TY - JOUR
T1 - Remote Management of Pacemaker Patients with Biennial In-Clinic Evaluation
T2 - Continuous Home Monitoring in the Japanese At-Home Study: A Randomized Clinical Trial
AU - Watanabe, Eiichi
AU - Yamazaki, Fumio
AU - Goto, Toshihiko
AU - Asai, Toru
AU - Yamamoto, Toshihiko
AU - Hirooka, Keiji
AU - Sato, Toshiaki
AU - Kasai, Atsunobu
AU - Ueda, Marehiko
AU - Yamakawa, Takeshi
AU - Ueda, Yasunori
AU - Yamamoto, Katsuhito
AU - Tokunaga, Takeshi
AU - Sugai, Yoshinao
AU - Tanaka, Kazuhiko
AU - Hiramatsu, Shigeki
AU - Arakawa, Tomoharu
AU - Schrader, Jürgen
AU - Varma, Niraj
AU - Ando, Kenji
N1 - Funding Information:
This work was supported by Biotronik Japan, Inc (Tokyo, Japan). Dr Watanabe designed the protocol with the sponsor. The sponsor managed the trial and performed the analysis. We take full responsibility for the result and the decision to submit the article.
Funding Information:
Dr Watanabe has received research grants from Abbott, Biotronik, Boston Sc., Daiichi-Sankyo, Medtronic and Nihon Koden and speaker fees from Boehringer Ingelheim, Daiichi-Sankyo, Eisai, and Pfizer. Drs Yamazaki, T. Yamamoto, Sato, Kasai, Yamakawa, Y. Ueda, K. Yamamoto, Tokunaga, Tanaka, and Asai have received research grants from Biotronik. Drs Goto, Hirooka, M. Ueda, Sugai, and Hiramatsu have received research grants and traveling support from Biotronik. Dr Arakawa has received research grants, travelling support and speakers feed from Biotronik. Dr Schrader is an employee of Biotronik. Dr Varma has received consultancy fees from Abbott, Biotronik, and Medtronic and lecture fees from Abbott and Biotronik. Dr Ando has received research grants from Biotronik, consultancy fees from Boston Sc., Japan Lifeline and Terumo, and speaker fees from Biotronik and Medtronic.
PY - 2020/5/1
Y1 - 2020/5/1
N2 - 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.
AB - 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.
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U2 - 10.1161/CIRCEP.119.007734
DO - 10.1161/CIRCEP.119.007734
M3 - Article
C2 - 32342703
AN - SCOPUS:85084941524
VL - 13
JO - Circulation: Arrhythmia and Electrophysiology
JF - Circulation: Arrhythmia and Electrophysiology
SN - 1941-3149
IS - 5
ER -