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- Title
Recurrent Implantable Cardioverter-Defibrillator Replacement Is Associated with an Increasing Risk of Pocket-Related Complications.
- Authors
JAN WILLEM BORLEFFS, C.; THIJSSEN, JOEP; De BIE, MIHÁLY K.; Van REES, JOHANNES B.; Van WELSENES, GUIDO H.; Van ERVEN, LIESELOT; BAX, JEROEN J.; CANNEGIETER, SUZANNE C.; SCHALIJ, MARTIN J.
- Abstract
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. (PACE 2010; 1013–1019)
- Subjects
ENGLAND; REOPERATION; ACADEMIC medical centers; ANALYSIS of variance; CARDIOVASCULAR surgery; CONFIDENCE intervals; EPIDEMIOLOGY; HEMATOMA; IMPLANTABLE cardioverter-defibrillators; INFECTION; POISSON distribution; RESEARCH funding; SURGICAL complications; SURVIVAL analysis (Biometry); ULCERS; DATA analysis; MEDICAL equipment reliability
- Publication
Pacing & Clinical Electrophysiology, 2010, Vol 33, Issue 8, p1013
- ISSN
0147-8389
- Publication type
Article
- DOI
10.1111/j.1540-8159.2010.02780.x