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Published in: Journal of Interventional Cardiac Electrophysiology 1/2018

01-06-2018 | MULTIMEDIA REPORT

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

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

Published in: Journal of Interventional Cardiac Electrophysiology | Issue 1/2018

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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.
Appendix
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Literature
4.
go back to reference Connolly SJ, Hallstrom AP, Cappato R, Schron EB, Kuck KH, Zipes DP, et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs implantable defibrillator study. Cardiac arrest study Hamburg. Canadian implantable defibrillator study. Eur Heart J. 2000;21(24):2071–8. https://doi.org/10.1053/euhj.2000.2476.CrossRefPubMed Connolly SJ, Hallstrom AP, Cappato R, Schron EB, Kuck KH, Zipes DP, et al. Meta-analysis of the implantable cardioverter defibrillator secondary prevention trials. AVID, CASH and CIDS studies. Antiarrhythmics vs implantable defibrillator study. Cardiac arrest study Hamburg. Canadian implantable defibrillator study. Eur Heart J. 2000;21(24):2071–8. https://​doi.​org/​10.​1053/​euhj.​2000.​2476.CrossRefPubMed
6.
go back to reference Kuck KH, Cappato R, Siebels J, Ruppel R. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). Circulation. 2000;102(7):748–54.CrossRefPubMed Kuck KH, Cappato R, Siebels J, Ruppel R. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). Circulation. 2000;102(7):748–54.CrossRefPubMed
7.
go back to reference Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877–83.CrossRefPubMed Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877–83.CrossRefPubMed
8.
go back to reference Buxton A, Hafley G, Lee K, Gold M, Packer D, Lehmann M, et al. Relation of ejection fraction and inducible ventricular tachycardia to mode of death in patients with coronary artery disease. Circulation. 2002;106:2466–72.CrossRefPubMed Buxton A, Hafley G, Lee K, Gold M, Packer D, Lehmann M, et al. Relation of ejection fraction and inducible ventricular tachycardia to mode of death in patients with coronary artery disease. Circulation. 2002;106:2466–72.CrossRefPubMed
9.
go back to reference Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–37.CrossRefPubMed Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med. 2005;352:225–37.CrossRefPubMed
10.
go back to reference Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (writing committee to revise the ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and Antiarrhythmia devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;51(21):e1–62. https://doi.org/10.1016/j.jacc.2008.02.032.CrossRefPubMed Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, et al. ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (writing committee to revise the ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and Antiarrhythmia devices) developed in collaboration with the American Association for Thoracic Surgery and Society of Thoracic Surgeons. J Am Coll Cardiol. 2008;51(21):e1–62. https://​doi.​org/​10.​1016/​j.​jacc.​2008.​02.​032.CrossRefPubMed
15.
go back to reference Wilson FN, Macleon FS, Barker PS. The T deflection of the electrocardiogram. Trans Assoc Am Phys. 1931;46:29–38. Wilson FN, Macleon FS, Barker PS. The T deflection of the electrocardiogram. Trans Assoc Am Phys. 1931;46:29–38.
17.
go back to reference Burch GE, Abildskov AA, Cronvich JA. A study of the spatial vectorcardiogram of the ventricular gradient. Circulation. 1954;9(2):267–75.CrossRefPubMed Burch GE, Abildskov AA, Cronvich JA. A study of the spatial vectorcardiogram of the ventricular gradient. Circulation. 1954;9(2):267–75.CrossRefPubMed
19.
go back to reference Hurst JW. Thoughts about the ventricular gradient and its current clinical use (part I of II). Clin Cardiol. 2005;28(4):175–80.CrossRefPubMed Hurst JW. Thoughts about the ventricular gradient and its current clinical use (part I of II). Clin Cardiol. 2005;28(4):175–80.CrossRefPubMed
20.
go back to reference Hurst JW. Thoughts about the ventricular gradient and its current clinical use (part II of II). Clin Cardiol. 2005;28(5):219–24.CrossRefPubMed Hurst JW. Thoughts about the ventricular gradient and its current clinical use (part II of II). Clin Cardiol. 2005;28(5):219–24.CrossRefPubMed
21.
go back to reference Burger HC. A theoretical elucidation of the notion ventricular gradient. Am Heart J. 1957;53(2):240–6.CrossRefPubMed Burger HC. A theoretical elucidation of the notion ventricular gradient. Am Heart J. 1957;53(2):240–6.CrossRefPubMed
22.
25.
go back to reference Antzelevitch C, Dumaine R. Electrical heterogeneity in the heart: physiological, pharmacological and clinical implications. Comprehensive Physiology. John Wiley & Sons, Inc.; 2011. Antzelevitch C, Dumaine R. Electrical heterogeneity in the heart: physiological, pharmacological and clinical implications. Comprehensive Physiology. John Wiley & Sons, Inc.; 2011.
28.
go back to reference Vassallo JA, Cassidy DM, Kindwall KE, Marchlinski FE, Josephson ME. Nonuniform recovery of excitability in the left ventricle. Circulation. 1988;78(6):1365–72.CrossRefPubMed Vassallo JA, Cassidy DM, Kindwall KE, Marchlinski FE, Josephson ME. Nonuniform recovery of excitability in the left ventricle. Circulation. 1988;78(6):1365–72.CrossRefPubMed
29.
go back to reference Kuo CS, Munakata K, Reddy CP, Surawicz B. Characteristics and possible mechanism of ventricular arrhythmia dependent on the dispersion of action potential durations. Circulation. 1983;67(6):1356–67.CrossRefPubMed Kuo CS, Munakata K, Reddy CP, Surawicz B. Characteristics and possible mechanism of ventricular arrhythmia dependent on the dispersion of action potential durations. Circulation. 1983;67(6):1356–67.CrossRefPubMed
36.
go back to reference Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604–12.CrossRefPubMedPubMedCentral Levey AS, Stevens LA, Schmid CH, Zhang YL, Castro AF 3rd, Feldman HI, et al. A new equation to estimate glomerular filtration rate. Ann Intern Med. 2009;150(9):604–12.CrossRefPubMedPubMedCentral
37.
go back to reference Kors JA, van Herpen G, Sittig AC, van Bemmel JH. Reconstruction of the frank vectorcardiogram from standard electrocardiographic leads: diagnostic comparison of different methods. EurHeart J. 1990;11(12):1083–92. Kors JA, van Herpen G, Sittig AC, van Bemmel JH. Reconstruction of the frank vectorcardiogram from standard electrocardiographic leads: diagnostic comparison of different methods. EurHeart J. 1990;11(12):1083–92.
39.
go back to reference Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc. 1999;94(446):496–509.CrossRef Fine JP, Gray RJ. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc. 1999;94(446):496–509.CrossRef
40.
44.
go back to reference Krahn AD, Lee DS, Birnie D, Healey JS, Crystal E, Dorian P, et al. Predictors of short-term complications after implantable cardioverter-defibrillator replacement: results from the Ontario ICD database. CircArrhythmElectrophysiol. 2011;4(2):136–42. https://doi.org/10.1161/CIRCEP.110.959791. Krahn AD, Lee DS, Birnie D, Healey JS, Crystal E, Dorian P, et al. Predictors of short-term complications after implantable cardioverter-defibrillator replacement: results from the Ontario ICD database. CircArrhythmElectrophysiol. 2011;4(2):136–42. https://​doi.​org/​10.​1161/​CIRCEP.​110.​959791.
46.
go back to reference Buxton AE, Lee KL, DiCarlo L, Gold MR, Greer GS, Prystowsky EN, et al. Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden death. N Engl J Med. 2000;342(26):1937–45.CrossRefPubMed Buxton AE, Lee KL, DiCarlo L, Gold MR, Greer GS, Prystowsky EN, et al. Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden death. N Engl J Med. 2000;342(26):1937–45.CrossRefPubMed
47.
go back to reference Goldenberg I, Vyas AK, Hall WJ, Moss AJ, Wang H, He H, et al. Risk stratification for primary implantation of a cardioverter-defibrillator in patients with ischemic left ventricular dysfunction. J Am Coll Cardiol. 2007;51:288–96.CrossRef Goldenberg I, Vyas AK, Hall WJ, Moss AJ, Wang H, He H, et al. Risk stratification for primary implantation of a cardioverter-defibrillator in patients with ischemic left ventricular dysfunction. J Am Coll Cardiol. 2007;51:288–96.CrossRef
48.
go back to reference Buxton AE, Lee KL, Hafley GE, Pires LA, Fisher JD, Gold MR, et al. Limitations of ejection fraction for prediction of sudden death risk in patients with coronary artery disease. Lessons from the MUSTT study. J Am Coll Cardiol. 2007;50:1150–7.CrossRefPubMed Buxton AE, Lee KL, Hafley GE, Pires LA, Fisher JD, Gold MR, et al. Limitations of ejection fraction for prediction of sudden death risk in patients with coronary artery disease. Lessons from the MUSTT study. J Am Coll Cardiol. 2007;50:1150–7.CrossRefPubMed
51.
go back to reference Yap YG, Duong T, Bland JM, Malik M, Torp-Pedersen C, Køber L, et al. Optimising the dichotomy limit for left ventricular ejection fraction in selecting patients for defibrillator therapy after myocardial infarction. Heart. 2007;93:832–6.CrossRefPubMedPubMedCentral Yap YG, Duong T, Bland JM, Malik M, Torp-Pedersen C, Køber L, et al. Optimising the dichotomy limit for left ventricular ejection fraction in selecting patients for defibrillator therapy after myocardial infarction. Heart. 2007;93:832–6.CrossRefPubMedPubMedCentral
52.
go back to reference Zipes D, Camm A, Borggrefe M, Buxton A, Chaitman B, Fromer M, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death—executive summary: a report of the American College of Cardiology/American Heart Association task force and the European Society of Cardiology Committee for practice guidelines (writing committee to develop guidelines for Management of Patients with Ventricular Arrhythmias and the prevention of sudden cardiac death). J Am Coll Cardiol. 2006;48:1064–108.CrossRef Zipes D, Camm A, Borggrefe M, Buxton A, Chaitman B, Fromer M, et al. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death—executive summary: a report of the American College of Cardiology/American Heart Association task force and the European Society of Cardiology Committee for practice guidelines (writing committee to develop guidelines for Management of Patients with Ventricular Arrhythmias and the prevention of sudden cardiac death). J Am Coll Cardiol. 2006;48:1064–108.CrossRef
Metadata
Title
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
Authors
Jonathan W. Waks
Christopher Hamilton
Saumya Das
Ashkan Ehdaie
Jessica Minnier
Sanjiv Narayan
Mark Niebauer
Merritt Raitt
Christine Tompkins
Niraj Varma
Sumeet Chugh
Larisa G. Tereshchenko
Publication date
01-06-2018
Publisher
Springer US
Published in
Journal of Interventional Cardiac Electrophysiology / Issue 1/2018
Print ISSN: 1383-875X
Electronic ISSN: 1572-8595
DOI
https://doi.org/10.1007/s10840-018-0342-2

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