Implications of Early Failure of Isolated Tibial Interventions

Abstract

Infrapopliteal disease is documented in 50% of patients presenting with rest pain and tissue loss, and tibial interventions for critical limb ischemia are frequent. The implications of early (≤30 days) failure of an isolated tibial intervention are still unclear. The aim of this study was to examine the patient-centered outcomes of failed isolated tibial intervention. A database of patients undergoing lower extremity endovascular interventions between 2006 and 2016 was retrospectively queried. Patients with critical ischemia (Rutherford 4, 5, and 6) were selected, and failures within 30 days were identified. 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 (MALE; above-ankle amputation of the index limb or major reintervention [new bypass graft, jump/interposition graft revision]) were evaluated. There were 1779 patients (58% male; average age, 65 years; 2898 vessels) who underwent tibial intervention for critical ischemia. Early failure was identified in 284 procedures (16%); 124 cases (44%) failed immediately (<24 hours), and 160 cases (56%) failed within the first 30 days after intervention. Two modes of failure occurred: hemodynamic failure (47%) and progression of critical ischemia (53%). Bypass after early failure was successful in patients with adequate vein, a target vessel of ≥3 mm, and good inframalleolar runoff. Progression of symptoms was associated with major amputation in patients with Rutherford 5 and 6 disease. Presentation with Wound, Ischemia, and foot Infection stage 3/4 disease, diabetes, and end-stage renal disease were identified as independent clinical predictors for early failure. Lesion calcification, reference vessel diameter <3 mm, lesion length >300 mm, and poor inframalleolar runoff were identified as independent anatomic predictors for early failure and increased MALEs. Early failure was predictive of a poor long-term clinical efficacy and amputation-free survival (Table).TableNo early failureEarly failureP valueNo. of limbs at risk1494284—Age, years, mean ± SD61 ± 969 ± 11NSHigh-risk PIII score2833.04WIfI stage 3/43943.02TASC I C/D7974NS30-day MACE13.0130-day MALE718.00130-day amputation935.0015-year clinical efficacy, mean ± SEM39 ± 826 ± 9.015-year AFS, mean ± SEM43 ± 337 ± 9.025-year MALE, mean ± SEM47 ± 931 ± 8.03AFS, Amputation-free survival; MACE, major adverse cardiovascular event; MALE, major adverse limb event; NS, not significant; PIII, PREVENT III; SD, standard deviation; SEM, standard error of the mean; TASC, TransAtlantic Inter-Society Consensus; WIfI, Wound, Ischemia, and foot Infection.Values are reported as % unless otherwise indicated. Open table in a new tab AFS, Amputation-free survival; MACE, major adverse cardiovascular event; MALE, major adverse limb event; NS, not significant; PIII, PREVENT III; SD, standard deviation; SEM, standard error of the mean; TASC, TransAtlantic Inter-Society Consensus; WIfI, Wound, Ischemia, and foot Infection. Values are reported as % unless otherwise indicated. Both clinical and anatomic factors can predict early failure of endovascular therapy for isolated tibial disease. Early failure significantly increases 30-day major amputation and 30-day MALEs and is associated with poor long-term patient-centered outcomes.