Pulsed Field Ablation-Based Pulmonary Vein Isolation Using a Simplified Single-Access Single-Catheter Approach ― The Fast and Furious PFA Study
Background: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closu...
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| Published in | Circulation Journal Vol. 87; no. 12; pp. 1722 - 1726 |
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| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Japan
The Japanese Circulation Society
24.11.2023
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Background: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.Methods and Results: Consecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm.Conclusions: The combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low. |
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| AbstractList | Background: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.Methods and Results: Consecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm.Conclusions: The combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low. Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system. Consecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm. The combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low. Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.BACKGROUNDPulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and fast method of pulmonary vein isolation (PVI) utilizing a penta-spline PFA catheter via a single femoral vein and a venous closure system.Consecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm.METHODS AND RESULTSConsecutive patients (n=50; mean age: 63.6±10.7 years, 38% female) presenting with AF (paroxysmal AF: 56%) underwent first-time PVI via PFA. A single ultrasound-guided femoral vein puncture and a single transseptal puncture were used. After PVI using the penta-spline PFA catheter, extra pulse trains were added to the posterior wall for wide antral circumferential ablation. A venous closure system was used and a Donati suture was performed. The pressure bandage was removed after 1 h. A total of 196 PVs were identified and isolated with PFA only. The mean procedural time was 27.4±6.6 min, and the mean dwelling time was 14.4±5.5 min. Time to ambulation was 3.3±3.1 h. No severe complications occurred. During a mean follow-up of 6.5±2.1 months, 41/50 patients (82%) remained in sinus rhythm.The combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low.CONCLUSIONSThe combination of a single venous puncture, single transseptal puncture approach using PFA and vascular closure device resulted in a 100% rate of acute PVI and an extraordinarily fast procedure and time to ambulation. The rate of periprocedural complications was low. |
| ArticleNumber | CJ-23-0389 |
| Author | Hatahet, Sascha Große, Niels Subin, Behnam Kuck, Karl-Heinz Kirstein, Bettina Lopez, Lisbeth Delgado Tilz, Roland R. Phan, Huong-Lan Heeger, Christian-H. Eitel, Charlotte Popescu, Sorin Ștefan Vogler, Julia |
| Author_xml | – sequence: 1 fullname: Vogler, Julia organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Kuck, Karl-Heinz organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Tilz, Roland R. organization: German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck – sequence: 1 fullname: Popescu, Sorin Ștefan organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Kirstein, Bettina organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Eitel, Charlotte organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Phan, Huong-Lan organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Lopez, Lisbeth Delgado organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Hatahet, Sascha organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Heeger, Christian-H. organization: German Center for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck – sequence: 1 fullname: Große, Niels organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein – sequence: 1 fullname: Subin, Behnam organization: Department of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein |
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| CitedBy_id | crossref_primary_10_1007_s10840_023_01664_z crossref_primary_10_1016_j_hrthm_2024_09_060 crossref_primary_10_1111_jce_16411 crossref_primary_10_4103_IJHR_IJHR_3_23 crossref_primary_10_1093_ehjdh_ztae013 crossref_primary_10_1111_jce_16113 crossref_primary_10_3390_biomedicines12102375 crossref_primary_10_1002_joa3_70011 crossref_primary_10_3390_jcm13113113 crossref_primary_10_1007_s00399_025_01071_z crossref_primary_10_1093_europace_euae105 crossref_primary_10_1016_j_jacasi_2024_09_014 crossref_primary_10_1253_circj_CJ_24_0859 crossref_primary_10_3390_medicina60050817 crossref_primary_10_1253_circj_CJ_23_0596 crossref_primary_10_31083_j_rcm2511415 |
| Cites_doi | 10.1161/CIRCEP.121.010817 10.1093/eurheartj/ehab648 10.1093/europace/euac050 10.1161/CIRCEP.119.007781 10.1161/CIRCEP.121.010516 10.1093/europace/euad022 10.1161/CIRCEP.122.011547 10.1093/eurheartj/ehad250 10.1016/j.jacc.2019.04.021 10.1007/s10840-023-01510-2 10.1093/europace/eux175 10.1093/europace/euac053.234 10.1093/europace/euac111 10.1016/j.ipej.2022.01.005 10.1161/CIRCULATIONAHA.119.042622 10.1093/europace/euac053.058 10.1016/j.hrthm.2022.03.488 10.1007/s12181-017-0179-4 10.1016/j.ijcha.2020.100576 10.1016/j.jacep.2021.02.014 |
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| Keywords | Pulse field ablation Venous closure system Atrial fibrillation Acute efficacy Pulmonary vein isolation |
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Preclinical evaluation of pulsed field ablation: Electrophysiological and histological assessment of thoracic vein isolation. Circ Arrhythm Electrophysiol 2019; 12: e007781. 2. Fabbricatore D, Buytaert D, Valeriano C, Mileva N, Paolisso P, Nagumo S, et al. Ambulatory pulmonary vein isolation workflow using the Perclose ProglideTM suture-mediated vascular closure device: The PRO-PVI study. Europace 2023; 25: 1361–1368. 5. Tilz RR, Schmidt V, Pürerfellner H, Maury P, Chun KJ, Martinek M, 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: 2458–2469. 6. 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: 1256–1266. 1. 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Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillation: A multicentre randomized efficacy and safety trial (ULTRA-FAST trial). Europace 2017; 20: 1107–1114. 11 12 13 14 15 16 17 18 19 1 2 3 4 5 6 7 8 9 20 10 37730372 - Circ J. 2023 Nov 24;87(12):1727-1729. doi: 10.1253/circj.CJ-23-0596 |
| References_xml | – reference: 4. Heeger CH, Tiemeyer CM, Phan HL, Meyer-Saraei R, Fink T, Sciacca V, et al. Rapid pulmonary vein isolation utilizing the third-generation laserballoon: The PhoeniX registry. Int J Cardiol Heart Vasc 2020; 29: 100576. – reference: 14. Nentwich K, Ene EE, Berkowitz AB, Simu GS, Sonne KS, Mueller JM, et al. Acute safety and efficacy outcome of pulmonary vein isolation using pulsed field ablation technology. EP Europace 2022; 24(Suppl 1): euac053.058, doi:10.1093/europace/euac053.058. – reference: 1. Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, et al. 2020 ESC guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of 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 2020; 42: 373–498. – reference: 20. Yamagata K, Wichterle D, Roubícek T, Jarkovský P, Sato Y, Kogure T, et al. Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillation: A multicentre randomized efficacy and safety trial (ULTRA-FAST trial). Europace 2017; 20: 1107–1114. – reference: 13. Winkelmann SJ, Lemoine MD, Wuerger T, Schleberger R, Rottner L, Dinshaw L, et al. Safety of pulsed-field ablation in patients with cardiac implantable electronic devices: A single-center pilot study. EP Europace 2022; 24(Suppl 1): euac053.234, doi:10.1093/europace/euac053.234. – reference: 10. Tilz RR, Chun KRJ, Deneke T, Kelm M, Piorkowski C, Sommer P, et al. Positionspapier der Deutschen Gesellschaft für Kardiologie zur Kardioanalgosedierung. Der Kardiologe 2017; 11: 369–382 (in German). – reference: 11. 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: 315–326. – reference: 5. Tilz RR, Schmidt V, Pürerfellner H, Maury P, Chun KJ, Martinek M, 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: 2458–2469. – reference: 8. Heeger CH, Tilz RR. Pulsed-field ablation: Are we ready for fast and furious atrial tachycardia ablation? J Interv Card Electrophysiol 2023, doi:10.1007/s10840-023-01510-2. – reference: 2. Fabbricatore D, Buytaert D, Valeriano C, Mileva N, Paolisso P, Nagumo S, et al. Ambulatory pulmonary vein isolation workflow using the Perclose ProglideTM suture-mediated vascular closure device: The PRO-PVI study. Europace 2023; 25: 1361–1368. – reference: 15. 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; 25: 65–73. – reference: 17. 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: 614–627. – reference: 18. Gunawardene M, Schaeffer B, Eickholt C, Hartmann J, Anwar O, Gessler N, et al. 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| Snippet | Background: Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe,... Pulsed field ablation (PFA) is a non-thermal energy source with promising safety and efficacy advantages. We aimed to develop a convenient, safe, effective and... |
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| SubjectTerms | Acute efficacy Aged Atrial fibrillation Atrial Fibrillation - surgery Catheter Ablation - methods Catheters Female Humans Male Middle Aged Pulmonary vein isolation Pulmonary Veins - surgery Pulse field ablation Treatment Outcome Venous closure system |
| Title | Pulsed Field Ablation-Based Pulmonary Vein Isolation Using a Simplified Single-Access Single-Catheter Approach ― The Fast and Furious PFA Study |
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