Pacemaker and ICD Generator Reliability: Meta-analysis of Device Registries

CONTEXT Despite there being millions of pacemaker and implantable cardioverter-defibrillator (ICD) generator implants worldwide, little is known about device reliability. OBJECTIVES To perform a meta-analysis of prospective pacemaker and ICD registries to determine annual rates of pacemaker and ICD...

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Bibliographic Details
Published in:JAMA : the journal of the American Medical Association 2006-04, Vol.295 (16), p.1929-1934
Main Author: Maisel, William H
Format: Article
Language:English
Subjects:
Acquisitions & mergers
Biological and medical sciences
Data analysis
Defibrillators, Implantable - adverse effects
Equipment Failure - statistics & numerical data
Failure
General aspects
Humans
Medical sciences
Meta-analysis
Pacemaker, Artificial - adverse effects
Patients
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Rates
Ratings & rankings
Registries
Systematic review
Transplants & implants
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Description
Summary:CONTEXT Despite there being millions of pacemaker and implantable cardioverter-defibrillator (ICD) generator implants worldwide, little is known about device reliability. OBJECTIVES To perform a meta-analysis of prospective pacemaker and ICD registries to determine annual rates of pacemaker and ICD malfunction and to identify trends in these rates. DATA SOURCES MEDLINE (January 1966 to April 2005), the Cochrane Central Register of Controlled Trials (through second quarter 2005), the Cochrane Database of Systematic Reviews (through second quarter 2005), and a bibliographic review of secondary sources. Search terms included pacemaker, artificial; defibrillators, implantable; registries; performance; and malfunction. STUDY SELECTION Eligible registries were prospective; reported the number of patients with pacemaker, ICD, or both; and allowed determination of the annual number of device malfunctions. Of 1007 references screened, 3 registries meeting the selection criteria were identified and included 2.1 million pacemaker person-years and 14 821 ICD person-years of observation. DATA EXTRACTION Included the annual number of patients with pacemakers and ICDs at risk of device failure and the annual number of generator malfunctions (1983-2004 for pacemakers, 1988-2004 for ICDs). A device malfunction was defined as an integral component failure that required device explantation prior to reaching elective replacement. Failures of pacemaker and ICD electrodes were not included in the study. DATA SYNTHESIS There were 2981 pacemaker and 384 ICD generator malfunctions. Pacemaker reliability improved markedly during the 1980s (P for trend
ISSN:0098-7484
1538-3598
DOI:10.1001/jama.295.16.1929