Evidence map›Paper›PMID 35947317›Full record

ArticleJournal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing2023

Steerable sheath visualizable under 3D electroanatomical mapping facilitates paroxysmal atrial fibrillation ablation with minimal fluoroscopy.

Anil Rajendra, Tina D Hunter, Gustavo X Morales, Paul Zei, Lee Ming Boo, Allyson Varley, Jose Osorio

Erratum issued Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04088071 (Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias Symptomatic Using Novel CARTO Technologies), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.1field-weighted citation impact, top 7% 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.

NCT04088071 recruitingnot on this map

Real-world Experience of Catheter Ablation for the Treatment of Arrhythmias Symptomatic Using Novel CARTO Technologies: REAL Registry

Typeobservational_patient_registrySponsorHeart Rhythm Clinical and Research Solutions, LLCRan2018 to 2028Enrolled20,000ConditionsParoxysmal Atrial Fibrillation, Persistent Atrial Fibrillation, Ventricular ArrhythmiaArmsCatheter ablation
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 19 citations in OpenAlex.

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  8. Intracardiac echocardiography, electroanatomical mapping, and the obsolescence of fluoroscopy for catheter ablation procedures.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
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  9. Article
  10. Evaluation of an Optimized Workflow for the Radiofrequency Catheter Ablation of Paroxysmal Atrial Fibrillation.Medical science monitor : international medical journal of experimental and clinical research · 2024
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  11. 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
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 1 country.

Anil RajendraAlabama Cardiovascular Group, Suite 720, Birmingham, AL, 3686, USA. arajendra@alcardio.com.ORCID http://orcid.org/0000-0001-7607-1479
Tina D HunterCTI Clinical Trial Services, Covington, KY, USA.
Gustavo X MoralesAlabama Cardiovascular Group, Suite 720, Birmingham, AL, 3686, USA.
Paul ZeiBrigham and Women's Hospital, Boston, MA, USA.
Lee Ming BooBiosense Webster, Inc, Irvine, CA, USA.
Allyson VarleyHeart Rhythm Clinical and Research Solutions, Birmingham, AL, USA.
Jose OsorioAlabama Cardiovascular Group, Suite 720, Birmingham, AL, 3686, USA.
Brigham and Women's Hospital · USCardiovascular Research Associates · USClinical Research Solutions · USClinical Trial and Consulting · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdvances in technology and workflows have facilitated substantial reductions in fluoroscopy utilization and procedure times for atrial fibrillation (AF) ablations. A recently available steerable sheath, visualizable on a 3D electroanatomical map (EAM), may further simplify low/zero fluoroscopy ablation workflows by facilitating understanding of the relative positions of the catheter and sheath. The objective of this study was to demonstrate feasibility, safety, procedural efficiency, and clinical effectiveness of incorporating the new visualizable sheath into a low-fluoroscopy workflow.

methodsConsecutive de novo paroxysmal AF procedures were performed with a porous tip contact force catheter at a high-volume site between January 2018 and May 2019. Procedures performed with and without the VIZIGO™ EAM-visualizable sheath (Vizigo) were compared. All ablations employed the same standardized low-fluoroscopy workflow. Statistical analyses employed stabilized inverse probability of treatment weights (IPTW) to balance cohorts by operator and key patient characteristics.

resultsCohorts of 142 Vizigo and 173 non-Vizigo patients were similar at baseline. Use of the Vizigo sheath was associated with approximately 10% improvement in catheter stability (p = 0.0005), 16% reduction in radiofrequency time (p < 0.0001), and 7% fewer ablations that used fluoroscopy (p = 0.0030). There was one cardiac tamponade in each cohort and no deaths, atrioesophageal fistulas, or strokes. Single-procedure freedom from atrial arrhythmia recurrence through 12 months was similar between cohorts (p = 0.9556).

conclusionsUse of a 3D EAM-visualizable sheath resulted in improved catheter stability, reduced radiofrequency time, and more procedures performed without fluoroscopy, without compromise to safety or effectiveness.

Indexed as

Atrial FibrillationCatheter AblationPulmonary VeinsCathetersFluoroscopyHumansTime FactorsTreatment OutcomeAtrial fibrillationCatheter ablationLow fluoroscopyVisualizable sheathVizigo

Identifiers

PMID35947317
PMCPMC9977702
OpenAlexW4294354138

What OpenQuestion holds

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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.