Evidence map›Paper›PMID 31758505›Full record

ArticleJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2020

Comparing rates of atrioesophageal fistula with contact force-sensing and non-contact force-sensing catheters: analysis of post-market safety surveillance data.

Hugh Calkins, Andrea Natale, Tara Gomez, Alex Etlin, Moe Bishara

Open access · hybridAbstract read
In one paragraph

Article in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 24% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pulsed field ablation versus thermal energy ablation for atrial fibrillation: a systematic review and meta-analysis of procedural efficiency, safety, and efficacy.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Pooled it
  2. Atrial Fibrillation (Part 2) - Catheter Ablation.Arquivos brasileiros de cardiologia · 2021
    Article
  3. Article
  4. 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

5 authors at 2 institutions in 1 country.

Hugh CalkinsJohns Hopkins Medical Institutions, 600 N. Wolfe Street, Sheikh Zayed Tower 7125R, Baltimore, MD, USA.
Andrea NataleTexas Cardiac Arrhythmia Institute, St. David's Medical Center, 3000 N. I-35, Suite 720, Austin, TX, 78705, USA.
Tara GomezBiosense Webster Inc., 33 Technology Dr, Irvine, CA, 92618, USA.
Alex EtlinBiosense Webster Inc., 33 Technology Dr, Irvine, CA, 92618, USA.
Moe BisharaBiosense Webster Inc., 33 Technology Dr, Irvine, CA, 92618, USA. mbishar@its.jnj.com.
Johns Hopkins University · USSt David's Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThere is limited data on the specific incidence of serious adverse events, such as atrioesophageal fistula (AEF), associated with either contact force (CF) or non-CF ablation catheters. Since the actual number of procedures performed with each type of catheter is unknown, making direct comparisons is difficult. The purpose of this study was to assess the incidence of AEF associated with the use of CF and non-CF catheters. Additionally, we aimed to understand the workflow present in confirmed AEF cases voluntarily provided by physicians.

methodsThe number of AEFs for 2014-2017 associated with each type of catheter was extracted from an ablation device manufacturer's complaint database. Proprietary device sales data, a proxy for the total number of procedures, were used as the denominator to calculate the incidence rates. Additional survey and workflow data were systematically reviewed.

resultsBoth CF and non-CF ablation catheters have comparably low incidence of AEF (0.006 ± 0.003% and 0.005 ± 0.003%, respectively, p = 0.69). CF catheters are the catheter of choice for left atrium (LA) procedures which pose the greatest risk for AEF injury. Retrospective analysis of seven AEF cases demonstrated that high power and force and long RF duration were delivered on the posterior wall of the left atrium in all cases.

conclusionsCF and non-CF ablation catheters were found to have similar AEF incidence, despite CF catheters being the catheter of choice for LA procedures. More investigation is needed to understand the range of parameters which may create risk for AEF.

Indexed as

Atrial FibrillationCatheter AblationFistulaCathetersHumansRetrospective StudiesTreatment OutcomeAtrial fibrillation (Afib)Atrioesophageal fistula (AEF)CARTO® 3Contact forceRadiofrequency (RF) ablationTHERMOCOOL SMARTTOUCH®

Identifiers

PMID31758505
PMCPMC7508752
OpenAlexW2991410533

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.