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Published on: February 28, 2012
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.
Insights
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.
Context:
Limited information exists to direct clinical management after an implantable device has been put under advisory. A better understanding of the risks and benefits of device replacement compared with continued clinical follow-up would be helpful to clinicians.
Objective:
Using the tools of decision analysis, to determine the best management approach (immediate device replacement vs continued monitoring) in the setting of a device advisory.
Design:
A decision model was constructed to evaluate the risks and benefits associated with immediate device replacement compared with continued monitoring.
Main Outcome Measures:
Variables considered included indications for device implantation, anticipated course following device failure, device failure rates from the advisory ranging from 0.0001% to 1.0% per year, and device replacement mortality rates ranging from 0.10% to 1.00% per procedure. Device replacement was preferred to continued follow-up when replacement led to greater patient survival.
Results:
The decision to replace a recalled device depends primarily on the advisory's estimated device failure rate and the likely effects of device failure on mortality. Procedural mortality is an important secondary factor, while patient age and remaining generator life have the least influence on the decision. For pacemaker-dependent patients, advisory device failure rates exceeding 0.3% warrant device replacement in most situations. In patients with implantable cardioverter-defibrillators for primary or secondary prevention, a failure rate associated with an advisory of 3.0% is needed to favor replacement in most cases, decreasing to close to 1.0% as procedural mortality rates decrease to 0.1% or risk of fatal arrhythmias increase to near 20% per year. In cases of pacemaker implantation for non-life-threatening situations (eg, carotid sinus hypersensitivity), most device advisories do not warrant device replacement.
Conclusions:
The decision to replace a device under advisory is determined primarily by the incidence of device malfunction and the likely effects of device failure. This analysis provides a framework for managing recalled devices in the context of device, patient, and institutional characteristics.
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