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Randomized Controlled Trial
. 2024 Oct 3;26(10):euae233.
doi: 10.1093/europace/euae233.

Comprehensive vs. standard remote monitoring of cardiac resynchronization devices in heart failure patients: results of the ECOST-CRT study

Cédric Klein  1 , Claude Kouakam  1 , Arnaud Lazarus  2 , Pascal de Groote  1 , Christophe Bauters  3 , Eloi Marijon  4 , Frédéric Mouquet  5 , Bruno Degand  6 , Yves Guyomar  7 , Jacques Mansourati  8 , Christophe Leclercq  9 , Laurence Guédon-Moreau  10 ; ECOST-CRT study Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Comprehensive vs. standard remote monitoring of cardiac resynchronization devices in heart failure patients: results of the ECOST-CRT study

Cédric Klein et al. Europace. .

Abstract

Aims: Integrating remote monitoring (RM) into existing healthcare practice for heart failure (HF) patients to improve clinical outcome remains challenging. The ECOST-CRT study compared the clinical outcome of a comprehensive RM scheme including a patient questionnaire capturing signs and symptoms of HF and notifications for HF specific parameters to traditional RM in patients with cardiac resynchronization therapy (CRT) devices.

Methods and results: Patients were randomized 1:1 to standard daily RM (notification for technical parameters and ventricular arrhythmias; control group) or comprehensive RM (adding a monthly symptom questionnaire and notifications for biventricular pacing, premature ventricular contraction, atrial arrhythmias; active group). The primary endpoint was all-cause mortality or hospitalization for worsening HF (WHF). Six hundred fifty-two patients (70.4 ± 10.3 years, 73% men, left ventricular ejection fraction 29.1 ± 7.6%, 68% CRT-Defibrillators, 32% CRT-Pacemakers) were enrolled. The COVID-19 pandemic caused an early termination of the study, so the mean follow-up duration was 18 ± 8 months. No statistically significant difference in the primary endpoint was found between the groups [59 (18.3%) control vs. 77 (23.3%) active group; log-rank test P = 0.13]. Among the secondary endpoints, the MLHF questionnaire showed a larger share of patients with improvement of quality of life compared to baseline in the active group (78%) vs. control (61%; P = 0.03).

Conclusion: The study does not support the notion that comprehensive RM, when compared to standard RM, in HF patients with CRT improves the clinical outcome of all-cause mortality or WHF hospitalizations. However, this study was underpowered due to an early termination and further trials are required.

Registration: Clinical Trials.gov Identifier: NCT03012490.

Keywords: Cardiac resynchronization therapy; Heart failure; Remote monitoring.

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Conflict of interest statement

Conflict of interest: C. Klein received consulting fees from Boston Scientific. L.G.-M. received consulting fees from Boston Scientific and Biotronik, and has grant support from Abbott, Medtronic, Phenix Cardiologie, Microport, and Zoll. A.L. is minor part-time employee of Biotronik France, has participated on a Data Safety Monitoring Board for Biotronik, has stock options from Implicity, and has received support for attending meetings from Boston Scientific France. P.d.G. received consulting fees from Astra Zeneca, Servier, Boehringer Ingelheim, and Bayer, and honoraria from Novartis, Astra Zeneca, Servier, BMS, Vifor, MSD, Boehringer Ingelheim, Bayer, and Pfizer. E.M. received research grants and consulting fees from Medtronic, Abbott, Boston Scientific, Biotronik, Microport, and Zoll. F.M. received consulting fees Newcard, honoraria from Novartis, BMS/Pfizer, Vifor, and Boehringer, and has received support for attending meetings from Boehringer and BMS/Pfizer. B.D. received consulting fees from Boston Scientific, Abbott, and Microport. Y.G. has received support for attending meetings from Biotronik. J.M. received consulting fees from Biotronik, Boston Scientific, Medtronic, and Microport. C.L. received consulting fees and has grant support from Biotronik, Medtronic, and Abbott. C.B. has no conflict of interests.

Figures

Graphical Abstract
Graphical Abstract
CRT, cardiac resynchronization therapy; HF, heart failure; PVC, premature ventricular contraction; RM, remote monitoring; WHF, worsening heart failure.
Figure 1
Figure 1
Design of the ECOST-CRT study.
Figure 2
Figure 2
Workflow for remote monitoring management.
Figure 3
Figure 3
Kaplan–Meier curve for the primary outcomes events in the ITT population. Panel A shows the Kaplan–Meier curves for the primary composite outcome of death from any cause or hospitalization for heart failure. Panel B shows the Kaplan–Meier curves for death from any cause.
Figure 4
Figure 4
Percentage of BiV pacing in class over the study per group. The percentage of BiV pacing daily transmitted by RM was evaluated at each time in the sub-population of patients who had a complete 27-month FU (73 active patients and 80 control patients).
See this image and copyright information in PMC

References

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