Document Detail

Subgroup analysis of a randomized controlled trial evaluating the safety and efficacy of cardiac contractility modulation in advanced heart failure.
MedLine Citation:
PMID:  21872139     Owner:  NLM     Status:  In-Data-Review    
BACKGROUND: Cardiac contractility modulation (CCM) signals are nonexcitatory electrical signals delivered during the absolute refractory period intended to improve contraction. We previously tested the safety and efficacy of CCM in 428 NYHA functional class III/IV heart failure patients with EF ≤35% and narrow QRS randomized to optimal medical treatment (OMT) plus CCM (n = 215) versus OMT alone (n = 213) and found no significant effect on ventilatory anaerobic threshold (VAT), the study's primary end point. In the present analysis, we sought to identify if there was a subgroup of patients who showed a response to CCM.
METHODS AND RESULTS: The protocol specified that multiregression analysis would be used to determine if baseline EF, NYHA functional class, pVO(2), or etiology of heart failure influenced the impact of CCM on AT. Etiology and baseline pVO(2) did not affect efficacy. However, baseline NYHA functional class III and EF ≥25% were significant predictors of increased efficacy. In this subgroup (comprising 97 OMT and 109 CCM patients, ∼48% of the entire population) VAT increased by 0.10 ± 2.36 in CCM versus -0.54 ± 1.83 mL kg(-1) min(-1) in OMT (P = .03) and pVO(2) increased by 0.34 ± 3.11 in CCM versus -0.97 ± 2.31 (P = .001) at 24 weeks compared with baseline; 44% of CCM versus 23% of OMT subjects showed improvement of ≥1 class in NYHA functional class (P = .002), and 59% of CCM versus 42% of OMT subjects showed a ≥10-point reduction in Minnesota Living with Heart Failure Questionnaire (P = .01). All of these findings were similar to those seen at 50 weeks.
CONCLUSIONS: The results of this retrospective hypothesis-generating analysis indicate that CCM significantly improves objective parameters of exercise tolerance in a subgroup of patients characterized by normal QRS duration, NYHA functional class III symptoms, and EF >25%.
William T Abraham; Koonlawee Nademanee; Kent Volosin; Steven Krueger; Suresh Neelagaru; Nirav Raval; Owen Obel; Stanislav Weiner; Marc Wish; Peter Carson; Kenneth Ellenbogen; Robert Bourge; Michael Parides; Richard P Chiacchierini; Rochelle Goldsmith; Sidney Goldstein; Yuval Mika; Daniel Burkhoff; Alan Kadish;
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Publication Detail:
Type:  Journal Article     Date:  2011-06-22
Journal Detail:
Title:  Journal of cardiac failure     Volume:  17     ISSN:  1532-8414     ISO Abbreviation:  J. Card. Fail.     Publication Date:  2011 Sep 
Date Detail:
Created Date:  2011-08-29     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9442138     Medline TA:  J Card Fail     Country:  United States    
Other Details:
Languages:  eng     Pagination:  710-7     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
Ohio State University Heart Center, Columbus, Ohio.
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