Dataset Information

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial.

ABSTRACT:

Aims

In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups.

Methods

Patients with LVEF???35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n?=?274) or CRT-D (n?=?390) were randomized 1:1 to telemonitoring or no telemonitoring for 12 months. Primary outcome measure was a composite clinical score, classified as worsened if the patient died or had heart failure-related hospitalization, worse NYHA class, or a worse self-reported overall condition.

Results

The prevalence of worsened score at study end was higher in CRT-D than ICD patients (26.4% vs. 18.2%; P?=?0.014), as was mortality (7.4% vs. 4.1%; P?=?0.069). With telemonitoring, odds ratios (OR) for worsened score and hazard ratios (HR) for mortality were similar in the ICD [OR?=?0.55 (P?=?0.058), HR?=?0.39 (P?=?0.17)] and CRT-D [OR?=?0.68 (P?=?0.10), HR?=?0.35 (P?=?0.018)] subgroups (insignificant interaction, P?=?0.58-0.91).

Conclusion

Daily multiparameter telemonitoring has a potential to reduce clinical endpoints in patients with chronic systolic heart failure both in ICD and CRT-D subgroups. The absolute benefit seems to be higher in higher-risk populations with worse prognosis.

SUBMITTER: Geller JC

PROVIDER: S-EPMC6753058 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial.

Geller Johann Christoph JC Lewalter Thorsten T Bruun Niels Eske NE Taborsky Milos M Bode Frank F Nielsen Jens Cosedis JC Stellbrink Christoph C Schön Steffen S Mühling Holger H Oswald Hanno H Reif Sebastian S Kääb Stefan S Illes Peter P Proff Jochen J Dagres Nikolaos N Hindricks Gerhard G

Clinical research in cardiology : official journal of the German Cardiac Society 20190314 10

<h4>Aims</h4>In the IN-TIME trial, automatic daily implant-based multiparameter telemonitoring significantly improved clinical outcomes in patients with chronic systolic heart failure and implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). We compared IN-TIME results for ICD and CRT-D subgroups.<h4>Methods</h4>Patients with LVEF ≤ 35%, NYHA class II/III, optimized drug treatment, no permanent atrial fibrillation, and a dual-chamber ICD (n = 27 ...[more]

PMID: 30874886

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Project description:ImportanceCardiac resynchronization therapy (CRT) provides significant reduction in morbidity and mortality in select patients with left ventricular systolic dysfunction and specific parameters of electrocardiographic evidence of dyssynchrony. Relative to the 2012 American College of Cardiology/American Heart Association/Heart Rhythm Society guideline update for patient selection, little is known about the contemporary use of CRT in the United States.ObjectiveTo describe the use of CRT defibrillator (CRT-D) in the period around guideline revision.Design, setting, and participantsAll patients undergoing new CRT-D implantations in the National Cardiovascular Data Registry for implantable cardioverter-defibrillators from January 1, 2012, to December 31, 2015, at 1710 participating hospitals were identified for this population-based study. Rates of CRT-D implantation that were concordant and discordant with the 2012 American College of Cardiology/American Heart Association/Heart Rhythm Society update of the 2008 guidelines for device-based therapy were determined. Analysis began in January 2012.Main outcomes and measuresIncrease in guideline-concordant CRT-D implantation.ResultsAmong 135 253 patients undergoing initial CRT-D implantation, 88 923 were included in the study cohort, of which 73 859 implants (83.1%) were guideline concordant. The proportion of guideline-concordant devices increased from 81.2% (16 710 of 20 481) in 2012 to 84.2% (20 515 of 24 356) in 2015 (P for trend < .001). Significant clustering was noted with 33% (565 of 1710) of hospitals accounting for greater than 70% (10 545 of 15 065) of guideline-discordant CRT-D implants. Conduction abnormalities, in particular, underlying right bundle branch block (3597 [23.9%] vs 7425 [10.1%]; P < .001) and nonspecific intraventricular conduction delay (3341 [22.2%] vs 4769 [6.5%]; P < .001) were more common in those who received guideline-discordant devices.Conclusions and relevanceRates of guideline-concordant CRT-D implantation increased during the study. The major fraction of guideline-discordant implants were clustered at a minority of hospitals. Conduction abnormalities, particularly non-left bundle branch block and nonspecific intraventricular conduction delay, correlated with guideline-discordant implants indicating continued opportunity for dissemination and understanding of guideline updates.

Project description:BACKGROUND:Little is known about real-world facility-level preferences for cardiac resynchronization therapy devices with (CRT-D) and without (CRT-P) defibrillator backup. We quantify this variation at the facility level and exploit this variation to compare outcomes of patients receiving these 2 devices. METHODS AND RESULTS:Claims data from fee-for-service Medicare beneficiaries were used to identify new CRT-P and CRT-D implants, 2006 to 2012. We modeled factors associated with receipt of each device, and compared mortality, hospitalizations, and reoperations for patients receiving each using both logistic regression and instrumental variable analysis to account for confounding. Among 71 459 device recipients (CRT-P, 11 925; CRT-D, 59 534; 31% women), CRT-P recipients were older, more likely to be women, and had more comorbidities. Variation in device selection among facilities was substantial: After adjustment for patient characteristics, the odds of receiving a CRT-P (versus CRT-D) device were 7.6× higher for a patient treated at a facility in the highest CRT-P use quartile versus a facility in the lowest CRT-P use quartile. Logistic modeling suggested a survival advantage for CRT-D devices but with falsification end points indicating residual confounding. By contrast, in the instrumental variable analysis using facility variability as the proposed instrument, clinical characteristics and falsification end points were well balanced, and 1-year mortality in patients who received CRT-P versus CRT-D implants did not differ, while CRT-P patients had a lower probability of hospitalizations and reoperations in the year following implant. CONCLUSIONS:CRT-P versus CRT-D selection varies substantially among facilities, adjusted for clinical factors. After instrumental variable adjustment for clinical covariates and facility preference, survival was no different between the devices. Therefore, CRT-P may be preferred for Medicare beneficiaries considering new CRT implantation.

Dataset Information

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial.

Aims

Methods

Results

Conclusion

Publications

Implant-based multi-parameter telemonitoring of patients with heart failure and a defibrillator with vs. without cardiac resynchronization therapy option: a subanalysis of the IN-TIME trial.

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