Evidence map›Paper›PMID 34113871›Full record

ArticleHeart rhythm O22020

Risk of atrioesophageal fistula with cryoballoon ablation of atrial fibrillation.

Jonathan P Piccini, Kendra M Braegelmann, Sara Simma, Jayanthi N Koneru, Kenneth A Ellenbogen

Open access · goldAbstract read
In one paragraph

Article in Heart rhythm O2, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.7field-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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Impact of Esophageal Temperature Monitoring on Esophageal Injury in PVI: A Systematic Review and Meta-Analysis.Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc · 2026
    Pooled it
  2. 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
  3. Article
  4. Review
  5. Article
  6. 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society 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 · 2024
    Article
  7. Innovations in atrial fibrillation ablation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2023
    Review
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
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  14. Article
  15. Routine measurement of oesophageal temperature during cryoballoon pulmonary vein isolation.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2021
    Article
  16. 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

5 authors at 3 institutions in 1 country.

Jonathan P PicciniCardiac Electrophysiology Section, Duke University Medical Center & Duke Clinical Research Institute, Durham, North Carolina.
Kendra M BraegelmannMedtronic, Inc, Minneapolis, Minnesota.
Sara SimmaMedtronic, Inc, Minneapolis, Minnesota.
Jayanthi N KoneruVirginia Commonwealth University Medical Center, Richmond, Virginia.
Kenneth A EllenbogenVirginia Commonwealth University Medical Center, Richmond, Virginia.
Medtronic (United States) · USVirginia Commonwealth University Medical Center · USDuke Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough there are considerable data on the safety of cryoablation, data on the rare but severe complication of atrioesophageal fistula (AEF) following cryoballoon ablation are limited.

objectiveTo report the global, user-reported incidence of AEF associated with cryoballoon ablation for the treatment of atrial fibrillation using Medtronic's complaint database.

methodsUser-reported cryoballoon ablation complications occurring between July 1, 2009, and March 31, 2019, were reviewed to identify cases of AEF. A global event rate of AEF was calculated by dividing the event count by total catheter utilization over the same period. Data on symptoms and patient sequalae were reported as available.

resultsMore than 500,000 Arctic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, Arctic Front Advance ST, and Arctic Front Advance Pro; Medtronic, Inc) were distributed globally during the 9.75-year study period. During this time, 18 confirmed AEF, 1 suspected AEF, and 1 pericardial esophageal fistula were identified; therefore, global incidence of AEF associated with the Arctic Front family of ablation catheters was 0.00396%. Patients most commonly presented with fever (88.2%), and initial symptoms were reported a median of 21 (interquartile range: 4-30) days after the ablation. Although rare, the development of an AEF resulted in death in 68.8% (11/16) of patients with known outcomes.

conclusionsAEF is a possible but rare complication of cryoballoon ablation with a reported frequency of 1 in every 25,000 patients treated. Awareness of the prevalence and manifestation of AEF associated with cryoballoon ablation is critical for early identification and treatment of this complication.

Indexed as

AblationAEFAtrial fibrillationAtrioesophageal fistulaCryoballoonSafety

Identifiers

PMID34113871
PMCPMC8183952
OpenAlexW3031237561

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.