Abstract

Therapeutic ultrasonic (195 kHz) catheters with 1.2 or 1.7 mm ball tips for coronary angioplasty have recently been developed. During the first phase of a multi-center European trial (CRUSADE) this system was evaluated in 100 patients (86% male, mean age 57 years) with symptomatic coronary artery disease or acute myocardial infarction. Lesions were located in the LAD (n = 61), CX (n = 17), and RCA (n = 22); 62% were type B or C; 11 lesions were restenotic, 19 occlusive, 9 longer than 20 mm, 37 calcified, 18 thrombotic, and 15 collateralised. The ultrasound catheter crossed 82/100 lesions, adjunctive balloon angioplastywas needed in 98 lesions. There was no death and myocardial infarction, or CABG in the first 24 hours. There was no perforation, but 2 acute vessel closures; intimal cleft or dissection was seen in 17 lesions of which 1 required stenting. Procedural success was obtained in 93%. At 24 hours 11/100 vessels were reoccluded. At 6 months angiographic follow-up in 51 patients restenosis (>50% stenosis) occured in 33%. Therapeutic ultrasound angioplasty is a feasible and safe new treatment modality. Adjunctive balloon angioplasty is regularly necessary. Preliminary experience suggests usefulness in lesions with visible thrombus, and undilatable or uncrossable lesions.

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