Abstract Body (Do not enter title and authors here): Background: Quality-of-life (OQL) is recognized as a proven benefit of atrial fibrillation (AF) ablation. The DEEP trial (NCT02393885) showed safety (6.7%) and efficacy (71.8%) of an epicardial-endocardial hybrid ablation (HA) approach with left atrial appendage exclusion (LAAE) for non-paroxysmal AF; results were consistent with two randomized trials comparing HA+LAAE to catheter ablation (CA). Limited data exist on QOL after HA+LAAE.
Goal: To evaluate QOL changes from baseline to 12-months post-HA+LAAE in the DEEP trial.
Methods: DEEP is a 17-site prospective, international, single arm trial. Key eligibility: adults with non-paroxysmal AF, left atrial diameter ≤5.5cm, failed class I/III anti-arrhythmic drugs, and ≤2 prior failed CA. Stage 1 was thoracoscopic radiofrequency epicardial ablation to isolate the pulmonary veins and left atrial posterior wall, and LAAE. Stage 2 was endocardial mapping and touchup ablation. QOL was measured via the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire at baseline and 12-months post-HA+LAAE. AFEQT yields scores from 0 to 100 (0 as complete disability and 100 as no disability) and includes an overall and four subscale scores. A 5-point AFEQT change is clinically important. Mean differences with 95% CIs were calculated; p-values are from paired t-tests.
Results: Of 85 patients, 82 completed both baseline and 12-month AFEQT. The mean change in overall score was 30.1 ± 19.8 (95% CI: 25.8-34.5; median 29.5, min, max: -15.4, 78.2; p<0.0001) (Figure). The greatest improvement was in the Treatment Satisfaction subscale with a mean score of 53.2 ± 29.9 (95% CI: 46.6-59.7; median 58.3, min, max: 0.0, 100.0; p<0.0001), followed by Treatment Concern, Daily Activities, and Symptoms subscale scores. All mean improvements from baseline exceeded a clinically meaningful 5-point change.
Conclusion: In the DEEP trial, HA+LAAE resulted in patient-reported QOL improvements at 12-months post-procedure.