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Updated: May 5, 2026
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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
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Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model
Mitesh S Amin1, David B Matchar, Mark A Wood
1Department of Internal Medicine, Virginia Commonwealth University Medical Center, Richmond, USA.
JAMA
|July 27, 2006
Summary
Deciding whether to replace an implantable device under advisory hinges on failure rates and mortality risks. Device replacement is often favored when failure rates exceed 0.3% for pacemakers or 1.0-3.0% for defibrillators.
Area of Science:
- Cardiology
- Biomedical Engineering
- Health Decision Analysis
Background:
- Clinical management guidelines for implantable devices under advisory are limited.
- Understanding risks and benefits of device replacement versus continued monitoring is crucial for clinicians.
Purpose of the Study:
- To determine the optimal management strategy for implantable devices under advisory using decision analysis.
- Compare immediate device replacement versus continued clinical follow-up.
Main Methods:
- A decision model was developed to assess risks and benefits of immediate replacement versus monitoring.
- Key variables included device failure rates (0.0001%–1.0% per year) and replacement mortality (0.10%–1.00%).
Main Results:
- Device replacement decisions are primarily driven by failure rates and mortality impact.
- Pacemaker-dependent patients may warrant replacement if failure rates exceed 0.3%.
- Implantable cardioverter-defibrillator replacement decisions vary based on failure rates (1.0%–3.0%), procedural mortality, and arrhythmia risk.
Conclusions:
- The decision to replace a recalled device depends on malfunction incidence and failure effects.
- This analysis offers a framework for managing recalled devices considering device, patient, and institutional factors.
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