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Complication risk with pulse generator change: implications when reacting to a device advisory or recall
Suraj Kapa1, Linda Hyberger, Robert F Rea
1Division of Cardiology, Mayo Clinic, Rochester, Minnesota 55905, USA.
Pacing and Clinical Electrophysiology : PACE
|June 6, 2007
Summary
Generator replacement in patients with pacemakers and implantable cardioverter-defibrillators (ICDs) has a low complication rate of 1.24%. Decisions for generator changes should consider these risks, especially for advisory devices.
Area of Science:
- Cardiology
- Medical Device Management
Background:
- Recent pacemakers and implantable cardioverter-defibrillators (ICDs) advisories and recalls necessitate evidence-based management recommendations.
- Evaluating risks and benefits of generator changes in patients with advisory devices is crucial.
Purpose of the Study:
- To assess operative complication rates associated with pulse generator changes in patients with pacemakers and ICDs.
Main Methods:
- A retrospective review of 732 pulse generator changes at Mayo Clinic-Rochester (2000-2005).
- Analysis included 570 elective replacement indicator (ERI) changes and 162 for manufacturer advisories/recalls.
- Complications defined as reoperations within 60 days for infection, hematoma, or incisional dehiscence.
Main Results:
- Overall complication rate was 1.24% (9 of 732 patients).
- Complications occurred in 1.40% of ERI changes (8 patients) and 0.62% of advisory/recall changes (1 patient).
- Specific complications included 5 infections, 3 hematomas, and 1 incisional dehiscence.
Conclusions:
- Pulse generator replacement is a procedure with inherent risks.
- Management decisions for patients with advisory or recalled devices must carefully weigh these operative risks against other clinical factors.
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