Evidence map›Paper›PMID 26826134›Full record

Trial reportEuropace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology2016

Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial.

Yves De Greef, Lukas Dekker, Lucas Boersma, Stephen Murray, Marcus Wieczorek, Stefan G Spitzer, Neil Davidson, Steve Furniss, Mélèze Hocini, J Christoph Geller and 2 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyMulticenter StudyClinical Trial
In one paragraph

Trial report in 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, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01767558 (Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD), which is not on this map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
5.8field-weighted citation impact, top 3% 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.

NCT01767558 nacompletednot on this map

Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD

TypeinterventionalSponsorMedtronic Cardiac Rhythm and Heart FailureRan2013 to 2014Enrolled56ConditionsAtrial FibrillationArmsAblation / MRI
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 3 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. 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
  2. 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
  3. 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
  4. Trial
  5. Pulmonary vein isolation using second-generation single-shot devices: not all the same?Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Trial
  6. Review
  7. Pre- and post-procedural cardiac imaging (computed tomography and magnetic resonance imaging) in electrophysiology: a clinical consensus statement of the European Heart Rhythm Association and European Association of Cardiovascular Imaging of the European Society of Cardiology.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
  8. Phased RF ablation with PVAC gold: evolution favors only the strong.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2022
    Article
  9. 2-year outcomes of phased radiofrequency ablation for atrial fibrillation with the second-generation PVAC Gold ablation catheter.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2022
    Article
  10. Article
  11. Article
  12. Acute success and safety of the second-generation PVAC GOLD phased RF ablation catheter for atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2021
    Article
  13. Article
  14. Paroxysmal and persistent atrial fibrillation ablation outcomes with the pulmonary vein ablation catheter GOLD duty-cycled phased radiofrequency ablation catheter: quality of life and 12-month efficacy results from the GOLD Atrial Fibrillation Registry.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 · 2020
    Article
  15. Article
  16. Article
  17. Article
  18. Observational
  19. Comparing learning curves of two established "single-shot" devices for ablation of atrial fibrillation.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2018
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 10 institutions in 6 countries.

Yves De GreefZNA Middelheim, Lindendreef 1, 2020 Antwerp, Belgium yves.degreef@zna.be.
Lukas DekkerCatharina Ziekenhuis, Eindhoven, The Netherlands.
Lucas BoersmaSt Antonius Ziekenhuis, Nieuwegein, The Netherlands.
Stephen MurrayFreeman Hospital, Newcastle, UK.
Marcus WieczorekSt Agnes Hospital, Witten/Herdecke University, School of Medicine, Bocholt, Germany.
Stefan G SpitzerPraxisklinik Herz und Gefäße, Dresden, Germany.
Neil DavidsonUniversity Hospital of South Manchester, Manchester, UK.
Steve FurnissEastbourne District General Hospital, Sussex, UK.
Mélèze HociniHôpital Cardiologique du Haut-Lévêque, Bordeaux, France.
J Christoph GellerDivision of Cardiology, Zentralklink Bad Berka, Bad Berka, Germany.
Zoltan CsanádiInstitute of Cardiology, University of Debrecen, Debrecen, Hungary.
PRECISION GOLD investigators
Catharina Ziekenhuis · NLEastbourne District General Hospital · GBFreeman Hospital · GBHôpital Cardiologique du Haut-Lévêque · FROrthopädische Praxis · DESt. Antonius Ziekenhuis · NLUniversity of Debrecen · HUWitten/Herdecke University · DEZentralklinik Bad Berka · DEZNA Middelheim Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis prospective, multicentre study (PRECISION GOLD) evaluated the incidence of asymptomatic cerebral embolism (ACE) after pulmonary vein isolation (PVI) using a new gold multi-electrode radiofrequency (RF) ablation catheter, pulmonary vein ablation catheter (PVAC) GOLD. Also, procedural efficiency of PVAC GOLD was compared with ERACE. The ERACE study demonstrated that a low incidence of ACE can be achieved with a platinum multi-electrode RF catheter (PVAC) combined with procedural manoeuvres to reduce emboli. METHODS AND

resultsA total of 51 patients with paroxysmal atrial fibrillation (AF) (age 57 ± 9 years, CHA2DS2-VASc score 1.4 ± 1.4) underwent AF ablation with PVAC GOLD. Continuous oral anticoagulation using vitamin K antagonists, submerged catheter introduction, and heparinization (ACT ≥ 350 s prior to ablation) were applied. Cerebral magnetic resonance imaging (MRI) scans were performed within 48 h before and 16-72 h post-ablation. Cognitive function assessed by the Mini-Mental State Exam at baseline and 30 days post-ablation. New post-procedural ACE occurred in only 1 of 48 patients (2.1%) and was not detectable on MRI after 30 days. The average number of RF applications per patient to achieve PVI was lower in PRECISION GOLD (20.3 ± 10.0) than in ERACE (28.8 ± 16.1; P = 0.001). Further, PVAC GOLD ablations resulted in significantly fewer low-power (<3 W) ablations (15 vs. 23%, 5 vs. 10% and 2 vs. 7% in 4:1, 2:1, and 1:1 bipolar:unipolar energy modes, respectively). Mini-Mental State Exam was unchanged in all patients.

conclusionAtrial fibrillation ablation with PVAC GOLD in combination with established embolic lowering manoeuvres results in a low incidence of ACE. Pulmonary vein ablation catheter GOLD demonstrates improved biophysical efficiency compared with platinum PVAC.

trial registrationClinicalTrials.gov NCT01767558.

Indexed as

GoldAgedAtrial FibrillationCatheter AblationElectrodes, ImplantedEquipment DesignEuropeFemaleHumansIncidenceInternational CooperationIntracranial EmbolismLinear ModelsLogistic ModelsMagnetic Resonance ImagingMaleGoldPlatinumAblationAsymptomatic cerebral embolismAtrial fibrillationPulmonary vein isolationPVAC GOLD

Identifiers

PMID26826134
PMCPMC4880114
OpenAlexW2265685608

What OpenQuestion holds

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LicenceCC BY-NC
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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.