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Characteristics and outcomes of patients receiving new and replacement implantable cardioverter-defibrillators: results from the NCDR.

ABSTRACT: Little is known about the clinical features, procedural risks, or survival of patients receiving replacement versus new implantable cardioverter-defibrillators (ICDs).Entries in the National Cardiovascular Data Registry (NCDR) ICD Registry from 2005 through 2010 were eligible for inclusion (n=463,978). Baseline demographic data, clinical information, and procedural variables were compared between patients receiving new (n=359,993; 77.6%) and replacement (n=103,985; 22.4%) ICDs and entered into a propensity match model to determine adjusted survival rates. Patients receiving replacement ICDs were older (70.7 versus 67.5 years of age) and more likely to have atrial fibrillation (41.8% versus 31.4%; P<0.001) and ventricular tachycardia (60.5% versus 33.9%; P<0.001) compared with patients receiving new ICDs. Median battery life was only 4.6 years (25%-75% interquartile range, 3.7-5.8) for all replaced devices, 5.8 (25%-75% interquartile range, 4.2-7.5) for single-chamber, 5.1 (25%-75% interquartile range, 4.1-6.1) for dual-chamber, and 3.9 (25%-75% interquartile range, 3.2-4.6) years for biventricular devices. Patients receiving replacement ICDs had lower rates of index admission complications (0.9% versus 3.2%; P<0.001) but greater risk for death compared receiving patients receiving new ICDs in unadjusted analysis (hazard ratio, 1.18; 95% confidence interval, 1.16-1.20; P<0.0001) and after propensity-score matching (hazard ratio, 1.28; 95% confidence interval, 1.25-1.30; P<0.0001).Patients receiving replacement ICDs are older and at greater risk for death compared with those receiving initial ICD implants. The battery life of initial ICDs is shorter than previously reported.

SUBMITTER: Kramer DB

PROVIDER: S-EPMC3839636 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

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Characteristics and outcomes of patients receiving new and replacement implantable cardioverter-defibrillators: results from the NCDR.

Kramer Daniel B DB Kennedy Kevin F KF Noseworthy Peter A PA Buxton Alfred E AE Josephson Mark E ME Normand Sharon-Lise SL Spertus John A JA Zimetbaum Peter J PJ Reynolds Matthew R MR Mitchell Susan L SL

Circulation. Cardiovascular quality and outcomes 20130611 4

<h4>Background</h4>Little is known about the clinical features, procedural risks, or survival of patients receiving replacement versus new implantable cardioverter-defibrillators (ICDs).<h4>Methods and results</h4>Entries in the National Cardiovascular Data Registry (NCDR) ICD Registry from 2005 through 2010 were eligible for inclusion (n=463,978). Baseline demographic data, clinical information, and procedural variables were compared between patients receiving new (n=359,993; 77.6%) and replace ...[more]

PMID: 23759471

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Project description:BACKGROUND:Primary prevention implantable cardioverter-defibrillators (ICDs) reduce mortality in selected patients with left ventricular systolic dysfunction by delivering therapies (antitachycardia pacing or shocks) to terminate potentially lethal arrhythmias; inappropriate therapies also occur. We assessed device therapies among adults receiving primary prevention ICDs in 7 healthcare systems. METHODS AND RESULTS:We linked medical record data, adjudicated device therapies, and the National Cardiovascular Data Registry ICD Registry. Survival analysis evaluated therapy probability and predictors after ICD implant from 2006 to 2009, with attention to Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups: left ventricular ejection fraction, 31% to 35%; nonischemic cardiomyopathy <9 months' duration; and New York Heart Association class IV heart failure with cardiac resynchronization therapy defibrillator. Among 2540 patients, 35% were <65 years old, 26% were women, and 59% were white. During 27 (median) months, 738 (29%) received ?1 therapy. Three-year therapy risk was 36% (appropriate, 24%; inappropriate, 12%). Appropriate therapy was more common in men (adjusted hazard ratio [HR], 1.84; 95% confidence interval [CI], 1.43-2.35). Inappropriate therapy was more common in patients with atrial fibrillation (adjusted HR, 2.20; 95% CI, 1.68-2.87), but less common among patients ?65 years old versus younger (adjusted HR, 0.72; 95% CI, 0.54-0.95) and in recent implants (eg, in 2009 versus 2006; adjusted HR, 0.66; 95% CI, 0.46-0.95). In Centers for Medicare and Medicaid Services Coverage With Evidence Development analysis, inappropriate therapy was less common with cardiac resynchronization therapy defibrillator versus single chamber (adjusted HR, 0.55; 95% CI, 0.36-0.84); therapy risk did not otherwise differ for Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups. CONCLUSIONS:In this community cohort of primary prevention patients receiving ICD, therapy delivery varied across demographic and clinical characteristics, but did not differ meaningfully for Centers for Medicare and Medicaid Services Coverage With Evidence Development subgroups.

Project description:BackgroundConventional risk factors for sudden cardiac death (SCD) justify primary prevention through implantable cardioverter-defibrillator (ICD) implantation in hypertrophic cardiomyopathy (HCM) patients. However, the positive predictive values for these conventional SCD risk factors are low. Left ventricular outflow tract obstruction (LVOTO) and midventricular obstruction (MVO) are potential risk modifiers for SCD. The aims of this study were to evaluate whether an elevated intraventricular pressure gradient (IVPG), including LVOTO or MVO, is a potential risk modifier for SCD and ventricular arrhythmias requiring ICD interventions in addition to the conventional risk factors among HCM patients receiving ICDs for primary prevention.MethodsWe retrospectively studied 60 HCM patients who received ICDs for primary prevention. An elevated IVPG was defined as a peak instantaneous gradient ≥ 30 mmHg at rest, as detected by continuous-wave Doppler echocardiography. The main outcome was a composite of SCD and appropriate ICD interventions, which were defined as an antitachycardia pacing or shock therapy for ventricular tachycardia or fibrillation. The Cox proportional hazards model was used to assess the relationships between risk factors and the occurrence of SCD and appropriate ICD interventions.ResultsThirty patients met the criteria of elevated IVPG (50%). During the median follow-up period of 66 months, 2 patients experienced SCD, and 10 patients received appropriate ICD interventions. Kaplan-Meier curves showed that the incidence of the main outcome was higher in patients with an IVPG ≥ 30 mmHg than in those without an IVPG ≥ 30 mmHg (log-rank P = 0.03). There were no differences in the main outcome between patients with LVOTO and patients with MVO. The combination of nonsustained ventricular tachycardia (NSVT) and IVPG ≥ 30 mmHg was found to significantly increase the risk of the main outcome (HR 6.31, 95% CI 1.36-29.25, P = 0.02). Five patients experienced ICD implant-related complications.ConclusionsOur findings showed that a baseline IVPG ≥ 30 mmHg was associated with an increased risk of experiencing SCD or appropriate ICD interventions among HCM patients who received ICDs for primary prevention. Combined with NSVT, which is a conventional risk factor, a baseline IVPG ≥ 30 mmHg may be a potential modifier of SCD risk in HCM patients.

Dataset Information

Characteristics and outcomes of patients receiving new and replacement implantable cardioverter-defibrillators: results from the NCDR.

Publications

Characteristics and outcomes of patients receiving new and replacement implantable cardioverter-defibrillators: results from the NCDR.

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