Evidence map›Paper›PMID 38192687›Full record

ArticleInternational journal of cardiology. Heart & vasculature2024

Initial clinical experience with the novel POLARx FIT cryoballoon system for pulmonary vein isolation in patients with atrial fibrillation.

Hiroshi Fukunaga, Yukio Sekiguchi, Jun Sawaguchi, Yosuke Hayashi, Sou Asano, Kei Mabuchi, Kanki Inoue, Kohei Tanizaki, Jun Umemura, Mitsuaki Isobe and 1 more

Open access · goldAbstract read
In one paragraph

Article in International journal of cardiology. Heart & vasculature, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 6% 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.

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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Recent highlights from theInternational journal of cardiology. Heart & vasculature · 2025
    Article
  5. Article
  6. Article
  7. Contemporary Trends in Pulsed Field Ablation for Cardiac Arrhythmias.Journal of cardiovascular development and disease · 2024
    Review
  8. Recent highlights from theInternational journal of cardiology. Heart & vasculature · 2024
    Article
  9. 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

11 authors at 1 institution in 1 country.

Hiroshi FukunagaDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Yukio SekiguchiDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Jun SawaguchiDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Yosuke HayashiDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Sou AsanoDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Kei MabuchiDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Kanki InoueDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Kohei TanizakiDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Jun UmemuraDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Mitsuaki IsobeDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Junichi NittaDepartment of Cardiology, Sakakibara Heart Institute, 3-16-1 Asahi-cho, Tokyo 183-0003, Japan.
Sakakibara Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The POLARx FIT system (Boston Scientific, MA, USA) is a novel cryoballoon (CB) ablation technology in which the balloon diameter can be expanded from 28 to 31 mm. The aim of this study was to compare the benefits and safety of the new POLARx FIT system to those of the existing POLARx system currently in use for pulmonary vein (PV) isolation (PVI) in patients with atrial fibrillation. Methods: The first 70 consecutive patients who underwent CB-based PVI with the POLARx FIT system were retrospectively compared with 200 consecutive patients treated with the POLARx system at Sakakibara Heart Institute from October 2021 to May 2023. Results: The POLARx FIT system yielded a higher mean ± standard deviation nadir temperature in the right inferior PV (-59.2 ± 5.29 °C vs. - 62.0 ± 5.08 °C, p = 0.006), but this required a balloon size reduction to 28 mm in 30 % of cases. No significant differences were detected in the time to isolation and thaw time of any PV between the two groups. After the CB-based PVI procedure, no residual PV carina potentials were observed with the POLARx FIT system, whereas 4/20 were with the POLARx system (p = 0.04). Conclusions: The POLARx FIT system had comparable effectiveness and safety to the basic POLARx system. This technology may improve the ablation area, including the PV carina. However, the 31-mm balloon alone was not sufficient to isolate certain PVs.

Indexed as

Atrial fibrillationCryoballoonPOLARx FIT systemPOLARx systemPulmonary vein isolation

Identifiers

PMID38192687
PMCPMC10772259
OpenAlexW4389914108

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.