Cardiovascular implantable electronic device lead safety: Harnessing real-world remote monitoring data for medical device evaluation

Caughron, Hope; Bowman, Hilary; Raitt, Merritt H.; Whooley, Mary A.; Tarasovsky, Gary; Shen, Hui; Matheny, Michael E.; Selzman, Kimberly A.; Wang, Li; Puigbo, Jacqueline; Odobasic, Hetal; Dhruva, Sanket S.

doi:10.1016/j.hrthm.2022.12.033

Cited by 3 publications

(1 citation statement)

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“…Previous studies have shown that remote device monitoring is safe; it decreases unnecessary outpatient visits and increases patient satisfaction [1][2][3][4][5][6]. There has been a substantial increase in remote monitoring (RM) after the coronavirus disease 2019 (COVID-19) pandemic in many countries [7][8][9][10].…”

Section: Introductionmentioning

confidence: 99%

The first pilot study on remote monitoring of implantable cardiac electronic devices in South Korea: rationale and study protocol of a REMOTE-CARE

Hwang

Bae

2023

Preprint

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Background: Previous studies have demonstrated that remote cardiac device monitoring reduces unnecessary outpatient visits and increases patient satisfaction. As domestic research on remote monitoring in Korea is lacking, there is a need for more evidence in order to develop remote monitoring-related policies or insurance standards. Based on our previous research on patient requirements for remote monitoring, we designed the first Korean study on remote cardiac device monitoring, including a 1-year follow-up period, to examine the patient satisfaction, medical safety, and efficacy of remote monitoring. Methods: The REMOTE-CARE study is a single university hospital observational survey study that will include 100 cardiac implantable electronic devices, including pacemakers (PMs), implantable cardioverter defibrillators (ICD), and cardiac resynchronisation therapy (CRT), compatible with the Biotronik Home Monitoring system. All study participants will be provided CardioMessenger Smart for remote monitoring during enrolment. Regular in-office visits will be planned every 6–12 months for patients with PM and every 3–6 months for those with ICD and those undergoing CRT. The time/medical cost efficacy and satisfaction index will be evaluated using electronic medical records during the 12-month follow-up period. Pre- and post-questionnaires will be administered before and at 1 year after remote monitoring, respectively. Discussion: The REMOTE-CARE study is the first prospective study to provide further insights on domestic remote monitoring applications based on patient perspectives in South Korea. The study will also provide evidence for developing policy or insurance standards for remote monitoring in Korea. Registration: The REMOTE-CARE study is registered at ClinicalTrials.gov with study ID NCT04557111. This study was approved by the Institutional Review Board (IRB) of the Catholic University of Korea St. Vincent’s Hospital (Suwon, South Korea; IRB No. VC20DISF0160).

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