Dataset Information

A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.

ABSTRACT:

Aims

The ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD).

Methods and results

The trial's primary objective was to randomly compare the proportions of patients experiencing ? 1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sample of 433 patients. The 221 patients assigned to the active group were seen once a year, unless HM reported an ICD dysfunction or a clinical event requiring an ambulatory visit, while the 212 patients in the control group underwent ambulatory visits every 6 months. The characteristics of the study groups were similar. Over a follow-up of 24.2 months, 38.5% of patients in the active and 41.5% in the control group experienced ? 1 MAE (P < 0.05 for non-inferiority). The overall number of shocks delivered was significantly lower in the active (n = 193) than in the control (n = 657) group (P < 0.05) and the proportion of patients who received inappropriate shocks was 52% lower in the active (n = 11) than in the control (n = 22) group (P < 0.05). At the end of the follow-up, the battery longevity was longer in the active group because of a lower number of capacitor charges (499 vs. 2081).

Conclusion

Our observations indicate that long-term HM of ICD is at least as safe as standard ambulatory follow-ups with respect to a broad spectrum of MAE. It also lowered significantly the number of appropriate and inappropriate shocks delivered, and spared the device battery. Clinical trials registration NCT00989417.

SUBMITTER: Guedon-Moreau L

PROVIDER: S-EPMC3578267 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Publications

A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.

Guédon-Moreau Laurence L Lacroix Dominique D Sadoul Nicolas N Clémenty Jacques J Kouakam Claude C Hermida Jean-Sylvain JS Aliot Etienne E Boursier Michel M Bizeau Olivier O Kacet Salem S

European heart journal 20121213 8

<h4>Aims</h4>The ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD).<h4>Methods and results</h4>The trial's primary objective was to randomly compare the proportions of patients experiencing ≥ 1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sampl ...[more]

PMID: 23242192

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Project description:IntroductionRemote monitoring (RM) technologies have the potential to improve patient care by increasing compliance, providing early indications of heart failure (HF), and potentially allowing for therapy optimization to prevent HF admissions. The aim of this retrospective study was to assess the clinical and economic consequences of RM vs. standard monitoring (SM) through in-office cardiology visits, in patients carrying a cardiac implantable electronic device (CIED).MethodsClinical and resource consumption data were extracted from the Electrophysiology Registry of the Trento Cardiology Unit, which has been systemically collecting patient information from January 2011 to February 2022. From a clinical standpoint, survival analysis was conducted, and incidence of cardiovascular (CV) related hospitalizations was measured. From an economic standpoint, direct costs of RM and SM were collected to compare the cost per treated patient over a 2-year time horizon. Propensity score matching (PSM) was used to reduce the effect of confounding biases and the unbalance of patient characteristics at baseline.ResultsIn the enrollment period, N = 402 CIED patients met the inclusion criteria and were included in the analysis (N = 189 patients followed through SM; N = 213 patients followed through RM). After PSM, comparison was limited to N = 191 patients in each arm. After 2-years follow-up since CIED implantation, mortality rate for any cause was 1.6% in the RM group and 19.9% in the SM group (log-rank test, p < 0.0001). Also, a lower proportion of patients in the RM group (25.1%) were hospitalized for CV-related reasons, compared to the SM group (51.3%; p < 0.0001, two-sample test for proportions). Overall, the implementation of the RM program in the Trento territory was cost-saving in both payer and hospital perspectives. The investment required to fund RM (a fee for service in the payer perspective, and staffing costs for hospitals), was more than offset by the lower rate of hospitalizations for CV-related disease. RM adoption generated savings of -€4,771 and -€6,752 per patient in 2 years, in the payer and hospital perspective, respectively.ConclusionRM of patients carrying CIED improves short-term (2-years) morbidity and mortality risks, compared to SM and reduces direct management costs for both hospitals and healthcare services.

Dataset Information

A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.

Aims

Methods and results

Conclusion

Publications

A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial.

Similar Datasets

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