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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:BackgroundHeart failure (HF) is the terminal stage of all cardiovascular events. Although implantable cardioverter defibrillator (ICD) therapies have reduced mortality among the high-risk HF population, it is necessary to determine whether certain factors can predict mortality even after cardiac device implantation. Growth stimulation expressed gene 2 (ST2) is an emerging biomarker for HF patient stratification in different clinical settings.AimsThis study aimed to investigate the relationship between baseline soluble ST2 (sST2) levels in serum and the clinical outcomes of high-risk HF patients with device implantation.MethodsBetween January 2017 and August 2018, we prospectively recruited consecutive patients implanted with an ICD for heart failure, with LVEF ≤35% as recommended, and analyzed the basic characteristics, baseline serum sST2, and NT-proBNP levels, with at least 1-year follow-up. All-cause mortality was the primary endpoint.ResultsDuring a 643-day follow-up, all-cause mortality occurred in 16 of 150 patients (10.67%). Incidence of all-cause mortality increased significantly in patients with sST2 levels above 34.98846 ng/ml (16.00% vs. 5.33%, P = 0.034). After adjusting the model (age, gender, device implantation, prevention of sudden death, LVEDD, LVEF, WBC and CLBBB, hsTNT, etiology, and eGFR) and the model combined with NT-proBNP, the risk of all-cause death was increased by 2.5% and 1.9%, respectively, per ng/ml of sST2. The best sST2 cutoff for predicting all-cause death was 43.42671 ng/ml (area under the curve: 0.72, sensitive: 0.69, and specificity: 0.69). Compared to patients with sST2 levels below 43.42671 ng/ml, the risk of all-cause mortality was higher in those with values above the threshold (5.1% vs. 21.2%, P = 0.002). ST2 level ≥43.42671 ng/ml was an independent predictor of all-cause mortality (HR: 3.30 [95% CI 1.02-10.67]). Age (HR: 1.06 [95% CI: 1.01-1.12]) and increased NT-proBNP per 100 (HR: 1.02 [95% CI: 1.01-1.03]) were also associated with all-cause mortality in ICD patients.ConclusionssST2 level was associated with risk of all-cause mortality, and a threshold of 43.43 ng/ml showed good distinguishing performance to predict all-cause mortality in patients with severe heart failure, recommended for ICD implantation. Patients with sST2 levels more than 43.42671 ng/ml even after ICD implantation should therefore be monitored carefully.

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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