AIMS: Pulsed field ablation (PFA) is a novel atrial fibrillation (AF) ablation modality that has demonstrated preferential tissue ablation, including no oesophageal damage, in first-in-human clinical trials. In the MANIFEST-PF survey, we investigated the 'real world' performance of the only approved PFA catheter, including acute effectiveness and safety-in particular, rare oesophageal effects and other unforeseen PFA-related complications. METHODS AND RESULTS: This retrospective survey included all 24 clinical centres using the pentaspline PFA catheter after regulatory approval. Institution-level data were obtained on patient characteristics, procedure parameters, acute efficacy, and adverse events. With an average of 73 patients treated per centre (range 7-291), full cohort included 1758 patients: mean age 61.6 years (range 19-92), female 34%, first-time ablation 94%, paroxysmal/persistent AF 58/35%. Most procedures employed deep sedation without intubation (82.1%), and 15.1% were discharged same day. Pulmonary vein isolation (PVI) was successful in 99.9% (range 98.9-100%). Procedure time was 65 min (38-215). There were no oesophageal complications or phrenic nerve injuries persisting past hospital discharge. Major complications (1.6%) were pericardial tamponade (0.97%) and stroke (0.4%); one stroke resulted in death (0.06%). Minor complications (3.9%) were primarily vascular (3.3%), but also included transient phrenic nerve paresis (0.46%), and TIA (0.11%). Rare complications included coronary artery spasm, haemoptysis, and dry cough persistent for 6 weeks (0.06% each). CONCLUSION: In a large cohort of unselected patients, PFA was efficacious for PVI, and expressed a safety profile consistent with preferential tissue ablation. However, the frequency of 'generic' catheter complications (tamponade, stroke) underscores the need for improvement.

Asklepios Hospital St Georg Hamburg Germany

Cardiology Department Na Homolce Hospital Homolka Hospital Roentgenova 37 2 15030 Praha 5 Prague Czech Republic

Clinic for Electrophysiology Herz und Diabeteszentrum NRW Ruhr University Bochum Bad Oeynhausen Germany

Copenhagen University Hospital Copenhagen Denmark

Department for Cardiovascular Diseases University Hospital Center Split Split Croatia

Department of Cardiology and Vascular Medicine West German Heart and Vascular Center Essen University Duisburg Essen Duisburg Germany

Department of Cardiology Catharina Ziekenhuis Eindhoven Eindhoven The Netherlands

Department of Cardiology Jessa Hospitals Hasselt Belgium

Department of Cardiology Rouen Hospital Rouen France

Department of Cardiology University Hospital Rangueil Toulouse France

Department of Electrophysiology Alfried Krupp Hospital Essen Germany

Department of Medicine Witten Herdecke University Witten Germany

Department of Rhythmology University Heart Center Lubeck Germany

German Center for Cardiovascular Research Partner Site Hamburg Kiel Lübeck Lübeck Germany

Heart Center Bad Neustadt Rhoen Clinic Campus Bad Neustadt Bad Neustadt an der Saale Germany

Heart Rhythm Department Clinique Pasteur Toulouse France

I2MC INSERM UMR 1297 Toulouse France

Icahn School of Medicine at Mount Sinai New York NY USA

IHU LIRYC CHU Bordeaux University of Bordeaux Bordeaux France

IKEM Institute for Clinical and Experimental Medicine Prague Czech Republic

Inselspital Bern University Hospital University of Bern Bern Switzerland

LANS Cardio Hamburg Germany

Medical University of Graz Graz Austria

MVZ CCB Frankfurt und Main Taunus GbR Frankfurt Germany

Neuron Medical Brno Czech Republic

Universitair Medish Groningen Groningen The Netherlands

Universitair Ziekenhuis VUB Brussels Belgium

Universitätsklinikum Freiburg Breisgau Germany

Universitätsklinikum Köln AöR Köln Germany

University Heart and Vascular Center University of Hamburg Hamburg Germany

Erratum v

Europace. 2023 Feb 16;25(2):449. doi: 10.1093/europace/euac250. PubMed

Zobrazit více v PubMed

Atrial fibrillation. Centers for Disease Control and Prevention. 2021 Sep 27 [accessed 2022 Jan 22]. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm.

Turagam MK, Musikantow D, Whang W, Koruth JS, Miller MA, Langan Net al. . Catheter ablation or antiarrhythmic drugs for first-line therapy of atrial fibrillation: a meta-analysis of randomized controlled trials. JAMA Cardiol 2021;6:697–705. PubMed PMC

Mark DB, Anstrom KJ, Sheng S, Piccini JP, Baloch KN, Monahan KHet al. . Effect of catheter ablation vs medical therapy on quality of life among patients with atrial fibrillation: the CABANA randomized clinical Trial. JAMA 2019;321:1275–85. PubMed PMC

Marrouche NF, Brachmann J, Andresen D, Siebels J, Boersma L, Jordaens Let al. . Catheter ablation for atrial fibrillation with heart failure. N Engl J Med 2018;378:417–27. PubMed

Turagam MK, Garg J, Sartori S, Dukkipati SR, Reddy VY. Catheter ablation of atrial fibrillation in patients with heart failure. Ann Intern Med 2019;171:76–7. PubMed

Packer DL, Piccini JP, Monahan KH, Al-Khalidi HR, Silverstein AP, Noseworthy PAet al. . Ablation versus drug therapy for atrial fibrillation in heart failure: results from the CABANA trial. Circulation 2021;143:1377–90. PubMed PMC

Kirchhof P, Camm AJ, Goette A, Brandes A, Eckardt L, Elvan Aet al. . Early rhythm-control therapy in patients with atrial fibrillation. N Engl J Med 2020;383:1305–16. PubMed

Singh SM, d’Avila A, Singh SK, Stelzer P, Saad EB, Skanes Aet al. . Clinical outcomes after repair of left atrial esophageal fistulas occurring after atrial fibrillation ablation procedures. Heart Rhythm 2013;10:1591–97. PubMed

Kotnik T, Rems L, Tarek M, Miklavčič D. Membrane electroporation and electropermeabilization: mechanisms and models. Annu Rev Biophys 2019;48:63–91. PubMed

Neven K, van Es R, van Driel V, van Wessel H, Fidder H, Vink Aet al. . Acute and long-term effects of full-power electroporation ablation directly on the porcine esophagus. Circ Arrhythm Electrophysiol 2017;10:e004672. PubMed

Reddy VY, Koruth J, Jais P, Petru J, Timko F, Skalsky Iet al. . Ablation of atrial fibrillation with pulsed electric fields: an ultra-rapid, tissue-selective modality for cardiac ablation. JACC Clin Electrophysiol 2018;4:987–95. PubMed

Koruth JS, Kuroki K, Iwasawa J, Enomoto Y, Viswanathan R, Brose Ret al. . Preclinical evaluation of pulsed field ablation: electrophysiological and histological assessment of thoracic vein isolation. Circ Arrhythm Electrophysiol 2019;12:e007781. PubMed PMC

Reddy VY, Neuzil P, Koruth JS, Petru J, Funosako M, Cochet Het al. . Pulsed field ablation for pulmonary vein isolation in atrial fibrillation. J Am Coll Cardiol 2019;74:315–26. PubMed

Koruth JS, Kuroki K, Kawamura I, Brose R, Viswanathan R, Buck EDet al. . Pulsed field ablation versus radiofrequency ablation: esophageal injury in a novel porcine model. Circ Arrhythm Electrophysiol 2020;13:e008303. PubMed PMC

Cochet H, Nakatani Y, Sridi-Cheniti S, Cheniti G, Ramirez FD, Nakashima Tet al. . Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation. Europace 2021;23:1391–9. PubMed PMC

Reddy VY, Dukkipati SR, Neuzil P, Anic A, Petru J, Funasako Met al. . Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II. JACC Clin Electrophysiol 2021;7:614–27. PubMed

Reddy VY, Anic A, Koruth J, Petru J, Funasako M, Minami Ket al. . Pulsed field ablation in patients with persistent atrial fibrillation. J Am Coll Cardiol 2020;76:1068–80. PubMed

Gunawardene MA, Schaeffer BN, Jularic M, Eickholt C, Maurer T, Akbulak RÖet al. . Coronary Spasm During Pulsed Field Ablation of the Mitral Isthmus Line. JACC Clin Electrophysiol 2021;7:1618–20. PubMed

van Driel VJ, Neven K, van Wessel H, Vink A, Doevendans PA, Wittkampf FH. Low vulnerability of the right phrenic nerve to electroporation ablation. Heart Rhythm 2015;12:1838–44. PubMed

Kuroki K, Whang W, Eggert C, Lam J, Leavitt J, Kawamura Iet al. . Ostial dimensional changes after pulmonary vein isolation: pulsed field ablation vs radiofrequency ablation. Heart Rhythm 2020;17:1528–35. PubMed

Deshmukh A, Patel NJ, Pant S, Shah N, Chothani A, Mehta Ket al. . In-hospital complications associated with catheter ablation of atrial fibrillation in the United States between 2000 and 2010: analysis of 93,801 procedures. Circulation 2013;128:2104–12. PubMed

Cheng EP, Liu CF, Yeo I, Markowitz SM, Thomas G, Ip JEet al. . Risk of mortality following catheter ablation of atrial fibrillation. J Am Coll Cardiol 2019;74:2254–64. PubMed

Kim IC, Hur SH, Park NH, Jun DH, Cho YK, Nam CWet al. . Incidence and predictors of silent embolic cerebral infarction following diagnostic coronary angiography. Int J Cardiol 2011;148:179–82. PubMed

Dorenbeck U, Simon B, Skowasch D, Stüsser C, Gockel A, Schild HHet al. . Cerebral embolism with interventional closure of symptomatic patent foramen ovale: an MRI-based study using diffusion-weighted imaging. Eur J Neurol 2007;14:451–4. PubMed

Kahlert P, Knipp SC, Schlamann M, Thielmann M, Al-Rashid F, Weber Met al. . Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation 2010;121:870–8. PubMed

Haeusler KG, Koch L, Herm J, Kopp UA, Heuschmann PU, Endres Met al. . 3 Tesla MRI-detected brain lesions after pulmonary vein isolation for atrial fibrillation: results of the MACPAF study. J Cardiovasc Electrophysiol 2013;24:14–21. PubMed

Neven K, van Driel V, van Wessel H, van Es R, Doevendans PA, Wittkampf F. Epicardial linear electroporation ablation and lesion size. Heart Rhythm 2014;11:1465–70. PubMed

Wong KC, Lim C, Sadarmin PP, Jones M, Qureshi N, De Bono Jet al. . High incidence of acute sub-clinical circumflex artery ‘injury’ following mitral isthmus ablation. Eur Heart J 2011;32:1881–90. PubMed

Höwel D, Fueting AV, Reinsch N, Brokkaar L, Essling A, Neven K. Pulsed field ablation for atrial fibrillation is safe for the bronchial system. Clin Res Cardiol 2021. doi:10.1007/s00392-021-01933-9. DOI

Sun JH, Zhu TY, Chen XH, Nie CH, Ren ZG, Zhou GHet al. . In vivo evaluation of bronchial injury of irreversible electroporation in a porcine lung ablation model by using laboratory, pathological, and CT findings. Int J Clin Exp Path 2018;11:1273–80. PubMed PMC

Prediction of major intravascular hemolysis during pulsed electric field ablation of atrial fibrillation using a pentaspline catheter

Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study

First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation

Long-term outcomes of the pentaspline pulsed-field ablation catheter for the treatment of paroxysmal atrial fibrillation: results of the prospective, multicentre FARA-Freedom Study

Catheter ablation for non-paroxysmal atrial fibrillation. A review

Clinical Outcomes by Sex After Pulsed Field Ablation of Atrial Fibrillation

Reversible Pulsed Electrical Fields as an In Vivo Tool to Study Cardiac Electrophysiology: The Advent of Pulsed Field Mapping

Practical guidance to reduce radiation exposure in electrophysiology applying ultra low-dose protocols: a European Heart Rhythm Association review

Paroxysmal Atrial Fibrillation Ablation Using a Novel Variable-Loop Biphasic Pulsed Field Ablation Catheter Integrated With a 3-Dimensional Mapping System: 1-Year Outcomes of the Multicenter inspIRE Study