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

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