Background
Patients with ischemic cardiomyopathy, non–left bundle branch block, or QRS duration
<150 ms have a lower response rate to cardiac resynchronization therapy (CRT) than
did other indicated patients. The ECG Belt system (EBS) is a novel surface mapping
system designed to measure electrical dyssynchrony via the standard deviation of the
activation times of the left ventricle.
Objectives
The objectives of this study were to evaluate the efficacy of the EBS in patients
less likely to respond to CRT and to determine whether EBS use in lead placement guidance
and device programming was superior to standard CRT care.
Methods
This was a prospective randomized trial of patients with heart failure and EBS-guided
CRT implantation and programming vs standard CRT care. The primary end point was relative
change in left ventricular end-systolic volume from baseline to 6 months postimplantation.
Results
A total of 408 subjects from centers in Europe and North America were randomized.
Although both patients with EBS and control patients had a mean improvement in left
ventricular end-systolic volume, there was no significant difference in relative change
from baseline (P = .26). While patients with a higher baseline standard deviation of the activation
times derived greater left ventricular reverse remodeling, improvement in electrical
dyssynchrony did not correlate with the extent of reverse remodeling.
Conclusion
The findings of the present study do not support EBS-guided therapy for CRT management of heart failure with reduced ejection fraction.
Keywords
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Article info
Publication history
Published online: November 25, 2022
Publication stage
In Press Journal Pre-ProofFootnotes
Funding Sources: This work was supported by the ECG Belt for CRT Response trial (ClinicalTrials.gov identifier NCT03504020), which was funded by Medtronic.
Disclosures: Dr Rickard reports consulting fees from Medtronic and speaking fees and research funding from Abbott. Dr Jackson serves as a consultant for Medtronic. Dr Gold serves as a consultant and performs clinical trials for Boston Scientific, EBR Systems and Medtronic and performs clinical trials for Abbott. Dr Biffi reports educational activity and speaker bureau from Boston Scientific, Biotronik, Medtronic, and Zoll. Dr Ziacchi reports speaker fees from Biotronik, Boston Scientific, and Abbott. Dr Silverstein serves as a consultant for Medtronic and Biosense Webster. Dr Metzl serves as a consultant from Abbott, Biosense Webster, Medtronic, Phillips, and Zoll. Dr Abben serves as a consultant for Medtronic. NJ serves as a researcher/PI/SC member/consultant for Abbott, Biotronik, Boston Scientific, EP Solutions, Medtronic, Impulse Dynamics, Implicity, PaceMate, and Cardiologs. Mr Jensen, Ms Wouters, and Dr Ghosh are employees and shareholders of Medtronic. Dr Vernooy serves as a consultant for Medtronic, Boston Scientific, Philips, Biosense Webster, and Abbott. Drs Ramza, Grubman, and Tabbal have no conflicts to disclose.
Trial Registration: ClinicalTrials.gov Identifier: NCT03504020
Identification
Copyright
© 2022 Published by Elsevier Inc. on behalf of Heart Rhythm Society.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Electrocardiogram Belt system: Opportunity for optimization?Heart Rhythm
- PreviewThe development and implementation of biventricular pacing or cardiac resynchronization therapy (CRT) for heart failure over the past several decades have been a remarkable technological and therapeutic advancement. Initial reports of multisite pacing for heart failure initially epicardial, then endocardial in observational studies progressed to a rapid expansion in the demonstration of benefits of CRT in clinical trials.1–4 In 2001, the first commercially available CRT pacemaker became available in the United States, and soon thereafter, CRT within an implantable cardiac defibrillator was also available.
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