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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Recurrent implantable cardioverter-defibrillator replacement is associated with an increasing risk of pocket-related
C Jan Willem Borleffs1, Joep Thijssen, Mihály K de Bie
1Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands.
Insights
Implantable cardioverter-defibrillator (ICD) replacement doubles the risk of pocket-related surgical re-interventions. This risk escalates with each subsequent device replacement, highlighting a growing concern for patient safety over time.
Area of Science:
- Cardiology
- Medical Devices
- Surgical Outcomes
Background:
- Implantable cardioverter-defibrillator (ICD) therapy is crucial for managing cardiac conditions.
- Limited device service life necessitates frequent ICD replacements.
- Data on pocket-related adverse events following ICD replacement is limited.
Purpose of the Study:
- To evaluate the incidence of pocket-related surgical re-interventions after ICD implantation and replacement.
- To assess the impact of device replacement on the risk of these complications.
Main Methods:
- Analysis of 2,415 patients who received an ICD between 1992 and 2008.
- Inclusion of 3,161 ICDs in the study cohort.
- Focus on pocket-related complications requiring surgical re-intervention, excluding elective replacements, lead failure, or device malfunction.
Main Results:
- A total of 145 surgical re-interventions were required in 114 (4.7%) unique patients.
- Replacement ICDs showed a doubled risk (rate ratio 2.2) of surgical re-intervention compared to initial implants.
- The risk of re-intervention increased with each successive replacement, from 1.5% for the first to 8.1% for the fourth implanted ICD.
Conclusions:
- ICD replacement significantly increases the risk of pocket-related surgical re-interventions.
- The cumulative risk of re-intervention escalates with each subsequent device replacement.
- These findings underscore the importance of monitoring and managing complications associated with repeated ICD procedures.
Background:
Despite beneficial effects of implantable cardioverter-defibrillator (ICD) therapy, limited service life results in replacement within the majority of patients. Data concerning the effect of replacement procedures on the occurrence of pocket-related adverse events are scarce. In this study, the requirement for pocket-related surgical re-interventions following ICD treatment and the effect of device replacement were evaluated.
Methods:
From 1992 to 2008, 2,415 patients receiving an ICD at the Leiden University Medical Center were analyzed. Pocket-related complications requiring surgical re-intervention following ICD implantation or replacement were noted. Elective device replacement, lead failure, and device malfunction were not considered pocket-related complications.
Results:
A total of 3,161 ICDs were included in the analysis. In total, 145 surgical re-interventions were required in 122 (3.9%) ICDs implanted in 114 (4.7%) unique patients. Three-year cumulative incidence for first surgical re-intervention in all ICDs was 4.7% (95% confidence interval [CI] 3.9-5.5%). Replacement ICDs exhibited a doubled requirement for surgical re-intervention (rate ratio 2.2, 95% CI 1.5-3.0). Compared to first implanted ICDs, the occurrence of surgical re-intervention in replacements was 2.5 (95% CI 1.6-3.7) times higher for infectious and 1.7 (95% CI 0.9-3.0) for noninfectious causes. Subdivision by the number of ICD replacements showed an increase in the annual risk for surgical re-intervention, ranging from 1.5% (95% CI 1.2-1.9%) for the first, to 8.1% (95% CI 1.7-18.3%) for the fourth implanted ICD.
Conclusions:
ICD replacement is associated with a doubled risk for pocket-related surgical re-interventions. Furthermore, the need for re-intervention increases with every consecutive replacement.
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