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

TY - JOUR

T1 - Acute safety, effectiveness, and real-world clinical usage of ultra-high density mapping for ablation of cardiac arrhythmias: results of the TRUE HD study

AU - Hindricks, Gerhard

AU - Weiner, Stanislav

AU - McElderry, Tom

AU - Jaïs, Pierre

AU - Maddox, William

AU - Garcia-Bolao, Jose Ignacio

AU - Yong Ji, Sang

AU - Sacher, Frederic

AU - Willems, Stephan

AU - Mounsey, John

AU - Maury, Philippe

AU - Bollmann, Andreas

AU - Duffy, Elizabeth

AU - Raciti, Giovanni

AU - Tung, Roderick

AU - Wong, Tom

N1 - © The Author(s) 2019. Published by Oxford University Press on behalf of the European Society of Cardiology.

PY - 2019/4/1

Y1 - 2019/4/1

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Arrhythmias, Cardiac/physiopathology

KW - Cardiac Tamponade/epidemiology

KW - Catheter Ablation/methods

KW - Electrophysiologic Techniques, Cardiac/instrumentation

KW - Female

KW - Heart Injuries/epidemiology

KW - Hematoma/epidemiology

KW - Humans

KW - Intraoperative Complications/epidemiology

KW - Male

KW - Middle Aged

KW - Postoperative Complications/epidemiology

KW - Prospective Studies

KW - Prosthesis Failure

KW - Treatment Outcome

KW - Workflow

U2 - 10.1093/europace/euy191

DO - 10.1093/europace/euy191

M3 - SCORING: Journal article

C2 - 30815690

VL - 21

SP - 655

EP - 661

JO - EUROPACE

JF - EUROPACE

SN - 1099-5129

IS - 4

ER -