VIABAHN Endoprosthesis for Severe Femoropopliteal Lesions 舒 畅 Dept. of Vascular Surgery, The 2nd Xiang-Ya Hospital, Central-South University 中南大学湘雅二医院血管外科 湖南省大血管疾病外科及微创介入诊疗中心 ： 舒 畅 Dept. of Vascular Surgery, The 2nd Xiang-Ya Hospital, Central-South University 中南大学湘雅二医院血管外科 湖南省大血管疾病外科及微创介入诊疗中心 ：

Background  rate of critical limb ischemia (CLI) caused by arteriosclerosis obliterans is increasing in China.  for now, PTA and bare stent implantation is the frequently used methods to treat CLI.

However, problems of these methods has been noticed: ① artery rupture during the endovascular treatment. Background

② debris goes into outflow Debris coming from the lesions in the bare stent delivery location goes to distal artery and causes ectopic embolization. It happens in carotid artery, why not in lower extremity? Background

③ Poor endothelization in inner layer at the bare stent location. A 79-year-old women received a bare metal Multi- Link Vision stent. 2 years antemortem demonstrates: (A)multiple stent struts (*) penetrating into the lipid- rich necrotic core (NC). (B)A thin layer of neointima (green arrow) is observed over the necrotic core. (C)In the distal region, all struts are shown to be covered by neointima with focal areas of calcification (black arrow). Pathology of Drug-Eluting Versus Bare Metal Stents in Saphenous Vein Bypass Graft Lesions----JACC Cardiovasc Interv. 2012;5 Bare stent struts penetrating the lesions, elongation time of endothelization! Background

④ Hard to bend when implant through articulation. Various kinds of bare stent may kinking or fracture when bend in articulation location. Background

Gore VIABAHN endoprosthesis covered, flexible stent graft may help us solve those problems !

Characteristics 1.Durability 2.Flexibility 3. Easy endothelization Easy to use in tutorous lesions. heparin-bonded surface ePTFE liner attached to an external nitinol stent structure.

Compare to Bare Stent VIASTAR Trial VIABAHN vs Bare Nitinol Stent  prospective, randomized, single-blind, multicenter  Indication: long lesions in SFA occlusive disease  141 patients: heparin-bonded VIABAHN (72 cases) vs BMS (69 cases)  clinical outcomes/patency rates ---- at 1, 6, and 12 months.

VIASTAR Trial VIABAHN vs Bare Nitinol Stent

Compare to Bare Stent VIASTAR Trial VIABAHN vs Bare Nitinol Stent Conclusion: For long femoropopliteal lesions, significant clinical and patency benefits for heparin-bonded covered stents compared with bare metal stent in lesions ≥20 cm were demonstrated. Heparin-Bonded Covered Stents Versus Bare-Metal Stents for Complex Femoropopliteal Artery LesionsThe Randomized VIASTAR Trial (Viabahn Endoprosthesis With PROPATEN Bioactive Surface [VIA] Versus Bare Nitinol Stent in the Treatment of Long Lesions in Superficial Femoral Artery Occlusive Disease) --J Am Coll Cardiol. 2013;62(15):

CASE 1 Patient data: 73 year-old, male. Claudication for 6 months and right lower extremity pain for 1 month. Skin temperature decrease in right lower extremity. Right dorsal disappeared. Two ulceration has been found in the foot. PS ： diabetes mellitus for 6 years.

Case in our hospital 2 CASE 1

Balloon angioplasty the occlusion lesion after the guide wire went through. Gore VIABAHN 6mm *150mm then balloon angioplasty, DSA showed nice result. CASE 1

Postoperatively, the SFA reconstructed by VIABAHN was patent. No operation related complication happened. CASE 1

Patient data: Female, 82 year-old, Claudication for 2 years, right foot pain and swell for 5 months. Right foot the first toe necrosis, right dorsal artery can not be touched. PS: hypertension for 20 years. CASE 2

Cases in our hospital 1 Gore VIABAHN 5mm*150mm Smooth contrast flow showed conception of “ re- line” CASE 2

Cases in our hospital 3 CASE 3 Patient data: 47 year-old, male patient complained of claudication for about 300 meteres, left foot pain for 2 months. Left skin temperature decrease, left dorsal and posterior tibial artery can not be touched. PS: history of myocardial infarction, hypertension for 6 years.

Guide wire go through the lesionDilated with balloon CASE 3

VIABAHN 7mm*150mm Then balloon treatment, DSA showed smooth and nice contrast flow. This is the conception of re- line ---- try best to mimic the normal lumen situation to human being vessel. CASE 3

CASE 4 Patient data: 80 year-old, male, complained of claudication for about 1 year, rest pain for half a year, foot ulcer for 1 week. right skin temperature decrease, bilateral dorsal and posterior tibial artery can not be touched. A 1.5cm*1.0cm ulcer on the first right digit. PS: history of hypertension for 50 years, diabetes mellitus for 11 years.

CASE 4

Dilated with a 6mm balloon first. VIABHAN 7mm*150mm 6mm*150mm Then, dilated with a 6mm balloon in the whole region.

CASE 5 Patient data: 89 year-old, male, complained of claudication for about 8 months, rest pain for 1 month left skin temperature decrease, bilateral dorsal and posterior tibial artery can not be touched. ABI: 0(left), 0.6( right) PS: history of hypertension for 23 years

CASE 5

VIABHAN 6mm*150mm 5mm*150mm

CASE 6 Patient data: 62 year-old, female, complained of claudication for about 1 months left skin temperature decrease, left dorsal and posterior tibial artery can not be touched. A 3.0mm*3.0mm ulcer on left foot. ABI: 0(left), 1.0 (right) PS: history of hypertension for 20 years diabetes mellitus for 10 years.

CASE 6

Right femoral approach. VIABHAN 5mm*100mm 5mm*150mm

CASE 6 傅世美

CASE 7 Patient data: 75 year-old, male, complained of claudication for 9 months. PE: right skin temperature decrease, femoral and popliteal artery can not be touched. ABI: 0(left), 1.1(right) PS: history of diabetes mellitus gout cerebral infarction hypertension et al.

CASE 7

EV3 8mm*120mm (in common femoral artery and bifurcation) Gore VIABAHN: (in SFA) 5mm*150mm 7mm*150mm

CASE 8 Patient data: 59 year-old, male, complained of right lower limb claudication for 3 years, rest pain for 3 days.. PE: right skin temperature decrease, femoral and popliteal artery can not be touched. ABI: 0.6(left), 0right)

CASE 8 Right femoral approach, embolectomy for the proximal and distal lesion first. pigtail catheter could be inserted into abdominal aorta to perform angiography. However, there was no blood stream to bilateral lower limbs.

CASE 8 2 VIABAHN 9mm*150mm were deployed in aorta-iliac segment, and dilated with balloon.

CASE 8 After the stent-graft deployment, blood supply of the right lower extremity recovered completely. For the left side, there was no symptom. So, conservative treatment with intensive follow up can be used.

Conclusion 1. VIABAHN is a durable flexible covered stent graft suitable for femoropopliteal stenosis and occlusion lesions. 2. Covered stent-graft can decrease the risk of artery rupture, especially for lethal iliac artery rupure. 3. No ectopic embolization of the distal branches by debris happened in this group

Conclusion 4. No re-stenosis caused by intimal hyperplasia during follow-up ( 3 months ~ 2 years) 5. In the tortuous segment, no fracture or kink of VIABAHN happened during follow-up. 6.More follow-up data for covered stent graft to bare metal stent in lower extremity occlusion is need for further evaluation.

Thank you very much !