Evidence map›Paper›PMID 25567067›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2015

Home monitoring of implantable cardioverter-defibrillators: interpretation reliability of the second-generation "IEGM Online" system.

Herbert Nägele, Jolana Lipoldová, Hanno Oswald, Gunnar Klein, Arif Elvan, Ernst Vester, Wolfgang Bauer, Hansjürgen Bondke, Sebastian Reif, Claudia Daub and 3 more

Abstract readClinical Trial
In one paragraph

Trial report in 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. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Remote monitoring of implantable cardioverter-defibrillators and resynchronization devices to improve patient outcomes: dead end or way ahead?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 · 2019
    Review
  4. Active periodic electrograms in remote monitoring of pacemaker recipients: the PREMS study.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 · 2019
    Observational
  5. Article
  6. 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

13 authors.

Herbert NägeleMedical Clinic, Hospital Reinbek St. Adolf Stift, Reinbek, Germany herbert.naegele@albertinen.de.
Jolana LipoldováSt. Anne's University Hospital and International Clinical Research Center, Brno, Czech Republic.
Hanno OswaldHannover Medical School, Hannover, Germany.
Gunnar KleinHannover Medical School, Hannover, Germany.
Arif ElvanDepartment of Cardiology, Isala Klinieken, Zwolle, The Netherlands.
Ernst VesterEvangelisches Krankenhaus, Düsseldorf, Germany.
Wolfgang BauerDepartment of Internal Medicine I and Comprehensive Heart Failure Centre, University Hospital Würzburg, Würzburg, Germany.
Hansjürgen BondkeCharité - University Medicine Berlin, Campus Charité Mitte, Berlin, Germany.
Sebastian ReifDepartment of Cardiology, Städtisches Klinikum München-Bogenhausen, Munich, Germany.
Claudia DaubElisabeth-Krankenhaus, Recklinghausen, Germany.
Frank MenzelKlinikum Frankfurt (Oder), Frankfurt (Oder), Germany.
Jürgen SchraderBiotronik SE and Co. KG, Berlin, Germany.
Göran ZachDepartment of Internal Medicine, LKH Bruck an der Mur, Bruck an der Mur, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsIntracardiac electrograms (IEGMs) are essential for the assessment of implantable cardioverter-defibrillator (ICD) function. The Biotronik Home Monitoring systems transmit an 'IEGM Online' that is shorter than the full-length programmer IEGM due to technical constrains. The aim of this study was to evaluate the accuracy of the physician's classification of the underlying rhythm based on the second-generation IEGM Online. METHODS AND

resultsIn total, 1533 patients treated with single- and dual-chamber ICDs and cardiac resynchronization therapy defibrillators were enrolled at 67 investigational sites and followed for 15 months. The investigators classified the rhythm shown in IEGM Online as ventricular tachycardia, ventricular fibrillation, atrial fibrillation, other supraventricular tachyarrhythmia, oversensing due to lead failure, T-wave oversensing, or other rhythm. At the next in-office follow-up, the investigators classified independently the rhythm seen in the corresponding programmer IEGM. The two rhythm classifications were compared thereafter. Both IEGM Online and programmer IEGM were available in 2099 arrhythmic or oversensing events, of which 146 (7.0%) were classified as other rhythm or artefacts and were excluded as inconclusive or atypical. The remaining 1953 events, affecting 352 patients (23.0%), were classified correctly in 1803 cases (92.3%). The accuracy of rough rhythm classification as ventricular, supraventricular, or oversensing was 97.2%.

conclusionThe Lumax and IEGM Online HD Evaluation study demonstrates that remote IEGM analysis is reasonably accurate in a remote monitoring system that transmits shorter IEGM than the full-length programmer IEGM for the sake of frequent, fully automatic data transmission.

Indexed as

Defibrillators, ImplantableArrhythmias, CardiacElectrocardiographyFemaleHumansMaleMiddle AgedObserver VariationOnline SystemsReproducibility of ResultsSensitivity and SpecificityTelemedicineTreatment OutcomeUser-Computer InterfaceArrhythmia detectionHome monitoringImplantable cardioverter-defibrillatorIntracardiac electrogramRemote monitoringTelemedicine

Identifiers

PMID25567067
PMCPMC4381835

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Registered trials

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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.