Endovascular therapy for acute limb ischemia.

BACKGROUND: Acute limb ischemia (ALI) of the lower extremities remains a challenging clinical dilemma. Treatment of ALI has shifted toward endovascular therapies. The purpose of this study was to assess outcomes in patients treated for ALI with intra-arterial thrombolysis and/or adjuvant endovascular techniques.

METHODS: Consecutive patients with ALI of the lower extremities treated via endovascular intra-arterial methods between January 1, 2005 and September 30, 2007 were identified and reviewed. Comparisons of success, thrombolysis days, and all 30-day outcomes except mortality were performed using generalized estimating equations with logistic and proportional odds regression. Thirty-day mortality was assessed using logistic regression. Long-term patency, limb salvage, and survival were assessed using time-to-event methods, including Kaplan-Meier estimation and Cox proportional hazards models.

RESULTS: The analyzed dataset included 129 limbs treated in 119 patients presenting with ALI (class I 68%, class IIa 23%, class IIb 9%). The mean follow-up was 16.8 months (range: 0-43 months). Technical success was achieved in 82% cases. The 30-day mortality rate was 6.0% with all 30-day deaths occurring in females (P = .002). One (0.76%) central nervous system hemorrhage (CNS) was noted in this cohort. Primary patency for the entire cohort at 12 and 24 months was 50.1% (95% confidence interval [CI], 39.5-60.7) and 37.7% (95% CI, 26.2-49.1), respectively, while secondary patency was 74.0% (95% CI, 64.9-83.1) and 65.3% (95% CI, 54.5-76.2). Multivariable analyses identified patients presenting with femoropopliteal (hazard ratio [HR] 2.63) or tibial thrombosis (HR 2.80); graft thrombosis (vs native artery thrombosis, HR 2.57) and long-term dialysis (HR 3.66, 95% CI, 2.35-5.71, P < .001) were associated with poorer primary patency rates. Cumulative limb salvage at 24 months was 68.8% (95% CI: 59.5-78.1) with female gender (HR 3.34, P = .002) and thrombolysis ≥ 3 days (HR 2.35, P = .019) associated with an increased risk of limb loss. Overall 36-month survival was 84.5% (95% CI: 77.5-91.6). Women had decreased survival rates both in the short- and midterm (HR 6.29; 95% CI, 1.78-22.28; P = .004).

CONCLUSIONS: Endovascular therapy with thrombolysis remains an effective treatment option for patients presenting with lower extremity ALI. Thrombolysis should be limited to <3 days. Female gender negatively affects the rates of limb salvage and survival.