Purpose: To evaluate long-term patency and clinical efficacy of subintimal angioplasty (SAP) of occluded infrainguinal arteries 3 years post procedure. Methods: One hundred eighty-one patients (92 men; median age 79 years) underwent attempted SAP in 193 limbs with occluded infrainguinal arteries during the period 1999 to 2001. Nearly half (83, 46%) of the patients had diabetes. Most (172, 95%) had critical ischemia (Fontaine classification >II). All patients surviving at least 3 years after the procedures were followed in January 2005 with questionnaires, clinical examinations, ankle-brachial index measurements, and duplex ultrasonography. All data were collected prospectively and analyzed retrospectively. Results: The primary technical success in the entire cohort was 77% (148/193). Thirty-day mortality was 10% (19/181); 113 (62%) patients died before the 3-year follow-up. In the 68 (38%) survivors (71 limbs), patency at 49.2 months (IQR 40.8–57.6) was 40% (26/65 limbs imaged by duplex). The TASC classification did not affect technical or clinical outcomes. Forty-six (68%) of the survivors presented with clinical improvement (lower Fontaine classification at postoperative follow-up versus baseline). The limb salvage at >3 years was 86% in the 58 primarily successful SAPs and 38% in the 13 procedures that failed initially. Conclusion: SAP is a minimally invasive option for patients with critical limb ischemia. A primary technical success is essential for good clinical outcome and primary technical failure is more devastating than late occlusion. TASC classification and length of the SAP are of poor predictive value. More data are needed to confirm the efficacy of SAP.
