Purpose: Cryopreserved saphenous vein allografts are used for femoral-infrapopliteal bypass graft purposes when adequate autogenous vein is unavailable. Anticoagulation, immunosuppression therapy, or both have been suggested means for improving allograft patency. Immunosuppression has significant cost and morbidity and has produced variable results. Our successful treatment of luminal surface hypercoagulability associated with certain endovascular procedures prompted the use of an anticoagulation protocol prospectively to improve graft patency and limb salvage for patients receiving femoral-infrapopliteal cryopreserved saphenous vein allografts. Methods: Between September 1995 and October 1999, 24 patients (15 men and nine women) were enrolled in a prospective clinical trial for salvage of 26 severely ischemic lower limbs with femoral-infrapopliteal cryopreserved saphenous vein allograft bypass grafts. All patients were treated with a protocol (aspirin, low-dose heparin, low molecular weight dextran 40, dipyridamole, and warfarin), and no immunosuppressive agents were used. The cryopreserved saphenous vein allografts were matched to patients by ABO and Rh compatibility. Indications for revascularization were ischemic rest pain (n = 8), nonhealing ulcer (n = 13), or focal gangrene (n = 5), and no usable autogenous vein was available. Follow-up ranged from 2 to 35 months (mean, 19 months). We studied the location and type of outflow anastomosis, specific outflow vessel, morbidity, death, secondary procedures (digital/transmetatarsal amputation), and complications related to the treatment protocol. Life table analyses of primary graft patency and limb salvage were compared with other current reported data. Results: Primary graft patency with Kaplan-Meier life table analysis was 96% at 6 months, 87% at 12 months, and 82% at 18 and 24 months. There were no reoperations for acute graft occlusion. One graft underwent late segmental aneurysmal degeneration and rupture. There were no procedure-related deaths or bleeding complications. During late follow-up, anticoagulation was discontinued in three patients (12%) because of gastrointestinal bleeding. Limb salvage was 88% at 6 months and 80% at 12, 18, and 24 months. Patients returned to ambulatory status that was limited only by their other comorbidities. Conclusion: Femoral-infrapopliteal bypass graft for limb salvage with a cryopreserved saphenous vein allograft can be an acceptable alternative when autogenous vein is not available. Our treatment protocol substantially improved allograft patency and limb salvage when compared with current published data.
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