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

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Title: Acute safety, effectiveness, and real-world clinical usage of ultra-high density mapping for ablation of cardiac arrhythmias: results of the TRUE HD study
Authors: Hindricks, G
Weiner, S
McElderry, T
Jaïs, P
Maddox, W
Garcia-Bolao, JI
Yong Ji, S
Sacher, F
Willems, S
Mounsey, J
Maury, P
Bollmann, A
Duffy, E
Raciti, G
Tung, R
Wong, T
Item Type: Journal Article
Abstract: AIMS: The 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 RESULTS: The 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. CONCLUSION: In 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.
Issue Date: 27-Feb-2019
Date of Acceptance: 4-Sep-2018
URI: http://hdl.handle.net/10044/1/67517
DOI: https://dx.doi.org/10.1093/europace/euy191
ISSN: 1099-5129
Publisher: Oxford University Press (OUP)
Journal / Book Title: EP-Europace
Copyright Statement: © The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/),which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contactjournals.permissions@oup.com
Keywords: Cardiac arrhythmias
Catheter ablation
Electro-anatomic mapping system
Ultra-high density electroanatomical mappping
1103 Clinical Sciences
Cardiovascular System & Hematology
Publication Status: Published online
Conference Place: England
Online Publication Date: 2019-02-27
Appears in Collections:National Heart and Lung Institute
Faculty of Medicine



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