nitinol and Critical-Illness

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 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 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

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

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

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

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

Pulmonary embolism (PE) is a potentially life-threatening complication of critical illness. In trauma and neurosurgical patients with contraindications to anticoagulation, inferior vena cava (IVC) filters have been used to prevent PE, but their associated long-term complication rates and difficulties associated with filter removal have limited their use. The Angel catheter is a temporary device, which combined an IVC filter with a triple-lumen central venous catheter (IVC filter-catheter) and is intended for bedside placement and removal when no longer indicated.. This study presents data from a European Registry of 60 critically ill patients in whom the IVC filter-catheter was used to prevent PE. The patients were all at high risk of PE development or recurrence and had contraindications to anticoagulation. The primary end points of this study were to evaluate the safety (in particular, the presence of infectious or thrombotic events) and effectiveness (the numbers of PEs and averted PEs) of the IVC filter-catheter.. The main diagnosis before catheter insertion was major trauma in 33 patients (55%), intracerebral hemorrhage or stroke in 9 (15%), a venous thromboembolic event in 9 (15%), and active bleeding in 6 (10%). The IVC filter-catheter was placed as prophylaxis in 51 patients (85%) and as treatment in the 9 patients (15%) with venous thromboembolic event. The devices were inserted at the bedside without fluoroscopic guidance in 54 patients (90%) and within a median of 4 days after hospital admission. They were left in place for a mean of 6 days (4-8 days). One patient developed a PE, without hemodynamic compromise; two PEs were averted. No serious adverse events were reported.. Early bedside placement of an IVC filter-catheter is possible, and our results suggest that this is a safe, effective alternative to short-term PE prophylaxis for high-risk patients with contraindications to anticoagulation.. Therapeutic study, level V.

Topics: Adult; Alloys; Catheterization, Central Venous; Critical Illness; Europe; Female; Humans; Male; Middle Aged; Pulmonary Embolism; Registries; Risk Factors; Treatment Outcome; Vena Cava Filters

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

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

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

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

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

Carotid blowout is a devastating complication in patients with head and neck malignancy. A covered stent offers an alternative to treatment of a carotid blowout patient thought to be at high risk for surgery or carotid occlusion. Stent placement in the common carotid artery or carotid bulb is a technical challenge because of large luminal diameter and luminal calibre discrepancy between internal carotid artery and common carotid artery. We present four patients with common carotid rupture and massive bleeding who were treated with self-expanding covered stents, among them, two cases were treated with newly designed self-expanding polytetrafluoroethylene (PTFE)-covered nitinol stents.

Topics: Aged; Alloys; Blood Vessel Prosthesis; Carotid Artery, Common; Carotid-Cavernous Sinus Fistula; Critical Illness; Equipment Design; Fatal Outcome; Head and Neck Neoplasms; Hemorrhage; Humans; Male; Middle Aged; Polytetrafluoroethylene; Radiography; Rupture, Spontaneous; Stents