Evidence map›Paper›PMID 32342703›Full record

Trial reportCirculation. Arrhythmia and electrophysiology2020

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 and 10 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Circulation. Arrhythmia and electrophysiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01523704 (Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up Via Home Monitoring vs. Conventional In-Office Follow-up), which is not on this map. Cited by 37 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01523704 nacompletednot on this map

Comparison of the Safety and Efficacy of the Management of Pacemaker Patients Followed-up Via Home Monitoring vs. Conventional In-Office Follow-up

TypeinterventionalSponsorBiotronik Japan, Inc.Ran2012 to 2016Enrolled1,327ConditionsBradyarrhythmiaArmsBIOTRONIK Home Monitoring System, BIOTRONIK Home Monitoring System with In-office Follow-up
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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  15. Heart rhythm management optimisation of pacemaker recipients using remote monitoring: the HERO registry.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Eiichi WatanabeDepartment of Cardiology, Fujita Health University School of Medicine, Aichi (E.W.).
Fumio YamazakiDepartment of Cardiovascular Surgery, Shizuoka City Shizuoka Hospital (F.Y.).
Toshihiko GotoDepartment of Cardiology, Nagoya City University Hospital (T.G.), Aichi, Japan.
Toru AsaiDepartment of Cardiology, Ichinomiya Municipal Hospital (T. Asai), Aichi, Japan.
Toshihiko YamamotoDepartment of Cardiology, Handa City Hospital (T. Yamamoto), Aichi, Japan.
Keiji HirookaDepartment of Cardiology, National Hospital Organization Osaka National Hospital (K.H.), Tokyo, Japan.
Toshiaki SatoDepartment of Cardiology, Kyorin University Hospital (T.S.), Tokyo, Japan.
Atsunobu KasaiDepartment of Cardiology, Japanese Red Cross Ise Hospital, Mie (A.K.).
Marehiko UedaDepartment of Cardiology, Chiba University Hospital (M.U.), Tokyo, Japan.
Takeshi YamakawaDepartment of Cardiology, Teikyo University Hospital (T. Yamakawa), Tokyo, Japan.
Yasunori UedaDepartment of Cardiology, Osaka Police Hospital, Japan (Y.U.).
Katsuhito YamamotoDepartment of Cardiology, Kochi Health Sciences Center, Japan (K.Y.).
Takeshi TokunagaDepartment of Cardiology, JA Toride Medical Ctr, Ibaraki, Japan (T.T.).
Yoshinao SugaiDepartment of Cardiology, Hiraka General Hospital, Akita, Japan (Y.S.).
Kazuhiko TanakaDepartment of Cardiology, Kasukabe Chuo General Hospital, Saitama, Japan (K.T.).
Shigeki HiramatsuDepartment of Cardiology, Fukuyama Cardiovascular Hospital, Hiroshima, Japan (S.H.).
Tomoharu ArakawaDepartment of Cardiology, Daido Hospital, Aichi, Japan (T. Arakawa).
Jürgen SchraderBiotronik, Berlin, Germany (J.S.).
Niraj VarmaCleveland Clinic, Heart & Vascular Institute, OH (N.V.).
Kenji AndoDepartment of Cardiology, Kokura Memorial Hospital, Fukuoka, Japan (K.A.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrent 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.

methodsIn 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.

resultsOf 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 (

conclusionsReplacing 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.

Indexed as

Cardiac Pacing, ArtificialHeart RateOffice VisitsPacemaker, ArtificialAction PotentialsAgedAged, 80 and overArrhythmias, CardiacEquipment DesignFemaleHeart Conduction SystemHumansJapanMaleMiddle AgedPredictive Value of TestsconsensusinsuranceJapanpacemakerstroke

Identifiers

PMID32342703
PMCPMC7237026

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.