Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial

Abstract

Purpose: To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries. Materials and Methods: This prospective, multicenter, single-arm trial ( ClinicalTrials.gov; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2–4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture. Results: Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up. Conclusion: The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement.

Distal Endarterectomy Combined With Endovascular Proximal Treatment: The Hybrid DEEP Retrograde Technique for High-Complexity Infrainguinal Disease

“…Heparin-bonded stent-graft (Viabahn, Gore) has the advantages of better patency than bare stents and a noticeable biodynamic performance. 17 –19 However, it shares the general limitations of all EVT and worse results have been described when facing long lesions (>25 cm-Viabahn), 17 heavily calcified, 20 or if the distal end of the VB lands below femoral condyles (39.7% BK vs 82.5% AK) 17 1-year patency and 34% BK vs 10% AK amputation rate. 21…”

“…Once these stenoses are corrected, the thrombotic material inside the VB is easily removed with standard thrombectomy, maintaining the patency of the revascularization. 19…”

“…Heparin-bonded stent-graft (Viabahn, Gore) has the advantages of better patency than bare stents and a noticeable biodynamic performance. [17][18][19] However, it shares the general limitations of all EVT and worse results have been described when facing long lesions (>25 cm-Viabahn), 17 heavily calcified, 20 or if the distal end of the VB lands below femoral condyles (39.7% BK vs 82.5% AK) 17 1-year patency and 34% BK vs 10% AK amputation rate. 21 We decided to use the VB endoprosthesis to apply the endo-bypass concept, because the possibility of performing the ¨pave and crack¨ technique and due to its ease of handling that allows us to tailoring its distal end.…”

Interventional Treatments for Femoropopliteal Arterial Disease and Recent Updates

“…Tsujimura 등( 52 )의 연구에 따르면, 10 cm 이상의 대퇴슬와동맥 병변에 대해 약물방출 스텐트인 Zilver PTX와 스텐트-그라프트인 Viabahn (Gore Medical, Flagstaff, AZ, USA)을 비교했을 때, 3년 개통률이 59.5% vs. 69.6%로 스텐트 그라프트가 더 좋은 것으로 나타났지만, freedom from stent thrombosis는 93.6% vs. 82.4%로 Zilver PTX가 더 좋게 보고되었다. 최근 헤파린을 부착한 스텐트 그라프트를 대퇴슬와동맥의 긴 병변에서 사용하였으나, 36개월 개통률이 40.6%라는 저조한 성적을 보여( 53 ), 추후 더 많은 연구가 필요할 것으로 생각된다. 하지만, 현재 국내에서는 Goremedical이 철수하여 Viabahn의 국내 사용이 불가한 상황이다.…”

Percutaneous Femoropopliteal Bypass: 2-Year Results of the DETOUR System

“…4 Covered stents have been used for longer femoropopliteal lesions, and recently heparin-coasted endoprostheses have been studied. [5][6][7][8] In general, however, the outcome of percutaneous technologies has been inferior for the treatment of longer, heavily calcific, and chronically occluded lesions. 9 The PQ Bypass DETOUR system was designed as a technique for femoropopliteal bypass via a minimally invasive, percutaneous revascularization method.…”