nitinol and Ischemia

This article reviews current knowledge and applications of drug-eluting devices in the treatment of peripheral arterial disease. The authors briefly report on the performance of plain old balloon angioplasty and bare metal stents in femoro-popliteal and below-the-knee lesions. This article explains the rationale behind the development of drug-eluting devices and describes the main technical features of currently available drug-eluting stents and drug-coated balloons. Dedicated sections discuss the results of trials investigating the potential benefits of these devices used in femoro-popliteal and infra-popliteal arterial vascular beds. Finally, ongoing studies and potential novel applications of drug-eluting technologies in other vascular beds are mentioned.

Topics: Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Drug-Eluting Stents; Evidence-Based Medicine; Femoral Artery; Humans; Ischemia; Leg; Metals; Popliteal Artery; Stents; Treatment Outcome

Infrainguinal peripheral occlusive disease is increasingly being treated by endovascular techniques. Bare metal stainless steel, self-expanding nitinol stents, drug-eluting and covered stents (stent grafts) are becoming increasingly more important adjuncts to percutaneous translumninal angioplasty in the treatment of peripheral artery disease. In this article the available evidence supporting the use of stents in the femoropopliteal and tibial arteries will be described as well as their limitations. Future stent developments will also be discussed.

Topics: Alloys; Angiography; Angioplasty, Balloon; Arterial Occlusive Diseases; Coated Materials, Biocompatible; Drug-Eluting Stents; Equipment Design; Equipment Failure; Humans; Ischemia; Recurrence; Stainless Steel; Stents

Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited.. The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%.. A total of 201 patients were enrolled and randomly assigned to treatment (. The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed.

Topics: Angioplasty; Angioplasty, Balloon; Drug-Eluting Stents; Humans; Ischemia; Paclitaxel; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Stents; Treatment Outcome; Vascular Patency

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

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

To compare primary placement of a self-expanding nitinol stent to percutaneous transluminal angioplasty (PTA) with bailout stenting in infrapopliteal arteries of patients with severe intermittent claudication or critical limb ischemia (CLI).. In the EXPAND trial (ClinicalTrials.gov; identifier NCT00906022), 92 patients (mean age 72.9±9.5 years; 62 men) undergoing treatment for infrapopliteal stenosis in 11 European centers were randomized 1:1 to either self-expanding nitinol stenting with the Astron Pulsar/Pulsar-18 nitinol stent or PTA with bailout stenting. The primary endpoint was sustainable clinical improvement after 12 months, defined as a ≥1-category increase for Rutherford category 3 patients or a ≥2-category increase for CLI patients (Rutherford categories 4/5) compared with baseline. Furthermore, target lesion revascularization (TLR), mortality, and amputation were assessed after 12 months.. Sustained clinical improvement at 1 year was observed in 74.3% of the patients treated with primary stenting and in 68.6% of the patients treated with PTA and bailout stenting (p>0.05). Kaplan-Meier estimates of freedom from TLR (76.6% and 77.6%), mortality (7.4% vs 2.1%), and amputation [8.9% (major 6.7%) vs 13.2% (major 8.7%)] at 1 year were not significantly different.. Primary self-expanding nitinol stenting did not show statistically different clinical outcomes compared to angioplasty with bailout stenting for infrapopliteal lesions.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Critical Illness; Disease Progression; Disease-Free Survival; Endovascular Procedures; Europe; Female; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Recurrence; Risk Assessment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

To determine the safety and efficacy of a new-generation nitinol stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).. The Complete Self-Expanding (SE) Multicenter Trial (ClinicalTrials.gov identifier NCT00814970) enrolled 196 patients (124 men; mean age 68.7±10.5 years) from 28 centers in the United States and Europe. The patients presented with intermittent claudication (193/196) or ischemic rest pain (3/196) and were treated with nitinol stents for obstructive lesions of the SFA or PPA. Over a quarter of lesions (29.9%) were chronic total occlusions. The mean lesion length was 60.7 mm. Moderate to severe calcification was present in 91.0% of lesions.. A total of 225 stents were successfully implanted in 213 (99.5%) of 214 lesions. Acute lesion success (<30% residual stenosis) was achieved in 90.0%. There were no in-hospital major adverse events. Primary patency (defined as a peak systolic velocity ratio <2.0) at 12 months was 72.6%. Clinically-driven target lesion revascularization (TLR) was required in 8.4% of patients at 12 months. The mean ankle-brachial index increased from 0.7 at baseline to 0.9, and there was sustained improvement in the Rutherford category, with 83% of patients classified as Rutherford category 0 or 1 at 12-month follow-up. No stent fractures were detected through 12 months.. In this multicenter trial, primary implantation of a new-generation self-expanding nitinol stent in the SFA and PPA was associated with a low rate of TLR and sustained clinical benefit at 12 months without stent fracture.

Topics: Aged; Alloys; Angioplasty, Balloon; Ankle Brachial Index; Blood Flow Velocity; Chronic Disease; Europe; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Prospective Studies; Prosthesis Design; Radiography; Recovery of Function; Stents; Time Factors; Treatment Outcome; United States; Vascular Calcification; Vascular Patency

To evaluate mid-term primary patency of the femoral artery stenting in correlation with usCRP level and characteristics of the population, morphological aspect of the lesions and interventional techniques.. Patients were prospectively included in a multicenter study (18 centers in France) after stenting (SMART, Cordis Johnson & Johnson, Issy-les-Moulineaux, France) of the superficial femoral artery (SFA). Inclusion and exclusion criteria were based on recommendations and every day practice of the centers.. Thus 255 patients (183 men; mean age: 69 years; range 44-92) were included. Technical success of the SFA stenting was 100% without any complications and primary angiographic success 97%. usCRP level increased significantly (p < 0.05) between before and 24h after SFA stenting. In the subgroup of patients without initial inflammation (n = 157), usCRP increased significantly (p < 0.05) in the group of patient with initial thrombosis and additional intervention (graft, amputation, angioplasty on other arterial bed) in the same procedure compared to the remaining patients. Restenosis rate was 12.4% (26/209 patients) at 7 ± 2 months. Before stenting, usCRP level was not predictive of a restenosis, whereas after stenting, an increase of the 24h usCRP level was significantly higher in the subgroup of patient with an occlusion at mid-term (8 patients; p < 0.05).. This study demonstrated good patency at 7 months of SFA stenting with nitinol SMART with an increase of the usCRP level 24h after stenting in favour of the presence of an occlusion at mid-term follow-up.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Angiography; Angioplasty; Arterial Occlusive Diseases; C-Reactive Protein; Female; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Leg; Magnetic Resonance Angiography; Male; Middle Aged; Prospective Studies; Prosthesis Failure; Recurrence; Risk Factors; Stents; Thrombosis; Tomography, X-Ray Computed; 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

Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year.. Two hundred forty-four patients (168 men; 66+/-9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease.. In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.

Topics: Aged; Alloys; Angioplasty, Balloon; Blood Vessel Prosthesis Implantation; Female; Femoral Artery; Graft Occlusion, Vascular; Humans; Ischemia; Male; Middle Aged; Stents; Ultrasonography

We investigated the efficacy of Xpert (Abbott Vascular Devices) nitinol stents for the treatment of infrapopliteal lesions in patients with critical limb ischemia (CLI).. Between May and October 2005, 47 CLI patients (35 men, mean age 73 years) received 67 Xpert stents for the treatment of 58 infrapopliteal lesions in 51 limbs; 43 patients (84.3%) were classified in Rutherford Category 4 and 8 (15.7%) in Category 5. Clinical examination and quantitative vascular analysis (QVA) were performed before and after the intervention and at 12-months follow-up. The primary endpoint was defined as 1-year angiographic binary restenosis rate (>50% stenosis on QVA); the secondary endpoints were 1-year primary patency and limb salvage rate.. QVA after 1 year showed a binary restenosis rate of 20.45%. Kaplan-Meier analysis revealed 1-year primary patency and limb salvage rates of 76.3% and 95.9%, respectively. The limb salvage rate was significantly better in patients with proximal below-the-knee (BTK) than in those with mid-section or distal lesions (100% vs 81.8%; P=0.0071).. Our results suggest that treatment with nitinol Xpert stents in CLI patients is effective and yields satisfactory angiographic and clinical outcome.

Topics: Aged; Alloys; Angioplasty, Balloon; Equipment Design; Female; Follow-Up Studies; Humans; Ischemia; Leg; Male; Prospective Studies; Radiography; Stents; Time Factors; Treatment Outcome

To investigate whether primary nitinol stenting in the superficial femoral artery (SFA) is beneficial to patients' quality of life (QoL).. One hundred four patients (55 men; mean age 66+/-19 years) with chronic limb ischemia and SFA disease were randomly assigned to primary stent implantation (n=51) or balloon angioplasty (n=53) with optional stenting for a suboptimal angioplasty result (17 of 53). QoL was measured by the SF-36 questionnaire at baseline and at 3, 6, and 12 months post intervention.. QoL was significantly improved post intervention and up to 12 months in both treatment groups. Significant inverse associations were observed between QoL parameters and restenosis. Comparing primary stenting (n=51) versus balloon angioplasty with optional stenting (n=53) by the intention to treat, no significant differences in QoL were observed. Analyses of stented patients (n=68) versus balloon angioplasty (n=36) patients, however, demonstrated significantly improved measures of QoL after stenting.. Endovascular revascularization of SFA disease improves QoL, and restenosis negatively affects QoL outcomes. After stent implantation, whether primary or secondary, QoL was significantly ameliorated compared to balloon angioplasty alone. However, it remains to be proven in larger cohorts whether primary stenting yields a QoL benefit compared to balloon angioplasty with optional secondary stenting.

Topics: Aged; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Chronic Disease; Female; Femoral Artery; Health Status Indicators; Humans; Ischemia; Male; Middle Aged; Prospective Studies; Prosthesis Design; Quality of Life; Recovery of Function; Recurrence; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Vascular Surgical Procedures; Walking

To evaluate the AngioSculpt (ASC), a novel scoring balloon catheter designed to treat complex diffuse fibro-calcific atherosclerotic lesions and avoid device slippage during deployment, in patients with infra-popliteal disease.. The ASC incorporates a flexible nitinol scoring element containing three or more spiral struts which encircle a minimally compliant balloon to create focal concentration of the dilating force. Patients scheduled for percutaneous intervention of infra-popliteal arteries or planned amputation and with a reference vessel diameter of 1.5-3.5 mm were included in the study.. A total of 42 patients and 56 lesions were treated at five sites. Of these, 38 patients (90.5%) presented with critical limb ischemia (Rutherford Class > or = 4). The ASC was successfully deployed in 98.2% (55/56) of lesions attempted and was used as primary therapy without stenting in 89.3% (50/56). Lesion morphology was complex, including moderate/severe calcification in 73%, lesion length 33.9 +/- 42.2 mm, bifurcation in 26.8%, and ostial in 12.5%. There was no significant device slippage and no perforations. Post-ASC dissections occurred in only six (10.7%) lesions and were minor or resolved with stenting. In 13 patients initially referred for amputation, ASC treatment resulted in limb salvage.. The ASC is highly effective in a broad range of complex lesion morphologies, in most cases as stand-alone therapy, is associated with a very low complication rate and avoids device slippage during deployment. Additional studies are planned to assess the long term efficacy of this promising new technology.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Critical Illness; Equipment Design; Europe; Female; Humans; Ischemia; Limb Salvage; Male; Peripheral Vascular Diseases; Popliteal Artery; Prospective Studies; Registries; Research Design; Severity of Illness Index; Treatment Outcome

Because stent implantation for disease of the superficial femoral artery has been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is preferred for endovascular treatment, and stenting is recommended only in the event of suboptimal technical results. We evaluated whether primary implantation of a self-expanding nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.. We randomly assigned 104 patients who had severe claudication or chronic limb ischemia due to stenosis or occlusion of the superficial femoral artery to undergo primary stent implantation (51 patients) or angioplasty (53 patients). Restenosis and clinical outcomes were assessed at 6 and 12 months.. The mean (+/-SD) length of the treated segment was 132+/-71 mm in the stent group and 127+/-55 mm in the angioplasty group. Secondary stenting was performed in 17 of 53 patients (32 percent) in the angioplasty group, in most cases because of a suboptimal result after angioplasty. At 6 months, the rate of restenosis on angiography was 24 percent in the stent group and 43 percent in the angioplasty group (P=0.05); at 12 months the rates on duplex ultrasonography were 37 percent and 63 percent, respectively (P=0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group.. In the intermediate term, treatment of superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting. (ClinicalTrials.gov number, NCT00281060.).

Topics: Aged; Alloys; Angioplasty, Balloon; Female; Femoral Artery; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Leg; Logistic Models; Male; Middle Aged; Peripheral Vascular Diseases; Recurrence; Statistics, Nonparametric; Stents; Ultrasonography

The excellent performance of the Supera Peripheral Stent System. A retrospective analysis was conducted of 136 consecutive limbs from 128 patients with atherosclerotic disease in the femoropopliteal region, treated with Supera stents between September 2010 and September 2017. As primary endpoints patency rates and freedom from target lesion revascularization (TLR) were calculated and presented using Kaplan-Meier analysis.. Fifty-five percent were treated for claudication (IC), 45% for chronical limb threatening ischemia (CLTI). The mean treated lesion length was 143 mm (±77.8). The majority of lesions (63%) were Trans-Atlantic Inter-Society Consensus Criteria II (TASC II) C/D lesions. The overall primary patency rates at 12 and 24 months of follow-up were 72.6% and 60.8% respectively. The primary patency at 12 and 24 months for TASC II A/B lesions was respectively 86% and 75.4%. For TASC II C/D lesions primary patency at 12 and 24 months was 64% and 51.1% respectively (. Endovascular treatment of femoropopliteal disease with Supera Stent is safe, even in extensive, highly calcified lesions. Patency rates and freedom from TLR are acceptable in a real-life population.

Topics: Arterial Occlusive Diseases; Humans; Ischemia; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm

Topics: Alloys; Amputation, Surgical; Chronic Limb-Threatening Ischemia; Follow-Up Studies; Humans; Ischemia; Limb Salvage; Peripheral Arterial Disease; Popliteal Artery; Prosthesis Design; Retrospective Studies; Stents; Treatment Outcome; Vascular Patency

To understand the histologic changes of prostate tissue induced by temporary implantable nitinol device (cTIND) in a canine model.. The cTIND is a small, symmetric device comprised of nitinol wire loops welded together on an axis, which exert radial force on the tissue to induce a targeted ischemic effect. The cTIND was implanted in three live canine models, which were monitored for 14 days post-index procedure. Device placement was monitored via serial fluoroscopy and biologic effects of cTIND were studied via histopathology.. The cTIND was successfully placed in the canine models and remained securely in position until the animal was sacrificed on postoperative day 14. The cTIND treated tissue demonstrated an abrupt transition from normal, viable prostatic glandular tissue to an area of shrunken necrosis and fibrosis between the two.. In the canine models, the cTIND created focal areas of ischemic necrosis resulting in incisions in the peri-urethral prostate with minimal inflammation.

Topics: Alloys; Animals; Dogs; Ischemia; Male; Minimally Invasive Surgical Procedures; Necrosis; Postoperative Complications; Prostate; Prostheses and Implants; Urologic Surgical Procedures, Male

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

It has long been known that hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) broadly reduce cardiovascular events in patients with peripheral vascular disease. It was the goal of this study to determine whether there is an association between statin therapy and primary patency after stenting of superficial femoral and popliteal arteries.. The records of all patients undergoing primary nitinol stenting of the femoral and popliteal arteries at a single institution and by a single surgeon during a 10-year period were reviewed. Demographic characteristics of the patients and risk factors were identified. TransAtlantic Inter-Society Consensus (TASC II) classifications were determined for all stented lesions. Analysis was performed to determine whether the use of statins at the time of stent placement was associated with a change in rates of primary patency. Loss of primary patency was said to have occurred when an intrastent occlusion or a ≥70% stenosis was identified by arterial duplex ultrasound or angiography. Kaplan-Meier survival curves were plotted, and differences between groups were tested by log-rank method.. Between 2004 and 2014, primary femoral or popliteal stenting was performed on 308 limbs in 250 patients. At the time of intervention, 52.4% of these patients were being treated with statin therapy; 137 interventions were done for claudication and 113 for critical limb ischemia. Of the lesions treated, 165 were TASC A or B and 85 were TASC C or D. Primary patency rates for all stented lesions were 75%, 54%, and 35% at 12, 24, and 36 months. The patency rates at 12, 24, and 36 months, respectively, were 80%, 55%, and 40% for those taking statins and 68%, 49%, and 28% for those not taking statins (P = .178). Statin therapy demonstrated a trend toward an association with improved primary patency rates in TASC A/B lesions but had no association in TASC C/D lesions (TASC A/B, P = .056; TASC C/D, P = .537). Statin compliance was found to be 87% at a mean follow-up of 24.1 months.. Although the use of statins has been shown to reduce cardiovascular morbidity and mortality in patients with peripheral vascular disease, overall there is not an association of these drugs with improved primary patency after primary stenting of femoral and popliteal artery lesions. However, when limbs are stratified for severity, less severe (TASC A/B) lesions demonstrated a trend toward a significant association between statin use and improved primary patency. This finding was not seen in more severe (TASC C/D) disease.

Topics: Aged; Aged, 80 and over; Alloys; Angiography; Critical Illness; Endovascular Procedures; Female; Femoral Artery; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Los Angeles; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency

The Tack implant is designed for focal, minimal metal management of dissections. This study evaluated Tacks for treating postpercutaneous transluminal angioplasty (PTA) dissection in patients with below-the-knee (BTK) arterial occlusive disease.. PTA is the most commonly used endovascular treatment for patients with occlusive disease of the BTK vessels. Post-PTA dissection is a significant clinical problem that results in poor outcomes, but currently there are limited treatment options for managing dissections.. This prospective, single-arm study evaluated patients with CLI and BTK lesions; 11.4% were Rutherford category (RC) 4 and 88.6% were RC 5. BTK occlusive disease was treated with standard PTA and post-PTA dissections were treated with Tack placement. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) at 30 days. Other endpoints included: device success; procedure success (vessel patency in the absence of MALE); freedom from clinically driven target lesion revascularization (CD-TLR); primary patency; and changes in RC. Data through 12 months are presented.. Thirty-two of 35 (91.4%) patients had post-PTA dissection and successful deployment of Tacks. Procedural success was achieved in 34/35 (97.1%) patients with no MALEs at 30 days. The 12-month patency rate was 78.4% by vessel, 77.4% by patient, and freedom from CD-TLR was 93.5%. Significant (P < .0001) improvement from baseline was observed in RC (75% of patients improved 4 or 5 steps).. Tack implant treatment of post-PTA dissection was safe and effective for treatment of BTK dissections and resulted in reasonable 12-month patency and low rates of CD-TLR.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Critical Illness; Endovascular Procedures; Europe; Female; Humans; Ischemia; Leg; Male; New Zealand; Peripheral Arterial Disease; Progression-Free Survival; Prospective Studies; Prosthesis Design; Risk Factors; Self Expandable Metallic Stents; Time Factors; Vascular Patency; Vascular System Injuries

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

There has been increasing evidence to support the endovascular-first approach in the treatment of below-the-knee (BTK) lesions. Plain old balloon angioplasty (POBA), with bailout bare-metal stent scaffolding in case of flow limiting dissection or recoil, have been considered the standard treatment of choice but industries are continually developing innovative equipment and dedicated technologies, such as drug-eluting platforms whose use is increasingly extended, despite significant costs and lack of high-quality evidence to support a well-established strategy. This study's objective was to analyze the 6-year results of "standard" endovascular treatment of BTK lesions in the era of drug-eluting devices.. From August 2008 to February 2010, 21 French speaking European centers consecutively enrolled critical limb ischemia (CLI) patients with BTK lesions treated endovascularly into the Angioplastie Jambière (ANJE) registry. Primary endpoint was 1-year limb salvage, a subgroup analysis was performed to compare POBA, bare nitinol stents and balloon-expandable stents (BESs).. Of the 282 patients included (61.7%, men, mean age 75.8±10.0 years), 53.5% were diabetic and 29.4% presented with chronic kidney disease. At 1 year, complete wound healing was described in 187 patients (82.7%), the overall limb salvage rate was 94.0% with a survival rates of 89.2%. The primary and secondary patency rates were 84.5% and 91.7% respectively with significantly lower primary patency rates after stenting (80.6% vs. 87.6% after POBA; P=0.043). The rate of freedom from target lesion revascularization (TLR) was 86.3% with significantly lower rates after stenting (81.8% vs. 89.9% after POBA; P=0.01). The subgroup analysis showed no significant difference between nitinol stents, BESs and POBA in terms of limb salvage and survival rates, however, primary and secondary patency rates were significantly lower after BESs (primary and secondary patency rates of 84.0% after nitinol stents vs. 77.4% after BES vs. 87.6% after POBA; P=0.012 and 93.0% vs. 77.4% vs. 87.6%; P=0.003, respectively), as well as freedom from TLR rates (82.3% vs. 81.2% vs. 89.9%; P=0.04).. In the drug eluting era, the endovascular first approach of BTK lesions based on POBA with bailout spot stenting is feasible, affordable but most importantly remains effective and should be the first line strategy until the place of drug eluting stents is precisely defined.

Topics: Adult; Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty, Balloon; Critical Illness; Disease-Free Survival; Drug-Eluting Stents; Europe; Female; Humans; Ischemia; Limb Salvage; Male; Middle Aged; Peripheral Arterial Disease; Prosthesis Design; Registries; Risk Factors; Self Expandable Metallic Stents; Stents; Time Factors; Treatment Outcome; Vascular Patency

Lower extremity ischemia following deployment of a vascular closure device for access site closure after a transfemoral endovascular procedure rarely occurs. A 68-year-old woman diagnosed with subarachnoid hemorrhage due to a ruptured anterior communicating aneurysm was treated by endovascular coil embolization. The StarClose SE device was deployed for right femoral arteriotomy closure. After 2 days, critical ischemia occurred on her right lower leg due to total occlusion of the popliteo-tibial artery. Emergent surgical embolectomy was performed and the nitinol clip of the StarClose device was captured in the lumen of the tibioperoneal trunk. Although StarClose is an extravascular closure system, intravascular deployment, distal migration, and resultant critical limb ischemia can occur.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Embolectomy; Embolization, Therapeutic; Female; Femoral Artery; Foreign-Body Migration; Hemostatic Techniques; Humans; Ischemia; Lower Extremity; Popliteal Artery; Surgical Instruments; Tibial Arteries; Treatment Outcome

To evaluate efficacy, safety, and midterm patency of endovascular treatment of obstructive popliteal artery (PA) disease.. A retrospective evaluation of patients with atherosclerotic PA disease who underwent percutaneous transluminal balloon angioplasty and provisional stent, based on both conventional and dynamic angiographies, was conducted from June 2011 to June 2014. Forty-three patients were included in the study, and most patients had limited surgical revascularization options. Demographic characteristics, angiographic findings, interventional data, complications, vessel patency, limb salvage rates, and survival rates were analyzed.. The median lesion length was 5 cm with 72.1% having total occlusions. The second popliteal segment (P2) was involved most frequently (60.5%, n = 26). Critical limb ischemia was present in 69.8%. The technical success rate was 92.9% (42/43 limbs), with 29 cases requiring adjunctive nitinol stents after balloon angioplasty (47.6% based on conventional angiography, 21.4% based on dynamic angiography, and 4.8% additional stents based on dynamic angiography). Complications included thromboembolism (2.3%), perforation (2.3%), pseudoaneurysm (2.3%), and myocardial infarction (2.3%). Stent fracture was present in three cases (7.1%) during the mean follow-up period of 18.3 months. The baseline ankle-brachial index significantly improved after the intervention, from 0.49 ± 0.11 to 0.92 ± 0.14 (P < .01). The Rutherford-Becker class decreased from 3.95 ± 0.76 to 1.76 ± 0.95 (P < .01) at 12 months. The 1-year primary, primary-assisted, and secondary patency rates were 75.2% ± 6.8%, 82.4% ± 6.0%, and 89.9% ± 4.8%, respectively. The limb salvage and amputation-free survival rates at 12 months were 91.6% and 87.0%, respectively.. Balloon angioplasty with a provisional stent based on dynamic angiography is a feasible, safe, and effective therapy for patients with obstructive PA disease. Although the occurrence of stent fracture is still inevitable, patients with critical limb ischemia who have limited surgical options may get more benefits from the endovascular treatment of PA obstructive diseases.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angiography; Angioplasty, Balloon; Ankle Brachial Index; Atherosclerosis; China; Critical Illness; Female; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Popliteal Artery; Predictive Value of Tests; Proportional Hazards Models; Prosthesis Design; Retreatment; Retrospective Studies; Risk Factors; Stents; Survival Rate; Time Factors; Treatment Outcome; Vascular Patency

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

The structural limitations of currently available laser-cut nitinol stents in the highly diseased arterial system of the lower extremity are well described. These devices are frequently used in long-segment occlusions, at the adductor hiatus, and across the knee into the popliteal artery and tibial-peroneal trunk despite concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. The Supera stent (Abbott Vascular, Santa Clara, Calif) was developed to provide superior radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents. This study represents the initial U.S. experience in the management of lower extremity artery atherosclerotic disease with the Supera interwoven wire stent.. Patients undergoing stent implantation in the 20-month period after the 2008 Food and Drug Administration clearance were included. Medical records, radiographic imaging, and procedural data were examined. Procedural angiograms were classified according to TransAtlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis.. There were 305 stents implanted in 147 patients. Clinical follow-up was a mean of 12.7 months (range, 0.2-33.7 months), and radiologic follow-up was a mean of 8.4 months (range, 0.2-26.8 months). Most patients had critical limb ischemia, with tissue loss (38.1%) or rest pain (28.6%) as the indication for intervention. Of the 147 patients, 75 (51.02%) underwent a concomitant adjunctive procedure in the treated extremity. Primary, assisted primary, and secondary patency rates at 12 months by duplex ultrasound imaging were 89.8%, 91.2%, and 93.2%, respectively, by Kaplan-Meier estimates, with a mean lesion length of 184.5 ± 131.80 mm and mean stented length of 197.5 ± 113.65 mm. Seventeen patients experienced an event requiring successful reintervention in the stented segment (13 for type I or II restenosis; four for type III). There were eight major amputations, with five of those eight having a patent stent at the time of limb sacrifice. The overall mortality was 11.6% during the study period. Knee radiography was performed in 47 patients with devices extending into the popliteal and tibial-peroneal segment, and no stent fractures were identified.. Stenting of the superficial femoral and popliteal arteries using the Supera stent system appears to be safe and effective. The interwoven stent design may better serve areas under extreme mechanical stress. Our results with this population of highly diseased patients including very long lesion lengths are consistent with outcomes of other publications reporting the use of this device.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Arizona; Critical Illness; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Middle Aged; Multivariate Analysis; Peripheral Arterial Disease; Popliteal Artery; Proportional Hazards Models; Prospective Studies; Prosthesis Design; Registries; Retreatment; Risk Factors; Stents; Time Factors; Treatment Outcome; Vascular Patency

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

Popliteal artery stenting is not routinely performed due to concerns related to the high mobility of the knee joint and the potential for external stent compression, fractures, and occlusion. Open bypass is traditionally considered the gold standard for popliteal artery atherosclerotic lesions. The Supera stent (IDEV Technologies Inc, Webster, Tex) was developed to provide superior radial strength, fracture resistance, and flexibility compared with laser-cut nitinol stents. This study represents the initial United States experience in the management of popliteal artery atherosclerotic disease with the Supera interwoven wire stent.. Patients undergoing stent implantation in the 20-month period after the 2008 Food and Drug Administration clearance were included. Medical records, radiographic imaging, and procedural data were examined. Procedural angiograms were classified according to Trans-Atlantic Inter-Society Consensus criteria. Patency and limb loss rates were calculated using Kaplan-Meier analysis.. A total of 39 stents were placed in 34 patients due to isolated popliteal artery occlusive disease. Clinical follow-up was a mean of 12.7 months (range, 0.2-33.7 months), and radiologic follow-up was a mean of 8.4 months (range, 0-26.8 months). Most patients had critical limb ischemia (CLI), with tissue loss (38.2%) or rest pain (35.3%) as the indication for intervention. In 20 patients (58.8%), the most distal end of the stent(s) landed in the below-the-knee popliteal segment, 12 (35.3%) landed in the above-the-knee segment, and two (5.9%) landed precisely at the knee. Other than angioplasty and stenting, 47% of patients did not receive any adjuvant concomitant therapy in the treated leg. Two patients underwent concomitant atherectomy of the popliteal segment. Primary, primary assisted, and secondary patency rates by duplex ultrasound imaging were 79.2%, 88.1% and 93%, respectively, by Kaplan-Meier estimates, with a mean stented length of 12 cm. Six instances of stent occlusion were noted, and six patients were identified with hemodynamically significant in-stent stenosis. Three patients sustained limb loss (8.8%), two related to uncontrolled infections, and one due to perioperative ischemic complications (both with patent stents at the time of limb loss). The overall mortality was 8.8% during the study period. Knee roentgenography was performed in all but one patient, and no stent fractures were identified.. Stenting of the popliteal artery using the Supera stent system appears to be safe and effective. The interwoven stent design may better serve areas under extreme mechanical stress. Our results with this highly diseased patient population justify a prospective trial in this subject.

Topics: Aged; Aged, 80 and over; Alloys; Amputation, Surgical; Angioplasty; Atherosclerosis; Critical Illness; Female; Hemodynamics; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Male; Middle Aged; Multivariate Analysis; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Radiography; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States; 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

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 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: Alloys; Arterial Occlusive Diseases; Endovascular Procedures; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Male; Popliteal Artery; Stents

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 assess outcomes in an elderly and diseased population after stenting in the femoropopliteal segment and evaluate risk factors for poor prognosis.. Retrospective study of femoropopliteal stents placed between March 2006 and January 2008. Patency was verified by duplex scanning. Risk factors associated with amputation or death and patency were analyzed using Cox regression.. A total of 117 limbs in 112 patients were observed for a median of 18 months. Median age of the patients was 79 years; 68% were treated for critical limb ischemia and 85% had occlusive lesions. Mean lesion length was 15.4 cm (SD: 9.2) and mean stented length was 19.7 cm (standard deviation: 9.8). At 1 year, primary patency was 63%, primary-assisted patency was 67%, and secondary patency was 69%. Stent diameter ≤6 versus 7 mm was a risk factor for loss of patency with a hazard ratio (HR) of 2.9 (95% CI: 1.1-7.7). Significant risk factors for death or amputation were as follows: HR for rest pain versus claudication was 5.9 (1.1-32.8), HR for tissue loss versus claudication was 5.8 (1.1-29.6), HR for stent diameter ≤6 versus 7 mm was 3.6 (1.0-12.3), and HR for 3-4 stents versus 1-2 was 2.6 (1.1-6.1).. Rutherford status is associated with death or amputation after stenting in the femoropopliteal segment. In addition, a smaller stent diameter and number of stents depict poorer prognosis independent of gender and anatomic level.

Topics: Age Factors; Aged; Aged, 80 and over; Alloys; Angioplasty; Arterial Occlusive Diseases; Chi-Square Distribution; Female; Femoral Artery; Humans; Ischemia; Kaplan-Meier Estimate; Limb Salvage; Male; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Recurrence; Registries; Retrospective Studies; Risk Assessment; Risk Factors; Stents; Sweden; 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

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

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 purpose of this study was to describe an alternative endovascular procedure to exclude iliac artery aneurysms, preserving perfusion to the internal iliac artery.. Two patients, considered unfit for open repair, underwent endovascular repair of iliac artery aneurysms. One of these occurred after previous placement of a bifurcated prosthesis. In both cases the aneurysms were excluded using a nitinol stent covered with expanded polytetrafluoroethylene from the external to the internal iliac artery. Using this technique, the internal iliac arteries were perfused in a retrograde manner. Both interventions were technically successful. The external-to-internal endograft remained patent after 6 and 16 months, respectively.. Endovascular placement of a stent-graft from the external iliac artery into the internal iliac artery may offer an alternative and minimal invasive alternative for the management of common and internal iliac artery aneurysms. With the use of this technique, pelvic perfusion is preserved. Further studies are warranted to appraise the advantages and risk of this approach for iliac artery aneurysms.

Topics: Aged; Aged, 80 and over; Alloys; Anastomosis, Surgical; Angiography, Digital Subtraction; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Humans; Iliac Aneurysm; Iliac Artery; Ischemia; Male; Pelvis; Polytetrafluoroethylene; Prosthesis Design; Regional Blood Flow; Stents; Time Factors; Tomography, X-Ray Computed; Treatment Outcome; Vascular Patency

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

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

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

To evaluate our initial experience with hypogastric artery occlusion using a nitinol vascular plug during endovascular aortic aneurysm repair (EVAR).. We reviewed the records and images of 23 consecutive patients who underwent transluminal vessel occlusion of the hypogastric artery with a nitinol plug, as well as a cohort of 19 patients who underwent hypogastric artery embolization with coils in conjunction with EVAR.. There were no demographic differences between the two groups of patients. Hypogastric artery occlusion was successful in all cases when a nitinol vascular plug was used. When coils were used, there was one unsuccessful embolization which required a second procedure. The number of embolic devices used in the coil group was 7.53 (range, three to 13) compared with 1.35 (range, one to six) in the plug group (P < .05). Only one plug was used in 19 of 23 cases. The average cost to embolize per hypogastric artery was $1,496 compared with $470 when a nitinol plug was used. There were two instances of coil migration. No other intraoperative complications occurred. At one month follow up, seven patients (35%) in the coil group complained of buttock claudication compared with two patients (9%) in the nitinol plug group (P = .027).. Our experience demonstrates the safety and effectiveness of the nitinol vascular plug for hypogastric artery occlusion during EVAR. When compared with coils for hypogastric embolization during EVAR, nitinol vascular plugs are less expensive, produce less technical complications, and are associated with a significantly lower incidence of gluteal claudication.

Topics: Aged; Alloys; Aortic Aneurysm; Blood Vessel Prosthesis Implantation; Buttocks; Embolization, Therapeutic; Equipment Design; Female; Hospital Costs; Humans; Iliac Aneurysm; Intermittent Claudication; Ischemia; Male; Medical Records; Time Factors; Tomography, X-Ray Computed; Treatment Outcome

A recent randomized trial suggested nitinol self-expanding stents (SES) were associated with reduced restenosis rates compared with simple percutaneous transluminal angioplasty (PTA). We evaluated our results with superficial femoral artery (SFA) SES to determine whether TransAtlantic InterSociety Consensus (TASC) classification, indication for intervention, patient risk factors, or Society of Vascular Surgery (SVS) runoff score correlated with patency and clinical outcome, and to evaluate if bare nitinol stents or expanded polytetrafluoroethylene (ePTFE) covered stent placement adversely impacts the tibial artery runoff.. A total of 109 consecutive SFA stenting procedures (95 patients) at two university-affiliated hospitals from 2003 to 2006 were identified. Medical records, angiographic, and noninvasive studies were reviewed in detail. Patient demographics and risk factors were recorded. Procedural angiograms were classified according to TASC Criteria (I-2000 and II-2007 versions) and SVS runoff scores were determined in every patient; primary, primary-assisted, secondary patency, and limb salvage rates were calculated. Cox proportional hazard model was used to determine if indication, TASC classification, runoff score, and comorbidities affected outcome.. Seventy-one patients (65%) underwent SES for claudication and 38 patients (35%) for critical limb ischemia (CLI). Average treatment length was 15.7 cm, average runoff score was 4.6. Overall 36-month primary, primary-assisted, and secondary rates were 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients. No limbs were lost following interventions in claudicants (mean follow-up 16 months). In 24 patients with stent occlusion, 15 underwent endovascular revision, only five (33%) ultimately remained patent (15.8 months after reintervention). In contrast, all nine reinterventions for in-stent stenosis remained patent (17.8 months). Of 24 patients who underwent 37 endovascular revisions for either occlusion or stenosis, eight (35%) had worsening of their runoff score (4.1 to 6.4). By Cox proportional hazards analysis, hypertension (hazard ratio [HR] 0.35), TASC D lesions (HR 5.5), and runoff score > 5 (HR 2.6) significantly affected primary patency.. Self-expanding stents produce acceptable outcomes for treatment of SFA disease. Poorer patency rates are associated with TASC D lesions and poor initial runoff score; HTN was associated with improved patency rates. Stent occlusion and in-stent stenosis were not entirely benign; one-third of patients had deterioration of their tibial artery runoff. Future studies of SFA interventions need to stratify TASC classification and runoff score. Further evaluation of the long-term effects of SFA stenting on tibial runoff is needed.

Topics: Alloys; Amputation, Surgical; Angioplasty, Balloon; Arizona; Arterial Occlusive Diseases; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Limb Salvage; Male; Polytetrafluoroethylene; Popliteal Artery; Proportional Hazards Models; Prosthesis Design; Radiography; Regional Blood Flow; Reoperation; Retrospective Studies; Risk Assessment; Severity of Illness Index; Stents; Tibial Arteries; Time Factors; Treatment Failure; Treatment Outcome; Vascular Patency

To evaluate the primary success and short-term patency associated with a new 4-F sheath-compatible self-expanding nitinol stent after failed conventional angioplasty of distal popliteal and infrapopliteal lesions in severe lifestyle-limiting claudication (LLC) and chronic critical limb ischemia (CLI).. Between May 2003 and July 2005, 35 patients with Rutherford category 3-5 disease (16 patients with CLI, 19 patients with LLC) underwent percutaneous transluminal angioplasty (PTA) and stent implantation. Indications for stent placement were residual stenosis, flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical investigation, color-flow and duplex Doppler ultrasonography, and digital subtraction angiography were performed. Technical success, primary patency at 6 months, clinical improvement as defined by Rutherford with clinical and hemodynamic measures, and complications were evaluated.. A total of 22 patients underwent distal popliteal artery stent placement and 13 underwent tibioperoneal artery stent placement. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 82%. The mean resting ankle-brachial index at baseline was 0.50 +/- 0.16 and significantly increased to 0.90 +/- 0.17 at 12-24 hours after intervention and 0.82 +/- 0.24 at latest follow-up (P < .001 for both). The sustained clinical improvement rate was 80% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 100%. The rate of major complications was 17%.. Infrapopliteal application of the new nitinol stent is a safe, feasible, and effective method with good short-term patency rate in the treatment of severe LLC and chronic CLI.

Topics: Aged; Aged, 80 and over; Alloys; Angiography, Digital Subtraction; Angioplasty; Angioplasty, Balloon; Critical Illness; Feasibility Studies; Female; Follow-Up Studies; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Laser-Doppler Flowmetry; Limb Salvage; Lower Extremity; Male; Middle Aged; Peripheral Vascular Diseases; Popliteal Artery; Prosthesis Design; Retrospective Studies; Severity of Illness Index; Stents; Tibial Arteries; Time Factors; Treatment Failure; Treatment Outcome; Ultrasonography, Doppler, Color; Vascular Patency

Since long-term patency and device integrity of nitinol stents in SFA lesions are not well studied, we examined clinical outcome, patency and device integrity after stenting long lesions using a standardized implantation technique.. Between 2001 and 2006, 59 patients (74 lesions) were treated with the same nitinol self-expandable stent (Zilver, Cook, USA) and technique for SFA recanalization. Clinical charts and imaging were retrospectively reviewed for patency (primary and assisted-primary), and device integrity.. Patients were 74.5 (10.9) years old (range 49 to 93), 64% male, 42% diabetic, 62% hypertensive and 67% current or former smokers. Lesions were 23% TASC B, 16% TASC C, or 61% TASC D. Mean recanalization length was 19 cm (range 3 to 53). Mean number of stents per patient was 2.8 (total 210). Mean follow-up time was 2.4 years (range 3 days to 4.8 years). Kaplan-Meier estimates for primary patency rates were 90%, 78%, 74%, 69%, and 69% at 1, 2, 3, 4 and 4.8 years, respectively. Ten restenoses at a mean of 500 (388) days (1-1251 days) were successfully recanalized. The assisted primary patency rates were 96%, 90%, 90%, 90% and 90% at 1, 2, 3, 4 and 5 years, respectively. Six complete occlusions could not be reverted by a second recanalization procedure, and were treated by surgical bypass (1 case), amputation (3 cases), or medical management (2 cases). One (1.04%) Class II stent fracture was noted.. SFA recanalization with a standardized implantation technique and nitinol stents provides good long-term primary and assisted-primary patency.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Arterial Occlusive Diseases; Equipment Failure; Female; Femoral Artery; Follow-Up Studies; Humans; Ischemia; Leg; Male; Middle Aged; Retreatment; Retrospective Studies; Stents

Topics: Alloys; Angioplasty, Balloon; Confounding Factors, Epidemiologic; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Leg; Peripheral Vascular Diseases; Research Design; Stents

To present a patient in whom severe external carotid artery (ECA) stenosis causing ocular ischemia was treated with a drug-eluting stent.. A 55-year-old woman with severe, diffuse atherosclerosis presented with impaired left ocular perfusion and amaurosis fugax. Duplex ultrasonography and angiography documented bilateral occlusion at the origin of the internal carotid arteries, bilateral subtotal ECA stenoses, and subtotal distal left common carotid artery (CCA) restenosis following endarterectomy. Percutaneous revascularization of the left ECA and CCA stenoses was performed using a short coronary balloon-expandable sirolimus-eluting stent and a self-expanding nitinol stent, respectively. The procedure was uneventful, and the ocular symptoms resolved. At 6 months, the patient remained asymptomatic, with angiographically patent stents.. Drug-eluting stenting may be a novel option to treat symptomatic ECA stenosis.

Topics: Alloys; Amaurosis Fugax; Angiography, Digital Subtraction; Blood Vessel Prosthesis Implantation; Carotid Artery, Common; Carotid Stenosis; Coated Materials, Biocompatible; Endarterectomy, Carotid; Eye; Female; Humans; Immunosuppressive Agents; Ischemia; Middle Aged; Postoperative Complications; Reoperation; Sirolimus; Stents; Vascular Patency

To report a retrospective cohort study of nitinol stent implantation in patients at high risk for restenosis owing to long-segment (> or =10 cm) femoropopliteal disease.. Sixty-five consecutive patients with peripheral artery disease underwent long-segment (> or =10 cm) femoropopliteal stent implantation using self-expanding nitinol stents after initial failure of plain balloon angioplasty (i.e., residual stenosis >30% or a flow-limiting dissection). Patients were followed for first occurrence of in-stent restenosis, defined as a >50% lumen diameter reduction by color-coded duplex sonography, with angiographic confirmation.. Cumulative median length of the stented segments was 16 cm (interquartile range [IQR] 12-25, absolute range 10-40) using up to 5 overlapping stents. During the median 8-month follow-up (IQR 6-11), no early thrombotic reocclusions occurred within 30 days, but 26 (40%) patients developed an in-stent restenosis. Cumulative freedom from restenosis at 6 and 12 months was 79% and 54% overall, respectively; at the same time periods, the rates were 84% and 71% in nondiabetic patients (n=41) versus 68% and 22% in diabetics (n=24) (adjusted hazard ratio 3.8, p=0.01). Cumulative stent length and number of implanted stents were not associated with restenosis.. Midterm restenosis after long-segment femoropopliteal stenting using self-expanding nitinol stents remains a major problem, particularly in patients with diabetes mellitus. The midterm results in nondiabetics are encouraging.

Topics: Aged; Alloys; Angioplasty, Balloon; Aortography; Arterial Occlusive Diseases; Cohort Studies; Confidence Intervals; Female; Femoral Artery; Follow-Up Studies; Humans; Ischemia; Leg; Male; Middle Aged; Popliteal Artery; Probability; Proportional Hazards Models; Prosthesis Design; Retrospective Studies; Risk Assessment; Severity of Illness Index; Statistics, Nonparametric; Stents; Treatment Outcome; Vascular Patency

The purpose of this study was to evaluate the safety and efficacy of self-expanding SMART nitinol stents in patients with chronic limb ischemia (CLI) demonstrating Type B or C TransAtlantic Inter-Society Consensus (TASC) lesions in the femoropopliteal (FP) arterial segment. There were 137 lower limbs in 122 patients with chronic limb ischemia, secondary to TASC A (n = 12) or TASC B,C (n = 125) lesions in the FP artery were treated with Cordis SMART self-expanding nitinol stents. Hemodynamic stent failure occurred with the presence of a greater than 50% stenosis within the stented segment, measured by standard Duplex velocity criteria, obtained at various postintervention intervals. The hemodynamic primary stent patency was calculated by life-table methods from the time of intervention, uninterrupted by hemodynamic stent failure. The mean lesion length was 12.2 cm (range, 4 to 28 cm). The technical success was 98%. Within the follow-up period (mean, 302 days), 24 limbs were diagnosed with hemodynamic stent failure. The hemodynamic primary stent patency rates were 92%, 76%, 66%, and 60% at 6, 12, 18, and 24-months, respectively. These data provide objective evidence that endovascular treatment of FP TASC A, B and C lesions using self-expanding nitinol SMART stents in patients with chronic limb ischemia provides favorable safety and durability outcomes. Further investigation is warranted.

Topics: Aged; Alloys; Angioplasty, Balloon; Catheterization, Peripheral; Chronic Disease; Female; Femoral Artery; Humans; Ischemia; Leg; Male; Popliteal Artery; Radiography, Interventional; Stents; Treatment Failure; Vascular Patency

To report our experience using a commercially available catheter-based system equipped with an intravascular ultrasound (IVUS) transducer to achieve controlled true lumen re-entry in patients undergoing subintimal angioplasty for chronic total occlusions (CTO) or aortic dissections.. During an 8-month period, 10 patients (6 men; mean age 73.4 years) with lower extremity (LE) ischemia from CTOs (n=7) or true lumen collapse from aortic dissections (n=3) were treated. Subintimal access and controlled re-entry of the CTOs were performed with a commercially available 6.2-F dual-lumen catheter, which contained an integrated 64-element phased-array IVUS transducer and a deployable 24-G needle through which a guidewire was passed once the target lumen was reached. The occluded segments were balloon dilated; self-expanding nitinol stents were deployed. In the aortic dissections, fenestrations were performed using the same device, with the IVUS unit acting as the guide. The fenestrations were balloon dilated and stented to support the true lumen.. Time to effective re-entry ranged from 6 to 10 minutes (mean 7) in the CTOs; antegrade flow was restored in all 7 CTOs, and the patients were free of ischemic symptoms at up to 8-month follow-up. In the aortic dissection cases, the fenestrations equalized pressures between the lumens and restored flow into the compromised vessels. There were no complications related to the use of this device in any of the 10 patients.. Our preliminary results demonstrate the feasibility of using this catheter-based system for subintimal recanalization with controlled re-entry in CTOs and for aortic flap fenestrations in aortic dissections. This approach can improve the technical success rate, reduce the time of the procedure, and minimize potential complications.

Topics: Aged; Aged, 80 and over; Alloys; Angioplasty, Balloon; Aortic Aneurysm, Abdominal; Aortic Dissection; Arterial Occlusive Diseases; Cost Savings; Female; Humans; Ischemia; Leg; Male; Middle Aged; Stents; Transducers; Treatment Outcome; Tunica Intima; Ultrasonography, Interventional

To evaluate, in a propensity score-adjusted analysis, the intermediate-term primary patency rates associated with nitinol versus stainless steel self-expanding stent placement for treatment of atherosclerotic lesions in femoropopliteal arteries.. The authors analyzed the clinical and imaging data of 175 consecutive patients with peripheral artery disease and either intermittent claudication (n = 150) or critical limb ischemia (n = 25) who underwent femoropopliteal artery implantation of nitinol (n = 104) or stainless steel (n = 123) stents in a nonrandomized setting. The stents were placed owing to either significant residual stenosis (ie, >30% lumen diameter reduction) or flow-limiting dissection after initial balloon angioplasty of the femoropopliteal artery. Patients were followed up for a median period of 9 months (mean, 13 months; range, 6-66 months) for the detection of a first in-stent restenosis, defined as a greater than 50% lumen diameter reduction that was seen at color-coded duplex ultrasonography and confirmed at angiography.. Cumulative patency rates at 6, 12, and 24 months were 85%, 75%, and 69%, respectively, after nitinol stent placement versus 78%, 54%, and 34%, respectively, after stainless steel stent placement (P =.008, log-rank test). There were no statistically significant differences in associated patency among the three different nitinol stents used (P =.72, log-rank test). Multivariate Cox proportional hazard analysis, in which the effect of propensity to receive a nitinol stent was considered, revealed a significantly reduced risk of restenosis with the nitinol stents compared with the risk of restenosis with the stainless steel stents (adjusted hazard ratio, 0.44; 95% confidence interval: 0.22, 0.85; P =.014).. Nitinol stents are associated with significantly improved primary patency rates in femoropopliteal arteries compared with stainless steel stents. Randomized controlled trials are needed to confirm these results.

Topics: Aged; Alloys; Arterial Occlusive Diseases; Arteriosclerosis; Female; Femoral Artery; Follow-Up Studies; Graft Occlusion, Vascular; Humans; Ischemia; Leg; Male; Middle Aged; Popliteal Artery; Prosthesis Design; Prosthesis Failure; Retrospective Studies; Stainless Steel; Stents; Ultrasonography, Doppler, Color; Vascular Patency

An iliac aneurysm developed after local lysis and balloon dilatation of the left iliofemoral arteries in a 66-year old male patient. This led to arterial embolism. A self-expanding Dacron-Nitinol vascular endoprosthesis was inserted without surgery. In this way, the aneurysm was isolated from the circulation.

Topics: Aged; Alloys; Aneurysm; Angiography; Angioplasty, Balloon; Blood Vessel Prosthesis; Combined Modality Therapy; Humans; Iliac Artery; Ischemia; Leg; Male; Polyethylene Terephthalates; Recurrence; Stents; Thrombolytic Therapy; Urokinase-Type Plasminogen Activator