Objective performance goals after endovascular intervention for critical limb ischemia

Abstract

During the last decade, primary endoluminal therapy for critical limb ischemia (CLI), assessed as rest pain and tissue loss of the lower extremity, has significantly increased. Reporting of patient-centered outcomes using the new Society for Vascular Surgery objective performance goals (OPGs) has been limited. This study examined the OPGs for infrainguinal endovascular management of CLI. A prospective database of patients undergoing endovascular treatment of the lower extremity for CLI between 2000 and 2011 was queried. Evaluated were clinical efficacy (absence of recurrent symptoms, maintenance of ambulation and absence of major amputation), amputation-free survival (survival without major amputation), and freedom from major adverse limb events (MALEs; above-ankle amputation of the index limb or major reintervention - new bypass graft, jump/interposition graft revision). A total of 728 patients (60% male; age, 68 ± 14 years) underwent lower extremity interventions for CLI (66% tissue loss); of these, 39% had superficial femoral artery and tibial interventions. Diabetes mellitus was present in 71%, hyperlipidemia in 64%, and chronic renal insufficiency in 37%. Technical success was 96%. The overall rate at 30 days of major adverse cardiovascular events (MACEs) was 3% and MALEs was 12%. At 5 years, clinical efficacy was (mean ± standard error of the mean) 42% ± 5%, amputation-free survival was 41% ± 7%, and freedom from MALEs was 51% ± 4%. Clinical efficacy was significantly different in those presenting with rest pain and tissue loss and in the anatomic high-risk group compared with the clinical high-risk group, and both were worse compared with the group without clinical or high-risk criteria. Endoluminal therapy for CLI is associated with early low MACE rates but high MALE rates. When the key outcome of amputation free survival is considered, predictors of a better outcome were absence of current smoking, a lower modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) amputation risk score, better preoperative ambulation status, lower MACEs, and discharge disposition to home. The presence of tissue loss and anatomic risk factors negatively affect outcomes. Longer-term outcomes after endovascular intervention for CLI remain relatively poor, with <40% success in objective performance outcomes at 5 years.