Remote Monitoring of Cardiac Devices and Clinical Outcomes in Patients with Structural Heart Diseases: Rationale and...

Background/Objectives: Whether remote monitoring reduces mortality in patients with heart failure remains controversial, and research on remote monitoring in South Korea is generally lacking. Therefore, we aim to evaluate the safety and efficacy of remote monitoring for patients in South Korea with severe structural heart diseases who have an implantable cardioverter-defibrillator or cardiac resynchronisation therapy pacemaker/defibrillator. Methods: This ReVe study is a multicentre, prospective, observational cohort study in which we will comprehensively evaluate the impact of remote monitoring on cardiovascular-related death and hospital admissions related to pre-existing cardiovascular disease (primary outcomes) and satisfaction with and cost of remote monitoring and the healthcare provider workload (secondary outcomes). Two patient groups are being recruited: (1) Patients in the historical group (n = 225) already had a cardiac implantable electronic device implanted after January 2020 and have attended outpatient device check-ups. (2) Those in the initiating group (planned n = 225) will undergo cardiac implantable electronic device implantation during this study. In-office visits are scheduled for every 3-6 months. The time/medical cost efficiency and satisfaction index will be evaluated during the 24-month follow-up period. Questionnaires regarding patient satisfaction will be administered every 6 months. Conclusions: This is the first prospective study involving patients with structural heart diseases who have implanted high-power cardiac electronic devices. It will provide insights into remote monitoring applications in South Korea and evidence for their use in such patients. It will also provide evidence of the efficacy, safety, and satisfaction with remote monitoring in this population.