Key result
Remote pacemaker follow-up is noninferior to in-office visits for major clinical events.
Why the study?
Expert consensus recommends CIED remote monitoring with at least annual in-office visits, but the safety and resource consumption of exclusive remote follow-up for 2 years were unknown.
Does remote follow-up with biennial in-clinic evaluation reduce resource consumption without increasing major cardiovascular events in pacemaker patients compared to conventional 6-monthly in-office follow-up?
RCT (n=1,274)
Open-label
1:1 centralized, concealed randomization stratified by site
Yes
Does remote follow-up with biennial in-clinic evaluation reduce resource consumption without increasing major cardiovascular events in pacemaker patients compared to conventional 6-monthly in-office follow-up?
Absolute Event Rate: 10.9% vs 11.8%
p-value: p=0.0012 for noninferiority
Exclusive remote follow-up for 2 years in pacemaker patients is non-inferior to conventional in-office follow-up for major cardiovascular events and significantly reduces healthcare resource consumption.
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Exclusive remote follow-up may safely replace annual in-office visits in pacemaker patients; challenges consensus requiring at least yearly in-person evaluation.
Watanabe et al. (2020) conducted an RCT in Pacemaker patients (n=1,274). Remote follow-up (RFU) vs. Conventional in-office follow-up (CFU) was evaluated on Composite of death, stroke, or cardiovascular surgical procedure (p=0.0012 for noninferiority). Replacing periodic in-office follow-ups with remote follow-ups for 2 years in pacemaker patients was noninferior for the composite of death, stroke, or cardiovascular surgery (10.9% vs 11.8%, p=0.0012 for noninferiority).
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