 mm in the stenting group vs. 66.7±41.3 mm in the BA group). Technical success was significantly higher in the stenting group compared to BA (95.8% vs. 64.2%; OR 0.31, 95% CI 0.09 to 0.92, p<0.001). Follow-up ranged from 12 to 24 months. Based on 3 studies, the TLR at 12 months favored the stent group (OR 2.47, 95% CI 0.72 to 8.49, p=0.065), but the difference did not reach statistical significance. However, the 12-month binary restenosis rate was significantly lower in the primary stenting group (OR 3.02, 95% CI 1.3 to 6.71, p<0.001). With respect to the safety endpoint, mortality was similar in both groups (OR 0.83, 95% CI 0.39 to 1.77, p<0.001).. This meta-analysis supports the use of the primary stenting, mainly for long lesions, as a first-line endovascular treatment for symptomatic disease in the femoropopliteal segment, contrary to indications for use in current clinical guidelines.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Evidence-Based Medicine; Female; Femoral Artery; Humans; Male; Middle Aged; Odds Ratio; Popliteal Artery; Prosthesis Design; Randomized Controlled Trials as Topic; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome

The 1- to 2-year primary patency rates associated with self-expanding nitinol stents for the treatment of symptomatic femoropopliteal disease are superior to those for percutaneous transluminal angioplasty (PTA) and the first-generation stainless steel balloon-expandable stents. The advantages of nitinol stents include improved radial strength and flexibility, the ability to recover from being crushed, reduced foreshortening, and (importantly) deployability without balloon dilation of the stent edge (which may decrease the incidence of the edge stenosis, or "candy-wrap" effect, often observed with balloon-expandable stents). The technical success rate associated with primary deployment of nitinol stents is very high, and acute to 6-month patency results are predictably excellent. Prior to the introduction of nitinol stents, the original guidelines (2000) of the multidisciplinary TransAtlantic Inter-Society Consensus (TASC I) recommended only an adjunctive role for femoropopliteal stents following suboptimal PTA. The abbreviated 2007 TASC II report essentially extended this recommendation to nitinol stents. Here, current trials of nitinol stenting in the femoropopliteal segment are discussed, with emphasis on the advantages of primary (and often direct) deployment in selected circumstances dependent on factors including lesion length, lesion location, indication for treatment (critical limb ischemia or claudication, in-stent restenosis, stent-graft restenosis), and the relative appropriateness of other modalities (e.g., covered stents). Technical considerations in primary nitinol stenting are briefly reviewed. Open questions regarding the factors involved in nitinol stent fracture and the possible association of fracture and restenosis are examined in the context of current clinical trials. A new generation of femoropopliteal nitinol stents combining superior durability and flexibility is expected soon. Development and implementation of uniform reporting and surveillance standards is important for optimizing current and future research.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Femoral Artery; Humans; Popliteal Artery; Practice Guidelines as Topic; Prosthesis Design; Prosthesis Failure; Radiography; Recurrence; Risk Assessment; Stents; Time Factors; Treatment Outcome; Vascular Patency

Despite technical advances in balloon design and technique, there has been little improvement of primary patency rates after balloon-based endovascular interventions for all but focal femoropopliteal lesions. Improving on stainless steel models, nitinol stents have been associated with favorable short- and midterm primary patency rates; studies with longer-term follow-up will be required to learn whether restenosis is ongoing, with continued loss of primary patency. Studies in recent years have shown varying incidences of mechanical fatigue leading to nitinol stent fracture. Covered stents are designed to prevent the tissue infiltration and intimal hyperplasia that can lead to bare metal in-stent restenosis. Several clinical studies, mainly single-center registries, have demonstrated a general effectiveness of the Hemobahn/Viabahn polytetrafluoroethylene-covered stent-grafts, approved for femoral arterial occlusive disease, and have helped to distinguish indications for use and to delineate possible failure modes. A multicenter randomized trial, which has completed enrollment, will compare the Viabahn with self-expanding bare nitinol stents. The primary use of drug-eluting stents (DES) has become routine clinical practice for coronary artery disease. The 2-phase multicenter randomized double-blind SIROCCO trials have been completed, with results published through 24 months. Follow-up demonstrated the feasibility and safety of deploying sirolimus-eluting stents in the femoropopliteal segment but failed to show superior efficacy for DES versus bare nitinol stents. However, the restenosis rates with bare metal stents were unexpectedly low. A paclitaxel-eluting stent without a polymer coating is currently being evaluated in the recently enrolled Zilver PTX randomized trial and international registry. A polymer-based everolimus-eluting stent is being evaluated for femoropopliteal use in the nonrandomized European STRIDES trial. Balloons coated with paclitaxel have recently been evaluated for simple femoropopliteal disease with encouraging results through 2 years of follow-up. The bioabsorbable stent concept emerged in response to the potential issues with metal stents, but to date no investigational device has successfully overcome issues such as relatively low radial force and variable degradation rates.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Drug-Eluting Stents; Femoral Artery; Humans; Metals; Multicenter Studies as Topic; Polytetrafluoroethylene; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Randomized Controlled Trials as Topic; Recurrence; Stents; Time Factors; Treatment Outcome; Vascular Patency

Endovascular stent implantation was introduced to femoropopliteal procedures almost two decades ago. Initial results with balloon-expandable stainless steel stents and self expanding Elgiloy stents, however, were disappointing. In particular, recurrence rates after long-segment femoropopliteal stenting were rather high, in the range of 60% to 80% at 1 year. After years of stagnation, recent developments in femoropopliteal stent technology have been promising. Self-expanding nitinol stents have been evaluated in several prospective studies. Initial problems with stent fractures seem to be resolved using second-generation devices. The second generation of Nitinol stents have an enhanced flexibility particularly also in axial direction due to a reduction of cell interconnections and a more spiral orientation of the interconnections. However, until now there is no proof of any impact of the stent design on restenosis rate. Otherwise, stenting has been shown to be beneficial compared to balloon angioplasty especially in longer femoropopliteal lesions. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The main unresolved problem with femoropopliteal stenting is the treatment of instent restenosis. Future concepts to further improve long-term patency after femoropopliteal stenting are therefore under investigation, including drug-eluting stents (DES), biodegradable stents, and coated stent-grafts. Stent grafts appear to be a viable option for the treatment of complex superficial femoral artery lesions, with comparable outcomes to prosthetic above-knee femoropopliteal bypass surgery. Concerning DES, we have to wait for the results of the ongoing studies.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Constriction, Pathologic; Drug-Eluting Stents; Femoral Artery; Humans; Male; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Radiography; Recurrence; Stents; Treatment Outcome

Post-pneumonectomy syndrome is an unusual condition, that can occur a variable period of time after a patient has had a pneumonectomy. Management of this syndrome has been described using a number of different techniques, often with considerable mortality. We present a case report where this condition was treated successfully by insertion of an expandable Nitinol stent. This is the first time this technique has been described to treat this condition, and we feel it may be the procedure of choice in managing these patients.

Topics: Alloys; Bronchi; Bronchography; Constriction, Pathologic; Dyspnea; Female; Humans; Middle Aged; Pneumonectomy; Stents; Syndrome; Time Factors; Tomography, X-Ray Computed

Optimal stenting strategy for long femoropopliteal artery lesions still remains undefined. Longer stent length has been shown to be associated with increased risk of restenosis. We sought to compare the efficacy of spot versus long stenting in the treatment of femoropopliteal artery disease.. This study was designed as a multicenter randomized controlled trial to compare immediate and mid-term outcomes of spot versus long primary stenting for femoropopliteal arterial lesions. A total of 125 patients were randomized 1:1 to spot stenting group (n = 59) or long stenting group (n = 66).. All lesions were treated with self-expanding bare nitinol stents. Baseline clinical and lesion characteristics were similar between the 2 groups except for male gender and current smoker. The mean lesion length was 24.1 ± 8.8 cm. Technical success was achieved in all patients. The 1-year primary patency and TLR-free (target lesion revascularization) survival did not differ significantly between the 2 groups. However, the spot stenting group showed a trend toward higher primary patency (86.1% vs. 72.7%, P = 0.158) and TLR-free survival (94.2% vs. 82.5%, P = 0.120). The total stented length (hazard ratio [HR] 1.01, 95% confidence interval [CI] 1.00-1.01, P = 0.011) and age (HR 0.94, 95% CI 0.90-1.00, P = 0.035) were independent predictors of restenosis.. The spot stenting appears to be more favorable than the long stenting in terms of primary patency and TLR-free survival, although the difference was not statistically significant. The stented length was an independent predictor of restenosis.

Topics: Aged; Alloys; Angioplasty, Balloon; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prosthesis Design; Recurrence; Republic of Korea; Risk Factors; Self Expandable Metallic Stents; Time Factors; Vascular Patency

The objective of this study was to assess the safety and efficacy of a dedicated venous stent (the VICI VENOUS STENT; VENITI, Fremont, Calif) for treatment of symptomatic iliofemoral venous outflow obstruction.. Thirty patients (24 female; median age, 43 years) were enrolled in the feasibility phase of an international, multicenter investigational device exemption trial from June 2014 to February 2015. All patients exhibited unilateral venous disease with ≥50% stenosis in the iliofemoral veins. Patients within 3 months of acute deep venous thrombosis or with prior surgical or endovascular intervention of the target vessel were excluded. Lesions were primarily of post-thrombotic causes (63%), with a left limb-right limb ratio of 5:1. Nine patients (30%) had lesions extending beneath the inguinal ligament. Median baseline stenosis was 91%; 11 patients (37%) had occlusions.. Fifty-one stents were implanted successfully in 30 patients. Median residual stenosis was 0%, as estimated by venography and intravascular ultrasound. Median follow-up was 701 days. At 12 months, primary, assisted-primary, and secondary patency was 93%, 96%, and 100%, respectively. The stent occluded in two patients through the 12-month window (occurring at 19 and 385 days). Both occlusions occurred in patients presenting with post-thrombotic obstruction. No patients in this cohort exhibited stent fracture at 12 months. Symptomatic improvement of ≥2 points on the Venous Clinical Severity Score was observed in 23 patients (85%) at 12 months (median score improvement, 5 points). There was a median 12-month pain reduction of 20 mm on the visual analog scale score and 15-point improvement on the Chronic Venous Insufficiency Questionnaire score. Scores improved significantly on all three clinical and quality of life scales at 6 and 12 months.. The VICI VENOUS STENT is safe and feasible for treatment of symptomatic iliofemoral venous obstruction, with excellent 12-month patency rates and significant improvement seen in clinical symptoms and quality of life indices. The pivotal phase (170 patients, 22 centers) of this investigational device exemption trial is currently ongoing.

Topics: Adult; Aged; Alloys; Constriction, Pathologic; Endovascular Procedures; Europe; Feasibility Studies; Female; Femoral Vein; Humans; Iliac Vein; Male; Middle Aged; Pain Measurement; Peripheral Vascular Diseases; Phlebography; Prospective Studies; Prosthesis Design; Quality of Life; Self Expandable Metallic Stents; Severity of Illness Index; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States; Vascular Patency; Young Adult

To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long.. The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI).. Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months.. In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Belgium; Cardiovascular Agents; Constriction, Pathologic; Critical Illness; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Self-expanding nitinol stents must be oversized at least by a minimal amount to ensure contact with the vessel wall and prevent migration. Once the stent is deployed it exerts a continuous force upon the vascular wall, termed chronic outward force (COF). Animal studies have found an increased neointimal hyperplasia in stents with high oversizing and thus high COF. Data about correlation between COF and neointimal hyperplasia in humans are currently lacking. The objective of the BIOFLEX-COF trial is to prospectively investigate differences in formation of intimal hyperplasia at 1 and 2 years after implantation of nitinol stents with high versus low COF in de novo femoropopliteal occlusive arterial lesions.. The BIOFLEX-COF trial is a prospective, quantitative, randomized study. Eighty subjects with symptomatic peripheral arterial lesions eligible for endovascular stent implantation will be enrolled and randomly assigned to either a high COF group (LifeStent Flexstar, Bard Peripheral Vascular Inc., Tempe, AZ, USA) or low COF group (Pulsar, Biotronik AG, Bülach, Switzerland) using an online randomization program to generate a random 1:1 group allocation (block randomization). After implantation and dilatation, COF at every 2 mm along the stent axis will be calculated from the actual stent diameter versus its nominal diameter. There will be two follow-up evaluations at 12 and 24 months. Primary endpoint is the amount of in-stent neointima at 1 year, assessed by contrast-enhanced CT angiography (CTA). In the control examinations, stent diameter and true lumen diameter will be measured on DICOM images every 2 mm along the stent axis to quantify the relative amount of in-stent restenosis. Secondary objectives are the amount of in-stent neointima at 2 years, device- and procedure-related adverse events and target lesion revascularization (TLR) rate. The scheduled time for recruitment is 2 years. Recruitment is expected to be complete in October 2017.. This trial is the first to prospectively investigate the influence of COF on stent patency. If successful, the results will aid in a more precise selection of stent type and size in a given target vessel. The present study is challenging in that it compares two different self-expanding nitinol stents head-to-head against each other. To optimize the power of this study, traditional binary outcome parameters such as TLR and restenosis at Doppler ultrasound were dropped as primary endpoints. Instead, the amount of neointima inside the stent accessed by CTA was selected as (continuous) outcome parameter.. ClinicalTrials.gov Identifier: NCT03097679 . Date of registration: 14 March 2017 (retrospectively registered).

Topics: Alloys; Austria; Clinical Protocols; Computed Tomography Angiography; Constriction, Pathologic; Endovascular Procedures; Femoral Artery; Humans; Neointima; Peripheral Arterial Disease; Popliteal Artery; Pressure; Prospective Studies; Prosthesis Design; Recurrence; Research Design; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

To report the 12-month results of the MAJESTIC clinical study of the self-expanding Eluvia paclitaxel-eluting stent in the treatment of femoropopliteal lesions.. The prospective, single-arm, multicenter trial (clinicaltrials.gov identifier NCT01820637) enrolled 57 patients (mean age 69±9 years; 47 men) with chronic lower limb ischemia referable to de novo or restenotic lesions in the native superficial femoral and/or proximal popliteal arteries. A third of the patients had diabetes. Mean lesion length was 70.8±28.1 mm, and diameter stenosis was 86.3%±16.2%; 26 (46%) lesions were occluded. Primary patency was defined as duplex ultrasound peak systolic velocity ratio ≤2.5 and the absence of target lesion revascularization (TLR) or bypass. Major adverse events (MAEs) included all-cause death through 1 month and target limb major amputation and TLR through 12 months.. All 57 patients had a single Eluvia stent implanted, employing pre- and postdilation in 93% (53/57) and 95% (54/57) of cases, respectively. Technical success was 97% (55/57; 2 failures due to residual stenosis >30%). At 12 months, primary patency was 96% (49/51) and the MAE rate was 4% (2/53); both MAEs were TLRs. No stent fractures were identified. There were no major amputations. One death occurred 368 days postprocedure, unrelated to the device or procedure. Improvements in the Rutherford category were sustained through 1 year, with 81% (43/53) exhibiting no symptoms (category 0) and 13% (7/53) presenting with mild claudication (category 1). Mean ABI improved from 0.73±0.22 at baseline to 1.02±0.20 at 12 months.. MAJESTIC results showed that patients whose femoropopliteal arteries were treated with the Eluvia drug-eluting stent sustained high patency and low MAE rates through 12 months.

Topics: Aged; Alloys; Ankle Brachial Index; Australia; Blood Flow Velocity; Cardiovascular Agents; Chronic Disease; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; New Zealand; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Regional Blood Flow; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The self-expandable COMPLETE™ stent (Medtronic) has greater elasticity, allowing it to regain its shape after the compression force reduces, and has higher trackability, thus is easier to maneuver through tortuous vessels, whereas the balloon-expandable SCUBA™ stent (Medtronic) has higher radial stiffness and can afford more accurate placement without geographic miss, which is important in aortoiliac bifurcation lesions. To date, there have been no randomized control trials comparing efficacy and safety between the self-expanding stent and balloon-expandable stent in advanced atherosclerotic iliac artery disease.. The purpose of our study is to examine primary patency (efficacy) and incidence of stent fracture and geographic miss (safety) between two different major representative stents, the self-expanding nitinol stent (COMPLETE-SE™) and the balloon-expanding cobalt-chromium stent (SCUBA™), in stenotic or occlusive iliac arterial lesions. This trial is designed as a prospective, randomized, multicenter trial to demonstrate a noninferiority of SCUBA™ stent to COMPLETE-SE™ stent following balloon angioplasty in iliac arterial lesions, and a total of 280 patients will be enrolled. The primary end point of this study is the rate of primary patency in the treated segment at 12 months after intervention as determined by catheter angiography, computed tomography angiography, or duplex ultrasound.. The SENS-ILIAC trial will give powerful insight into whether the stent choice according to deployment mechanics would impact stent patency, geographic miss, or stent fracture in patients undergoing stent implantation in iliac artery lesions.. National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT01834495 ), registration date: May 8, 2012.

Topics: Alloys; Angioplasty, Balloon; Chromium Alloys; Clinical Protocols; Constriction, Pathologic; Elasticity; Humans; Iliac Artery; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Prosthesis Failure; Republic of Korea; Research Design; Self Expandable Metallic Stents; Stents; Time Factors; Treatment Outcome; Vascular Patency

To assess safety and efficacy of the S.M.A.R.T. Vascular Stent System (Cordis Corp, Fremont, California) in obstructive superficial femoral artery (SFA) disease.. The single-arm, multicenter STROLL study (S.M.A.R.T. Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease) included 250 patients (250 lesions in SFA or proximal popliteal artery). The efficacy endpoint was primary patency defined by freedom from binary restenosis (peak systolic velocity ratio > 2.5) as derived by duplex ultrasound plus clinically driven target lesion revascularization (TLR) at 12 months.. Mean age of patients was 67.7 years ± 10.3; 47.2% of patients had diabetes; distribution of Rutherford/Becker classes 2, 3, and 4 was 45.8%, 51.4%, and 2.8%. Mean lesion length and reference vessel diameter were 77.3 mm ± 35.3 and 4.9 mm ± 0.7, respectively (23.6% cases with total occlusions). The 30-day freedom from major adverse events (death, index limb amputation, clinically driven TLR) was 100%. The 1-year primary patency was 81.7% by Kaplan-Meier estimate. The presence of diabetes or total occlusion had no effect on primary patency. Ankle-brachial index was 0.4-0.8 in 84.6% of patients at baseline and improved to > 0.8 in 81.0% of patients at 12 months. The proportion of patients in Rutherford/Becker class 3-4 was reduced from 54.2% at baseline to 8.0% at 12 months. Four patients (2.0%) experienced single-stent strut fracture (type I) at 1 year, without associated loss of stent patency.. The S.M.A.R.T. Vascular Stent System proved to be safe and effective for endovascular treatment of obstructive SFA and proximal popliteal artery disease, based on 1-year vessel patency and associated hemodynamic and clinical improvements.

Topics: Aged; Alloys; Atherosclerosis; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Peripheral Arterial Disease; Stents; Treatment Outcome; Ultrasonography, Interventional

The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR).. Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging.. The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure.. Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74).. The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

Topics: Aged; Alloys; Amputation, Surgical; Angioplasty, Balloon; Atherectomy; Chronic Disease; Combined Modality Therapy; Constriction, Pathologic; Female; Femoral Artery; Humans; Laser Therapy; Lasers, Excimer; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency

To report the 1-year results of a pivotal study for a new-generation nitinol stent for the treatment of iliac atherosclerotic lesions.. The ORION trial (ClinicalTrials.gov identifier NCT00896337) was a single-arm, non-randomized, prospective, multicenter clinical trial that enrolled 125 patients (81 men; mean age 61.1±9.3 years) implanted with the EPIC self-expanding nitinol stent system in 166 de novo or restenotic iliac artery lesions ≤13 cm long. The primary endpoint was the 9-month major adverse event rate [i.e., device- or procedure-related death within 30 days, myocardial infarction during the index hospitalization, target vessel revascularization (TVR), or index limb amputation]. Follow-up occurred at hospital discharge and at 1, 9, and 12 months. An independent core laboratory evaluated ultrasound results at 1, 9, and 12 months.. The primary endpoint met the prespecified performance goal, with only 3.4% (4/117) of patients experiencing a major adverse event by 9 months (p<0.0001). By 12 months, 6 (5.4%) of 111 patients had TVR; none had an index limb amputation. The ankle-brachial index, Walking Impairment Questionnaire, and Rutherford classifications all showed sustained improvements through 12 months. Primary patency was 94.4% with comparable results for lesions classified as complex (TASC II C/D 95.5%) or non-complex (TASC II A/B 95.0%).. The EPIC stent system demonstrated safety and effectiveness through 12 months, including improvements for complex lesions. The EPIC stent is a viable alternative to surgery for patients with either complex or non-complex lesions.

Topics: Aged; Alloys; Ankle Brachial Index; Constriction, Pathologic; Disability Evaluation; Endovascular Procedures; Female; Humans; Iliac Artery; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Interventional; United States; Vascular Patency

This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR).. ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR.. This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVER-PTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents.. Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≥3; at 2 years, 60.9% of patients had Rutherford scores ≤1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified.. Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Canada; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Europe; Exercise Test; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Prosthesis Failure; Recurrence; Registries; Republic of Korea; Risk Factors; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Patency

Restenosis after percutaneous transluminal angioplasty (PTA) of the superficial femoral artery (SFA) may occur in 45% of patients at 2 years follow-up. Paclitaxel-coated balloons have been found to reduce neointimal hyperplasia, and thus reduce restenosis. Recently, the Legflow(®) paclitaxel-coated balloon (Cardionovum Sp.z.o.o., Warsaw, Poland) (LPEB) has been introduced. This balloon is covered with shellac, a Food and Drug Administration (FDA) approved natural resin, to obtain an equally distributed tissue concentration of paclitaxel. The RAPID trial is designed to assess restenosis after PTA using the Legflow balloon combined with nitinol stenting versus uncoated balloons with nitinol stenting in SFA lesions >5 cm.. A total of 176 adult patients with Rutherford class 2 to class 6 symptoms due to intermediate (5-15 cm) or long (>15 cm) atherosclerotic lesions in the SFA will be randomly allocated for treatment with LPEB with nitinol stenting or uncoated balloon angioplasty with stenting. Stenting will be performed using the Supera(®) stent in both groups (IDEV Technologies Inc., Webster, TX). The primary endpoint is the absence of binary restenosis of the treated SFA segment. Secondary outcomes are target lesion revascularization (TLR), clinical and hemodynamic outcome, amputation rate, mortality rate, adverse events, and device-specific adverse events. Follow up consists of four visits in which ankle-brachial indices (ABI), toe pressure measurements, and duplex ultrasound (DUS) will be performed. Furthermore, a peripheral artery questionnaire (PAQ) will be completed by the patients at each follow-up. In the event that DUS reveals a symptomatic >50% restenosis, or a >75% asymptomatic restenosis, additional digital subtraction angiography will be performed with any necessary re-intervention.. The RAPID trial is a multicenter randomized controlled patient blind trial that will provide evidence concerning whether the use of the Legflow paclitaxel/shellac coated balloons with nitinol stenting significantly reduces the frequency of restenosis in intermediate and long SFA lesions compared to standard PTA and stenting.. ISRCTN47846578.

Topics: Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Clinical Protocols; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Equipment Failure; Femoral Artery; Hemodynamics; Humans; Hyperplasia; Limb Salvage; Neointima; Netherlands; Paclitaxel; Predictive Value of Tests; Prosthesis Design; Prosthesis Failure; Recurrence; Research Design; Resins, Plant; Single-Blind Method; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Access Devices

Angioplasty and stenting are options for revascularization of symptomatic femoral popliteal disease. Although angioplasty alone is effective in short lesions, longer lesions are often treated with stents. Multiple overlapping stents are expensive and may be associated with stent fracture. This trial evaluated the safety and efficacy of a single self-expanding stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery.. Patients with lesions >4 cm and <18 cm were enrolled in this nonrandomized, prospective, multicenter trial that evaluated the Protégé EverFlex Self-Expanding Peripheral Stent System (Covidien, Plymouth, Minn). The study's primary end points were the 30-day major adverse event rate and duplex ultrasound-assessed patency at 1 year. These were compared with published performance goals. A preplanned analysis was conducted for the primary effectiveness end points at 1 year. Follow-up, including history, ankle-brachial index, patient-reported outcomes, duplex ultrasound assessment, and radiographs, is planned through 3 years. There was core laboratory review of angiograms, ultrasound scans, and plain radiographs. A subgroup of patients was studied with graded treadmill testing.. The study enrolled 287 patients (66% male; mean age, 68 years) with stenotic, restenotic, or occluded lesions of the SFA at 44 investigational sites in the United States and Europe. Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%), and prior SFA intervention (41%). The mean lesion length measured by the core laboratory was 89 mm. The mean normal-to-normal lesion length measured by sites was 110 mm. A total of 303 stents were implanted, and 95% of patients received a single stent. No major adverse events occurred at 30 days. At 1 year, primary outcome of duplex ultrasound stent patency was 67.7% in evaluable patients, and among 1-year secondary outcomes, the mean ankle-brachial index increased by 0.25. Walking Improvement Questionnaire scores improved in pain by 33.7, distance by 37.1, speed by 18.6, and stair climbing by 24.7. The Kaplan-Meier estimate of primary patency was 77.2%, primary assisted patency was 86.9%, and secondary patency was 87.3%. Rutherford clinical category improved in 83.5% of patients. Stent fracture rate was 0.4%. Matched absolute claudication distance was 412 feet greater and was not statistically different in this subgroup of 29 individuals.. The results of DURABILITY II (StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protégé EverfLex NitInol Stent SYstem II) suggest that a new single stent strategy is safe and effective for the treatment of long lesions of the SFA and proximal popliteal arteries at 1 year.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Chi-Square Distribution; Constriction, Pathologic; Disease-Free Survival; Europe; Exercise Test; Exercise Tolerance; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States; Vascular Patency

It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy for femoropopliteal lesions, also reduces angiographic restenosis.. The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study investigated whether cilostazol reduces the 12-month angiographic restenosis rate after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. Two hundred patients with femoropopliteal lesions treated from March 2009 to April 2011 at 13 cardiovascular centers were randomly assigned 1:1 to receive oral aspirin with or without cilostazol. The primary end point was 12-month angiographic restenosis rate. Secondary end points were the restenosis rate on duplex ultrasound, the rate of major adverse cardiac events, and target lesion event-free survival. Researchers evaluated all follow-up data and assessed the end points in a blinded fashion. The mean lesion length and reference vessel diameter at the treated segment were 128±86 mm and 5.4±1.4 mm, respectively. The frequency of stent used was similar between groups (88% versus 90% in the cilostazol and noncilostazol group, respectively, P=0.82). During the 12-month follow-up period, 11 patients died and 152 patients (80%) had evaluable angiographic data at 12 months. The angiographic restenosis rate at 12 months was 20% (15/75) in the cilostazol group versus 49% (38/77) in the noncilostazol group (P=0.0001) by intention-to-treat analysis. The cilostazol group also had a significantly higher event-free survival at 12 months (83% versus 71%, P=0.02), although cardiovascular event rates were similar in both groups.. Cilostazol reduced angiographic restenosis after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions.. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00912756; and URL: https://www.umin.ac.jp. Unique identifier: UMIN000002091.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Aspirin; Cardiovascular Diseases; Cilostazol; Constriction, Pathologic; Disease-Free Survival; Drug Therapy, Combination; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Prospective Studies; Radiography; Recurrence; Single-Blind Method; Stents; Tetrazoles; Ultrasonography; Vasodilator Agents

The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation.. One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention.. The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups.. The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Graft Occlusion, Vascular; Hemodynamics; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polytetrafluoroethylene; Prosthesis Design; Prosthesis Failure; Quality of Life; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency

This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis.. PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma.. A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach.. Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach.. Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Disease-Free Survival; Equipment Design; Female; Femoral Artery; Humans; Italy; Kaplan-Meier Estimate; Limb Salvage; Male; Paclitaxel; Peripheral Arterial Disease; Prospective Studies; Radiography; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Angioplasty and stenting using nitinol stents is a recognized treatment option for intracranial atherosclerosis.. To identify procedure-related factors that may affect patient safety and technical outcome.. In this prospective study of 57 consecutive patients, the primary end points were intraprocedural technical problems, periprocedure morbidity, and complications. Major periprocedure complication was defined as all stroke or death at 30 days. Technical failure was defined as the inability to complete the procedure because of technical or safety problems. Procedure failure was defined as a procedure outcome of technical failure or major periprocedure complication. Secondary end points were procedure-related factors that may affect patient safety and technical outcome.. Procedure failure rate was 12.3% (7/57) (major periprocedure complication rate, 5.3% [3/57]; technical failure rate, 7% [4/57]). Initial failure in tracking of balloon or stent occurred in 20 patients, other technical problems occurred in 11 patients, including kinking or trapping of balloon catheter (2 cases), difficulty in unsheathing of stent (3 cases), forward migration of stent during deployment (4 cases), trapping of nose cone after stent deployment (1 case), fracture of delivery system (2 cases), and guidewire fracture (1 case). Unfavorable vascular morphology signified by the presence of 2 or more reverse curves along the access path was found to associate with initial failure in the tracking of instruments (OR = ∞), and occurrence of other technical problems (OR = 25).. Procedure-related factors could be identified and lead to improvements in patient safety and technical outcome. Tortuous vascular morphology is a key factor to be overcome.

Topics: Aged; Alloys; Angioplasty; Angioplasty, Balloon; Cerebral Arteries; Constriction, Pathologic; Equipment Failure; Female; Humans; Intracranial Arteriosclerosis; Male; Middle Aged; Patient Safety; Postoperative Complications; Process Assessment, Health Care; Prospective Studies; Radiography; Stents; Treatment Outcome

To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty.. Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment.. The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented.. In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chi-Square Distribution; Constriction, Pathologic; Europe; Female; Femoral Artery; Humans; Intermittent Claudication; Kaplan-Meier Estimate; Male; Middle Aged; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Radiography; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States; Vascular Patency

Topics: Alloys; Cholangitis; Cholestasis, Extrahepatic; Common Bile Duct Diseases; Constriction, Pathologic; Device Removal; Female; Follow-Up Studies; Humans; Liver Function Tests; Male; Middle Aged; Pancreatitis, Chronic; Polytetrafluoroethylene; Prosthesis Failure; Recurrence; Silicones; Stents

This study investigated the results with primary stenting using the Protégé EverFlex 200-mm-long self-expanding nitinol stent (ev3 Endovascular Inc, Plymouth, Minn) in femoropopliteal TransAtlantic Inter-Society Consensus (TASC) C and D lesions of at least 150 mm in length.. Between March 2008 and June 2009, 100 patients (66 men) presenting with 100 symptomatic TASC C and D femoropopliteal lesions were treated with at least one 200-mm-long Protégé EverFlex stent. The intention of this study was to treat all lesions with as few stents as possible. The primary study end point was primary patency at 12 months, defined as the absence of hemodynamically significant stenosis on duplex ultrasound imaging (systolic velocity ratio <2.4) at the target lesion and without target lesion revascularization (TLR) ≤12 months. Stent fracture occurrence was assessed at the 12-month follow-up by conventional x-ray imaging.. Average patient age was 70 years. Preoperative symptom assessment reported 71 patients (71%) had claudication vs 29 (29%) with critical limb ischemia. Average lesion length was 242 mm (range, 160-450 mm), and 27 patients (27%) presented with popliteal involvement. A total of 158 Protégé EverFlex stents were used to treat 100 lesions. Kaplan-Meier estimation reported a 12-month freedom from target lesion revascularization of 68.2% and a primary patency rate of 64.8%. Stent fractures occurred in six patients (6.0%) when x-ray images taken immediately after the procedure were compared with those taken after 1 year.. The results of our Durability-200 study show an acceptable primary patency rate after 1 year was obtained in this patient cohort with TASC C and D femoropopliteal lesions.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Belgium; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Popliteal Artery; Prospective Studies; Prosthesis Design; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

This is a randomized prospective study comparing the treatment of superficial femoral artery occlusive disease percutaneously with an expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent graft (stent graft) versus surgical femoral to above-knee popliteal artery bypass with synthetic graft material.. One hundred limbs in 86 patients with superficial femoral artery occlusive disease were evaluated from March 2004 to May 2005. Patient symptoms included both claudication and limb threatening ischemia with or without tissue loss. Trans-Atlantic InterSociety Consensus (TASC II) A (n = 18), B (n = 56), C (n = 11), and D (n = 15) lesions were included. Patients were randomized prospectively into one of two treatment groups; a percutaneous treatment group (group A; n = 50) with angioplasty and placement of one or more stent grafts, or a surgical treatment group (group B; n = 50) with a femoral to above-knee popliteal artery bypass using synthetic conduit (Dacron or ePTFE). Patients were followed for 48 months. Follow-up evaluation included clinical assessment, physical examination, ankle-brachial indices, and color flow duplex sonography at 3, 6, 9, 12, 18, 24, 36, and 48 months.. Mean total lesion length of the treated arterial segment in the stent graft group was 25.6 cm (SD = 15 cm). The stent graft group demonstrated a primary patency of 72%, 63%, 63%, and 59% with a secondary patency of 83%, 74%, 74%, and 74% at 12, 24, 36, and 48 months, respectively. The surgical femoral-popliteal group demonstrated a primary patency of 76%, 63%, 63%, and 58% with a secondary patency of 86%, 76%, 76%, and 71% at 12, 24, 36, and 48 months, respectively. No statistical difference was found between the two groups with respect to primary (P = .807) or secondary (P = .891) patency.. Management of superficial femoral artery occlusive disease with percutaneous stent grafts exhibits similar primary patency at 4-year (48 month) follow up when compared with conventional femoral-popliteal artery bypass grafting with synthetic conduit. This treatment method may offer an alternative to treatment of the superficial femoral artery segment for revascularization when prosthetic bypass is being considered or when autologous conduit is unavailable.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty; Ankle Brachial Index; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polyethylene Terephthalates; Polytetrafluoroethylene; Popliteal Artery; Prospective Studies; Prosthesis Design; Reoperation; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; United States; Vascular Patency

Recent randomized trials investigating stent implantation compared with balloon angioplasty for treatment of superficial femoral artery (SFA) disease have given divergent results in short (mean 5 cm) and intermediate (mean 10 cm) lesions. We reinvestigated whether primary nitinol stenting is associated with a morphologic and clinical benefit when compared with percutaneous transluminal angioplasty with optional stenting (PTA) in intermediate-length lesions.. We randomly assigned 73 patients with severe claudication or chronic limb ischemia and average 8 cm long (range 3-20 cm) SFA stenosis or occlusion to primary stent implantation (n = 34) or PTA (n = 39). Restenosis >50% and clinical outcome were assessed at 3, 6, and 12 months postintervention.. Average length of the treated segments was 98 + or - 54 mm and 71 + or - 43 mm in the stent and PTA groups (P = 0.011), respectively. In the PTA group, secondary stenting was performed in 10 of 39 patients (26%) due to a suboptimal result after balloon dilation. Restenosis rates in the stent and PTA groups were 21.9% versus 55.6% (P = 0.005) at 6 months by CT-angiography, and 2.9% versus 18.9% (P = 0.033), 18.2% versus 50.0% (P = 0.006), and 34.4% versus 61.1% (P = 0.028) at 3, 6, and 12 months by sonography, respectively. Clinically, patients in the stent group reported a significantly higher maximum walking capacity compared with the PTA group at 6 and 12 months.. In this randomized multicenter trial, primary stenting with a self-expanding nitinol stent for treatment of intermediate length SFA disease resulted morphologically and clinically superior midterm results compared with balloon angioplasty with optional secondary stenting.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Austria; Constriction, Pathologic; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Prospective Studies; Prosthesis Design; Recovery of Function; Recurrence; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency; Walking

Early recurrent stenosis of the cephalic arch in autogenous arteriovenous access for hemodialysis is a common problem that requires stenting to prevent thrombosis. Because the results of stenting are unsatisfactory, we compared the efficacy of stent grafts with bare stents in these patients.. All patients who presented with recurrent cephalic arch stenosis >50% within 3 months of successful balloon angioplasty were randomized to have angioplasty and stenting with either a bare nitinol stent or a stent graft. Outcome was assessed by angiography 3 months later. Restenosis was defined as >50% narrowing of the stent lumen or of the vessel margin up to 0.5 cm adjacent to the stent. There were no exclusions.. This report includes data on the outcome of 25 consecutive patients with recurrent cephalic arch stenosis who were treated from April to August 2006. At 3 months, three patients had died and one had undergone a renal transplant. The 21 patients who had angiography at 3 months had patent stents. Restenosis rates were seven of 10 (70%) in the bare stent group and two of 11 (18%) in the stent graft group (P = .024). Life-table analysis at 3 and 6 months showed that primary patency was 82% in the stent graft group and 39% in the bare stent group. One-year primary patency was 32% in the stent graft group and 0% in the bare stent group (P = .0023). During a mean follow-up of 13.7 months, nine patients died, four in the bare stent group and five in the stent graft group. Two patients in the stent graft group had received a renal transplant. The number of interventions per patient-year was 1.9 in the bare stent group and 0.9 in the stent graft group (P = .02).. The use of stent grafts in angioplasty for recurrent cephalic arch stenosis significantly improved short-term restenosis rates and long-term patency compared with the use of bare stents. The significant improvement that emerged during the study caused accrual of patients to be halted for ethical reasons. This study altered our usage of stents for venous stenoses in arteriovenous accesses by eliminating bare nitinol stents in favor of stent grafts.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis; Brachiocephalic Veins; Constriction, Pathologic; Female; Follow-Up Studies; Humans; Kidney Failure, Chronic; Male; Middle Aged; Prospective Studies; Recurrence; Renal Dialysis; Stents; Treatment Outcome; Ultrasonography, Doppler; Vascular Diseases

The purpose of this study was to evaluate the long-term results of iliac artery stent placement with use of the symphony stent for the treatment of patients with intermittent claudication. In a prospective study, 31 cases of iliac occlusive arterial disease were treated in 26 patients. Stenoses (n = 27) were treated after failed angioplasty, and occlusions (n = 4) were treated with primary stent placement. Clinical history, clinical stage and the ankle brachial-index (ABI) examination measurement were assessed. The patients were followed up with clinical examination, ABI examination measurement and intravenous angiography. The follow-up period ranged between 9.5 months and 7.5 years (median = 5.9 yr). Data were analyzed using the univariate analysis (Kaplan-Meier method). The mean+/-SD ABI pre-, post-procedure and in the last control was 0.70+/-0.17, 0.97+/-0.15, and 0.96+/-0.20, respectively. Primary patency rates (%) +/- SE were 83+/-7 after 3 years, 75+/-8 after five years, and 67+/-9 after seven years, and secondary patency rates were 93+/-5 after three years, 86+/-7 after five years, and 86+/-7 after seven years. During the first 24 hours, one patient presented occlusion of the treated segment. During follow-up, 9 (29%) patients were admitted to our hospital because of worsening of the symptoms. In this study, the symphony stent has been proven to be a good device to treat lesions in the iliac region but more experience is needed to optimize endovascular treatment in this area. In our experience the treatment of iliac artery occlusive disease with symphony stents can be considered a good option with acceptable patency rates and low morbidity and mortality.

Topics: Adult; Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Arteriosclerosis Obliterans; Constriction, Pathologic; Female; Follow-Up Studies; Humans; Iliac Artery; Intermittent Claudication; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Stents; Vascular Patency

We tested the value of hemobahn-endoprosthesis in a prospective, nonrandomized, clinical trial in PAD-patients with femoral artery occlusive disease. During 4 years we placed in 52 patients (55 extremities) a total of 78 hemobahn-endoprostheses for treatment of stenoses (15%) or occlusions (85%) of femoral artery. The average length of the treated lesions was 11.6 cm, the mean length of the hemobahn-endoprosthesis was 15.9 cm, the average device diameter 6.1 mm. In 45% of the patients we used cross-over and in 55% ipsilateral antegrade technique. Fontaine's clinical stages were II b (89%), III (2%) and IV (9%); there were 15 diabetics. The average period of follow-up was 33 months (1-52 months). The primary/secondary patency rates after the first year (n = 50) were 64% vs. 78%, after 2 years (n = 46) 61% vs. 76%, after 3 years (n = 32) 53% vs. 66% and after 4 years (n = 14) 29% vs. 50%. After the first experiences in 1998 with 10 stent-occlusions in 14 treated extremities, indications were checked and thereafter hemobahn was only used in "ideal indications" as segments with a length of > or = 1 cm proximal and distal without any obstruction, no lesions in the popliteal artery, at least one open lower leg vessel and no severe calcifications. The primary/secondary patency rates were significantly better after exclusion of nonideal patients treated during the first year: Thus, primary/secondary patency rates were 76 % vs. 90% after first year (n = 32), 74 % vs. 89% after second year (n = 38) and 71% vs. 83% after third year (n = 24); after 4 years of 8 treated arteries 4 were primary and 7 were secondary open. Hemobahn-endoprostheses are suitable for treatment of long femoral artery occlusions. The medium patency rate in "ideal indications" is higher than that obtained by angioplasty with or without uncovered stents.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Stents; Time Factors; Vascular Patency

Juxta-anastomotic stenosis (JXAS) is a common problem afflicting the arteriovenous fistula (AVF). This study aimed to evaluate the safety and long-term efficacy of an interwoven nitinol stent (Supera, Abbott Vascular, Santa Clara, CA, USA) in the treatment of radiocephalic AVF JXAS.. A single-center, retrospective, observational study was conducted of patients with failing AVF due to JXAS treated with an interwoven nitinol stent. End points included JXAS target lesion primary patency, access circuit primary patency, assisted access circuit primary patency, and endovascular intervention rate (EIR).. Sixty patients were treated with a Supera stent in the JXAS between February 2014 and March 2020. One patient was excluded (AVF used for illicit drug use), leaving 59 patients (67.8% male, mean age 66.9 ± 11.4 years [range: 40-84]) with typical medical comorbidities. Overall, 45.8% of patients had previous AVF intervention. The stent was inserted with a 100% technical success rate with a mean follow-up of 729.6 ± 456.0 days (range: 5-2182 days). Juxta-anastomotic stenosis target lesion primary patency was 68.2 ± 6.6%, 53.3 ± 7.5%, and 46.2 ± 8.1% at 12, 24, and 36 months, respectively. The EIR was .64 (0-3.29) procedures/patient/year, after which the assisted access circuit primary patency rate was 94.3 ± 3.2% at 12, 24, and 36 month time points. Three thrombosed circuits occurred which were all successfully salvaged with no difference in patency by indication for procedure and no AVFs lost/abandoned out to 3 years. Avoidance of stent post-dilatation and the presence of stent mal-apposition were associated with improved primary patency, and reduced EIR, which may suggest an importance in vessel preparation prior to stent implantation.. Interwoven nitinol stent treatment of the failing AVF with JXAS results in promising 3 year JXAS patency, with a low rate of endovascular re-intervention for those circuits developing restenosis. All AVFs were maintained over 3 years, demonstrating this treatment allows for long-term radiocephalic AVF vascular access.

Topics: Aged; Angioplasty, Balloon; Arteriovenous Fistula; Arteriovenous Shunt, Surgical; Constriction, Pathologic; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Renal Dialysis; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

To analyze the outcomes of Supera stent deployment in Chinese patients with atherosclerotic femoropopliteal artery (FPA) disease in a real-world setting.. This retrospective cohort study collected and analyzed the medical records of 246 consecutive patients who received Supera stents for FPA disease at the China Academy of Chinese Medical Sciences Xiyuan Hospital between February 2017 and December 2019. All study patients underwent balloon angioplasty and were treated with Supera stents (Abbott Vascular, Santa Clara, CA, USA). The primary outcome was the rate of primary patency 12 months after discharge.. The analyses included 246 consecutive patients and 260 lesions. The mean ± SD age was 73.2 ± 9.9 years and most patients (60.2%) were males. Of the 260 treated lesions, Supera stents were deployed in eight (3.1%) cases after a previous stent fracture. Critical limb ischemia was diagnosed in 87.3% of the limbs, and 84 (32.3%) and 83 (31.5%) cases were classified as TransAtlantic Inter-Society Consensus (TASC) C and D, respectively. Most of the lesions were in situ (80.8%) and located in the superficial femoral artery (45.0%) or the FPA (45.8%). The mean lesion length was 147.7 mm. Nominal deployment (-10 to 10% compression) was the most common deployment scenario (84.1%). The 1-year primary patency rate was 80.6%. Lesions that occurred as restenosis (odds ratio [OR]: = 3.34, 95% confidence interval [CI]: 1.03-10.85, P = 0.045) or in-stent restenosis (OR: = 2.88, 95% CI: 1.03-8.07, P = 0.045) were independently associated with occlusion or stenosis after stent deployment. No stent fracture was observed in this study.. Our study indicates that the use of Supera stents is feasible for the treatment of Chinese patients with FPA disease. The long-term results reveal high primary patency.

Topics: Aged; Aged, 80 and over; Alloys; Atherosclerosis; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Treatment Outcome; Vascular Patency

A stent is a mesh tube inserted into a natural passage in the body to prevent disease induction. Self-expandable esophageal nitinol stents such as SX-ELLA Stent Esophageal HV (HV Stent Plus) can be indicated for palliation of malignant esophageal strictures, for the treatment of benign esophageal strictures that are refractory to standard therapy and for the treatment of esophago-respiratory fistulas. A silicone-stent coating is used for tumor in-growth prevention and esophago-respiratory fistula occlusion. The thickness of the stent and the overall integrity of the silicone coating of all wires indicate the overall mechanical properties of the esophageal stent and the resistance to external adverse events such as corrosion and mechanical and chemical resistance.. The polymer multicomponent epoxy resin - a mixture of Epon and Durcupan - was used as a method for robust sample stabilization. A cutting system using a thin water beam with a powder (Blue Line) was chosen as the best variant to obtain 6 samples for both-sided measurement (10 measuring sides). The optical microscopic reflective light method was used to examine wire crossing points in the sections. Fifty values were measured on either sample side for the internal, external and mesh thickness of the silicone stent layer. The wire crossing points were selected so that the silicone layer structure could be clearly seen, and the wires approached each other most closely. Only approximately 4 to 8 crossing points in each section could be measured when applying this approach. The resolution of the microscope and calibration (based on the camera used) was 0.677 μm/pixel.. Additional data could be obtained on 8 planes. Two boundary samples were destroyed by the cutting process. Whole coating of the stent was around all mesh wires, especially in areas with higher mechanical stress (wire crossing). The minimum detectable and admissible value determined for all 3 measuring areas (internal, external, mesh) on the wire crossings was 6.77 μm, i.e., 10 pixels, based on the microscope resolution and manufacturer's methodology. The results were characterized by p < 0.001 for all 3 parameters. We tested opposite samples in each section to verify the section quality and data consistency. For the 4 areas, the data were significantly different, but the thickness differences were only on the order of units percent, so the measurements were not appreciably affected. We assume that the material cutting loss, making up 1-2 mm, contributed to the differences in the sections.. We examined the overall integrity of the silicone coating of the esophageal stent. The method of HV stent anchoring in a polymeric bath followed by cutting with a waterjet and sample measurement under an optical microscope proved to be very simple and reliable. Sufficient thicknesses of the silicone layer on the wire cross sections were verified. The coated silicone layer thickness appeared to be significantly different along the stent from the proximal part to the distant part, presumably due to the manufacturing technology.

Topics: Airway Obstruction; Alloys; Constriction, Pathologic; Humans; Silicones; Stents

To investigate the feasibility, methods and efficacy of ultrasound-guided nitinol stent implantation for the treatment of early recurrent stenosis of arteriovenous fistula (AVF). Thirty patients with early recurrent stenosis after percutaneous transluminal angioplasty (PTA) who received ultrasound-guided nitinol stent implantation in Sir Run Run Shaw Hospital of Zhejiang University from April 2018 to July 2020 were followed up. The imaging features of the procedure and the interventional devices were observed under ultrasonography. The technical success rate and the clinical success rate as well as the incidence of complication were assessed. The post-interventional primary patency rates of access circuit, primary patency rates of target lesion and secondary patency rates were estimated. Ultrasonography was able to demonstrate the operation process and the interventional devices clearly. The technical and clinical success rates were both 100.0%. Eight patients had in-stent restenosis, which were treated by PTA. The post-interventional primary patency rates of the access circuit after 3, 6, 9 and were 91.3%, 86.2%, 86.2% and 64.2%, respectively; the post-interventional primary patency rates of target lesion were 100.0%, 100.0%, 86.4% and 69.3%, respectively; the post-interventional secondary patency rates were 100.0%, 100.0%, 100.0% and 94.4%, respectively. Compared with previous PTA in these cases, stent implantation had a higher post-interventional primary patency rates of target lesion and a lower cost-effectiveness (both <0.05). No other complications such as vascular rupture, pseudohemangioma, stent infection, stent displacement and stent exposure were observed during the follow-up. Ultrasonography can accurately guide the nitinol stent implantation in AVF, and the technique is feasible in treatment for the early recurrent stenosis after PTA with good short- and medium-term efficacy.

Topics: Alloys; Arteriovenous Fistula; Constriction, Pathologic; Humans; Renal Dialysis; Stents; Treatment Outcome; Ultrasonography; Ultrasonography, Interventional

To compare the double mesh nitinol stent (DNS) versus the self-expanding stent-graft (SES) in recurrent/resistant cephalic vein arch stenosis in dialysis fistulae.. 17 cases with recurrent/resistant stenosis of the cephalic vein arch treated with a DNS were compared retrospectively with 18 cases treated with an SES. Stenting was performed either for significant recoil post-angioplasty with high-pressure balloons or in recurrent stenoses. Patients were followed up with Doppler ultrasound in our vascular access surveillance programme. Primary and assisted primary patency rates at 3, 6 and 12 months were estimated by Kaplan-Meier analysis.. Both stents showed 100% technical success immediately post-stenting, defined as residual stenosis < 30%. 3, 6 and 12 month primary patency of the DNS was 82.4%, 69.7% and 28.1% versus 88.9%, 77.8% and 72.2% for the SES. The DNS had a mean primary patency of 242.4 days compared to 896.3 days for the SES (p = 0.021). 12 month assisted primary patency was 88.2% (DNS) and 100% (SES). The DNS had a mean assisted primary patency of 812 days compared to 1390.3 days for the SES, though this did not reach statistical significance. No stent fractures were identified at 2 years in either group.. Both stents had 100% technical success with no stent fractures. SES showed statistically significant higher primary patency. Assisted primary patency was also higher, though this did not reach statistical significance.

Topics: Aged; Alloys; Arteriovenous Shunt, Surgical; Brachiocephalic Veins; Constriction, Pathologic; Equipment Design; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Recurrence; Renal Dialysis; Retrospective Studies; Stents; Surgical Mesh; Treatment Outcome; Ultrasonography, Doppler; Vascular Diseases

In our previous study, to find out the optimal alloy suitable for biliary surgery, magnesium alloy Jiao Da Bio-magnesium (denoted as JDBM) alloy, Zn-3Cu alloys, and their respective coating (MgF

Topics: Alloys; Animals; Bile Ducts; Biocompatible Materials; Cell Adhesion; Cell Survival; Coated Materials, Biocompatible; Compressive Strength; Constriction, Pathologic; Dogs; Electrochemistry; In Vitro Techniques; Magnesium; Materials Testing; Mice; Perfusion; Postoperative Period; Stents; Stress, Mechanical

Despite considerable morbid-mortality rates, common femoral endarterectomy is still considered the gold standard for atherosclerotic common femoral artery (CFA) disease. The aim of this study was to demonstrate computed tomography angiography based long-term patency after CFA stent placement and to analyze associated risk factors for restenosis.. A retrospective and observational study was carried out in consecutive patients treated with endovascular stent placement in CFA lesions. A clinical follow-up and imaging study was performed using MD-CTA to assess different degrees of in stent restenosis (ISR) and primary, assisted, and secondary patency rates.. In a 5-year period, 35 extremities were treated in 33 patients with self-expandable nitinol stents. The technical success was 100% without complications related to the procedure. The mean follow-up (FU) was 32.2 months, and 8 limbs were lost. The degree of CFA stenosis was reduced from 79.69 ± 26.47% to 11.23 ± 24.53%. ISR < 20%, 20-70%, and ≥ 70% was evident in 15 (55.6%), 9 (33.3%), and 3 (11.1%) limbs, respectively. Estimated primary, assisted, and secondary patency was 79.5, 96.3, and 96.3%, respectively, after 24 months and 79.5, 96.3, and 96.3%, respectively after 60 months, with a freedom of clinical driven target lesion revascularisation rate of 87.8%.. Endovascular treatment with self-expandable nitinol stents in CFA lesions had a high technical success rate and was related to few complications. A mild form of intimal hyperplasia was observed in a considerable number of cases. However, long-term patency was high; therefore, CFA stent placement might be a suitable therapeutic alternative in selected patients.

Topics: Aged; Aged, 80 and over; Alloys; Computed Tomography Angiography; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Predictive Value of Tests; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Self-expanding nitinol stent (SENS) implantation is commonly oversized in the superficial femoral artery (SFA), and leads to chronic outward force (COF) and in-stent restenosis (ISR). This study aimed to investigate the impact of COF of oversizing SENS on ISR of SFA.. In patients with implanted SENS in SFA, intimal hyperplasia especially between proximal segment and distal segment was evaluated by quantitative angiography, and the impact of COF on mid-term angiographic outcomes was investigated. In addition, porcine model with implanted SENS was used to evaluate the impact of COF on angiographic and histopathologic outcomes at 1 month. Excised stented arteries were evaluated by histopathologic analysis.. COF is an important cause of restenosis in the distal portion of the SFA stent. Optimal sizing of the SFA stent is important to reduce the incidence of restenosis. Therefore, COF was an important factor of restenosis following distal SFA stenting.

Topics: Alloys; Angioplasty; Animals; Constriction, Pathologic; Female; Femoral Artery; Hemodynamics; Humans; Models, Animal; Neointima; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Registries; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Stress, Mechanical; Sus scrofa; Time Factors; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon; Constriction, Pathologic; Graft Occlusion, Vascular; Humans; Iliac Vein; Liver Transplantation; Male; Mesenteric Veins; Portal Vein; Prosthesis Design; Self Expandable Metallic Stents; Treatment Failure; Vascular Diseases; Vascular Grafting; Vascular Patency; Young Adult

Topics: Alloys; Angioplasty, Balloon; Constriction, Pathologic; Critical Illness; Femoral Artery; Humans; Ischemia; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Stents; Treatment Outcome; Vascular Calcification; Vascular Patency

To examine clinical outcomes for combination therapy of heparin-bonded covered stent [VIABAHN™ stent (VIA)] and bare-nitinol stent (BNS), and to determine independent predictors of restenosis after VIA implantation assessed by intravascular ultrasound (IVUS). A retrospective analysis was conducted on VIA use in the femoropopliteal artery of 71 patients (81 lesions) treated between June 2012 and November 2018. We divided the treated lesions into two groups; that is, whether BNS was added at the proximal site of the VIA or not (combination of VIA and BNS group [COM; n = 21] vs. VIA group [n = 60]). The median follow-up duration was 21.6 months (interquartile range, 13.2-28.8 months). Restenosis at 2 years was observed in 5 lesions (33%) in COM group and 17 lesions (38%) in VIA group (log-rank, P = 0.74). In VIA group, 14 lesions developed restenosis within 12 months. Multivariate logistic regression analysis of VIA group revealed that the proximal plaque burden was an independent predictor of restenosis within 12 months after VIA implantation (odds ratio 1.15, 95% confidence interval 1.01-1.30, P = 0.01), with the optimal cutoff value of 43% (area under the receiver operator characteristic curve 0.79, sensitivity 91%, specificity 69%). A remaining plaque of > 43% at the proximal reference segment was an independent predictor of restenosis after VIA implantation. When residual stenosis is observed at the proximal site of SFA after VIA implantation, combination therapy of VIA and BNS would be an optimal management.

Topics: Aged; Aged, 80 and over; Alloys; Anticoagulants; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Heparin; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

To report safety and efficacy of a skip stent technique using nitinol stents in patients with chronic bilateral iliocaval venous occlusions.. A retrospective analysis of 48 consecutive patients (32 men; mean age, 40.7 years; age range, 18-68 years) with chronic bilateral iliocaval obstructions treated using a nonoverlapping stent technique was conducted at a single center. None of the patients had May-Thurner syndrome. Iliocaval confluence was treated by deploying a nitinol stent in inferior vena cava (IVC) and a nitinol stent in each common iliac vein close to the caval stent. Patency of stents was assessed by duplex US at 2 weeks, 3 months, and 6 months and yearly thereafter.. Recanalization and stent reconstruction was technically successful in 47 (98%) patients. The sinus-XL venous stent was used to treat IVC (95 [100%]). Common iliac and external iliac veins were treated with sinus-Venous and VENOVO stents (80 [83%] and 16 [17%] limbs, respectively). External iliac and common femoral veins were treated with sinus-Venous and VENOVO stents (83 [92%] and 7 [18%] limbs, respectively). Early thrombosis (< 30 days) of the iliac vein with stent occurred in 2 limbs. Cumulative primary, assisted primary, and secondary patency rates at 30 months were 74%, 83%, and 97%.. Findings of this study suggest that leaving a skipped lesion at the level of iliocaval confluence may not adversely affect stent patency. Patency rates were comparable with other reported techniques of stent reconstruction at the level of iliocaval confluence.

Topics: Adolescent; Adult; Aged; Alloys; Chronic Disease; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Iliac Vein; Male; Middle Aged; Retrospective Studies; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Diseases; Vascular Patency; Vena Cava, Inferior; Young Adult

Topics: Alloys; Arteriovenous Fistula; Arteriovenous Shunt, Surgical; Constriction, Pathologic; Humans; Stents; Treatment Outcome; Vascular Patency

Endovascular treatment is indicated for the treatment of symptomatic thoracic central vein obstruction (TCVO) but is limited by high rates of restenosis and the need for re-intervention. The aim was to assess the safety and mid-term patency of a novel dedicated venous stent for the treatment of TCVO of benign aetiology.. This was a prospective single centre observational study of 20 patients (median age 65 years, 50% male) referred for the treatment of symptomatic chronic (>three months duration) TCVO between May 2016 and January 2018. Balloon angioplasty with implantation of a self expanding nitinol stent (Vici, Boston Scientific, Marlborough, MA, USA) was performed in all patients. Clinical records including demographics, aetiologies and types of TCVO, and procedural details were recorded. Patients were followed up clinically at one, six, and 12 months. Primary and assisted primary patency were reported.. All 20 lesions were total occlusions, of which 55% (n = 11) were de novo, 10% (n = 2) peri-stent restenosis, and 35% (n = 7) in-stent re-occlusion. The aetiology of TCVO was predominantly (95%) because of multiple or prolonged central venous line insertion. The procedural success rate was 90% (18/20) with no procedural complications. The median follow up was 13.5 months. Primary patency was 100% at 6 months. One patient required re-intervention for stent in segment restenosis at 7 months. The assisted primary patency rate was 100% at 12 months.. Endovascular treatment of benign TCVO with the novel dedicated venous stent was safe and effective in relieving obstructive symptoms with excellent one year patency rates.

Topics: Aged; Alloys; Chronic Disease; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Male; Middle Aged; Phlebography; Prospective Studies; Registries; Risk Factors; Self Expandable Metallic Stents; Thorax; Time Factors; Treatment Outcome; Vascular Diseases; Vascular Patency; Veins

Although the Innova. In this multicenter study, 481 lesions in 453 consecutive patients with peripheral artery disease (PAD) (74±9 years; male, 70%; diabetes mellitus, 61%; dialysis, 27%; critical limb ischemia, 37%) who underwent endovascular therapy with the implantation of Innova. The mean lesion length was 18±10 cm. One-year restenosis and major adverse limb event rates were 36% and 18%, respectively. Multivariate analysis revealed that the presence of diabetes mellitus (odds ratio [OR]: 1.83; 95% confidence interval [CI]: 1.07-3.13), distal reference vessel diameter (OR: 1.86; 95% CI: 1.09-3.16), spot stenting (OR: 2.27; 95% CI: 1.27-4.06), and lack of one-year cilostazol treatment (OR: 0.58; 95% CI: 0.33-1.00) were independent risk factors for one-year restenosis.. The current study demonstrated one-year clinical outcomes after Innova

Topics: Aged; Alloys; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Peripheral Arterial Disease; Popliteal Artery; Stents; Treatment Outcome

The Supera peripheral stent system has a woven wire design that may confer a potential advantage and has higher resistive radial strength of traditional stents, which gives it the ability to avoid kinking. Because a stent is a permanent implant in the target vessels and they would be subjected to a wide variety of torsion, compression, and stress, a rupture is not surprising. Only three cases of ruptured Supera stents have been published in literature. We present a case of P2 popliteal segment thrombosis secondary to Supera stent fracture. A 51-year-old male patient presented with lifestyle-limiting intermittent claudication after 6 months of popliteal recanalization and Supera stent implantation. The computed tomography angiography demonstrated a popliteal artery occlusion secondary to stent fracture. The lesion was satisfactorily treated by endovascular recanalization and with a new Supera stent deployment. The duplex examination after 3 and 6 months demonstrated stent's permeability, and the plain anteroposterior and lateral radiographs did not reveal new stent fractures. Our data suggested that Supera stents are not free of fractures during follow-up and their treatment depends on the type of fracture, with the possibility for endovascular treatment in type III fractures.

Topics: Alloys; Angioplasty, Balloon; Computed Tomography Angiography; Constriction, Pathologic; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Retreatment; Stents; Treatment Outcome; Vascular Patency

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09-208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37-1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9-98.1) and 88% (95% CI = 75.7-94.5), respectively. The assisted primary was 94% (95% CI = 82.9-98.1) and secondary patency was 96% (95% CI = 85.2-99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83-98%) at 12-month follow-up and 88% (95% CI = 76-94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

Topics: Aged; Alloys; Angioplasty, Balloon; Australia; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Self Expandable Metallic Stents; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

We investigated 2-year clinical outcomes after implantaton of Epic. This study was a multicenter and retrospective study. From February 2013 through October 2014, 292 lesions (chronic total occlusion, 21%; TASC Ⅱ C/D, 35%) in 217 consecutive patients (74±8 years; male, 81%; diabetes mellitus, 47%; dialysis, 21%; critical limb ischemia, 29%) who had undergone endovascular therapy (EVT) with Epic. The mean follow-up duration was 19.1±8.5 months. Primary patency was 87.3% at 2 years. Freedom from TLR rate was 94.1% at 2 years. Multivariate analysis revealed that the presence of diabetes mellitus was associated with a loss of patency.. The Epic

Topics: Aged; Alloys; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Retrospective Studies; Stents; Treatment Outcome

To evaluate the clinical and health status outcomes of patients undergoing superficial femoral artery (SFA) revascularization using the Shape Memory Alloy Recoverable Technology (S.M.A.R.T.®) nitinol self-expanding stent through 3 years of follow-up.. Limited long-term data are available describing the durability of benefits after femoropopliteal revascularization.. In a multicenter, prospective, core-lab adjudicated study, 250 subjects with de novo or restenotic femoropopliteal arterial lesions were treated with the S.M.A.R.T.® stent. The primary endpoint of target vessel patency, a composite of ultrasound-assessed patency and freedom from clinically driven target lesion revascularization (TLR), was evaluated through 3 years. Secondary endpoints included stent fracture and health status. Health status was measured using generic and disease-specific instruments, including the Peripheral Artery Questionnaire (PAQ).. At 3-year follow-up, Kaplan-Meier estimated target vessel patency was 72.7%, freedom from clinically driven TLR was 78.5%, and the incidence of stent fracture was 3.6%. The PAQ summary score was markedly impaired at baseline (mean 37.3 ± 19.6 points) and improved substantially at 1 month (mean change from baseline of 31.4 points, 95% CI: 28.5-34.3; P < 0.001). Disease-specific health status benefits assessed by the PAQ were largely preserved through 3 years of follow-up (mean change from baseline, 28.0 points, 95% CI: 24.3-31.7; P < 0.0001).. In patients undergoing revascularization for moderately complex SFA disease, use of the self-expanding S.M.A.R.T® stent was associated with a high rate of target vessel patency through 3 years and led to substantial and sustained health status benefits.

Topics: Aged; Alloys; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Health Status; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Progression-Free Survival; Prospective Studies; Prosthesis Design; Prosthesis Failure; Quality of Life; Self Expandable Metallic Stents; Surveys and Questionnaires; Time Factors; Ultrasonography, Interventional; United States; Vascular Patency

Occlusion of the inferior vena cava (IVC) often causes venous claudication, leg swelling, or skin changes. We hypothesized that the outcome of nitinol stents for endovascular reconstruction of the IVC is similar to the outcome reported for steel alloy stents.. From the prospective Bern Venous Stent Registry, we investigated technical success, patency rates, and clinical outcome in consecutive patients with endovascular IVC reconstruction. During routine follow-up visits, stent patency was assessed by duplex ultrasound. Clinical outcomes were evaluated using the Bozkaya score, Villalta score, and revised Venous Clinical Severity Score.. Of the 62 patients (mean age, 46 ± 18 years), 33 (53%) patients were treated for the post-thrombotic syndrome, 17 (27%) for acute thrombosis, and 12 (19%) for nonthrombotic IVC occlusion. Technical success was achieved in 61 (98%) patients, with a mean of 4.5 ± 1.9 stents (iliac kissing stents in 84%). During follow-up (mean, 21 months), 22 (36%) underwent endovascular reintervention for symptomatic stent stenosis (13 [21%] with complete stent occlusion). Primary, primary assisted, and secondary patency rates at 24 months were 57% (95% confidence interval [CI], 50%-73%), 76% (95% CI, 65%-86%), and 87% (95% CI, 80%-95%), respectively. None developed new ulcers, and all eight patients with venous ulcers at baseline had complete healing. Twenty-nine (48%) patients showed significant clinical improvement, and another 26 (43%) were free from any symptoms or signs of venous hypertension. Patients with post-thrombotic venographic changes of the femoral veins at baseline or a history of thrombosis were more likely to lose primary patency compared with patients with normal leg inflow veins and no history of thrombosis (19 [48%] vs 3 [16%]; P = .02).. The clinical outcome of endovascular reconstruction of the IVC with nitinol stents was favorable. However, approximately one-third of the patients required reintervention to maintain stent patency, most likely because of the impaired venous inflow.

Topics: Adult; Aged; Alloys; Constriction, Pathologic; Endovascular Procedures; Female; Follow-Up Studies; Humans; Male; Middle Aged; Prospective Studies; Registries; Self Expandable Metallic Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Vena Cava, Inferior; Venous Thrombosis

The DURABILITY Iliac clinical study evaluated the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic common and external iliac artery lesions up to 10 cm in length and >50% stenosis in subjects with Rutherford classification peripheral arterial disease stages 2-4.. DURABILITY Iliac was a prospective, multicenter, core lab adjudicated, nonrandomized clinical study enrolling 75 subjects from 15 sites in the United States and Europe. Clinical follow-up visits were at 30 days, 9 months, and 1, 2, and 3 years after procedure. The primary outcome measured was the major adverse event (MAE) rate at 9 months, defined as a composite of periprocedural death, in-hospital myocardial infarction (MI), clinically driven target lesion revascularization (CD-TLR), and amputation of the treated limb through 9 months after procedure. Secondary outcomes included primary patency rate at 9 months, clinically driven target vessel revascularization (CD-TVR), change in ankle-brachial index, and change in Walking Impairment Questionnaire score at 30 days and 9 months. Device success was defined as the ability to deploy the stent as intended at the treatment site.. The MAE rate at 9 months was 1.3% (1/75), with 1 subject experiencing a CD-TLR. No periprocedural deaths, MIs, or amputations were reported. Primacy patency at 9 months was 95.8%. Freedom from CD-TVR was 98.6% at 9 months. Subjects improved in Walking Impairment Questionnaire scores for all categories (walking impairment, walking speed, walking distance, and stair climbing) at the 30-day and 9-month visit. Device success was 100%.. The 9-month results of the DURABILITY Iliac study demonstrate the safety and effectiveness of 2 nitinol self-expanding stents for the treatment of atherosclerotic lesions of the common and external iliac arteries.

Topics: Aged; Alloys; Ankle Brachial Index; Constriction, Pathologic; Endovascular Procedures; Europe; Exercise Tolerance; Female; Hospital Mortality; Humans; Iliac Artery; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Recovery of Function; Risk Factors; Self Expandable Metallic Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; United States; Vascular Patency; Walking

With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran-Mantel-Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or 'bail-out') versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for 'bail-out' indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary 'real-world' adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions. ClinicalTrials.gov Identifier: NCT01904851.

Topics: Aged; Alloys; Amputation, Surgical; Angioplasty, Balloon; Coated Materials, Biocompatible; Comorbidity; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Registries; Risk Factors; Stents; Time Factors; Treatment Outcome; United States; Vascular Access Devices

Topics: Adult; Alloys; Arterial Occlusive Diseases; Brachiocephalic Trunk; Cardiovascular Abnormalities; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Ischemia; Osteotomy; Risk Factors; Self Expandable Metallic Stents; Subclavian Artery; Thoracic Outlet Syndrome; Treatment Outcome

To present a Supera stent fracture following treatment of popliteal artery stenosis.. A 60-year-old man previously treated with angioplasty/stenting of a popliteal artery lesion with a Supera stent presented at 8 months with in-stent occlusion that proved to be secondary to stent fracture.. Supera interwoven nitinol stents, despite having higher radial force and conformability than classic tube stents, are not free from fracture. Moreover, due to their peculiar structure, a break in these stents results in complete loss of integrity and consequent device collapse, thus jeopardizing endovascular recanalization and relining.

Topics: Alloys; Angiography; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Humans; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Failure; Stents; Treatment Outcome; Vascular Patency

The aim was to compare outcomes of self expanding PTFE covered stents (CSs) with bare metal stents (BMSs) in the treatment of iliac artery occlusions (IAOs).. Between January 2009 and December 2015, 128 iliac arteries were stented for IAO. A CS was implanted in 78 iliac arteries (61%) and a BMS in 50 (49%). After propensity score matching, 94 limbs were selected and underwent stenting (47 for each group). Thirty day outcomes and midterm patency were compared; follow-up results were analysed with Kaplan-Meier curves.. Overall, iliac lesions were classified by limb as TASC B (19%), C (21%), and D (60%). Technical success was 98%. Comparing CS versus BMS, the early cumulative surgical complication rate (12% vs. 12%, p = 1.0) and 30 day mortality rate (2% vs. 2%, p = 1.0) were equivalent. At 36 months (average 23 ± 17), overall primary patency was similar between CS and BMS (87% vs. 66%, p = .06), and this finding was maintained after stratification by TASC B (p = .29) and C (p = .27), but for TASC D, CSs demonstrated a higher patency rate (CS, 88% vs. BMS, 54%; p = .03). In particular, patency was in favour of CSs for IAOs > 3.5 cm in length (p = .04), total lesion length > 6 cm (p = .04), and IAO with calcification > 75% of the arterial wall circumference (p = .01).. Overall, the use of self expanding CS for IAOs has similar early and midterm outcomes compared with BMS. Even if further confirmatory studies are needed, CSs seem to have higher midterm patency rates than BMSs for TASC D lesions, IAOs with a total lesion length > 6 cm, occlusion length > 3.5 cm, and calcification involving > 75% of the arterial wall circumference. These specific anatomical parameters may be useful to the operator when deciding between CS and BMS during endovascular planning.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Chi-Square Distribution; Chronic Disease; Coated Materials, Biocompatible; Computed Tomography Angiography; Constriction, Pathologic; Female; Humans; Iliac Artery; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Peripheral Arterial Disease; Polytetrafluoroethylene; Propensity Score; Prosthesis Design; Retrospective Studies; Risk Factors; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

Covered stents have been demonstrated to reduce restenosis; however, the membrane's limited biocompatibility can still lead to thrombus formation. To obtain optimal surface hemocompatibility, endothelialization of the luminal surface has been proposed. However, the effect of delivery procedures, such as crimping and balloon dilatation, on the endothelial layer has not been quantified. This study investigated the impact of such procedures on endothelialized covered stents in vitro.. Using an injection molding technique, bare metal stents were covered with fibrin subsequently, endothelialized and conditioned in a bioreactor under arterial pressure (80-120 mmHg) and shear stress (1 Pa). For each set of experiments, three covered stents were prepared, one being subjected to crimping alone, one to crimping followed by balloon dilatation and one serving as control. The experiment was repeated three times. The endothelial coverage was quantified by scanning electron microscopy (SEM). The functionality of the endothelium after exposure to platelet-rich plasma was evaluated by immunohistochemistry and SEM.. The mean endothelial coverage of control, crimped, crimped and balloon-dilated stents was 87.6, 80.1 and 52.1%, respectively, indicating that endothelial cells detached significantly not after crimping (P = 0.465) but following balloon dilatation (P < 0.001). The cells present on the stent's surface, either after crimping or crimping followed by balloon dilatation, expressed eNOS and CD31 and exhibited no platelet adhesion.. The simulated delivery procedure resulted in the retention of viable cells on more than half of the luminal surface. The main damage to the layer occurred during balloon dilatation.

Topics: Alloys; Angioplasty, Balloon; Animals; Biocompatible Materials; Constriction, Pathologic; Dilatation; Endothelium, Vascular; Fibrin; Gels; Humans; In Vitro Techniques; Microscopy, Electron, Scanning; Models, Cardiovascular; Self Expandable Metallic Stents; Thrombosis

To report the real-world incidence and risk factors of stent thrombosis in the aortoiliac and femoropopliteal arteries in case of bare nitinol stent (BNS) or covered nitinol stent (CNS) placement from a single-centre retrospective audit.. Medical records of consecutive patients treated with peripheral stent placement for claudication or critical limb ischemia were audited for definite stent thrombosis defined as imaging confirmed stent thrombosis that presented as acute limb-threatening ischemia. Cases were stratified between aortoiliac and femoropopliteal anatomy. Cox regression analysis was employed to adjust for baseline clinical and procedural confounders and identify predictors of stent thrombosis and major limb loss.. 256 patients (n = 277 limbs) were analysed over a 5-year period (2009-2014) including 117 aortoiliac stents (34 CNS; 12.8 ± 5.0 cm and 83 BNS; 7.8 ± 4.0 cm) and 160 femoropopliteal ones (60 CNS; 21.1 ± 11.0 cm and 100 BNS; 17.5 ± 11.9 cm). Median follow-up was 1 year. Overall stent thrombosis rate was 6.1% (17/277) after a median of 43 days (range 2-192 days) and affected almost exclusively the femoropopliteal segment (12/60 in the CNS cohort vs. 4/100 in the BNS; p = 0.001). Annualized stent thrombosis rates (per 100 person-years) were 12.5% in case of CNS and 1.4% in case of BNS (HR 6.3, 95% CI 2.4-17.9; p = 0.0002). Corresponding major amputations rates were 8.7 and 2.5%, respectively (HR 4.5, 95% CI 2.7-27.9; p = 0.0006). On multivariable analysis, critical leg ischemia and CNS placement were the only predictors of stent thrombosis. Diabetes, critical leg ischemia, femoropopliteal anatomy, long stents and CNS were independent predictors of major amputations.. Placement of long femoropopliteal covered nitinol stents is associated with an increased incidence of acute stent thrombosis and ensuing major amputation. Risks are significantly lower in the aortoiliac vessels and with use of bare nitinol stents.

Topics: Acute Disease; Aged; Alloys; Amputation, Surgical; Aorta; Causality; Comorbidity; Constriction, Pathologic; Extremities; Female; Femoral Artery; Follow-Up Studies; Humans; Incidence; Intermittent Claudication; Ischemia; Male; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Risk Factors; Stents; Thrombosis; Time Factors; Treatment Outcome; Vascular Patency

Preliminary results in small single-center studies after stenting with the GORE TIGRIS Vascular Stent (W. L. Gore & Associates, Flagstaff, Ariz) show promising short-term primary patency rates, but larger, multicenter studies are needed. This study therefore investigated the performance of the GORE TIGRIS Vascular Stent at three different centers in France in patients with symptomatic peripheral artery disease.. This retrospective, single-arm, multicenter cohort study included 215 patients with peripheral artery disease (Rutherford-Becker category 2-6) who were treated with the GORE TIGRIS Vascular Stent, a dual-component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure. The efficacy end point was primary patency defined by freedom from binary restenosis as derived by duplex ultrasound imaging until 2 years after the intervention. Primary, secondary, and primary assisted patency rates at 3, 6, 12, 18, and 24 months were estimated by Kaplan-Meier analysis.. The GORE TIGRIS Vascular Stent was used to successfully treat 239 lesions, of which 141 lesions were located in the superficial femoral artery and 98 in the popliteal artery. Patients were a mean age of 74 ± 12 years. Mean lesion length was 86.8 ± 44.7 mm. After 12 and 24 months, the overall primary patency rates were 81.5% and 67.2%, respectively, and primary assisted patency was 94.9% and 84.8%. Secondary patency was achieved in 99.1% at 24 months.. Our multicenter experience with the GORE TIGRIS Vascular Stent demonstrates continued good results at 2 years for endovascular treatment of challenging obstructive superficial femoral artery and popliteal artery disease.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Anticoagulants; Blood Vessel Prosthesis; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Femoral Artery; Heparin; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Polytetrafluoroethylene; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

This study reports our experience during the first 50 cases of use of Supera stent for popliteal atherosclerotic lesions treatment.. This prospective single-arm trial enrolled the first 50 limbs (46 patients) treated in our center with a Supera stent for symptomatic atherosclerotic disease of the popliteal artery and a follow-up longer than 12 months.. Tissue loss (43.5%) was the most common primary indication for intervention, followed by claudication (37.0%) and rest pain (19.5%). Stent implantation was successful in all patients. The majority of lesions were Trans-Atlantic Inter-Society Consensus (TASC) II type D lesions (64%). The lesions treated were localized in P3 zone in 64%, P2 zone in 28%, and P1 zone in 8%. One runoff vessel was the most common situation (42%). Mean follow-up was 16.5 months (range 12-46). The mean preoperative ankle-brachial index increased from 0.38 + 0.37 before intervention to 0.63 + 0.86 postoperatively at 12 months (P = 0.014). Primary patency rates at 3, 6, 9, and 12 months were 95.9%, 91.7%, 89.6%, and 89.6%, and primary assisted patency rates were 95.9%, 93.8%, 93.8%, and 93.8%, respectively. In-stent restenosis was associated with the following: patient <75 years (P = 0.023), female sex (P = 0.032), and TASC-II D lesions (P = 0.041). Implantation defects did not constitute a risk factor for stent restenosis.. The implantation of the interwoven nitinol stents in patients with popliteal occlusive disease is safe and effective, with encouraging patency rates and clinical results after a 12-month follow-up. In our experience, we have not seen significant differences in patency at 1-year follow-up in patients with implantation defects.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Ankle Brachial Index; Constriction, Pathologic; Female; Humans; Intermittent Claudication; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Risk Factors; Spain; Stents; Time Factors; Treatment Outcome; Vascular Patency

The clinical outcomes of nitinol stents for femoropopliteal arterial (FP) disease in patients on hemodialysis were assessed. Endovascular therapy (EVT) is accepted for symptomatic FP disease. However, the clinical outcomes of patients on dialysis are not well known. A multicenter retrospective study was conducted with data between November 2010 and August 2013. A total of 484 consecutive patients who successfully underwent EVT for FP disease with nitinol stents were recruited and analyzed. Patients were categorized into the hemodialysis group (N = 161) and non-hemodialysis group (N = 323). The primary measure was primary patency verified by duplex ultrasound at a rest peak systolic velocity (PSVR) of >2.5, and secondary measures were freedom from target lesion revascularization (TLR) and major amputation-free survival (AFS). Average follow-up duration was 19.5 ± 13.5 months. The primary patency rate at 3 years was significantly lower in the hemodialysis group than the non-hemodialysis group (33.8 vs. 43.7 %; p = 0.036). Freedom from TLR at 3 years was 55.0 % in the hemodialysis group and 66.1 % in the non-hemodialysis group (p = 0.032). The hemodialysis group showed a significantly lower AFS rate at 3 years than the non-hemodialysis group (86.4 vs. 58.2 %; p < 0.001). In hemodialysis patients, nitinol stent use resulted in a lower patency rate, higher TLR rate, and lower AFS rate compared to non-hemodialysis patients. These data suggest that nitinol stent implantation for FP arteries in hemodialysis patient needs to be reconsidered.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Recurrence; Renal Dialysis; Renal Insufficiency, Chronic; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Mechanical tests assessing Nitinol stents used for the superficial femoral artery (SFA) are designed without taking into account their deployment environments. The objectives of this study were (1) to create normal and pathologic femoral artery models, (2) to run mechanical tests reproducing the stresses of the SFA, and (3) to study and compare Nitinol stents in those conditions.. Femoral artery models with identical mechanical properties to the SFA were created using the 3-dimensional printing technology. Those models were designed with and without an asymmetric focal 50% stenosis. Three mechanical tests (bending-compression, bending-compression-torsion, and multiple bending tests) were created and 1 flexible stent was tested, of 6 and 7-mm diameter. Three samples of the stent, LifeStent (Bard(®)), were deployed and tested in the models. Stents alone were evaluated in the same conditions. The analysis focused on the comparison of rheologic curves, level of kink, and the energy deployed for each stent to kink.. In the 3 tests, all stents deployed in the models presented a kink during their evaluation. When tested alone, during the compression-bending and bending-compression-torsion tests, no plicature was observed. During the multiple bending test, the energy deployed to plicature for the stent tested alone was of 1.4 ± 0.10 and 2.84 ± 0.1 J compared with 9.7 ± 0.6 and 8.25 ± 0.6 J when deployed in the model for the Lifestent 6 × 80 and 7 × 80 mm, respectively. For all of these 3 tests, 6-mm diameter stents exhibited a level of kink and energy of kink higher than 7 mm stents. The behavior of the stents changed in the stenosed model whatever diameter is taken into account. Analysis of the rheologic curves showed a decrease in the inflection of the curve related to the plication. In the bending-compression test, the presence of a stenosis lead to an early plication of the model, with less deployed kinking energy whereas in the bending, compression, and torsion test, this earliness was absent.. This study permitted the creation of a mechanical test platform evaluating Nitinol stents in bending situations. It tends to confirm the mechanical deleterious effect of excessive oversizing. This study confirms the necessity to evaluate Nitinol stents in their deployment environments.

Topics: Alloys; Arterial Occlusive Diseases; Compressive Strength; Constriction, Pathologic; Elastic Modulus; Endovascular Procedures; Equipment Failure Analysis; Femoral Artery; Hemodynamics; Humans; Materials Testing; Models, Anatomic; Models, Statistical; Printing, Three-Dimensional; Prosthesis Design; Prosthesis Failure; Regional Blood Flow; Rheology; Stents; Stress, Mechanical; Tensile Strength; Torsion, Mechanical

To present a propensity score matching analysis comparing the 1-year outcomes of de novo femoropopliteal lesions treated with drug-eluting stents (DES) or bare nitinol stents (BNS).. A retrospective review was conducted of 452 limbs in 389 patients (mean age 74±8 years; 284 men) treated with DES implantation and 1808 limbs in 1441 patients (mean age 72±9 years; 1023 men) implanted with BNS for de novo femoropopliteal lesions. One-year follow-up data were available on all patients. The primary endpoint was 12-month restenosis assessed by duplex ultrasonography or follow-up angiography within ±2 months. Secondary endpoint was major adverse limb events (MALE) including major amputation, any reintervention, and restenosis.. The BNS group was more likely to have current smoking, chronic total occlusion, and poor below-the-knee runoff. The stratification analysis demonstrated that diabetes mellitus (DM) and reference vessel diameter (RVD) had a significant interaction on the association of DES vs BNS implantation with restenosis (interaction p<0.05). Thus, the population was stratified into 4 subgroups (1: -DM, RVD ≥5 mm, 2: +DM, RVD ≥5 mm, 3: -DM, RVD <5 mm, and 4: +DM, RVD <5 mm); the RVD threshold was empirically determined. There were no significant intergroup differences in baseline variables after matching. There was no significant difference in restenosis risk between DES and BNS in the RVD ≥5 mm subgroup regardless of the presence of DM. The DES group had a significantly higher restenosis risk in the RVD <5 mm subgroup regardless of the presence of DM. No significant difference was observed in the risk of major amputation, reintervention, or MALE in any subgroup.. These results suggest that a first-generation DES was not superior to a conventional BNS for femoropopliteal lesions.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Constriction, Pathologic; Drug-Eluting Stents; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Prosthesis Design; Recurrence; Registries; Retreatment; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To describe and compare primary patency rates in patients undergoing endovascular femoropopliteal interventions with standard or interwoven nitinol stents or drug-coated balloons.. A cohort of 1292 patients was treated for symptomatic femoropopliteal occlusive disease classified as Rutherford category ≥ 1 at a large vascular center between June 2006 and August 2013 using either standard nitinol stents (SNS; n=432), interwoven nitinol stents (INS; n=470), or drug-coated balloons (DCB; n=390). Primary patency rates were assessed by ultrasound or angiographic readings for over 3 years of follow-up. Propensity score-matched pairs were formed to compare each treatment with another using survival analysis.. Survival curves of primary patency favored INS compared with SNS in 368 propensity score-matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 86.6%, 76.4%, and 68.9%, respectively, in the INS group vs 60.5%, 46.1%, and 42.1%, respectively, in the SNS group. No significant difference (p=0.232) was seen for the comparison of SNS vs DCB in 284 matched pairs over long-term follow-up (primary patency estimates at 1, 2, and 3 years were 79.8%, 53.8%, and 32.9%, respectively, in the DCB group vs 60.5%, 44.8%, and 40.3%, respectively, in the SNS group). Survival curves of primary patency favored INS over DCB in 254 matched pairs (p<0.001). Kaplan-Meier estimates at 1, 2, and 3 years were 79.0%, 51.2%, and 30.1%, respectively, in the DCB group vs 89.0%, 76.9%, and 66.2%, respectively, in the INS group.. Propensity score-based analysis of primary patency suggests profound differences in restenosis rates between various treatment modalities for femoropopliteal disease for over 3 years of follow-up.

Topics: Aged; Alloys; Chi-Square Distribution; Coated Materials, Biocompatible; Constriction, Pathologic; Databases, Factual; Endovascular Procedures; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Proportional Hazards Models; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Access Devices; Vascular Patency

Critical limb ischemia may be the consequence of chronic occlusion of an aneurysm of popliteal artery. Endovascular repairs have the potential to be less invasive than open surgery and to allow the treatment, during the same procedure, of occlusive infrapopliteal diseases achieving a better distal outflow. Eleven patients with occluded popliteal artery aneurysm (PAA) underwent an endovascular repair of PAA using a new technique, by positioning of a Viabahn graft inside a bare nitinol stent, deployed at the level of aneurysm with the intent to avoid distal embolization and to assure an external scaffold for the Viabahn graft. Immediate success rate was 100%. A peroneal artery embolization occurred in 1 patient (9%) and was successfully treated by stent implantation. Four (36.4%) patients needed a below-the-knee revascularization to achieve at least 1 vessel line to the foot. Mean postoperative hospital stay was 2.6 days. At 24-month follow-up, primary patency, target lesion revascularization, and major amputation rates were 82%, 9%, and 0%, respectively. All patients are still alive at last follow-up visit. The endovascular repair with the combined use of a bare metal stent and Viabahn graft resulted in a low incidence of distal embolization and major amputation rate, with an excellent 24-month patency rate, and may offer a safe alternative to open surgery for the treatment of occluded PAAs.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chronic Disease; Constriction, Pathologic; Endovascular Procedures; Female; Humans; Limb Salvage; Male; Popliteal Artery; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the safety and midterm patency of the Supera interwoven nitinol stent in a real-world population and determine deployment and patient-related factors that may predispose to loss of patency.. A retrospective analysis was conducted of 111 consecutive limbs from 97 patients (mean age 75.3 years; 68 men) with severe atherosclerotic disease of the superficial femoral and popliteal arteries that were treated with Supera stents between June 2012 and October 2014. Half the patients had claudication (56%); the remainder had rest pain (19%) and tissue loss (26%). Forty-eight (43%) lesions were chronic total occlusions, and more than half were classified as TransAtlantic Inter-Society Consensus C (22%) or D (30%).. All 146 Supera stents (1.32 stents per limb) were deployed successfully, extending over a mean length of 175.5±130.5 mm to treat lesions averaging 151.5±127.1 mm long. At 30 days, Kaplan-Meier estimated freedom from death, target lesion revascularization, and amputation was 97.3%. Primary patency and freedom from clinically driven target lesion revascularization rates were 87.1% and 95.0% at 6 months, respectively, and 78.9% and 87.6% at 12 months, respectively. Four distinct mechanisms for failure were identified in the 13 limbs in which patency was lost; stent intussusception (n=4), compromised inflow or outflow (n=2), gross oversizing (n=1), and neoplastic thrombophilia (n=1); the cause of 5 occlusions could not be identified.. In this heterogeneous group that included long and complex atheromatous femoropopliteal lesions, the Supera stent achieved excellent clinical and patency results at 1 year. Further improvement may be achieved through careful patient selection and the avoidance of deployment pitfalls.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Constriction, Pathologic; Disease-Free Survival; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; New South Wales; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Failure; Vascular Patency

To compare optimal balloon angioplasty with nitinol stenting and drug-eluting stent (DES) implantation for femoropopliteal in-stent occlusion (ISO).. A dual center, retrospective study was performed from January 2004 to December 2014 encompassing 110 ISOs after bare nitinol stenting for a femoropopliteal lesion in 100 patients (mean age 72.7±10.1 years; 58 men). These patients underwent optimal balloon angioplasty with implantation of a bare stent (conventional group, n=79) or a DES (n=21). The primary endpoint was recurrent in-stent restenosis (Re-ISR); secondary endpoints were recurrent target lesion revascularization (Re-TLR), reocclusion, and major adverse limb events (MALE). Re-ISR or reocclusion was defined as ISR or occlusion after TLR. Restenosis was defined as a peak systolic velocity ratio >2.4 on a duplex scan or >50% stenosis on angiography. Univariate Cox regression analysis was used to identify any relationships between patient and procedure variables and the occurrence of Re-ISR; the results are presented as the hazard ratio (HR) and the 95% confidence interval (CI).. The mean follow-up period was 34.9±27.4 months. At 2 years, Kaplan-Meier estimated freedom from Re-ISR rates were 79.3% in the DES group and 20.2% in the conventional group, respectively (p<0.001). The rates of freedom from Re-TLR, reocclusion, and MALE at 2 years were 85.7%, 85.9%, and 85.7% in the DES group and 27.1%, 42.5%, and 25.3% in the conventional group, respectively (p<0.001, p=0.006, and p<0.001, respectively). Univariate analysis showed only postprocedure stenosis (HR 1.04, 95% CI 1.02 to 1.07, p<0.001) as a predictor of Re-ISR. Postprocedure ABI (HR 0.06, 95% CI 0.01 to 0.30, p<0.001) and DES use (HR 0.20, 95% CI 0.07 to 0.44, p<0.001) were associated with a lower likelihood of developing Re-ISR.. In this small comparative study, DES stent implantation gives more favorable outcomes than conventional treatment for ISO after femoropopliteal stenting.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Chi-Square Distribution; Constriction, Pathologic; Databases, Factual; Disease-Free Survival; Drug-Eluting Stents; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome

To identify intravascular ultrasound (IVUS) measurements that can predict angiographic in-stent restenosis (ISR) following nitinol stent implantation in superficial femoral artery (SFA) lesions.. A retrospective review was conducted of 97 patients (mean age 72.9±8.9 years; 63 men) who underwent IVUS examination during endovascular treatment of 112 de novo SFA lesions between July 2012 and December 2014. Self-expanding bare stents were implanted in 46 lesions and paclitaxel-eluting stents in 39 lesions. Six months after stenting, follow-up angiography was conducted to assess stent patency. The primary endpoint was angiographic ISR determined by quantitative vascular angiography analysis at the 6-month follow-up. Variables associated with restenosis were sought in multivariate analysis; the results are presented as the odds ratio (OR) and 95% confidence interval (CI).. At follow-up, 27 (31.8%) angiographic ISR lesions were recorded. The lesions treated with uncoated stents were more prevalent in the ISR group compared with the no restenosis group (74.1% vs 44.8%, p=0.02). Lesion length was longer (154.4±79.5 vs 109.0±89.3 mm, p=0.03) and postprocedure minimum stent area (MSA) measured by IVUS was smaller (13.9±2.8 vs 16.3±1.6 mm(2), p<0.001) in the ISR group. Multivariate analysis revealed that bare stent use (OR 7.11, 95% CI 1.70 to 29.80, p<0.01) and longer lesion length (OR 1.08, 95% CI 1.01 to 1.16, p=0.04) were predictors of ISR, while increasing postprocedure MSA (OR 0.58, 95% CI 0.41 to 0.82, p<0.01) was associated with lower risk of ISR. Receiver operating characteristic analysis identified a MSA of 15.5 mm(2) as the optimal cutpoint below which the incidence of restenosis increased (area under the curve 0.769).. Postprocedure MSA can predict ISR in SFA lesions, which suggests that adequate stent enlargement during angioplasty might be required for superior patency.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty, Balloon; Area Under Curve; Cardiovascular Agents; Chi-Square Distribution; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Paclitaxel; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; ROC Curve; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

Topics: Aged; Alloys; Angiography; Angioplasty; Constriction, Pathologic; Femoral Artery; Humans; Male; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Self Expandable Metallic Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

To evaluate the safety and efficacy of a self-expanding bare-metal nitinol stent (Astron; BIOTRONIK AG, Bülach, Switzerland) for the treatment of atherosclerotic lesions in the common and external iliac arteries. This study tested the hypothesis that the major adverse event (MAE) rate at 12 months was less than or equal to a performance goal of 15%.. In a prospective study that began in November 2011, 161 patients with symptomatic iliac lesions were treated with an Astron stent in the United States, Canada, and Austria. The primary endpoint was a composite rate of procedure- and stent-related MAEs at 12 months that included 30-day mortality, clinically indicated target lesion revascularization (TLR), and index limb amputation.. The MAE rate at 12 months was 2.1% (3/146; [95% CI: 0.4% to 5.9%]; p < 0.001). The acute procedural success and 30-day clinical success outcomes were both 95% (153/161). The primary patency rate at 12 months was 89.8% (115/128). The comparison of baseline and 12-month Ankle Brachial Index (ABI) measurements showed a mean increase of 0.23 ± 0.19 (p < 0.001). The Walking Impairment Questionnaire (WIQ) PAD specific score, walking distance score, walking speed score and stair climbing score paired each showed a significant increase from baseline to 12 months (p<0.001).. The Astron stent system was shown to be safe and effective in the treatment of patients with atherosclerotic disease. The observed MAE rate met the pre-specified performance goal of 15%. The stent demonstrated a high 12-month primary patency rate and showed improvement in quality of life measures.

Topics: Aged; Alloys; Ankle Brachial Index; Austria; Canada; Constriction, Pathologic; Endovascular Procedures; Exercise Test; Exercise Tolerance; Female; Humans; Iliac Artery; Intermittent Claudication; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Quality of Life; Recovery of Function; Registries; Self Expandable Metallic Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; United States; Vascular Patency; Walking

To compare primary patency between MISAGO (Terumo Corporation, Tokyo, Japan) and S.M.A.R.T. CONTROL (Cordis Corporation, Miami Lakes, Florida), second-generation and first-generation nitinol stents, in femoropopliteal lesions.. This multicenter, retrospective study included 240 cases with MISAGO stent implantation and 1,265 cases with S.M.A.R.T. stent implantation. The S.M.A.R.T. group had more Trans-Atlantic Inter-Society of Consensus (TASC) II class C/D lesions (53% vs 41%, P = .001) and smaller reference vessel diameter (RVD) (5.3 mm ± 0.9 vs 5.5 mm ± 0.9, P < .001).. Kaplan-Meier estimates of 2-year primary patency after S.M.A.R.T. and MISAGO stent implantation were 67% and 55% (P = .007). Interaction analysis revealed that TASC II classification and RVD had a significant influence on the association of MISAGO versus S.M.A.R.T. stents with the outcome. The study population was stratified according to TASC II classification and RVD, and MISAGO and S.M.A.R.T. stents were compared after propensity score matching. There was no significant difference in 2-year patency between the 2 stents in the subgroup with TASC II class A/B and RVD ≥ 5 mm (S.M.A.R.T. 82% ± 4 vs MISAGO 74% ± 5, P = .480). MISAGO stents had lower primary patency than S.M.A.R.T. stents in cases with TASC II class C/D or RVD < 5 mm (S.M.A.R.T. 62% ± 6 vs MISAGO 25% ± 6, P = .015).. S.M.A.R.T. and MISAGO stents had similar patency in simple lesions, but MISAGO stents had lower patency than S.M.A.R.T. stents in more complex lesions.

Topics: Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Proportional Hazards Models; Prosthesis Design; Prosthesis Failure; Recurrence; Retrospective Studies; Self Expandable Metallic Stents; Time Factors; Treatment Outcome; Vascular Patency

One of the major problems in end-stage bronchotracheal cancer is stenosis of the upper airways, either due to luminal ingrowth of the tumor or mucus plugging. Airway stents that suppress tumor ingrowth and sustain mucociliary transport can alleviate these problems in end-stage bronchial cancer. We evaluated different types of polymeric covers for a tissue engineered airway stent. The distinguishing feature of this stent concept is that respiratory epithelial cells can grow on the luminal surface of the stent which facilitates mucociliary clearance. To facilitate growth of epithelial cells at the air-liquid interface of the stent, we developed a polyurethane cover that allows transport of nutrients to the cells. Nonwoven polycarbonate urethane (PCU) covers were prepared by a spraying process and evaluated for their porosity and glucose permeability. Respiratory epithelial cells harvested from sheep trachea were cultured onto the selected PCU cover and remained viable at the air-liquid interface when cultured for 21days. Lastly, we evaluated the radial force of a PCU-covered nitinol stent, and showed the PCU covers did not adversely affect the mechanical properties of the stents for their intended application in the smaller bronchi. These in vitro data corroborate the design of a novel airway stent for palliative treatment of bronchotracheal stenosis by combination of stent-technology with tissue-engineered epithelial cells.

Topics: Alloys; Animals; Bronchi; Carcinoma, Bronchogenic; Cells, Cultured; Constriction, Pathologic; Epithelial Cells; Equipment Design; Glucose; Permeability; Polycarboxylate Cement; Polyurethanes; Porosity; Respiratory System; Sheep; Stents; Tissue Engineering; Trachea

Recanalization of long segmental occlusions of femoropopliteal arteries can be achieved by angioplasty and implantation of nitinol stents with high procedural success rates. However, due to recurrent in-stent restenoses (ISR) some patients need repeated interventions and their intermediate success rates are uncertain.. Patients who were treated in our center from March 2008 through February 2011 due to symptomatic ISR (as determined by Duplex sonography) were retrospectively included in the study. After endovascular treatment of their ISR, they were prospectively evaluated with regard to recurrent ISR of the target lesions.. A total of 36 limbs (=lesions) in 32 patients (69% male, mean age 69±9 years) were successfully treated by balloon-angioplasty. Adjunctive cutting balloons and drug eluting balloons were used in 78% and 8%, respectively. Mean follow-up was 326 days. Recurrent ISR occurred in 10 (28%) lesions, while 26 (78%) lesions showed no recurrence of ISR. In a multivariate logistic regression analysis, age, gender, cardiovascular risk factors, renal failure and medication with cilostazol were not significantly associated with recurrent ISR. Moreover, the number of previous interventions of the target lesions was not an independent predictor of recurrent ISR.. Patients with multiple recurrences of ISR seem to have the same prospects of acute and mid-term success for endovascular treatment as those with first presentation of ISR. However, this observation has to be confirmed by prospective, large scale studies with a longer follow-up period to determine the significance of endovascular intervention within the scope of different revascularization approaches for treatment of recurrent ISR.

Topics: Aged; Alloys; Angioplasty, Balloon; Constriction, Pathologic; Drug-Eluting Stents; Female; Femoral Artery; Humans; Logistic Models; Lower Extremity; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Recurrence; Retrospective Studies; Risk Factors; Vascular Patency

This study describes our technique of aggressive angioplasty with juxta-anastomotic stenting (JXAS) in the autogenous arteriovenous fistula and reviews our outcomes with this technique in its mature form.. We developed a JXAS technique during the last 7 years. Since 2006, we have placed 135 JXASs. The study period reviews 68 consecutive JXASs placed from 2008 to 2012 using the mature technique. We retrospectively analyzed the prospectively collected data. Thirty-three fistulas received JXAS for failure to mature, and 35 were mature but inadequately dialyzing fistulas (problem fistulas). The JXAS technique involves (1) treating the JXA segment as a unit, (2) aggressive angioplasty with rupture of stenoses, and (3) placement of an uncovered nitinol stent.. Technical success was 97%. Of the fistulas that had failed to mature, 75% were brought to maturity by 6 months and 88% by 12 months. Adequate dialysis was achieved in all 35 problem fistulas immediately postoperatively. Assisted fistula patency was 90% at 2 years and 80% at 4 years.. JXAS is an effective technique for maturing and maintaining the wrist radiocephalic arteriovenous fistula.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arteriovenous Shunt, Surgical; Constriction, Pathologic; Female; Graft Occlusion, Vascular; Humans; Male; Middle Aged; Prosthesis Design; Radial Artery; Regional Blood Flow; Renal Dialysis; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency; Veins; Wrist; Young Adult

The aim of this paper was to report the continued mid-term follow-up of the first patients world-wide treated with the GORE(®) TIGRIS(®) Vascular Stent, a dual component stent consisting of a nitinol wire frame combined with a fluoropolymer-interconnecting structure.. From December 2011 until November 2012, 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (5% occlusions) underwent angioplasty and implantation of a GORE(®) TIGRIS(®) Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for duplex ultrasound and assessment of Rutherford-Becker class (RBC) and Ankle-Brachial Index (ABI). Here we report the completed 6-month follow-up and, for the first time, a 12-month follow-up.. The median follow-up was 418 days. During the 12-month follow-up 4 patients died. Restenosis or reocclusion of the stent in this time period was observed in 5 lesions (12.5%), resulting in a cumulative primary patency rate of 85.5±6.0%. The ABI increased pre-interventionally from 0.65±0.18 to 0.91±0.18 (P<0.0001) at the 12-month visit. The median RBC improved from 3 to 1 (P<0.0001). No stent thrombosis related to discontinuation of dual antiplatelet therapy 4 weeks after the index procedure was observed.. The mid-term follow-up of the dual component GORE(®) TIGRIS(®) Vascular Stent showed promising results with high 12-month primary patency rates after femoropopliteal endovascular interventions. These first clinical data are very promising compared to other stent concepts in the superficial femoral and popliteal artery.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty; Ankle Brachial Index; Constriction, Pathologic; Drug Administration Schedule; Drug Therapy, Combination; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Endovascular therapy for aortoiliac (AI) lesions using stents is widely accepted. However, the long-term outcome of 2 different types of nitinol stents for AI lesions is unknown. The aim of this study was to examine the long-term outcome of the SMART and Luminexx nitinol stents for the treatment of de novo AI lesions.. This study was a multicenter retrospective analysis of a prospectively maintained database. The study enrolled consecutive patients undergoing primary stenting for de novo AI artery stenosis between January 2005 and December 2009. A total of 1503 lesions in 1229 patients treated with SMART or Luminexx primary stenting were enrolled. The primary end point was primary patency, secondary end points were the primary assisted patency, secondary patency, and major adverse limb events (MALEs), which included major amputation and major reintervention. To minimize the differences between the groups, a propensity score matching analysis was performed, and 284 lesions per group were analyzed to identify outcomes.. After the propensity score matching analysis, the lesion length was 60 ± 37 and 57 ± 31 mm (P = .275), and the reference vessel diameter was 8.2 ± 1.5 and 8.3 ± 1.5 mm (P = .482) in the SMART and Luminexx groups, respectively. The primary patency at 3 years was not significantly different between the groups (83.5% vs 82.2%, P = .842, respectively). The assisted primary patency and secondary patency rates were also not significantly different (91.7% vs 93.2%, P = .340, 99.2% vs 98.8%, P = .922). In addition, the MALE rate was not significantly different between the groups (98.3% vs 97.3%, P = .821).. The current data suggest that the use of nitinol stents for the AI artery provided good long-term patency and freedom from MALE for 3 years of follow-up, regardless of whether SMART or Luminexx stents were used.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Aortic Diseases; Arterial Occlusive Diseases; Constriction, Pathologic; Databases, Factual; Endovascular Procedures; Female; Humans; Iliac Artery; Japan; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Middle Aged; Propensity Score; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

The Supera stent (Abbott Laboratories, Abbott Park, Ill) has a unique biomimetic design allowing axial and longitudinal flexibility and fracture resistance. The aim of this retrospective study was to assess the midterm patency of Supera stents used to treat patients with superficial femoral and popliteal arterial disease by a single practice.. From April 2010 to December 2011, 53 patients and 59 limbs with symptomatic femoropopliteal lesions underwent angioplasty and stenting with the Supera stent. Five patients had no follow-up and were excluded. Demographics of the patients, radiographic images, morphologic features of the lesions, procedural reports, reinterventions, and follow-up clinical visit notes were reviewed. Primary patency was defined as clinical resolution of symptoms with no secondary interventions. Primary and secondary patency rates at 12, 24, and 36 months were estimated by Kaplan-Meier analysis.. A total of 48 patients (42 men, six women; 54 limbs; mean age, 64.3 years [range, 51-87]) received Supera stents and had at least one follow-up visit as part of their treatment for femoropopliteal disease. Primary indications for intervention included claudication, rest pain, and tissue loss, at rates of 54% (29 of 54), 26% (14 of 54), and 20% (11 of 54), respectively; 22% of lesions were TransAtlantic Inter-Society Consensus type A or B and 78% were type C or D. Mean lesion length was 24.0 cm (range, 3-51). Mean follow-up was 27.5 months (range, 1-45). The ankle-brachial index increased from 0.58 ± 0.20 preoperatively to 0.77 ± 0.18 postoperatively (P = .00004). Primary, primary assisted, and secondary patency rates at latest follow-up were 79.6%, 88.9%, and 92.3%, respectively. Cumulative primary patency rates by Kaplan-Meier analysis at 12, 24, and 36 months were 85.6%, 83.1%, and 76.7%, respectively. Secondary patency rates by Kaplan-Meier estimates at 12, 24, and 36 months were 93.8%, 93.8%, and 89.3%, respectively. No stent fractures were found at the time of any reinterventions. Long lesions >30 cm (n = 18) showed equivalent patency to lesions of 1 to 15 cm (n = 18) and lesions 15 to 30 cm in length (n = 18).. Our midterm results show that Supera stents are durable in treating femoropopliteal lesions, with notably high patency rates in patients with long lesion lengths.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Missouri; Peripheral Arterial Disease; Popliteal Artery; Postoperative Complications; Prosthesis Design; Retreatment; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the technical and clinical success of percutaneous superior mesenteric vein (SMV) stenting in symptomatic patients using self-expanding nitinol stents.. We retrospectively analyzed the technical and clinical success of percutaneous SMV stenting of 6 symptomatic patients (3 men, mean age 67 years, range 48-81 years). Stenosis of the SMV was caused by postoperative stricture (n=3), pancreas carcinoma (n=1) and pancreatitis (n=2). As a result of the stenosis, 3 patients had symptomatic ascites, 2 patients showed signs of mesenteric ischemia and 1 patient had recurrent gastrointestinal bleeding. Stenting was performed by a percutaneous transhepatic approach using self-expanding nitinol stents.. Stenting of the SMV was technically and clinically successful in all patients. No peri-interventional complications occurred. The stent diameters ranged from 6 to 14 mm. During the mean follow-up of 6 months (range, 2-10 months) 1 patient presented early stent occlusion 2 weeks after placement.. Stenting of a symptomatic SMV stenosis using self-expanding nitinol stents is feasible and clinically effective.

Topics: Aged; Aged, 80 and over; Alloys; Anticoagulants; Ascites; Catheterization; Constriction, Pathologic; Female; Follow-Up Studies; Heparin, Low-Molecular-Weight; Humans; Male; Mesenteric Ischemia; Mesenteric Vascular Occlusion; Mesenteric Veins; Middle Aged; Pancreatic Neoplasms; Pancreatitis; Portal Vein; Postoperative Complications; Punctures; Retrospective Studies; Self Expandable Metallic Stents; Treatment Outcome; Ultrasonography, Doppler, Color

The femoropopliteal arteries are subjected to considerable axial and bending deformity due to flexion at the hip and knee joints. The Supera helical interwoven nitinol stent system (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Tex) has good conformability and flexibility, with a very low incidence of mechanical fatigue. This study reviewed our experience with the use of Supera stents for femoropopliteal atherosclerotic lesions and identified risk factors for restenosis or occlusion.. Patients with symptomatic femoropopliteal atherosclerotic diseases who underwent lower limb angioplasty and Supera stent insertion were studied. All patients had regular clinical follow-up and underwent a Doppler ultrasound examination at 3 months and then every 6 months, and radiography of the stents at 6, 12, 18, 24, 30, and 36 months. Patency rates were analyzed using Kaplan-Meier curves. We also evaluated the prospectively maintained cohort to identify predictors of restenosis.. From October 2011 to December 2014, 164 legs in 153 symptomatic patients (96 male, 57 female) with femoropopliteal occlusive disease, with mean age of 76.7 years (range, 46-100 years), were included. Ninety-five patients (58%) had claudication, nine (5%) had rest pain, and 60 (37%) had tissue loss. Disease distribution was 64 proximal superficial femoral arteries (SFAs; 39%), 107 middle SFAs (65%), 127 distal SFAs (77%), 78 above-knee popliteal arteries (48%), and 19 below-knee popliteal arteries (12%). Lesion classification by TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A, B, C, and D was 49 (30%), 79 (48%), 31 (19%), 3 (1%), respectively. The mean lesion length was 105.6 mm (range, 3-400 mm), and more than one Supera stent was inserted in 26 patients. Procedure success (residual stenosis <30%) was achieved in 100% of procedures. The primary patency rates (>50% patency) at 6, 12, 24, and 30 months were (±standard error) 86.7% ± 3.1%, 81.4% ± 3.7%, 79.9% ± 4.0%, and 77 ± 3.0%, respectively. The ankle-brachial pressure index increased from 0.57 ± 0.15 preoperatively to 0.87 ± 0.14 postoperatively. No stent fractures occurred. There were three 30-day deaths not related to the procedure or device, one major amputation 3 months after revascularization, and 29 late deaths (>30 days) of unrelated medical causes in follow-up. In-stent restenosis was associated with younger patient age and with dyslipidemia, long lesion, and stent length.. Our midterm experience showed that the implantation of the helical interwoven nitinol stents in patients with femoropopliteal occlusive disease is safe and effective, with encouraging patency rates and clinical results.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Hong Kong; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Radiography; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

Placement of self-expandable nitinol stents is useful for the treatment of esophageal and upper gastrointestinal (GI) obstruction. However, complications such as stent migration, tumor overgrowth, and bleeding occur. Although stent migration and tumor overgrowth are well documented in previous studies, the occurrence of bleeding has not been fully evaluated.. To evaluate the incidence, management strategies, and predictors of bleeding after placement of self-expandable nitinol stents in patients with esophageal and upper GI obstruction.. We retrospectively reviewed the medical records and results of computed tomography and endoscopy of 1485 consecutive patients with esophageal and upper GI obstructions who underwent fluoroscopically guided stent placement.. Bleeding occurred in 25 of 1485 (1.7%) patients 0 to 348 days after stent placement. Early stent-related bleeding occurred in 10 patients (40%) and angiographic embolization was used for 5/10. Late bleeding occurred in 15 patients (60%) and endoscopic hemostasis was used for 7/15. Twenty-two of 25 (88%) patients with bleeding had received prior radiotherapy and/or chemotherapy.. Bleeding is a rare complication after placement of expandable nitinol stents in patients with esophageal and upper GI obstruction, but patients with early bleeding may require embolization for control. Care must be exercised on placing stents in patients who have received prior radiotherapy or chemotherapy.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Embolization, Therapeutic; Esophageal Stenosis; Esophagoscopy; Female; Fluoroscopy; Gastrointestinal Hemorrhage; Hemostasis, Surgical; Humans; Incidence; Male; Middle Aged; Patient Selection; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Tomography, X-Ray Computed; Tracheal Stenosis; Treatment Outcome

Widespread use of self-expanding nitinol stent-based endovascular treatment (EVT) for femoropopliteal (FP) lesions has been fueled by its less-invasive nature and modest durability; however, prevalence, predictors and prognosis of in-stent occlusion are undefined and were investigated here.. This study entailed a multicenter, retrospective analysis of a prospectively maintained database. Between January 2004 and December 2011, 2447 de novo FP lesions (mean length, 143 ± 87 mm; 52% chronic total occlusions) from 2008 patients (mean age, 73.0 ± 9.2 years; 71% male; 61% diabetics; 32% critical limb ischemia; and 24% on hemodialysis) were treated with nitinol stent-based EVT. Study outcome was in-stent occlusion: rates (1, 3, and 5 years), predictors and association with limb prognosis.. In-stent occlusion rate was 5.2%, 11.2%, and 16.4% at 1, 3, and 5 years, respectively (mean follow-up, 2.3 ± 1.7 years). Female sex, critical limb ischemia, and Transatlantic Inter-Society Consensus II class C/D (multivariate Cox proportional hazard ratio [HR], 1.75, 1.49, and 3.34, respectively) were independent predictors of in-stent occlusion after FP stenting, which was associated with poor limb prognosis (major amputation, HR 6.35; major adverse limb event, major adverse limb event, HR, 21.1).. Moderate in-stent occlusion rates were observed after nitinol stent-based EVT. Closer attention is warranted with high-risk cases because of poorer limb prognosis.

Topics: Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Incidence; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Multicenter Studies as Topic; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Recurrence; Registries; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome

Removal of biliary Fully Covered Self Expandable Metal Stents can fail due to stent migration and/or hyperplastic ingrowth/overgrowth.. A case series of 5 patients with benign biliary strictures (2 post-cholecystectomy, 2 following liver transplantation and 1 related to chronic pancreatitis) is reported. The biliary stricture was treated by temporary insertion of Fully Covered Self Expandable Metal Stents. Stent removal failed due to proximal stent migration and/or overgrowth. Metal stent removal was attempted a few weeks after the insertion of another Fully Covered Metal Stent into the first one.. The inner Fully Covered Self Expandable Metal Stent compressed the hyperplastic tissue, leading to the extraction of both the stents in all cases. Two complications were reported as a result of the attempt to stents removal (mild pancreatitis and self-limited haemobilia).. In the present series, the "SEMS in SEMS" technique revealed to be effective when difficulties are encountered during Fully Covered Self Expandable Metal Stents removal.

Topics: Aged; Alloys; Bile Duct Diseases; Bile Ducts; Cholangiopancreatography, Endoscopic Retrograde; Cholecystectomy, Laparoscopic; Constriction, Pathologic; Device Removal; Female; Humans; Liver Transplantation; Male; Middle Aged; Pancreatitis; Prosthesis Failure; Stents

The indication for use of drug-eluting stents (DES) in lower limb arteries is still undefined. We report our series of patients treated with Zilver PTS DES, in treating in-stent restenosis (ISR) and Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC) C/D femoropopliteal lesions.. The Zilver PTX DES is a self-expanding nitinol stent with a polymer-free Paclitaxel coating. Patients with symptomatic de novo TASC C/D lesions or IRS lesions of femoropopliteal segment were eligible for enrollment. We evaluated patients at one month, six months and one year after treatment. We used clinical evaluation criteria and US Doppler for primary and secondary patency-free rates.. From November 2010 to November 2012, we treated 69 patients with DES Zilver PTX. Indication to treat was given in 36 lesions (52%) by an ISR and in 33 cases (48%) by a TASC C/D lesion. Lesions were staged in the superficial femoral artery (SFA) level in 59 patients (85.6%), in the popliteal artery in 6 patients (8.7%), in a femoropopliteal bypass in 4 patients (5.7%). The mean follow-up was 5.3 months (range 1-24). At 12 months the overall primary patency was 85.5%, secondary patency 89.8% and limb salvage 100%.. Zilver PTX DES seems to be effective in treating TASC C/D lesions and ISR in femoropopliteal lesions at short term. Therefore DES should be recommended when treating those complex lesions.

Topics: Aged; Aged, 80 and over; Alloys; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Female; Humans; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Paclitaxel; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

To report experience with the novel interwoven-wire self-expanding nitinol SUPERA stent (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Texas) for the treatment of severely diseased superficial femoral and popliteal arteries.. Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA stents (n = 80 patients [98 limbs]; mean age, 70.8 y; 80% male) were retrospectively identified. Patients were followed for an average of 14.3 months after intervention.. Total occlusions were present in 39% of the lesions, 21% had tissue loss, and 61% demonstrated calcification on fluoroscopy. Patients were prescribed dual antiplatelet therapy (aspirin and clopidogrel) for at least 30 days unless contraindicated, followed by aspirin alone indefinitely. The mean (± SD) lesion length was 143 mm (± 98). Based on need for clinical intervention, primary patency was 96.9% at 6 months and 85.8% at 12 months (Kaplan-Meier estimates). Assisted primary patency and secondary patency rates at 12 months were 96.8% and 100%, respectively. Ankle-brachial index increased from 0.60 at baseline to 0.83 at last follow-up (P < .001). No stent fractures were found by fluoroscopy inspection in 19 limbs (16 patients) that required reintervention.. Based on experience with multiple operators at a single clinical center, the interwoven nitinol stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.

Topics: Aged; Aged, 80 and over; Alloys; Ankle Brachial Index; Aspirin; Clopidogrel; Constriction, Pathologic; Drug Therapy, Combination; Endovascular Procedures; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Radiography; Retrospective Studies; Severity of Illness Index; Stents; Ticlopidine; Time Factors; Treatment Outcome; Vascular Patency

Maintaining vascular access in patients undergoing chronic hemodialysis is a challenging process, especially in patients enduring multiple central line placements and in whom peripheral options have been exhausted.. We present a case of a 60-year-old male without options for peripheral vascular access due to multiple failed arteriovenous fistulas for hemodialysis. Furthermore, bilateral subclavian, brachiocephalic veins and iliac veins were occluded or significantly obstructed. After long segment central vein recanalization, an upper arm loop arteriovenous graft was implanted. The recanalized segment was stented with a 12-mm dedicated venous nitinol stent.. Chronic central vein obstructions demand stents with both high radial force and flexibility. We recommend dedicated venous stents to improve technical success and reduce stent-related complications like early re-occlusion due to fracturing, kinking or straightening.

Topics: Alloys; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Brachiocephalic Veins; Catheterization, Central Venous; Constriction, Pathologic; Humans; Kidney Failure, Chronic; Male; Middle Aged; Phlebography; Prosthesis Design; Renal Dialysis; Stents; Subclavian Vein; Treatment Outcome; Upper Extremity; Vascular Patency

To evaluate the 1-year patency of the 4-F Pulsar-18 self-expanding nitinol stent for treatment of femoropopliteal occlusive disease in a national, prospective, multicenter, all-comers registry.. Between January and June 2012, the German PEACE I all-comers prospective registry enrolled 148 patients with symptomatic femoropopliteal lesions (Rutherford category 2-5) undergoing recanalization and implantation of the Pulsar-18 SE nitinol stent at 6 clinical centers. Thirty patients did not have the 12-month follow-up visit (18 declined reevaluation, 5 withdrew consent, and 7 died), leaving 118 patients (64 men; mean 71.9±9.6 age years) for the 1-year evaluation. The average lesion length was 111.5±71.4 mm, and 38 of the 118 lesions were classified as TASC II D. More than half the lesions (67, 56.7%) were chronic total occlusions (CTO). The popliteal segment was involved in 22 (18.7%) lesions. The mean stented length was 122.7±64.5 mm. Routine follow-up included duplex ultrasound at 6 and 12 months. Outcome measures were primary patency and no clinically driven target lesion revascularization (TLR) within 12 months.. The overall primary patency rates after 6 and 12 months were 87.4% and 79.5%, respectively; in the popliteal segments, the rate was 71.4% after 12 months. The overall freedom from TLR was 93.2% after 6 months and 81% after 12 months. Ankle-brachial index, pain-free walking distance, and Rutherford category all improved significantly (p<0.0001) after 6 and 12 months. The primary patency rates in patients with diabetes (p=1.0) and those with renal insufficiency (p=0.8) were not significantly lower compared to the overall rate. There was no significant difference (p=0.67) in restenosis rate for recanalization of CTOs compared to non-CTO lesions.. In this all-comers registry, the use of the Pulsar-18 self-expanding nitinol stent in femoropopliteal lesions averaging 111.5 mm long showed promising primary patency and freedom from TLR after 6 and 12 months. Diabetes had no negative impact on patency. Primary patency in the popliteal segments was acceptable at 12 months.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Constriction, Pathologic; Disease-Free Survival; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Topics: Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Aorta, Abdominal; Constriction, Pathologic; Device Removal; Foreign-Body Migration; Humans; Iliac Artery; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Stents; Treatment Outcome; Vascular System Injuries

To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants.. Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months.. Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047).. Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.

Topics: Aged; Alloys; Angioplasty, Balloon; Constriction, Pathologic; Female; Femoral Artery; Germany; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Peripheral Arterial Disease; Prospective Studies; Prosthesis Design; Recurrence; Registries; Risk Factors; Sex Factors; Stents; Time Factors; Treatment Outcome

To investigate whether use of intravascular ultrasound (IVUS) improves primary patency following nitinol stenting for TASC II (TransAtlantic Inter-Society Consensus) A-C femoropopliteal lesions.. Using a retrospective multicenter database of 1198 limbs from 965 patients (695 men; mean age 72±9 years) with TASC II A-C lesions (28% critical limb ischemia) treated by provisional stenting from April 2004 to December 2011, primary patency rate was compared between 234 propensity score-matched pairs with vs. without IVUS use.. IVUS was used in 22% (n=268) of the overall population. It was more likely to be used in cases with generally more complicated femoropopliteal lesions (e.g., more severe TASC II class, longer lesion length, and narrower reference diameter). Analysis of the 234 propensity score-matched pairs (mean follow-up 1.9±1.5 years; 142 events) revealed higher 5-year primary patency with than without IVUS use (65%±6% vs. 35%±6%, p<0.001). IVUS resulted in significantly better assisted primary patency (p<0.001), secondary patency (p=0.004), freedom from any reintervention (p<0.001), freedom from any adverse limb event (p<0.001), and event-free survival (p<0.001).. IVUS use in femoropopliteal stenting for TASC II A-C lesions appears to be associated with higher primary patency rate.

Topics: Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Databases, Factual; Disease-Free Survival; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Propensity Score; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Vascular Patency

To report a novel indication for the use of chimney grafts to preserve flow to the inferior mesenteric artery (IMA) in patients undergoing endovascular aneurysm repair (EVAR) for aortobi-iliac aneurysms with coexistent bilateral occlusion of the internal iliac arteries (IIA).. Via a cutdown over the left axillary artery, a 5-F vertebral catheter was delivered over a conventional 0.035-inch hydrophilic guidewire to selectively catheterize the IMA via a 7-F shuttle sheath, which was then advanced at least 2 cm into the target vessel. The first chimney graft was advanced into the sheath, and a standard EVAR procedure followed. The chimney graft was deployed at least 2 cm in the IMA; a second chimney graft was advanced and deployed with at least 2 cm overlapping with the first chimney stent parallel and outside of the main abdominal endograft and below the lowest renal artery. The chimney grafts were lined with additional bare nitinol stents. The technique is demonstrated in two male patients who suffered from symptomatic aortobi-iliac aneurysm with patent IMAs and bilateral IIA occlusion. The procedure was completed successfully in both cases without bowel ischemia. At 12 and 6 months, respectively, the chimney grafts remained patent without endoleak. The patients are asymptomatic.. The IMA chimney endovascular technique can be considered in EVAR cases with coexistent bilateral IIA occlusion to minimize the risk for bowel ischemia.

Topics: Aged; Alloys; Aortic Aneurysm, Abdominal; Aortography; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Endovascular Procedures; Humans; Iliac Artery; Male; Mesenteric Artery, Inferior; Prosthesis Design; Regional Blood Flow; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Counterpulsation; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Prosthesis Failure; Recurrence; Risk Factors; Stents; Tomography, X-Ray Computed; Treatment Outcome

To investigate the 5-year patency rates and predictors of restenosis after self-expanding nitinol stent implantation for chronic total occlusion (CTO) in superficial femoral and proximal popliteal artery (SFPA) lesions.. Outcomes and long-term patency rates after self-expanding nitinol stent for CTO in the SFPA lesions have not been clarified.. From January 2004 to December 2009, 861 serial arteriosclerosis obliterans patients, 1,017 limbs, underwent endovascular therapy with implantation of a self-expanding nitinol stent for SFPA lesions at four institutions in Japan. Of the cohort, 352 patients, 383 limbs, had self-expanding nitinol stents implanted for CTOs in the SFPA and were followed for 5 years. We retrospectively investigated patency rate and multivariate predictors associated with restenosis.. Mean age was 72 ± 9 years and 31% were female patients. In total, 58% of the patients had diabetes mellitus and 25% were patients with critical limb ischemia. Occluded length was 194 ± 89 mm, mean total stent length was 198 ± 7 mm, and mean stent diameter was 7.1 ± 0.9 mm. Five-year primary and secondary patency rates were 51.8 and 79.5%, respectively, and the rates of freedom from bypass surgery, major or minor amputation, and all-cause death were 96.1, 96.2, and 78.4%, respectively. Female gender (odds ratio, 1.95; P = 0.0051) and mean stent diameter (odds ratio, 0.77; P = 0.0324) were factors strongly associated with restenosis.. Women and patients requiring small stents failed to maintain primary patency when treated with self-expanding nitinol stents for CTO lesions in the SFPA. Although primary patency was low, the secondary patency rate was acceptable.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Constriction, Pathologic; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Popliteal Artery; Prosthesis Design; Recurrence; Retrospective Studies; Risk Factors; Sex Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Airway Obstruction; Alloys; Bronchial Diseases; Bronchoscopy; Carcinoma, Squamous Cell; Constriction, Pathologic; Humans; Laser Therapy; Lung Neoplasms; Male; Middle Aged; Neoplasm Staging; Predictive Value of Tests; Prosthesis Design; Stents; Tomography, X-Ray Computed; Tracheal Stenosis; Treatment Outcome

Topics: Alloys; Bronchial Diseases; Ciliary Motility Disorders; Constriction, Pathologic; Humans; Lung Neoplasms; Mucociliary Clearance; Nasal Mucosa; Palliative Care; Prosthesis Design; Quality of Life; Stents

The degeneration of pancreaticoduodenal arcade vessels due to pancreaticoduodenal artery aneurysms is associated with celiac artery stenosis or occlusion. While technical advances have made it possible to treat pancreaticoduodenal arcade aneurysms (PDAA) and celiac artery stenosis by endovascular techniques, there is no consensus regarding their optimal treatment.. To treat pancreaticoduodenal arcade aneurysms (PDAA) by simultaneous coil embolization and celiac artery stenting, and propose indications for treating PDAA with celiac artery stenosis by this method.. We reviewed 11 patients who underwent transcatheter coil embolization (TCE) to treat PDAA. When the aneurysmal neck size was less than half of the short axis of the aneurysm we used packing only, when it was more than half of the short axis we undertook isolation. In the latter situation, when there was evidence of celiac artery stenosis, we performed celiac artery stenting using self-expandable stents.. Ten of the 11 patients (91%) presented with celiac axis stenosis due to median arcuate ligament compression. Coil-packing of the aneurysmal sac only, thus preserving the native arterial circulation, was done in five patients, another five underwent isolation by embolization of vessels distal and proximal to the PDAA with simultaneous stenting of the stenotic celiac axis, and one patient was treated by isolation only. One patient developed acute pancreatitis. There were no other complications and all aneurysms were successfully excluded. In one patient the celiac stent thrombosed after stopping the antiplatelet regimen.. TCE can be effective in patients with PDAA. In the presence of celiac artery stenosis, we recommend isolation of the aneurysms with simultaneous stenting of the stenotic celiac trunk using self-expandable stents.

Topics: Aged; Alloys; Aneurysm; Angioplasty; Celiac Artery; Constriction, Pathologic; Embolization, Therapeutic; Female; Humans; Iopamidol; Male; Middle Aged; Pancreas; Radiographic Image Enhancement; Stents; Treatment Outcome

The clinical impact of stent fractures is still controversial. This study analyzed the incidence and the clinical impact of stent fractures after stenting of long femoropopliteal lesions.. From November 2008 to October 2009, 58 patients (62 limbs) were treated in a single center with a primary nitinol self-expanding stent for Trans-Atlantic Inter-Consensus (TASC) C and D de novo femoropopliteal lesions. Patients were prospectively followed by medical and duplex scan examinations. Stent fractures were assessed by biplane X-rays at 12 months. Logistic regression analysis was performed.. At 1 year a complete follow-up was obtained in 42 limbs/90 stents. The median length of the stented segment was 240 ± 180 cm with a mean of 2.1 (1-4) stents per patient. Sixteen stents (17.8%) were fractured: one type I (asymptomatic); seven type II (2 restenosis); five type III (asymptomatic), and three type IV stent fractures (1 restenosis). Stent diameter (p = .04) and stent implantation in the distal part of the superficial femoral artery (p = .05) were positively associated with stent fractures. Stent fracture had no influence on restenosis.. This study suggests that the high stent fracture rate associated with endovascular treatment of long femoropopliteal lesions should be balanced with its low clinical impact.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prospective Studies; Prosthesis Design; Prosthesis Failure; Radiography; Recurrence; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Aim of the study was to assess the long-term clinical results of primary stent placement in patients with femoro-popliteal lesions and intermittent claudication (IC) or critical limb ischemia (CLI).. Prospectively collected data of 517 patients (543 limbs) treated for IC (N.=422; 77.5%) and CLI (N.=121; 22.5%), between September 2006 and December 2010 were evaluated. Survival, limb salvage and patency rates were analyzed and multivariate analysis was performed to evaluate possible risk factors for the development of restenosis.. Mean patients' age was 70.6 years (SD ±10); 64.8% of the patients (N.=335) were male. Angiography revealed TASC A or B lesions in 64.5% (N.=350), TASC C or D lesions in 35.5% (N.=193) of the patients. Two hundred thirty-two patients had evidence of occluded femoropopliteal artery (42.7%) and the remaining patients had evidence of high grade (>70%) stenosis. In total, 827 bare metal nitinol stents (1.53±0.9 per limb) were used. No early (<30-day) procedure-related death was recorded. After a mean follow-up period of 60 months (SD ±13.5), 69 patients died (13.4%). Eight (1.5%) patients underwent major amputation. The amputation rate was significantly higher in the CLI group compared to the IC group (P=0.03). Primary patency rates were 86.2%, 79.1%, 75.1% and 62.2% after 1, 2, 3 and 5 years, respectively. No difference in terms of patency rates was found between the results of the treatment of TASC A/B versus TASC C/D lesions and the patient groups with IC versus CLI.. The endovascular-first line treatment with use of nitinol stents for patients with femoropopliteal artery lesions is associated with acceptable long-term patency rates, even in patients with long lesions.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Chi-Square Distribution; Constriction, Pathologic; Critical Illness; Endovascular Procedures; Female; Femoral Artery; Germany; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Lower Extremity; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Single center observational study analyzing the primary patency rate and freedom from target lesions revascularization rate of the Pulsar-18 nitinol stent after recanalization of long superficial femoral artery (SFA) occlusions (TASC D) in 22 patients with critical limb ischemia (CLI).. Between 1/2011 and 7/2011, 22 consecutive patients (9 male, 13 female) with chronic total occlusions (CTO) of the femoro-popliteal arteries presenting with CLI (17 patients with Rutherford 4 score, and 5 patients with Rutherford 5 score) were enrolled and successfully recanalized using the Pulsar-18 self-expanding (SE) nitinol stent (BIOTRONIK AG, Buelach, Switzerland). Primary patency at 12 months was defined as no binary restenosis (>50%) on Duplex ultrasound (PSVR<2.5) and respectively no target lesion revascularization performed within 12 months. The average lesion length of the treated femoro-popliteal segment was 315 mm. Performing spot stenting average stent length in all patients was 245 mm (minimal 215 mm, maximal 315 mm).. Technical success, with establishing an antegrade straight line flow to the foot through a reopened SFA, was achieved in all 22 patients. Subintimal and intraluminal recanalization techniques were used. Two patients with Rutherford 5 score had a minor amputation shortly after the recanalization procedure. All other patients had a complete wound healing of their lesions during a 6 month follow-up. After 12 month follow-up the primary patency rate of the Pulsar-18 SE nitinol stent was 77% with a per protocol restenosis in 5 of 22 patients. Seventeen patients showed a walking capacity on treadmill test >300 meters (Rutherford II). Two patients with a documented restenosis were Rutherford, these patients were treated conservatively. Three patients with restenosis and a Rutherford III score were scheduled for an endovascular target lesion revascularization leading to a freedom from target lesion revascularization rate of 86%.. Endovascular intervention of long SFA occlusions using subintimal or intraluminal recanalization technique with implantation of the Pulsar-18 SE nitinol stent in CLI patients is safe and clinically effective with a primary patency rate after 12 months of 77% and a freedom from target lesion revascularization rate of 86%.

Topics: Aged; Alloys; Amputation, Surgical; Angioplasty, Balloon; Chronic Disease; Constriction, Pathologic; Critical Illness; Exercise Test; Exercise Tolerance; Female; Femoral Artery; Germany; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Recovery of Function; Registries; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Wound Healing

This study was designed to investigate the immediate and one-year outcomes of polymer-free paclitaxel coated drug-eluting stent (DES) implantation in a consecutive series of patients presenting with stenosis of infrainguinal bypass grafts.. Between January 2011 and January 2012, 11 patients with failing infrainguinal bypass grafts were treated in two institutions. Clinical status and Duplex scan parameters were recorded at baseline and over a follow-up period of one year.. DES implantation was successfully performed in all patients. Ten patients received a single stent and one patient received two stents. At one year, one patient showed total bypass graft occlusion (9%). In all the remaining patients, Duplex scan examination documented patency of the treated grafts.. DES implantation in failing infrainguinal bypass grafts can be safely performed and provides satisfactory clinical outcomes. The patency rate of 91% favourably compares with those obtained with other endovascular treatments such as plain balloon or cutting balloon angioplasty.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Cardiovascular Agents; Constriction, Pathologic; Drug-Eluting Stents; Female; Graft Occlusion, Vascular; Humans; Italy; Lower Extremity; Male; Middle Aged; Paclitaxel; Prosthesis Design; Prosthesis Failure; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The aim of this study was to collect procedural and clinical data assessing safety and performance of the GORE® TIGRIS® Vascular Stent, a novel dual component stent, made of a nitinol wire frame combined with a fluoropolymer-interconnecting structure.. This retrospective analysis included 32 consecutive patients (20 men, mean age 72.8 years) with 40 atherosclerotic femoropopliteal lesions (occlusions in 5%) who underwent angioplasty and implantation of a GORE® TIGRIS® Vascular Stent. The patients were scheduled for follow-up at 3, 6 and 12 months after stent implantation for Duplex ultrasound and assessment of Rutherford Becker class (RBC) and Ankle-Brachial Index (ABI) RESULTS: The mean implanted stent length was 62.3 mm (range 30-100 mm). Procedural success (residual stenosis <30%) was achieved in 100% of the lesions. At 6 months 2 restenosis in 2 patients were observed, resulting in a cumulative primary patency rate (±standard error) of 91.7±8.0%. Between baseline and 6 months the ABI increased from 0.65±0.18 to 0.96±0.12 (P<0.0001) and the median of RBC increased from 3 to 1.5 (P<0.0005). No stent thrombosis was found.. In this retrospective collection of patients all lesions could be successfully treated with this novel hybrid TIGRIS stent. These preliminary results show promising primary patency rates at 6 months. In addition, significant improvements were observed in symptom classification and hemodynamics.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Topics: Alloys; Cholestasis; Colonic Diseases; Constriction, Pathologic; Duodenal Obstruction; Equipment Design; Esophageal Stenosis; Foreign-Body Migration; Humans; Intestinal Atresia; Postoperative Complications; Stents

To evaluate the efficacy and safety of the EPIC self-expanding nitinol stent in patients with femoropopliteal occlusive disease.. The prospective, multicenter, nonrandomized SUMMIT study (ClinicalTrials.gov identifier NCT01336101) enrolled 100 patients (76 men; mean age 67.6 years) with symptomatic de novo femoropopliteal disease undergoing angioplasty and subsequent implantation of EPIC stents from April 2011 to October 2011. The mean lesion length was 69.5±40.5 mm; 29 of the lesions were total occlusions. Clinical examination and duplex sonography were prospectively performed after 6 and 12 months. The primary endpoint was in-stent restenosis as assessed by duplex ultrasound (peak systolic velocity ratio ≥2.5). Further outcome measures were patency rates, improvement in the Rutherford category and ankle-brachial index (ABI), as well as stent integrity based on plain radiography.. A residual stenosis <30% was achieved in all procedures. The primary patency rates were 96.8% after 6 months and 85.1% at 1 year. The secondary patency rates were 97.9% and 91.2% at the same intervals. The 1-year binary >50% restenosis rate was 15.7%. Freedom from target lesion revascularization at 1 year was 92.3%. Between baseline and the 12-month follow-up, the mean ABI increased from 0.73 to 0.96, and the mean Rutherford category decreased from 2.9 to 1.0 (p<0.001 for both comparisons). Plain radiographs from 86 patients at the 12-month examination confirmed the absence of stent fractures.. The outcome of the SUMMIT registry demonstrates that the EPIC self-expanding nitinol vascular stent is a safe and effective device for treating peripheral artery disease in the femoropopliteal segment.

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Constriction, Pathologic; Female; Femoral Artery; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Registries; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The primary patency of superficial femoral artery (SFA) stents is evaluated by measuring PSVR. However, each trial uses a different definition of PSVR. We investigated the impact of changing PSVR thresholds on the patency rates of SFA recanalisation with self-expanding nitinol stents.. A single-centre retrospective study was conducted. Between 2003 and 2006, 76 consecutive patients (83 limbs) were treated using nitinol self-expanding stents for SFA disease. Primary patency was defined as categories 1 (PSVR <2.0), 2 (PSVR <2.4) and 3 (PSVR <2.85). The mean follow-up time was 51±27 months. For one, five, and seven years, Kaplan-Meier estimates for primary patency rates were 62.6%, 36.8%, and 27.6%, respectively, in category 1; 75.2%, 46.5%, and 37.1%, respectively, in 2; and 75.2%, 46.1%, and 46.1%, respectively, in 3. The primary patency between categories 1 and 3 (p=0.038) was significantly different. No difference was observed between categories 2 and 3 (p=0.786), and a trend for differences was observed between categories 1 and 2 (p=0.069).. PSVR definition may influence the reported long-term patency rate of a SFA stent. We should consider the definition of restenosis in each trial.

Topics: Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Female; Femoral Artery; Follow-Up Studies; Humans; Male; Middle Aged; Retrospective Studies; Stents; Vascular Patency

To elucidate the optimal cutoff and accuracy of duplex ultrasonography (DUS) parameters for in-stent restenosis (ISR) after nitinol stenting in the superficial femoral artery (SFA).. Few data are available regarding the performance of DUS for binary ISR based on quantitative vessel analysis (QVA) in the era of SFA nitinol stenting.. This retrospective study included 74 in-stent stenoses of SFA who underwent DUS before follow-up angiography. DUS parameters, such as peak systolic velocity (PSV) and the peak systolic velocity ratio (PSVR), were compared with percent diameter stenosis (%DS) from a QVA basis.. There was a statistically significant correlation (P < 0.001) between "%DS and PSV" and "%DS and PSVR," and the correlation with %DS proved to be stronger in PSVR (R = 0.720) than in PSV (R = 0.672). The best performing parameter for ISR (50% or greater stenosis) was revealed PSVR, as the areas under the receiver operator characteristics curves using PSVR and PSV were 0.908 and 0.832, respectively. A PSVR cut off value of 2.85 yielded the best predictive value with sensitivity of 88%, specificity of 84%, and accuracy of 86%. The positive predictive value was 85% and the negative predictive value was 88%.. A PSVR of 2.85 is the optimal threshold for ISR after nitinol stenting in the SFA. Further large prospective studies are required for the validation and establishment of uniform criteria for DUS parameters.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Area Under Curve; Blood Flow Velocity; Constriction, Pathologic; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Predictive Value of Tests; Prosthesis Design; Radiography; Recurrence; Regional Blood Flow; Retrospective Studies; ROC Curve; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Intracranial atherosclerosis may be the underlying pathology in up to 15% of ischemic strokes, but may account for about 40% of strokes in some populations. After an ischemic event determined by intracranial atherosclerosis, patients have a 12% annual risk of stroke recurrence, mostly during the first year.. To evaluate procedural safety, clinical outcome and restenosis rate of Wingspan stent placement.. Twenty-one caucasoid patients were enrolled. Target patients were affected by high-grade, symptomatic, intracranial atherosclerotic lesions, were on antithrombotic therapy and at high stroke risk. All patients were treated with the Wingspan stent system.. Technical success resulted 100%, with all target lesions being reduced to <50%. No stroke or death were observed at 30. The mean percent of stenosis was reduced from a middle value of 84% to a middle value of 17% after stent placement. Medium follow-up was 19.5months (range 6-36months). No stroke or death occurred in any patient. None of the patients presented a <50% stent patency rate at follow-up.. The short-term results and follow up analysis provide evidence demonstrating the safety of the Wingspan system when used in high-risk patient population. Due to concerns regarding long-term stent patency and ischemic events occurrence emerged from clinical trials such as the SAMMPRIS, intracranial angioplasty and stent with the Wingspan system should be considered only for high risk patients in which it may be considered the only viable therapeutic option.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Brain Ischemia; Cerebral Angiography; Constriction, Pathologic; Endpoint Determination; Female; Fibrinolytic Agents; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Magnetic Resonance Angiography; Male; Middle Aged; Plaque, Atherosclerotic; Platelet Aggregation Inhibitors; Recurrence; Stents; Stroke; Survival Rate; Tomography, X-Ray Computed; Treatment Outcome

A case of femoral artery obstruction following application of a StarClose type arterial puncture closing device (APCD) is presented. Ultrasonographic and angiographic imaging of this complication was obtained. The posterior wall of the vessel was accidentally caught in the anchoring element of the nitinol clip. This complication was successfully resolved by endovascular treatment and the implantation of a stent.

Topics: Alloys; Arterial Occlusive Diseases; Constriction, Pathologic; Equipment Design; Femoral Artery; Hemostatic Techniques; Humans; Male; Middle Aged; Punctures; Radiography; Stents; Treatment Outcome; Ultrasonography; Vascular Surgical Procedures

We examined the efficacy and durability of a new interwoven self-expanding nitinol stent system in the treatment of complex popliteal artery lesions in unselected patients.. The optimal endovascular treatment strategy for atherosclerotic popliteal artery disease is not known.. We retrospectively analyzed the data gathered in 101 consecutive patients presenting with atherosclerotic, popliteal arterial disease, who underwent implantation of 125 stents. The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI).. The mean age of the patients was 73.1 years, and 52.5% were men. Total occlusions were present in 48 patients (47.5%). The mean stent length was 84.3 ± 45.1 mm (range 40 to 240 mm). A <30% residual stenosis was achieved in 98.0% of procedures. The 6- and 12-month primary patency rates were 94.6 ± 2.3% and 87.7 ± 3.7%, respectively, and the secondary patency rates 97.9 ± 1.5% and 96.5 ± 2.0%, respectively. Between baseline and 12 months of follow-up, mean ABI increased from 0.58 ± 0.15 to 0.97 ± 0.18, and mean RBC decreased from 3.1 ± 0.9 to 1.4 ± 0.8 (p < 0.001 for both comparisons). Radiographs performed on 51 patients, at a mean of 15.2 months, confirmed the absence of stent fractures in 100% of examinations.. Over a 12-month observation period, the patency rate and durability of SUPERA stents implanted for severe popliteal artery disease were high.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Ankle Brachial Index; Constriction, Pathologic; Female; Germany; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Predictive Value of Tests; Prosthesis Design; Radiography; Registries; Retrospective Studies; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Vascular Patency

Restenosis after endovascular treatment for superficial femoral artery (SFA) disease remains a significant clinical issue. We assessed whether cilostazol reduce restenosis after SFA stenting with self-expandable nitinol stent.. The study was a multicenter, prospective maintained database, retrospective analysis. From April 2004 to December 2009, 861 consecutive patients (mean age 71 years, 71% male) who underwent successful stenting for de novo lesions were retrospectively identified. Of them, 492 received cilostazol (cilostazol(+)) and 369 did not receive cilostazol (cilostazol(-)) after procedure. Propensity-score analyses matched 281 cilostazol(+) with 281 cilostazol (-) group. Primary endpoint was binary restenosis rate. Secondary endpoints were reocclusion, all-cause mortality and limb salvage in patients with critical limb ischemia (CLI). Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex.. Mean follow-up period was 25 months. According to analysis of matched pairs, binary restenosis rates were significantly lower (31.2% vs. 42.9% at 5-year, P = 0.02). In-stent re-occlusion rate tended to be lower in patients who received cilostazol (10.8% vs. 18.2% at 5-year, P = 0.09) compared with control. No significant difference of all-cause mortality (21.4% vs. 18.3% at 5-year, P = 0.84) and limb salvage rate in patients with CLI (86.2% vs. 78.5% at 5-year, P = 0.29) was found between both groups. After adjustment for prespecified risk factors, cilostazol was an independent negative predictor of restenosis. In subgroup analysis, male, age <75 years, claudicant patients, TASCII C/D, small vessels and poor runoff vessel was significantly lower in binary restenosis.. Cilostazol reduced restenosis after SFA stenting with self-expandable nitinol stent and it seems to be more effective in high-risk patients for restenosis.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Chi-Square Distribution; Cilostazol; Constriction, Pathologic; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Limb Salvage; Logistic Models; Male; Matched-Pair Analysis; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Platelet Aggregation Inhibitors; Propensity Score; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Secondary Prevention; Stents; Tetrazoles; Time Factors; Treatment Outcome

Non-vascular drug-eluting stents have been studied for the treatment of gastrointestinal cancer and cancer-related stenosis. In this study, we designed and evaluated a gemcitabine (GEM)-eluting covered nonvascular stent. Polyurethane (PU)/polytetrafluoroethylene (PTFE) film was selected for the drug loading and eluting membrane. The membrane was fabricated by dip-coating on a Teflon bar (∅; 10mm), air-dried, peeled off and applied to a self-expanding Nitinol stent. Various amounts of poloxamer 407 (PL, Lutrol F127, BASF) (8%, 10%, or 12% of PU by weight) were added to control the release of GEM from membranes. The membrane containing 12% PL (GEM-PU-PL12%) showed the most favourable release properties; 70% of the loaded GEM released within 35 days, including the 35% released during the initial burst. The biological activities of GEM-PU-PL12% were evaluated using human cholangiocarcinoma cells (SK-ChA-1). GEM-PU-PL12% most efficiently inhibited the proliferation of cholangiocarcinoma cells and most highly induced pro-inflammatory cytokines (TNF-α, IL-1β and IL-12) and p38 MAPKs in the cells. Subtumoural insertion of the GEM-PU-PL12% membrane more efficiently inhibited the growth of CT-26 colon cancer than other membranes. In this study, the GEM-eluting metal stents covered with PU-PL12% showed considerable feasibility for the treatment of malignant gastrointestinal cancer as well as cancer-related stenosis.

Topics: Alloys; Animals; Antimetabolites, Antineoplastic; Cell Count; Cell Proliferation; Cell Survival; Colonic Neoplasms; Constriction, Pathologic; Cytokines; Deoxycytidine; Drug-Eluting Stents; Gastrointestinal Neoplasms; Gemcitabine; Humans; Membranes, Artificial; Mice; p38 Mitogen-Activated Protein Kinases; Poloxamer; Polymers; Polytetrafluoroethylene; Polyurethanes

Percutaneous transluminal angioplasty (PTA) with stent deployment of infrapopliteal arteries is an accepted but unproven therapy for patients with critical limb ischemia (CLI). We evaluated the safety and effectiveness of the Xpert™ self-expanding nitinol stent (Abbott Vascular, Redwood City, CA) in Rutherford Class 4-6 subjects with infrapopliteal lesions of 4-15 cm in length.. 120 patients (140 limbs, 212 implanted devices) underwent primary infrapopliteal nitinol stent deployment as part of this multicenter registry. The primary endpoint was 12-month amputation-free survival (AFS); secondary endpoints included limb salvage, target lesion revascularization (TLR), 6- month angiographic patency, and 6- and 12-month outcomes of wound healing and pain relief. Despite a 6-month binary stent restenosis rate of 68.5%, the 12-month AFS rate was 78.3%. Stratified according to baseline Rutherford classes 4, 5 and 6, the 12-month AFS rates were 100%, 77.3%, and 55.2%, respectively, and freedom from major amputation rates were 100%, 90.9%, and 70.1%, respectively. The 12-month freedom from major amputation rate and clinically driven TLR were 89.6% and 70.1%, respectively. The 6- and 12-month complete wound-healing rates were 49.0% and 54.4%, respectively. Rutherford class 4 patients had significant pain relief through 12-months (P<0.05).. Primary infrapopliteal nitinol stenting to treat CLI is safe and effective in improving 6-and 12-month clinical outcomes.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Constriction, Pathologic; Critical Illness; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Pain; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; Treatment Outcome; United States; Vascular Patency; Wound Healing

To evaluate efficacy, safety, and midterm patency of a helical, self-expanding nitinol stent after failed percutaneous transluminal angioplasty (PTA) of popliteal artery segments P1 and P2 in patients with chronic critical limb ischemia (CLI) or lifestyle-limiting claudication.. Between February 2009 and March 2011, 40 patients (23 men; mean age 77±10 years) classified as Rutherford category 3 (n = 10) or 4/5 (n = 30) underwent PTA of the proximal and mid popliteal artery followed by implantation of a SUPERA stent for elastic recoil, residual stenosis, or flow-limiting dissection. All patients had an elevated operative risk. Before and after the procedure and during the 12-month follow-up, a clinical investigation, ankle-brachial-index (ABI) measurement, and color-coded duplex sonography and/or digital subtraction angiography were performed. Primary endpoints were limb salvage and anatomical patency at 12 months.. Stent implantation was successful in all patients. The major complication rate was 7.5% (an access-site pseudoaneurysm, 2 retroperitoneal hematomas, and 1 death from retroperitoneal bleeding). Mean follow-up was 15.9 months (range 0.5-27.9). The mean baseline ABI of 0.37 significantly increased to 0.91 at 12 months (p<0.01). Three (7.5%) patients underwent bypass surgery owing to lack of clinical improvement (<0.10 improvement in ABI). Primary and secondary patency rates at 12 months in the 34 patients eligible for follow-up were 68.4% and 79.8%, respectively. The major amputation rate was 5% at 1 year. Five (12.5%) in-stent stenoses and 1 of 2 (5.0%) in-stent occlusions were successfully recanalized (the second occlusion was asymptomatic).. Implantation of this helical stent into segments of the popliteal artery at the knee joint in CLI patients is a safe and clinically effective bailout method with acceptable intermediate patency.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Constriction, Pathologic; Critical Illness; Female; Germany; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Magnetic Resonance Angiography; Male; Middle Aged; Popliteal Artery; Prosthesis Design; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

To evaluate the clinical efficacy of EverFlex stents (length, 6-20 cm) for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA).. Over a period of 18 months, 56 SFA lesions in 53 patients were treated with an EverFlex stent. The following parameters were documented before the intervention, immediately afterward, and 12 months later: clinical stage, ankle-brachial index, and peak systolic velocity ratio (PSVR). The primary study endpoint was the primary patency rate after 12 months (defined as a PSVR < 2.5).. In 18% of the 56 lesions, complete occlusions were present. Mean lesion length was 9.4 cm ± 5.3, and mean stent length was 12.6 cm ± 5.6. Of the 53 patients enrolled in the study, a 12-month follow-up was performed in 46. The primary patency rate after 12 months was 71.7%. In-stent restenosis or occlusion occurred in 13 patients. Compared with the total study group, the mean stent length in these 13 patients was greater (14.0 cm ± 7.3) and the incidence of de novo lesions was lower. In the patient group with stents less than 10 cm in length (n = 24), six patients (25%) required a repeat intervention, compared with seven patients (32%) in the group with stents longer than 12 cm.. Although the primary patency rate associated with the EverFlex stent is comparable to those in published data, the present results demonstrate a higher percentage of in-stent stenoses in patients in whom longer SFA stents were implanted.

Topics: Aged; Alloys; Ankle Brachial Index; Blood Flow Velocity; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Recurrence; Regional Blood Flow; Retrospective Studies; Stents; Time Factors; Treatment Outcome; Vascular Patency

To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117).. Between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed.. In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure.. The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Chi-Square Distribution; Chile; Constriction, Pathologic; Disease-Free Survival; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Israel; Life Tables; Male; Middle Aged; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recurrence; Registries; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Aged; Alloys; Aneurysm, False; Angiography, Digital Subtraction; Arterial Occlusive Diseases; Constriction, Pathologic; Endovascular Procedures; Femoral Artery; Humans; Male; Prosthesis Design; Stents; Treatment Outcome

The aim of the present study was to assess the mid-term patency rate of nitinol stent implantation in patients with long superficial femoral artery (SFA) stenosis or occlusion. This is a retrospective, single-center study.. The data of 138 patients were retrospectively assessed in our center to determine the patency rate after nitinol stenting of the SFA.. Data for 165 limbs from 138 patients were collected. Each limb showed a long lesion with a total occlusion of >10 cm and mean lesion length of 20.35 ± 9.46 cm (range, 10-32 cm). Nitinol self-expanding stent implantations were performed in each limb. A total of 258 stents were implanted into 165 limbs (average, 1.56 stents/limb). Each patient received clinical and ultrasound/computerized tomographic angiography/magnetic resonance angiography evaluations before the procedure and underwent clinical status evaluation and an ankle-brachial index test at discharge and at 12, 24, and 36 months thereafter.. The initial technical success rate of revascularization was 91.51% (151/163). During follow-up, nine patients died because of myocardial infarction, cerebral infarction, and pneumonia, and 14 patients were lost to follow-up. The mean follow-up period for 150 limbs from 124 patients was 25.46 months (range, 6-51). During follow-up, 19 in-stent restenoses and 15 occlusions were diagnosed. In all, 30 re-interventions were performed, including six balloon angioplasties, three secondary cutting balloon angioplasties, 10 restenting procedures, four bypass surgeries, two bone marrow stem cell transplantations, and five limb amputations. Analysis showed the primary patency rates at 12, 24, and 36 months were 92.4%, 78.3%, and 62.1%, respectively, and the overall assisted-primary patency rates were 94.4%, 84.6%, and 75.8%, respectively.. Nitinol self-expanding stent implantation seems to be a good choice for older patients with long SFA occlusions. Although the short- and mid-term patency results were good, more observations are needed to assess its long-term efficiency.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; China; Constriction, Pathologic; Critical Illness; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Magnetic Resonance Angiography; Male; Middle Aged; Prosthesis Design; Recurrence; Retrospective Studies; Stem Cell Transplantation; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency; Vascular Surgical Procedures

To investigate the use of an expanded polytetrafluoroethylene-coated nitinol stent-graft in patients with failing hemodialysis access circuits and compare grafts with and without a heparin-coated surface.. A single-institution retrospective review of 16 patients (average age, 55 years; seven men) treated for hemodialysis access circuit stenoses was performed. Patients had a prosthetic arteriovenous (AV) graft (n = 10) or autogenous AV fistula (n = 6), all with clinically relevant access stenoses that were refractory to angioplasty alone; 10 patients also had access circuit thrombosis at the time of treatment. Stents were placed in the basilic (n = 4), brachial (n = 7), cephalic (n = 4), and femoral (n = 1) veins. Study endpoints included primary treatment area patency, primary circuit patency, primary assisted circuit patency, and secondary circuit patency, followed to a maximum of 6 months.. Primary treatment area patency rates at 30 days and 180 days were 75% and 31%, respectively. Secondary patency rates at the same time points were 88% and 68%, respectively. Mean primary treatment area patency was 93 days. Thrombosis was a major cause of failure, occurring in seven of 11 cases of primary treatment area patency loss. Subgroup analysis demonstrated that the heparin-coated configuration (n = 7) showed a 6-month primary patency rate of 57%, compared with 11% for the stent-grafts without heparin bonding (n = 9; P = .06).. Overall, the majority of deployed stent-grafts lost primary patency within 6 months, with thrombosis a major cause of failure. However, the addition of a heparin-coated surface appeared to improve results in these otherwise treatment-refractory access circuits.

Topics: Adult; Aged; Alloys; Angioplasty; Anticoagulants; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Graft Occlusion, Vascular; Heparin; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polytetrafluoroethylene; Prosthesis Design; Renal Dialysis; Retrospective Studies; Secondary Prevention; Stents; Time Factors; Treatment Outcome; Vascular Patency; Venous Thrombosis

We sought to investigate the timing of restenosis and the restenosis factors following nitinol stenting in the superficial femoral artery (SFA).. Restenosis following nitinol stenting in the SFA remains unsolved.. We analyzed 742 limbs in consecutive 585 patients who underwent successful endovascular therapy for de novo SFA lesions. Patency was assessed by duplex ultrasonography. Primary patency was defined as treated vessels without restenosis and secondary patency was defined as target vessels reopened by repeat revascularization. Receiver-operating characteristic (ROC) analysis was performed to delineate the timing of restenosis. Patients were subsequently classified into three groups: no restenosis, early restenosis, and late restenosis. Cox proportional hazard regression analyses were performed to explore the determinants of restenosis in each restenosis group.. Primary and secondary patency was 67 and 86% at 6 years, respectively. ROC curves indicated the 369th day was the best cutoff point distinguishing the early (144 limbs) and the late (42 limbs) restenoses. Sustained patency was observed in 556 limbs. After multivariate analysis, cilostazol (P = 0.0007) was negatively associated; female gender (P = 0.0071), diabetes mellitus (P = 0.0428), critical limb ischemia (P = 0.0435), and stent fracture (P = 0.0004) were positively associated with the early restenosis. Trans Atlantic Inter-Society Consensus II C/D was positively associated with both the early (P = 0.0017) and the late (P = 0.0359) restenoses.. Restenosis predominantly occurred within a year following nitinol stenting in the SFA, and the factors associated with the early restenosis were different from those with the late restenosis.

Topics: Aged; Aged, 80 and over; Alloys; Arterial Occlusive Diseases; Chi-Square Distribution; Constriction, Pathologic; Endovascular Procedures; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Proportional Hazards Models; Prosthesis Design; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable nitinol stent in the superficial femoral artery (SFA).. This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful nitinol stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group.. The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P < .0001 and P < .0001, respectively). Overall survival rates were 96.8%, 89.5%, and 81.8% in the low-risk group; 91.5%, 74.4%, and 68.7% in the moderate-risk group; and 78.2%, 63.2%, and 48.7% in the high-risk group at 1, 3, and 5 years, respectively. There were also significant differences in mortality (P < .0001).. New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable nitinol stenting for SFA disease.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Arterial Occlusive Diseases; Chi-Square Distribution; Constriction, Pathologic; Diabetes Complications; Female; Femoral Artery; Health Status Indicators; Humans; Ischemia; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Predictive Value of Tests; Prosthesis Design; Registries; Renal Dialysis; Retrospective Studies; Risk Assessment; Risk Factors; Severity of Illness Index; Sex Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ).. The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites.. Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months.. These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Canada; Cardiovascular Agents; Constriction, Pathologic; Disease-Free Survival; Drug-Eluting Stents; Endovascular Procedures; Europe; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Recovery of Function; Recurrence; Republic of Korea; Severity of Illness Index; Time Factors; Treatment Outcome; Vascular Patency

To evaluate safety and results of the Freepac drug-eluting balloon (DEB) technology for the treatment of chronic femoropopliteal steno-occlusions.. In a multicentre registry we enrolled 66 patients with symptomatic femoropopliteal stenosis and/or occlusion <15 cm (Rutherford stages 2 to 4). Patients were treated first with an undersized uncoated balloon and then with an appropriate sized DEB. In case of unsatisfactory results, nitinol stents were implanted. Clinical evaluations and echo-duplex were performed at baseline, at discharge, and at three months after intervention. Procedural success was 100%. Stents were implanted in 10.8% of the patients. At three months follow-up, the mean ankle-brachial index (ABI) significantly improved from 0.58 ± 0.13 to 0.82 ± 0.25, thus resulting in a Rutherford class improvement (p <0.01) and amelioration of the claudication distance (102 ± 87 vs. 403 ± 160 meters) (p<0.001). No serious adverse events occurred during the follow-up.. The results of this registry demonstrate the safety of mediated paclitaxel elution for the prevention of restenosis in the superficial femoral and popliteal arteries after angioplasty. This technique was associated with encouraging results in terms of clinical improvement as well as a lack of adverse events, including target lesion revascularisation, at three months.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Arterial Occlusive Diseases; Cardiovascular Agents; Coated Materials, Biocompatible; Constriction, Pathologic; Drug Delivery Systems; Equipment Design; Female; Femoral Artery; Humans; Italy; Male; Middle Aged; Paclitaxel; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Registries; Stents; Time Factors; Treatment Outcome

To evaluate the feasibility of using covered stents vs. bare stents in a model of central vein stenosis with an arteriovenous graft created to mimic the conditions in hemodialysis patients.. In 7 mongrel dogs, an expanded polytetrafluoroethylene-covered nitinol stent was placed in one common iliac vein and a bare stent was placed in the contralateral vein. Arteriovenous grafts were created bilaterally between the common femoral artery and vein to induce endothelial damage. Neointima formation in the covered stents was compared to the bare stents at 12 weeks using microscopy and histochemical staining.. Two dogs were excluded due to thrombosis and infection of the arteriovenous grafts, but all stents in the remaining 5 dogs were patent. Smooth, complete neointimal coverage was observed on the inner surface of all the covered stents without intraluminal thrombus. In contrast, incomplete neointimal coverage was seen in all bare stents, with small focal thrombi adhering to the neointima on 3 bare stents. Focal nodular neointimal hyperplasia with denudation of the endothelium was observed in only 2 bare stents. Mean neointimal thickening was significantly greater in the covered stents. Eccentric neointimal thickening was observed at the inflow and outflow segments of both types of stents.. Covered stents are technically feasible for the treatment of central vein stenosis, and they demonstrate complete, smooth neointimal coverage in normal central veins, but they also display greater neointimal thickening than bare stents.

Topics: Alloys; Animals; Arteriovenous Anastomosis; Blood Vessel Prosthesis; Constriction, Pathologic; Disease Models, Animal; Dogs; Feasibility Studies; Femoral Artery; Iliac Vein; Neointima; Polytetrafluoroethylene; Prosthesis Design; Renal Dialysis; Stents

We evaluated the effectiveness of a double-layered polytetrafluoroethylene (PTFE)-covered nitinol stent in the palliative treatment of malignant esophageal strictures. A double-layered PTFE-covered nitinol stent was designed to reduce the propensity to migration of conventional covered stent. The stent consists of an inner PTFE-covered stent and an outer uncovered nitinol stent tube. With fluoroscopic guidance, the stent was placed in 32 consecutive patients with malignant esophageal strictures. During the follow-up period, the technical and clinical success rates, complications, and cumulative patient survival and stent patency were evaluated. Stent placement was technically successful in all patients, and no procedural complications occurred. After stent placement, the symptoms of 30 patients (94%) showed improvement. During the mean follow-up of 103 days (range, 9-348 days), 11 (34%) of 32 patients developed recurrent symptoms due to tumor overgrowth in five patients (16%), tumor ingrowth owing to detachment of the covering material (PTFE) apart from the stent wire in 3 (9%), mucosal hyperplasia in 2 (6%), and stent migration in 1 (3%). Ten of these 11 patients were treated by means of placing a second covered stent. Thirty patients died, 29 as a result of disease progression and 1 from aspiration pneumonia. The median survival period was 92 days. The median period of primary stent patency was 190 days. The double-layered PTFE-covered nitinol stent seems to be effective for the palliative treatment of malignant esophageal strictures. We believe that the double-layer configuration of this stent can contribute to decreasing the stent's migration rate.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Coated Materials, Biocompatible; Constriction, Pathologic; Equipment Design; Esophageal Neoplasms; Esophageal Stenosis; Esophagus; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polytetrafluoroethylene; Radiography; Radiology, Interventional; Recurrence; Stents; Survival Analysis; Treatment Outcome; Vascular Patency

The aim of the study was to investigate long-term incidence of stent fractures and patency after femoropopliteal stenting.. Sixty consecutive patients (mean age 70 + or - 7 years) were treated with implantation of single (31 patients) or multiple (29 patients) self-expandable nitinol SMART stents (Cordis, Miami, Florida, USA; mean stent length 108.8 + or - 73 mm) between year 2000 and 2005. At a mean follow-up of 66 + or - 20 months, 37 patients (85% men, mean age 71 + or - 7 years) were alive and underwent plain radiograph and color-coded duplex sonography. A peak systolic velocity was measured proximally, intrastent and distally.. Stent fractures were detected by radiograph in three of the 39 (7.7%) legs (mean stented segment 207 + or - 64 mm). In one case, a moderate strut fracture was associated with in-stent occlusive restenosis confirmed by angiography. Color-coded duplex sonography revealed a mean in-lesion peak systolic velocity of 73 + or - 35 cm/s, six (15%) in-stent restenoses and four (11%) total occlusions. Primary patency rate 5 years after nitinol SMART stent implantation was 74.6%. Patients symptomatic for claudication or presenting with diagnosis of in-stent restenosis underwent angiography.. Long-term femoral SMART stenting showed minimal incidence of fractures compared with previously published data with different stent types. In-stent restenosis and occlusive restenosis seem to be correlated with stented segment length.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty; Arterial Occlusive Diseases; Blood Flow Velocity; Constriction, Pathologic; Equipment Failure Analysis; Female; Femoral Artery; Humans; Italy; Male; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Radiography; Recurrence; Regional Blood Flow; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

A 66-year-old man was treated for disabling right leg calf claudication with angioplasty and stenting of a chronically occluded superficial femoral artery. During attempted subintimal passage, the guidewire tracked extralumenally, which was not recognized, but it was successfully redirected into the true lumen distal to the occlusion with the use of the Outback (Cordis Endovascular, Miami Lakes, Fla) re-entry device. A bare metal nitinol stent was initially deployed extralumenally in the perivascular soft tissue. The patient returned for reintervention 9 days later complaining of pain and discoloration of the popliteal space. Duplex evaluation of the superficial femoral artery revealed a pseudoaneurysm, and Viabahn stent grafts (W. L. Gore & Assoc, Flagstaff, Ariz) were successfully deployed to produce an endovascular percutaneous prosthetic bypass.

Topics: Aged; Alloys; Aneurysm, False; Angioplasty, Balloon; Arterial Occlusive Diseases; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Chronic Disease; Constriction, Pathologic; Femoral Artery; Humans; Intermittent Claudication; Male; Prosthesis Design; Stents; Treatment Outcome; Ultrasonography, Doppler, Duplex

This study evaluated the durability of nitinol stent placement in high-risk patients with chronic critical limb ischemia (CLI) and infrapopliteal lesions after suboptimal balloon angioplasty.. Between January 2006 and January 2009, 53 high-risk patients (24 women; mean age, 71.8 +/- 5.1 years) with CLI underwent infragenicular stent placement with a 4F sheath-compatible self-expanding nitinol stent. Patients had three or more serious cardiopulmonary comorbidities, including chronic obstructive pulmonary disease, congestive heart failure, coronary artery occlusive disease, American Society of Anesthesiologists score >/=3, previous myocardial infarction, coronary stent or bypass, or infection after peripheral revascularization. Endovascular therapy was performed in 30 stenoses and 23 occlusions in 53 patients. The mean stenosis length was 5.5 +/- 1.9 cm. The mean occlusion length was 6.5 +/- 2.9 cm. The mean follow-up was 24.1 +/- 7.3 months and consisted of clinical examination, ankle-brachial index (ABI) measurements, and duplex ultrasound imaging. Digital subtraction angiography was performed if restenosis or reocclusion was suspected.. The technical success rate was 98.1%. The 24-month cumulative primary patency rate was 75.5%. During the follow-up, two patients underwent successful repeat angioplasty, and four patients required crural bypass. The 24-month secondary patency and freedom from amputation rates were 88.7% and 88.7%, respectively. The mean ABI increased significantly at 12 and 24 months (P < .001). Risk stratification to detect predictors that influenced the patency rate showed that proximal lesions had significant better patency than distal crural lesions (83.3% vs 65.2%, P = .04). The morphology of the lesions (stenoses vs occlusions, P = .88) did not seem to influence primary patency. Four patients died from nonprocedure-related causes during the follow-up, including lung cancer, myocardial infarction, and glioblastoma multiforme. No procedure-related deaths were recorded.. The 2-year outcome of our series underscores the value of infrapopliteal nitinol stent placement as a durable bailout treatment option in high-risk CLI patients with suboptimal angioplasty.

Topics: Aged; Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle Brachial Index; Constriction, Pathologic; Critical Illness; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Lower Extremity; Male; Peripheral Vascular Diseases; Prosthesis Design; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency; Vascular Surgical Procedures

Long-term clinical outcomes after femoropopliteal (FP) stenting with nitinol stents have not yet been clear. We investigated the mid-term efficacy of FP stenting with nitinol stents.. This study was a multicenter retrospective study. From April 2004 to December 2008, 511 consecutive patients (639 limbs; mean age 71 +/- 7 years; 71% male) who underwent successful FP stenting with nitinol stents for de novo lesions were retrospectively selected and analyzed in this multicenter study. All patients had a minimum follow-up of 6 months. Restenosis was defined as >2.4 of peak systolic velocity ratio by duplex or >50% stenosis by angiogram. Primary patency was defined as treated vessels without restenosis and repeat revascularization. Secondary patency was defined as target vessels that become totally occluded and are reopened by repeat revascularization.. Sixty-one percent of the patients had diabetes, 76% were claudicant, and 20% were on hemodialysis. Mean lesion length was 151 +/- 75 mm. Mean follow-up period was 22 +/- 11 months. Primary patency was 79.8%, 66.7%, and 63.1%, and secondary patency was 90.4%, 87.3%, and 86.2% at 1, 3, and 5 years, respectively. During the follow-up period, 53 patients (10%) died. Of them, cardiovascular death was 38% and stent fracture had occurred in 14%. On multivariate analysis by Cox proportional hazard ratio, cilostazol administration (hazard ratio [HR], 0.52;P < .0001), stent fracture (HR, 1.6; P = .03), hemodialysis (HR, 1.7; P = .01), and Trans Atlantic Inter-Society Consensus (TASC) II class C/D (HR, 2.4; P < .0001) were the independent predictors of primary patency after successful FP stenting.. Clinical efficacy of nitinol stent implantation for FP disease was favorable for up to 5 years.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chi-Square Distribution; Constriction, Pathologic; Female; Femoral Artery; Humans; Japan; Kaplan-Meier Estimate; Male; Middle Aged; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Radiography; Recurrence; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The authors report the case of a patient with acute lower limb ischemia (category IIa) after occlusion of the popliteal artery due to fracture of a long indwelling stent. The patient refused surgical therapy for religious reasons, and an interventional revascularization was performed as acute rescue therapy. After reentry into the distal popliteal artery was achieved, the artery was dilated, and the fragmented stent was crushed, followed by implantation of two helical nitinol stents with high radial force and a third self-expandable nitinol stent. Sufficient primary technical success was achieved, and stent patency was present at midterm follow-up.

Topics: Acute Disease; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Humans; Ischemia; Lower Extremity; Magnetic Resonance Angiography; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Stents; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

The potential role of AERO tracheobronchial covered stents in the management of recurrent postinfectious strictures of the bronchus intermedius was studied in three lung transplant recipients. Six devices were inserted. Five of the stents migrated immediately on placement. Buildup of thick mucus was observed in all stents remaining in the airway for longer than 1 week. Strictures recurred in all patients 1, 3, and 5 months after stent deployment. Attempts at stent retrieval were successful for three of five devices. The use of AERO stents may not offer a therapeutic advantage versus balloon dilation of bronchus intermedius strictures in lung transplant recipients.

Topics: Adult; Aged; Airway Obstruction; Alloys; Bronchial Diseases; Bronchoscopy; Catheterization; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Foreign-Body Migration; Humans; Lung Transplantation; Male; Middle Aged; Polyurethanes; Prosthesis Design; Recurrence; Stents; Time Factors; Treatment Outcome

Percutaneous revascularization of superficial femoral artery (SFA) is increasingly carried out to treat patients with peripheral vascular disease and either intermittent claudication or critical limb ischemia. Transradial vascular access is increasingly adopted for invasive procedures due to reduced access-site complications and improved patient's comfort, compared with transfemoral. However, compared with coronary interventions, the adoption of transradial access in peripheral procedures is limited. Concerning SFA interventions, transradial access is usually prevented by the distance between the vascular access and the target lesion, which extends over the length of the currently available devices. Thanks to technical improvements, resulting in specifically dedicated low-profile equipment with adequate shaft length availability, transradial access is now feasible for the treatment of selected SFA lesions. We report the first two cases of SFA stenting performed by transradial access with a new specifically developed self-expanding nitinol stent with extended delivery system length. This report suggests that, with proper technique and specifically dedicated equipment, transradial SFA stenting is feasible. Treatment of SFA disease by transradial route, allowing for immediate post-procedure walking and simultaneous bilateral interventions, may represent an alternative for effective treatment of selected patients with SFA lesions.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Catheters; Constriction, Pathologic; Equipment Design; Femoral Artery; Humans; Male; Middle Aged; Prosthesis Design; Radial Artery; Radiography; Stents; Treatment Outcome

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Catheters; Constriction, Pathologic; Equipment Design; Femoral Artery; Humans; Prosthesis Design; Radial Artery; Radiography; Stents; Treatment Outcome

To evaluate the effectiveness of nitinol stent placement in long infrapopliteal lesions in patients with critical limb ischaemia.. Between January 2005 and January 2008, 34 high-risk patients (18 female; mean age: 73.8+/-6.1 years) with critical limb ischaemia underwent infragenicular stenting. They had serious cardiovascular co-morbidities (>3, such as chronic obstructive pulmonary disease (COPD), congestive heart failure and coronary artery occlusive disease), American Society of Anaesthesiologists score of 3 or more, previous myocardial infarction, coronary stent or bypass. The mean stenosis length was 6.5+/-0.9 cm (range: 2.2-8 cm), and the mean occlusion length was 7.5+/-2.9 cm (range: 3-9.6 cm). Primary stent implantation was performed for long stenosis or occlusion based on the TransAtlantic InterSociety Consensus (TASC) C and D classification, secondary stenting for flow-limiting dissections or elastic recoil after balloon dilatation. All patients who returned to the outpatient clinic were assessed for claudication by clinical examination, ankle-brachial index (ABI) measurements, colour flow and duplex Doppler ultrasound (US). Digital subtraction angiography was performed if restenosis or re-occlusion was identified by Doppler US or transcutaneous measurement of partial oxygen pressure (TcpO(2)) measurements, when appropriate.. The technical success rate was 97.1% (33 of 34 cases). The crude rate of primary patency rate was 91.1% during a follow-up period of 10.4+/-7.3 months. The mean ankle-brachial index increased significantly following intervention (0.45+/-0.25-0.92+/-0.13, p<0.001). Two patients underwent successful redo angioplasty after tibioperoneal interventions due to in-stent restenosis (>70%) with relevant limitation of pain-free walking distance. In another patient, bypass surgery to the anterior tibial artery 6 months after primary intervention was necessary due to rest pain. Two patients required surgical revision of the femoral artery after antegrade access. No procedure-related death was recorded in the entire follow-up period.. The mid-term outcome underscores infrapopliteal stent placement as a reliable treatment option in patients with critical limb ischaemia. In patients at high risk for crural bypass, with no flow-limiting supragenicular lesions, below-knee stent-supported angioplasty should be considered as a first choice of treatment.

Topics: Aged; Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Ankle; Arterial Occlusive Diseases; Blood Gas Monitoring, Transcutaneous; Blood Pressure; Brachial Artery; Constriction, Pathologic; Critical Illness; Feasibility Studies; Female; Humans; Ischemia; Lower Extremity; Male; Patient Selection; Popliteal Artery; Prosthesis Design; Recurrence; Regional Blood Flow; Retrospective Studies; Risk Assessment; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Critical Illness; Hemodynamics; Humans; Ischemia; Lower Extremity; Patient Selection; Popliteal Artery; Prosthesis Design; Recurrence; Risk Assessment; Stents; Time Factors; Treatment Outcome; Vascular Patency

An increasing spectrum of complex peripheral arterial disease may be successfully treated using percutaneous revascularization techniques. A pair of challenging peripheral revascularization procedures in patients with critical limb ischemia is presented, where an array of interventional tools and techniques were required, and the off-label use of the Boomerang catalyst system closure device was important in managing a variety of complex arterial access issues and ultimately allowing procedural success.

Topics: Aged; Alloys; Amputation, Surgical; Angiography, Digital Subtraction; Angioplasty, Balloon; Anticoagulants; Arterial Occlusive Diseases; Coated Materials, Biocompatible; Constriction, Pathologic; Critical Illness; Equipment Design; Female; Hemostatic Techniques; Hemostatics; Humans; Ischemia; Leg; Male; Middle Aged; Stents; Treatment Outcome

Over the last decade, the number of endovascular procedures performed on the superficial femoral (SFA) and popliteal arteries (PA) has significantly increased. There is no consensus on the optimal form of intervention used in this arterial segment. While some have advocated balloon angioplasty alone, others have championed either selective or primary stenting of these lesions. It is the purpose of this study to determine the efficacy and durability of primary stenting of the superficial femoral and popliteal artery.. All patients undergoing peripheral angioplasty by a single vascular surgeon were prospectively enrolled in an Institutional Review Board-approved, primary-stenting protocol. During a 44-month period, all patients undergoing percutaneous transluminal angioplasty of the SFA or PA also received primary arterial stenting with bare, self-expanding nitinol stents. Patient demographics and risk factors were identified. TransAtlantic InterSociety Consensus (TASC) classifications were determined for all lesions. Loss of primary patency was said to have occurred when an occlusion or a 50% or greater stenosis in any treated arterial segment was diagnosed by arterial duplex or angiography. Only time to loss of primary patency was recorded. Kaplan-Meier survival curves were plotted and differences between groups tested by log rank method.. Between January 16, 2004 and August 13, 2007, 201 angioplasties with primary stenting were performed on 161 patients. One hundred twenty-three stents were placed for claudication, and 78 for critical limb ischemia. Forty-six segments treated were TASC A, 82 were TASC B, 38 were TASC C, and 35 were TASC D. Patient follow-up ranged from three to 1329 days (mean: 426 days). Primary patency rates for TASC A and B lesions were 79%, 67%, and 57% at 12, 24, and 36 months. For TASC C and D lesions, primary patency rates were 52.7%, 36%, and 19% at the same time intervals. Primary patency rates for TASC A and B lesions were significantly higher than for C and D lesions (P < .001). The limb salvage rate was 88.5% in patients with critical limb ischemia. Distal runoff did not influence patency (P = .827).. Primary stenting of the SFA and PA provides durable results in patients with TASC A and B lesions and may be an effective treatment strategy. This approach is significantly less effective when used in treating those with TASC C and D disease. Based on the results in this series, the use of primary stenting does not extend the anatomic limits of the current treatment recommendations for catheter-based intervention in patients with infrainguinal occlusive disease.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Patient Selection; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Radiography; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography; Vascular Patency

To evaluate the safety and feasibility of self-expandable stents (OptiMed) for treatment of abdominal aortic stenosis in the situations in which the aortic stenosis locates near the origin of celiac, superior mesenteric, renal and inferior mesenteric arteries.. Five consecutive patients scheduled for endovascular treatment of abdominal aortic stenosis by self-expandable nitinol stent (Sinus-Aorta/OptiMed) implantation. The diameter of the stent was chosen as 10-30% more than that of the normal portion of the aorta above the stenosis. Long stents of 60 mm or longer were chosen. After stent deployment, balloon postdilation was performed with a balloon in patients with residual gradient > 5 mm Hg.. All patients were successfully treated with the OptiMed stents. The balloon predilation was performed in one patient due to severe stenosis. The mean diameter and length of the stents deployed were 20.4 +/- 2.9 (range, 16-24 mm) and 64 +/- 8.9 (range, 60-80 mm), respectively. The balloon postdilation was performed in all cases. The mean diameter of the balloons was 13.6 +/- 1.5 (range, 12-15 mm). The mean diameter of stenosis increased from 4.8 +/- 1.9 to 14.4 +/- 1.8 mm after stent placement. The mean peak systolic gradient decreased from 46.8 +/- 31.5 mm Hg to 0.8 +/- 1.8 mm Hg. During follow-up (22.8 +/- 14.3 months), none of the patients had restenosis within the stent, occlusion of any branches of the aorta, or other related complications.. In our small series, we observed that abdominal aortic stenosis can be successfully and effectively treated with OptiMed stents in the situations in which the stenotic segment is located next to the origins of the main visceral branches of abdominal aorta.

Topics: Adult; Aged; Alloys; Angioplasty, Balloon; Aorta, Abdominal; Aortic Coarctation; Aortography; Constriction, Pathologic; Feasibility Studies; Female; Humans; Male; Middle Aged; Prosthesis Design; Regional Blood Flow; Severity of Illness Index; Stents; Tomography, X-Ray Computed; Treatment Outcome

We investigated the time course of stent patency in the femoro-popliteal artery for as long as 4 years.. Stent fracture has been related to poor 2-year patency in the femoro-popliteal artery.. We studied 239 consecutive patients who underwent provisional de novo stenting with nitinol stents for 333 limbs (Luminexx stent [C. R. Bard, Inc., Murray Hill, New Jersey] in 91 limbs; Smart stent [Cordis Corp., Miami Lakes, Florida] in 242 limbs) from April 2004 to December 2007. Stent fracture was determined by X-ray with multiple projections. Patency was assessed by duplex ultrasonography as peak systolic velocity ratio <2.4 or by angiography (% diameter stenosis <50%). Primary patency in those with and without stent fracture at follow-up was assessed along with factors influencing stent fracture.. Primary patency was 81%, 74%, 68%, and 65% at 1, 2, 3, and 4 years, respectively. Stent fracture occurred in 14% (78 of 544) per stent and 17% (55 of 333) per limbs. Stent fracture was significantly associated with multiple stent deployments (with fracture = 2.3 +/- 0.9 stents vs. without fracture = 1.5 +/- 0.7 stents, p < 0.001) and long lesions (with fracture = 208 +/- 84 mm vs. without fracture = 121 +/- 79 mm, p < 0.001). Primary patency was 68% with fracture versus 83% without fracture at 1 year, p = 0.03; 65% versus 75% at 2 years, p = 0.05; 61% versus 69% at 3 years, p = 0.06; and 61% versus 65% at 4 years, p = 0.07. Neither type 1 nor type 3 fracture affected patency, although type 2 showed the worst patency.. Stent fracture worsened the patency during the first 2 years, but it did not apparently affect patency beyond 2 years. In particular, complete stent separation did not affect patency.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Female; Femoral Artery; Humans; Kaplan-Meier Estimate; Male; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Radiography; Retrospective Studies; Severity of Illness Index; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty; Arteriovenous Shunt, Surgical; Blood Vessel Prosthesis; Brachiocephalic Veins; Constriction, Pathologic; Female; Graft Occlusion, Vascular; Humans; Kidney Failure, Chronic; Male; Middle Aged; Recurrence; Renal Dialysis; Stents; Treatment Outcome; Ultrasonography, Doppler; Vascular Diseases; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Popliteal Artery; Prosthesis Design; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

Although percutaneous transluminal angioplasty (PTA) has become a common therapeutic standard for peripheral artery disease (PAD), high restenosis rates in the superficial femoral artery (SFA) remain a major problem. Nitinol stent implantation is reported to reduce restenosis in SFA after PTA in the general population; however, little is known about whether the nitinol stent improves primary patency after PTA in hemodialysis patients who are at higher risk of revascularization failure. The aim of this study was to clarify the effects of nitinol stent implantation for primary patency in SFA after PTA in hemodialysis patients with PAD.. Eighty consecutive hemodialysis patients (167 SFA lesions) who underwent PTA with nitinol stents from January 2006 to January 2008 were compared with 64 hemodialysis patients (128 SFA lesions) who received stainless steel stents in the preceding 2 years. In the follow-up study to 2 years, incidence of restenosis, amputation, and all-cause mortality were analyzed. End points between the groups were examined with the Kaplan-Meier and log-rank methods. Prognostic values for end points were calculated by a Cox univariate analysis and Cox multivariable regression models. To statistically minimize the differences in each stent group, a propensity-matched analysis was also performed using the model including male gender, age, diabetes, hypertension, hyperlipidemia, smoking, incidence of ulcer/gangrene, and TransAtlantic Inter-Society Consensus (TASC) type C+D.. The 2-year primary patency rate was 58% in the nitinol group vs 42% in the stainless steel group (hazard ratio [HR], 0.58; 95% confidence interval [CI], 0.39-0.84; P = .0045), despite a higher prevalence of TASC C+D lesion in the nitinol group (68% vs 49%, P = .0014). In 108 lesions matched after propensity score analysis, the primary patency for 2 years was 64% in the nitinol group vs 42% in the stainless steel group (HR, 0.39; 95% CI, 0.24-0.65; P = .0003). Cox multivariate models showed nitinol stent (HR, 0.42; 95% CI, 0.25-0.73; P = .002), age (HR, 1.04; 95% CI, 1.01-1.08; P = .031), and incidence of ulcer/gangrene (HR, 2.35; 95% CI, 1.17-4.75; P = .017) were independent predictors of restenosis.. These data suggest that nitinol stent implantation improves primary patency in SFA after PTA compared with the stainless steel stent, even in hemodialysis patients with PAD.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Proportional Hazards Models; Prosthesis Design; Renal Dialysis; Retrospective Studies; Risk Assessment; Risk Factors; Stainless Steel; Stents; Time Factors; Treatment Outcome; Vascular Patency

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Prosthesis Design; Stents; Treatment Outcome; Vascular Patency

Self-expanding metal stents (SEMSs) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. The use of colonic larger-diameter SEMSs may improve bowel function and reduce migration risk.. To evaluate the effectiveness and safety of a novel large-diameter SEMS (WallFlex) designed for delivery through the endoscope in treating malignant colonic obstruction.. Prospective clinical cohort study.. Two Italian study centers.. Forty-two consecutive patients with malignant colonic obstruction: 23 requiring palliation and 19 bridging to surgery.. Colorectal SEMS placement.. Technical success, defined as accurate SEMS deployment across the stricture on the first attempt; clinical success, ie, complete relief of bowel obstruction without complications; and bridging to surgery, denoting the performance of elective one-stage surgery.. The rate of technical success was 93% (95% CI, 81%-99%) and of initial clinical success was 95% (95% CI, 84%-99%). In 58% (95% CI, 40%-84%) of the palliation group, clinical success was maintained after 6 months. All 19 patients with operable tumors were successfully bridged to one-stage elective surgery within a median of 5 days. One perforation and one stent migration occurred. All complications could be resolved nonsurgically.. No control group was included.. In a prospective study of through-the-scope WallFlex stent placement for malignant colonic obstruction, high rates of technical and initial clinical success, and bridging to surgery were achieved. Complications could be readily managed.

Topics: Adenocarcinoma; Aged; Aged, 80 and over; Alloys; Colon, Sigmoid; Colonic Neoplasms; Constriction, Pathologic; Female; Humans; Intestinal Obstruction; Male; Middle Aged; Prospective Studies; Prosthesis Design; Sigmoid Diseases; Stents

To evaluate the efficacy and safety of an expanded polytetrafluoroethylene-fluorinated ethylene-propylene (ePTFE/FEP)-covered metallic stent in the management of malignant biliary obstruction. Eighty consecutive patients with malignant common bile duct strictures were treated by placement of 83 covered metallic stents. The stent-graft consists of an inner ePTFE/FEP lining and an outer supporting structure of nitinol wire. Clinical evaluation, assessment of serum bilirubin and liver enzyme levels were analyzed before biliary drainage, before stent-graft placement and during the follow-up period at 1, 3, 6, 9 and 12 months. Technical success was obtained in all cases. After a mean follow-up of 6.9+/-4.63 months, the 30-day mortality rate was 14.2%. Survival rates were 40% and 20.2% at 6 and 12 months, respectively. Stent-graft patency rates were 95.5%, 92.6% and 85.7% at 3, 6 and 12 months, respectively. Complications occurred in five patients (6.4%); among these, acute cholecystitis was observed in three patients (3.8%). A stent-graft occlusion rate of 9% was observed. The percentage of patients undergoing lifetime palliation (91%) and the midterm patency rate suggest that placement of this ePTFE/FEP-covered stent-graft is safe and highly effective in achieving biliary drainage in patients with malignant strictures of the common bile duct.

Topics: Aged; Aged, 80 and over; Alloys; Antibiotic Prophylaxis; Cholangiography; Cholestasis; Coated Materials, Biocompatible; Common Bile Duct Neoplasms; Constriction, Pathologic; Female; Humans; Liver Function Tests; Male; Middle Aged; Palliative Care; Pancreatic Neoplasms; Polytetrafluoroethylene; Postoperative Complications; Prosthesis Design; Stents; Survival Rate

To evaluate the frequency, clinical significance, and predictive factors of membrane degradation of covered stents in the upper gastrointestinal (UGI) tract.. From 1996 to 2006, 166 stents were removed from 151 patients. Indications for stent removal included temporary stent placement for esophageal cancer before radiation therapy or radiation-chemotherapy (n = 53), stent migration (n = 40), temporary stent placement for a benign UGI stricture (n = 32), pain (n = 21), recurrent obstruction (n = 16), incomplete stent expansion (n = 1), recurrent transesophageal fistula (n = 2), and aspiration (n = 1). Removed stents were examined to evaluate possible causes of membrane degradation. Multivariate analysis was performed to determine the predictive factors of membrane degradation.. Degradation of the covering membrane occurred in 14 of the 166 stents (8%). Recurrent obstruction due to tumor ingrowth (n = 7) and reopening of the transesophageal fistula (n = 1) through the degraded membrane occurred in eight stents (5%). At multivariate logistic regression analysis, the type of covering membrane (P = .018), stricture location (P = .006), and duration of stent placement (P = .002) were significantly associated with degradation of the covering membrane.. Degradation of the covering membrane after stent placement in the UGI tract is not an uncommon event, and recurrent obstruction or fistula can occur through the degraded membrane. A polyurethane membrane is not biostable and dissolves over time, particularly in the gastroduodenal area.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Device Removal; Female; Gastrointestinal Diseases; Humans; Logistic Models; Male; Middle Aged; Polytetrafluoroethylene; Prospective Studies; Prosthesis Failure; Stents; Upper Gastrointestinal Tract

We describe a case of symptomatic common femoral artery stenosis following use of a vascular clip closure device (StarClose). Operative repair was performed, with removal of the clip device and subsequent vein patch angioplasty.

Topics: Adult; Alloys; Angioplasty; Arterial Occlusive Diseases; Constriction, Pathologic; Coronary Angiography; Device Removal; Equipment Design; Female; Femoral Artery; Hemorrhage; Hemostatic Techniques; Humans; Intermittent Claudication; Punctures

Topics: Alloys; Angioplasty; Arterial Occlusive Diseases; Constriction, Pathologic; Coronary Angiography; Device Removal; Equipment Design; Evidence-Based Medicine; Femoral Artery; Hemorrhage; Hemostatic Techniques; Humans; Intermittent Claudication; Patient Selection; Punctures; Risk Assessment

To evaluate the technical success and initial clinical safety and effectiveness of the use of a Y-shaped metallic stent for complex stenoses involving the carina.. Thirty-five consecutive patients with complex tracheobronchial stenoses involving the carina were treated with an integrated self-expandable inverted Y-shaped metallic stent and delivery system. The Y-shaped metallic stents were placed in the tracheobronchial tree with fluoroscopic guidance. Technical success, clinical success, Hugh-Jones classification, and complications were assessed during follow-up.. The delivery of the integrated self-expandable Y-shaped metallic stent in the carinal areas was technically successful and well-tolerated in all patients. Clinical success was achieved in 31 patients (89%) 1-7 days after stent placement; the procedure failed in four patients (11%). The improvement between pre- and postoperative Hugh-Jones classification grade was statistically significant (P<.001). During follow-up (mean follow-up, 192 days+/-169), all stenoses were resolved, and general physical examination of the 31 patents showed improvement with no obvious dyspnea or bleeding. Twenty-one patients were healthy without evidence of dyspnea, and the remaining 14 patients died (mean survival, 189 days+/-172) at the time of this report. The mean and median survival periods were 217 days+/-30 and 215 days+/-108, respectively. The mean and median stent patency periods were 216 days+/-30 and 215 days+/-119, respectively.. Deployment of an integrated, self-expandable inverted Y-shaped metallic stent with the delivery system was a safe and effective procedure for the treatment of complex tracheobronchial stenoses involving the carina.

Topics: Aged; Aged, 80 and over; Alloys; Bronchial Diseases; Constriction, Pathologic; Contrast Media; Female; Fluoroscopy; Humans; Iohexol; Male; Middle Aged; Prosthesis Design; Radiography, Interventional; Stents; Tracheal Stenosis; Treatment Outcome

Despite being commercially available for a few years now, the literature regarding the outcome of Ultraflex stent insertion in complex malignant airway stenoses is sparse.. To assess long-term complications and survival in patients with complex malignant airway stenoses treated with insertion of nitinol stents.. 60 consecutive patients with Ultraflex stent insertion for malignant airway stenoses were included. Follow-up was obtained in all patients.. 62 Ultraflex stents (covered = 51, uncovered = 11) were implanted in 60 patients. Diagnoses were bronchial carcinoma (n = 50), esophageal carcinoma (n = 3) and metastases (n = 7). Stents were inserted in the trachea (n = 5), main bronchi/intermediate bronchus (n = 22), from main bronchi/intermediate bronchus to lobar bronchi (n = 28) or in the lobar bronchi themselves (n = 7). Successful reopening of the stenoses and relief were achieved in all patients. There was no procedure-related mortality. Complications included mucous plugging in 8%, stenosing granulation tissue in 5%, tumor ingrowth in 5% and stent migration in 5% of patients. Using Kaplan-Meier estimates, the overall mean survival was 160 days (standard error: 30). Median survival was 91 days. The overall 3- and 6-month survival were 52 and 20%, respectively. Death (n = 59, 98%) was attributed mainly to disease progression with cachexia and metastases, pneumonia (n = 5, 10%), and hemoptysis (n = 1, 2%).. Ultraflex stents have a low complication rate and can be effectively used in complex malignant airway stenoses with marked asymmetry or irregularity, angulation or changing diameters.

Topics: Adult; Aged; Airway Obstruction; Alloys; Bronchial Neoplasms; Carcinoma; Constriction, Pathologic; Female; Humans; Male; Middle Aged; Retrospective Studies; Stents; Survival Analysis

A metallic stent for tracheobronchial stenosis provides a possible solution for poststenting complications such as sputum retention. We describe our experience with a novel anatomy-conforming metal stent placement at the carina.. A windowed stent was designed to match the tracheobronchial anatomy. The lateral window was used as a passage from the trachea to the contralateral main bronchus.. Six windowed stents were placed in 6 patients (mean age, 52.3 years). Two patients received an additional short straight stent placed in the contralateral bronchus, forming an overall Y stent at the carina. All patients had immediate relief from respiratory distress, and no sputum retention or stent migration occurred during the subsequent treatment period. Follow-up data showed that 4 patients are still alive. One patient died 2 months after stent placement of postradiation hemoptysis, and another died of metastasis 14 months after stent placement.. This anatomy-conforming metal stent has several advantages and its application in carinal stenosis is both effective and safe.

Topics: Adult; Alloys; Bronchial Diseases; Bronchoscopy; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Constriction, Pathologic; Dyspnea; Equipment Design; Female; Humans; Lung Neoplasms; Male; Middle Aged; Palliative Care; Respiratory Insufficiency; Stents; Tomography, X-Ray Computed; Tracheal Neoplasms; Tracheal Stenosis

Topics: Adult; Alloys; Bronchial Diseases; Carcinoma, Small Cell; Carcinoma, Squamous Cell; Constriction, Pathologic; Equipment Design; Female; Humans; Lung Neoplasms; Male; Middle Aged; Palliative Care; Stents; Tracheal Neoplasms; Tracheal Stenosis

The incidence of hematometra caused by cervical stenosis after conization is <1%. Nevertheless, if dilatation was unsuccessful, further therapy often remains unclear, and the clinical consequences can be severe, including hysterectomy.. Case report.. University hospital.. A 33-year old patient who developed recurrent cervical stenosis with consecutive hematometra after two conizations during lactation amenorrhea that could not be treated by dilatation and insertion of a temporary plastic catheter according to the manufacturer's instructions.. Insertion of a coated nitinol stent in the cervical canal after dilatation and hysteroscopic removal of the hematometra.. Normal menstruation, future pregnancy.. The patient was free of symptoms, had a normal menstruation, and has become pregnant.. The insertion of a coated vessel stent in the uterine cervix appears to be a valid alternative in patients with recurrent cervical stenosis and hematometra after conization to preserve childbearing function.

Topics: Adult; Alloys; Cervix Uteri; Constriction, Pathologic; Female; Fertility; Hematometra; Humans; Infertility, Female; Recurrence; Stents; Uterine Cervical Diseases

Topics: Alloys; Cholestasis; Constriction, Pathologic; Female; Humans; Hypersensitivity, Immediate; Middle Aged; Nickel; Stents

The present report describes three young adults with nutcracker syndrome caused by left renal vein stenosis managed with nitinol stent implantation. The patients treated included a 20-year-old woman with persistent microhematuria and dyspareunia and two 18-year-old men with proteinuria, hematuria, and flank pain. All three patients were asymptomatic after a follow-up of 14-18 months.

Topics: Adolescent; Adult; Alloys; Aorta, Abdominal; Constriction, Pathologic; Drug-Eluting Stents; Dyspareunia; Female; Hematuria; Humans; Male; Mesenteric Artery, Superior; Peripheral Vascular Diseases; Proteinuria; Renal Veins

To assess the safety and clinical effectiveness of the parallel placement of covered retrievable expandable metallic stents in the palliative treatment of malignant esophageal and tracheobronchial strictures.. Under fluoroscopic guidance, parallel stents were placed in 12 symptomatic patients with both malignant esophageal and tracheobronchial strictures. Seven of these 12 patients also had an esophagorespiratory fistula (ERF) and one patient had an esophagocutaneous fistula. Technical success, clinical improvement, complications, and survival rates were evaluated.. A total of 28 esophageal and airway stents were successfully placed. The grade of dysphagia and dyspnea score significantly decreased after stent placement (P=0.002 and 0.003, respectively). ERF and esophagocutaneous fistula were sealed off in all eight patients after esophageal stent placement; however, the esophagocutaneous fistula reopened 1 month later. Complications included stent migration or expectoration (n=3), tracheal compression by the esophageal stent (n=3), new fistula development due to covering membrane degradation of the esophageal stent (n=1), and symptomatic sputum retention (n=1). Stent removal was easily performed for two stents; one migrated stent and the other with covering membrane degradation. All 12 patients died within the mean survival period of 72.50 days (range 7-375 days).. Parallel placement of covered retrievable expandable metallic stents is safe and effective for the palliative treatment of malignant esophageal and tracheobronchial strictures.

Topics: Adult; Aged; Alloys; Bronchial Diseases; Constriction, Pathologic; Esophageal Fistula; Esophageal Stenosis; Esophagus; Female; Follow-Up Studies; Head and Neck Neoplasms; Humans; Lung Neoplasms; Male; Middle Aged; Palliative Care; Postoperative Complications; Radiography; Retrospective Studies; Stents; Survival Rate; Trachea; Tracheal Stenosis; Treatment Outcome

To evaluate the safety and clinical effectiveness of placement of covered retrievable expandable metallic stents in seven children with tracheobronchial obstruction.. Using bronchoscopic and fluoroscopic guidance, stent placement was performed in seven children (median age, 12 y; range, 2 mo-14 y). The stents were electively removed 6 months after placement or whenever there were symptom-producing complications. During the follow-up period, technical and clinical success, complications and related reinterventions, and long-term prognosis were retrospectively evaluated.. Stent placement was technically successful for a total of eight stents in all seven patients. Stent removal was also successful for six stents in five patients; two stents were removed electively 6 months after placement, and four stents were removed due to symptom-producing complications. Clinical success defined as ventilator weaning, extubation, or dyspnea improvement was achieved in all patients 1 week after stent placement. A possible infection source in one stent and abundant granulation tissue caused by three stents necessitated removal of four stents in three patients. During the mean follow-up period of 18.7 months (range, 1-31 mo) after stent placement, three patients died due to the progression of underlying cardiopulmonary disease or malignancy. There were no deaths directly related to stent placement or related complications.. Although the findings were based on a small series, placement of covered retrievable expandable metallic stents seems to be safe and effective for the treatment of pediatric tracheobronchial obstruction. Ventilator weaning, extubation, or dyspnea improvement was possible in all patients after stent placement.

Topics: Adolescent; Alloys; Bronchial Diseases; Bronchoscopy; Catheterization; Child; Child, Preschool; Constriction, Pathologic; Device Removal; Female; Fluoroscopy; Humans; Imaging, Three-Dimensional; Infant; Male; Prognosis; Radiography, Interventional; Respiratory Function Tests; Retrospective Studies; Stents; Tomography, X-Ray Computed; Tracheal Stenosis; Treatment Outcome

To evaluate the clinical effectiveness of polytetrafluoroethylene (PTFE)-covered retrievable expandable nitinol stents in tracheobronchial strictures.. With fluoroscopic guidance, PTFE-covered retrievable expandable nitinol stents were placed in 15 symptomatic patients with benign (n = 6) or malignant (n = 9) tracheobronchial strictures. Complications and improvement in respiratory status were evaluated. Stents were removed electively 6 months after placement in benign strictures or if complications occurred. Membrane degradation or separation from the wire mesh was evaluated in removed stents.. A total of 17 stents were successfully placed and were well tolerated in all patients. Sputum retention, stent migration, and tissue hyperplasia occurred in 23.5% (n = 4), 17.6% (n = 3), and 17.6% (n = 3) of stents, respectively. A total of 11 stents were successfully removed electively 6 months after placement (n = 4) or when complications occurred (n = 7). All 11 such stents were removed without difficulty with use of standard techniques, antecedent balloon dilation being necessary in two cases as a result of tissue hyperplasia. No removed stent showed signs of membrane degradation, and two removed stents showed signs of membrane separation from the mesh.. PTFE-covered retrievable expandable nitinol stents were effective in the treatment of tracheobronchial strictures. Stent removal was easy with use of standard techniques, and no removed stent showed evidence of membrane degradation.

Topics: Adolescent; Adult; Aged; Alloys; Bronchial Diseases; Child; Child, Preschool; Constriction, Pathologic; Device Removal; Female; Fluoroscopy; Humans; Infant; Male; Middle Aged; Polytetrafluoroethylene; Radiography, Interventional; Stents; Tracheal Stenosis; Treatment Outcome

We developed a technique for laparoscopic ureterocalicostomy with the use of intracorporeal suturing and subsequently simplified the technique by application of experimental Nitinol clips.. We performed laparoscopic ureterocalicostomy on 16 domestic swine divided into four groups of four animals each. The kidney was exposed laparoscopically, and the renal artery was atraumatically clamped. The lower pole of the kidney was amputated to expose a lower-pole calix, and hemostasis of the cut renal surface was obtained with a wet monopolar electrosurgical device (Floating Ball device [FB]; TissueLink, Dover, NH). Anastomosis of the ureter to the lower-pole calix was performed over a guidewire using 3-0 Vicryl suture in group 1 and Nitinol clips in group 3. A double-J ureteral stent was then deployed retrograde under fluoroscopic guidance. In addition, we evaluated the use of fibrin glue as a sealant over the sutured or clipped anastomotic site (groups 2 and 4, respectively). Ureteral stents were removed after 3 weeks, and the animals were evaluated and sacrificed after an additional 3 weeks.. Laparoscopic ureterocalicostomy was completed in all 16 animals. In each case, excellent renal parenchymal hemostasis was obtained with the FB device, with a mean hemostasis time of 4.1 minutes. The mean anastomotic time with standard suture reconstruction was 37.1 +/- 5.4 minutes, while the anastomotic time with the Nitinol clips was 29.0 +/- 8.0 minutes (P = 0.0339). Retrograde pyelograms in groups 1 and 3 (no fibrin glue) showed a patent anastomosis with no hydronephrosis in three of the four animals in each group. One animal in group 1 and one animal in group 3 developed large urinomas secondary to anastomotic failure. The animals that received fibrin glue over the anastomotic site (groups 2 and 4) all showed narrowed anastomoses with severe hydronephrosis.. With available instrumentation, laparoscopic ureterocalicostomy is technically feasible. Nitinol clip technology significantly reduces collecting-system reconstruction time. Application of fibrin glue as a urinary tract sealant resulted in an unexpected adverse outcome.

Topics: Alloys; Anastomosis, Surgical; Animals; Constriction, Pathologic; Electrosurgery; Fibrin Tissue Adhesive; Hemostatics; Hydronephrosis; Kidney Calices; Laparoscopy; Models, Animal; Radiography; Stents; Sutures; Swine; Ureter; Ureteral Obstruction; Ureterostomy

Serial dilatation, the mainstay of benign 'neopharyngeal' stricture management, can have inconsistent results. Nitinol stents, as a metallic self-expanding coil, may have a role in such patients. Such stents were inserted in four patients but two had to be removed because of intractable pain. It is concluded that nitinol stents are unlikely to have a significant role in the management of neopharyngeal stricture management.

Topics: Aged; Alloys; Constriction, Pathologic; Device Removal; Dilatation; Female; Humans; Laryngeal Neoplasms; Laryngectomy; Male; Middle Aged; Pain; Pharyngeal Diseases; Postoperative Care; Quality of Life; Radiotherapy, Adjuvant; Recurrence; Reoperation; Stents; Treatment Failure

To determine the effect of Neuroform stent (Boston Scientific/Target, Fremont, CA) deployment on parent vessel lumen and detect in-stent changes in patients harboring wide-necked intracranial aneurysms treated with the stent-coil technique.. Parent vessel dimensions were quantified before and after the procedure and at intermediate follow-up examinations by use of high-resolution three-dimensional rotational angiography. By use of shaded surface segmentation of the acquired volume, measurements of the parent vessel proximal to the stent (Point A), at three points within the stented vascular segment (Points B, C, and D), and distal to the stent (Point E) at each study time were compared by use of paired t tests. Correlation between degree of in-stent stenosis and reported ischemic events was estimated by use of a linear regression model.. Stent and coil deployment had no immediate effect on parent vessel dimensions. At angiographic follow-up, there was no significant change in vessel size proximal to the stent. Within the stent and distal to it, however, there was a statistically significant 0.31- to 0.41-mm reduction in average diameter (P < 0.001, P < 0.011, P < 0.003, and P < 0.014 for Points B, C, D, and E, respectively). The highest degree of stenosis occurred at Point B, with an average decrease in cross sectional surface area of 2.4 mm (P < 0.001), corresponding to a 19% stenosis and 52% estimated increase in focal hemodynamic resistance by Poiseuille's law. No clinical correlation was noted with the degree of in-stent stenosis.. Intracranial stenting using a soft self-expanding stent without angioplasty induced a statistically, but not clinically, significant decrease in cross sectional area. Further research and longer-term follow-up are needed to elucidate the mechanism and clinical importance of this response.

Topics: Alloys; Cerebral Angiography; Cohort Studies; Constriction, Pathologic; Embolization, Therapeutic; Equipment Design; Follow-Up Studies; Humans; Imaging, Three-Dimensional; Intracranial Aneurysm; Rotation; Stents

To evaluate the efficacy and safety of use of a retrieval hook for removal of retrievable expandable tracheobronchial stents.. With fluoroscopic guidance, a retrieval hook was used to remove 45 retrievable expandable tracheobronchial stents in 31 patients. Indications for stent removal included tissue hyperplasia (n = 16), stent migration (n = 10), stent misplacement (n = 2), tumor overgrowth (n = 2), persistent gastrobronchial fistula (n = 1), and incompletely expanded stent (n = 1). Thirteen stents were electively removed after temporary use. The success rate, causes of failure, and complications related to stent removal with a retrieval hook were analyzed.. Forty-one of 45 stents (91.1%) were successfully removed with a retrieval hook. The following difficulties were encountered: disruption of the polyurethane membrane (n = 3) and an untied drawstring (n = 1). The removal procedure failed in four cases (8.9%) because of excessive tissue hyperplasia (n = 4) in the proximal portion of the stent. The hook wire fractured in two of the four failed cases. The overall complication rate was 4.4% (minor bleeding, n = 2).. For complications with or temporary use of retrievable expandable tracheobronchial stents, removal with a retrievable hook shows promising initial results.

Topics: Adult; Alloys; Bronchial Diseases; Bronchoscopy; Constriction, Pathologic; Device Removal; Equipment Design; Female; Fluoroscopy; Humans; Male; Middle Aged; Stents; Surgical Instruments; Tracheal Stenosis; Treatment Outcome

Temporary placement of a polytetrafluoroethylene (PTFE)-covered retrievable expandable nitinol stent was performed to treat a benign anastomotic duodenojejunal stricture that was refractory to repeated balloon dilation procedures. The procedure provided a favorable outcome for the patient and was completed without complications. This result suggests that successful treatment of benign strictures of the gastric outlet or duodenum is possible with use of retrievable stents.

Topics: Adult; Alloys; Barium Sulfate; Coated Materials, Biocompatible; Constriction, Pathologic; Duodenal Obstruction; Female; Humans; Jejunal Diseases; Polytetrafluoroethylene; Stents

We evaluated the treatment of ureteral stenosis using a self-expanding nitinol stent covered with expanded polytetrafluoroethylene (ePTFE).. Between January 2001 and April 2003, 37 ePTFE covered metal stents were implanted in 20 patients with a total of 29 ureteral stenoses due to various causes. In general the stents were introduced by using a retrograde approach under combined endoscopic and fluoroscopic guidance with patients under spinal block and sedation. Followup assessments in 18 patients, including urography, were done 3, 6, 12, 18 and 24 months after the procedure. Followup endoscopic examinations were performed at 6 and 12 months in 8 patients.. Immediate ureteral patency was achieved during all insertion procedures and maintained in most patients. Four patients died of the neoplastic process 3 to 12 months after implantation. Four stent migrations occurred in 3 patients (22.2%), which was resolved by implanting a new stent. Nonobstructive mucous hyperplasia was observed in 5 patients (27.7%) at the end of the stent, although there was no internal calcification. In all cases the stents remained patent until the current time or until patient death.. We found that ePTFE covered nitinol stents were safe and effective for ureteral stenosis. Their resistance to calcification was high with nonobstructive hyperplasia developing in only a few cases and only at the stent ends. The ideal material for covering stents would produce no mucous hyperplasia.

Topics: Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Female; Fluoroscopy; Humans; Male; Middle Aged; Polytetrafluoroethylene; Stents; Ureter

Covered retrievable expandable nitinol stents were successfully placed in nine patients with tuberculous bronchial strictures refractory to balloon dilation. Complications included stent migration (n = 1) and tissue hyperplasia at the proximal portion of the stent (n = 2). During the follow-up period (5-52 months), stricture recurred in three of five patients (60%) after temporary stent placement for 2 months, whereas stricture did not recur in the other four patients after temporary stent placement for 6 months. Temporary placement of covered retrievable stents appears to be an effective method for the treatment of patients with tuberculous bronchial strictures refractory to balloon dilation.

Topics: Adolescent; Adult; Alloys; Bronchial Diseases; Constriction, Pathologic; Female; Follow-Up Studies; Humans; Male; Stents; Tuberculosis; Tuberculosis, Pulmonary

To investigate the technical feasibility and clinical effectiveness of a dual expandable nitinol stent in the palliative treatment of malignant gastroduodenal strictures.. The dual stent consisted of two stents, an outer partially covered stent and an inner bare nitinol stent. The outer diameter of the stent delivery system was 3.8 mm. With fluoroscopic guidance, the outer stent was placed into the stricture, followed by coaxial placement of the inner stent. The stent placement was attempted in 102 consecutive patients with malignant gastroduodenal strictures. The underlying causes of malignant strictures were gastric cancer (n = 55), pancreatic cancer (n = 24), gallbladder cancer (n = 7), cholangiocarcinoma (n = 5), duodenal cancer (n = 5), and metastatic cancer (n = 6). All patients presented with symptoms of gastric outlet obstruction.. Stent placement was technically successful and well tolerated in 101 of 102 patients (99%). After stent placement, 85 of the 101 patients (84%) with technical success experienced improvement of their symptoms. Tumor overgrowth occurred in five patients, stent migration in two, mucosal hyperplasia in one, bleeding in one, and jaundice in two. Seventy one of the 101 patients died 5 to 340 days (mean, 71 days) after stent placement from progression of their disease, myocardial infarction, bleeding, or sepsis. The remaining 30 patients are still alive 6 to 227 days (mean, 39 days) after stent placement. The 30-day, 60-day, 90-day, and 180-day survival rates were 78%, 58%, 39%, and 8%, respectively.. The dual stent with a 3.8-mm stent delivery system is easy to insert, safe, and reasonably effective for the palliative treatment of malignant gastroduodenal strictures.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Constriction, Pathologic; Duodenal Obstruction; Feasibility Studies; Female; Fluoroscopy; Gastric Outlet Obstruction; Humans; Male; Middle Aged; Palliative Care; Pilot Projects; Radiography, Interventional; Statistics, Nonparametric; Stents; Survival Analysis; Treatment Outcome

To evaluate the safety and clinical effectiveness of a covered retrievable expandable nitinol stent for the treatment of malignant tracheobronchial stricture and/or esophagorespiratory fistula (ERF).. With fluoroscopic guidance, stents were placed in 35 symptomatic patients with malignant tracheobronchial stricture and/or ERF in most cases caused by lung or esophageal cancer. The site of stricture was most commonly at the trachea or left main bronchus. If there were complications, the stent was removed with a retrieval set. Nine patients had combined symptomatic ERF.. A total of 47 tracheobronchial stents were placed and were technically successful and well-tolerated in all patients. Improvement of dyspnea was achieved in 92% of the patients (24 of 26 patients). Associated ERF in nine patients was effectively treated with tracheobronchial stent placement with or without esophageal stent placement. Stent migration, tumor overgrowth, symptomatic sputum retention, and hemoptysis occurred in 17% (6/35), 6% (2/35), 20% (7/35), and 17% (6/35) of patients, respectively. There were no documented cases of tumor ingrowth. Stent removal was performed easily in five patients when stent migration (n = 2), severe pain (n = 1), tumor overgrowth (n = 1), or persistent gastrobronchial fistula (n = 1) developed. All patients died 2 days to 26 weeks (mean, 9.62 weeks) after stent placement because of disease progression (n = 18), pneumonia (n = 9), hemoptysis (n = 5), or unknown cause (n = 3).. Use of a covered retrievable expandable nitinol stent is a safe and effective method for relieving dyspnea. This procedure contributed to improved quality of life for patients with malignant tracheobronchial stricture and/or ERF. Stent retrievability was useful in resolving stent-related complications.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Bronchial Diseases; Constriction, Pathologic; Dyspnea; Esophageal Neoplasms; Female; Humans; Lung Neoplasms; Male; Middle Aged; Palliative Care; Radiography, Interventional; Stents; Tracheal Stenosis; Tracheoesophageal Fistula; Treatment Outcome

Several types of metal stents are available for the treatment of tracheobronchial stenosis. They can be self-expanding, balloon expandable, covered with a silicone membrane or uncovered. We have used a new self-expanding tracheobronchial nitinol wire stent since 1998, and our results are presented below.. Over a period of two years, 25 patients had a stent in the trachea or bronchus. The stents were inserted while the patients were under general anaesthesia, and flexible bronchoscopy was used. Respiratory function, histopathology, stent data, complications, and mortality were prospectively recorded.. Eighteen patients had a malignant stenosis. Bronchial stenosis following a single lung transplantation (3) was the most frequent reason for a benign stenosis (7). Most of the patients had the stent placed in the trachea (14). All the stent insertions were performed without complications, and respiratory function was immediately improved in all patients except for two. The postoperative complications were inflammatory granuloma (5), stent dislocation (3), delayed expansion (2), stent rupture (1), and stent occlusion caused by retained secretions (1).. The tracheobronchial ultraflex nitinol stent was easy to handle and was troublesome for only a few patients. Nitinol stents are considered to have a good biocompatibility, but 12% of the patients developed inflammatory granulations requiring electroresection.

Topics: Adult; Aged; Alloys; Bronchial Diseases; Coated Materials, Biocompatible; Constriction, Pathologic; Female; Follow-Up Studies; Humans; Male; Middle Aged; Postoperative Complications; Prospective Studies; Stents; Tracheal Stenosis; Treatment Outcome

Following single lung transplantation, the native lung remains a potential source of morbidity from spontaneous pneumothorax, hyperinflation, bacterial and fungal infection and malignancy. The case of a single lung transplant recipient for idiopathic pulmonary fibrosis who developed a recurrent, non-resolving, spontaneous multiloculated pneumothorax in the native lung following thoracoscopic talc pleurodesis is reported. The pneumothorax ultimately resolved following insertion of a nitinol stent for coexisting bronchostenosis in the transplanted lung. In a single lung transplantation recipient in whom a native lung pneumothorax reoccurs or persists despite appropriate initial management, it may be useful to undertake bronchoscopy to exclude the possibility of bronchostenosis in the transplanted lung.

Topics: Adult; Alloys; Bronchial Diseases; Bronchoscopy; Constriction, Pathologic; Humans; Lung Transplantation; Lung Volume Measurements; Male; Pleurodesis; Pneumothorax; Recurrence; Stents

To report on a prospective two-center study to evaluate safety and effectiveness of a self-expanding nitinol coil stent in patients with femoropopliteal obstructive disease.. The IntraCoil nitinol stent was used in 37 patients (28 men and nine women; mean age, 62.4 y plus minus 10.7; range, 43-81 y) presenting with high-grade stenoses (n = 23) or short (<3 cm) occlusions (n = 17) of the superficial femoral artery (SFA; n = 33) or popliteal artery (n = 4). Indications for stent placement were significant residual stenosis (>30%) or dissection after angioplasty. Follow-up evaluations with measurement of the Doppler ankle-brachial index (ABI), assessment of Rutherford clinical stage, and color-coded duplex sonography were performed at discharge and 1, 3, 6, 12, and 18 months thereafter. Primary endpoints of the study were immediate technical and clinical success and 1-year patency.. Initial technical success was achieved in all patients. In 10 patients (27%), more than one 40-mm-long device had to be implanted for total lesion coverage; in three patients (8.1%), stents were placed in two separate segments of the SFA simultaneously. The total number of stents deployed was 50. Stent placement induced an initial improvement of the ABI from 0.54 plus minus 0.2 to 0.92 plus minus 0.11 (P <.01). Follow-up data for 12 months after treatment are available for 29 of 37 patients (78.4%); mean follow-up is 15.6 months (range, 1-26 mo). Primary patency rates at 6 and 12 months were 97.1% (SE = 2.9) and 86.2% (SE = 6.5). The primary assisted patency rate was 100% at 12 months.. Endovascular placement of the IntraCoil self-expanding nitinol coil stent for salvage of failed angioplasty in patients with femoropopliteal obstructive disease is an effective and safe procedure with promising mid-term results.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Female; Femoral Artery; Humans; Longitudinal Studies; Male; Middle Aged; Patient Selection; Peripheral Vascular Diseases; Popliteal Artery; Safety; Stents; Treatment Outcome

The purpose of this study was to evaluate the potential utility of implantation of a nickel-titanium alloy (nitinol) stent for the treatment of malignant or benign tracheobronchial stenosis.. We evaluated 18 patients (14 men and 4 women) who received 24 nitinol stents, between November 1997 and May 2000. All 18 patients had severe dyspnea caused by tracheobronchial stenosis. The underlying condition was malignant disease in 15 patients, and benign tracheal collapse in the other 3 patients.. Implantation of the stent was successfully performed in all patients. Seventeen patients experienced immediate clinical improvement in respiratory symptoms. The remaining 1 patient with a bronchial fistule after lobectomy did not benefit, and died of pneumonia at 16 days after the implantation. In 15 patients, the procedure was performed using a flexible bronchoscope under local anesthesia alone, while the remaining 3 patients needed intravenous sedation. There was no complication resulting from the stent implantation. Among the 3 patients with benign tracheal collapse, 2 patients were alive at 746 and at 401 days after the stent implantation, at the time of this report. One patient with cicatricial stenosis after intubation died of heart failure due to previous myocardial infarction. Among the 15 patients with malignant disease, 4 patients have survived for 177 to 305 days to date, while the other 11 patients have died of primary malignancy with a mean survival duration of 60.2 days.. The nitinol stent was effective in treating malignant or benign tracheobronchial stenosis, and had some remarkable advantages compared with other tracheobronchial stents. In stenting, most procedures can be performed using flexible bronchoscope under local anesthesia.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Anesthesia, Local; Bronchial Diseases; Bronchoscopy; Constriction, Pathologic; Female; Humans; Male; Middle Aged; Stents; Tracheal Neoplasms; Tracheal Stenosis

Topics: Airway Obstruction; Alloys; Bronchial Diseases; Constriction, Pathologic; Foreign-Body Migration; Humans; Stents; Tracheal Stenosis

Topics: Alloys; Angiography, Digital Subtraction; Angioplasty, Balloon; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Constriction, Pathologic; Female; Humans; Iliac Artery; Inflammation; Middle Aged; Polyethylene Terephthalates; Recurrence; Stents; Syndrome; Ureter; Ureteral Obstruction

Self-expanding spiral nitinol stents are potentially removable and may be useful in the treatment of benign strictures. We evaluated the histologic response to stent placement and technical aspects of their placement and removal in a porcine model.. Nine animals were studied. Stents were placed above the papilla in six surviving animals. After intervals of one, two or three months cholangiography and attempted stent removal was performed. Four animals were then sacrificed acutely with their stent in place, and two were sacrificed after a one-month healing interval. The results of placement, follow-up cholangiography and histology are reported.. Cholangiography and stent placement succeeded in 26 of 27 and 11 of 16 attempts, respectively. Three placement failures were attributed to stent/duct size disparity or a faulty release mechanism, resulting in stent kinking and/or duct twisting. Among the successfully deployed stents, two animals developed strictures where stents traversed bifurcations and one exhibited partial luminal compromise by tissue entrapment between coils. Fluoroscopically guided removal was successful in two of five stents positioned above the papilla. Histology was non-specific but minimally changed in those given a one-month healing interval after removal. Others exhibited moderate inflammation, fibrosis and an intramural abscess at sites of induced stricture.. Spiral metal stents for the treatment of benign strictures remain experimental. Care must be taken to deploy them in bile ducts of adequate diameter and endoscopic removal is not yet demonstrably reliable and safe.

Topics: Alloys; Animals; Bile Ducts; Biliary Tract Diseases; Cholangiography; Constriction, Pathologic; Disease Models, Animal; Evaluation Studies as Topic; Prosthesis Design; Stents; Swine

Silicone and metal stents are available for the treatment of malignant bronchial stenoses. This project sought to compare the self-expanding nitinol Accuflex stent (Boston Scientific Corp; Watertown, Mass) with the passively expandable tantalum Strecker stent (Boston Scientific Corp; Watertown, Mass), both implanted by flexible bronchoscopy under local anesthesia and sedation. In 51 patients with malignant bronchial stenosis, 14 nitinol and 51 tantalum stents were used and stenoses of 75 to 100% were treated. The intervention was successful in all but one patient; a mean patency of 93% was achieved. In the follow-up period, the probability of survival was significantly lower in patients with total bronchus occlusion than in patients with stenotic alterations (44 vs 109 days; p<0.05). In 10 patients, lung function analysis after stent implantation revealed a significant increase in PaO2 (65 vs 71 mm Hg; p<0.01), inspiratory vital capacity (2.5 vs 2.7 L; p<0.05), and FEV1 (1.8 vs 2.0 L; p<0.05). Mucus retention was the main (39%) adverse factor in the early phase after stent implantation, whereas tumor penetration became the most frequent problem (67%) in the later phase. Recanalizing interventions were necessary in 18% of the cases in which tumor penetration occurred. Stent distortion occurred in 12 patients with Strecker and in none with Accuflex stents. In comparison to the Strecker stent, the self-expanding Accuflex stent is preferable owing to its excellent flexibility and faster delivery system. Both types of stents could be sufficiently deployed within the lesion and allowed for highly precise positioning. Furthermore, no general anesthesia was required. The fiberbronchoscopic mode of implantation under sedation is very efficient even for tumor patients with severe impairment of their physical and respiratory condition.

Topics: Alloys; Anesthesia, Local; Bronchial Diseases; Bronchoscopes; Bronchoscopy; Constriction, Pathologic; Equipment Design; Esophageal Neoplasms; Female; Follow-Up Studies; Humans; Lung Neoplasms; Male; Middle Aged; Respiratory Function Tests; Stents; Survival Rate; Tantalum; Time Factors

A 68-year-old man was admitted because of dyspnea. Nine months earlier, he had undergone radiotherapy for esophageal carcinoma. Chest CT scan obtained on admission showed a tumor shadow behind the tracheal carina. Bronchoscopy revealed that the lower trachea and bilateral main bronchi were compressed from the back and narrowed by the esophageal cancer. To maintain the airway, under fluoroscopic and guide-wire control, a self-expanding nitinol stent (SENS, Accuflex, Microvasive) was implanted in the lower trachea and left main bronchus. At the same time, other SENS was similarly implanted in the lower trachea and right main bronchus. During the implantation, the left nitinol stent was connected to the side of the right nitinol stent to form a T-shape. There was little sputum at the joint portion of the stents and the ventilation of both lungs remained adequate. Severe dyspnea markedly improved after placement of two nitinol stents. Knitted SENS is made of a nickel titanium alloy. SENS was formulated for use in the management of biliary obstruction. However, it is highly flexible and easy to implant. So, it is suitable for the treatment of airway obstruction. Although the implantation of SENS in extensive tracheobronchial stenosis has not previously been reported, it should be useful for prevention of airway obstruction.

Topics: Aged; Alloys; Bronchial Diseases; Carcinoma, Squamous Cell; Constriction, Pathologic; Esophageal Neoplasms; Humans; Male; Stents

Stent implantation in malignant bronchial stenoses is a highly effective method of providing symptomatic relief by restoring bronchial patency. Whether an improvement in ventilatory conditions is paralleled by an increase in blood flow and gas exchange has not yet been determined.. Fourteen patients with malignant, high-grade obstruction of bronchi who had metal stent implantation were investigated. Before the intervention and again 8 days afterward, both quantitative technegas ventilation and 99mTc-MAA perfusion scans (V/Q scans) and lung function tests were performed.. Stent implantation was successful in all patients, with a significant reduction in the degree of bronchial stenosis (pre-stent: 93% +/- 1.5%; post-stent: 16% +/- 3.5%). After stent implantation, ventilation scintigraphy revealed an improvement in tracer deposition by 65% (pre-stent: 37% +/- 8%; post-stent: 61% +/- 6%; p < 0.05) within the affected lung. A complementary increase of 71% by perfusion scintigraphy was obtained (pre-stent: 27% +/- 4%; post-stent: 46% +/- 5%; p < 0.01%). Based on scintigraphic criteria, stenting was successful in 93% (n = 13) of all patients. Lung function studies performed after the intervention showed significant improvement in vital capacity (VC, p < 0.01), forced expiratory volume in 1 sec (FEV1, p < 0.05), peak expiratory flow (PEF, p < 0.05), arterial oxygen (PaO2, p < 0.05) and carbon dioxide (PaCO2, p < 0.05) tension, and oxygen saturation (p < 0.05).. Stenting of malignant high-grade bronchial obstructions leads to an increase in bronchial patency and in activity distribution of both ventilation and perfusion scintigraphy of the affected lung, accompanied by significant improvement in lung function parameters.

Topics: Alloys; Bronchial Diseases; Constriction, Pathologic; Equipment Design; Female; Graphite; Humans; Lung; Lung Neoplasms; Male; Middle Aged; Radionuclide Imaging; Respiratory Function Tests; Sodium Pertechnetate Tc 99m; Stents; Tantalum; Technetium Tc 99m Aggregated Albumin; Ventilation-Perfusion Ratio

Metallic stents in small vessels go along with a significant risk of restenosis and reocclusion. Different models of stents and covering materials have been purported to prevent intraluminal neointimal proliferation by cover-based closure of the spaces in the wire mesh.. Tantalum stents covered with polyethylacrylate/polymethylmethacrylate (PEM) were implanted in the infrarenal aorta of six New Zealand white rabbits by aortotomy and compared with eight rabbits treated with uncovered tantalum stents. For deployment, covered and uncovered stents necessitated a 7-French (F) and 5-F sheath, respectively. In addition, nine human patients with arteriosclerotic lesions of the superficial femoral arteries (stenosis > 5 cm or total occlusion) were treated percutaneously with a Dacron-covered nitinol vascular stent via a 9-F sheath. Patients were followed for a mean of 13.5 months, and control angiography was performed after 6 months.. Experimental placement of the tantalum Wiktor stent was feasible technically in all cases. Five of six stents covered with PEM were occluded 3 days after placement despite the intravenous use of heparin and aspirin. In the group with uncovered stents, no area of stenosis greater than 10% was observed. There was a neointimal layer of 89 +/- 68 microns around the stent wires. Stent placement was successful in all patients. In four patients, a hyperergic reaction occurred, resulting in noninfectious periarteriitis. This complication was treated successfully with nonsteroidal antiinflammatory drugs. The primary patency was 50%, and the secondary patency (after application of a second covered stent in two patients) was 63%.. The uncovered stent induces little neointimal proliferation around the stent wires. The insertion of stents covered with PEM into the rabbit aorta was accompanied by a strong thrombotic reaction, despite sufficient anticoagulation. Dacron-covered nitinol stents showed a surprisingly high restenosis rate after 9 months of follow-up. Further research concerning the in vivo properties of new covering materials is mandatory before routine vascular clinical application.

Topics: Aged; Alloys; Animals; Aorta, Abdominal; Aortic Diseases; Arteriosclerosis; Biocompatible Materials; Constriction, Pathologic; Equipment Design; Female; Femoral Artery; Humans; Iliac Artery; Male; Polyethylene Terephthalates; Polymethacrylic Acids; Rabbits; Recurrence; Stents; Tantalum; Thrombosis

We report here on two cases of fractured nitinol stents in the esophagus. In case 1, the correctly inserted stent broke spontaneously shortly after insertion. In a second case, a nitinol stent broke after laser application due to tumor ingrowth with massive bleeding. In both cases, a second stent was implanted in order to reestablish food passage. The fracture of the stent in case 1 seemed to be caused by defective material, whilst in case 2 the stent broke because of thermal overstrain during laser application. The use of electrocoagulation or laser in the stent area should therefore be avoided; argon plasma coagulation may offer an effective alternative in treating tumor ingrowth. As there was a risk from piercing broken filaments with the second stent, covering a fracture using stents with tight walls or plastic tubes seems to be a more effective approach than the inserting an uncovered stent type.

Topics: Aged; Alloys; Carcinoma, Squamous Cell; Constriction, Pathologic; Esophageal Neoplasms; Fatal Outcome; Female; Humans; Stents

To evaluate a new self-expanding nitinol coil stent in stenotic or occluded peripheral arteries.. Seventy-three symptomatic patients (58 men; mean age 67 years) were treated with nitinol stents for lesions in the iliac artery (9 stenoses); superficial femoral artery (SFA) (39 stenoses, 6 occlusions); popliteal artery and tibioperoneal trunk (9 stenoses, 7 occlusions); and 3 bypass grafts. Mean diameter stenosis was 84.4% +/- 9.9% (range 75% to 100%), and mean lesion length was 45 +/- 23 mm (range 20 to 120 mm).. Eighty-eight 40-mm-long stents with diameters between 5 and 8 mm were implanted percutaneously for suboptimal dilation (n = 45); dissection (n = 21); and restenosis (n = 7). All stents but one were implanted successfully; the malpositioned stent was removed, and another stent was successfully deployed. There were 3 (4.1%) failures due to thrombosis at 24 hours. During the mean 16-month follow-up (range to 44 months), 4 restenoses (3 femoral, 1 popliteal) have occurred; 2 were treated with repeat dilation and 2 underwent bypass. Primary and secondary patency rates at 18 months were 87% and 90%, respectively, for all lesions (iliac: 100% for both; femoral: 85% and 88%; popliteal: 87% and 100%).. This new nitinol stent seems to be safe and effective with favorable long-term results, even in distal SFA lesions and popliteal arteries. Its flexibility and resistance to external compression allow its placement in tortuous arteries and near joints.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Constriction, Pathologic; Equipment Design; Evaluation Studies as Topic; Female; Follow-Up Studies; Humans; Life Tables; Male; Peripheral Vascular Diseases; Stents; Time Factors; Treatment Outcome; Vascular Patency

The authors implanted a duodenal stent in a woman with a high-grade duodenal stenosis due to inoperable tumor compression. A flexible self-expanding knitted nitinol stent that conformed to the shape of the duodenum was introduced orally to keep the duodenal passage patent. After stent implantation, repeated vomiting stopped and the patient was able to eat and drink. This technique resolved the patient's duodenal stenosis.

Topics: Adenocarcinoma; Alloys; Colonic Neoplasms; Constriction, Pathologic; Duodenal Obstruction; Equipment Design; Female; Humans; Middle Aged; Palliative Care; Radiography, Interventional; Stents

To compare technical aspects and neointima formation of a new Nitinol stent and a Wallstent.. A Nitinol sten and a Wallstent were placed into the iliac arteries of 14 sheep (total of 28 stents) and followed angiographically. Seven sheep were killed after 1 month and 7 after 4.5 months. Examination of histologic specimen by light microscopy was performed to determine neointimal and medial thickness inside the stents. Measurements were analyzed statistically.. Neointima was thicker in Nitinol stents (N) than in Wallstents (W) (P < 0.004), both adjacent to (W = 0.265 mm, N = 0.596 mm) and between the stent wires (W = 0.177 mm, N = 0.361 mm). Because of poor radiopacity and the Crochê releasing technique, delivery was more difficult with Nitinol stents. High-grade stenosis was found in two Nitinol stents at 1 and 4.5 months of follow-up, respectively. One Wallstent was insufficiently incorporated into the vessel wall.. The observed difference in neointima formation that may be caused by differences in design, mechanical properties or the metal alloy of the stents probably is too insignificant to be relevant to patency of large arteries. However, it may be relevant in small vessels such as coronary arteries.

Topics: Alloys; Animals; Arterial Occlusive Diseases; Biomechanical Phenomena; Cobalt; Constriction, Pathologic; Equipment Design; Follow-Up Studies; Iliac Artery; Iron; Radiography; Sheep; Stents; Surface Properties; Tunica Intima; Tunica Media; Vascular Patency

To determine the feasibility of use of a self-expanding nitinol stent covered with polyester fabric in long iliac stenoses.. In 10 patients with 12 iliac artery stenoses (6-10 cm long [mean, 7.5 cm]), a Cragg endoluminal graft was placed percutaneously after failure of percutaneous transluminal angioplasty.. At angiography after implantation of 15 Cragg endoluminal grafts, patency was restored and the dissection flap was eliminated without any residual stenosis in all cases. At 1-13-month follow-up (mean, 7 months), eight patients were asymptomatic, with a mean ankle-brachial index of 0.90 +/- 0.15 (standard deviation). Arterial rupture occurred in one patient, with thrombosis of the artery with the stent within 1 day. In one patient, tight restenosis was seen at the proximal part of the stent. In another patient, moderate restenosis was seen at the distal junction of the prosthesis with the native artery, but restenosis did not occur within the stent. The 6-month primary patency rate of the stent graft was 80%.. In long iliac artery stenoses, the deployment of the Cragg endoluminal graft is feasible and no short-term complications were seen.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Combined Modality Therapy; Constriction, Pathologic; Female; Humans; Iliac Artery; Male; Middle Aged; Radiography, Interventional; Stents; Vascular Patency

A new design of endoprosthesis, made of shape-memory nitinol alloy, was used to replace the currently used one, which was soon clogged with bile mud. After nitinol wire coil stent was slenderized in ice water, it was inserted into the strictured bile duct by endoscopy or operation. When nitinol wire coil was positioned in a narrowed biliary segment, normal saline heated to 39 degrees C was rapidly hand-injected into the lumen of the inner transport catheter to make the alloy coil to resume its original shape with a length of 3 to 10cm, and a diameter of 5 to 10mm. Since June 1991, 13 patients with malignant biliary strictures were treated with nitinol endoprosthesis. The follow-up period ranged from 1 to 16 months (average 6 months). Biliary sludge was not found in the endoprosthesis during the period. The results suggested that shape-memory nitinol alloy endoprosthesis could maintain long term patency without severe infection or obstruction due to biliary sludge.

Topics: Adult; Aged; Alloys; Biliary Tract Diseases; Biliary Tract Neoplasms; Constriction, Pathologic; Female; Humans; Male; Middle Aged; Nickel; Stents; Titanium

The paper is concerned with the description of the first experience in a new method of roentgen endoprosthetics of the cervical canal of the uterus using a nitinol spiral prosthesis. The spiral has a shape memory effect. Prostheses were implanted to 13 patients with strictures or atresia of the cervical canal after bougienage for a period of 193 days. A new canal was formed with further epithelialization within this period. Recurrences after prosthesis removal were unnoticed.

Topics: Adult; Alloys; Carcinoma in Situ; Cervix Uteri; Constriction, Pathologic; Dilatation; Female; Humans; Laser Therapy; Postoperative Complications; Prostheses and Implants; Prosthesis Design; Radiography; Time Factors; Uterine Cervical Neoplasms

Topics: Aged; Alloys; Constriction, Pathologic; Dilatation; Esophageal Neoplasms; Esophageal Stenosis; Humans; Intestinal Obstruction; Male; Rectal Diseases; Rectal Neoplasms