Subintimal angioplasty: Our experience in the treatment of 506 infrainguinal arterial occlusions.

OBJECTIVE: The treatment of patients with chronic arterial occlusions involving the superficial femoral artery has changed significantly with the incorporation of subintimal angioplasty (SIA) into vascular surgery practice. To more clearly define technical feasibility, patency, and clinical outcomes of SIA, we reviewed our cumulative experience. METHODS: A retrospective review of all patients who underwent SIA of arterial occlusions originating in the superficial femoral artery was performed. Patient history, demographics, procedural details, and follow-up information were collected and analyzed. Patency, limb salvage, sustained improvement in claudication, freedom from surgical bypass, and survival were determined by Kaplan-Meier analysis. RESULTS: From December, 2002, through July, 2006, 506 infrainguinal SIA procedures were performed in 472 patients with chronic arterial occlusion involving the superficial femoral artery. The mean age of patients treated was 69.4 +/- 11.9 years and the indication for intervention was critical limb ischemia in 63% of limbs (n = 317) and disabling claudication in 37% (n = 189). Forty-seven percent of limbs (n = 237) had isolated SFA occlusions, 40% (n = 205) had femoropopliteal occlusions, and 13% of limbs had occlusions beginning in the SFA and extending into the tibial arteries (n = 64). Technical success was achieved in 87% of procedures. Following successful SIA, the mean ankle-brachial index increased by 54%, from 0.50 +/- 0.16 to 0.77 +/- 0.23 (P < .0001). Median follow-up was 12.4 months (0-48 months) and 30-day mortality was 0.8%. Primary patency at 12 and 36 months was 45% (SE 3.0%) and 25% (SE 3.6%) respectively. Secondary patency was 76% (SE 2.6%) and 50% (SE 4.8%) at 12 and 36 months. Factors associated with reduced primary patency included femorotibial occlusions (HR 1.57, CI 1.05-2.36) and the presence of critical limb ischemia (HR 1.39, CI 1.02-1.89). Limb salvage in patients with critical limb ischemia was 75% (SE 5.9%) at 36 months. Freedom from surgical bypass in patients with either critical limb ischemia or disabling claudication was 77% (SE 4.1%) at 36 months. CONCLUSION: SIA is an effective percutaneous technique for the revascularization of patients with lower extremity chronic arterial occlusions involving the superficial femoral artery. The procedure is successfully performed in all segments of the lower extremity with minimal morbidity or mortality. Rates of limb salvage and improvement in claudication are similar to those achieved by open surgical bypass, while modest reductions in limb salvage and primary patency are experienced in limbs with femorotibial occlusions.

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.