National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety.
Atrial fibrillation
Clinical practice
Electroporation
Learning curve
Pulsed-field ablation
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:
30 May 2024
30 May 2024
Historique:
received:
16
02
2024
accepted:
23
05
2024
medline:
30
5
2024
pubmed:
30
5
2024
entrez:
30
5
2024
Statut:
aheadofprint
Résumé
Recent data on pulsed field ablation (PFA) for atrial fibrillation (AF) ablation suggest a progressive reduction in procedural times. Real-world data regarding the relationship between the learning curve of PFA and clinical outcomes are scarce. The objective was to evaluate the PFA learning curve and its impact on acute outcomes. Consecutive patients undergoing AF ablation with the FARAPULSE™ PFA system were included in a prospective, non-randomized multicenter study. Procedural times were stratified on the operators' learning curve. Comparative analysis of skin-to-skin time was conducted with radiofrequency (RF) and cryoablation (CB) pulmonary vein isolation (PVI) procedures performed by the same operators in the previous year. Among 752 patients, 35.1% were females, and 66.9% had paroxysmal AF; mean age was 62.2 ± 10 years. A total of 62.5% of procedures were performed by operators with > 20 PFA procedures. Both time to PVI (25.6 ± 10 min vs 16.5 ± 8, p < 0.0001) and fluoroscopy time (19.8 ± 8 min vs 15.9 ± 8 min, p = 0.0045) significantly improved after 10 associated with consistent linear trend towards procedural time reduction (R In this nationwide multicentric experience, the novel PFA system proved to be fast, safe, and acutely effective in both paroxysmal and persistent AF patients. The learning curve appears to be rapid, as improvements in procedural parameters were observed after only a few procedures. Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.
Sections du résumé
BACKGROUND
BACKGROUND
Recent data on pulsed field ablation (PFA) for atrial fibrillation (AF) ablation suggest a progressive reduction in procedural times. Real-world data regarding the relationship between the learning curve of PFA and clinical outcomes are scarce. The objective was to evaluate the PFA learning curve and its impact on acute outcomes.
METHODS
METHODS
Consecutive patients undergoing AF ablation with the FARAPULSE™ PFA system were included in a prospective, non-randomized multicenter study. Procedural times were stratified on the operators' learning curve. Comparative analysis of skin-to-skin time was conducted with radiofrequency (RF) and cryoablation (CB) pulmonary vein isolation (PVI) procedures performed by the same operators in the previous year.
RESULTS
RESULTS
Among 752 patients, 35.1% were females, and 66.9% had paroxysmal AF; mean age was 62.2 ± 10 years. A total of 62.5% of procedures were performed by operators with > 20 PFA procedures. Both time to PVI (25.6 ± 10 min vs 16.5 ± 8, p < 0.0001) and fluoroscopy time (19.8 ± 8 min vs 15.9 ± 8 min, p = 0.0045) significantly improved after 10 associated with consistent linear trend towards procedural time reduction (R
CONCLUSIONS
CONCLUSIONS
In this nationwide multicentric experience, the novel PFA system proved to be fast, safe, and acutely effective in both paroxysmal and persistent AF patients. The learning curve appears to be rapid, as improvements in procedural parameters were observed after only a few procedures.
CLINICAL TRIAL REGISTRATION
BACKGROUND
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456.
Identifiants
pubmed: 38814525
doi: 10.1007/s10840-024-01835-6
pii: 10.1007/s10840-024-01835-6
doi:
Banques de données
ClinicalTrials.gov
['NCT05617456']
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014;129(8):837–47.
doi: 10.1161/CIRCULATIONAHA.113.005119
pubmed: 24345399
Dong XJ, Wang BB, Hou FF, et al. Global burden of atrial fibrillation/atrial flutter and its attributable risk factors from 1990 to 2019. Europace. 2023;25(3):793–803.
doi: 10.1093/europace/euac237
pubmed: 36603845
pmcid: 10062373
Hindricks G, Potpara T, Dagres N, 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). Eur Heart J. 2021;42(5):373–498.
doi: 10.1093/eurheartj/ehaa612
pubmed: 32860505
Kim J, Kim D, Yu HT, et al. Revisiting symptomatic pulmonary vein stenosis after high-power short-duration radiofrequency ablation in patients with atrial fibrillation. Europace. 2023;25(10)
Tilz RR, Schmidt V, Pürerfellner H, et al. A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: The POTTER-AF study. Eur Heart J. 2023;44(27):2458–69.
doi: 10.1093/eurheartj/ehad250
pubmed: 37062040
pmcid: 10344651
Sairaku A, Nakano Y, Oda N, et al. Learning curve for ablation of atrial fibrillation in medium-volume centers. J Cardiol. 2011;57(3):263–8.
doi: 10.1016/j.jjcc.2011.01.005
pubmed: 21333498
Kuck K-H, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374(23):2235–45.
doi: 10.1056/NEJMoa1602014
pubmed: 27042964
Chun JKR, Bordignon S, Last J, et al. Cryoballoon versus laser balloon: insights from the first prospective randomized balloon trial in catheter ablation of atrial fibrillation. Circ Arrhythmia Electrophysiol. 2021;14(2):E009294.
doi: 10.1161/CIRCEP.120.009294
Gasperetti A, Assis F, Tripathi H, et al. Determinants of acute irreversible electroporation lesion characteristics after pulsed field ablation: the role of voltage, contact, and adipose interference. Europace. 2023;25(9)
Turagam MK, Neuzil P, Schmidt B, et al. Safety and effectiveness of pulsed field ablation to treat atrial fibrillation: one-year outcomes from the MANIFEST-PF Registry. Circulation. 2023;148(1):35–46.
doi: 10.1161/CIRCULATIONAHA.123.064959
pubmed: 37199171
Schmidt B, Bordignon S, Neven K, et al. EUropean real-world outcomes with Pulsed field ablatiOn in patients with symptomatic atRIAl fibrillation: lessons from the multi-centre EU-PORIA registry. Europace. 2023;25(7)
Ekanem E, Reddy VY, Schmidt B, 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
Ruwald MH, Johannessen A, Hansen ML, Haugdal M, Worck R, Hansen J. Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings. J Interv Card Electrophysiol. 2023;66(8)
Füting A, Reinsch N, Höwel D, Brokkaar L, Rahe G, Neven K. First experience with pulsed field ablation as routine treatment for paroxysmal atrial fibrillation. Europace. 2022;24(7):1084–92.
doi: 10.1093/europace/euac041
pubmed: 35513354
Kueffer T, Baldinger SH, Servatius H, et al. Validation of a multipolar pulsed-field ablation catheter for endpoint assessment in pulmonary vein isolation procedures. Europace. 2022;24(8):1248–55.
doi: 10.1093/europace/euac044
pubmed: 35699395
Magni FT, Mulder BA, Groenveld HF, et al. Initial experience with pulsed field ablation for atrial fibrillation. Front Cardiovasc Med. 2022;9:959186.
doi: 10.3389/fcvm.2022.959186
pubmed: 36426226
pmcid: 9679623
Schmidt B, Bordignon S, Tohoku S, et al. 5S Study: safe and simple single shot pulmonary vein isolation with pulsed field ablation using sedation. Circ Arrhythmia Electrophysiol. 2022;15(6):E010817.
doi: 10.1161/CIRCEP.121.010817
Kuck KH, Brugada J, Fürnkranz A, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. J Cardiopulm Rehabil Prev. 2016;36(5):393–4.
Rovaris G, Ciconte G, Schiavone M, et al. Second-generation laser balloon ablation for the treatment of atrial fibrillation assessed by continuous rhythm monitoring: The LIGHT-AF study. Europace. 2021;23(9):1380–90.
doi: 10.1093/europace/euab085
pubmed: 33837418
Almorad A, Chierchia GB, Pannone L, Osorio TG, Sorgente A, Bisignani A, Bala G, Overeinder I, Ströker E, Brugada P, Sieira J, de Asmundis C. The optimized clinical workflow for pulmonary vein isolation with the radiofrequency balloon. J Interv Card Electrophysiol. 2022;64(2):531–8.
doi: 10.1007/s10840-021-01094-9
pubmed: 34791605
Bisignani A, Cecchini F, Mugnai G, Overeinder I, Sieira J, Osório TG, Miraglia V, Monaco C, Sofianos D, Boveda S, Bala G, Ströker E, Paparella G, Westra SW, Brouwer MA, Brugada P, de Asmundis C, Chierchia GB. Single procedural outcomes in the setting of percutaneous ablation for persistent atrial fibrillation: a propensity-matched score comparison between different strategies. J Interv Card Electrophysiol. 2022;64(1):9–16.
doi: 10.1007/s10840-021-00968-2
pubmed: 33629193
Steinbeck G, Sinner MF, Lutz M, Müller-Nurasyid M, Kääb S, Reinecke H. Incidence of complications related to catheter ablation of atrial fibrillation and atrial flutter: a nationwide in-hospital analysis of administrative data for Germany in 2014. Eur Heart J.
Arbelo E, Brugada J, Hindricks G, et al. The Atrial Fibrillation Ablation Pilot Study: an European Survey on Methodology and results of catheter ablation for atrial fibrillation conducted by the European Heart Rhythm Association. Eur Heart J. 2014;35(22):1466–78.
doi: 10.1093/eurheartj/ehu001
pubmed: 24487524
De Greef Y, Ströker E, Schwagten B, et al. Complications of pulmonary vein isolation in atrial fibrillation: predictors and comparison between four different ablation techniques: results from the MIddelheim PVI-registry. Europace. 2018;20(8):1279–86.
doi: 10.1093/europace/eux233
pubmed: 29016870
Reddy VY, Gerstenfeld EP. Natale A, et al, Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. N Engl J Med. 2023;
Koruth JS, Kuroki K, Iwasawa J, et al. Endocardial ventricular pulsed field ablation: a proof-of-concept preclinical evaluation. Europace. 2020;22(3):434–9.
doi: 10.1093/europace/euz341
pubmed: 31876913
Mohanty S, Casella M, Compagnucci P, Torlapati PG, Della Rocca DG, La Fazia VM, Gianni C, Chierchia GB, MacDonald B, Mayedo A, Khan UN, Allison J, Bassiouny M, Gallinghouse GJ, Burkhardt JD, Horton R, Al-Ahmad A, Di Biase L, de Asmundis C, et al. Acute Kidney Injury resulting from hemoglobinuria after pulsed-field ablation in atrial fibrillation: is it preventable? JACC Clin Electrophysiol. 2024:S2405-500X(23)00959-3.
Venier S, Vaxelaire N, Jacon P, Carabelli A, Desbiolles A, Garban F, Defaye P. Severe acute kidney injury related to haemolysis after pulsed field ablation for atrial fibrillation. Europace. 2023;26(1):euad371.
doi: 10.1093/europace/euad371
pubmed: 38175788
Lemoine MD, Fink T, Mencke C, 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. 2023;112(6):795–806.
doi: 10.1007/s00392-022-02091-2
pubmed: 36131138
Urbanek L, Bordignon S, Schaack D, et al. Pulsed field versus cryoballoon pulmonary vein isolation for atrial fibrillation: efficacy, safety, and long-term follow-up in a 400-patient cohort. Circ Arrhythmia Electrophysiol. 2023;16(7):389–98.
doi: 10.1161/CIRCEP.123.011920