Sonotherapy, antirestenotic therapeutic ultrasound in coronary arteries: The first clinical experience

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.

A European multi‐center trial investigating the anti‐restenotic effect of intravascular sonotherapy after stenting of de novo lesions (EUROSPAH: EUROpean Sonotherapy Prevention of Arterial Hyperplasia)

“…19,20 Prior to this randomized trial, two clinical registries took place and one has been formally published in a peer-reviewed journal. 13 This study reported a restenosis rate of 25% in a population receiving a stent with an average length of 23 mm. The apparent absence of effect in this registry should have been more critically considered before engaging in two medium-sized randomized trials in Europe and in the USA.…”

“…13 However, this observational study did not address the ef®cacy of this new modality of treatment in a randomized fashion. The purpose of the present study therefore, is to evaluate the short-term and long-term safety and ef®cacy of intravascular sonotherapy in patients, when given immediately following de novo stenting.…”

Role of the endothelium in modulating neointimal formation

“…Intravascular sonotherapy has demonstrated its efficacy in the prevention of neointimal hyperplasia after stent implantation (28). In addition to its capability in decreasing cellular proliferation (29), there is new evidence of a positive effect of intravascular sonotherapy on cell recovery through the …”

Robust intravascular optical coherence elastography driven by acoustic radiation pressure

“…Intravascular high intensity ultrasound transducers in the 1 MHz frequency range have been realized for therapy purposes. 39,40 These will be suitable to deliver a local pushing field that is pointed radially outward from the catheter by definition and eliminates the need for extracorporeal excitation.…”