Evidence map›Paper›PMID 40170320›Full record

ArticleJournal of cardiovascular electrophysiology2025

Real-World Impact of Steerable Sheaths for Paroxysmal Atrial Fibrillation Catheter Ablation: The INSIGHT Study.

Yasuo Okumura, Tsunesuke Kono, Akira Mizukami, Osamu Inaba, Yuji Wakamatsu, Daisuke Yamagishi, Satoshi Nakamura, Takumi Arashiro, Akira Sato, Yi Wang and 1 more

Abstract readMulticenter Study
In one paragraph

Article in Journal of cardiovascular electrophysiology, 2025. 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. 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

11 authors.

Yasuo OkumuraNihon University Itabashi Hospital, Tokyo, Japan.ORCID 0000-0002-2960-4241
Tsunesuke KonoNagano Chuo Hospital, Nagano, Japan.ORCID 0000-0001-7988-7836
Akira MizukamiKameda Medical Center, Kamogawa, Japan.ORCID 0000-0001-8193-6617
Osamu InabaSaitama Red Cross Hospital, Saitama, Japan.ORCID 0000-0003-2179-3786
Yuji WakamatsuNihon University Itabashi Hospital, Tokyo, Japan.ORCID 0000-0002-1540-8514
Daisuke YamagishiNagano Chuo Hospital, Nagano, Japan.ORCID 0009-0003-8261-6131
Satoshi NakamuraKobe City Medical Center General Hospital, Kobe, Japan.
Takumi ArashiroKameda Medical Center, Kamogawa, Japan.
Akira SatoSaitama Red Cross Hospital, Saitama, Japan.ORCID 0000-0002-5216-7107
Yi WangBiosense Webster, Inc., Part of Johnson & Johnson MedTech, Irvine, California, USA.
Atsushi KoboriKobe City Medical Center General Hospital, Kobe, Japan.ORCID 0000-0002-5360-5009

Funding

This study was funded by Biosense Webster, Inc., part of Johnson & Johnson MedTech.
6 · The paper itself

Abstract

introductionIn atrial fibrillation (AF) ablation procedures, the CARTO VIZIGO Bidirectional Guiding Sheath has previously shown promising results in reducing fluoroscopy times without compromising clinical effectiveness or safety compared with non-steerable sheaths.

methodsThis non-randomized, multicenter, retrospective cohort study (INSIGHT) aimed to determine the real-world impact of the VIZIGO sheath on procedural efficiency, clinical effectiveness, and safety in paroxysmal AF (PAF) catheter ablation. Consecutive adults who underwent de novo radiofrequency (RF) ablation for PAF with a non-VIZIGO sheath (January 2019-July 2021) or VIZIGO sheath (January 2020-July 2021) were included. Procedural characteristics, primary adverse events (PAEs), and 12-month effectiveness (freedom from repeat ablation or recurrent atrial arrhythmia) were evaluated.

resultsOf 199 patients included (mean age, 69.7 years; 59.3% male), 97 had ablation with a VIZIGO sheath and 102 with a non-VIZIGO sheath. Significantly shorter mean times were achieved in the VIZIGO vs. non-VIZIGO group for time to left PVI (18.1 ± 7.5 vs. 19.9 ± 5.6 min, p = 0.046), right PVI (16.5 ± 6.1 vs. 23.1 ± 9.9 min, p < 0.001), total PVI (34.6 ± 9.7 vs. 42.9 ± 11.4 min, p = 0.002), and fluoroscopy time (7.3 ± 10.4 vs. 18.3 ± 13.3 min, p < 0.001). Mean fluoroscopy dose was significantly lower (45.9 ± 112.0 vs. 139.5 ± 251.5 mGy, p < 0.001) with VIZIGO vs. non-VIZIGO sheaths. Catheter stability was comparable between groups. PAE rates were similar in the VIZIGO (3.1%) and non-VIZIGO (4.9%) groups. Freedom from repeat ablation and recurrent atrial arrhythmia at 12 months were also similar in the two groups.

conclusionThese real-world data demonstrate that use of the VIZIGO sheath in PAF ablation procedures allows for significantly lower fluoroscopy time and dose with significantly shorter PVI isolation time, without compromising acute and long-term effectiveness or safety.

Indexed as

Atrial FibrillationCardiac CathetersCatheter AblationAction PotentialsAgedEquipment DesignFemaleHeart RateHumansMaleMiddle AgedRecurrenceRetrospective StudiesRisk FactorsTime FactorsTreatment OutcomeAFatrial fibrillationcatheter ablationreal‐world studysteerable sheath

Identifiers

PMID40170320
PMCPMC12160683

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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.