PERIPHERAL ATHERECTOMY WITH THE ROTABLATOR - A MULTICENTER REPORT

Purpose: Our purpose was to evaluate the efficacy and limitations of t he Auth Rotablator, an atherectomy device recently approved by the U.S . food and Drug Administration for general use in treating peripheral arterial occlusive lesions. Methods: Between August 1987 and December 1990, 72 patients from three medical centers (University of California , Los Angeles, Montefore, and Stanford) underwent atherectomy with the Auth Rotablator in 79 limbs and 107 arteries: 2 iliac, 45 femoral, 29 popliteal, and 31 tibial. The average age among the 72 patients was 6 9 years (43 to 91 years), and 67% were men. Indications for atherectom y were claudication in 34 (43%), limb threat in 44 (56%), and asymptom atic in 1 (1%) case. Average ankle-brachial index was 0.47 (0 to 0.81) . Average length of lesions was 9 cm (1 to 40 cm); 70 treated arterial segments were less than 10 cm and 37 were greater than 10 cm. All pat ients underwent arterial pulse examination, vascular laboratory Dopple r measurement of ankle-brachial indexes, and arteriography before and after surgery and at follow-up intervals during a period of 15 to 41 m onths (mean 27 months). Results: Angiographic success (residual lumen < 25% stenosis) was achieved in 70 (89%) of 79 limbs and 82 (77%) of 1 07 arteries: iliac 1 (50%) of 2, femoral 38 (84%) of 45, popliteal 24 (83%) of 29, and tibial 19 (61%) of 31. In-hospital clinical and hemod ynamic success was achieved in 61 (77%) of 79 limbs. The cumulative pr imary patency rate was 47% at 6 months, 31% at 12 months, and 18.6% at 24 months. Complications included hemoglobinuria in 10 cases (13%), e mboli in eight cases (10%), dissection in five cases (6%), perforation in three cases (4%), hematoma in four cases (5%), and infection in on e case (1%). There were nine early thromboses (11%) and two device-rel ated amputations (2.5%). Conclusion: Peripheral atherectomy with the A uth Rotablator currently has limited application because of frequent e arly thromboembolic complications and poor late patency rates. Atherec tomy is not generally recommended for treating peripheral arterial occ lusive lesions until these problems with early thromboemboli, occlusio ns, and late restenoses are solved.