Textbook outcomes after revascularization for chronic limb threatening ischemia remain rare.

Abstract

Background: Suggested performance outcome metrics and traditional surgical benchmarks may be inadequate proxies for evaluating the quality of revascularization in chronic limb threatening ischemia (CLTI). Textbook outcomes (TO) following revascularization in CLTI are poorly described, and limited to cohorts studying open bypass only. We aim to propose a TO in CLTI to provide a more comprehensive evaluation of modern CLTI outcomes.

Methods: A nine-year retrospective, single-center analysis of consecutive CLTI patients undergoing revascularization (open, endovascular, or hybrid) was performed. Data on demographics, length of stay, comorbidities, procedural data, Wound, Ischemia, and foot Infection (WIfI) scores, limb salvage, post-operative complications, wound-healing, return to baseline, and/or normalized ambulatory status and survival were collected. TO was defined as a composite of survival, limb-salvage, without re-interventions (wound or vascular), freedom from major complications and reinterventions, 1 ≤ wound-related procedure, return to baseline function and complete wound-healing. Descriptive statistics and binary logistic regression were used to evaluate factors associated with TO.

Results: Over nine years, 702 CLTI patients (N=445 male; 63.4%, median age 66.6, IQR 59.2, 73.9 years; 915 limbs; median follow-up 25, IQR 11,47 months) were studied. Significant patient-level co-morbidities include diabetes mellitus (N=458, 65.3%); chronic kidney disease (N=451, 64%) and dialysis dependence (N=225, 32%). Initially, 915 limbs were treated with 646 (71%) endovascular, 215 (24%) open, and 49 (5%) hybrid procedures. TO was achieved in 225 limbs (24.6%). For the overall cohort, each component of TO at one-year were as follows: survival (n=610, 86.9%), limb-salvage (n=787, 86%), freedom from major postoperative complications (n=788, 86%), freedom from re-interventions (n=513, 56%), < 1 wound procedure (n=607, 66%), return to baseline, and/or normalized ambulatory status(n=587, 64.2%), and complete wound healing (n=347, 62%). Multivariable analysis identified factors associated with TO as follows: anticoagulant use (OR 0.5, 95% CI 0.4-0.8, p<0.01); WIfI Stage 1 (OR 2.6 95% CI 1.5-4.5; p < 0.001), diabetes OR 0.42 95% CI 0.29-0.60)<.001 and residence in an assisted living facility (OR 0.13(0.03-0.55) 95% CI p=.006).

Conclusions: Despite excellent survival and limb-salvage, TO was achieved in less than one-fourth of patients undergoing re-vascularization for CLTI. Patients with WIfI stage 1 have a greater than two-fold odds of having a TO compared to all other WIfI stages, whereas those living in an assisted living facility, diabetics and/or taking oral anticoagulants were less likely to achieve a TO. Our data highlight the fact that current performance metrics fail to capture the true procedural burden associated with revascularization, which merits consideration when educating patients, selecting patients for intervention, and outcome adjudication in clinical trials and quality assessments.