Evidence map›Paper›PMID 38305503›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2024

Pulmonary vein narrowing after pulsed field versus thermal ablation.

Moussa Mansour, Edward P Gerstenfeld, Chinmay Patel, Andrea Natale, William Whang, Frank A Cuoco, Stavros E Mountantonakis, Douglas N Gibson, John D Harding, Scott K Holland and 7 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report 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, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07021313 (Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
18.5field-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.

NCT07021313 naactive not recruitingnot on this mapstarted 2025, after this paper: background citation

Deliver mOre aPplications for More Durable Pulmonary Vein IsOlation

TypeinterventionalSponsorR&D CardiologieRan2025 to 2028Enrolled378ConditionsAtrial FibrillationArmsPulmonary vein isolation by percutaneous endocardial catheter ablation using the FARAPULSE pulsed high voltage electrical field system in patients with atrial fibrillation, Pulmonary vein isolation by percutaneous endocardial catheter ablation using a pentaspline pulsed high voltage electrical field system in patients with atrial fibrillation
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 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. Trial
  3. Trial
  4. 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
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Pulsed field ablation: focused on atrial fibrillation ablation.The Korean journal of internal medicine · 2026
    Review
  11. Article
  12. Article
  13. Review
  14. Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results.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
    Article
  15. Article
  16. Review
  17. Serious iatrogenic complications: pulmonary vein stenosis after ablation of atrial fibrillation.European heart journal supplements : journal of the European Society of Cardiology · 2025
    Article
  18. Article
  19. Review
  20. Article
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

17 authors at 11 institutions in 1 country.

Moussa MansourMassachusetts General Hospital, GRB 815, 55 Fruit Street, Boston, MA, USA.ORCID 0000-0003-3326-9973
Edward P GerstenfeldSection of Cardiac Electrophysiology, University of California San Francisco, San Francisco, CA, USA.
Chinmay PatelHeart and Vascular Institute, University of Pittsburgh Medical Center Pinnacle, Harrisburg, PA, USA.ORCID 0009-0007-7172-2026
Andrea NataleTexas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, TX, USA.ORCID 0000-0002-5487-0728
William WhangHelmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, NY, USA.
Frank A CuocoTrident Medical Center, Charleston, SC, USA.
Stavros E MountantonakisLenox Hill Hospital, Northwell Health, New York City, NY, USA.
Douglas N GibsonScripps Clinic and Prebys Cardiovascular Institute, San Diego, CA, USA.ORCID 0000-0002-8248-5827
John D HardingDoylestown Hospital, Doylestown, PA, USA.
Scott K HollandMedpace Core Laboratories, Cincinnati, OH, USA.ORCID 0000-0003-3719-0875
Anitha B AchyuthaDepartment of Electrophysiology, Boston Scientific Corporation, Menlo Park, CA, USA.
Christopher W SchneiderDepartment of Electrophysiology, Boston Scientific Corporation, Menlo Park, CA, USA.ORCID 0009-0005-9675-8258
Andrew S MugglinParadigm Biostatistics LLC, Anoka, MN, USA.ORCID 0000-0002-4862-8214
Elizabeth M AlbrechtDepartment of Electrophysiology, Boston Scientific Corporation, St. Paul, MN, USA.
Kenneth M SteinDepartment of Electrophysiology, Boston Scientific Corporation, St. Paul, MN, USA.
John W LehmannLehmann Consulting, Naples, FL, USA.
Vivek Y ReddyHelmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, NY, USA.ORCID 0000-0002-5638-4993
Boston Scientific (United States) · USMount Sinai Hospital · USDoylestown Hospital · USMassachusetts General Hospital · USMedpace (United States) · USNorthwell Health · USParadigm Pharmaceuticals (United States) · USScripps Clinic · USSt David's Medical Center · USUniversity of California, San Francisco · USUPMC Central Pa · US

Funding

Farapulse Boston Scientific
6 · The paper itself

Abstract

aimsWhen it occurs, pulmonary vein (PV) stenosis after atrial fibrillation (AF) ablation is associated with significant morbidity. Even mild-to-moderate PV narrowing may have long-term implications. Unlike thermal ablation energies, such as radiofrequency (RF) or cryothermy, pulsed field ablation (PFA) is a non-thermal modality associated with less fibrotic proliferation. Herein, we compared the effects of PFA vs. thermal ablation on PV narrowing after AF ablation. METHODS AND

resultsADVENT was a multi-centre, randomized, single-blind study comparing PFA (pentaspline catheter) with thermal ablation-force-sensing RF or cryoballoon (CB)-to treat drug-refractory paroxysmal AF. Pulmonary vein diameter and aggregate cross-sectional area were obtained by baseline and 3-month imaging. The pre-specified, formally tested, secondary safety endpoint compared a measure of PV narrowing between PFA vs. thermal groups, with superiority defined by posterior probability > 0.975. Among subjects randomized to PFA (n = 305) or thermal ablation (n = 302), 259 PFA and 255 thermal ablation (137 RF and 118 CB) subjects had complete baseline and 3-month PV imaging. No subject had significant (≥70%) PV stenosis. Change in aggregate PV cross-sectional area was less with PFA (-0.9%) than thermal ablation (-12%, posterior probability > 0.999)-primarily driven by the RF sub-cohort (-19.5%) vs. CB sub-cohort (-3.3%). Almost half of all PFA PV diameters did not decrease, but the majority (80%) of RF PVs decreased, regardless of PV anatomic location.

conclusionIn this first randomized comparison of PFA vs. thermal ablation, PFA resulted in less PV narrowing-thereby underscoring the qualitatively differential and favourable impact of PFA on PV tissue.

Indexed as

Atrial FibrillationCatheter AblationPulmonary VeinsStenosis, Pulmonary VeinConstriction, PathologicHumansSingle-Blind MethodTreatment OutcomeAtrial fibrillationPulmonary vein stenosisPulsed field ablationRandomized controlled trial

Identifiers

PMID38305503
PMCPMC10875916
OpenAlexW4391463573

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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.