title: Low rate of asymptomatic cerebral embolism and improved procedural efficiency with the novel pulmonary vein ablation catheter GOLD: results of the PRECISION GOLD trial.
abstract: OBJECTIVE
  This 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.
  
  
  RESULTS
  A 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.
  
  
  CONCLUSIONS
  Atrial 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01767558.
authors.affiliation: ZNA Middelheim, Lindendreef 1, 2020 Antwerp, Belgium yves.degreef@zna.be.
authors.forename: Yves
authors.initials: Y
authors.lastname: De Greef
authors.affiliation: Catharina Ziekenhuis, Eindhoven, The Netherlands.
authors.forename: Lukas
authors.initials: L
authors.lastname: Dekker
authors.affiliation: St Antonius Ziekenhuis, Nieuwegein, The Netherlands.
authors.forename: Lucas
authors.initials: L
authors.lastname: Boersma
authors.affiliation: Freeman Hospital, Newcastle, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Murray
authors.affiliation: St Agnes Hospital, Witten/Herdecke University, School of Medicine, Bocholt, Germany.
authors.forename: Marcus
authors.initials: M
authors.lastname: Wieczorek
authors.affiliation: Praxisklinik Herz und Gefäße, Dresden, Germany.
authors.forename: Stefan G
authors.initials: SG
authors.lastname: Spitzer
authors.affiliation: University Hospital of South Manchester, Manchester, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: Davidson
authors.affiliation: Eastbourne District General Hospital, Sussex, UK.
authors.forename: Steve
authors.initials: S
authors.lastname: Furniss
authors.affiliation: Hôpital Cardiologique du Haut-Lévêque, Bordeaux, France.
authors.forename: Mélèze
authors.initials: M
authors.lastname: Hocini
authors.affiliation: Division of Cardiology, Zentralklink Bad Berka, Bad Berka, Germany.
authors.forename: J Christoph
authors.initials: JC
authors.lastname: Geller
authors.affiliation: Institute of Cardiology, University of Debrecen, Debrecen, Hungary.
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Csanádi
mesh_terms: D000368:Aged; D001281:Atrial Fibrillation / Q000601:surgery*; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation*; D004567:Electrodes, Implanted / Q000009:adverse effects; D004867:Equipment Design; D005060:Europe; D005260:Female; D006046:Gold; D006801:Humans; D015994:Incidence; D007391:International Cooperation; D020766:Intracranial Embolism / Q000000981:diagnostic imaging / Q000453:epidemiology* / Q000209:etiology; D016014:Linear Models; D016015:Logistic Models; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D010984:Platinum; D011446:Prospective Studies; D011667:Pulmonary Veins / Q000601:surgery*; D016896:Treatment Outcome
chemical_list: D010984:Platinum; D006046:Gold
keywords: Ablation; Asymptomatic cerebral embolism; Atrial fibrillation; PVAC GOLD; Pulmonary vein isolation
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