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

被引:37
作者
De Greef, Yves [1 ]
Dekker, Lukas [2 ]
Boersma, Lucas [3 ]
Murray, Stephen [4 ]
Wieczorek, Marcus [5 ]
Spitzer, Stefan G. [6 ]
Davidson, Neil [7 ]
Furniss, Steve [8 ]
Hocini, Meleze [9 ]
Geller, J. Christoph [10 ]
Csanadi, Zoltan [11 ]
机构
[1] ZNA Middelheim, Lindendreef 1, B-2020 Antwerp, Belgium
[2] Catharina Hosp, Eindhoven, Netherlands
[3] St Antonius Hosp, Nieuwegein, Netherlands
[4] Freeman Rd Hosp, Newcastle, NSW, Australia
[5] Univ Witten Herdecke, St Agnes Hosp, Sch Med, Bocholt, Germany
[6] Praxisklin Herz & Gefasse, Dresden, Germany
[7] Univ S Manchester Hosp, Manchester M20 8LR, Lancs, England
[8] Eastbourne Dist Gen Hosp, Sussex, E Sussex, England
[9] Hop Cardiol Haut Leveque, Bordeaux, France
[10] Zent Klin Bad Berka, Div Cardiol, Bad Berka, Germany
[11] Univ Debrecen, Inst Cardiol, Debrecen, Hungary
来源
EUROPACE | 2016年 / 18卷 / 05期
关键词
Atrial fibrillation; Ablation; Asymptomatic cerebral embolism; Pulmonary vein isolation; PVAC GOLD; PERSISTENT ATRIAL-FIBRILLATION; CAVOTRICUSPID ISTHMUS ABLATION; IRRIGATED RADIOFREQUENCY; ANTICOAGULATION MANAGEMENT; PREVALENCE; LESIONS; THROMBOEMBOLISM; ASSOCIATION; IMPACT; SAFETY;
D O I
10.1093/europace/euv385
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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. A total of 51 patients with paroxysmal atrial fibrillation (AF) (age 57 +/- 9 years, CHA(2)DS(2)-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 a parts per thousand yen 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. 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. ClinicalTrials.gov NCT01767558.
引用
收藏
页码:687 / 695
页数:9
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