Evidence map›Paper›PMID 39243306›Full record

ArticleJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2025

Safety, efficacy, and quality of life outcomes of pulsed field ablation in Japanese patients with atrial fibrillation: results from the PULSED AF trial.

Teiichi Yamane, Tetsuo Sasano, Hirofumi Tomita, Daisetsu Aoyama, Shinsuke Miyazaki, Masateru Takigawa, Masaomi Kimura, Taihei Itoh, Seigo Yamashita, Jada M Selma and 4 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04198701 (Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

NCT04198701 nacompletednot on this map

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

TypeinterventionalSponsorMedtronic Cardiac Ablation SolutionsRan2019 to 2022Enrolled421ConditionsAtrial FibrillationArmsMedtronic PulseSelect Pulsed Field Ablation (PFA) System
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

14 authors.

Teiichi YamaneDivision of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Tetsuo SasanoDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.ORCID http://orcid.org/0000-0003-3582-6104
Hirofumi TomitaDepartment of Cardiology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.ORCID http://orcid.org/0000-0001-8149-3043
Daisetsu AoyamaDepartment of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Shinsuke MiyazakiDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Masateru TakigawaDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Masaomi KimuraDepartment of Cardiology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.ORCID http://orcid.org/0000-0003-0229-0569
Taihei ItohDepartment of Cardiology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.ORCID http://orcid.org/0000-0002-8473-0320
Seigo YamashitaDivision of Cardiology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Jada M SelmaCardiac Ablation Solutions, Medtronic, Inc, Minneapolis, MN, USA.ORCID http://orcid.org/0000-0003-2671-0265
Jeffrey CerkvenikCardiac Ablation Solutions, Medtronic, Inc, Minneapolis, MN, USA.
Atul VermaDivision of Cardiology, McGill University Health Centre, Montreal, QC, Canada.
Hiroshi TadaDepartment of Cardiovascular Medicine, Faculty of Medical Sciences, University of Fukui, Fukui, Japan. htada@u-fukui.ac.jp.ORCID http://orcid.org/0000-0001-8578-2328
PULSED AF Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPulsed field ablation (PFA), a novel treatment for atrial fibrillation (AF), has yet to be evaluated in a Japanese cohort.

methodsIn this sub-analysis of the PULSED AF trial, 12-month outcomes of paroxysmal AF (PAF) and persistent AF (PsAF) patients treated with PFA in four Japan centers were assessed. After a 90-day blanking period, primary efficacy was determined via freedom from a composite endpoint of acute procedural failure, arrhythmia recurrence, or antiarrhythmic drug escalation over 1 year. Patient improvement was evaluated via two quality of life (QoL) surveys (AFEQT and EQ-5D) at baseline and 12 months.

resultsThe analysis included 32 patients, 16 PAF and 16 PsAF, with PAF patients averaging 61.1 ± 10.6 years and PsAF patients averaging 62.8 ± 11.5 years of age. Females made up 31% of PAF and 25% of PsAF cohorts. Acute pulmonary vein isolation was achieved in 100% of both cohorts. The primary efficacy success rate at 12 months was 75.0% for PAF and 56.3% for PsAF patients. No primary safety events occurred. The mean AFEQT score significantly increased for both PAF (25.9 points, p < 0.0001) and PsAF (13.2 points, p = 0.0002) patients, while the EQ-5D-5L score improved significantly for PAF (0.12 points, p = 0.048) patients but not for PsAF (0.04 points, p = 0.08) patients.

conclusionsSimilar to outcomes in the global cohort, ablation with the PulseSelect™ PFA catheter was efficient, effective, and safe in a Japanese population, resulting in improved QoL for PAF and PsAF patients. CLINICAL

trial registrationClinicalTrials.gov Identifier: NCT04198701.

Indexed as

Atrial FibrillationCatheter AblationQuality of LifeAgedEast Asian PeopleFemaleHumansJapanMaleMiddle AgedTreatment OutcomeAtrial fibrillationCatheter ablationJapanPulsed field ablation

Identifiers

PMID39243306
PMCPMC11832727

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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.