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Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories
Paul A Gould1, Andrew D Krahn,
1Division of Cardiology, Department of Medicine, University of Western Ontario, London.
Insights
Implantable cardioverter-defibrillator (ICD) generator replacement due to advisories has a high complication rate, including death. This highlights the need for new guidelines for managing patients with advisory ICDs.
Area of Science:
- Cardiology
- Medical Device Safety
- Electrophysiology
Background:
- Recent implantable cardioverter-defibrillator (ICD) advisories and recalls create management challenges for physicians.
- No specific guidelines or outcome data exist for current management strategies of advisory ICDs.
- The complication risk of ICD generator replacement in this population remains unassessed.
Purpose of the Study:
- To determine the complication rate associated with ICD generator replacement specifically for current ICD advisories.
- To provide data for developing management guidelines for patients with advisory ICDs.
Main Methods:
- A survey of 17 Canadian ICD implanting centers was conducted.
- Data on complication rates from elective ICD generator replacements due to advisories were collected from October 2004 to October 2005.
- Complications were tracked during follow-up after generator replacement.
Main Results:
- Out of 533 patients who had advisory ICDs replaced, 8.1% experienced complications.
- Major complications requiring reoperation occurred in 5.8% of patients, with 2 deaths reported due to pocket infection.
- Minor complications were observed in 2.3% of patients.
Conclusions:
- ICD generator replacement in patients with advisory devices is linked to a significant complication rate, including mortality.
- These findings underscore the necessity of considering complication risks when developing treatment guidelines for advisory ICDs.
- Further research is needed to establish optimal management strategies for patients with recalled or advisory ICDs.
Context:
Recent implantable cardioverter-defibrillator (ICD) advisories and recalls have caused management dilemmas for physicians, particularly because there are no specific guidelines or data on outcomes from current management strategies. The risk of ICD generator replacement has not been assessed in this population.
Objective:
To determine the complication rate associated with ICD generator replacement for the current ICD advisories.
Design And Setting:
Seventeen ICD implanting centers in Canada were surveyed to assess complication rates as a result of generator replacements because of ICD advisories from October 2004 to October 2005.
Main Outcome Measure:
Complications associated with elective ICD generator replacement for current device advisories.
Results:
At the 17 surveyed centers, 2915 patients had recall devices, including 533 (18.3%) who had advisory ICDs replaced a mean (SD) of 26.5 (11.5) months after their initial implant. Of these patients, 66% had a secondary prevention ICD, and 45% had received a previous appropriate shock. During a mean (SD) of 2.7 (2.8) months' follow-up after ICD generator replacement, complications occurred in 43 patients (8.1%). Major complications attributable to advisory device replacement requiring reoperation occurred in 31 patients (5.8%), with death in 2 patients after extraction for pocket infection. Minor complications occurred in 12 patients (2.3%). There were 3 (0.1%) advisory-related device malfunctions reported, without clinical consequences.
Conclusions:
ICD generator replacement in patients with advisory devices is associated with a substantial rate of complications, including death. These complications need to be considered in the development of guidelines determining the appropriate treatment of patients with advisory devices.
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