학술논문
Abstract 15606: Effectiveness and Safety of the Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects With Persistent or Long Standing Persistent Atrial Fibrillation (PersAF/LSPAF) With Radiofrequency Ablation
Document Type
Academic Journal
Author
Ellenbogen, Kenneth; Khoynezhad, Ali; de Asmundis, Carlo; KASIRAJAN, Vigneshwar; koneru, Jayanthi; Johnkoski, John; Rist, Kevin; Mumtaz, Mubashir; Link, Michael; de Groot, Joris R; Driessen, Antoine; Lee, Mark; Hoff, Steven; Bello, David; Dunnington, Gansevoort; Eisenberg, Susan; Vloka, Margot; Taylor, Benedict; Jones, Stephen; Philpott, Jonathan; Beaver, Thomas; Miles, William; khan, junaid; Kang, Steven; Gandhi, Gaurang; Okum, Eric; Badhwar, Nitesh; Baykaner, Tina; Lee, Anson M; Vesco, Paul A; Smith, J Michael; Gaynor, Sydney; Frazier, Ken; La Meir, Mark
Source
Circulation. Nov 07, 2023 148(Suppl_1 Suppl 1):A15606-A15606
Subject
Language
English
ISSN
0009-7322
Abstract
Background: A collaborative approach between Electrophysiologists (EP) and Cardiothoracic Surgeons (CTS) to effectively target pulmonary veins (PVs) and substrate beyond PVs may improve outcomes for persistent and longstanding persistent AF (PersAF/LSPerAF).Hypothesis: A minimally invasive hybrid approach of bilateral thoracoscopic epicardial ablation and left atrial appendage exclusion (LAAE) with endocardial mapping/ablation (Hybrid approach) is safe and effective to treat advanced AF patients who have failed medical therapy. Aim: DEEP (NCT02393885) aims to establish safety and effectiveness of a Bipolar Radiofrequency (RF) System in a Hybrid approach to treat PersAF/LSPerAF.Methods: DEEP is a prospective, international, single arm trial at 17 sites. Key eligibility: adults with drug refractory PersAF/LSPerAF, left atrial diameter (LAD) ≤5.5cm, failed class I/III AAD, and ≤2 previous failed endocardial catheter ablations (CA). Epicardial surgical ablation included PV isolation, roof and floor lines (posterior LA box), left superior PV to LAA lesion, ganglionic plexi and Ligament of Marshall ablation and LAAE. CA followed 91-121 D post epicardial procedure. After 90 D blanking and 90 D AAD optimization periods, 24-hr rhythm monitoring and ECG were performed 6 and 12 M post CA with symptom driven monitoring between. Primary effectiveness was defined as freedom from atrial arrhythmia (>30 sec) absent new/increased dose of previously failed AAD through 12 M. Safety was device/procedure-related SAEs within 30 D of epicardial ablation and 7 D of CA in all who received anesthesia.Results: Ninety patients were enrolled in 2015-2020, 83.3% PersAF, 16.7% LSPerAF, mean age 63.4±7.74 yrs, 83.3% male, mean BMI 29.9, CHAD2DS2-VASc median 2.0 (1.0, 3.0), 48% failed CA, median AF duration 3.8 yrs, mean LAD 4.5cm. Primary effectiveness 70.6% (60/85; 95% CI 60.9%, 80.3%, p=0.0232) and freedom from AF through 12 M 78.8% (p=0.0002). The adverse event rate was 6.7% (6/90); equal in epi- and endocardial cohort. Both primary endpoints met prespecified success criteria.Conclusion: A collaborative approach between EP and CTS to Hybrid ablation is effective for PersAF/LSerPAF when benefit-risk is deemed favorable, given limited alternative treatments.