Key result
The mean annual implantable cardioverter-defibrillator malfunction rate was approximately 20-fold higher than the pacemaker malfunction rate (26.5 vs 1.3 per 1000 person-years, P<.001).
Why the study?
What are the annual rates and trends of pacemaker and ICD generator malfunctions?
Meta-Analysis
What are the annual rates and trends of pacemaker and ICD generator malfunctions?
Effect estimate: 20-fold higher
Absolute Event Rate: 26.5% vs 1.3%
p-value: p=<.001
ICD generator malfunction rates are approximately 20-fold higher than pacemaker malfunction rates, highlighting the need for continued monitoring of device performance.
Authors
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Urges intensified ICD generator surveillance in practice; extends device safety data by quantifying type-specific malfunction disparities.
William H. Maisel (2006) conducted a meta-analysis in Pacemaker and implantable cardioverter-defibrillator (ICD) implants. Implantable cardioverter-defibrillator (ICD) vs. Pacemaker was evaluated on Annual rate of generator malfunction (integral component failure requiring explantation prior to elective replacement) (20-fold higher, p=<.001). The mean annual implantable cardioverter-defibrillator malfunction rate was approximately 20-fold higher than the pacemaker malfunction rate (26.5 vs 1.3 per 1000 person-years, P<.001).
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