Expert Consensus Statement: Committee on Implantable Devices and Committee on Social Issues, Japanese Heart Rhythm Society ( JHRS ) Statement on Remote Monitoring of Cardiac Implantable Electronic Devices

Figures

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  FIGURE 1. TRUST Study (number of office visits) Patients with ICDs were randomized to the ambulatory treatment group (conventional) and RM group at the ratio of 1:2. Device data were automatically transmitted every day in the RM group, while patients in the ambulatory treatment group were examined in person 4 times a year. Both the number of scheduled visits and the number of unscheduled visits decreased by around 50% in the RM group compared to the ambulatory treatment group. HM: Home monitoring [NB: HM (Remote Home Monitoring) is a trademark of Biotronik Company. It is referred to as HM in figures in Literature 4. Functionally, it is synonymous with RM.] [Extracted from Literature 4].

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  FIGURE 2. TRUST Study (Number of days from detection of arrhythmia events to intervention) The number of days from the detection of initial atrial fibrillation, ventricular tachycardia, and ventricular fibrillation to medical intervention (All in the figure) was significantly reduced in the RM group compared to the ambulatory treatment group (median: 1 day vs. 35.5 days, p < 0.001). In addition, asymptomatic arrhythmia events (initial atrial fibrillation, ventricular tachycardia, ventricular fibrillation, and supraventricular tachycardia) (Silent in the figure) were significantly shortened in the RM group compared to the ambulatory treatment group (median: 1 day vs. 41.5 days, p < 0.001). Refer to Figure 1 for abbreviations. [Extracted from Literature 4].

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  FIGURE 3. IN‐TIME study The IN‐TIME study enrolled chronic heart failure patients of NYHA class II to III with an ejection fraction of ≤ 35% who recently had a dual chamber ICD or CRT‐D implanted. Patients were randomized into a control group given the standard treatment and an intervention group given the standard treatment plus RM at a ratio of 1:1 and followed up to 12 months. The primary endpoint was a composite clinical score that combined all‐cause deaths, admission of 1 day or longer due to heart failure, changes in NYHA class, and overall assessment by patients themselves. Data were submitted to intention‐to‐treat analysis. Daily RM showed significant improvement of clinical outcome in heart failure patients. [Extracted from Literature 10].

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  FIGURE 4. Work needed when introducing a remote monitoring system and after obtaining informed consent. This schematic illustrates the workflow required for implementation of a remote monitoring (RM) system, including patient education prior to initiation and operational procedures after informed consent. Key steps include explanation of system functions, transmitter setup, patient enrollment, and scheduling of RM data transmission.

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  FIGURE 5. Actions to be taken after introduction of remote monitoring system. This schematic illustrates the interaction among patients, healthcare providers, and device manufacturers after RM initiation. Data transmitted from cardiovascular implantable electronic devices (CIEDs) are analyzed at the medical institution, while manufacturers maintain secure data servers and provide technical support to ensure stable system operation.

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  FIGURE 6. Roles of remote monitoring management team members from different professions. This diagram illustrates the roles of healthcare professionals involved in RM management. Physicians provide clinical oversight and final decision‐making, whereas allied professionals conduct data analysis, alert management, and patient education. Administrative staff support operational tasks such as scheduling and documentation.

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  FIGURE 7. Examples of patient management by remote monitoring. In case RM is started after CIED implantation—(A) In‐person consultation twice a year while continuing RM every month (in persons with implanted pacemakers for instance); (B) In‐person consultations once a year while continuing RM every month (in persons requiring ILR or heart failure management for instance); (C) In‐person consultations once a year with RM 3 times a year; (D) The medical institution may contact the patient when the alert is activated or the patient may contact the medical institution by pushing the patient's button on the management device; (E) Alert‐based monitoring with an in‐person consultation once a year and response only when the alert is activated (in stable persons with an implanted pacemaker for instance).

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  FIGURE 8. Remote monitoring involving third parties (example). This schematic illustrates an RM architecture incorporating third‐party data management systems. Device data transmitted from patients with CIEDs are stored on manufacturer‐managed servers and subsequently integrated into hospital electronic medical records through data‐visualization platforms, enabling unified data management across device manufacturers.

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  FIGURE 9. Attendance of medical device manufacturers. This figure shows representative documents used to confirm manufacturer attendance for ensuring appropriate use of medical devices. Such documentation supports regulatory compliance, transparency, and appropriate technical assistance during device‐related procedures or training activities.