The effect of cardiac shock wave therapy on myocardial function and perfusion in the randomized, triple-blind, sham-procedure controlled study

Authors

Jelena Čelutkienė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania. jelena.celutkiene@santa.lt.
Greta Burneikaitė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Evgeny Shkolnik, Yale-New Haven Health Bridgeport Hospital, 267 Grant St, Bridgeport, 06610, CT, USA.
Gabrielius Jakutis, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Donatas Vajauskas, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Kamilė Čerlinskaitė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Gitana Zuozienė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Birutė Petrauskienė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Roma Puronaitė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Renata Komiagienė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Irena Butkuvienė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Rima Steponėnienė, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Jonas Misiūra, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.
Aleksandras Laucevičius, Institute of Clinical Medicine of the Faculty of Medicine of Vilnius University, Santariskiu St. 2, 08661, Vilnius, Lithuania.

Document Type

Article

Publication Title

Cardiovascular ultrasound

Abstract

BACKGROUND: Recent triple-blind sham procedure-controlled study revealed neutral effects of the cardiac shock wave therapy (CSWT) on exercise tolerance and symptoms in patients with stable angina. Current data about the effects of CSWT on global and regional myocardial contractility and perfusion is limited. Hereby we report the results of an imaging sub-study that evaluated the capacity of CSWT to ameliorate myocardial ischemia induced during dobutamine stress echocardiography (DSE) and cardiac single photon emission computed tomography (SPECT). METHODS: Prospective, randomized, triple-blind, sham procedure-controlled study enrolled 72 adult subjects who complied with defined inclusion criteria. The subjects were assigned to the OMT + CSWT and the OMT + sham procedure study groups with 1:1 ratio. Application of the CSWT covered all segments of the left ventricle. Imaging ischemia tests were performed in 59 study patients: DSE and SPECT before the CSWT treatment and after 6 months, with DSE carried out additionally at 3 months after randomization. Co-primary endpoints of the study were: change in wall motion score index (WMSI), representing the stress-induced impairment of regional myocardial function, and change in summed difference score (SDS), representing the amount of perfusion defect. RESULTS: OMT + CSWT and OMT + sham procedure study groups included 30 and 29 patients, respectively. Regional myocardial contractility during DSE significantly improved at 3 months follow-up in OMT + CSWT group compared to baseline as shown by WMSI at stress (1.4 ± 0.4 vs 1.6 ± 0.4, p = 0.001), but not in OMT + sham procedure group (1.5 ± 0.3 vs 1.6 ± 0.4, p = 0.136). The difference in stress DSE results between both study groups disappeared after 6 months. SPECT results demonstrated a significant reduction of inducible ischemia in OMT + CSWT group compared to OMT + sham procedure group at 6 months follow-up (SDS dropped from 5.4 ± 3.7 to 3.6 ± 3.8 vs 6.4 ± 5.9 to 6.2 ± 5 respectively, p = 0.034). CONCLUSIONS: Cardiac shock wave treatment showed the ability to reduce stress-induced myocardial ischemia, as assessed by wall motion abnormalities and perfusion defects, compared to sham procedure. TRIAL REGISTRATION: Clinicaltrials.gov ( NCT02339454 ). The trial was registered retrospectively on 12 January 2015.

First Page

13

DOI

10.1186/s12947-019-0163-1

Publication Date

7-4-2019

Recommended Citation

Čelutkienė, Jelena; Burneikaitė, Greta; Shkolnik, Evgeny; Jakutis, Gabrielius; Vajauskas, Donatas; Čerlinskaitė, Kamilė; Zuozienė, Gitana; Petrauskienė, Birutė; Puronaitė, Roma; Komiagienė, Renata; Butkuvienė, Irena; Steponėnienė, Rima; Misiūra, Jonas; and Laucevičius, Aleksandras, "The effect of cardiac shock wave therapy on myocardial function and perfusion in the randomized, triple-blind, sham-procedure controlled study" (2019). Randomized Controlled Trial. 18.
https://scholar.bridgeporthospital.org/randomized_trial/18

Identifier

31272465 (pubmed); PMC6610956 (pmc); 10.1186/s12947-019-0163-1 (doi); 10.1186/s12947-019-0163-1 (pii)