Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial
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Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial. / Willems, Stephan; Verma, Atul; Betts, Timothy R; Murray, Steven; Neuzil, Petr; Ince, Hüseyin; Steven, Daniel; Sultan, Arian; Heck, Patrick M; Hall, Mark C; Tondo, Claudio; Pison, Laurent; Wong, Tom; Boersma, Lucas V; Meyer, Christian; Grace, Andrew.
in: CIRC-ARRHYTHMIA ELEC, Jahrgang 12, Nr. 7, 07.2019, S. e007233.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Targeting Nonpulmonary Vein Sources in Persistent Atrial Fibrillation Identified by Noncontact Charge Density Mapping: UNCOVER AF Trial
AU - Willems, Stephan
AU - Verma, Atul
AU - Betts, Timothy R
AU - Murray, Steven
AU - Neuzil, Petr
AU - Ince, Hüseyin
AU - Steven, Daniel
AU - Sultan, Arian
AU - Heck, Patrick M
AU - Hall, Mark C
AU - Tondo, Claudio
AU - Pison, Laurent
AU - Wong, Tom
AU - Boersma, Lucas V
AU - Meyer, Christian
AU - Grace, Andrew
PY - 2019/7
Y1 - 2019/7
N2 - Background Identification and elimination of nonpulmonary vein targets may improve clinical outcomes in patients with persistent atrial fibrillation (AF). We report on the use of a novel, noncontact imaging and mapping system that uses ultrasound to reconstruct atrial chamber anatomy and measures timing and density of dipolar, ionic activation (ie, charge density) across the myocardium to guide ablation of atrial arrhythmias. Methods The prospective, nonrandomized UNCOVER AF trial (Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation) was conducted at 13 centers across Europe and Canada. Patients with persistent AF (>7 days, <1 year) aged 18 to 80 years, scheduled for de novo catheter ablation, were eligible. Before pulmonary vein isolation, AF was mapped and then iteratively remapped to guide each subsequent ablation of charge density-identified targets. AF recurrence was evaluated at 3, 6, 9, and 12 months using continuous 24-hour ECG monitors. The primary effectiveness outcome was freedom from AF >30 seconds at 12 months for a single procedure with a secondary outcome being acute procedural efficacy. The primary safety outcome was freedom from device/procedure-related major adverse events. Results Between October 2016 and April 2017, 129 patients were enrolled, and 127 underwent mapping and catheter ablation. Acute procedural efficacy was demonstrated in 125 patients (98%). At 12 months, single procedure freedom from AF on or off antiarrhythmic drugs was 72.5% (95% CI, 63.9%-80.3%). After 1 or 2 procedures, freedom from AF was 93.2% (95% CI, 87.1%-97.0%). A total of 29 (23%) retreatments because of arrhythmia recurrence were performed with average time from index procedure to first retreatment being 7 months. The primary safety outcome was 98% with no device-related major adverse events reported. Conclusions This novel ultrasound imaging and charge density mapping system safely guided ablation of nonpulmonary vein targets in persistent AF patients with 73% single procedure and 93% second procedure freedom from AF at 12 months. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02825992 EU/NCT02462980 CN.
AB - Background Identification and elimination of nonpulmonary vein targets may improve clinical outcomes in patients with persistent atrial fibrillation (AF). We report on the use of a novel, noncontact imaging and mapping system that uses ultrasound to reconstruct atrial chamber anatomy and measures timing and density of dipolar, ionic activation (ie, charge density) across the myocardium to guide ablation of atrial arrhythmias. Methods The prospective, nonrandomized UNCOVER AF trial (Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation) was conducted at 13 centers across Europe and Canada. Patients with persistent AF (>7 days, <1 year) aged 18 to 80 years, scheduled for de novo catheter ablation, were eligible. Before pulmonary vein isolation, AF was mapped and then iteratively remapped to guide each subsequent ablation of charge density-identified targets. AF recurrence was evaluated at 3, 6, 9, and 12 months using continuous 24-hour ECG monitors. The primary effectiveness outcome was freedom from AF >30 seconds at 12 months for a single procedure with a secondary outcome being acute procedural efficacy. The primary safety outcome was freedom from device/procedure-related major adverse events. Results Between October 2016 and April 2017, 129 patients were enrolled, and 127 underwent mapping and catheter ablation. Acute procedural efficacy was demonstrated in 125 patients (98%). At 12 months, single procedure freedom from AF on or off antiarrhythmic drugs was 72.5% (95% CI, 63.9%-80.3%). After 1 or 2 procedures, freedom from AF was 93.2% (95% CI, 87.1%-97.0%). A total of 29 (23%) retreatments because of arrhythmia recurrence were performed with average time from index procedure to first retreatment being 7 months. The primary safety outcome was 98% with no device-related major adverse events reported. Conclusions This novel ultrasound imaging and charge density mapping system safely guided ablation of nonpulmonary vein targets in persistent AF patients with 73% single procedure and 93% second procedure freedom from AF at 12 months. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT02825992 EU/NCT02462980 CN.
KW - Action Potentials
KW - Adolescent
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Atrial Fibrillation/diagnostic imaging
KW - Canada
KW - Catheter Ablation
KW - Electrocardiography, Ambulatory
KW - Electrophysiologic Techniques, Cardiac
KW - Europe
KW - Female
KW - Heart Conduction System/diagnostic imaging
KW - Heart Rate
KW - Humans
KW - Male
KW - Middle Aged
KW - Non-Randomized Controlled Trials as Topic
KW - Predictive Value of Tests
KW - Progression-Free Survival
KW - Prospective Studies
KW - Pulmonary Veins/physiopathology
KW - Recurrence
KW - Time Factors
KW - Ultrasonography
KW - Young Adult
U2 - 10.1161/CIRCEP.119.007233
DO - 10.1161/CIRCEP.119.007233
M3 - SCORING: Journal article
C2 - 31242746
VL - 12
SP - e007233
JO - CIRC-ARRHYTHMIA ELEC
JF - CIRC-ARRHYTHMIA ELEC
SN - 1941-3149
IS - 7
ER -