Remote Management of Pacemaker Patients with Biennial In-clinic Evaluation: Continuous Home Monitoring in the Japanese At Home Study - A Randomized Clinical Trial.

Background 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 two years. Methods - In Japan, consecutive pacemaker patients committed to RM were randomized to either RFU or conventional in-office follow-up (CFU) at twice-yearly intervals. RFU patients were only seen if indicated by remote monitoring. All returned to hospital after two years. The primary endpoint was a composite of death, stroke, or cardiovascular events requiring surgery, and the primary hypothesis was non-inferiority with 5% margin. Results - Of 1274 randomized patients (50.4% female, age 77+/-10 years), 558 (RFU) and 550 (CFU) patients reached either the primary endpoint or 24 months follow-up. The primary endpoint occurred in 10.9% and 11.8%, resp. (P=0.0012 for non-inferiority). The median (IQR) number of in-office follow-ups was 0.50 (0.50 - 0.63) in RFU and 2.01 (1.93 - 2.05) in CFU 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 CFU (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 RM does not increase the occurrence of major cardiovascular events and reduces resource consumption. Clinical Trial Registration - The trial was registered at https://clinicaltrials.gov; Unique Identifier: NCT01523704.