Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

1st Chair and Department of Cardiology Warsaw Medical University Warsaw Poland

Allgemeines Krankenhaus Universitätsklinik Wien Wien Austria

Aragón Health Research Institute Zaragoza Spain

Arrhythmia Unit Cardiology Department Lisbon Academic Medical Center Santa Maria University Hospital Lisbon Portugal

Arrhythmia Unit Cardiology Department University Hospital Ramón y Cajal Madrid Spain

Arrhythmias Unit Cardiology Department Lozano Blesa Clinical University Hospital Zaragoza Spain

Arrhythmology Clinic Department Azienda Ospedaliera Universitaria delle Marche Ancona Italy

Arrhytmia Service Cardiology Department University Hospital Marqués de Valdecilla Santander Spain

Asklepios Hospital St Georg Hamburg Germany

Atrial Fibrillation Institute Mater Private Hospital Dublin Ireland

Az sint jan Hospital Bruges Belgium

Black Rock Clinic Dublin Ireland

Campus Virchow Klinikum Deutsches Herzzentrum der Charité Berlin Germany

Capio Arytmi center Stockholm Sweden

Cardioangiologisches Centrum Bethanien Frankfurt Germany

Cardiology Department Grenoble Alpes University Hospital and University Grenoble France

Cardiology Department Royal Papworth Hospital Cambridge UK

Cardiovascular Research Institute Royal College of Surgeons in Ireland Dublin Ireland

Carl Thiem Klinikum Cottbus Cottbus Germany

Catharina Ziekenhuis Eindhoven Eindhoven the Netherlands

Centre Cardiologique du Nord Saint Denis France

Centre Hospitalier Princesse Grace Jardin Exotico Monaco

Ceske Budejovice Hospital and Faculty of Health and Social Sciences University of South Bohemia in Ceske Budejovice Ceske Budejovice Czech Republic

Christliches Klinikum Unna Unna Germany

CHRU de Tours Hôpital Trousseau Saint Avertin France

Clermont Ferrand university hospital Clermont Ferrand France

Clinic for Cardiology 2 Electrophysiology University of Münster Münster Germany

Clinica Universidad de Navarra University of Navarra Pamplona Spain

Clinique du Millenaire Montpellier France

Copenhagen University Hospital Gentofte Gentofte Denmark

Department for Electrophysiology Heart Center University Cologne Cologne Germany

Department of Biomedical Science and Public Health UNIVPM Ancona Italy

Department of Biomedical Surgical and Dental Sciences University of Milan Milan Italy

Department of Cardiology and Intensive Care Medicine St Vincenz Hospital Paderborn Germany

Department of Cardiology Cardiovascular Research Institute Maastricht Maastricht University Medical Centre Maastricht the Netherlands

Department of Cardiology Inselspital Bern University Hospital University of Bern Bern Switzerland

Department of Cardiology Medical University of Lublin Lublin Poland

Department of Cardiology San Bortolo Hospital Vicenza Italy

Department of Electrophysiology Alfried Krupp Hospital Essen Germany

Department of Internal Medicine and Cardiology University Clinical Center Medical University of Warsaw Warsaw Poland

Department of Medicine Witten Herdecke University Witten Germany

Department of Rhythmology University Heart Center Lübeck University Hospital Schleswig Holstein Lübeck Germany

Faculty of Health and Medical Sciences Department of Biomedical Sciences University of Copenhagen Copenhagen Denmark

FNKV Prague Czech Republic

German Center for Cardiovascular Research Partner Site Lübeck Lübeck Germany

GHICL Hôpital Saint Philibert Saint Philibert France

GHP Ambroise Paré Hartmann Neuilly sur Seine France

Göttingen University Medical Center Göttingen Germany

Hannover Heart Rhythm Center Department of Cardiology and Angiology Hannover Medical School Hannover Germany

Heart and Diabetes Center NRW Ruhr University Bochum Bochum Germany

Heart Center Bad Neustadt Neustadt Germany

Heart Center Bonn Department of Internal Medicine 2 University Hospital Bonn Bonn Germany

Heart Rhythm Management Centre Postgraduate Program in Cardiac Electrophysiology and Pacing Universitair Ziekenhuis Brussel Vrije Universiteit Brussel European Reference Networks Guard Heart Brussels Belgium

Heart Rhythm Management Department Clinique Pasteur Toulouse France

Henry Dunant Hospital Athens Greece

Hirslanden Klinik Beau Site Bern Switzerland

Homolka Hospital Prague Czech Republic

Hopital de la Croix Rousse Nord Nord France

Hospital Clínico Universitario de Valencia Valencia Spain

Hospital de Santa Cruz Carnaxide Portugal

Hospital Doce de Octubre Madrid Spain

Hospital Quironsalud Zaragoza Spain

Icahn School of Medicine at Mount Sinai New York NY USA

IHU LIRYC CHU Bordeaux University of Bordeaux Bordeaux France

IKEM Prague Czech Republic

Instituto de Investigación Sanitaria de Navarra Pamplona Spain

Jessa Hospitals Hasselt Belgium

Kantonsspital Baden AG Baden Switzerland

Klinikum Ingolstadt Ingolstadt Germany

Knappschaftskrankenhaus Recklinghausen Recklinghausen Germany

L'Hôpital Privé du Confluent Nantes France

Linköpings University Hospital Linköping Sweden

Liverpool Heart and Chest Hospital Liverpool UK

MAESTRIA Consortium at AFNET Münster Germany

Maria Cecilia Hospital Cotignola Italy

Medical University of Graz Graz Austria

Medical University of Tuebingen Tuebingen Germany

Medisch Spectrum Twente Enschede the Netherlands

MITERA Hospital Marousi Greece

Montevergine Clinic Mercogliano Italy

National Institute of Cardiology Warsaw Poland

Neuron Medical Brno Czech Republic

NHSSC Royal Bournemouth Hospital Bournemouth UK

OLVG Amsterdam the Netherlands

Onassis Cardiac Surgery Center Department of Cardiac Electrophysiology and Pacing Athens Greece

Ordensklinikum Linz Elisabethinen Linz Austria

Ospedale dell'Angelo Mestre Italy

Ospedale Isola Tiberina Gemelli Rome Italy

Otto von Guericke University Magdeburg Germany

Pole Sante Republique Elsan Clermont Ferrand France

Polytechnic and University La Fe Hospital Valencia Spain

Praxisklinik Herz und Gefäße Dresden Germany

Privathospitalet mølholm a s Vejle Denmark

Regional Hospital Liberec Liberec Czech Republic

Rigshospitalet University Hospital of Copenhagen Copenhagen Denmark

Rouen Hospital Rouen France

Royal Brompton and Harefield Hospitals Guy's and St Thomas' NHS Foundation Trust King's College and Imperial College London UK

Semmelweis University Cardiovascular Center Budapest Hungary

Sorbonne Université APHP Pitié Salpêtrière Hospital Institute of Cardiology ICAN Institute for Cardiometabolism and Nutrition Paris France

St Johannes Hospital Dortmund Dortmund Germany

Städtisches Klinikum Karlsruhe Karlsruhe Germany

Tampere Heart Hospital Tampere University Hospital Tampere Finland

Tel Aviv Sourasky Medical Center Tel Aviv Israel

Uniklinikum RWTH Aachen Department of Cardiology Aachen Germany

Universitair Medish Groningen Groningen the Netherlands

Universitätsklinikum Düsseldorf Düsseldorf Germany

Universitätsklinikum essen Essen Germany

Universitätsklinikum Freiburg Freiburg Germany

Universitätsklinikum Köln AöR Köln Germany

University Duisburg Essen Duisburg Germany

University Heart and Vascular Center Hamburg Germany

University Hospital Basel Basel Switzerland

University Hospital Center Split Split Croatia

University Hospital Frankfurt Goethe University Frankfurt Frankfurt Germany

University Hospital Olomouc Olomouc Czech Republic

University Hospital Rangueil Toulouse France

University of Brussels VUB Jette Brussels Belgium

Vivantes Klinikum Am Urban Berlin Germany

Winchester Cardiology and Vascular Medicine Winchester Medical Center Valley Health Winchester VA USA

Ziekenhuis Oost Limburg Genk Belgium

Zobrazit více v PubMed

Mark, D. B. et al. Effect of catheter ablation vs medical therapy on quality of life among patients with atrial fibrillation. PubMed DOI PMC

Turagam, M. K. et al. Catheter ablation of atrial fibrillation in patients with heart failure. PubMed DOI

Marrouche, N. F. et al. Catheter ablation for atrial fibrillation with heart failure. PubMed DOI

Packer, D. L. et al. Ablation versus drug therapy for atrial fibrillation in heart failure: results from the CABANA trial. PubMed DOI PMC

Kuck, K.-H. et al. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. PubMed DOI PMC

Turagam, M. K. et al. Assessment of catheter ablation or antiarrhythmic drugs for first-line therapy of atrial fibrillation. PubMed DOI PMC

Kirchhof, P. et al. Early rhythm-control therapy in patients with atrial fibrillation. PubMed DOI

Tilz, R. R. et al. A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study. PubMed DOI PMC

Calkins, H. et al. HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation. PubMed DOI

Deshmukh, A. et al. In-hospital complications associated with catheter ablation of atrial fibrillation in the United States between 2000 and 2010. PubMed DOI

Kotnik, T., Rems, L., Tarek, M. & Miklavčič, D. Membrane electroporation and electropermeabilization: mechanisms and models. PubMed DOI

Reddy, V. Y. et al. Ablation of atrial fibrillation with pulsed electric fields. PubMed DOI

Neven, K. et al. Acute and long-term effects of full-power electroporation ablation directly on the porcine esophagus. PubMed DOI

Koruth, J. et al. Preclinical evaluation of pulsed field ablation: electrophysiological and histological assessment of thoracic vein isolation. PubMed DOI PMC

Koruth, J. S. et al. Pulsed field ablation versus radiofrequency ablation: esophageal injury in a novel porcine model. PubMed DOI PMC

Cochet, H. et al. Pulsed field ablation selectively spares the oesophagus during pulmonary vein isolation for atrial fibrillation. PubMed DOI PMC

Reddy, V. Y. et al. Pulsed field ablation for pulmonary vein isolation in atrial fibrillation. PubMed DOI

Reddy, V. Y. et al. Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II. PubMed DOI

Reddy, V. Y. et al. Pulsed field ablation in patients with persistent atrial fibrillation. PubMed DOI

Ekanem, E. et al. Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF). PubMed DOI PMC

Turagam, M. K. et al. Safety and effectiveness of pulsed field ablation to treat atrial fibrillation: one-year outcomes from the MANIFEST-PF registry. PubMed DOI

Schmidt, B. et al. European real-world outcomes with pulsed field ablation in patients with symptomatic atrial fibrillation: lessons from the multi-centre EU-PORIA registry. PubMed DOI PMC

Reddy, V. Y. et al. Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation. PubMed DOI

Kawasaki, R., Gauri, A., Elmouchi, D., Duggal, M. & Bhan, A. Atrioesophageal fistula complicating cryoballoon pulmonary vein isolation for paroxysmal atrial fibrillation. PubMed DOI

Metzner, A. et al. Increased incidence of esophageal thermal lesions using the second-generation 28-mm cryoballoon. PubMed DOI

Straube, F. et al. Comparison of the first and second cryoballoon: high-volume single-center safety and efficacy analysis. PubMed DOI

Bakir, N. H. et al. Concomitant surgical ablation for atrial fibrillation is associated with increased risk of acute kidney injury but improved late survival. PubMed DOI PMC

van Driel, V. J. H. M. et al. Low vulnerability of the right phrenic nerve to electroporation ablation. PubMed DOI

Yavin, H. et al. Pulsed field ablation using a lattice electrode for focal energy delivery: biophysical characterization, lesion durability, and safety evaluation. PubMed DOI PMC

Kuroki, K. et al. Ostial dimensional changes after pulmonary vein isolation: pulsed field ablation vs radiofrequency ablation. PubMed DOI

Meissner, A. et al. Impact of irrigated energy application on the right coronary artery hemodynamics: FFR measurement in patients who underwent ablation of common type atrial flutter. PubMed DOI

Wong, K. C. K. et al. High incidence of acute sub-clinical circumflex artery ‘injury’ following mitral isthmus ablation. PubMed DOI

Reddy, V. Y. et al. Coronary arterial spasm during pulsed field ablation to treat atrial fibrillation. PubMed DOI

Zhang, C. et al. Coronary artery spasm during pulsed field vs radiofrequency catheter ablation of the mitral isthmus. PubMed DOI PMC

Gunawardene, M. A. et al. Coronary spasm during pulsed field ablation of the mitral isthmus line. PubMed DOI

Della Rocca, D. G. et al. Transient inferior ST-segment elevation and ventricular fibrillation after cavotricuspid isthmus pulsed-field ablation. PubMed DOI

Nakamura, T. et al. Incidence and characteristics of coronary artery spasms related to atrial fibrillation ablation procedures – large-scale multicenter analysis. PubMed DOI

Kinosita, K. Jr. & Tsong, T. Y. Voltage-induced pore formation and hemolysis of human erythrocytes. PubMed DOI

Moroz, V. V., Bogushevich, M. S., Chernysh, A. M., Kozlova, E. K. & Sharakshane, A. S. Effect of defibrillation pulses of different shapes on biomembranes: experimental study. PubMed DOI

Davong, B. et al. Pulsed-field ablation on mitral isthmus in persistent atrial fibrillation: preliminary data on efficacy and safety. PubMed DOI

Cheng, E. P. et al. Risk of mortality following catheter ablation of atrial fibrillation. PubMed DOI

Kim, I.-C. et al. Incidence and predictors of silent embolic cerebral infarction following diagnostic coronary angiography. PubMed DOI

Kahlert, P. et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation. PubMed DOI

Verma, A. et al. Pulsed field ablation for the treatment of atrial fibrillation: Pulsed af pivotal trial. PubMed DOI PMC

Haeusler, K. G. et al. MRI-detected brain lesions and cognitive function in patients with atrial fibrillation undergoing left atrial catheter ablation in the randomized AXAFA-AFNET 5 trial. PubMed DOI

High-Voltage Focal Pulsed Field Ablation to Treat Scar-Related Ventricular Tachycardia: The First-in-Human VCAS Trial

Pulsed field ablation and the risk of hemolysis-driven acute kidney injury: a systematic review and meta-analysis

Acute durability of cavotricuspid isthmus block after pulsed electric field ablation: randomized comparison of two pentaspline catheter configurations (SECTION trial)

Real-world experience with the pentaspline pulsed field ablation system: one-year outcomes of the FARADISE registry

Repeat procedures after pulsed field ablation for atrial fibrillation: MANIFEST-REDO study

Safety and effectiveness of the first balloon-in-basket pulsed field ablation system for the treatment of atrial fibrillation: VOLT CE Mark Study 6-month results

Mapping and ablation of ventricular tachycardia using dual-energy lattice-tip focal catheter: early feasibility and safety study