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

Jonathan W. Waks, Christopher Hamilton, Saumya Das, Ashkan Ehdaie, Jessica Minnier, Sanjiv Narayan, Mark Niebauer, Merritt Raitt, Christine Tompkins, Niraj Varma, Sumeet Chugh, Larisa Tereshchenko

Research output: Contribution to journalArticle

Abstract

Purpose: 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. Methods: 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. Results: We describe the study protocol of the first multicenter retrospective cohort of primary prevention ICD patients with recorded at baseline digital 12-lead ECG. Conclusion: Findings from this study will inform future trials to identify patients who are most likely to benefit from primary prevention ICD. Trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03210883.

Original languageEnglish (US)
Pages (from-to)1-13
Number of pages13
JournalJournal of Interventional Cardiac Electrophysiology
DOIs
StateAccepted/In press - Mar 14 2018

Fingerprint

Implantable Defibrillators
Sudden Cardiac Death
Multicenter Studies
Cohort Studies
Primary Prevention
Tachycardia
Systolic Heart Failure
Channelopathies
Independent Living
Therapeutics
Cardiomyopathies
Cause of Death
Electrocardiography
Outcome Assessment (Health Care)
Survival

Keywords

  • Electrocardiogram
  • Implantable cardioverter-defibrillators
  • Risk stratification
  • Sudden cardiac death
  • Vectorcardiogram
  • Ventricular arrhythmias

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

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. / Waks, Jonathan W.; Hamilton, Christopher; Das, Saumya; Ehdaie, Ashkan; Minnier, Jessica; Narayan, Sanjiv; Niebauer, Mark; Raitt, Merritt; Tompkins, Christine; Varma, Niraj; Chugh, Sumeet; Tereshchenko, Larisa.

In: Journal of Interventional Cardiac Electrophysiology, 14.03.2018, p. 1-13.

Research output: Contribution to journalArticle

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abstract = "Purpose: 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. Methods: 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. Results: We describe the study protocol of the first multicenter retrospective cohort of primary prevention ICD patients with recorded at baseline digital 12-lead ECG. Conclusion: Findings from this study will inform future trials to identify patients who are most likely to benefit from primary prevention ICD. Trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03210883.",
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AU - Waks, Jonathan W.

AU - Hamilton, Christopher

AU - Das, Saumya

AU - Ehdaie, Ashkan

AU - Minnier, Jessica

AU - Narayan, Sanjiv

AU - Niebauer, Mark

AU - Raitt, Merritt

AU - Tompkins, Christine

AU - Varma, Niraj

AU - Chugh, Sumeet

AU - Tereshchenko, Larisa

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AB - Purpose: 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. Methods: 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. Results: We describe the study protocol of the first multicenter retrospective cohort of primary prevention ICD patients with recorded at baseline digital 12-lead ECG. Conclusion: Findings from this study will inform future trials to identify patients who are most likely to benefit from primary prevention ICD. Trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03210883.

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KW - Ventricular arrhythmias

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