Balloon-Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease: 9-Month Results from the BOLSTER Multicenter Study.

PURPOSE: This study sought to assess the performance of the LIFESTREAM balloon-expandable covered stent for the treatment of iliac artery atherosclerotic lesions. METHODS: A total of 155 patients were treated in a prospective, single-arm study at 17 centers in the United States, Europe, and New Zealand. The primary endpoint was a composite of device- or procedure-related death or myocardial infarction (MI) over the course of 30 days, or target lesion revascularization (TLR), major amputation of the target limb, or re-stenosis through 9-months. Secondary endpoints included primary patency, TLR, sustained clinical success, quality of life, and major adverse events (MAE). RESULTS: At 9 months, the primary composite endpoint rate was 16.2% (93.5% confidence interval [CI]: 10.6%-23.2%), primary patency was 89.1% (95% CI: 82.6%-93.7%), and freedom from TLR was 96%. There was a cumulative clinical improvement of at least one Rutherford category from baseline to 9 months of 90.5% (95% CI: 84.3%-94.9%). Quality of life, assessed by using the Walking Impairment Questionnaire (WIQ), demonstrated a mean change in total score from baseline through 9 months of 32.1 ± 26.84; overall, improvements were noted from baseline in each WIQ category. Seven of one-hundred fifty patients (4.7%; 95% CI: 1.9%-9.4%) experienced MAEs, but none were determined to be related to device or procedure. CONCLUSIONS: The LIFESTREAM balloon-expandable covered stent provided satisfactory 9-month clinical outcomes including a low rate of target lesion revascularization for the treatment of stenotic and occlusive lesions of the iliac arteries.

Very distal vein bypass in patients with thromboangiitis obliterans.

BACKGROUND: Surgical revascularization for chronic critical limb ischaemia in patients with thromboangiitis obliterans (TAO) still remains controversial. Generally, besides cessation of smoking, conservative treatment supported by intravenous administration of vasoactive agents is regarded as the treatment of choice, in combination with local wound therapy or minor amputation. PATIENTS AND METHODS: In four male patients (42-47 years) surgical revascularization was chosen as therapy for established gangrene or non-healing ulceration after unsuccessful conservative treatment and cessation of smoking. Angiography was able to identify a suitable distal arterial segment for the bypass which was revascularized by means of an autologous vein graft. Grafts were followed with repetitive duplex ultrasound. Revision of the bypass graft was initiated if indicated by pathological duplex findings. RESULTS: In all cases a bypass could be constructed with either the ipsilateral greater saphenous vein or arm veins. A distal origin configuration was possible in three cases with popliteo-pedal or cruro-pedal bypasses. In the fourth case the distal superficial femoral artery was used for inflow. Two early graft thromboses underwent successful revision. During follow-up, duplex ultrasound identified graft stenoses in three bypasses which were successfully treated with endovascular techniques. All grafts are patent with complete resolution of ischaemic symptoms after 46, 42, 32, and 29 months. The patients remained non-smokers and returned to a professional life. CONCLUSIONS: Surgical therapy with distal vein bypass for persistent ischaemic symptoms after definitive cessation of smoking seems feasible in selected cases with TAO and a suitable distal artery. Close follow-ups of the patients with duplex ultrasound are necessary to identify developing vein graft stenoses. Angioplasty seems to be an important part of the long-term therapeutic concept.

German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization.

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

Long-Term Results of Femorodistal Sequential Composite-Bypass Combining Heparin-Bonded PTFE-Prosthesis and Autologous Vein Using the Deutsch Bridge Technique in Critical Limb-Threatening Ischemia.

BACKGROUND: Autologous vein bypass provides excellent long-term results in critical limb-threatening ischemia (CLTI), but a substantial portion of patients have insufficient vein length. In limbs with two distal outflow vessels and limited vein length, a vascular prosthesis may be combined with autologous vein for a sequential composite bridge bypass (SCBB). Results regarding graft function, limb salvage and reinterventions are presented. METHODS: Between January 2010 and December 2019, 47 consecutive SCBB operations with a heparin-bonded PTFE-prosthesis and autologous vein were performed. Grafts were followed with a duplex scan with prospective documentation in a computerized vascular database. Retrospective analysis of graft patency, limb salvage and patient survival was performed. RESULTS: Mean follow-up was 34 months (range 1-127 months). 30-day mortality was 10.6% and 5-year patient survival 32%. Postoperative bypass occlusion occurred in 6.4% and late occlusions or graft stenoses in 30%. Two prostheses developed late infection and seven legs were amputated. Primary, primary assisted, secondary patency and limb salvage rate were 54%, 63%, 66% and 85% after 5 years, respectively. CONCLUSIONS: SCBB patency and limb salvage were good despite a high early postoperative mortality. Combination of a heparin-bonded PTFE-prosthesis and autologous vein appears to be a valuable tool in CLTI in case of insufficient vein.

Self-Expanding Versus Balloon-Expandable Stents for Iliac Artery Occlusive Disease: The Randomized ICE Trial.

OBJECTIVES: Atherosclerosis of iliac arteries is widespread. As inflow vessels, they are of great clinical significance and increasingly being treated by endovascular means. Most commonly, stents are implanted. BACKGROUND: So far, due to a lack of comparative data, no guideline recommendations on the preferable stent type, balloon-expandable stent (BE) or self-expanding stent (SE), have been issued. METHODS: In this randomized, multicenter study, patients with moderate to severe claudication from common or external iliac artery occlusive disease were assigned 1:1 to either BE or SE. The primary endpoint was binary restenosis at 12 months as determined by duplex ultrasound. Key secondary endpoints were walking impairment, freedom from target lesion revascularization (TLR), hemodynamic success, target limb amputation, and all-cause death. RESULTS: Six hundred sixty patients with 660 lesions were enrolled at 18 German and Swiss sites over a period of 34 months; 24.8% of the patients had diabetes and 57.4% were current smokers. The common iliac artery was affected in 58.9%. One hundred nine (16.5%) lesions were totally occluded and 25.6% heavily calcified. Twelve-month incidence of restenosis was 6.1% after SE implantation and 14.9% after BE implantation (p = 0.006). Kaplan-Meier estimate of freedom from TLR was 97.2% and 93.6%, respectively (p = 0.042). There was no between-group difference in walking impairment, hemodynamic success, amputation rate, all-cause death, or periprocedural complications. CONCLUSIONS: The treatment of iliac artery occlusive disease with SE as compared with BE resulted in a lower 12-month restenosis rate and a significantly reduced TLR rate. No safety concerns arose in both groups. (Iliac, Common and External [ICE] Artery Stent Trial; NCT01305174).