TY - JOUR
T1 - Effect of Catheter Ablation Using Pulmonary Vein Isolation with vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients with Persistent Atrial Fibrillation
T2 - The CAPLA Randomized Clinical Trial
AU - Kistler, Peter M.
AU - Chieng, David
AU - Sugumar, Hariharan
AU - Ling, Liang-Han
AU - Segan, Louise
AU - Azzopardi, Sonia
AU - Al-Kaisey, Ahmed
AU - Parameswaran, Ramanathan
AU - Anderson, Robert D.
AU - Hawson, Joshua
AU - Prabhu, Sandeep
AU - Voskoboinik, Aleksandr
AU - Wong, Geoffrey
AU - Morton, Joseph B.
AU - Pathik, Bhupesh
AU - McLellan, Alex J.
AU - Lee, Geoffrey
AU - Wong, Michael
AU - Finch, Sue
AU - Pathak, Rajeev K.
AU - Raja, Deep Chandh
AU - Sterns, Laurence
AU - Ginks, Matthew
AU - Reid, Christopher M.
AU - Sanders, Prashanthan
AU - Kalman, Jonathan M.
N1 - Funding Information:
Funding/Support: This study was supported by seed grant funding from the Baker Department of Cardiometabolic Health, University of Melbourne.
Publisher Copyright:
© 2023 American Medical Association. All rights reserved.
PY - 2023/1/10
Y1 - 2023/1/10
N2 - Importance: Pulmonary vein isolation (PVI) alone is less effective in patients with persistent atrial fibrillation (AF) compared with paroxysmal AF. The left atrial posterior wall may contribute to maintenance of persistent AF, and posterior wall isolation (PWI) is a common PVI adjunct. However, PWI has not been subjected to randomized comparison. Objective: To compare PVI with PWI vs PVI alone in patients with persistent AF undergoing first-time catheter ablation. Design, Setting, and Participants: Investigator initiated, multicenter, randomized clinical trial involving 11 centers in 3 countries (Australia, Canada, UK). Symptomatic patients with persistent AF were randomized 1:1 to either PVI with PWI or PVI alone. Patients were enrolled July 2018-March 2021, with 1-year follow-up completed March 2022. Interventions: The PVI with PWI group (n = 170) underwent wide antral pulmonary vein isolation followed by posterior wall isolation involving linear ablation at the roof and floor to achieve electrical isolation. The PVI-alone group (n = 168) underwent wide antral pulmonary vein isolation alone. Main Outcomes and Measures: Primary end point was freedom from any documented atrial arrhythmia of more than 30 seconds without antiarrhythmic medication at 12 months, after a single ablation procedure. The 23 secondary outcomes included freedom from atrial arrhythmia with/without antiarrhythmic medication after multiple procedures, freedom from symptomatic AF with/without antiarrhythmic medication after multiple procedures, AF burden between study groups at 12 months, procedural outcomes, and complications. Results: Among 338 patients randomized (median age, 65.6 [IQR, 13.1] years; 76.9% men), 330 (97.6%) completed the study. After 12 months, 89 patients (52.4%) assigned to PVI with PWI were free from recurrent atrial arrhythmia without antiarrhythmic medication after a single procedure, compared with 90 (53.6%) assigned to PVI alone (between-group difference, -1.2%; hazard ratio [HR], 0.99 [95% CI, 0.73-1.36]; P =.98). Of the secondary end points, 9 showed no significant difference, including freedom from atrial arrhythmia with/without antiarrhythmic medication after multiple procedures (58.2% for PVI with PWI vs 60.1% for PVI alone; HR, 1.10 [95% CI, 0.79-1.55]; P =.57), freedom from symptomatic AF with/without antiarrhythmic medication after multiple procedures (68.2% vs 72%; HR, 1.20 [95% CI, 0.80-1.78]; P =.36) or AF burden (0% [IQR, 0%-2.3%] vs 0% [IQR, 0%-2.8%], P =.47). Mean procedural times (142 [SD, 69] vs 121 [SD, 57] minutes, P <.001) and ablation times (34 [SD, 21] vs 28 [SD, 12] minutes, P <.001) were significantly shorter for PVI alone. There were 6 complications for PVI with PWI and 4 for PVI alone. Conclusions and Relevance: In patients undergoing first-time catheter ablation for persistent AF, the addition of PWI to PVI alone did not significantly improve freedom from atrial arrhythmia at 12 months compared with PVI alone. These findings do not support the empirical inclusion of PWI for ablation of persistent AF. Trial Registration: anzctr.org.au Identifier: ACTRN12616001436460.
AB - Importance: Pulmonary vein isolation (PVI) alone is less effective in patients with persistent atrial fibrillation (AF) compared with paroxysmal AF. The left atrial posterior wall may contribute to maintenance of persistent AF, and posterior wall isolation (PWI) is a common PVI adjunct. However, PWI has not been subjected to randomized comparison. Objective: To compare PVI with PWI vs PVI alone in patients with persistent AF undergoing first-time catheter ablation. Design, Setting, and Participants: Investigator initiated, multicenter, randomized clinical trial involving 11 centers in 3 countries (Australia, Canada, UK). Symptomatic patients with persistent AF were randomized 1:1 to either PVI with PWI or PVI alone. Patients were enrolled July 2018-March 2021, with 1-year follow-up completed March 2022. Interventions: The PVI with PWI group (n = 170) underwent wide antral pulmonary vein isolation followed by posterior wall isolation involving linear ablation at the roof and floor to achieve electrical isolation. The PVI-alone group (n = 168) underwent wide antral pulmonary vein isolation alone. Main Outcomes and Measures: Primary end point was freedom from any documented atrial arrhythmia of more than 30 seconds without antiarrhythmic medication at 12 months, after a single ablation procedure. The 23 secondary outcomes included freedom from atrial arrhythmia with/without antiarrhythmic medication after multiple procedures, freedom from symptomatic AF with/without antiarrhythmic medication after multiple procedures, AF burden between study groups at 12 months, procedural outcomes, and complications. Results: Among 338 patients randomized (median age, 65.6 [IQR, 13.1] years; 76.9% men), 330 (97.6%) completed the study. After 12 months, 89 patients (52.4%) assigned to PVI with PWI were free from recurrent atrial arrhythmia without antiarrhythmic medication after a single procedure, compared with 90 (53.6%) assigned to PVI alone (between-group difference, -1.2%; hazard ratio [HR], 0.99 [95% CI, 0.73-1.36]; P =.98). Of the secondary end points, 9 showed no significant difference, including freedom from atrial arrhythmia with/without antiarrhythmic medication after multiple procedures (58.2% for PVI with PWI vs 60.1% for PVI alone; HR, 1.10 [95% CI, 0.79-1.55]; P =.57), freedom from symptomatic AF with/without antiarrhythmic medication after multiple procedures (68.2% vs 72%; HR, 1.20 [95% CI, 0.80-1.78]; P =.36) or AF burden (0% [IQR, 0%-2.3%] vs 0% [IQR, 0%-2.8%], P =.47). Mean procedural times (142 [SD, 69] vs 121 [SD, 57] minutes, P <.001) and ablation times (34 [SD, 21] vs 28 [SD, 12] minutes, P <.001) were significantly shorter for PVI alone. There were 6 complications for PVI with PWI and 4 for PVI alone. Conclusions and Relevance: In patients undergoing first-time catheter ablation for persistent AF, the addition of PWI to PVI alone did not significantly improve freedom from atrial arrhythmia at 12 months compared with PVI alone. These findings do not support the empirical inclusion of PWI for ablation of persistent AF. Trial Registration: anzctr.org.au Identifier: ACTRN12616001436460.
UR - http://www.scopus.com/inward/record.url?scp=85146137575&partnerID=8YFLogxK
U2 - 10.1001/jama.2022.23722
DO - 10.1001/jama.2022.23722
M3 - Article
C2 - 36625809
AN - SCOPUS:85146137575
SN - 0098-7484
VL - 329
SP - 127
EP - 135
JO - JAMA: Journal of the American Medical Association
JF - JAMA: Journal of the American Medical Association
IS - 2
ER -