Same-day discharge after dual-energy ablation for atrial fibrillation
M Y Lo, G Rackauskas, M Manninger, S Sundaram, A A Hussein, A Bulava, F X Roithinger, P Tung, J M Kalman, P Sanders, I Deisenhofer, J P Piccini, D Scherr, P Della Bella, J SilberbauerAbstract
Background/Introduction
Same-day discharge (SDD) after atrial fibrillation ablation procedures is increasingly common. However, data on the feasibility and safety of SDD following dual-energy radiofrequency (RF)/pulsed-field (PF) ablation remains limited.
Purpose
Demonstrate the feasibility and safety of SDD after dual-energy ablation.
Methods
The FlexPulse and FOCALFLEX studies were prospective, single-arm, multicenter, clinical studies evaluating the safety and effectiveness of a novel dual-energy (RF/PF) focal ablation catheter with a flexible, laser-cut tip for paroxysmal atrial fibrillation (AF). In both studies, the primary safety endpoint was the proportion of subjects experiencing a predefined safety event within 7 days. Acute effectiveness was defined as confirmation of entrance block in all pulmonary veins after a minimum waiting period of 20 minutes. The study designs and ablation procedures have been previously reported. A pooled analysis was conducted to compare procedural details and outcomes in cases with SDD compared to those with an overnight stay (ONS).
Results
The sub-analysis included 127 subjects with SDD (39.2%) and 197 subjects with an ONS (60.8%). Baseline demographics (age, sex, BMI, CHA2DS2Vasc, LVEF, LAD) did not differ between the two populations, with the exception that heart failure was more common in ONS subjects compared to SDD subjects (NYHA Class I: 22.8% (45/197) vs. 8.7% (11/127), NYHA Class II: 10.2% (20/197) vs. 4.7% (6/127), No Heart Failure: 67.0% (132/197) vs. 86.6% (110/127), p=0.0003). LA dwell time was significantly longer in subjects with an ONS (79.4±22.2 vs. 70.6±21.8 min, p=0.0005). There was no difference in the total number of PF applications (SDD: 103.3±34.0, ONS: 97.9±34.3, p=0.1693). Procedures with SDD were more likely to have used intracardiac echocardiography (ICE) (75.6% (96/127) vs. 37.1% (73/197), p<0.0001). Subjects with ONS were more likely to have had a procedure start time in the afternoon (29.1% (37/127) vs. 47.7% (94/197), p=0.0009). Rates of first pass isolation were comparable for SDD and ONS (92.1% (117/127) vs. 91.9% (181/197), p=0.9361). Acute effectiveness was 100% (127/127) for SDD and 99.5% (196/197) for ONS. Subjects with SDD experienced a primary safety endpoint rate of 0.8% (1/129), compared to 2.0% (4/199) for those with an ONS (p=0.6519). There was also no significant difference in the rates of serious adverse events or adverse device effects. Freedom from documented arrhythmia recurrence rates at 6 months were also comparable at 84.0% and 84.6% for SDD and ONS subjects, respectively.
Conclusion
SDD after AF ablation with a novel dual energy system is both feasible and safe, with no significant differences in safety and effectiveness compared to those admitted for an ONS.