Beyond Patency: Patient-Centered Outcomes and the Proposed Accountability Gap in Chronic Limb-Threatening Ischemia.

Abstract

Chronic limb-threatening ischemia (CLTI) carries 1-year mortality of 20% to 25%, comparable with many solid-organ malignancies. Technically successful revascularization, defined by anatomical patency, does not reliably deliver pain relief, restored function, or sustained quality of life. This narrative review synthesizes landmark randomized trials (BEST-CLI, BASIL-1, BASIL-2) and current European and United States guidelines, grading every claim with a scheme in which population indirectness downgrades design strength. We examine 4 domains of morbidity persisting after anatomically successful revascularization: mechanistically heterogeneous pain; functional and quality-of-life decline; psychological burden; and sustained health care use, including chronic opioid use (approximately 35%), unhealed wounds at 1 year (10%-32%), and unplanned 30-day readmission (approximately 25%). No patient-reported outcome measure has been validated specifically for CLTI or used as a co-primary trial endpoint. We propose an accountability gap: the under-measured transfer of unresolved morbidity from vascular services to primary care. We state it as a falsifiable prediction about the discrimination of patency rather than prevalence, with a pre-specified effect size, explicit treatment of death as a competing risk, and a core outcome battery justified against COSMIN criteria. Patient co-production is the indispensable next step.