Evidence map›Paper›PMID 27381589›Full record

Trial reportEuropean heart journal2016

Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial.

Karl-Heinz Kuck, Alexander Fürnkranz, K R Julian Chun, Andreas Metzner, Feifan Ouyang, Michael Schlüter, Arif Elvan, Hae W Lim, Fred J Kueffer, Thomas Arentz and 6 more

6 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European heart journal, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 155 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
155citing papers in PubMed, 14 pooled it
30.0field-weighted citation impact, top 1% 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.

NCT01490814 nacompletednot on this map

A Controlled, Prospective, Non-Inferiority, Parallel-Group, Randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the PVs With a Cryoballoon Catheter vs a Radiofrequency Ablation With a ThermoCool Catheter in Patients With PAF

TypeinterventionalSponsorMedtronic Cardiac Ablation SolutionsRan2011 to 2016Enrolled769ConditionsSymptomatic Paroxysmal Atrial Fibrillation (PAF)ArmsElectrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
NCT03044925 naunknown statusnot on this map

Remote Magnetic Navigation-guided Ablation Versus Cryoablation for Persistent Atrial Fibrillation: A Prospective, Controlled Study

TypeinterventionalSponsorRuijin HospitalRan2016 to 2020Enrolled200ConditionsPersistent Atrial FibrillationArmsRemote magnetic navigation, Cryoablation
NCT03365700 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial

TypeinterventionalSponsorLuigi Sacco University HospitalRan2018 to 2020Enrolled303ConditionsPersistent Atrial FibrillationArmsRadiofrequency Ablation, Cryoballoon ablation
NCT03388658 completednot on this map

Safety and Efficacy of Cryoballoon Pulmonary Vein Isolation : a Single Center Registry

TypeobservationalSponsorUniversity Hospital, GrenobleRan2007 to 2017Enrolled1,003ConditionsAtrial Fibrillation
NCT03636100 terminatednot on this mapstarted 2018, after this paper: background citation

Systemic Release of Acetylcholine From the Autonomic Ganglionated Plexus: a Proposed Mechanism of Induced Hypotension During the Thaw Phase of Cryoballon Pulmonary Vein Ablation (GP RESPONSE Study)

TypeobservationalSponsorSaint Luke's Health SystemRan2018 to 2019Enrolled7ConditionsAtrial FibrillationArmsCryoballoon ablation
NCT04704986 phase4completednot on this mapstarted 2021, after this paper: background citation

Comparison of the PolarX and the Arctic Front Cryoballoon for Pulmonary Vein Isolation in Patients With Symptomatic Paroxysmal Atrial Fibrillation - A Multi-Center Non-Inferiority Design Clinical Trial

TypeinterventionalSponsorInsel Gruppe AG, University Hospital BernRan2021 to 2025Enrolled202ConditionsParoxysmal Atrial FibrillationArmsPVI using the Arctic Front Cryoballoon (Medtronic), PVI using the PolarX Cryoballoon (Boston Scientific)
3 · Its place in the literature

Who cites it

155 citing papers in PubMed, 14 syntheses or guidelines pooled it, 345 citations in OpenAlex.

  1. Esophageal injury, perforation, and fistula formation following atrial fibrillation ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Pooled it
  2. Pooled it
  3. Guideline
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Second-generation cryoballoon vs. contact-force sensing radiofrequency catheter ablation in atrial fibrillation: a meta-analysis of randomized controlled trials.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Pooled it
  10. Pooled it
  11. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary.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 · 2018
    Guideline
  12. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation.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 · 2018
    Guideline
  13. Pooled it
  14. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society.Heart rhythm · 2012
    Guideline
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Cryoballoon vs. radiofrequency catheter ablation: insights from NOrwegian randomized study of PERSistent Atrial Fibrillation (NO-PERSAF study).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 · 2022
    Trial
  20. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation.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 · 2021
    Trial

95 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 7 countries.

Karl-Heinz KuckDepartment of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany k.kuck@asklepios.com.
Alexander FürnkranzCardioangiologisches Centrum Bethanien, Frankfurt, Germany.
K R Julian ChunCardioangiologisches Centrum Bethanien, Frankfurt, Germany.
Andreas MetznerDepartment of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany.
Feifan OuyangDepartment of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany.
Michael SchlüterDepartment of Cardiology, Asklepios Klinik St. Georg, Lohmühlenstr. 5, 20099 Hamburg, Germany.
Arif ElvanIsala Klinieken, Zwolle, The Netherlands.
Hae W LimMedtronic, Inc., Minneapolis, MN, USA.
Fred J KuefferMedtronic, Inc., Minneapolis, MN, USA.
Thomas ArentzHerz-Zentrum, Bad Krozingen, Germany.
Jean-Paul AlbenqueClinique Pasteur, Toulouse, France.
Claudio TondoCentro Cardiologico Monzino, University of Milan, Milan, Italy.
Michael KühneUniversitätsspital Basel, Basel, Switzerland.
Christian SticherlingUniversitätsspital Basel, Basel, Switzerland.
Josep BrugadaHospital Clinic, University of Barcelona, Barcelona, Spain.
FIRE AND ICE Investigators
Asklepios Klinik St. Georg · DECardiovascular Center Bethanien · DEMedtronic (United States) · USUniversity Hospital of Basel · CHClinique Pasteur · FRIsala · NLUniversitat de Barcelona · ESUniversitäts-Herzzentrum Freiburg-Bad Krozingen · DEUniversity of Milan · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThe primary safety and efficacy endpoints of the randomized FIRE AND ICE trial have recently demonstrated non-inferiority of cryoballoon vs. radiofrequency current (RFC) catheter ablation in patients with drug-refractory symptomatic paroxysmal atrial fibrillation (AF). The aim of the current study was to assess outcome parameters that are important for the daily clinical management of patients using key secondary analyses. Specifically, reinterventions, rehospitalizations, and quality-of-life were examined in this randomized trial of cryoballoon vs. RFC catheter ablation. METHODS AND

resultsPatients (374 subjects in the cryoballoon group and 376 subjects in the RFC group) were evaluated in the modified intention-to-treat cohort. After the index ablation, log-rank testing over 1000 days of follow-up demonstrated that there were statistically significant differences in favour of cryoballoon ablation with respect to repeat ablations (11.8% cryoballoon vs. 17.6% RFC; P = 0.03), direct-current cardioversions (3.2% cryoballoon vs. 6.4% RFC; P = 0.04), all-cause rehospitalizations (32.6% cryoballoon vs. 41.5% RFC; P = 0.01), and cardiovascular rehospitalizations (23.8% cryoballoon vs. 35.9% RFC; P < 0.01). There were no statistical differences between groups in the quality-of-life surveys (both mental and physical) as measured by the Short Form-12 health survey and the EuroQol five-dimension questionnaire. There was an improvement in both mental and physical quality-of-life in all patients that began at 6 months after the index ablation and was maintained throughout the 30 months of follow-up.

conclusionPatients treated with cryoballoon as opposed to RFC ablation had significantly fewer repeat ablations, direct-current cardioversions, all-cause rehospitalizations, and cardiovascular rehospitalizations during follow-up. Both patient groups improved in quality-of-life scores after AF ablation. CLINICAL

trial registrationClinicalTrials.gov identifier: NCT01490814.

Indexed as

Atrial FibrillationCatheter AblationCryosurgeryHumansPulmonary VeinsQuality of LifeRecurrenceTreatment OutcomeAtrial fibrillationCatheter ablationCryoballoonFollow-upRadiofrequencyRehospitalization

Identifiers

PMID27381589
PMCPMC5070448
OpenAlexW2463182173

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.