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A meta‐analysis of arrhythmia endpoints in randomized controlled trials of transendocardial stem cell injections for chronic ischemic heart disease
Author(s) -
Fernandes Gilson C.,
Fernandes Amanda D. F.,
Rivera Manuel,
Khan Aisha,
Schulman Ivonne H.,
Lambrakos Litsa K.,
Myerburg Robert J.,
Goldberger Jeffrey J.,
Hare Joshua M.,
Mitrani Raul D.
Publication year - 2019
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/jce.14185
Subject(s) - medicine , cardiology , placebo , meta analysis , sudden cardiac death , odds ratio , stem cell therapy , myocardial infarction , clinical endpoint , heart failure , randomized controlled trial , transplantation , pathology , alternative medicine
Abstract Introduction The electrophysiologic impact of cell‐based therapy on the injured myocardium remains highly controversial. We aimed to perform a meta‐analysis of studies comparing arrhythmia burden following transendocardial stem cell therapy vs placebo in patients with chronic ischemic heart disease (CIHD). Methods and Results PubMed, Embase, and Cochrane Central Register of Controlled Trials were searched. No restriction of stem cell type was specified. The outcomes included sustained supraventricular or ventricular arrhythmias (VAs), sudden cardiac death (SCD), and resuscitated sudden cardiac arrest (SCA). Effect sizes were reported as odds ratio (OR) and 95% CI. Poisson regression was used to account for zero‐events data. Twelve randomized trials that included 736 patients (384 in the cell therapy group and 352 in the placebo group) were analyzed. Six different cell types were used. Follow‐up ranged from 6 to 12 months. There was a significant decrease in risk of SCD in the cell therapy group, (FE OR, 0.19 [0.04, 0.93]; P = .04). In subgroup analysis, there was a significantly lower risk of SCD or resuscitated SCA in the cell therapy group limited to studies that did not use skeletal myoblasts, (FE OR, 0.23 [0.06, 0.83]; P = .03). There was no significant difference in the incidence of sustained VA between groups (FE OR, 0.91 [0.47, 1.77]; P = .8), even after stratifying by cell type. There was no difference in supraventricular arrhythmias between groups. Conclusion Nonskeletal myoblast transendocardial cell therapy was associated with a significantly lower risk of SCD or resuscitated SCA compared to control, with no proarrhythmic effects.