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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation

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

William H Maisel¹

¹Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass 02215, USA. wmaisel@bidmc.harvard.edu

|April 28, 2006

Summary

Pacemaker reliability has significantly improved. Implantable cardioverter-defibrillator (ICD) malfunction rates initially decreased but then increased before a recent decline, requiring ongoing monitoring.

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Area of Science:

Cardiovascular Medicine
Biomedical Engineering
Medical Device Technology

Background:

Millions of pacemaker and implantable cardioverter-defibrillator (ICD) devices are implanted globally.
Limited data exists regarding the long-term reliability and malfunction rates of these cardiac devices.

Purpose of the Study:

To conduct a meta-analysis of prospective registries for pacemakers and ICDs.
To determine annual malfunction rates and identify trends in device reliability.
To compare the reliability of pacemakers versus ICDs.

Main Methods:

A comprehensive literature search was performed across multiple databases (MEDLINE, Cochrane).
Three prospective registries meeting specific inclusion criteria were identified, encompassing over 2.1 million pacemaker and 14,821 ICD person-years.
Data on generator malfunctions (excluding leads) from 1983-2004 for pacemakers and 1988-2004 for ICDs were extracted.

Main Results:

Pacemaker reliability showed marked improvement in the 1980s, with consistently low malfunction rates thereafter.
Implantable cardioverter-defibrillator (ICD) reliability initially improved, but malfunction rates increased significantly from 1998-2002 before decreasing.
The annual ICD malfunction rate was approximately 20 times higher than the pacemaker rate, with battery failure being the most common cause.

Conclusions:

Pacemaker reliability has substantially improved over time.
Implantable cardioverter-defibrillator (ICD) reliability experienced a transient increase in malfunction rates before recent improvements.
Continued surveillance of pacemaker and ICD performance is essential to understand device reliability trends.