Abstract

Inframalleolar (pedal) artery disease has been demonstrated to be a predictor of limb salvage and wound healing in this cohort of patients. The aim of this study was to examine the patient-centered outcomes after isolated inframalleolar (pedal artery) interventions. A database of patients undergoing lower extremity endovascular interventions for tissue loss between 2007 and 2017 was retrospectively queried. Patients with tissue loss (Rutherford 5 and 6) were selected, and those undergoing isolated inframalleolar intervention on the dorsalis pedis and medial and lateral tarsal arteries were identified. Patients with concomitant superficial femoral artery and tibial interventions were excluded. Intention-to-treat analysis by patient was performed. Patient-oriented outcomes of 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 (above-ankle amputation of the index limb or major reintervention [new bypass graft, jump/interposition graft revision]) were evaluated. There were 109 patients (48% male; average age, 65 years; 153 vessels) who underwent isolated inframalleolar intervention for tissue loss. All patients had diabetes, 94% had hypertension, 63% had hyperlipidemia, and 53% had chronic renal insufficiency (47% of these were on hemodialysis). The majority of the patients had Wound, Ischemia, and foot Infection (WIfI) stage 3 disease. Technical success was 81%, with a median of one vessel treated per patient and a mean preoperative pedal runoff score of 12 that improved to a mean of 6 after intervention (<7 is considered good pedal runoff); 34% of interventions were a direct revascularization of the intended angiosome. Overall major adverse cardiovascular event rate was <1% at 90 days after the procedure. The majority of patients underwent some form of planned forefoot amputations (single digit, multiple digits, ray amputation, or transmetatarsal amputation). Wound healing at 3 months was 76%. Those who failed to heal underwent below-knee amputations. The clinical efficacy was 25% ± 7% (mean ± standard error of the mean) at 5 years. The 5-year amputation-free survival rate was 33% ± 8%, and the 5-year major adverse limb event rate was 27% ± 9%. On Cox proportional multivariate analysis, predictors for amputation-free survival were absence of significant coronary disease, a pedal runoff <7, WIfI stage 3 disease, and absence of end-stage renal disease. Predictors for wound healing were improved pedal runoff score (<7), absence of infection, direct angiosome revascularization, and absence of end-stage renal disease. Inframalleolar intervention can be successfully performed in high-risk limbs with high expectation of good short-term results. Long-term patient-centered results remain poor because of the underlying disease process.

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