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Implications of Early Failure of Isolated Tibial interventions
Tracy Cheun, MD, Georges M. Haidar, MD, Taylor D. Hicks, MD, Lori L. Pounds, MD, Matthew J. Sideman, MD, Mark G. Davies, MD PhD MBA.
UT Health, San Antonio, TX, USA.

Objectives Infra-popliteal 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 after failed isolated tibial intervention
Methods: 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 orientated outcomes of clinical efficacy (CE; absence of recurrent symptoms, maintenance of ambulation and absence of major amputation), amputation-free survival (AFS; survival without major amputation) and freedom from major adverse limb events (MALE; Above ankle amputation of the index limb or major re-intervention (new bypass graft, jump/interposition graft revision) were evaluated.
Results: 1779 patients (58% male, average age 65 years; 2898 vessels) underwent tibial intervention for critical ischemia. 284 procedures (16%) were early failures. 124 cases (44%) failed immediately (<24hrs), and 160 cases (56%) failed within the first 30 days following 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 ≥ 3mm and good infra-malleolar run-off. Progression of symptoms was associated with major amputation in patients with Rutherford 5 and 6 disease. Presentation with WIFI stage 3/4 disease, diabetes and ESRD were identified as independent clinical predictors for early failure. Lesion calcification, reference vessel diameter <3 mm, lesion length >300 mm and poor infra-malleolar run-off were identified as independent anatomical predictors for early failure and increased MALE. Early failure was predictive of a poor long-term CE and AFS.

TABLENo Early FailureEarly Failurep-value
Number Limbs at Risk (n)1494284-
Age (mean±SD) yrs61±969±11ns
High Risk PIII score (%)28%33%0.04
WIFi Stage 3/439%43%0.02
TASC I C/D (%)79%74%ns
30day MACE (%)1%3%0.01
30 day MALE (%)7%18%0.001
30 day Amputation (%)9%35%0.001
5yr-CE (Mean±SEM %)39±826±90.01
5yr-AFS (Mean±SEM %)43±337±90.02
5yr-MALE (Mean±SEM %)47±931±80.03

Conclusions:
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 MALE and is associated poor long-term patient centered outcomes.


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