Abstract
The aim of this study was 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 noncomplex and complex patients (i.e., end stage renal disease/history of prosthetic conduit) with chronic limb-threatening ischemia (CLTI). Patients diagnosed with CLTI undergoing endovascular procedures from March 2016 to April 2017 were included, and medical records were examined. Patients were categorized as OPG risk (OPGR) and non-OPG risk (nOPGR) groups in accordance with 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 (MALEs), and major adverse cardiovascular events (MACEs), and 1-year outcomes (efficacy) were limb salvage, MALE+30-day perioperative death (MALE+POD), and survival. Mortality was demonstrated using Kaplan-Meier analysis. A total of 72 patients were included (OPGR=58.3% vs. nOPGR=41.7%). Mean follow-up was 20months (range, 1-40months). Retrograde pedal access was used in 65.2% of patients. The overall AMP rate was 2.7% (OPGR=4.7%, nOPGR=0%, P=0.225, vs. SVS OPG<3%), MALE was 4.1% (OPGR=7.1%, nOPGR=0%, P=0.135, vs. SVS OPG<8%), and MACE was 6.9% (OPGR=2.3%, nOPGR=13.3%, P=0.071, vs. SVS OPG<8%). The limb salvage was 90.3% (OPGR=88%, nOPGR=93.3%, P=0.46, 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%). The SVS OPGs 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 endpoints proposed by the limited risk OPG panel.
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