Evidence map›Paper›PMID 35647644›Full record

ArticleEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2022

Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF).

Emmanuel Ekanem, Vivek Y Reddy, Boris Schmidt, Tobias Reichlin, Kars Neven, Andreas Metzner, Jim Hansen, Yuri Blaauw, Philippe Maury, Thomas Arentz and 41 more

Erratum issued 4 registry-linked trialsOpen access · bronzeAbstract read
In one paragraph

Article in 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, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 207 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
207citing papers in PubMed, 8 pooled it
50.4field-weighted citation impact, top 1% of its field
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.

NCT06096428 unknown statusnot on this mapstarted 2023, after this paper: background citation

The Assessment of Intravascular Peri-procedural Hemolysis During Catheter Ablation for Atrial Fibrillation Using Radiofrequency and Pulsed-field Energy

TypeobservationalSponsorCharles University, Czech RepublicRan2023 to 2024Enrolled60ConditionsAtrial Fibrillation, Hemolysis, Pulsed-field AblationArmsPulsed-field ablation, Radiofrequency ablation
NCT06144632 nacompletednot on this mapstarted 2023, after this paper: background citation

Safety and Effectiveness Evaluation of the THERMOCOOL SMARTTOUCH SF Catheter With the TRUPULSE Generator for Treatment of Drug Refractory Symptomatic Paroxysmal Atrial Fibrillation (PAF)

TypeinterventionalSponsorBiosense Webster, Inc.Ran2023 to 2025Enrolled237ConditionsDrug Refractory Paroxysmal Atrial FibrillationArmsTHERMOCOOL STSF Bi- Directional Navigation Catheter, TRUPULSE Generator
NCT06198933 unknown statusnot on this mapstarted 2024, after this paper: background citation

The Assessment of Hemolysis and Renal Functions During and After Catheter Ablation for Atrial Fibrillation Using Pulsed-field Energy

TypeobservationalSponsorCharles University, Czech RepublicRan2024 to 2024Enrolled100ConditionsAtrial FibrillationArmsPulsed-field ablation
NCT06364215 naterminatednot on this mapstarted 2024, after this paper: background citation

Posterior Wall Substrate Modification Using Irreversible Electroporation for the Treatment of Paroxysmal Atrial Fibrillation

TypeinterventionalSponsorJorge RomeroRan2024 to 2025Enrolled198ConditionsAtrial Fibrillation ParoxysmalArmsFarapulse PFA, Pulmonary Vein Isolation alone, Farapulse PFA, Pulmonary Vein Isolation and Left atrial Posterior Wall Isolation
3 · Its place in the literature

Who cites it

207 citing papers in PubMed, 8 syntheses or guidelines pooled it, 315 citations in OpenAlex.

  1. 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
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Multielectrode catheter-based pulsed electric field vs. cryoballoon for atrial fibrillation ablation: a systematic review and meta-analysis.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 · 2024
    Pooled it
  6. Same-day discharge vs. overnight stay following catheter ablation for atrial fibrillation: a comprehensive review and meta-analysis by the European Heart Rhythm Association Health Economics Committee.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 · 2024
    Pooled it
  7. Pulsed field ablation versus thermal energy ablation for atrial fibrillation: a systematic review and meta-analysis of procedural efficiency, safety, and efficacy.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Pooled it
  8. Durability of pulmonary vein isolation for atrial fibrillation: a meta-analysis and systematic review.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 · 2023
    Pooled it
  9. Trial
  10. Trial
  11. 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
  12. Procedural characteristics and clinical outcomes from same-day discharge after pulsed field ablation treatment for atrial fibrillation: an admIRE trial sub-analysis.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 · 2025
    Trial
  13. Trial
  14. Efficacy and safety of a novel hexaspline pulsed field ablation system in patients with paroxysmal atrial fibrillation: the PLEASE-AF 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 · 2024
    Trial
  15. Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF 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 · 2024
    Trial
  16. First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation.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 · 2024
    Trial
  17. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation 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 · 2023
    Trial
  18. Sedation strategies for pulsed-field ablation of atrial fibrillation: focus on deep sedation with intravenous ketamine in spontaneous respiration.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 · 2023
    Trial
  19. Trial
  20. Pulsed field ablation in patients with cardiac implantable electronic devices: an ex vivo assessment of safety.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

51 authors at 20 institutions in 10 countries.

Emmanuel EkanemIcahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID 0000-0002-4128-8800
Vivek Y ReddyIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Boris SchmidtMVZ CCB Frankfurt und Main-Taunus GbR, Frankfurt, Germany.
Tobias ReichlinInselspital-Bern University Hospital, University of Bern, Bern, Switzerland.ORCID 0000-0002-7197-8415
Kars NevenDepartment of Electrophysiology, Alfried Krupp Hospital, Essen, Germany.ORCID 0000-0002-2075-8113
Andreas MetznerUniversity Heart and Vascular Center, University of Hamburg, Hamburg, Germany.ORCID 0000-0002-6818-6396
Jim HansenCopenhagen University Hospital, Copenhagen, Denmark.
Yuri BlaauwUniversitair Medish Groningen, Groningen, The Netherlands.
Philippe MauryDepartment of Cardiology, University Hospital Rangueil, Toulouse, France.
Thomas ArentzUniversitätsklinikum Freiburg, Breisgau, Germany.
Philipp SommerClinic for Electrophysiology, Herz- und Diabeteszentrum NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany.
Ante AnicDepartment for Cardiovascular Diseases, University Hospital Center Split, Split, Croatia.ORCID 0000-0002-6864-3999
Frederic AnselmeDepartment of Cardiology, Rouen Hospital, Rouen, France.
Serge BovedaHeart Rhythm Department, Clinique Pasteur, Toulouse, France.ORCID 0000-0002-8425-3544
Tom DenekeHeart Center Bad Neustadt, Rhoen-Clinic Campus Bad Neustadt, Bad Neustadt an der Saale, Germany.
Stephan WillemsAsklepios Hospital St Georg, Hamburg, Germany.ORCID 0000-0002-8890-5749
Pepijn van der VoortDepartment of Cardiology, Catharina Ziekenhuis Eindhoven, Eindhoven, The Netherlands.
Roland TilzDepartment of Rhythmology, University Heart Center, Lubeck, Germany.
Moritoshi FunasakoCardiology Department, Na Homolce Hospital, Homolka Hospital, Roentgenova 37/2, 15030 Praha 5 Prague, Czech Republic.
Daniel ScherrMedical University of Graz, Graz, Austria.
Reza WakiliDepartment of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Duisburg-Essen, Duisburg, Germany.
Daniel StevenUniversitätsklinikum Köln AöR, Köln, Germany.ORCID 0000-0001-6839-5895
Josef KautznerIKEM-Institute for Clinical and Experimental Medicine, Prague, Czech Republic.ORCID 0000-0002-1632-6182
Johan VijgenDepartment of Cardiology, Jessa Hospitals, Hasselt, Belgium.
Pierre JaisIHU LIRYC, CHU Bordeaux, University of Bordeaux, Bordeaux, France.ORCID 0000-0002-4700-7811
Jan PetruCardiology Department, Na Homolce Hospital, Homolka Hospital, Roentgenova 37/2, 15030 Praha 5 Prague, Czech Republic.
Julian ChunMVZ CCB Frankfurt und Main-Taunus GbR, Frankfurt, Germany.
Laurent RotenInselspital-Bern University Hospital, University of Bern, Bern, Switzerland.
Anna FütingDepartment of Electrophysiology, Alfried Krupp Hospital, Essen, Germany.ORCID 0000-0003-2116-1690
Andreas RilligUniversity Heart and Vascular Center, University of Hamburg, Hamburg, Germany.
Bart A MulderUniversitair Medish Groningen, Groningen, The Netherlands.
Arne JohannessenCopenhagen University Hospital, Copenhagen, Denmark.
Anne RollinDepartment of Cardiology, University Hospital Rangueil, Toulouse, France.
Heiko LehrmannUniversitätsklinikum Freiburg, Breisgau, Germany.
Christian SohnsClinic for Electrophysiology, Herz- und Diabeteszentrum NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany.ORCID 0000-0003-0490-5862
Zrinka JurisicDepartment for Cardiovascular Diseases, University Hospital Center Split, Split, Croatia.ORCID 0000-0001-7583-9036
Arnaud SavoureDepartment of Cardiology, Rouen Hospital, Rouen, France.
Stephanes CombesHeart Rhythm Department, Clinique Pasteur, Toulouse, France.
Karin NentwichHeart Center Bad Neustadt, Rhoen-Clinic Campus Bad Neustadt, Bad Neustadt an der Saale, Germany.
Melanie GunawardeneAsklepios Hospital St Georg, Hamburg, Germany.
Alexandre OussDepartment of Cardiology, Catharina Ziekenhuis Eindhoven, Eindhoven, The Netherlands.
Bettina KirsteinDepartment of Rhythmology, University Heart Center, Lubeck, Germany.
Martin ManningerMedical University of Graz, Graz, Austria.
Jan Eric BohnenDepartment of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Duisburg-Essen, Duisburg, Germany.
Arian SultanUniversitätsklinikum Köln AöR, Köln, Germany.
Petr PeichlIKEM-Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
Pieter KoopmanDepartment of Cardiology, Jessa Hospitals, Hasselt, Belgium.
Nicolas DervalIHU LIRYC, CHU Bordeaux, University of Bordeaux, Bordeaux, France.
Mohit K TuragamIcahn School of Medicine at Mount Sinai, New York, NY, USA.
Petr NeuzilCardiology Department, Na Homolce Hospital, Homolka Hospital, Roentgenova 37/2, 15030 Praha 5 Prague, Czech Republic.
MANIFEST-PF Cooperative
Na Homolce Hospital · CZAsklepios Klinik St. Georg · DECardiovascular Center Frankfurt · DECentrum für Integrierte Onkologie · DECopenhagen University Hospital · DKGerman Centre for Cardiovascular Research · DEHeart and Diabetes Center North Rhine-Westphalia · DEIcahn School of Medicine at Mount Sinai · USInstitute of Clinical and Experimental Medicine · CZJessa Hospital · BEMedical University of Graz · ATRadboud University Nijmegen · NLRhön-Klinikum · DEUniversitair Ziekenhuis Brussel · BEUniversität Hamburg · DEUniversité de Bordeaux · FRUniversity Medical Center Freiburg · DEUniversity of Bern · CHUniversity of Split · HRWest German Heart and Vascular Center Essen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsPulsed 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

resultsThis 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).

conclusionIn 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.

Indexed as

Atrial FibrillationCatheter AblationPulmonary VeinsStrokeAdultAgedAged, 80 and overFemaleHumansMiddle AgedRetrospective StudiesTreatment OutcomeYoung AdultAtrial fibrillationCatheter ablationPulsed field ablationSurvey

Identifiers

PMID35647644
PMCPMC9435639
OpenAlexW4226412814

What OpenQuestion holds

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LicenceCC BY-NC
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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.