Sonotherapy, antirestenotic therapeutic ultrasound in coronary arteries: the first clinical experience. |
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Authors: | E Regar A Thury W J van der Giessen G Sianos J Vos P C Smits S G Carlier P de Feyter D P Foley Patrick W Serruys |
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Affiliation: | Department of Cardiology, Thoraxcentre, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands. |
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Abstract: | We studied the safety and feasibility of intracoronary sonotherapy (IST) and its effect on the coronary vessel at 6 months. Thirty-seven patients with stable or unstable angina were included (40 lesions). The indication was de novo lesion (n = 26), restenosis (n = 2), in-stent restenosis (n = 11), and a total occlusion of a venous bypass graft. After successful angioplasty, IST was performed using a 5 Fr catheter with three serial ultrasound transducers operating at 1 MHz. IST was successfully performed in 36 lesions (success rate, 90%). IST exposure time per lesion was 718 +/- 127 sec. During hospital stay, one patient died due to a bleeding complication. At 6-month follow-up, one patient experienced acute myocardial infarction, eight patients underwent repeat PTCA. No patient underwent CABG. Late lumen loss was 1.05 +/- 0.70 mm with a restenosis rate of 25%. IVUS analysis revealed a neointima burden of 25% +/- 11%. IST can be applied safely and with high acute procedural success. Sonotherapy-related major adverse events were not observed. Late lumen loss and neointimal growth were similar to conventional PTCA approaches. These results justify the initiation of randomized clinical efficacy studies. |
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Keywords: | therapeutic ultrasound angioplasty restenosis safety sonotherapy |
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