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Repeated procedures at the generator pocket are a determinant of implantable cardioverter-defibrillator infection.

ABSTRACT: BACKGROUND:Rates of cardiac-device infections have increased in recent years, but the current incidence and risk factors for infection in patients with implantable cardioverter-defibrillators (ICDs) are not well known. HYPOTHESIS:The increasing number of ICD infections is related to accumulated pocket manipulations over time. METHODS:This single-center, prospective study included patients that underwent ICD implantation from 2008 to 2015. The endpoint was time to infection. Multivariate analysis was performed to identify independent risk factors related to infection. RESULTS:The study included a total of 570 patients, of whom 419 (73.5%) underwent a first implantation. Mean age was 59 ± 14 years, and 80% were male. During a median follow-up of 36 months (interquartile range, 18-61 months; 1887 patient-years), infection was identified in 26 patients (4.56%), an incidence of 14.9 × 1000 patient-years. Median time to infection was 9.7 months (interquartile range, 1.35-23.4 months), and 38.5% were late infections (beyond 12 months of follow-up). In patients with replacement implants, the incidence was 3-fold higher than in first implantations (27.7 vs 9.1 × 1000 patient-years; P = 0.002). Cox regression identified 2 independent predictors of ICD infection: cumulative number of interventions at the generator pocket (hazard ratio: 1.92, 95% confidence interval: 1.42-2.6, P < 0.001) and pocket hematoma (hazard ratio: 7.0, 95% confidence interval: 2.7-17.9, P < 0.0001). CONCLUSIONS:The incidence of infection in ICD patients is greater than previously reported, largely due to late infections. Each new cumulative intervention at the same generator pocket nearly doubles the risk of infection.

SUBMITTER: Arana-Rueda E

PROVIDER: S-EPMC6490359 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Repeated procedures at the generator pocket are a determinant of implantable cardioverter-defibrillator infection.

Arana-Rueda Eduardo E Pedrote Alonso A Frutos-López Manuel M Acosta Juan J Jauregui Beatriz B García-Riesco Lorena L Arce-León Álvaro Á Gómez-Pulido Federico F Sánchez-Brotons Juan A JA Gutiérrez-Carretero Encarnación E de Alarcón-González Arístides A

Clinical cardiology 20170621 10

<h4>Background</h4>Rates of cardiac-device infections have increased in recent years, but the current incidence and risk factors for infection in patients with implantable cardioverter-defibrillators (ICDs) are not well known.<h4>Hypothesis</h4>The increasing number of ICD infections is related to accumulated pocket manipulations over time.<h4>Methods</h4>This single-center, prospective study included patients that underwent ICD implantation from 2008 to 2015. The endpoint was time to infection. ...[more]

PMID: 28636098

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Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Project description:ImportanceCardiac resynchronization therapy (CRT) reduces the risk for mortality and heart failure-related events in select patients. Little is known about the use of CRT in combination with an implantable cardioverter defibrillator (ICD) in patients who are eligible for this therapy in clinical practice.ObjectiveTo (1) identify patient, clinician, and hospital characteristics associated with CRT defibrillator (CRT-D) use and (2) determine the extent of hospital-level variation in the use of CRT-D among guideline-eligible patients undergoing ICD placement.Design, setting, and participantsMulticenter retrospective cohort from 1428 hospitals participating in the National Cardiovascular Data Registry ICD Registry between April 1, 2010, and June 30, 2014. Adult patients meeting class I or IIa guideline recommendations for CRT at the time of device implantation were included in this study.Main outcomes and measuresImplantation of an ICD with or without CRT.ResultsA total of 63 506 eligible patients (88.6%) received CRT-D at the time of device implantation. The mean (SD) ages of those in the ICD and CRT-D groups were 67.9 (12.2) years and 68.4 (11.5) years, respectively. In hierarchical multivariable models, black race was independently associated with lower use of CRT-D (odds ratio [OR], 0.77; 95% CI, 0.71-0.83) as was nonprivate insurance (OR, 0.90; 95% CI, 0.85-0.95 for Medicare and OR, 0.73; 95% CI, 0.65-0.82 for Medicaid). Clinician factors associated with greater CRT-D use included clinician implantation volume (OR, 1.01 per 10 additional devices implanted; 95% CI, 1.01-1.01) and electrophysiology training (OR, 3.13 as compared with surgery-boarded clinicians; 95% CI, 2.50-3.85). At the hospital level, the overall median risk-standardized rate of CRT-D use was 79.9% (range, 26.7%-100%; median OR, 2.08; 95% CI, 1.99-2.18).Conclusions and relevanceIn a national cohort of patients eligible for CRT-D at the time of device implantation, nearly 90% received a CRT-D device. However, use of CRT-D differed by race and implanting operator characteristics. After accounting for these factors, the use of CRT-D continued to vary widely by hospital. Addressing disparities and variation in CRT-D use among guideline-eligible patients may improve patient outcomes.

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Repeated procedures at the generator pocket are a determinant of implantable cardioverter-defibrillator infection.

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Repeated procedures at the generator pocket are a determinant of implantable cardioverter-defibrillator infection.

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