Early results of infrageniculate arterial reconstruction using cryopreserved homograft saphenous conduit (CADVEIN) and combination low-dose systemic immunosuppression.

BACKGROUND

The search continues for the ideal conduit for infrageniculate arterial reconstructions when the autogenous vein is unsuitable or unavailable. Based on experimental observations in our laboratory demonstrating improvement in canine cryopreserved allograft vein patency using systemic immunosuppression (Imsup), and the remarkable clinical success achieved in older (greater than 60 years of age) solid organ transplant recipients using combination low-dose Imsup, we studied the effects of Imsup on patency of cryopreserved homograft saphenous vein (CADVEIN) used for infrageniculate arterial reconstructions.

STUDY DESIGN

Under the Institutional Review Board protocol, 21 infrageniculate CADVEIN grafts were placed in 19 patients between July 1993 and August 1994 for limb salvage when autogenous veins were unavailable. An immunopharmacologic protocol consisting of low-dose cyclosporine A, azathioprine, prednisone, warfarin, aspirin, and vasodilators given orally was instituted. For various reasons, 15 patients in group 1 received Imsup; five patients never received Imsup, and one patient in group 2 received Imsup briefly. Follow-up examinations were completed using the time range of six to 18 months (mean, eight plus or minus one month).

RESULTS

One patient died (5.3 percent) 30 days after emergency combined venous graft and bilateral CADVEIN bypass. The actuarial 12-month primary patency in group 1 was 59.4 percent compared with 16.7 percent in group 2 (p < 0.015, log-rank test). Cellular rejection was typically seen in explanted CADVEIN. Systemic morbidity related to Imsup was minimal. The CADVEIN morbidity rate was significant: three graft aneurysms and four early graft ruptures. Major amputations were necessary in eight of 12 patients with graft closure.

CONCLUSIONS

The data suggest that Imsup significantly improves CADVEIN patency with limited systemic morbidity; however, complications related to the conduit itself occurred with greater frequency and cause greater morbidity than when the autogenous veins were used. Much has yet to be learned regarding the preservation characteristics of CADVEIN and the immunologic interactions in patients receiving CADVEIN grafts, before further clinical use of this conduit can be recommended.