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

Eiichi Watanabe, Fumio Yamazaki, Toshihiko Goto, Toru Asai, Toshihiko Yamamoto, Keiji Hirooka, Toshiaki Sato, Atsunobu Kasai, Marehiko Ueda, Takeshi Yamakawa, Yasunori Ueda, Katsuhito Yamamoto, Takeshi Tokunaga, Yoshinao Sugai, Kazuhiko Tanaka, Shigeki Hiramatsu, Tomoharu Arakawa, Jürgen Schrader, Niraj Varma, Kenji Ando, Eiichi Watanabe, Fumio Yamazaki, Toshihiko Goto, Toru Asai, Toshihiko Yamamoto, Keiji Hirooka, Toshiaki Sato, Atsunobu Kasai, Marehiko Ueda, Takeshi Yamakawa, Yasunori Ueda, Katsuhito Yamamoto, Takeshi Tokunaga, Yoshinao Sugai, Kazuhiko Tanaka, Shigeki Hiramatsu, Tomoharu Arakawa, Jürgen Schrader, Niraj Varma, Kenji Ando

Abstract

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://ichgcp.net/clinical-trials-registry/NCT01523704" title="See in ClinicalTrials.gov">NCT01523704.

Keywords: Japan; consensus; insurance; pacemaker; stroke.

Figures

Figure 1.
Figure 1.
Trial flowchart. FU indicates follow-up.
Figure 2.
Figure 2.
Kaplan-Meier curves of incidence of primary end points, starting at randomization. CFU indicates conventional follow-up; and RFU, remote follow-up.

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