Remote Management of Pacemaker Patients With Biennial In-Clinic Evaluation

Author:

Watanabe Eiichi1ORCID,Yamazaki Fumio2,Goto Toshihiko3,Asai Toru4,Yamamoto Toshihiko5,Hirooka Keiji6,Sato Toshiaki7,Kasai Atsunobu8,Ueda Marehiko9,Yamakawa Takeshi10,Ueda Yasunori11,Yamamoto Katsuhito12,Tokunaga Takeshi13,Sugai Yoshinao14,Tanaka Kazuhiko15,Hiramatsu Shigeki16,Arakawa Tomoharu17,Schrader Jürgen18,Varma Niraj19ORCID,Ando Kenji20

Affiliation:

1. Department of Cardiology, Fujita Health University School of Medicine, Aichi (E.W.).

2. Department of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital (F.Y.)

3. Department of Cardiology, Nagoya City University Hospital (T.G.), Aichi, Japan.

4. Department of Cardiology, Ichinomiya Municipal Hospital (T. Asai), Aichi, Japan.

5. Department of Cardiology, Handa City Hospital (T. Yamamoto), Aichi, Japan.

6. Department of Cardiology, National Hospital Organization Osaka National Hospital (K.H.), Tokyo, Japan.

7. Department of Cardiology, Kyorin University Hospital (T.S.), Tokyo, Japan.

8. Department of Cardiology, Japanese Red Cross Ise Hospital, Mie (A.K.).

9. Department of Cardiology, Chiba University Hospital (M.U.), Tokyo, Japan.

10. Department of Cardiology, Teikyo University Hospital (T. Yamakawa), Tokyo, Japan.

11. Department of Cardiology, Osaka Police Hospital, Japan (Y.U.).

12. Department of Cardiology, Kochi Health Sciences Center, Japan (K.Y.).

13. Department of Cardiology, JA Toride Medical Ctr, Ibaraki, Japan (T.T.).

14. Department of Cardiology, Hiraka General Hospital, Akita, Japan (Y.S.).

15. Department of Cardiology, Kasukabe Chuo General Hospital, Saitama, Japan (K.T.).

16. Department of Cardiology, Fukuyama Cardiovascular Hospital, Hiroshima, Japan (S.H.).

17. Department of Cardiology, Daido Hospital, Aichi, Japan (T. Arakawa).

18. Biotronik, Berlin, Germany (J.S.).

19. Cleveland Clinic, Heart & Vascular Institute, OH (N.V.).

20. Department of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan (K.A.).

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://clinicaltrials.gov ; Unique identifier: NCT01523704.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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