Abstract
Purpose: To investigate the thus far poorly defined impact of perioperative complications (POCs) on clinical outcomes after endovascular therapy (EVT) of diabetic patients with critical limb ischemia (CLI) due to isolated infrapopliteal lesions. Methods: A multicenter registry of CLI patients was interrogated to identify 780 consecutive diabetic patients (mean age 71±10 years; 553 men) who successfully underwent balloon angioplasty for isolated infrapopliteal lesions. More than half of the population (487 patients) was on dialysis. Independent predictors (logistic regression) and prognostic impact on outcomes (Cox proportional hazards model) of POC (ie, death, myocardial infarction, stroke, pseudoaneurysm, puncture site hemorrhage/hematoma, distal emboli, vascular rupture, transfusion, dialysis, and gastrointestinal hemorrhage) were investigated. Outcomes are presented as the odds ratio (OR) and hazard ratio (HR), respectively, with 95% confidence intervals (CI). Results: POCs occurred in 12.3% (96/780) of the population. Multivariate modeling identified body mass index (BMI) <18.5 kg/m2 (adjusted OR 1.71, 95% CI 1.01 to 2.89, p=0.047) and tissue loss (adjusted OR 2.43, 95% CI 1.14 to 5.15, p=0.021) as independent predictors of POCs. In a Cox regression model adjusted for baseline clinical characteristics, the occurrence of POCs was independently associated with major adverse limb events (HR 1.87, 95% CI 1.12 to 3.13, p=0.016) but not with mortality or wound healing. In follow-up, freedom from major adverse limb events was higher in the group without POC (85.2%) than with POC (69.7%, p=0.006) at up to 3 years. Conclusion: POCs within 30 days after balloon angioplasty for infrapopliteal disease in diabetics with CLI were more likely to occur in patients with low BMI and tissue loss. POC occurrence was associated with major adverse limb events in follow-up but not with mortality or wound healing.
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