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Complications of replacing implantable devices in response to advisories: a single center experience
John W Moore1, William Barrington, Raveen Bazaz
1Cardiovascular Institute of the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, USA.
Insights
Replacing cardiac implantable electronic devices due to advisories had a low major complication rate (2.1%). This study suggests advisory device replacement is safe and informs future management strategies for these patients.
Area of Science:
- Cardiology
- Biomedical Engineering
Background:
- Advisories for implanted devices lack specific replacement guidelines, posing management challenges.
- Assessing complication rates is crucial for informed decision-making regarding device replacement.
Purpose of the Study:
- To review institutional experience with device replacement prompted by advisories.
- To evaluate the safety and complication rates associated with advisory-driven device replacement.
Main Methods:
- Retrospective review of 237 patients undergoing device replacement due to advisories between February 2005 and June 2006.
- Analysis of patient demographics, device types (87% implantable cardioverter-defibrillators), manufacturers, and follow-up data.
Main Results:
- The overall complication rate was 5.5%, with major complications requiring re-operation in 2.1% of patients.
- No deaths occurred. Device failure before replacement was documented in 1.7% of cases.
- Comorbidities like diabetes or peripheral vascular disease did not predict post-replacement complications.
Conclusions:
- This single-center study indicates a lower major complication rate for advisory device replacement than previously reported.
- Findings support the safety of advisory-driven device replacement and can guide future patient management.
Background:
Advisories for implanted devices present a challenging management problem since no specific guidelines exist for device replacement under these circumstances. Since the rate and severity of complications is an important factor in the decision-making, we sought to review our experience with replacement of devices under advisory.
Methods:
Medical records of patients with devices under advisory were reviewed. A total of 237 patients (age 68+/-13 years, men 71%, implantable cardioverter-defibrillator (ICD) 87%) underwent device replacement in response to advisories (Medtronic Inc. 43% and Guidant Inc. 57%) at our institution between February 2005 and June 2006.
Results:
The mean time from original device implantation to replacement was 31+/-16 months (3-73 months). During a mean follow-up of 198+/-103 days, there was a 5.5% overall rate of complications related to the procedure. Major complications requiring re-operation affected 2.1% of patients. There were no deaths associated with device replacement. Device failure prior to replacement was documented in 1.7% of patients, with syncope occurring in one patient. A history of diabetes mellitus (23%), peripheral vascular disease (4%), obstructive lung disease (7%), end-stage renal disease (2%), or use of anticoagulation (44%) did not predict the occurrence of complications after advisory device replacement.
Conclusion:
This single center experience shows a lower major complication rate from replacement of devices under advisory than previously reported. Experience from this center and others may be useful in guiding future management of patients in the setting of device advisories.
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