Evidence map›Paper›PMID 26208329›Full record

Trial reportPloS one2015

ICD Shock, Not Ventricular Fibrillation, Causes Elevation of High Sensitive Troponin T after Defibrillation Threshold Testing--The Prospective, Randomized, Multicentre TropShock-Trial.

Verena Semmler, Jürgen Biermann, Bernhard Haller, Clemens Jilek, Nikolaus Sarafoff, Carsten Lennerz, Hrvoje Vrazic, Bernhard Zrenner, Stefan Asbach, Christof Kolb

Registry-linked trialOpen access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01230086 (hs Troponin Release in Relation to Different ICD-Implantation Procedures), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 9% of its field
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.

NCT01230086 phase4completednot on this map

hs Troponin Release in Relation to Different ICD-Implantation Procedures

TypeinterventionalSponsorDeutsches Herzzentrum MuenchenRan2010 to 2013Enrolled195ConditionsDefibrillation Testing - ICD Therapy OptimisationArmsICD Implantation without DFT testing, Upper limit of vulnerability testing, T-wave shock with induction of ventricular fibrillation
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
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  13. Defibrillation testing during implantation of the subcutaneous implantable cardioverter-defibrillator: a necessary standard or becoming redundant?Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2020
    Review
  14. Review
  15. Article
  16. Effects of defibrillation shock in patients implanted with a subcutaneous defibrillator: a biomarker 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 · 2018
    Observational
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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

10 authors at 6 institutions in 2 countries.

Verena SemmlerDeutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung für Elektrophysiologie, Faculty of Medicine, Technische Universität München, Munich, Germany.
Jürgen BiermannCardiology and Angiology I, Heart Center, Freiburg University, Freiburg, Germany.
Bernhard HallerKlinikum rechts der Isar, Institut für Medizinische Statistik und Epidemiologie, Technische Universität, Munich, Germany.
Clemens JilekDeutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung für Elektrophysiologie, Faculty of Medicine, Technische Universität München, Munich, Germany; Schön Klinik Starnberger See, Kardiologie, Starnberg, Germany.
Nikolaus SarafoffDeutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung für Elektrophysiologie, Faculty of Medicine, Technische Universität München, Munich, Germany; Medizinische Klinik I und Poliklinik, Klinikum der Ludwig-Maximilians-Universität, Munich, Germany.
Carsten LennerzDeutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung für Elektrophysiologie, Faculty of Medicine, Technische Universität München, Munich, Germany.
Hrvoje VrazicDeutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung für Elektrophysiologie, Faculty of Medicine, Technische Universität München, Munich, Germany; University Hospital Dubrava, Division of Cardiology, Department of Internal Medicine, Zagreb, Croatia.
Bernhard ZrennerKrankenhaus Landshut-Achdorf, Medizinische Klinik I, Kardiologie, Landshut, Germany.
Stefan AsbachCardiology and Angiology I, Heart Center, Freiburg University, Freiburg, Germany.
Christof KolbDeutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung für Elektrophysiologie, Faculty of Medicine, Technische Universität München, Munich, Germany.
Technical University of Munich · DEDeutsches Herzzentrum München · DEUniversity of Freiburg · DEKlinikum rechts der Isar · DEMünchen Klinik · DEUniversity of Applied Sciences Landshut · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe placement of an implantable cardioverter defibrillator (ICD) has become routine practice to protect high risk patients from sudden cardiac death. However, implantation-related myocardial micro-damage and its relation to different implantation strategies are poorly characterized.

methodsA total of 194 ICD recipients (64±12 years, 83% male, 95% primary prevention of sudden cardiac death, 35% cardiac resynchronization therapy) were randomly assigned to one of three implantation strategies: (1) ICD implantation without any defibrillation threshold (DFT) testing, (2) estimation of the DFT without arrhythmia induction (modified "upper limit of vulnerability (ULV) testing") or (3) traditional safety margin testing including ventricular arrhythmia induction. High-sensitive Troponin T (hsTnT) levels were determined prior to the implantation and 6 hours after.

resultsAll three groups showed a postoperative increase of hsTnT. The mean delta was 0.031±0.032 ng/ml for patients without DFT testing, 0.080±0.067 ng/ml for the modified ULV-testing and 0.064±0.056 ng/ml for patients with traditional safety margin testing. Delta hsTnT was significantly larger in both of the groups with intraoperative ICD testing compared to the non-testing strategy (p≤0.001 each). There was no statistical difference in delta hsTnT between the two groups with intraoperative ICD testing (p = 0.179).

conclusionHigh-sensitive Troponin T release during ICD implantation is significantly higher in patients with intraoperative ICD testing using shock applications compared to those without testing. Shock applications, with or without arrhythmia induction, did not result in a significantly different delta hsTnT. Hence, the ICD shock itself and not ventricular fibrillation seems to cause myocardial micro-damage.

trial registrationClinicalTrials.gov NCT01230086.

Indexed as

Defibrillators, ImplantableAgedAnalysis of VarianceArrhythmias, CardiacBiomarkersCardiac Resynchronization TherapyCreatine Kinase, MB FormDeath, Sudden, CardiacElectric CountershockEndpoint DeterminationFemaleHeart Conduction SystemHumansIntraoperative PeriodMaleMiddle AgedBiomarkersCreatine Kinase, MB FormTroponin T

Identifiers

PMID26208329
PMCPMC4514854
OpenAlexW1759855952

What OpenQuestion holds

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LicenceCC BY
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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.