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Association of Implantable Cardioverter Defibrillators With Survival in Patients With and Without Improved Ejection Fraction: Secondary Analysis of the Sudden Cardiac Death in Heart Failure Trial.

ABSTRACT: 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.

SUBMITTER: Adabag S

PROVIDER: S-EPMC5710619 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Association of Implantable Cardioverter Defibrillators With Survival in Patients With and Without Improved Ejection Fraction: Secondary Analysis of the Sudden Cardiac Death in Heart Failure Trial.

Adabag Selcuk S Patton Kristen K KK Buxton Alfred E AE Rector Thomas S TS Ensrud Kristine E KE Vakil Kairav K Levy Wayne C WC Poole Jeanne E JE

JAMA cardiology 20170701 7

<h4>Importance</h4>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.<h4>Objective</h4>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.<h4>Design ...[more]

PMID: 28724134

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Project description:Clinical trials of prophylactic implantable cardioverter-defibrillators (ICDs) have included a minority of patients with a left ventricular ejection fraction (LVEF) between 30% and 35%. Because a large number of ICDs in the United States are implanted in such patients, it is important to study survival associated with this therapy.To characterize patients with LVEF between 30% and 35% and compare the survival of those with and without ICDs.Retrospective cohort study of Medicare beneficiaries in the National Cardiovascular Data Registry ICD registry (January 1, 2006, through December 31, 2007) with an LVEF between 30% and 35% who received an ICD during a heart failure hospitalization and similar patients in the Get With The Guidelines-Heart Failure (GWTG-HF) database (January 1, 2005, through December 31, 2009) with no ICD. The analysis was repeated in patients with an LVEF less than 30%. There were 3120 patients with an LVEF between 30% and 35% (816 in matched cohorts) and 4578 with an LVEF less than 30% (2176 in matched cohorts). Propensity score matching and Cox models were applied.The primary outcome was all-cause mortality; data were obtained from Medicare claims through December 31, 2011.There were no significant differences in the baseline characteristics of the matched groups (n?=?408 for both groups). Among patients with an LVEF between 30% and 35%, there were 248 deaths in the ICD Registry group, within a median follow-up of 4.4 years (interquartile range, 2.7-4.9) and 249 deaths in the GWTG HF group, within a median follow-up of 2.9 years (interquartile range, 2.1-4.4). The risk of all-cause mortality in patients with an LVEF between 30% and 35% and an ICD was significantly lower than that in matched patients without an ICD (3-year mortality rates: 51.4% vs 55.0%; hazard ratio, 0.83 [95% CI, 0.69-0.99]; P?=?.04). Presence of an ICD also was associated with better survival in patients with an LVEF less than 30% (3-year mortality rates: 45.0% vs 57.6%; 634 and 660 total deaths; hazard ratio, 0.72 [95% CI, 0.65-0.81]; P?<?.001) (P?=?.20 for interaction).Among Medicare beneficiaries hospitalized for heart failure and with an LVEF between 30% and 35% and less than 30%, survival at 3 years was better in patients who received a prophylactic ICD than in comparable patients with no ICD. These findings support guideline recommendations to implant prophylactic ICDs in eligible patients with an LVEF of 35% or less.

Project description:Wearable cardioverter-defibrillators (WCDs) protect patients from sudden cardiac death (SCD) by detecting and treating life-threatening ventricular tachycardia/fibrillation (VT/VF). Recently, two large studies evaluating WCDs were published. However, the results of older and newer studies have yet to be systematically summarized. The objective of the current study was to conduct a meta-analysis assessing the use and effectiveness of WCDs. We searched MEDLINE and Scopus (January 1998-July 2017) as well as the gray literature. We included registry/observational studies that (1) evaluated adult patients using WCDs; (2) provided data on one or more outcomes of interest; and (3) were full-text studies published in English. We calculated pooled incidence and/or rate [with 95% confidence intervals (CIs)] estimates from nonoverlapping populations using a random-effects meta-analysis model. Statistical heterogeneity was assessed via the I2 statistic. We identified 11 studies (19,882 patients) with nonoverlapping populations/endpoints; seven of them evaluated WCD use across various indications, while the remaining studies restricted their focus to a single indication. Most of the studies were retrospective (82%) and multicenter (64%) in nature, with 45% using manufacturers' registry data. The median duration of WCD use was three or more months in nine (82%) studies, and daily wear time ranged from a mean/median of 17 hours to 24 hours per day across included studies. Seven (64%) studies reported a mean/median daily wear time of more than 20 hours. This meta-analysis showed that the incidences of all-cause and SCD-related mortality among WCD patients were 1.4% (95% CI: 0.7%-2.4%) and 0.2% (95% CI: 0.1%-0.3%), respectively. VT/VF occurred in 2.6% (95% CI: 1.8%-3.5%) of patients. Across patients, 1.7% (95% CI: 1.4%-2.0%) received appropriate WCD treatment, corresponding to a rate of 9.1 patients/100 person-years (95% CI: 6.2-11.9 patients/100 person-years). Successful VT/VF termination following appropriate treatment occurred in 95.5% of patients (95% CI: 92.0%-98.0%) and the incidence of inappropriate treatment was infrequent (0.9%; 95% CI: 0.5%-1.4%). A moderate-to-high degree of statistical heterogeneity was observed in pooled analyses of mortality, VT/VF occurrence, and appropriate/inappropriate treatment (I2 ≥ 41% for all). In conclusion, WCDs appear to be successful in terms of terminating VT/VF in patients with an elevated risk of SCD and are appropriate for use while long-term risk management strategies are being identified.

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

Association of Implantable Cardioverter Defibrillators With Survival in Patients With and Without Improved Ejection Fraction: Secondary Analysis of the Sudden Cardiac Death in Heart Failure Trial.

Publications

Association of Implantable Cardioverter Defibrillators With Survival in Patients With and Without Improved Ejection Fraction: Secondary Analysis of the Sudden Cardiac Death in Heart Failure Trial.

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