Endovascular therapy in an ‘all-comers’ risk group for chronic limb-threatening ischemia demonstrate safety and efficacy when compared to the established performance criteria proposed by the society for vascular surgery

Abstract Purpose To describe the applicability of the Society for Vascular Surgery (SVS) Objective Performance Goals (OPGs) as a tool to evaluate results in the context of endovascular management of non-complex and complex patients (i.e., end stage renal disease/history of prosthetic conduit) with chronic limb-threatening ischemia (CLTI). Methods Patients diagnosed with CLTI undergoing endovascular procedures from March 2016 – April 2017 were included, and medical records were examined. Patients were categorized as OPG Risk (OPGR) and non-OPG Risk (nOPGR) groups according to the SVS performance criteria. We compared clinical events between the two groups and then further to the SVS OPGs. Thirty-day outcomes (safety) were: major amputation (AMP), major adverse limb events (MALE), major adverse cardiovascular events (MACE); and 1-year outcomes (efficacy) were: limb salvage, major adverse limb events + 30-day perioperative death (MALE + POD), and survival. Mortality was demonstrated using Kaplan-Meier analysis. Results A total of 72 patients were included (OPGR=58.3% vs nOPGR=41.7%). Mean follow-up was 20 months (range, 1-40 months). Retrograde pedal access was used in 65.2%. The overall AMP rate was 2.7% (OPGR=4.7%, nOPGR=0%, P=0.225, vs SVS OPG 84% ), MALE + POD was 76.4% (OPGR=78.6%, nOPGR=73.4%, P=0.606, vs SVS OPG>71%), and survival was 77.7% (OPGR=83.3%, nOPGR=70%, P=0.18, vs SVS OPG>80%). Conclusion The SVS OPG set appropriate safety and efficacy standards as a bar for new technologies. In this series, endovascular therapy in all-comers exceeded the safety and efficacy end-points proposed by the limited risk OPG panel.