Right ventricular pacing for hypertrophic obstructive cardiomyopathy: meta-analysis and meta-regression of clinical trials
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Published version
Author(s)
Type
Journal Article
Abstract
Aims
Right ventricular pacing for left ventricular outflow tract gradient reduction in hypertrophic obstructive cardiomyopathy remains controversial. We undertook a meta-analysis for echocardiographic and functional outcomes.
Methods and results
Thirty-four studies comprising 1135 patients met eligibility criteria. In the four blinded randomized controlled trials (RCTs), pacing reduced gradient by 35% [95% confidence interval (CI) 23.2–46.9, P < 0.0001], but there was only a trend towards improved New York Heart Association (NYHA) class [odds ratio (OR) 1.82, CI 0.96–3.44; P = 0.066]. The unblinded observational studies reported a 54.3% (CI 44.1–64.6, P < 0.0001) reduction in gradient, which was a 18.6% greater reduction than the RCTs (P = 0.0351 for difference between study designs). Observational studies reported an effect on unblinded NYHA class at an OR of 8.39 (CI 4.39–16.04, P < 0.0001), 450% larger than the OR in RCTs (P = 0.0042 for difference between study designs). Across all studies, the gradient progressively decreased at longer follow durations, by 5.2% per month (CI 2.5–7.9, P = 0.0001).
Conclusion
Right ventricular pacing reduces gradient in blinded RCTs. There is a non-significant trend to reduction in NYHA class. The bias in assessment of NYHA class in observational studies appears to be more than twice as large as any genuine treatment effect.
Right ventricular pacing for left ventricular outflow tract gradient reduction in hypertrophic obstructive cardiomyopathy remains controversial. We undertook a meta-analysis for echocardiographic and functional outcomes.
Methods and results
Thirty-four studies comprising 1135 patients met eligibility criteria. In the four blinded randomized controlled trials (RCTs), pacing reduced gradient by 35% [95% confidence interval (CI) 23.2–46.9, P < 0.0001], but there was only a trend towards improved New York Heart Association (NYHA) class [odds ratio (OR) 1.82, CI 0.96–3.44; P = 0.066]. The unblinded observational studies reported a 54.3% (CI 44.1–64.6, P < 0.0001) reduction in gradient, which was a 18.6% greater reduction than the RCTs (P = 0.0351 for difference between study designs). Observational studies reported an effect on unblinded NYHA class at an OR of 8.39 (CI 4.39–16.04, P < 0.0001), 450% larger than the OR in RCTs (P = 0.0042 for difference between study designs). Across all studies, the gradient progressively decreased at longer follow durations, by 5.2% per month (CI 2.5–7.9, P = 0.0001).
Conclusion
Right ventricular pacing reduces gradient in blinded RCTs. There is a non-significant trend to reduction in NYHA class. The bias in assessment of NYHA class in observational studies appears to be more than twice as large as any genuine treatment effect.
Date Issued
2019-10-01
Date Acceptance
2019-01-31
Citation
European Heart Journal - Quality of Care and Clinical Outcomes, 2019, 5 (4), pp.321-333
ISSN
2058-5225
Publisher
Oxford University Press (OUP)
Start Page
321
End Page
333
Journal / Book Title
European Heart Journal - Quality of Care and Clinical Outcomes
Volume
5
Issue
4
Copyright Statement
© 2019 The Author(s). Published by Oxford University Press on behalf of the European Society of Cardiology.This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permitsunrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Sponsor
Foundation for Circulatory Health
British Heart Foundation
British Heart Foundation
Wellcome Trust
British Heart Foundation
Imperial College Healthcare NHS Trust- BRC Funding
Wellcome Trust
British Heart Foundation
Grant Number
ICCH/12/5039
FS/15/53/31615
FS/11/92/29122
203928/Z/16/Z
FS/13/44/30291
RDB02
PS3162_WHCP
CS/15/3/31405
Subjects
Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
Hypertrophic cardiomyopathy
Meta-analysis
Right ventricular pacing
1102 Cardiorespiratory Medicine and Haematology
Cardiovascular System & Hematology
Publication Status
Published
Date Publish Online
2019-01-31