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Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings

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Abstract

Background

Pulsed field ablation (PFA) is a novel method of cardiac ablation demonstrated in early pre-clinical and clinical settings. The aim of this study was to report the safety and clinical efficacy of pulmonary vein isolation (PVI) with PFA for real-world atrial fibrillation (AF) patients.

Methods

All-comer AF patients (n = 121, 59% paroxysmal) were prospectively included and underwent PFA with 100% high-density voltage maps performed after PVI. Clinical outcomes were gathered by chart review.

Results

PVI was achieved with PFA-only in 119 (98%) of the cases. During the implementation phase the mean procedure and fluoroscopy time was reduced from 85 ± 34 to 72 ± 18 min (p = 0.044) and 22 ± 9 to 16 ± 4 (p = 0.034). We observed one phrenic nerve palsy with only partial remission at follow-up. Other adverse events were numerically comparable to standard PVI procedures. Over a mean follow-up of 308 ± 87 days, a total of 22/121 (18.2%) cases experienced clinically significant recurrence or initiation of anti-arrhythmic drugs with Kaplan–Meier event-free estimate at 365 days of 80% (88% for paroxysmal versus 69% for persistent). In five of eight re-do procedures, gaps were primarily located at the right pulmonary veins.

Conclusions

PFA was a highly efficient method to achieve PVI with reductions in procedure time and fluoroscopy over the implementation period. The procedural data and clinical recurrence rates from initial trials were confirmed in real-life non-selected AF patients. More data is needed to establish lesion durability and limitations of PFA.

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Authors and Affiliations

  1. Division of Electrophysiology, Department of Cardiology, Herlev-Gentofte Hospital, Hellerup, Denmark

    Martin H. Ruwald, Arne Johannessen, Morten Lock Hansen, Martin Haugdal, Rene Worck & Jim Hansen

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  1. Martin H. Ruwald
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  2. Arne Johannessen
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  3. Morten Lock Hansen
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  4. Martin Haugdal
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  5. Rene Worck
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  6. Jim Hansen
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Corresponding author

Correspondence to Martin H. Ruwald.

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Conflict of interest

MHR, AJ, MLH and MH has nothing to disclose. RW has received research grants and speaker honoraria from Biosense Webster not related to the present work and JH has received grants, speaker honoraria and consultant fees from Biosense Webster and speaker honoraria and consultant fees from Boston Scientific.

Ethical approval

This research study was conducted retrospectively from data obtained for clinical purposes utilising anonymized data approved by Herlev-Gentofte University Hospital Institutional Review Board (Case Number:22035743).

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What’s new:

*Single-shot pulsed field ablation with map** allowed for a relatively short learning curve with reduced short procedure and fluoroscopy times during implementation.

*Pulsed field ablation resulted in a high rate of acute pulmonary vein isolation, low rate of adverse events and a slightly lower rate of clinical recurrences than what has been reported for radiofrequency or cryoballoon ablation.

*Operator experience and use of high-density map** prompted a temporal change towards more frequent pulsed field ablation with left atrium posterior wall isolation, which was deemed feasible and with relatively low procedure times.

*We observed one phrenic nerve palsy unresolved at follow-up. This unexpected finding warrants further verification in larger cohorts.

*Re-do procedures suggest limited durability of right sided PV ablations.

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Ruwald, M.H., Johannessen, A., Hansen, M.L. et al. Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings. J Interv Card Electrophysiol 66, 1837–1848 (2023). https://doi.org/10.1007/s10840-023-01495-y

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