Evidence map›Paper›PMID 38977913›Full record

ArticleNature medicine2024

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

Emmanuel Ekanem, Petr Neuzil, Tobias Reichlin, Joseph Kautzner, Pepijn van der Voort, Pierre Jais, Gian-Battista Chierchia, Alan Bulava, Yuri Blaauw, Tomas Skala and 129 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Nature medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07621003 (PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The "PULSE - Study"), which is not on this map. Cited by 291 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
291citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07621003 narecruitingnot on this mapstarted 2026, after this paper: background citation

PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The "PULSE - Study"

TypeinterventionalSponsorAsklepios proresearchRan2026 to 2031Enrolled264ConditionsAtrial FibrillationArmsAblation of atrial fibrillation (AF)
3 · Its place in the literature

Who cites it

291 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pulsed field ablation for the interventional treatment of atrial fibrillation: a scientific statement of the European Heart Rhythm Association of the European Society of Cardiology, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, the Latin American Heart Rhythm Society, and the Canadian Heart Rhythm Society.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Guideline
  3. Pulsed field ablation and the risk of hemolysis-driven acute kidney injury: a systematic review and meta-analysis.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Ethanol infusion of the vein of marshall-based strategies for persistent atrial fibrillation: a systematic review and meta-analysis of randomized trials.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pulmonary vein isolation durability in a randomized trial comparing fluoroscopy-only vs. electroanatomic mapping strategies for pulmonary vein isolation with balloon-in-basket pulsed-field ablation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Trial
  11. Autonomic effects and ablation success after pulsed field and cryoballoon ablation: a SINGLE SHOT CHAMPION substudy.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Trial
  12. Safety and effectiveness of the TactiFlex duo system: 6-month results of the FOCALFLEX study.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Trial
  13. Trial
  14. Trial
  15. Trial
  16. Impact of saline irrigation on haemolysis, silent cerebral lesion incidence, thermal dynamics, and bubble formation in pulsed field ablation with a variable-loop circular catheter.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Trial
  17. Biophysical principles of pulsed field ablation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Review
  18. Specific effects of Pulsed Field Ablation on the cardiac tissue, the nervous system and the conduction system in experimental and clinical studies.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Review
  19. The future of PFA in cardiac ablation procedures.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Review
  20. Safety considerations and clinical monitoring during pulsed field ablation.Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2026
    Review

231 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

139 authors.

Emmanuel EkanemIcahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-4128-8800
Petr NeuzilHomolka Hospital, Prague, Czech Republic.
Tobias ReichlinDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Joseph KautznerIKEM, Prague, Czech Republic.
Pepijn van der VoortCatharina Ziekenhuis Eindhoven, Eindhoven, the Netherlands.
Pierre JaisIHU LIRYC, CHU Bordeaux, University of Bordeaux, Bordeaux, France.
Gian-Battista ChierchiaHeart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, European Reference Networks Guard-Heart, Brussels, Belgium.
Alan BulavaCeske Budejovice Hospital and Faculty of Health and Social Sciences, University of South Bohemia in Ceske Budejovice, Ceske Budejovice, Czech Republic.
Yuri BlaauwUniversitair Medish Groningen, Groningen, the Netherlands.
Tomas SkalaUniversity Hospital Olomouc, Olomouc, Czech Republic.
Martin FialaNeuron Medical, Brno, Czech Republic.
Mattias DuytschaeverAz sint jan Hospital, Bruges, Belgium.
Gabor SzeplakiAtrial Fibrillation Institute, Mater Private Hospital, Dublin, Ireland.
Boris SchmidtCardioangiologisches Centrum Bethanien, Frankfurt, Germany.
Grégoire MassoullieClermont Ferrand university hospital, Clermont-Ferrand, France.ORCID 0000-0002-9547-0835
Kars NevenDepartment of Electrophysiology, Alfried Krupp Hospital, Essen, Germany.ORCID 0000-0002-2075-8113
Olivier ThomasGHP Ambroise Paré Hartmann, Neuilly sur Seine, France.
Johan VijgenJessa Hospitals, Hasselt, Belgium.
Estelle GandjbakhchSorbonne Université, APHP, Pitié-Salpêtrière Hospital, Institute of Cardiology, ICAN Institute for Cardiometabolism and Nutrition, Paris, France.
Daniel ScherrMedical University of Graz, Graz, Austria.
Arne JohannessenCopenhagen University Hospital Gentofte, Gentofte, Denmark.
David KeaneBlack Rock Clinic, Dublin, Ireland.
Serge BovedaHeart Rhythm Management Department, Clinique Pasteur, Toulouse, France.ORCID 0000-0002-1280-7042
Philippe MauryUniversity Hospital Rangueil, Toulouse, France.
Ignacio García-BolaoClinica Universidad de Navarra, University of Navarra, Pamplona, Spain.
Ante AnicUniversity Hospital Center Split, Split, Croatia.
Peter Steen HansenPrivathospitalet mølholm a/s, Vejle, Denmark.
Franck RaczkaClinique du Millenaire, Montpellier, France.
Antoine LepillierCentre Cardiologique du Nord, Saint-Denis, France.
Yves GuyomarGHICL Hôpital Saint Philibert, Saint Philibert, France.
Dhiraj GuptaLiverpool Heart and Chest Hospital, Liverpool, UK.
Jurren Van OpstalMedisch Spectrum Twente, Enschede, the Netherlands.
Pascal DefayeCardiology Department, Grenoble Alpes University Hospital and University, Grenoble, France.
Christian SticherlingUniversity Hospital Basel, Basel, Switzerland.ORCID 0000-0001-8428-7050
Philipp SommerHeart and Diabetes Center NRW, Ruhr University Bochum, Bochum, Germany.
Pavel KuceraRegional Hospital Liberec, Liberec, Czech Republic.
Joaquin OscaPolytechnic and University La Fe Hospital, Valencia, Spain.
Fariborz TabriziCapio Arytmi center, Stockholm, Sweden.
Antoine RouxPole Sante Republique Elsan, Clermont-Ferrand, France.
Michael GramlichUniklinikum RWTH Aachen, Department of Cardiology, Aachen, Germany.
Stefano BianchiOspedale Isola Tiberina Gemelli, Rome, Italy.ORCID 0000-0002-2307-8105
Pedro AdragãoHospital de Santa Cruz, Carnaxide, Portugal.
Francesco SolimeneMontevergine Clinic (AV), Mercogliano, Italy.
Claudio TondoDepartment of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.
Antonio Dello RussoDepartment of Biomedical Science and Public Health, UNIVPM, Ancona, Italy.
Jürgen SchreieckMedical University of Tuebingen, Tuebingen, Germany.
Armin LuikStädtisches Klinikum Karlsruhe, Karlsruhe, Germany.
Obaida RanaUniversitätsklinikum Düsseldorf, Düsseldorf, Germany.ORCID 0000-0002-7956-3249
Gerrit FrommeyerClinic for Cardiology II, Electrophysiology, University of Münster, Münster, Germany.
Frédéric AnselmeRouen Hospital, Rouen, France.
Ingo KreisSt. Johannes Hospital Dortmund, Dortmund, Germany.
Raphael RossoTel Aviv Sourasky Medical Center, Tel Aviv, Israel.
Andreas MetznerUniversity Heart and Vascular Center, Hamburg, Germany.
Laszlo GellerSemmelweis University, Cardiovascular Center, Budapest, Hungary.
Samuel H BaldingerHirslanden Klinik Beau-Site, Bern, Switzerland.
Angel FerreroHospital Clínico Universitario de Valencia, Valencia, Spain.
Stephan WillemsAsklepios Hospital St. Georg, Hamburg, Germany.
Andreas GoetteDepartment of Cardiology and Intensive Care Medicine, St. Vincenz-Hospital, Paderborn, Germany.ORCID 0000-0002-8223-7209
Greg MellorCardiology Department, Royal Papworth Hospital, Cambridge, UK.
Shibu MathewUniversitätsklinikum essen, Essen, Germany.ORCID 0000-0001-6884-9690
Lukasz SzumowskiNational Institute of Cardiology, Warsaw, Poland.
Roland TilzDepartment of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.
Saverio IacopinoMaria Cecilia Hospital, Cotignola, Italy.
Peter Karl JacobsenRigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-1520-8774
Andrikopoulos GeorgeHenry Dunant Hospital, Athens, Greece.
Pavel OsmancikFNKV, Prague, Czech Republic.
Stefan SpitzerPraxisklinik Herz und Gefäße, Dresden, Germany.
Richard BalasubramaniamNHSSC Royal Bournemouth Hospital, Bournemouth, UK.
Abdul Shokor ParwaniCampus Virchow Klinikum, Deutsches Herzzentrum der Charité, Berlin, Germany.
Thomas DenekeHeart Center Bad Neustadt, Neustadt, Germany.
Andrzej GlowniakDepartment of Cardiology, Medical University of Lublin, Lublin, Poland.ORCID 0000-0001-5398-4179
Antonio RossilloDepartment of Cardiology, San Bortolo Hospital, Vicenza, Italy.
Helmut PürerfellnerOrdensklinikum Linz Elisabethinen, Linz, Austria.
David DunckerHannover Heart Rhythm Center, Department of Cardiology and Angiology, Hannover Medical School, Hannover, Germany.ORCID 0000-0003-2996-6338
Peter ReilKlinikum Ingolstadt, Ingolstadt, Germany.
Thomas ArentzUniversitätsklinikum Freiburg, Freiburg, Germany.
Daniel StevenUniversitätsklinikum Köln AöR, Köln, Germany.
Juan José OlallaArrhytmia Service, Cardiology Department, University Hospital Marqués de Valdecilla, Santander, Spain.
Jonas S S G de JongOLVG, Amsterdam, the Netherlands.
Reza WakiliUniversity Duisburg-Essen, Duisburg, Germany.
Selim AbbeyL'Hôpital Privé du Confluent, Nantes, France.
Gottschling TimoChristliches Klinikum Unna, Unna, Germany.
Antonio AssoHospital Quironsalud, Zaragoza, Spain.
Tom WongRoyal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Foundation Trust, King's College and Imperial College, London, UK.
Bertrand PierreCHRU de Tours, Hôpital Trousseau, Saint-Avertin, France.
Niels Christian EwertsenVivantes Klinikum Am Urban, Berlin, Germany.
Leonard BergauGöttingen University Medical Center, Göttingen, Germany.ORCID 0000-0001-7025-9315
Cristina Lozano-GraneroArrhythmia Unit, Cardiology Department, University Hospital Ramón y Cajal, Madrid, Spain.
Maximo RiveroZiekenhuis Oost Limburg, Genk, Belgium.
Alexander BreitensteinKantonsspital Baden AG, Baden, Switzerland.
Jaakko InkovaaraTampere Heart Hospital, Tampere University Hospital, Tampere, Finland.ORCID 0009-0006-3915-9758
Samir FarehHopital de la Croix Rousse Nord, Nord, France.
Decebal Gabriel LatcuCentre Hospitalier Princesse Grace, Jardin Exotico, Monaco.
Dominik LinzDepartment of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Centre, Maastricht, the Netherlands.
Patrick MüllerKnappschaftskrankenhaus Recklinghausen, Recklinghausen, Germany.
Javier Ramos-MaquedaArrhythmias Unit, Cardiology Department, Lozano Blesa Clinical University Hospital, Zaragoza, Spain.
Thomas BeiertHeart Center Bonn, Department of Internal Medicine II, University Hospital Bonn, Bonn, Germany.ORCID 0000-0001-5398-403X
Sakis ThemistoclakisOspedale dell'Angelo, Mestre, Italy.
Dirk Grosse MeininghausCarl-Thiem-Klinikum Cottbus, Cottbus, Germany.ORCID 0000-0003-1532-1934
Günter StixAllgemeines Krankenhaus Universitätsklinik Wien, Wien, Austria.
Stylianos TzeisMITERA Hospital, Marousi, Greece.
Jakub BaranDepartment of Internal Medicine and Cardiology University Clinical Center, Medical University of Warsaw, Warsaw, Poland.ORCID 0000-0003-3049-5182
Henrik AlmrothLinköpings University Hospital, Linköping, Sweden.
Daniel Rodriguez MunozHospital Doce de Octubre, Madrid, Spain.
João de SousaArrhythmia Unit, Cardiology Department, Lisbon Academic Medical Center, Santa Maria University Hospital, Lisbon, Portugal.ORCID 0000-0003-2782-8214
Michalis EfremidisOnassis Cardiac Surgery Center, Department of Cardiac Electrophysiology and Pacing, Athens, Greece.
Pawel Balsam1st Chair and Department of Cardiology, Warsaw Medical University, Warsaw, Poland.
Jan PetruHomolka Hospital, Prague, Czech Republic.
Thomas KüfferDepartment of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Petr PeichlIKEM, Prague, Czech Republic.ORCID 0000-0002-5625-0071
Lukas DekkerCatharina Ziekenhuis Eindhoven, Eindhoven, the Netherlands.ORCID 0000-0002-8166-3716
Domenico G Della RoccaHeart Rhythm Management Centre, Postgraduate Program in Cardiac Electrophysiology and Pacing, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, European Reference Networks Guard-Heart, Brussels, Belgium.
Ondrej MoravecUniversity Hospital Olomouc, Olomouc, Czech Republic.
Moritoshi FunasakoNeuron Medical, Brno, Czech Republic.ORCID 0000-0002-1620-3924
Sebastien KnechtAz sint jan Hospital, Bruges, Belgium.
Gael JauvertAtrial Fibrillation Institute, Mater Private Hospital, Dublin, Ireland.
Julian ChunCardioangiologisches Centrum Bethanien, Frankfurt, Germany.
Romain EschalierClermont Ferrand university hospital, Clermont-Ferrand, France.
Anna FütingDepartment of Electrophysiology, Alfried Krupp Hospital, Essen, Germany.
Alexandre ZhaoGHP Ambroise Paré Hartmann, Neuilly sur Seine, France.
Pieter KoopmanJessa Hospitals, Hasselt, Belgium.
Mikael LaredoSorbonne Université, APHP, Pitié-Salpêtrière Hospital, Institute of Cardiology, ICAN Institute for Cardiometabolism and Nutrition, Paris, France.
Martin ManningerMedical University of Graz, Graz, Austria.
Jim HansenCopenhagen University Hospital Gentofte, Gentofte, Denmark.
Daniel O'HareBlack Rock Clinic, Dublin, Ireland.
Anne RollinUniversity Hospital Rangueil, Toulouse, France.
Zrinka JurisicUniversity Hospital Center Split, Split, Croatia.
Thomas FinkHeart and Diabetes Center NRW, Ruhr University Bochum, Bochum, Germany.
Corentin ChaumontRouen Hospital, Rouen, France.
Andreas RilligUniversity Heart and Vascular Center, Hamburg, Germany.
Melanie GunawerdeneAsklepios Hospital St. Georg, Hamburg, Germany.
Claire MartinCardiology Department, Royal Papworth Hospital, Cambridge, UK.
Bettina KirsteinDepartment of Rhythmology, University Heart Center Lübeck, University Hospital Schleswig-Holstein, Lübeck, Germany.ORCID 0000-0002-6881-871X
Karin NentwichHeart Center Bad Neustadt, Neustadt, Germany.
Heiko LehrmannUniversitätsklinikum Freiburg, Freiburg, Germany.
Arian SultanUniversitätsklinikum Köln AöR, Köln, Germany.ORCID 0000-0003-1807-4860
Jan BohnenUniversity Duisburg-Essen, Duisburg, Germany.
Mohit K TuragamIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Vivek Y ReddyIcahn School of Medicine at Mount Sinai, New York, NY, USA. vivek.reddy@mountsinai.org.ORCID 0000-0002-5638-4993

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Atrial FibrillationCatheter AblationAgedFemaleHumansMaleMiddle AgedPostoperative ComplicationsTreatment Outcome

Identifiers

PMID38977913
PMCPMC11271404

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.