Dataset Information

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

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.

SUBMITTER: Watanabe E

PROVIDER: S-EPMC7237026 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Publications

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

Watanabe Eiichi E Yamazaki Fumio F Goto Toshihiko T Asai Toru T Yamamoto Toshihiko T Hirooka Keiji K Sato Toshiaki T Kasai Atsunobu A Ueda Marehiko M Yamakawa Takeshi T Ueda Yasunori Y Yamamoto Katsuhito K Tokunaga Takeshi T Sugai Yoshinao Y Tanaka Kazuhiko K Hiramatsu Shigeki S Arakawa Tomoharu T Schrader Jürgen J Varma Niraj N Ando Kenji K

Circulation. Arrhythmia and electrophysiology 20200428 5

<h4>Background</h4>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.<h4>Methods</h4>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 ...[more]

PMID: 32342703

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Project description:ImportancePatients will decide whether to adopt remote digital monitoring (RDM) for diabetes by weighing its health benefits against the inconvenience it may cause.ObjectiveTo identify the minimum effectiveness patients report they require to adopt 36 different RDM scenarios.Design, setting, and participantsThis survey study was conducted among adults with type 1 or type 2 diabetes living in 30 countries from February to July 2019.ExposuresSurvey participants assessed 3 randomly selected scenarios from a total of 36. Scenarios described different combinations of digital monitoring tools (glucose, physical activity, food monitoring), duration and feedback loops (feedback in consultation vs real-time telefeedback by a health care professional or by artificial intelligence), and data handling modalities (by a public vs private company), reflecting different degrees of RDM intrusiveness in patients' personal lives.Main outcomes and measuresParticipants assessed the minimum effectiveness for 2 diabetes-related outcomes (reducing hypoglycemic episodes and preventing ophthalmologic complications) for which they would adopt each RDM (from much less effective to much more effective than their current monitoring).ResultsOf 1577 individuals who consented to participate, 1010 (64%; 572 [57%] women, median [interquartile range] age, 51 [37-63] years, 524 [52%] with type 1 diabetes) assessed at least 1 vignette. Overall, 2860 vignette assessments were collected. In 1025 vignette assessments (36%), participants would adopt RDM only if it was much more effective at reducing hypoglycemic episodes compared with their current monitoring; in 1835 assessments (65%), participants would adopt RDM if was just as or somewhat more effective. The main factors associated with required effectiveness were food monitoring (??=?0.32; SE, 0.12; P?=?.009), real-time telefeedback by a health care professional (??=?0.49; SE, 0.15; P?=?.001), and perceived intrusiveness (??=?0.36; SE, 0.06; P?<?.001). Minimum required effectiveness varied among participants; 34 of 36 RDM scenarios (94%) were simultaneously required to be just as or less effective by at least 25% of participants and much more effective by at least 25% of participants. Results were similar for participant assessments of scenarios regarding the prevention of ophthalmologic complications.Conclusions and relevanceThe findings of this study suggest that patients require greater health benefits to adopt more intrusive RDM modalities, food monitoring, and real-time feedback by a health care professional. Patient monitoring devices should be designed to be minimally intrusive. The variability in patients' requirements points to a need for shared decision-making.

Dataset Information

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

Publications

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

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