Evidence map›Paper›PMID 24595864›Full record

Trial reportEuropean heart journal2014

Superiority of automatic remote monitoring compared with in-person evaluation for scheduled ICD follow-up in the TRUST trial - testing execution of the recommendations.

Niraj Varma, Justin Michalski, Bruce Stambler, Behzad B Pavri, TRUST Investigators

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

Trial report in European heart journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00336284 (TRUST), which is not on this map. Cited by 41 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing 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.

NCT00336284 phase4completednot on this map

TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

TypeinterventionalSponsorBiotronik, Inc.Ran2005 to 2009Enrolled1,450ConditionsPatient Indicated for an ICDArmsHome Monitoring, In-Office Conventional Follow-up
3 · Its place in the literature

Who cites it

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

  1. Knowledge Update on the Economic Evaluation of Pacemaker Telemonitoring Systems.International journal of environmental research and public health · 2021
    Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Trial
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  9. Trial
  10. Article
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  12. Review
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  15. Article
  16. Remote monitoring of cardiac implantable electronic devices and disease management.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
    Article
  17. Article
  18. 2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2023
    Article
  19. Review
  20. Article
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

5 authors.

Niraj VarmaJ2-2 Cardiac Pacing and Electrophysiology, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA varman@ccf.org.
Justin MichalskiBiotronik, 6024 Jean Road, Lake Oswego, OR 97035-5571, USA.
Bruce StamblerCase Medical Center, 11100 Euclid Avenue, Cleveland, OH 44106, USA.
Behzad B PavriJefferson Hospital, 111 South 11th Street, Philadelphia, PA 19107, USA.
TRUST Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo test recommended implantable cardioverter defibrillator (ICD) follow-up methods by 'in-person evaluations' (IPE) vs. 'remote Home Monitoring' (HM). METHODS AND

resultsICD patients were randomized 2:1 to automatic HM or to Conventional monitoring, with follow-up checks scheduled at 3, 6, 9, 12, and 15 months post-implant. Conventional patients were evaluated with IPE only. Home Monitoring patients were assessed remotely only for 1 year between 3 and 15 month evaluations. Adherence to follow-up was measured. HM and Conventional patients were similar (age 63 years, 72% male, left ventricular ejection fraction 29%, primary prevention 73%, DDD 57%). Conventional management suffered greater patient attrition during the trial (20.1 vs. 14.2% in HM, P = 0.007). Three month follow-up occurred in 84% in both groups. There was 100% adherence (5 of 5 checks) in 47.3% Conventional vs. 59.7% HM (P < 0.001). Between 3 and 15 months, HM exhibited superior (2.2×) adherence to scheduled follow-up [incidence of failed follow up was 146 of 2421 (6.0%) in HM vs. 145 of 1098 (13.2%) in Conventional, P < 0.001] and punctuality. In HM (daily transmission success rate median 91%), transmission loss caused only 22 of 2275 (0.97%) failed HM evaluations between 3 and 15 months; others resulted from clinic oversight. Overall IPE failure rate in Conventional [193 of 1841 (10.5%) exceeded that in HM [97 of 1484 (6.5%), P < 0.001] by 62%, i.e. HM patients remained more loyal to IPE when this was mandated.

conclusionAutomatic remote monitoring better preserves patient retention and adherence to scheduled follow-up compared with IPE. CLINICAL

trial registrationNCT00336284.

Indexed as

Defibrillators, ImplantableCoronary Artery DiseaseFemaleHome Care ServicesHumansMaleMiddle AgedMonitoring, AmbulatoryMyocardial IschemiaPatient ComplianceProspective StudiesRemote ConsultationDefibrillatorsFollow-upPatient monitoringRemote Monitoring' Guidelines

Identifiers

PMID24595864
PMCPMC4028610

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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.