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Subintimal angioplasty for the treatment of claudication and critical limb ischemia: 3-year results.

OBJECTIVE: Subintimal angioplasty (SIA) is an increasingly used method of lower extremity revascularization for patients with chronic arterial occlusions. To assess the technical feasibility, safety, and 3-year outcomes of patients treated with SIA, we performed a retrospective review of our early experience.

METHODS: Patient information-including demographics, indications, procedures, noninvasive arterial studies, and postprocedural events-was recorded in a database. Outcomes were determined on an intention-to-treat basis, as well as by technical success, by using Kaplan-Meier survival analysis. Continuous data were compared by using the Student t test, and survival curves were compared by log-rank testing.

RESULTS: From December 2002 through December 2003, 104 patients (105 limbs) underwent SIA of 159 occlusive lesions involving the iliac (n = 10), superficial femoral (n = 85), popliteal (n = 48), or tibial (n = 16) arteries. Sixty-six (62.9%) patients were treated for critical limb ischemia, and 39 patients (37.1%) were treated for disabling claudication. Technical success was achieved in 91 procedures (86.7%) and resulted in a mean increase in ankle-brachial index of 0.36 +/- 0.16. The mean follow-up was 23.4 months (range, 0-46 months). During this period, 18 patients (17.0%) died, and 15 amputations (14.3%) were performed, 6 of which were performed for patients on whom SIA had been unsuccessful. In patients undergoing successful SIA, the primary patency was 55%, 43%, and 35% at 12, 24, and 36 months, respectively. Twenty-one patients underwent a total of 23 percutaneous procedures to maintain or restore patency of the SIA during the study period. This resulted in secondary patency rates of 71%, 63%, and 51% at 12, 24, and 36 months, respectively. Multivariate analysis revealed critical limb ischemia to be the only predictor of reduced primary patency. Fifteen patients with inoperable critical limb ischemia underwent successful SIA. Limb salvage in this group was 54% and 43% at 12 and 36 months, respectively. Limb salvage in operative candidates was 100% and 88% at the same intervals. In patients with disabling claudication, 94% experienced improvement in symptoms 3 months after the procedure, and 68% of patients reported sustained improvement at 36 months. In all operative candidates successfully treated with SIA, freedom from surgical bypass was 83% and 73% at 12 and 36 months, respectively.

CONCLUSIONS: SIA for the treatment of lower extremity chronic arterial occlusions is technically feasible, results in minimal morbidity, and provides satisfactory revascularization without surgical bypass. Secondary patency is comparable to that of autologous vein bypass and is achieved with a low rate of reintervention. When used as first-line therapy, SIA provides most patients with limb salvage and freedom from surgical bypass at 3 years.

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