Pulmonary vein and posterior wall isolation via single-shot pulse field ablation catheters: peri-procedural details, safety, and operator experience

Background

Pulsed field ablation (PFA) is a novel energy source for catheter ablation of atrial fibrillation (AF). Three PFA technologies are currently fully commercially available; however, evidence comparing peri-procedural performances and operator experience of these different systems is still limited.

Purpose

To compare acute procedural characteristics, safety, and operator experience of pulmonary vein isolation (PVI) +/- posterior wall isolation (PWI) performed with a pentaspline (PS), a variable-loop circular (VL) and a fixed-loop circular (FL) catheter.

Methods

Overall, 450 consecutive patients (150 per PFA technology) undergoing first-time PFA were included (64.9 ± 11 years, 46.2% female, 62% paroxysmal AF). Each group had an equal distribution of PVI-only or PVI+PWI (50:50 ratio) cases. Procedures were performed by 25 operators at 8 European, USA and Asian centers, with an experience of at least 20 cases per PFA technology. Each operator was also asked to answer a 5-point Likert-scale survey on several procedural aspects (Figure 1).

Results

Acute PVI and PWI were achieved in all patients; however, first-pass PVI per patient was significantly different among groups (PS: 97.3%, VL: 86.0%, FL: 86.9%; p<0.001). On a pulmonary vein level, significant differences in first-pass isolation were documented for LSPV (p<0.001) and RSPV (p<0.001).

Among PVI-only procedures (Table 1), procedural time was shorter with PS (50 [40-60] min) compared to VL (60 [50-70] min, p = 0.002) and FL (60 [47-75] min, p = 0.003).

Among PVI+PWI procedures (Table 1), PS led to significantly shorter procedures compared to FL (p=0.021) and showed a trend towards shorter procedures compared to VL (p=0.08); no differences were observed between VL and FL (p=0.3).

Radiation exposure was significantly shorter with VL compared to both PS and FL, irrespective of the lesion set (PVI vs PVI plus PWI).

Safety outcomes were comparable among technologies, with low rates of major (0.7%) and minor (1.8%) peri-procedural complications.

Operators’ ratings were significantly higher with PS regarding maneuverability, ease of PVI/PWI, and perceived safety (all p < 0.001, Figure 1). No differences were documented regarding ease of catheter preparation. The perceived learning curve was short and similar across systems (<10 cases), with the right inferior PV being reported as the most challenging vein to cannulate (Figure 1).

Conclusion

Among single-shot PFA systems, PS was associated with shorter procedural times and higher first-pass PVI rates, while VL provided the lowest radiation exposure. All three systems showed a favorable and comparable safety profile. Operators preferred PS for catheter handling and ease of PVI/PWI, with a short and similar learning curve across all systems.