Determinants of Long‐Term Outcomes and Costs in the Management of Critical Limb Ischemia: A Population‐Based Cohort Study

Abstract

BackgroundThe optimal treatment for critical limb ischemia remains controversial owing to conflicting conclusions from previous studies.Methods and ResultsWe obtained administrative claims on Medicare beneficiaries with initial critical limb ischemia diagnosis in 2011. Clinical outcomes and healthcare costs over 4 years were estimated among all patients and by first treatment (endovascular revascularization, surgical revascularization, or major amputation) in unmatched and propensity‐score–matched samples. Among 72 199 patients with initial primary critical limb ischemia diagnosis in 2011, survival was 46% (median survival, 3.5 years) and freedom from major amputation was 87%. Among 9942 propensity‐score–matched patients (8% rest pain, 26% ulcer, and 66% gangrene), survival was 38% with endovascular revascularization (median survival, 2.7 years), 40% with surgical revascularization (median survival, 2.9 years), and 23% with major amputation (median survival, 1.3 years; P<0.001 for each revascularization procedure versus major amputation). Corresponding major amputation rates were 6.5%, 9.6%, and 10.6%, respectively (P<0.001 for all pair‐wise comparisons). The cost per patient year during follow‐up was $49 700, $49 200, and $55 700, respectively (P<0.001 for each revascularization procedure versus major amputation).ConclusionsLong‐term survival and cost in critical limb ischemia management is comparable between revascularization techniques, with lower major amputation rates following endovascular revascularization. Primary major amputation results in shorter survival, higher risk of subsequent major amputation, and higher healthcare costs versus revascularization. Results from this observational research may be susceptible to bias because of the influence of unmeasured confounders.

Tibiopedal arterial minimally invasive retrograde revascularization (TAMI) in patients with peripheral arterial disease and critical limb ischemia. On behalf of the Peripheral Registry of Endovascular Clinical Outcomes (PRIME)

“…A recent study of 72 thousand Medicare CLI patients, analyzed outcomes of revascularization (surgical and endovascular) vs major amputation, showing that revascularization was more cost effective and produced better outcomes. Survival rates were significantly better in the revascularization arm (38% endovascular and 40% surgical) vs. the amputation arm (23%, p < .001) . Patients with advanced PAD and CLI have complex vascular anatomies and comorbidities which can limit successful revascularizations.…”

“…Survival rates were significantly better in the revascularization arm (38% endovascular and 40% surgical) vs. the amputation arm (23%, p < .001). 13 Patients with advanced PAD and CLI have complex vascular anatomies and comorbidities which can limit successful revascularizations. In an attempt to overcome these hurdles, the TAMI strategy was proposed, 6 however not validated until now.…”

The patient presenting with chronic limb‐threatening ischaemia. Does diabetes influence presentation, limb outcomes and survival?

“…A recent study examined Medicare records of 72,199 patients diagnosed with primary CLTI and assessed clinical outcomes over a 4‐year period . In a multi‐variate model of the association of baseline variables on outcomes, diabetes had a significant association with mortality (HR, 1.09; IC, 1.06‐1.11) but not with major amputation.…”

“…In a multi‐variate model of the association of baseline variables on outcomes, diabetes had a significant association with mortality (HR, 1.09; IC, 1.06‐1.11) but not with major amputation. However, diabetes was not included in a reduced multi‐variate model identifying the strongest predictors of mortality and major amputation …”

Worth an Arm and a Leg: The Critical Importance of Limb Ischemia

“…In the article by Mustapha et al in this issue of the Journal of the American Heart Association ( JAHA ),6 the authors describe the clinical and financial burden of CLI among Medicare patients. Using administrative billing codes, the authors identified all Medicare beneficiaries (72 199) treated for this condition in a single calendar year (2011).…”