ResultsTechnical and clinical successes were achieved in 91% of the patients with aneurysms, 91% with occlusive lesions, and 100% with traumatic arterial lesions. These patients and grafts have been followed from 1 to 30 months (mean, 13 months). The primary and secondary patency rates at 18 months for aortoiliac occlusions were 77% and 95%, respectively. The 18-month limb salvage rate was 98%. Immediately after aortic aneurysm exclusion, a total of 6 (33%) perigraft channels were detected; 3 of these closed within 8 weeks. Endovascular stented graft procedures were associated with a 10% major and a 14% minor complication rate. The overall 30-day mortality rate for this entire series was 6%. ConclusionsThis initial experience with endovascular graft repair of complex arterial lesions justifies further use and careful evaluation of this technique for major arterial reconstruction. 449

This report describes the use of an endoluminally placed stented graft to repair a large (2.6 by 2.6 by 15 cm) popliteal aneurysm in a 63-year-old man with advanced heart disease. Two balloon-expandable stents were attached to a 6 mm polytetrafluoroethylene graft, which was inserted with the patient receiving local anesthetic through a proximal superficial femoral artery arteriotomy. Repeat arteriography and duplex ultrasonography performed up to 3 months after the procedure documented graft and distal artery patency and complete aneurysmal exclusion without distal emboli. This experience demonstrates technical feasibility and early graft patency. However, additional experience and follow-up will be needed to assess the value of this minimally invasive procedure in the management of popliteal aneurysmal disease.

From January 1, 1974 to December 31, 1989, we treated 2829 patients with critical lower-extremity ischemia. In the last 5 years, 13% of patients had therapeutically significant stenoses or occlusions above and below the groin, while 35% had them at two or three levels below the inguinal ligament. Unobstructed arterial flow to the distal half of the thigh was present in 26% of patients, and 16% had unobstructed flow to the upper third of the leg with occlusions of all three leg arteries distal to this point and reconstitution of some patent named artery in the lower leg or foot. In the last 2 years, 99% of all patients with a threatened limb and without severe organic mental syndrome or midfoot gangrene were amenable to revascularization by percutaneous transluminal angioplasty (PTA), arterial bypass, or a combination of the two, although some distal arteries used for bypass insertion were heavily diseased or isolated segments without an intact plantar arch. Limb salvage was achieved and maintained in more than 90% of recent patient cohorts, with a mean procedural mortality rate of 3.3%. Recent strategies that contributed to these results include (1) distal origin short vein grafts from the below-knee popliteal or tibial arteries to an ankle or foot artery (291 cases); (2) combined PTA and bypass (245 cases); (3) more distal PTA of popliteal and tibial artery stenoses (233 cases); (4) use of in situ or ectopic reversed autogenous vein for infrapopliteal bypasses, even when vein diameter was 3 to 4 mm; (5) composite-sequential femoropopliteal-distal (PTFE/vein) bypasses; (6) reintervention when a procedure thrombosed (637 cases) or was threatened by a hemodynamically significant inflow, outflow, or graft lesion (failing graft, 252 cases); (7) frequent follow-up to detect threatening lesions before graft thrombosis occurred and to permit correction of lesions by PTA (58%) or simple reoperation; and (8) unusual approaches to all infrainguinal arteries to facilitate secondary operations, despite scarring and infection. Primary major amputation rates decreased from 41% to 5% and total amputation rates decreased from 49% to 14%. Aggressive policies to save threatened limbs thus are supported.

Our continuing experience with UVg confirms that favorable results can be obtained with this biologic alternative to autologous vein for lower limb revascularization. Concern regarding biodegradation and aneurysm formation even after 5 years are unfounded at this time. Improved patency and limb salvage rates can be achieved in concert with lower nonthrombotic failure rates, increasing performance of associated endovascular procedures, use of tourniquets, and the addition of dAVF for crural bypass grafting. Prospective randomized studies are still necessary for the assessment of the comparative role of all graft materials, a project that continues to evade our specialty.

These results indicate that a PTFE bypass to an infrapopliteal artery remains a worthwhile option in patients without usable autologous vein. The secondary patency and limb salvage rates were acceptable in this setting and were not significantly different from the best results reported with prosthetic tibial/peroneal bypasses with distal vein cuffs or patches (74% at 1 year; 58% at 3 years), arteriovenous fistulas (71% at 1 year) or composite arm vein grafts (39% and 29% at 3 and 5 years, respectively).

We conclude that GSVs with thick and calcified walls or hypercellular intima at the time of grafting are at increased risk of developing intragraft lesions that may lead to graft failure. Frequent duplex ultrasonography surveillance is particularly warranted for such high-risk grafts.

These preliminary observations on the healing of PTFE endovascular stented grafts in human beings demonstrate limited plaque hyperplasia and the presence of endothelial cells on the luminal surface remote from the graft-artery anastomosis. It is unclear whether this is a unique manifestation of healing in prosthetic grafts inserted within the walls of arteries.

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