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Rates of and Factors Associated With Infection in 200,909 Medicare Implantable Cardioverter-Defibrillator Implants: Results From the NCDR®
Study Questions:
What are the rates and predictors of implantable cardioverter-defibrillator (ICD) infection in a large cohort of Medicare patients?
Methods:
Cases submitted to the NCDR® ICD Registry from 2006-2009, were matched to Medicare fee-for-service claims data using indirect patient identifiers. ICD infections occurring within 6 months of hospital discharge after implantation were identified by ICD-9 codes. Logistic regression was used to examine factors associated with risk of ICD infection.
Results:
Out of 200,909 implants, 3,390 patients (1.7%) developed an ICD infection. The infection rate was 1.4%, 1.5%, and 2.0% for single, dual, and biventricular ICDs, respectively (p < 0.001). Generator replacement had a higher rate compared to initial implant (1.9% vs. 1.6%, p < 0.001). The factors associated with infection were adverse event during implant requiring reintervention (odds ratio [OR], 2.692; 95% confidence interval [CI], 2.304-3.145), prior valvular surgery (OR, 1.525; 95% CI, 1.375-1.692), reimplantation for device upgrade, malfunction, or manufacturer advisory (OR, 1.354; 95% CI, 1.196-1.533), renal failure on dialysis (OR, 1.342; 95% CI, 1.123-1.604), chronic lung disease (OR, 1.215; 95% CI, 1.125-1.312), cerebrovascular disease (OR, 1.172; 95% CI, 1.076-1.276), and warfarin (OR, 1.155; 95% CI, 1.060-1.257).
Conclusions:
Patients who developed an ICD infection were more likely to have had peri-ICD implant complications requiring early reintervention, prior valve surgery, device replacement for reasons other than battery depletion, and increased comorbidity burden. Efforts should be made to carefully consider when to reenter the pocket at any time other than battery replacement.
Perspective:
It is important to note that 6-month mortality was 12% in those with ICD infection and 6.5% in those without. Measures to reduce perioperative infection have the potential to significantly improve mortality in patients receiving ICDs.
Keywords: Renal Dialysis, Renal Insufficiency, International Classification of Diseases, Replantation, Warfarin, Comorbidity, Pacemaker, Artificial, Medicare, Defibrillators, Implantable, Equipment Failure, Lung Diseases, National Cardiovascular Data Registries, ICD Registry
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