Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery.

OBJECTIVE: We assessed the long-term safety and efficacy of endovascular stent grafting to treat long, complex lesions in the superficial femoral artery (SFA). METHODS: The present prospective, multicenter study at 15 Japanese hospitals assessed heparin-bonded stent grafts used to treat long SFA lesions in patients with symptomatic peripheral arterial disease. The inclusion criteria were Rutherford category 2 to 5 symptoms (grade 5 without active infection), an ankle brachial index of ≤0.9, and SFA lesions ≥10 cm long with ≥50% stenosis. The key efficacy and safety outcomes were primary-assisted patency and adverse events through 24 months, respectively. The secondary outcomes included primary patency, secondary patency, freedom from target lesion revascularization (fTLR), and Vascular Quality of Life questionnaire score. RESULTS: Of the 103 patients (mean age, 74.2 ± 7.0 years; 82.5% male), 100 (97.1%) had intermittent claudication. The average lesion length was 21.8 ± 5.8 cm; 87 lesions (84.5%) were TASC (Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease) C or D (65.7% chronic total occlusions). Of the 103 patients, 92 and 61 were evaluable through 24 and 60 months, respectively. At 24 months, the Kaplan-Meier-estimated primary-assisted patency, primary patency, and secondary patency rate was 85.7% (95% confidence interval [CI], 76.3%-91.5%), 78.8% (95% CI, 68.8%-85.9%), and 92.0% (95% CI, 82.4%-96.5%), respectively. The mean ankle brachial index was 0.64 ± 0.12 at baseline and 0.94 ± 0.19 at 24 months (P < .0001). At 24 and 60 months, the fTLR was 87.2% (95% CI, 78.9%-92.3%) and 79.1% (95% CI, 67.9%-86.8%), respectively. No device- or procedure-related life- or limb-threatening critical events or acute limb ischemia cases were observed through 5 years. No stent fractures were detected on the annually scheduled follow-up radiographs. The vascular quality of life questionnaire and walking impairment questionnaire scores were significantly increased at 1 through 24 months compared with the baseline scores (P < .0001 for both). One patient had required conversion to open bypass during the 5-year follow-up period. CONCLUSIONS: Stent grafting of long and complex SFA lesions in patients with claudication is safe and effective through long-term follow-up, with 79.1% fTLR and no leg amputation, acute limb ischemia, or stent fractures through 5 years.

Evaluation of heparin-bonded ePTFE grafts for forearm loop vascular access: Comparison between Gore® PROPATEN vascular graft and ACUSEAL vascular graft.

BACKGROUND: This retrospective study evaluates the clinical outcomes of two heparin-bonded expanded polytetrafluoroethylene grafts, PROPATEN and ACUSEAL (W. L. Gore & Associates, Flagstaff, AZ, USA), for forearm loop vascular access. METHODS: We prospectively collected data on 60 patients who had undergone arteriovenous graft of the forearm loop type between January 2015 and December 2019. The primary endpoints were graft primary, assisted primary, and secondary patency rates. Secondary endpoints were time to first cannulation and postoperative complications. RESULTS: We enrolled 36 patients in the PROPATEN group (Group P) and 24 in the ACUSEAL group (Group A). All procedures were successful without any 30-day mortality. The median times to first cannulation were 16.5 days and 3 days in Groups P and A, respectively (p < 0.001). Mean follow-up periods were 13.4 ± 14.5 and 17.3 ± 9.3 months, respectively. Primary patency rates were 81% and 64%, respectively, at 6 months, and 60% and 40%, respectively, at 12 months (p = 0.008). Assisted primary patency rates were 96% and 83% at 6 months, 91% and 73% at 12 months, and 81% and 35% at 24 months (p = 0.044). Secondary patency rates were 96% and 81% at 12 months, and 87% and 62% at 24 months (p = 0.207). As a remote-period complication, disruption of the luminal layer of the graft was observed in two patients (4.2%) in Group A due to puncture and thrombectomy. CONCLUSIONS: Although the ACUSEAL graft offers the advantage of early cannulation, its primary and assisted primary patency outcomes were inferior to those of the PROPATEN graft. It is important for physicians to be aware of the different characteristics of each graft to select the best option for each patient.