Evidence map›Paper›PMID 30815690›Full record

Observational studyEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2019

Acute safety, effectiveness, and real-world clinical usage of ultra-high density mapping for ablation of cardiac arrhythmias: results of the TRUE HD study.

Gerhard Hindricks, Stanislav Weiner, Tom McElderry, Pierre Jaïs, William Maddox, Jose Ignacio Garcia-Bolao, Sang Yong Ji, Frederic Sacher, Stephan Willems, John Mounsey and 6 more

Open access · bronzeAbstract readObservational Study
In one paragraph

Observational study 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, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 18% 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.

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

4 citing papers in PubMed, 12 citations in OpenAlex.

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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

16 authors at 14 institutions in 5 countries.

Gerhard HindricksDepartment of Electrophysiology, Heart Center Leipzig, Strümpellstr., Leipzig, Germany.
Stanislav WeinerClinic Electrophysiology Department, Trinity Mother Frances, Tyler, TX, USA.
Tom McElderryCardiac Electrophysiology, Division of Cardiovascular Disease, University of Alabama Birmingham, Birmingham, AL, USA.
Pierre JaïsElectrophysiology and Ablation Unit, University of Bordeaux, CHU Bordeaux, IHU LIRYC, Bordeaux, France.
William MaddoxCardiac Electrophysiology, Division of Cardiovascular Disease, University of Alabama Birmingham, Birmingham, AL, USA.
Jose Ignacio Garcia-BolaoArrhythmia Unit, Cardiology Service, University of Navarra, Pamplona, Spain.
Sang Yong JiCardiac Electrophysiology, Division of Cardiology, Torrance Memorial Medical Center, Torrance, CA, USA.
Frederic SacherElectrophysiology and Ablation Unit, University of Bordeaux, CHU Bordeaux, IHU LIRYC, Bordeaux, France.
Stephan WillemsDepartment of Cardiac Electrophysiology, University Medical Center Hamburg Eppendorf, Hamburg, Germany.
John MounseyDivision of Cardiology, University of North Carolina Hospitals, Chapel Hill, NC, USA.
Philippe MauryDivision of Cardiology, University Hospital Rangueil, Toulouse, France.
Andreas BollmannDepartment of Electrophysiology, Heart Center Leipzig, Strümpellstr., Leipzig, Germany.
Elizabeth DuffyRhythm Management, Boston Scientific, St. Paul, MN, USA.
Giovanni RacitiRhythm Management, Boston Scientific, St. Paul, MN, USA.
Roderick TungCenter for Arrhythmia Care, Heart and Vascular Center, The University of Chicago Medicine, Chicago, IL, USA.
Tom WongHeart Rhythm Centre, Royal Brompton and Harefield foundation Trust and Imperial College, London, UK.
Leipzig Heart Institute · DEUniversity of Alabama at Birmingham · USBoston Scientific (United States) · USElectrophysiology and Heart Modeling Institute · FRHôpital Rangueil · FRImperial College London · GBRhythm (United states) · USTorrance Memorial Medical Center · USTrinity Mother Frances Hospitals and Clinics · USUniversidad de Navarra · ESUniversité de Bordeaux · FRUniversity Medical Center Hamburg-Eppendorf · DEUniversity of Chicago · USUniversity of North Carolina Hospitals · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe objective of this study was to verify acute safety, performance, and usage of a novel ultra-high density mapping system in patients undergoing ablation procedure in a real-world clinical setting. METHODS AND

resultsThe TRUE HD study enrolled patients undergoing catheter ablation with mapping for all arrhythmias (excluding de novo atrial fibrillation) who were followed for 1 month. Safety was determined by collecting all serious adverse events and adverse events associated with the study devices. Performance was determined as the composite of: ability to map the arrhythmia/substrate, complete the ablation applications, arrhythmia termination (where applicable), and ablation validation. Use of mapping system in the ablation validation workflow was also evaluated. Among the 519 patients who underwent a complete (504) or attempted (15) procedure, 21 (4%) serious ablation-related complications were collected, with 3 (0.57%) potentially related to the mapping catheter. Four hundred and twenty treated patients resulted in a successful procedure confirmed by arrhythmia-specific validation techniques (83.3%; 95% confidence interval: 79.8-86.5%). A total of 1419 electroanatomical maps were created with a median acquisition time of 9:23 min per map. Of these, 372 maps in 222 (44%) patients were collected for ablation validation purposes. Following validation mapping, 162/222 (73%) patients required additional ablation.

conclusionIn the TRUE HD study mapping was associated with rates of acute success and complications consistent with previously published reports. Importantly, a low percentage of events (0.57%) was attributed to the mapping catheter. When performed, validation mapping was useful for identifying additional targets for ablation in the majority of patients.

Indexed as

AdultAgedArrhythmias, CardiacCardiac TamponadeCatheter AblationElectrophysiologic Techniques, CardiacFemaleHeart InjuriesHematomaHumansIntraoperative ComplicationsMaleMiddle AgedPostoperative ComplicationsProspective StudiesProsthesis FailureCardiac arrhythmiasCatheter ablationElectro-anatomic mapping systemUltra-high density electroanatomical mappping

Identifiers

PMID30815690
PMCPMC6452400
OpenAlexW2918647065

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.