Evidence map›Paper›PMID 30756393›Full record

Trial reportPacing and clinical electrophysiology : PACE2019

Shorter cryoballoon applications times do effect efficacy but result in less phrenic nerve injury: Results of the randomized 123 study.

Marleen M D Molenaar, Carl C Timmermans, Tim Hesselink, Marcoen F Scholten, Rachel M A Ter Bekke, Justin G L M Luermans, Marjolein Brusse-Keizer, Karin Kraaier, Bernard Ten Haken, Jan G Grandjean and 2 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Pacing and clinical electrophysiology : PACE, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 8% 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, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Article
  6. Observational
  7. Review
  8. Observational
  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

12 authors at 3 institutions in 1 country.

Marleen M D MolenaarMedisch Spectrum Twente, Enschede, The Netherlands.ORCID 0000-0001-5658-8905
Carl C TimmermansMaastricht University Medical Centre, Maastricht, The Netherlands.
Tim HesselinkMedisch Spectrum Twente, Enschede, The Netherlands.
Marcoen F ScholtenMedisch Spectrum Twente, Enschede, The Netherlands.
Rachel M A Ter BekkeMaastricht University Medical Centre, Maastricht, The Netherlands.ORCID 0000-0003-4278-0132
Justin G L M LuermansMaastricht University Medical Centre, Maastricht, The Netherlands.
Marjolein Brusse-KeizerMedisch Spectrum Twente, Enschede, The Netherlands.ORCID 0000-0003-1781-5794
Karin KraaierMedisch Spectrum Twente, Enschede, The Netherlands.
Bernard Ten HakenUniversiteit Twente, Enschede, The Netherlands.ORCID 0000-0001-8159-7424
Jan G GrandjeanMedisch Spectrum Twente, Enschede, The Netherlands.
Kevin VernooyMaastricht University Medical Centre, Maastricht, The Netherlands.
Jurren M van OpstalMedisch Spectrum Twente, Enschede, The Netherlands.
Medisch Spectrum Twente · NLMaastricht University Medical Centre · NLUniversity of Twente · NL

Funding

Medtronic
6 · The paper itself

Abstract

backgroundThe second-generation cryoballoon significantly improves outcome of pulmonary vein isolation (PVI) but may cause more complications than the first generation. Currently, no consensus regarding optimal cryoballoon application time exists. The 123-study aimed to assess the minimal cryoballoon application duration necessary to achieve PVI (primary endpoint) and the effect of application duration on prevention of phrenic nerve injury (PNI).

methodsPatients <75 years of age with paroxysmal atrial fibrillation, normal PV anatomy, and left atrial size <40 cc/m² or <50 mm were randomized to two applications of different duration: "short," "medium," or "long." A total of 222 patients were enrolled, 74 per group.

resultsDuration per application was 105 (101-108), 164 (160-168), and 224 (219-226) s and isolation was achieved in 79, 89, and 90% (P < 0.001) of the PVs after two applications in groups short, medium, and long, respectively. Only for the left PVs, the success rate of the short group was significantly less compared to the medium- and long-duration groups (P < 0.001). PNI during the procedure occurred in 19 PVs (6.5%) in the medium and in 20 PVs (6.8%) in the long duration groups compared to only five PVs (1.7%) in the short duration group (P < 0.001).

conclusionsShort cryoballoon ablation application times, less than 2 min, did affect the success for the left PVs but not for the right PVs and resulted in less PNI. A PV tailored approach with shorter application times for the right PVs might be advocated.

Indexed as

Atrial FibrillationCryosurgeryFemaleHumansMaleMiddle AgedPhrenic NervePulmonary VeinsTime Factorsatrial fibrillationcryoballoonphrenic nerve injurypulmonary vein isolationsafety

Identifiers

PMID30756393
PMCPMC6850154
OpenAlexW2914898945

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.