Comparison of Cryopreserved Arterial Allografts Versus Heparin-bonded Vascular Grafts in Infragenicular Bypass for Chronic Limb Threatening Ischemia

Abstract

Background: The purpose of this study was to compare cryopreserved arterial allograft (CAA) to heparin-bonded prosthesis (HBP) in infragenicular bypasses for patients with chronic limb-threatening ischemia (CLTI).

Methods: This retrospective study took place in 2 university hospitals and included 41 consecutive patients treated for CLTI. In the absence of a suitable saphenous vein, an infragenicular bypass was performed using either CAA (24 cases) or HBP (17 cases). Kaplan-Meyer analysis compared primary and secondary patency and amputation-free survival rates. Binomial logistic regression analyzed risk factors for major amputation and thrombosis.

Results: The mean followup was 18.5 months (±14.3) in the CAA group, 17.6 (±6.1) in the HBP group. In the CAA group, primary and secondary patency rates at 12 months were 52% (±10.6) and 61% (±10.3), compared to 88% (±7.8) and 94% (±5.7) in the HBP group, respectively. The difference in patency rates was not statistically different (P = 0.27 and P = 0.28, respectively). The statistically significant factors of graft thrombosis were, a stage 4 from the WIfI classification (Wound Ischemia foot Infection) with a 6 times higher risk (P = 0.04), and a distal anastomosis on a leg artery with a 9 times higher risk of thrombosis (P = 0.03). Amputation-free survival rates at 18 months were similar between the groups (CCA: 75% (±9) versus HBP: 94% (±6), P = 0.11). Patients classified as WIfI stage 4 had 13 times higher odds to undergo major amputation than patients with WIfI stage 2 or 3 (95% CI, 1.16-160.93; P = 0.04). The intervention was longer in the CCA group of 74 min (278 min ± 86) compared to the HBP group (203 min ± 69). This difference was statistically significant (95% CI, 17.86-132.98), t(35) = 2.671, P = 0.01.

Conclusions: CCA is not superior to HBP in infragenicular bypasses for CLTI, and may not be worth the extra cost and the longer operative duration.