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

Abstract

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/mm) 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.

Cardiac Shock Wave Therapy for Coronary Heart Disease: an Updated Meta-analysis

“…The number of studies included involving LVEF were 12 [ 4 , 9 , 11 , 12 , 16 - 18 , 20 , 21 , 24 , 27 , 29 ] , with a total of 566 patients. The included study types were nine single-arm studies, two cohort studies, and one RCT.…”

“…The number of studies included involving SDS were two [ 4 , 6 ] , with a total of 306 patients. These were single-arm studies.…”

“…Currently, there are quite a few clinical trials that have reported the clinical effects of CSWT. In 2018, a multi-centre study by Yoku [ 4 ] examined 41 patients with ischaemic cardiomyopathy and included three months of follow-up before and after treatment. The evaluation of symptoms, exercise tolerance, cardiac function, and other indicators confirmed the effectiveness and safety of CSWT.…”

Non-pharmacological Treatment of Refractory Angina and Microvascular Angina

“…A data from both small randomized-controlled trials and real-world experiences confirmed the efficacy of ESMR in terms of symptom improvement, reduced use of short-acting nitrates and hospitalizations, increased myocardial perfusion at different follow-up periods up to 72 months in patients with stable CAD and specifically RA patients [ 66 , 67 , 68 , 69 , 70 , 71 ]. A prospective controlled study of 72 RA patients showed improved symptoms and quality of life parameters, increased myocardial perfusion at six months [ 67 ] with sustained effect at a longer time period (2.88 ± 1.65 years) [ 68 ].…”

The waves that make the pattern: a review on acoustic manipulation in biomedical research

“…Mechanical stimulation, or, for example, shock waves, have been known for their beneficial effect in various medical conditions to stimulate angiogenesis [ 105 , 106 ], in the field of cardiac regeneration [ 107 , 108 ] or to steer the inflammatory response [ 109 ]. Comparable investigations on sound-induced effects are currently lacking and need to be further investigated.…”