دورية أكاديمية
National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety.
العنوان: | National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety. |
---|---|
المؤلفون: | Bisignani A; Center of Excellence in Cardiovascular Sciences, Ospedale Isola Tiberina - Gemelli Isola, Via di Ponte Quattro Capi 39, 00186, Rome, Italy. abisignani@hotmail.it., Schiavone M; Monzino Cardiological Center, Milan, Italy., Solimene F; Montevergine Clinic, Mercogliano, AV, Italy.; Department of Biomedical Sciences and Public Health, Marche Polytechnic University, Ancona, Italy., Dello Russo A; Department of Biomedical Sciences and Public Health, Marche Polytechnic University, Ancona, Italy.; Department of Cardiology and Arrhythmology Clinic, University Hospital Ospedali Riuniti Umberto I-Lancisi-Salesi, Ancona, Italy., Filannino P; Maria Cecilia Hospital, Cotignola, RA, Italy., Magnocavallo M; Center of Excellence in Cardiovascular Sciences, Ospedale Isola Tiberina - Gemelli Isola, Via di Ponte Quattro Capi 39, 00186, Rome, Italy., Tondo C; Monzino Cardiological Center, Milan, Italy., Schillaci V; Montevergine Clinic, Mercogliano, AV, Italy., Casella M; Department of Cardiology and Arrhythmology Clinic, University Hospital Ospedali Riuniti Umberto I-Lancisi-Salesi, Ancona, Italy.; Department of Clinical, Special and Dental Sciences, Marche Polytechnic University, Ancona, Italy., Petretta A; Maria Cecilia Hospital, Cotignola, RA, Italy., Rossi P; Center of Excellence in Cardiovascular Sciences, Ospedale Isola Tiberina - Gemelli Isola, Via di Ponte Quattro Capi 39, 00186, Rome, Italy., Fassini G; Monzino Cardiological Center, Milan, Italy., Rossillo A; San Bortolo Hospital, Vicenza, Italy., Maggio R; Degli Infermi Hospital, Rivoli, TO, Italy., Themistoclakis S; Dell'Angelo Hospital, Mestre, VE, Italy., Pandozi C; San Filippo Neri Hospital, Rome, Italy., Polselli M; Center of Excellence in Cardiovascular Sciences, Ospedale Isola Tiberina - Gemelli Isola, Via di Ponte Quattro Capi 39, 00186, Rome, Italy., Tundo F; Monzino Cardiological Center, Milan, Italy., Arestia A; Montevergine Clinic, Mercogliano, AV, Italy., Compagnucci P; Department of Biomedical Sciences and Public Health, Marche Polytechnic University, Ancona, Italy.; Department of Cardiology and Arrhythmology Clinic, University Hospital Ospedali Riuniti Umberto I-Lancisi-Salesi, Ancona, Italy., Valente Perrone A; Boston Scientific, Milan, Italy., Malacrida M; Boston Scientific, Milan, Italy., Iacopino S; Maria Cecilia Hospital, Cotignola, RA, Italy., Bianchi S; Center of Excellence in Cardiovascular Sciences, Ospedale Isola Tiberina - Gemelli Isola, Via di Ponte Quattro Capi 39, 00186, Rome, Italy. |
المصدر: | Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing [J Interv Card Electrophysiol] 2024 May 30. Date of Electronic Publication: 2024 May 30. |
Publication Model: | Ahead of Print |
نوع المنشور: | Journal Article; Review |
اللغة: | English |
بيانات الدورية: | Publisher: Springer Country of Publication: Netherlands NLM ID: 9708966 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1572-8595 (Electronic) Linking ISSN: 1383875X NLM ISO Abbreviation: J Interv Card Electrophysiol Subsets: MEDLINE |
أسماء مطبوعة: | Publication: Amsterdam : Springer Original Publication: Norwell, MA : Kluwer Academic Publishers, c1997- |
مستخلص: | 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: 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: 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 2 0.92-0.68 across various procedural metrics). Current PFA skin-to-skin time was lower than the historical skin-to-skin one in 217 (62.4%) procedures; it was similar in 112 (32.2%) cases and higher than the historical skin-to-skin one in 19 (5.5%). No major complications were reported. 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: Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/ Identifier: NCT05617456. (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.) |
References: | 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. (PMID: 10.1161/CIRCULATIONAHA.113.00511924345399) 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. (PMID: 10.1093/europace/euac2373660384510062373) 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. (PMID: 10.1093/eurheartj/ehaa61232860505) 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. (PMID: 10.1093/eurheartj/ehad2503706204010344651) 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. (PMID: 10.1016/j.jjcc.2011.01.00521333498) 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. (PMID: 10.1056/NEJMoa160201427042964) 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. (PMID: 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. (PMID: 10.1161/CIRCULATIONAHA.123.06495937199171) 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. (PMID: 10.1093/europace/euac050356476449435639) 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. (PMID: 10.1093/europace/euac04135513354) 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. (PMID: 10.1093/europace/euac04435699395) Magni FT, Mulder BA, Groenveld HF, et al. Initial experience with pulsed field ablation for atrial fibrillation. Front Cardiovasc Med. 2022;9:959186. (PMID: 10.3389/fcvm.2022.959186364262269679623) 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. (PMID: 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. (PMID: 10.1093/europace/euab08533837418) 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. (PMID: 10.1007/s10840-021-01094-934791605) 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. (PMID: 10.1007/s10840-021-00968-233629193) 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. (PMID: 10.1093/eurheartj/ehu00124487524) 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. (PMID: 10.1093/europace/eux23329016870) 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. (PMID: 10.1093/europace/euz34131876913) 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. (PMID: 10.1093/europace/euad37138175788) 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. (PMID: 10.1007/s00392-022-02091-236131138) 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. (PMID: 10.1161/CIRCEP.123.011920) |
فهرسة مساهمة: | Keywords: Atrial fibrillation; Clinical practice; Electroporation; Learning curve; Pulsed-field ablation |
سلسلة جزيئية: | ClinicalTrials.gov NCT05617456 |
تواريخ الأحداث: | Date Created: 20240530 Latest Revision: 20240530 |
رمز التحديث: | 20240530 |
DOI: | 10.1007/s10840-024-01835-6 |
PMID: | 38814525 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1572-8595 |
---|---|
DOI: | 10.1007/s10840-024-01835-6 |