Pacemaker and ICD generator reliability: meta-analysis of device registries

JAMA : the Journal of the American Medical Association
William H Maisel

Abstract

Despite there being millions of pacemaker and implantable cardioverter-defibrillator (ICD) generator implants worldwide, little is known about device reliability. 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. 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. 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. 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 malfunct...Continue Reading

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