Safety and Efficacy of Extracorporeal Shock Wave Myocardial Revascularization Therapy for Refractory Angina Pectoris

Abstract

Objective: To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris. Patients and Methods: A single-arm multicenter prospective trial to assess safety and efficacy of the ESMR therapy in patients with refractory angina (class III/IV angina) was performed. Screening exercise treadmill tests and pharmacological single-photon emission computed tomography (SPECT) were performed for all patients to assess exercise capacity and ischemic burden. Patients were treated with 9 sessions of ESMR to ischemic areas over 9 weeks. Efficacy end points were exercise capacity by using treadmill test as well as ischemic burden on pharmacological SPECT at 4 months after the last ESMR treatment. Safety measures included electrocardiography, echocardiography, troponin, creatine kinase, and brain natriuretic peptide testing, and pain questionnaires. Results: Fifteen patients with medically refractory angina and no revascularization options were enrolled. There was a statistically significant mean increase of 122.3±156.9 seconds (38% increase compared with baseline; P=.01) in exercise treadmill time from baseline (319.8±157.2 seconds) to last follow-up after the ESMR treatment (422.1±183.3 seconds). There was no improvement in the summed stress perfusion scores after pharmacologically induced stress SPECT at 4 months after the last ESMR treatment in comparison to that at screening; however, SPECT summed stress score revealed that untreated areas had greater progression in ischemic burden vs treated areas (3.69±6.2 vs 0.31±4.5; P=.03). There was no significant change in the mean summed echo score from baseline to posttreatment (0.4±5.1; P=.70). The ESMR therapy was performed safely without any adverse events in electrocardiography, echocardiography, troponins, creatine kinase, or brain natriuretic peptide. Pain during the ESMR treatment was minimal (a score of 0.5±1.2 to 1.1±1.2 out of 10). Conclusion: In this multicenter feasibility study, ESMR seems to be a safe and efficacious treatment for patients with refractory angina pectoris. However, larger sham-controlled trials will be required to confirm these findings.

The beneficial effect of extracorporeal shockwave myocardial revascularization in patients with refractory angina

“…The current study extends previous smaller clinical trials and showed that ESMR therapy is an effective and safe option for patients with refractory angina pectoris and improves exercise capacity and reduces nitroglycerin use in patients with end-stage ischemic heart disease with no procedural complications or side effects [30,33,34,37–39]. The clinical improvement of myocardial ischemia correlates with the SPECT finding that shows a significantly improved myocardial perfusion after the ESMR.…”

“…However recent randomized study failed to show a beneficial effect of SCS on symptoms as well as functional capacity [30,33]. Moreover SCS is an invasive strategy that can carry some complications such as infections or lead migration or fracture [46].…”

“…Our study can be considered an extension of a previous multicenter study performed by the group at the Mayo Clinic, in which, however, there was no control group [30]. …”

Extracorporeal shockwave myocardial therapy is efficacious in improving symptoms in patients with refractory angina pectoris – a multicenter study

“…As in other studies, no complications or adverse events were observed [1]. Cassar et al [33] in a multicenter study based in the USA also reported improved symptoms with shockwave therapy, but did not report any change in myocardial perfusion. Most recently, the CELLWAVE trial studied similar patients with ischemic cardiomyopathy who had received bone marrow-derived stem cells and ESMT and found a significant improvement in left ventricular function at 4 months [34].…”

Can a Vibratory Back Massage Induce Neo-Coronary Growth? A Blinded, Randomized Controlled Pilot Study Protocol

“…However a highly skilled professional for targeting the shock waves is needed (hence the technique may not be affordable to all patients) and ESMR's therapeutic impact is somewhat questionable with a noted absence of randomized controlled clinical trials (again placebo effect?) and recent RFA studies showing only borderline to absent improvements of empirically measurable perfusion [36,37].…”