Feasibility and efficacy of single-shot PFA technology for redo procedures after a previous atrial fibrillation ablation procedure

Abstract

Abstract Introduction Despite significant technological advancements and a better understanding of atrial tachyarrhythmia pathophysiology, a non-negligible percentage of atrial fibrillation (AF) patients undergoing catheter ablation experiences arrhythmia relapse. Repeat procedures have been traditionally performed via thermal energy systems, which carry a certain risk of collateral damage to adjacent tissues. Pulsed Field Ablation (PFA) has emerged as an alternative non-thermal energy source for cardiac ablation. The main advantage is its selectivity to cardiac tissue. FarapulseTM is the first PFA technology to have received regulatory approval and includes a pentaspline PFA catheter. Although designed for pulmonary vein isolation, its use for extrapulmonary vein site ablation has been previously documented. Purpose To evaluate the feasibility and efficacy of the pentaspline FarawaveTM for redo procedures. Methods Patients referred for a redo procedure using FarapulseTM system were enrolled in 3 high-volume European centers. A workflow (Figure 1.A) was established based on rhythm at presentation (Group 1: sinus rhythm; Group 2: AFL; Group 3: AF). Results A total of 117 patients were included (64 in Group 1, 18 in Group 2, and 35 in Group 3). The mean number of previous procedures was 1.26, and 23 patients (19.66%) had already undergone ≥2 procedures. Previous ablation targets included PVI, either alone (46.15%) or in combination with other targets, including posterior mitral line (39.32%), posterior wall (6.84%), or anterior mitral line (2.56%). Electroanatomical mapping (EAM) was adopted in 15.38% of the cases. Specifically, in 27.78% (n=5) of group 2, 15.63% (n=10) of group 1 and 8.57% (n= 3) of group 3 cases. Additional focal radiofrequency ablation was required in 4 patients for CTI line ablation. Lesion sets are depicted in Figure 2. Mean procedural and LA dwelling time were 95.2 ± 38.0 and 50.7 ± 36.7 minutes, respectively. There was a total of one major complication (intracranial haemorrhage) and 5 minor complications (two vascular site related, and three reversible ST segment changes, related to applications on the mitral annulus area). A total of 100 patients completed at least 3 months of follow-up (FU), with a median FU time was 7.55 months (IQR 5.18 – 11.85). The total number of recurrences was 20, including 2 during the blanking period. Survival function (excluding blanking period) was 88.6 (95% CI 79.7 – 93.8) at 6 months and 80.0% (95% CI 67.3 – 88.3) 12 months. Atrial arrhythmia free-survival was higher in patients presenting in sinus rhythm, compared to the other two groups (p = 0.0135), as displayed in Figure 1.B. Conclusion The proposed stepwise approach to repeat AF ablation procedures based on the use of the single-shot PFA system (with or without EAM) was feasible, safe, fast and effective at one year follow-up.Flow chart and Kaplan Meier curveLesion sets