Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings.
Atrial fibrillation
Electrophysiology
High density
Mapping
Pulsed field ablation
Recurrence rate
Safety
Journal
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
ISSN: 1572-8595
Titre abrégé: J Interv Card Electrophysiol
Pays: Netherlands
ID NLM: 9708966
Informations de publication
Date de publication:
Nov 2023
Nov 2023
Historique:
received:
03
01
2023
accepted:
25
01
2023
pubmed:
9
2
2023
medline:
9
2
2023
entrez:
8
2
2023
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 36753029
doi: 10.1007/s10840-023-01495-y
pii: 10.1007/s10840-023-01495-y
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1837-1848Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): the Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021;42(5):373–498.
doi: 10.1093/eurheartj/ehaa612
pubmed: 32860505
Sorensen SK, Johannessen A, Worck R, Hansen ML, Hansen J. Radiofrequency Versus cryoballoon catheter ablation for paroxysmal atrial fibrillation: durability of pulmonary vein isolation and effect on atrial fibrillation burden: the RACE-AF randomized controlled trial. Circ Arrhythm Electrophysiol. 2021;14(5):e009573.
doi: 10.1161/CIRCEP.120.009573
pubmed: 33835823
pmcid: 8136462
Neven K, van Es R, van Driel V, van Wessel H, Fidder H, Vink A, et al. Acute and long-term effects of full-power electroporation ablation directly on the porcine esophagus. Circ Arrhythm Electrophysiol. 2017;10(5).
Neven K, Futing A, Byrd I, Heil RW Jr, Fish JM, Feeney DA, et al. Absence of (sub-)acute cerebral events or lesions after electroporation ablation in the left-sided canine heart. Heart Rhythm. 2021;18(6):1004–11.
doi: 10.1016/j.hrthm.2021.02.015
pubmed: 33617997
Koruth JS, Kuroki K, Kawamura I, Brose R, Viswanathan R, Buck ED, et al. Pulsed Field ablation versus radiofrequency ablation: esophageal injury in a novel porcine model. Circ Arrhythm Electrophysiol. 2020;13(3):e008303.
doi: 10.1161/CIRCEP.119.008303
pubmed: 31977250
pmcid: 7069397
Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako M, et al. Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol. 2021;7(5):614–27.
doi: 10.1016/j.jacep.2021.02.014
pubmed: 33933412
Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet H, et al. Pulsed field ablation for pulmonary vein isolation in atrial fibrillation. J Am Coll Cardiol. 2019;74(3):315–26.
doi: 10.1016/j.jacc.2019.04.021
pubmed: 31085321
Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami K, et al. Pulsed field ablation in patients with persistent atrial fibrillation. J Am Coll Cardiol. 2020;76(9):1068–80.
doi: 10.1016/j.jacc.2020.07.007
pubmed: 32854842
Ruwald MH, Johannessen A, Hansen ML, Haugdal M, Worck R, Hansen J. Utility of high-density 3d-bipolar voltage map after pulmonary vein isolation by pulsed-field ablation. JACC: Clin Electrophysiol. 2023. https://doi.org/10.1016/j.jacep.2022.11.030
Lyng Lindgren F, Brix Christensen S, Lundbye-Christensen S, Kragholm K, Johannessen A, Jacobsen PK, et al. Validation of the national Danish ablation database: a retrospective, registry-based validation study. Scand Cardiovasc J. 2022;56(1):285–91.
doi: 10.1080/14017431.2022.2099009
pubmed: 35866506
Ekanem E, Reddy VY, Schmidt B, Reichlin T, Neven K, Metzner A, et al. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). Europace. 2022;24(8):1256–66.
doi: 10.1093/europace/euac050
pubmed: 35647644
pmcid: 9435639
Duytschaever M, De Pooter J, Demolder A, El Haddad M, Phlips T, Strisciuglio T, et al. Long-term impact of catheter ablation on arrhythmia burden in low-risk patients with paroxysmal atrial fibrillation: The CLOSE to CURE study. Heart Rhythm. 2020;17(4):535–43.
doi: 10.1016/j.hrthm.2019.11.004
pubmed: 31707159
Nakagawa H, Castellvi Q, Neal R, Girouard S, Ikeda A, Kuroda S, et al. Effects of contact force on lesion size during pulsed field ablation. Heart Rhythm. 2021;18(PO03-131):S242–3.
doi: 10.1016/j.hrthm.2021.06.605
Futing A, Reinsch N, Howel D, Brokkaar L, Rahe G, Neven K. First experience with pulsed field ablation as routine treatment for paroxysmal atrial fibrillation. Europace. 2022.
Schmidt B, Bordignon S, Tohoku S, Chen S, Bologna F, Urbanek L, et al. 5S study: safe and simple single shot pulmonary vein isolation with pulsed field ablation using sedation. Circ Arrhythm Electrophysiol. 2022;15(6):e010817.
doi: 10.1161/CIRCEP.121.010817
pubmed: 35617232
Andrade JG, Champagne J, Dubuc M, Deyell MW, Verma A, Macle L, et al. Cryoballoon or radiofrequency ablation for atrial fibrillation assessed by continuous monitoring: a randomized clinical trial. Circulation. 2019;140(22):1779–88.
doi: 10.1161/CIRCULATIONAHA.119.042622
pubmed: 31630538
Andrade JG, Deyell MW, Verma A, Macle L, Khairy P. The cryoballoon vs irrigated radiofrequency catheter ablation (CIRCA-DOSE) study results in context. Arrhythm Electrophysiol Rev. 2020;9(1):34–9.
doi: 10.15420/aer.2019.13
pubmed: 32637118
pmcid: 7330729
Worck R, Sorensen SK, Johannessen A, Ruwald M, Haugdal M, Hansen J. Posterior wall isolation in persistent atrial fibrillation feasibility, safety, durability, and efficacy. J Cardiovasc Electrophysiol. 2022;33(8):1667–74.
doi: 10.1111/jce.15556
pubmed: 35598313
pmcid: 9543717
Lemoine MD, Fink T, Mencke C, Schleberger R, My I, Obergassel J, et al. Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario. Clin Res Cardiol. 2022. https://doi.org/10.1007/s00392-022-02091-2
Bohnen M, Weber R, Minners J, Jadidi A, Eichenlaub M, Neumann FJ, et al. Characterization of circumferential antral pulmonary vein isolation areas resulting from pulsed-field catheter ablation. Europace. 2022. https://doi.org/10.1093/europace/euac111
Tohoku S, Chun KRJ, Bordignon S, Chen S, Schaack D, Urbanek L, et al. Findings from repeat ablation using high-density mapping after pulmonary vein isolation with pulsed field ablation. Europace. 2022. https://doi.org/10.1093/europace/euac211
Ruwald MH, Johannessen A, Hansen ML, Worck R, Hansen J. Pulsed field ablation of the cavotricuspid isthmus using a multispline-electrode pulsed field ablation catheter. HeartRhythm Case Rep. 2022;8(3):147–50.
doi: 10.1016/j.hrcr.2021.12.009
pubmed: 35492844
Reddy VY, Petru J, Funasako M, Kopriva K, Hala P, Chovanec M, et al. Coronary arterial spasm during pulsed field ablation to treat atrial fibrillation. Circulation. 2022;146(24):1808–19