Clinical Trial of Percutaneous Peripheral Ultrasound Angloplasty

Objectives: The purpose of this study was to present follow-up data as well as short-term results on a larger clinical series of patients undergoing ultrasound angioplasty. Background: Previous pilot studies have demonstrated the feasibility of peripheral arterial ultrasound angioplasty. Methods: We performed percutaneous ultrasound angioplasty on 50 arterial lesions in 45 patients. Our ultrasound ablation system had a frequency of 19.5 kHz. A fixed-wire probe with 2- or 3-mm ball tips and a 3-mm over-the-wire probe were used to treat 40 femoral, 7 popliteal and 3 tibioperoneal lesions. Seventeen (34%) of the lesions were calcific. Thirty (86%) of 35 occluded segments, 0.5 to 28 cm long (mean 6.2 +/- 5.7), were recanalized. Results: In the 45 patent arteries, the stenosis decreased from 94 +/- 10% to 55 +/- 23% after ultrasound angioplasty and to 12 +/- 8% after balloon angioplasty. Mechanical arterial dissections (n = 4) and perforations (n = 4) without clinical consequence occurred only with the fixed non-over-the-wire probes. No evidence of embolism or vasospasm was detected; in fact, vasodilation occurred. There were no clinical manifestations of acute reocclusion. At 24 h, ankle-brachial indexes increased by 0.23 +/- 0.21 (range -0.27 to 0.72). Six- to 12-month clinical and ankle-brachial index follow-up data for 35 patients treated with ultrasound and adjunctive balloon angioplasty were indicative of restenosis in 7 patients (20%). Conclusions: Our findings indicate that percutaneous peripheral ultrasound angioplasty 1) is useful for recanalization of fibrous, calcific and thrombotic arterial occlusions; 2) reduces arterial stenoses; and 3) has clinical and ankle-brachial index data indicative of a restenosis rate of 20% at 6 to 12 months in a small cohort of patients. A larger randomized series of patients will need to be studied to assess the impact of ultrasound ablation on restenosis.