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.
Abbreviations and Acronyms:
BNP (brain natriuretic peptide), CAD (coronary artery disease), CK (creatine kinase), ECG (electrocardiogram/electrocardiographic), ESMR (extracorporeal shockwave myocardial revascularization), ETT (exercise treadmill test), SDS (summed difference score), SPECT (single-photon emission computed tomography), SRS (summed rest score), SSS (summed stress score), SWA (shock wave applicator)To read this article in full you will need to make a payment
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Article Info
Footnotes
Grant Support: This study was supported by an unrestricted grant from MediSpec Ltd.
Identification
Copyright
© 2014 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.
