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Is Time From Last Hospitalization for Heart Failure to Placement of a Primary Prevention Implantable Cardioverter-Defibrillator Associated With Patient Outcomes?

ABSTRACT: BACKGROUND:Landmark studies have demonstrated the safety and efficacy of implantable cardioverter-defibrillators (ICDs) in selected stable ambulatory patients with heart failure (HF) with a reduced ejection fraction receiving optimal medical therapy. It is not known whether a recent hospitalization for HF before ICD placement is associated with subsequent outcomes. METHODS:A post hoc analysis was performed of Medicare beneficiaries enrolled in the National Cardiovascular Data Registry's ICD Registry with a known diagnosis of HF and an ejection fraction ?35% underdoing a new ICD placement for primary prevention. Patients were grouped based on the timing of ICD placement from the last hospitalization for HF. The association between timing of ICD placement and outcomes was assessed by using multivariable logistic regression models. RESULTS:The final analytic cohort included 81?180 patients undergoing initial ICD placement for primary prevention who were currently hospitalized for HF (n=11?563, 14%), hospitalized for HF within 3 months (n=6252, 8%), or hospitalized for HF >3 months previously or had no previous hospitalizations for HF (n=63?365, 78%). Patients currently or recently hospitalized for HF had a higher unadjusted composite periprocedural complication rate (2.60% versus 1.71% versus 1.25%, P<0.001). After adjusting for potential confounders, patients currently hospitalized for HF were at higher risk for death (odds ratio, 2.25; 95% CI, 2.02-2.52; P <0.001) and all-cause readmission (odds ratio, 1.89; 95% CI, 1.79-1.99; P <0.001) at 90 days. CONCLUSION:Older patients currently or recently hospitalized for HF undergoing initial ICD placement for primary prevention experienced a higher rate of periprocedural complications and were at increased risk of death in comparison with those receiving an ICD without recent HF hospitalization. Additional prospective, real-world, pragmatic, comparative effectiveness studies should be conducted to define the optimal timing of ICD placement.

SUBMITTER: Ambrosy AP

PROVIDER: S-EPMC6931009 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Is Time From Last Hospitalization for Heart Failure to Placement of a Primary Prevention Implantable Cardioverter-Defibrillator Associated With Patient Outcomes?

Ambrosy Andrew P AP Parzynski Craig S CS Friedman Daniel J DJ Fudim Marat M Hernandez Adrian F AF Fonarow Gregg C GC Masoudi Frederick A FA Al-Khatib Sana M SM

Circulation 20181201 24

<h4>Background</h4>Landmark studies have demonstrated the safety and efficacy of implantable cardioverter-defibrillators (ICDs) in selected stable ambulatory patients with heart failure (HF) with a reduced ejection fraction receiving optimal medical therapy. It is not known whether a recent hospitalization for HF before ICD placement is associated with subsequent outcomes.<h4>Methods</h4>A post hoc analysis was performed of Medicare beneficiaries enrolled in the National Cardiovascular Data Regi ...[more]

PMID: 30565983

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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:BackgroundImplantable cardioverter-defibrillator (ICD) placement in heart failure (HF) patients during or early after (≤90 days) unplanned cardiovascular hospitalizations has been associated with poor outcomes. Racial and ethnic differences in this "peri-hospitalization" ICD placement have not been well described.MethodsUsing a 20% random sample of Medicare beneficiaries, we identified older (≥66 years) patients with HF who underwent ICD placement for primary prevention from 2008 to 2018. We investigated racial and ethnic differences in frequency of peri-hospitalization ICD placement using modified Poisson regression. We utilized Kaplan-Meier analyses and Cox regression to investigate the association of peri-hospitalization ICD placement with differences in all-cause mortality and hospitalization (HF, cardiovascular and all-cause) within and between race and ethnicity groups for up to 5-year follow-up.ResultsAmong the 61,710 beneficiaries receiving ICDs (35% female, 82% White, 10% Black, 6% Hispanic), 44% were implanted peri-hospitalization. Black [adjusted rate ratio (RR) 95% Confidence Interval (95% CI): 1.16 (1.12, 1.20)] and Hispanic [RR (95% CI): 1.10 (1.06, 1.14)] beneficiaries were more likely than White beneficiaries to have ICD placement peri-hospitalization. Peri-hospitalization ICD placement was associated with an at least 1.5× increased risk of death, 1.5× increased risk of re-hospitalization and 1.7× increased risk of HF hospitalization during 3-year follow-up in fully adjusted models. Although beneficiaries with peri-hospitalization placement had the highest mortality and readmission rates 1- and 3-year post-implant (log-rank p < 0.0001), the magnitude of the associated risk did not differ significantly by race and ethnicity (p = NS for interaction).ConclusionsICD implantation occurring during the peri-hospitalization period was associated with worse prognosis and occurred at higher rates among Black and Hispanic compared to White Medicare beneficiaries with HF during the period under study. The risk associated with peri-hospitalization ICD placement did not differ by race and ethnicity. Future paradigms aimed at enhancing real-world effectiveness of ICD therapy and addressing disparate outcomes should consider timing and setting of ICD placement in HFrEF patients who otherwise meet guideline eligibility.

Dataset Information

Is Time From Last Hospitalization for Heart Failure to Placement of a Primary Prevention Implantable Cardioverter-Defibrillator Associated With Patient Outcomes?

Publications

Is Time From Last Hospitalization for Heart Failure to Placement of a Primary Prevention Implantable Cardioverter-Defibrillator Associated With Patient Outcomes?

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