Sonotherapy, antirestenotic therapeutic ultrasound in coronary arteries: the first clinical experience.
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.
Regar
E
E
Department of Cardiology, Thoraxcentre, Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands.
Thury
A
A
van der Giessen
W J
WJ
Sianos
G
G
Vos
J
J
Smits
P C
PC
Carlier
S G
SG
de Feyter
P
P
Foley
D P
DP
Serruys
Patrick W
PW
D000368:Aged; D000789:Angina, Unstable / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary; D001158:Arteries / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D001807:Blood Vessel Prosthesis; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D004562:Electrocardiography; D004867:Equipment Design; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D017052:Hospital Mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000627:therapeutic use; D012307:Risk Factors; D015607:Stents; D016896:Treatment Outcome; D014464:Ultrasonic Therapy; D018084:Ultrasonography, Interventional
D019039:Platelet Glycoprotein GPIIb-IIIa Complex