A multicenter trial of extracorporeal cardiac shock wave therapy for refractory angina pectoris

report of the highly advanced medical treatment in Japan

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

Research output: Contribution to journalArticle

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 2 ) 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.

Original languageEnglish
Pages (from-to)104-113
Number of pages10
JournalHeart and Vessels
Volume34
Issue number1
DOIs
Publication statusPublished - 22-01-2019

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Convulsive Therapy
Angina Pectoris
Multicenter Studies
Japan
Heart Ventricles
Myocardial Perfusion Imaging
Percutaneous Coronary Intervention
Coronary Artery Bypass
Therapeutics
Myocardial Ischemia
Myocardium
Nitroglycerin
Pharmaceutical Preparations
Stroke Volume
Walking
Echocardiography
Swine
Ischemia
Magnetic Resonance Imaging
Safety

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Kikuchi, Yoku ; Ito, Kenta ; Shindo, Tomohiko ; Hao, Kiyotaka ; Shiroto, Takashi ; Matsumoto, Yasuharu ; Takahashi, Jun ; Matsubara, Takao ; Yamada, Akira ; Ozaki, Yukio ; Hiroe, Michiaki ; Misumi, Kazuo ; Ota, Hideki ; Takanami, Kentaro ; Hiraide, Tomomichi ; Takase, Kei ; Tanji, Fumiya ; Tomata, Yasutake ; Tsuji, Ichiro ; Shimokawa, Hiroaki. / A multicenter trial of extracorporeal cardiac shock wave therapy for refractory angina pectoris : report of the highly advanced medical treatment in Japan. In: Heart and Vessels. 2019 ; Vol. 34, No. 1. pp. 104-113.
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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 2 ) 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.",
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Kikuchi, Y, Ito, K, Shindo, T, Hao, K, Shiroto, T, Matsumoto, Y, Takahashi, J, Matsubara, T, Yamada, A, Ozaki, Y, Hiroe, M, Misumi, K, Ota, H, Takanami, K, Hiraide, T, Takase, K, Tanji, F, Tomata, Y, Tsuji, I & Shimokawa, H 2019, 'A multicenter trial of extracorporeal cardiac shock wave therapy for refractory angina pectoris: report of the highly advanced medical treatment in Japan', Heart and Vessels, vol. 34, no. 1, pp. 104-113. https://doi.org/10.1007/s00380-018-1215-4

A multicenter trial of extracorporeal cardiac shock wave therapy for refractory angina pectoris : report of the highly advanced medical treatment in Japan. / Kikuchi, Yoku; Ito, Kenta; Shindo, Tomohiko; Hao, Kiyotaka; Shiroto, Takashi; Matsumoto, Yasuharu; Takahashi, Jun; Matsubara, Takao; Yamada, Akira; Ozaki, Yukio; Hiroe, Michiaki; Misumi, Kazuo; Ota, Hideki; Takanami, Kentaro; Hiraide, Tomomichi; Takase, Kei; Tanji, Fumiya; Tomata, Yasutake; Tsuji, Ichiro; Shimokawa, Hiroaki.

In: Heart and Vessels, Vol. 34, No. 1, 22.01.2019, p. 104-113.

Research output: Contribution to journalArticle

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T1 - A multicenter trial of extracorporeal cardiac shock wave therapy for refractory angina pectoris

T2 - report of the highly advanced medical treatment in Japan

AU - Kikuchi, Yoku

AU - Ito, Kenta

AU - Shindo, Tomohiko

AU - Hao, Kiyotaka

AU - Shiroto, Takashi

AU - Matsumoto, Yasuharu

AU - Takahashi, Jun

AU - Matsubara, Takao

AU - Yamada, Akira

AU - Ozaki, Yukio

AU - Hiroe, Michiaki

AU - Misumi, Kazuo

AU - Ota, Hideki

AU - Takanami, Kentaro

AU - Hiraide, Tomomichi

AU - Takase, Kei

AU - Tanji, Fumiya

AU - Tomata, Yasutake

AU - Tsuji, Ichiro

AU - Shimokawa, Hiroaki

PY - 2019/1/22

Y1 - 2019/1/22

N2 - 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 2 ) 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.

AB - 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 2 ) 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.

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