Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation: Continuous Home Monitoring in the...

Area of Science:

• Cardiology
• Medical Device Technology
• Health Economics

Background:

• Current guidelines recommend annual in-office follow-ups for cardiac implantable electronic devices.
• This study investigated the safety and resource implications of exclusive remote follow-up (RFU) for pacemaker patients over two years.

Purpose of the Study:

• To evaluate the safety and resource consumption of exclusive remote follow-up (RFU) compared to conventional in-office follow-up in pacemaker patients.
• To determine if RFU is non-inferior to conventional follow-up regarding major adverse cardiovascular events.

Main Methods:

• A randomized controlled trial in Japan involving pacemaker patients committed to remote monitoring.
• Patients were randomized to either RFU or conventional in-office follow-up (twice yearly).
• The primary endpoint was a composite of death, stroke, or cardiovascular events requiring surgery over two years.

Main Results:

• The primary endpoint occurred in 10.9% of RFU patients and 11.8% of conventional follow-up patients, demonstrating non-inferiority (P=0.0012).
• RFU significantly reduced in-office follow-ups (0.50 vs. 2.01 per patient-year, P<0.001) and associated healthcare costs.
• Only 1.4% of remote follow-ups triggered unscheduled in-office visits, and 1.5% of scheduled visits were actionable.

Conclusions:

• Replacing periodic in-office follow-ups with RFU for pacemaker patients is safe and does not increase major cardiovascular events.
• Exclusive RFU significantly reduces resource consumption and healthcare costs.
• This study supports the adoption of remote monitoring as a primary follow-up strategy for pacemaker patients.