Peripheral atherectomy with the rotablator: a multicenter report. The Collaborative Rotablator Atherectomy Group (CRAG).

PURPOSE

Our purpose was to evaluate the efficacy and limitations of the 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, Montefiore, 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 69 years (43 to 91 years), and 67% were men. Indications for atherectomy were claudication in 34 (43%), limb threat in 44 (56%), and asymptomatic 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 patients underwent arterial pulse examination, vascular laboratory Doppler measurement of ankle-brachial indexes, and arteriography before and after surgery and at follow-up intervals during a period of 15 to 41 months (mean 27 months).

RESULTS

Angiographic success (residual lumen < 25% stenosis) was achieved in 70 (89%) of 79 limbs and 82 (77%) of 107 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 hemodynamic success was achieved in 61 (77%) of 79 limbs. The cumulative primary patency rate was 47% at 6 months, 31% at 12 months, and 18.6% at 24 months. Complications included hemoglobinuria in 10 cases (13%), emboli in eight cases (10%), dissection in five cases (6%), perforation in three cases (4%), hematoma in four cases (5%), and infection in one case (1%). There were nine early thromboses (11%) and two device-related amputations (2.5%).

CONCLUSION

Peripheral atherectomy with the Auth Rotablator currently has limited application because of frequent early thromboembolic complications and poor late patency rates. Atherectomy is not generally recommended for treating peripheral arterial occlusive lesions until these problems with early thromboemboli, occlusions, and late restenoses are solved.