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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
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.
... The "Pivotal Study Of A Dual Epicardial and Endocardial Procedure (DEEP) Approach for Treatment of Subjects With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation" aimed to demonstrate safety and efficacy of combining epicardial with endocardial procedures for patients with persistent AF or longstanding persistent AF [5,71]. Results from the DEEP treatment approach for persistent or longstanding persistent AF with RF energy application were summarized in a 2023 abstract [72]. ...
... Inclusion criteria were failed class I/ III antiarrhythmic drugs, a left atrial diameter (LAD) ≤ 5.5 cm, and ≤ 2 prior unsuccessful endocardial catheter ablations. Persistent AF was present in 83.3% and 16.7% had longstanding persistent AF [72]. ...
... Epicardial surgical ablation consisted of PV isolation, creation of floor and roof lines (to form a posterior LA box), left superior PV to left atrial appendage ablation, ablation of ganglionic plexi plus the ligament of Marshall as well as left atrial appendage exclusion. Catheter ablation was performed 91-121 days after the epicardial procedure [72]. ...
Although significant strides have been made in non-pharmacologic management of atrial fibrillation (AF), these treatments remain a work in progress. While catheter ablation is often effective for management of paroxysmal AF, it is less successful in patients with persistent or longstanding persistent AF. This review was undertaken to clarify the risks, benefits, and alternatives to catheter ablation for non-pharmacologic AF management. In order to clarify the roles of surgical and hybrid ablation, this narrative review was undertaken by searching MEDLINE to identify peer-reviewed clinical trials, randomized controlled trials, meta-analyses, review articles, and other clinically relevant studies. The search was limited to English-language reports published between 1960 and 2023. Atrial fibrillation was searched using the terms surgical ablation, catheter ablation, hybrid ablation, stroke prevention, left atrial occlusion, and atrial excision. Google and Google Scholar, as well as bibliographies of identified articles, were also reviewed for additional references. The Cox-maze surgical approach is still the most efficacious non-pharmacological treatment for AF. Hybrid ablation, combining cardiac surgical and catheter ablation techniques, has become an attractive option for persistent or longstanding persistent AF.
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