Evidence map›Paper›PMID 38588039›Full record

Observational studyEuropace : 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

Incidence of phrenic nerve injury during pulmonary vein isolation using different cryoballoons: data from a large prospective ablation registry.

Shinichi Tachibana, Shinsuke Miyazaki, Junichi Nitta, Yasuhiro Shirai, Yasutoshi Nagata, Yuichiro Sagawa, Yukio Sekiguchi, Yukihiro Inamura, Takeshi Sasaki, Yasuteru Yamauchi and 15 more

Abstract readObservational StudyMulticenter StudyComparative Study
In one paragraph

Observational study 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. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Single-shot ablation for AF: Real-world procedural and one-year outcomes with the newly adopted PulseSelect PFA compared with cryoballoon from the 1STOP project.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  4. Procedural outcomes of single versus double transeptal access for ablation of atrial fibrillation: Data from the NCDR Afib ablation registry.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2026
    Article
  5. Article
  6. Article
  7. Article
  8. Impact of cryoballoon size adjustability on procedural and clinical outcomes.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
  9. Article
  10. 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

25 authors.

Shinichi TachibanaDepartment of Cardiology, Japanese Red Cross Saitama Hospital, Saitama, Japan.ORCID 0000-0003-3413-2629
Shinsuke MiyazakiDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo-ku, Tokyo 113-8510, Japan.ORCID 0000-0002-0230-0934
Junichi NittaDepartment of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.ORCID 0000-0003-3255-6065
Yasuhiro ShiraiDepartment of Cardiology, Disaster Medical Center, Tokyo, Japan.ORCID 0000-0001-6321-2797
Yasutoshi NagataDepartment of Cardiology, Japanese Red Cross Musashino Hospital, Tokyo, Japan.ORCID 0000-0002-2484-5919
Yuichiro SagawaDepartment of Cardiology, Japanese Red Cross Yokohama City Bay Hospital, Kanagawa, Japan.ORCID 0000-0002-2588-3757
Yukio SekiguchiDepartment of Cardiology, Sakakibara Heart Institute, Tokyo, Japan.
Yukihiro InamuraDepartment of Cardiology, Japanese Red Cross Saitama Hospital, Saitama, Japan.ORCID 0000-0002-7027-2613
Takeshi SasakiDepartment of Cardiology, Disaster Medical Center, Tokyo, Japan.ORCID 0000-0001-5085-0810
Yasuteru YamauchiDepartment of Cardiology, Japanese Red Cross Yokohama City Bay Hospital, Kanagawa, Japan.ORCID 0000-0002-4661-2999
Osamu InabaDepartment of Cardiology, Japanese Red Cross Saitama Hospital, Saitama, Japan.
Yuichi OnoDepartment of Cardiology, Ome Municipal General Hospital, Tokyo, Japan.ORCID 0000-0001-8900-0506
Makoto SuzukiDepartment of Cardiology, Yokohama Minami Kyosai Hospital, Kanagawa, Japan.
Atsushi SuzukiHeart Center, Tokyo Yamate Medical Center, Tokyo, Japan.ORCID 0000-0002-8747-1635
Shinsuke IwaiDepartment of Cardiology, Hiratsuka Kyosai Hospital, Kanagawa, Japan.ORCID 0000-0001-7775-6429
Hiroyuki OkadaDepartment of Cardiology, Soka Municipal Hospital, Saitama, Japan.
Akira MizukamiDepartment of Cardiology, Kameda Medical Center, Chiba, Japan.ORCID 0000-0001-8193-6617
Koji AzegamiDepartment of Cardiology, Shin-Yurigaoka General Hospital, Kanagawa, Japan.ORCID 0000-0002-2089-5118
Hitoshi HachiyaCardiovascular Center, Tsuchiura Kyodo Hospital, Ibaraki, Japan.ORCID 0000-0003-2808-1933
Keita HandaDivision of Cardiology, Kashiwa City Hospital, Chiba, Japan.
Kentaro GotoDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo-ku, Tokyo 113-8510, Japan.ORCID 0000-0002-0089-9779
Takuro NishimuraDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo-ku, Tokyo 113-8510, Japan.ORCID 0000-0002-0234-390X
Kenzo HiraoArrhythmia Advanced Therapy Center, AOI Universal Hospital, Kanagawa, Japan.
Atsushi TakahashiDepartment of Cardiology, Yokosuka Kyosai Hospital, Kanagawa, Japan.ORCID 0009-0003-1515-1100
Tetsuo SasanoDepartment of Cardiovascular Medicine, Tokyo Medical and Dental University, Yushima 1-5-45, Bunkyo-ku, Tokyo 113-8510, Japan.ORCID 0000-0003-3582-6104

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsPhrenic nerve injury (PNI) is the most common complication during cryoballoon ablation. Currently, two cryoballoon systems are available, yet the difference is unclear. We sought to compare the acute procedural efficacy and safety of the two cryoballoons.

methodsThis prospective observational study consisted of 2,555 consecutive atrial fibrillation (AF) patients undergoing pulmonary vein isolation (PVI) using either conventional (Arctic Front Advance) (AFA-CB) or novel cryoballoons (POLARx) (POLARx-CB) at 19 centers between January 2022 and October 2023.

resultsAmong 2,555 patients (68.8 ± 10.9 years, 1,740 men, paroxysmal AF[PAF] 1,670 patients), PVIs were performed by the AFA-CB and POLARx-CB in 1,358 and 1,197 patients, respectively. Touch-up ablation was required in 299(11.7%) patients. The touch-up rate was significantly lower for POLARx-CB than AFA-CB (9.5% vs. 13.6%, p = 0.002), especially for right inferior PVs (RIPVs). The touch-up rate was significantly lower for PAF than non-PAF (8.8% vs. 17.2%, P < 0.001) and was similar between the two cryoballoons in non-PAF patients. Right PNI occurred in 64(2.5%) patients and 22(0.9%) were symptomatic. It occurred during the right superior PV (RSPV) ablation in 39(1.5%) patients. The incidence was significantly higher for POLARx-CB than AFA-CB (3.8% vs. 1.3%, P < 0.001) as was the incidence of symptomatic PNI (1.7% vs. 0.1%, P < 0.001). The difference was significant during RSPV (2.5% vs. 0.7%, P < 0.001) but not RIPV ablation. The PNI recovered more quickly for the AFA-CB than POLARx-CB.

conclusionsOur study demonstrated a significantly higher incidence of right PNI and lower touch-up rate for the POLARx-CB than AFA-CB in the real-world clinical practice.

Indexed as

Atrial FibrillationCryosurgeryPeripheral Nerve InjuriesPhrenic NervePulmonary VeinsRegistriesAgedCatheter AblationFemaleHumansIncidenceMaleMiddle AgedProspective StudiesTreatment OutcomeAtrial fibrillationCatheter ablationCryoballoonPhrenic nerve injury

Identifiers

PMID38588039
PMCPMC11057019

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.