Author + information
- Received September 10, 2018
- Revision received November 1, 2018
- Accepted November 8, 2018
- Published online December 26, 2018.
- Fehmi Keçe, MDa,
- Eline F. Bruggemans, MScb,
- Marta de Riva, MDa,
- Reza Alizadeh Dehnavi, MD, PhDa,
- Adrianus P. Wijnmaalen, MD, PhDa,
- Tamara J. Meulman, MDc,
- Julia A. Brugman, MScd,
- Anouk M. Rooijmans, MScd,
- Mark A. van Buchem, MD, PhDc,
- Huub A. Middelkoop, PhDd,
- Jeroen Eikenboom, MD, PhDe,
- Martin J. Schalij, MD, PhDa,
- Katja Zeppenfeld, MD, PhDa and
- Serge A. Trines, MD, PhDa,∗ ()
- aDepartment of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, the Netherlands
- bDepartment of Cardio-thoracic Surgery, Heart Lung Center, Leiden University Medical Center, Leiden, the Netherlands
- cDepartment of Radiology, Leiden University Medical Center, Leiden, the Netherlands
- dDepartment of Neurology & Clinical Neuropsychology, Leiden University Medical Center, Leiden, the Netherlands
- eDepartment of Internal Medicine, Division of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands
- ↵∗Address for correspondence:
Dr. Serge A. Trines, Department of Cardiology, Heart Lung Center, Leiden University Medical Center, P.O. Box 9600, 2300 RC Leiden, the Netherlands.
Objectives The purpose of this study was to randomly compare the incidence of asymptomatic cerebral embolism (ACE) between the second-generation pulmonary vein ablation catheter (PVAC Gold) and the irrigated Thermocool catheter.
Background Pulmonary vein isolation (PVI) with the pulmonary vein ablation catheter (PVAC) is associated with ACE. The PVAC Gold was designed to avoid this complication.
Methods Patients with paroxysmal atrial fibrillation were randomized 1:1 to PVI with the PVAC Gold or Thermocool catheter. Cerebral magnetic resonance imaging was performed in the days before and after ablation and repeated after 3 months in case of a new lesion. Monitoring for microembolic signals (MES) was performed by using transcranial Doppler ultrasonography. Parameters of coagulation were determined before, during, and after ablation. Neuropsychological tests and questionnaires were applied 10 days before and 3 months after ablation.
Results Seventy patients were included in the study (mean age 61 ± 9 years; 43 male subjects; CHA2DS2-VASc [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65 to 74 years, sex category] score 1.6 ± 1.2; international normalized ratio 2.7 ± 0.5; activated clotting time 374 ± 24 s; p > 0.05 for all parameters). Procedural duration was shorter in the PVAC Gold group (140 ± 34 vs. 207 ± 44 min; p < 0.001). Eight (23%; 7 infarcts) patients in the PVAC Gold group exhibited a new ACE, compared with 2 (6%; no infarcts) patients in the Thermocool group (p = 0.042). Median number of MES was higher in the PVAC Gold group (1,111 [interquartile range, 715-2,234] vs. 787 [interquartile range, 532-1,053]; p < 0.001). There were no differences between groups regarding coagulation and neuropsychological outcomes.
Conclusion PVI with the new PVAC Gold was associated with a higher incidence of ACE/cerebral infarcts and number of MES. Both catheters induced a comparable procoagulant state. Because there were no measurable differences in neuropsychological status, the clinical significance of ACE remains unclear. (Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) (CE-AF); NCT01361295)
- asymptomatic cerebral embolism
- atrial fibrillation
- catheter ablation
- cooled radiofrequency ablation
- pulmonary vein isolation
- PVAC Gold
The Department of Cardiology Leiden receives unrestricted research and fellowship grants from Abbott, Boston Scientific, Medtronic, and Biotronik. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Received September 10, 2018.
- Revision received November 1, 2018.
- Accepted November 8, 2018.
- 2018 The Authors