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, Philippe Maury, Andreas Bollmann, Elizabeth Duffy, Giovanni Raciti, Roderick Tung, Tom Wong

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)655-661
Number of pages7
JournalEuropace
Volume21
Issue number4
DOIs
StatePublished - Apr 1 2019
Externally publishedYes

Keywords

  • Cardiac arrhythmias
  • Catheter ablation
  • Electro-anatomic mapping system
  • Ultra-high density electroanatomical mappping

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

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