Evidence map›Paper›PMID 41732239›Full record

ArticleHeart rhythm O22026

First multicenter Japanese registry on tissue proximity-guided pulsed field ablation: Procedural safety and mid-term outcomes.

Masanaru Sawada, Hirotsugu Sato, Koichi Nagashima, Ryuta Watanabe, Yuji Saito, Yuji Wakamatsu, Naoto Otsuka, Shu Hirata, Moyuru Hirata, Shiro Nakahara and 14 more

Abstract read
In one paragraph

Article in Heart rhythm O2, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Irrigation-dependent acute ganglionated plexus modulation during variable-loop 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
    Observational
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

24 authors.

Masanaru SawadaDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Hirotsugu SatoDepartment of Cardiology, Dokkyo Medical University, Saitama Medical Center, Saitama, Japan.
Koichi NagashimaDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Ryuta WatanabeDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Yuji SaitoDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Yuji WakamatsuDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Naoto OtsukaDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Shu HirataDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Moyuru HirataDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Shiro NakaharaDepartment of Cardiology, Dokkyo Medical University, Saitama Medical Center, Saitama, Japan.
Kennosuke YamashitaHeart Rhythm Center, Department of Cardiovascular Medicine, Sendai Kosei Hospital, Miyagi, Japan.
Daiki KumazawaHeart Rhythm Center, Department of Cardiovascular Medicine, Sendai Kosei Hospital, Miyagi, Japan.
Yu-Ki IwasakiDepartment of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.
Yuhi FujimotoDepartment of Cardiovascular Medicine, Nippon Medical School, Tokyo, Japan.
Masahide HaradaDepartment of Cardiology, Fujita Health University, Aichi, Japan.
Hitoshi MoriDepartment of Cardiology, Saitama Medical University, International Medical Center, Saitama, Japan.
Kazuhisa MatsumotoDepartment of Cardiology, Saitama Medical University, International Medical Center, Saitama, Japan.
Keiichi AshikagaDepartment of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan.
Hiroyuki TakekawaDepartment of Cardiology, Miyazaki Medical Association Hospital, Miyazaki, Japan.
Takayuki OtsukaDepartment of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.
Atsuhiko YagishitaDepartment of Cardiology, Tokai University, Kanagawa, Japan.
Yoshihisa NaruseDivision of Cardiology, Internal Medicine III Hamamatsu University School of Medicine, Shizuoka, Japan.
Kazuki ItoDivision of Cardiology, Internal Medicine III Hamamatsu University School of Medicine, Shizuoka, Japan.
Yasuo OkumuraDivision of Cardiology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Pulsed field ablation (PFA) is a novel therapy for atrial fibrillation (AF) with myocardial selectivity and safety. The VARIPULSE catheter (variable-loop circular catheter [VLCC]; Biosense Webster, Inc.) was recently introduced in Japan, but multicenter real-world data remain scarce. Objective: This study aimed to evaluate procedural features, acute safety, and early outcomes of tissue proximity indication (TPI)-guided PFA under structured training and standardized protocols. Methods: We retrospectively analyzed 387 consecutive patients with AF (66.4 ± 10.9 years, 69% male, 87.1% paroxysmal) undergoing initial pulmonary vein isolation (PVI) with the VLCC at 10 Japanese centers (April 2024-May 2025). TPI-guided first-pass PVI targeted ≥12 applications per vein in 4 sets (proximal/distal), with additional ablation at TPI-negative sites. Operators received training and followed a harmonized workflow emphasizing TPI guidance and sheath management. Results: First-pass PVI was achieved in 360 patients (93.0%). After limited touch-up (6.9 ± 3.6 applications), complete PVI was obtained in all. Mean PVI time was 32.1 minutes, procedure duration 89.7 minutes, and median fluoroscopy time 3.0 minutes. Three patients (0.8%) had vascular complications; no tamponade, stroke, transient ischemic attack, or renal injury occurred. Predictors of first-pass failure were higher body mass index and lack of pre-mapping, mainly in early cases, declining from 11.4% to 3.0% ( Conclusion: In this first multicenter real-world study, TPI-guided PFA with the VLCC demonstrated high acute efficacy, no clinical strokes or TIAs, low complication rates, and favorable mid-term outcomes with structured training and standardized protocols.

Indexed as

Atrial fibrillationEfficacyMulticenter studyPulmonary vein isolationPulsed field ablationSafetyTissue proximity indicationVARIPULSE catheter

Identifiers

PMID41732239
PMCPMC12925750

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Registered trials

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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.