Related Experiment Video
Updated: Jun 27, 2026
A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Outcome of advisory implantable cardioverter-defibrillator replacement: one-year follow-up
Paul A Gould1, Lorne J Gula, Jean Champagne
1University of Western Ontario, London, Ontario, Canada.
Insights
Advisory implantable cardioverter defibrillator (ICD) generator replacement leads to frequent complications, including death. Patients with multiple prior pocket procedures face increased risks during ICD replacement.
Area of Science:
- Cardiology
- Medical Device Technology
- Patient Safety
Background:
- Implantable cardioverter defibrillator (ICD) advisories create management challenges due to risks of device failure versus replacement complications.
- Limited long-term data exists on complications from advisory ICD generator replacement.
Purpose of the Study:
- To assess replacement-related complications in a large, multicenter advisory ICD generator replacement cohort.
- To identify risk factors for complications to aid in replacement decision-making.
Main Methods:
- A nested case-control analysis was performed on 451 advisory ICD replacements across 12 centers over 1 year.
- Complication and non-complication groups were compared for risk factors.
Main Results:
- 9.1% of replacements (41/451) resulted in complications, with 5.9% requiring reoperation (including two deaths).
- Multiple previous pocket procedures increased complication risk.
- Combined operator experience (consultant and fellow) decreased complication rates compared to single operators.
Conclusions:
- Advisory ICD generator replacement carries a significant risk of complications, including infection and rare deaths.
- Increased risk of replacement complications is linked to a history of multiple pocket procedures.
Background:
Implantable cardioverter defibrillator (ICD) generator advisories present management dilemmas for physicians regarding competing risks of ICD failure and replacement-related complications. There is currently a paucity of long-term data concerning the complications associated with advisory ICD replacement.
Objective:
In a large multicenter advisory ICD generator replacement cohort followed for 12 months, we aimed to assess replacement-related complications by performing a case-control determination of complication risk factors to identify characteristics that could assist with advisory ICD replacement decision making.
Methods:
Twelve large ICD implanting centers reviewed the 1-year follow-up outcome of advisory ICDs replaced between October 2004 and October 2005. The complication cohort was characterized and compared in a nested case-control analysis with age- and gender-matched controls without complications from the same replacement population.
Results:
At the 12 participating institutions, 451 of 2635 advisory ICD devices were replaced (17.1%). Over 355 +/- 204 days of follow-up, there were 41 (9.1%) complications; 27 (5.9%) required reoperation and included two deaths. There were 14 minor complications (3.1%). Multivariate analysis demonstrated that the number of previous pocket procedures was associated with an increase in complications and that combined consultant and fellow operators was associated with a decrease in complications compared with a single operator alone.
Conclusions:
Complications from advisory ICD generator replacement are frequent and include infection and, rarely, death. The risk of replacement is increased in patients with multiple previous pocket procedures.
Related Concept Videos
01:29Cardiomyopathy V: Interprofessional Care
01:30Cardiomyopathy II: Dilated Cardiomyopathy
01:18Endocarditis III: Medical Management
01:22Heart Failure VI: Adjunct Therapies