Evidence map›Paper›PMID 23868932›Full record

Trial reportEuropean heart journal2014

Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial.

Gerhard Hindricks, Christian Elsner, Christopher Piorkowski, Milos Taborsky, Jan Christoph Geller, Burghard Schumacher, Jan Bytesnik, Hans Kottkamp

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 NCT00401466 (Remote Follow-up for ICD-Therapy in Patients Meeting MADIT II Criteria), which is not on this map. Cited by 41 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
41citing papers in PubMed, 2 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.

NCT00401466 phase4completednot on this map

Remote Follow-up for ICD-Therapy in Patients Meeting MADIT II Criteria (REFORM)

TypeinterventionalSponsorBiotronik SE & Co. KGRan2004 to 2008Enrolled155ConditionsVentricular Fibrillation, Ventricular TachycardiaArmsImplantable Cardioverter Defibrillator
3 · Its place in the literature

Who cites it

41 citing papers in PubMed, 2 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. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Home monitoring of implantable cardioverter-defibrillators: interpretation reliability of the second-generation "IEGM Online" system.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 · 2015
    Trial
  9. Trial
  10. Review
  11. The digital journey: 25 years of digital development in electrophysiology from an Europace perspective.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
    Review
  12. 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
  13. Article
  14. 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
  15. Review
  16. Review
  17. Article
  18. Big Data in electrophysiology.Herzschrittmachertherapie & Elektrophysiologie · 2022
    Review
  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

8 authors.

Gerhard HindricksInternal Medicine and Cardiology Division, University of Leipzig Heart Center, Strümpellstrasse 39, Leipzig D-04289, Germany.
Christian Elsner
Christopher Piorkowski
Milos Taborsky
Jan Christoph Geller
Burghard Schumacher
Jan Bytesnik
Hans Kottkamp

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe rapidly increasing number of patients with implantable cardioverter-defibrillators (ICD) places a large burden on follow-up providers. This study investigated the possibility of longer in-office follow-up intervals in primary prevention ICD patients under remote monitoring with automatic daily data transmissions from the implant memory. METHODS AND

resultsConducted in 155 ICD recipients with MADIT II indications, the study compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (SF-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals in the period between 3 and 27 months after implantation. Remote monitoring (Biotronik Home Monitoring) was used equally in all patients. In contrast to previous clinical studies, no calendar-based remote data checks were performed between scheduled in-office visits. Compared with the 3-month follow-up interval, the 12-month interval resulted in a minor increase in the number of unscheduled follow-ups (0.64 vs. 0.27 per patient-year; P = 0.03) and in a major reduction in the total number of in-office ICD follow-ups (1.60 vs. 3.85 per patient-year; P < 0.001). No significant difference was found in mortality, hospitalization rate, or hospitalization length during the 2-year observation period, but more patients were lost to follow-up in the 12-month group (10 vs. 3; P = 0.04). The SF-36 scores favoured the 12-month intervals in the domains 'social functioning' and 'mental health'.

conclusionIn prophylactic ICD recipients under automatic daily remote monitoring, the extension of the 3-month in-office follow-up interval to 12 months appeared to safely reduce the ICD follow-up burden during 27 months after implantation. CLINICALTRIALSGOV IDENTIFIER: NCT00401466 (http://www.clinicaltrials.gov/ct2/show/NCT00401466).

Indexed as

Defibrillators, ImplantableArrhythmias, CardiacFemaleFollow-Up StudiesHeart FailureHome Care ServicesHospitalizationHumansMaleMiddle AgedMonitoring, AmbulatoryMyocardial InfarctionOffice VisitsQuality of LifeRemote ConsultationTime FactorsImplantable defibrillatorOffice visitsPatient scheduleQuality of lifeRemote sensing technologyTelemedicine

Identifiers

PMID23868932
PMCPMC3882723

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.