Exclusive remote follow-up for 2 years was noninferior to conventional in-office follow-up for death, stroke, or cardiovascular events requiring surgery (10.9% vs 11.8%; P=0.0012 for noninferiority).
RCT (n=1,274)
randomized
Does exclusive remote follow-up for 2 years reduce resource consumption without increasing major cardiovascular events in pacemaker patients compared to conventional in-office follow-up?
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 resource consumption.
Absolute Event Rate: 10.9% vs 11.8%
p-value: p=0.0012 for noninferiority
Background: Current expert consensus recommends remote monitoring for cardiac implantable electronic devices, with at least annual in-office follow-up. We studied safety and resource consumption of exclusive remote follow-up (RFU) in pacemaker patients for 2 years. Methods: In Japan, consecutive pacemaker patients committed to remote monitoring were randomized to either RFU or conventional in-office follow-up (conventional follow-up) at twice yearly intervals. RFU patients were only seen if indicated by remote monitoring. All returned to hospital after 2 years. The primary end point was a composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was noninferiority with 5% margin. Results: Of 1274 randomized patients (50.4% female, age 77±10 years), 558 (RFU) and 550 (Conventional follow-up) patients reached either the primary end point or 24 months follow-up. The primary end point occurred in 10.9% and 11.8%, respectively ( P =0.0012 for noninferiority). The median (interquartile range) number of in-office follow-ups was 0.50 (0.50–0.63) in RFU and 2.01 (1.93–2.05) in conventional follow-up per patient-year ( P <0.001). Insurance claims for follow-ups and directly related diagnostic procedures were 18 800 Yen (16 500–20 700 Yen) in RFU and 21 400 Yen (16 700–25 900 Yen) in conventional follow-up ( P <0.001). Only 1.4% of remote follow-ups triggered an unscheduled in-office follow-up, and only 1.5% of scheduled in-office follow-ups were considered actionable. Conclusions: Replacing periodic in-office follow-ups with remote follow-ups for 2 years in pacemaker patients committed to remote monitoring does not increase the occurrence of major cardiovascular events and reduces resource consumption. Registration: URL: https://clinicaltrials.gov ; Unique identifier: NCT01523704.
Watanabe et al. (Tue,) conducted a rct in pacemaker patients (n=1,274). exclusive remote follow-up (RFU) vs. conventional in-office follow-up was evaluated on composite of death, stroke, or cardiovascular events requiring surgery (p=0.0012 for noninferiority). Exclusive remote follow-up for 2 years was noninferior to conventional in-office follow-up for death, stroke, or cardiovascular events requiring surgery (10.9% vs 11.8%; P=0.0012 for noninferiority).