Longitudinal study of implantable cardioverter-defibrillators: methods and clinical characteristics of patients receiving implantable cardioverter-defibrillators for primary prevention in contemporary practice.

Abstract

BACKGROUND:

Implantable cardioverter-defibrillators (ICDs) are increasingly used for primary prevention after randomized, controlled trials demonstrating that they reduce the risk of death in patients with left ventricular systolic dysfunction. The extent to which the clinical characteristics and long-term outcomes of unselected, community-based patients with left ventricular systolic dysfunction undergoing primary prevention ICD implantation in a real-world setting compare with those enrolled in the randomized, controlled trials is not well characterized. This study is being conducted to address these questions.

METHODS AND RESULTS:

The study cohort includes consecutive patients undergoing primary prevention ICD placement between January 1, 2006 and December 31, 2009 in 7 health plans. Baseline clinical characteristics were acquired from the National Cardiovascular Data Registry ICD Registry. Longitudinal data collection is underway, and will include hospitalization, mortality, and resource use from standardized health plan data archives. Data regarding ICD therapies will be obtained through chart abstraction and adjudicated by a panel of experts in device therapy. Compared with the populations of primary prevention ICD therapy randomized, controlled trials, the cohort (n=2621) is on average significantly older (by 2.5-6.5 years), more often female, more often from racial and ethnic minority groups, and has a higher burden of coexisting conditions. The cohort is similar, however, to a national population undergoing primary prevention ICD placement.

CONCLUSIONS:

Patients undergoing primary prevention ICD implantation in this study differ from those enrolled in the randomized, controlled trials that established the efficacy of ICDs. Understanding a broad range of health outcomes, including ICD therapies, will provide patients, clinicians, and policy makers with contemporary data to inform decision-making.

• Authors: Frederick A Masoudi, Alan S Go, David J Magid, Andrea E Cassidy-Bushrow, Jonathan M Doris, Frances Fiocchi, Romel Garcia-Montilla, Karen A Glenn, Robert J Goldberg, Nigel Gupta, Jerry H Gurwitz, Stephen C Hammill, John J Hayes, Nathaniel Jackson, Alan Kadish, Michael Lauer, Aaron W Miller, Deborah Multerer, Pamela N Peterson, Liza M Reifler, Kristi Reynolds, Jane S Saczynski, Claudio Schuger, Param P Sharma, David H Smith, Mary Suits, Sue Hee Sung, Paul D Varosy, Humberto J Vidaillet, Robert T Greenlee
• Journal: Circulation. Cardiovascular quality and outcomes (Circ Cardiovasc Qual Outcomes) Vol. 5 Issue 6 Pg. e78-85 (Nov 2012) ISSN: 1941-7705 [Electronic] United States
• PMID: 23170006 (Publication Type: Comparative Study, Journal Article, Multicenter Study)

Topics

• Aged
• Chi-Square Distribution
• Death, Sudden, Cardiac (etiology, prevention & control)
• Defibrillators, Implantable
• Electric Countershock (adverse effects, instrumentation, mortality)
• Female
• Hospitalization
• Humans
• Longitudinal Studies
• Male
• Middle Aged
• Primary Prevention (methods)
• Registries
• Research Design
• Time Factors
• Treatment Outcome
• United States
• Ventricular Dysfunction, Left (complications, diagnosis, mortality, therapy)