Improving sudden cardiac death risk stratification by evaluating electrocardiographic measures of global electrical heterogeneity and clinical outcomes among patients with implantable cardioverter-defibrillators: rationale and design for a retrospective, multicenter, cohort study
Implantable cardioverter-defibrillators (ICDs) improve survival of systolic heart failure (HF) patients who are at risk of sudden cardiac death (SCD). We recently showed that electrocardiographic (ECG) global electrical heterogeneity (GEH) is independently associated with SCD in the community-dwelling cohort and developed GEH SCD risk score. The Global Electrical Heterogeneity and Clinical Outcomes (GEHCO) study is a retrospective multicenter cohort designed with two goals: (1) validate an independent association of ECG GEH with sustained ventricular tachyarrhythmias and appropriate ICD therapies and (2) validate GEH ECG risk score for prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic HF patients with primary prevention ICD.
All records of primary prevention ICD recipients with available data for analysis are eligible for inclusion. Records of ICD implantation in patients with inherited channelopathies and cardiomyopathies are excluded. Raw digital 12-lead pre-implant ECGs will be used to measure GEH (spatial QRST angle, spatial ventricular gradient magnitude, azimuth, and elevation, and sum absolute QRST integral). The primary endpoint is defined as a sustained ventricular tachyarrhythmia event with appropriate ICD therapy. All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy will serve as a primary competing outcome. The study will draw data from the academic medical centers.
We describe the study protocol of the first multicenter retrospective cohort of primary prevention ICD patients with recorded at baseline digital 12-lead ECG.
Findings from this study will inform future trials to identify patients who are most likely to benefit from primary prevention ICD.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT03210883.
KeywordsSudden cardiac death Implantable cardioverter-defibrillators Electrocardiogram Vectorcardiogram Ventricular arrhythmias Risk stratification
Global electrical heterogeneity
Sudden cardiac death
Left ventricular ejection fraction
Spatial ventricular gradient
American Heart Association
This study is funded through the AHA Grant-In-Aid no. 17GRNT33670428. AHA has no role in study design, collection, management, analysis, and interpretation of data and reporting the study results. This publication was made possible with support from the Oregon Clinical and Translational Research Institute (OCTRI), grant number UL1 RR024140 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research.
Compliance with ethical standards
The multicenter study has been approved by the OHSU Institutional Review Board (IRB).
Conflict of interests
The Johns Hopkins University owns the patent US8880159 B2 “Methods for determining risk of ventricular arrhythmia” (Inventor LGT; 100% assigned to the Johns Hopkins University; not licensed).
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