Prospective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death: study design and cohort description.

Alan Cheng, Darshan Dalal, Barbara Butcher, Sanaz Norgard, Yiyi Zhang, Timm Dickfeld, Zayd A. Eldadah, Kenneth A. Ellenbogen, Eliseo Guallar, Gordon F. Tomaselli

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Primary-prevention implantable cardioverter-defibrillators (ICDs) reduce total mortality in patients with severe left ventricular systolic function. However, only a minority of patients benefit from these devices. We designed the Prospective Observational Study of Implantable Cardioverter-Defibrillators (PROSE-ICD) to identify risk factors and enhance our understanding of the biological mechanisms that predispose to arrhythmic death in patients undergoing ICD implantation for primary prevention of sudden death. This is a multicenter prospective cohort study with a target enrollment of 1200 patients. The primary end point is ICD shocks for adjudicated ventricular tachyarrhythmias. The secondary end point is total mortality. All patients undergo a comprehensive evaluation including history and physical examination, signal-averaged electrocardiograms, and blood sampling for genomic, proteomic, and metabolomic analyses. Patients are evaluated every 6 months and after every known ICD shock for additional electrocardiographic and blood sampling. As of December 2011, a total of 1177 patients have been enrolled with more nonwhite and female patients compared to previous randomized trials. A total of 143 patients have reached the primary end point, whereas a total of 260 patients died over an average follow-up of 59 months. The PROSE-ICD study represents a real-world cohort of individuals with systolic heart failure receiving primary-prevention ICDs. Extensive electrophysiological and structural phenotyping as well as the availability of serial DNA and serum samples will be important resources for evaluating novel metrics for risk stratification and identifying patients at risk for arrhythmic sudden death. URL: http://clinicaltrials.gov/ Unique Identifier: NCT00733590.

Original languageEnglish (US)
JournalJournal of the American Heart Association
Volume2
Issue number1
DOIs
StatePublished - Feb 1 2013
Externally publishedYes

Fingerprint

Implantable Defibrillators
Sudden Cardiac Death
Primary Prevention
Observational Studies
Cohort Studies
Prospective Studies
Sudden Death
Shock
Systolic Heart Failure
Metabolomics
Mortality
Left Ventricular Function
Tachycardia
Proteomics
Physical Examination
Electrocardiography
History

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Prospective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death : study design and cohort description. / Cheng, Alan; Dalal, Darshan; Butcher, Barbara; Norgard, Sanaz; Zhang, Yiyi; Dickfeld, Timm; Eldadah, Zayd A.; Ellenbogen, Kenneth A.; Guallar, Eliseo; Tomaselli, Gordon F.

In: Journal of the American Heart Association, Vol. 2, No. 1, 01.02.2013.

Research output: Contribution to journalArticle

Cheng, Alan ; Dalal, Darshan ; Butcher, Barbara ; Norgard, Sanaz ; Zhang, Yiyi ; Dickfeld, Timm ; Eldadah, Zayd A. ; Ellenbogen, Kenneth A. ; Guallar, Eliseo ; Tomaselli, Gordon F. / Prospective observational study of implantable cardioverter-defibrillators in primary prevention of sudden cardiac death : study design and cohort description. In: Journal of the American Heart Association. 2013 ; Vol. 2, No. 1.
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