Pulsed field versus cryoballoon ablation of atrial fibrillation: A comparison of efficacy and safety in a 400 patient cohort
Authors: Urbanek L , Bordignon S , Schaack D , Chen S , Plank K , Hirokami J , Schulte-Hahn B , Schmidt B , Chun K R J 
Published: May 2023

Funding Acknowledgements

Type of funding sources: Private company. Main funding source(s): Boris Schmidt, KR Julian Chun and Stefano Bordignon received speaking honoraria from Medtronic and Boston Scientific

Background

The cryoballoon (CB) is one of the most commonly used single shot devices for pulmonary vein isolation in patients with atrial fibrillation (AF). Pulsed field ablation (PFA) is a new non-thermal, tissue selective approach for pulmonary vein isolation.

Purpose

We sought to compare procedural safety and efficacy of these single shot ablation techniques.

Methods

Consecutive AF patients (paroxysmal / persistent AF) who underwent CB based pulmonary vein isolation (PVI) between November 2020 and February 2022 were enrolled and compared with patients who underwent PFA ablation in the same time period. Patients that underwent ablation beyond PVI (except for cavo-tricuspid isthmus ablation) were excluded. CB PVI was performed using the second-generation CB (CB 28 mm) with 240 sec based freeze protocol and bonus freeze delivery in case of time-to-isolation (TTI) &gt;75 sec. PFA was performed using the Farawave catheter, using the 31 or 35 mm device. All procedures were performed under deep sedation.

Results

Data from 400 consecutive patients were collected. Most baseline characteristics like age (CB: 67,5 ± 15,3; PFA: 68,4 ± 11; p=0,49), BMI (CB: 28,6 ± 6,3; PFA: 27,9 ± 5,6; p=0,27) and gender (male) (CB: 54%; PFA: 59%; p=0,31) were comparable between the two groups. All PVIs were successfully completed.

In 98% (196) of patients in the CB group and 100% (200) in the PFA group, PVI was performed using solely CB or PFA respectively, meaning additional touch up ablation was only needed in 4 CB patients (2%; p=0,044) and 4 veins.

Procedure time was significantly shorter in the PFA group (CB: 53 ± 15,3 minutes; PFA: 36,8 ± 13,5 minutes; p&lt;0,001), whereas no difference in fluoroscopy time (CB: 8,1 ± 4,4 minutes; PFA: 7,8 ± 3,3 minutes; p=0,2) was observed. The rate of concomitant CTI-ablation was equal in both groups (CB: 1,5%; PFA: 1,5%; p=1,0). Complication rate was 3,5% with PFA and 6,5% in CB (p=0,17), a difference mostly driven by persistent phrenic nerve palsies (CB: 1,5%; PFA: 0%; p=0,08).

All patients are out of the blanking period. There were 80 recurrences in blanking time (CB: 41; PFA: 39; p=0,8). In CB 19,5% of blanking time recurrences were atrial tachycardias compared to 35,9% in PFA (p=0,1). The average time to blanking recurrence was 14,1 ± 21,5 days in CB and 20,5 ± 23,2 in PFA (p=0,2). In total, there were 7 repeat procedures (4 in CB and 3 in PFA; p=0,7) during blanking time due to arrhythmias, despite of antiarrhythmic drugs and/or cardioversion.

At the time of this analysis, the first hundred patients in each group reached one-year follow-up. Recurrence free survival after one year for patients with PAF was 82,6% in CB and 80,0% in PFA. In patients with persistent AF it was 70,8% in CB and 67,8% in PFA.

Conclusion

Cryoballoon and pulsed field ablation are both highly effective and safe techniques for PVI. PFA had a shorter procedure time, whereas the one year follow up was similar for both techniques.