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Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study
E. Ekanem, P. Neuzil, T. Reichlin, J. Kautzner, P. van der Voort, P. Jais, GB. Chierchia, A. Bulava, Y. Blaauw, T. Skala, M. Fiala, M. Duytschaever, G. Szeplaki, B. Schmidt, G. Massoullie, K. Neven, O. Thomas, J. Vijgen, E. Gandjbakhch, D....
Language English Country United States
Document type Journal Article, Multicenter Study
NLK
ProQuest Central
from 2000-01-01 to 1 year ago
Health & Medicine (ProQuest)
from 2000-01-01 to 1 year ago
- MeSH
- Atrial Fibrillation * surgery therapy MeSH
- Catheter Ablation * adverse effects methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Postoperative Complications epidemiology etiology MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
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 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
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 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 Medicine Witten Herdecke University Witten Germany
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
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 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
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
Semmelweis University Cardiovascular Center Budapest Hungary
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
References provided by Crossref.org
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- 700 1_
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