Retrospective multicenter Evaluation of cold-stored saphenous Vein Allografts in peripheral arterial diSease (REVAS study).

Abstract

Autologous great saphenous vein remains the reference conduit for infrainguinal bypass, but is unavailable or unsuitable in a substantial proportion of patients. In complex redo reconstructions, infrageniculate targets, or infected fields, alternative options (arm veins or endovascular reconstructions) may also be limited. Cold-stored venous allografts (CSVAs) represent a biological salvage conduit in such settings, although concerns persist regarding durability. This study evaluated the midterm outcomes of infrainguinal bypass using CSVA in routine practice. This retrospective multicenter study included consecutive patients undergoing infrainguinal bypass with cold-stored great saphenous vein allografts (+4°C) between January 2018 and February 2024 across four French centers. Indications included chronic limb-threatening ischemia, disabling claudication, acute-on-chronic ischemia, and vascular prosthesis infection. The primary end point was graft-related complications (aneurysmal degeneration, graft infection, rupture, occlusion). Secondary end points included primary and secondary patency, major adverse limb events (MALEs), limb salvage, reinterventions, and survival. Kaplan-Meier methods and multivariable regression analyses were performed. Two hundred lower limbs (195 patients; mean age 70 ± 11 years; 159 men [79.5%]) were included. Indications were chronic limb-threatening ischemia in 131 (65.5%), acute-on-chronic ischemia in 26 (13.0%), disabling claudication in 24 (12.0%), and vascular prosthesis infection in 28 (13.7%). Infrageniculate targets were used in 150 (75.0%) and redo revascularization was performed in 131 (65.5%). The mean follow-up was 24 months. Graft-related complications occurred in 108 (54.0%), including bypass occlusion in 93 (46.5%), rupture in 15 (7.5%), aneurysmal degeneration in 11 (5.5%), pseudoaneurysm in 5 (2.5%), and graft infection in 8 (4.0%). Major reinterventions were required in 88 (44.0%), and major adverse limb events occurred in 104 (52.0%). Primary patency was 59.5% (95% confidence interval [CI], 51.5-66.5) at 1 year and 36.5% (95% CI, 27.5-45.5) at 5 years; secondary patency was 64.1% (95% CI, 56.2-71.0) at 1 year and 44.5% (95% CI, 35.0-53.6) at 5 years. Freedom from major amputation was 75.0% at 1 year and 61.5% at 5 years. Multiple segment grafts (120 [60.0%]) were independently associated with increased graft-related complications (adjusted odds ratio, 2.27; 95% CI, 1.44-3.69) and reduced primary patency (adjusted HR 1.35; 95% CI, 1.02-1.77). In patients lacking suitable autologous conduit and durable endovascular options, CSVAs provide meaningful limb salvage, but are associated with limited patency and substantial reintervention burden. Their use should remain restricted to carefully selected salvage scenarios with structured surveillance.