A multicenter trial of extracorporeal cardiac shock wave therapy for refractory angina pectoris: report of the highly advanced medical treatment in Japan

• DOI: 10.1007/s00380-018-1215-4
• Publication Date: 2018-06-25T15:42:51Z
• Authors: Yoku Kikuchi; Kenta Ito; Tomohiko Shindo; Kiyotaka Hao; Takashi Shiroto; Yasuharu Matsumoto; Jun Takahashi; Takao Matsubara; Akira Yamada; Yukio Ozaki; Michiaki Hiroe; Kazuo Misumi; Hideki Ota; Kentaro Takanami; Tomomichi Hiraide; Kei Takase; Fumiya Tanji; Yasutake Tomata; Ichiro Tsuji; Hiroaki Shimokawa
• Keywords: Extracorporeal Shockwave Therapy; Male; Myocardial ischemia; Myocardial Perfusion Imaging; Magnetic Resonance Imaging, Cine; Cardiovascular medicine and haematology; Refractory angina pectoris; Angina Pectoris; High-Energy Shock Waves; 3. Good health; Electrocardiography; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Japan; Echocardiography; Humans; Female; Angiogenesis; Cardiac shock wave therapy; Aged

We have previously demonstrated that cardiac shock wave therapy (CSWT) effectively improves myocardial ischemia through coronary neovascularization both in a porcine model of chronic myocardial ischemia and in patients with refractory angina pectoris (AP). In this study, we further addressed the efficacy and safety of CSWT in a single-arm multicenter study approved as a highly advanced medical treatment by the Japanese Ministry of Health, Labour and Welfare. Fifty patients with refractory AP [mean age 70.9 ± 12.6 (SD) years, M/F 38/12] without the indications of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) were enrolled in 4 institutes in Japan. Ischemic myocardial regions in the left ventricle (LV) were identified by drug-induced stress myocardial perfusion imaging (MPI). Shock waves (200 shots/spot at 0.09 mJ/mm2) were applied to 40-60 spots in the ischemic myocardium 3 times in the first week. The patients were followed up for 3 months thereafter. Forty-one patients underwent CSWT and completed the follow-up at 3 months. CSWT markedly improved weekly nitroglycerin use [from 3.5 (IQR 2 to 6) to 0 (IQR 0 to 1)] and the symptoms [Canadian Cardiovascular Society functional class score, from 2 (IQR 2 to 3) to 1 (IQR 1 to 2)] (both P < 0.001). CSWT also significantly improved 6-min walking distance (from 384 ± 91 to 435 ± 122 m, P < 0.05). There were no significant changes in LV ejection fraction evaluated by echocardiography and LV stroke volume evaluated by cardiac magnetic resonance imaging (from 56.3 ± 14.7 to 58.8 ± 12.8%, P = 0.10, and from 52.3 ± 17.4 to 55.6 ± 15.7 mL, P = 0.15, respectively). Percent myocardium ischemia assessed by drug-induced stress MPI tended to be improved only in the treated segments (from 16.0 ± 11.1 to 12.1 ± 16.2%, P = 0.06), although no change was noted in the whole LV. No procedural complications or adverse effects related to the CSWT were noted. These results of the multicenter trial further indicate that CSWT is a useful and safe non-invasive strategy for patients with refractory AP with no options of PCI or CABG.