Dataset Information

Maximum potential benefit of implantable defibrillators in preventing sudden death after hospital admission because of heart failure.

ABSTRACT:

Background

Implantable defibrillators are recommended for the prevention of sudden cardiac death in patients with heart failure. However, criteria to identify those who would benefit most from this therapy are lacking. We assessed the maximum potential benefit of preventing sudden death in patients with repeated hospital admissions because of heart failure.

Methods

Using a cohort assembled from an administrative database, we identified 14,374 patients admitted to hospital for the first time because of heart failure between Jan. 1, 2000, and Dec. 31, 2004. We followed subsequent admissions related to heart failure as well as mortality and causes of death to Mar. 31, 2006. We regarded all out-of-hospital cardiac deaths as sudden deaths. We calculated the maximum potential benefit of preventing sudden death by subtracting the observed survival after each hospital admission from the hypothetical survival whereby all out-of-hospital cardiac deaths were assumed to be preventable.

Results

The mean age of the cohort was 77 years, 45% were women, 11% had cerebrovascular disease, and 21% had chronic kidney disease. Out-of-hospital cardiac deaths constituted 13.7% (1226/8967) of all deaths during 32,055 person-years of follow-up. The median survival declined with each subsequent hospital admission related to heart failure. The hypothetical prevention of all out-of-hospital deaths prolonged life by 0.63 (95% confidence interval [CI] 0.49 to 0.77) years after the first hospital admission. This potential benefit dropped to 0.28 (95% CI 0.10 to 0.46) years after 3 hospital admissions related to heart failure. Among patients less than 65 years old, and older patients without kidney disease, dementia or cancer, more than 50% survived longer than 2 years until they had 2 or 3 hospital admissions related to heart failure.

Interpretation

The use of implantable defibrillators to prevent sudden death would provide limited benefit among older patients with comorbidities and among patients with multiple hospital admissions related to heart failure.

SUBMITTER: Setoguchi S

PROVIDER: S-EPMC2653568 | biostudies-literature | 2009 Mar

REPOSITORIES: biostudies-literature

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Publications

Maximum potential benefit of implantable defibrillators in preventing sudden death after hospital admission because of heart failure.

Setoguchi Soko S Nohria Anju A Rassen Jeremy A JA Stevenson Lynne Warner LW Schneeweiss Sebastian S

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20090301 6

<h4>Background</h4>Implantable defibrillators are recommended for the prevention of sudden cardiac death in patients with heart failure. However, criteria to identify those who would benefit most from this therapy are lacking. We assessed the maximum potential benefit of preventing sudden death in patients with repeated hospital admissions because of heart failure.<h4>Methods</h4>Using a cohort assembled from an administrative database, we identified 14,374 patients admitted to hospital for the ...[more]

PMID: 19289804

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Project description:Importance:Improvement in left ventricular ejection fraction (EF) to >35% occurs in many patients with reduced EF at baseline. To our knowledge, whether implantable cardioverter defibrillator (ICD) therapy improves survival for these patients is unknown. Objective:To examine the efficacy of ICD therapy in reducing risk of all-cause mortality and sudden cardiac death among patients with an EF ?35% at baseline, with or without an improvement in EF to >35% during follow-up. Design, Setting, and Participants:This retrospective analysis examined data collected in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), which randomly assigned 2521 patients to placebo, amiodarone, or ICD between 1997 and 2001. A subset of 1902 participants (75.4%) of the SCD-HeFT had a repeated assessment of EF a mean (SD) of 13.5 (6) months after randomization. We stratified these patients by EF ?35% and >35% based on the first repeated EF measurement after randomization and compared all-cause mortality in 649 patients randomized to placebo vs 624 patients randomized to ICD. Follow-up started with the repeated EF assessment. Analysis was performed between January 2016 and July 2016. Exposures:Implantable cardioverter-defibrillator therapy. Main Outcomes and Measures:All-cause mortality and sudden cardiac death. Results:Of the included 1273 patients, the mean (SD) age was 59 (12) years, and 977 (76.7%) were male and 1009 (79.3%) were white. Repeated EF was >35% in 186 participants (29.8%) randomized to ICD and 185 participants (28.5%) randomized to placebo. During a median follow-up of 30 months, the all-cause mortality rate was lower in the ICD vs placebo group, both in patients whose EF remained ?35% (7.7 vs 10.7 per 100 person-year follow-up) and in those whose EF improved to >35% (2.6 vs 4.5 per 100 person-year follow-up). Compared with placebo, the adjusted hazard ratio for the effect of ICD on mortality was 0.64 (95% CI, 0.48-0.85) in patients with a repeated EF of ?35% and 0.62 (95% CI, 0.29-1.30) in those with a repeated EF >35%. There was no interaction between treatment assignment and repeated EF for predicting mortality. Conclusions and Relevance:Among participants in the SCD-HeFT who had a repeated EF assessment during the course of follow-up, those who had an improvement in EF to >35% accrued a similar relative reduction in mortality with ICD therapy as those whose EF remained ?35%. Prospective randomized clinical trials are needed to test ICD efficacy in patients with an EF >35%. Trial Registration:clinicaltrials.gov Identifier: NCT01114269.

Project description:IntroductionPredicting sudden cardiac death (SCD) is challenging as current risk predictors have significant limitations. Evaluating magnetocardiogram (MCG) parameters could be of great value and we plan to assess the capability of a new mobile unshielded MCG device in predicting SCD and ventricular arrhythmias (VA) in patients undergoing implantable cardioverter defibrillator (ICD) implantation.Methods and analysisA prospective multicentre (University Hospitals Coventry and Warwickshire (UHCW) National Health Service (NHS) Trust/University Hospital North Midlands NHS Trust, UK) observational study evaluating the VitalScan MCG (Creavo Medical Technologies, UK) to predict future VA risk; 270 patients meeting criteria for primary or secondary prevention ICDs (ischaemic or non-ischaemic aetiology) are being recruited. The first patient was recruited September 2019 and the study will be completed at final participant follow-up. The primary endpoint is appropriate ICD therapy for VA, secondary endpoint is SCD. Previous trials using MCG identified late QRS signals/QRS fragmentation as potential indicators of SCD in small samples using large shielded expensive MCG devices that were difficult to use clinically. It is hoped the MAGNETO-SCD trial will show this new MCG device can provide real world risk stratification for SCD/VA risk. The trial has recruited 25 patients (13 with secondary prevention indication) from a single site (UHCW) with recruitment starting at the second site in March 2020.Ethics and disseminationResearch Ethics Committee, Yorkshire and Humber Sheffield Research Ethics Committee UK (Ref: 19/YH/0143) and Health Research Authority (IRAS reference 254466, EDGE ID: 123146) approval received on 17/07/2019. The Medicines and Healthcare products Regulatory Agency approval received 11/07/2019. Results will be disseminated via a peer-reviewed publication and presentation at international conferences.Trial registration numbersClinicalTrials.gov Registry (NCT04352816) and EU Clinical Trials Registry (EudraCT2019-002994-78).

Dataset Information

Maximum potential benefit of implantable defibrillators in preventing sudden death after hospital admission because of heart failure.

Background

Methods

Results

Interpretation

Publications

Maximum potential benefit of implantable defibrillators in preventing sudden death after hospital admission because of heart failure.

Similar Datasets

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