Author + information
- Received January 23, 2011
- Revision received March 21, 2011
- Accepted April 27, 2011
- Published online August 9, 2011.
- Claudia Herrera Siklódy, MD⁎,⁎ (, )
- Thomas Deneke, MD‡,
- Mélèze Hocini, MD§,
- Heiko Lehrmann, MD⁎,
- Dong-In Shin, MD‡,
- Shinsuke Miyazaki, MD§,
- Susanne Henschke, MD†,
- Peter Fluegel, MD†,
- Jochen Schiebeling-Römer, MD⁎,
- Paul M. Bansmann, MD‡,
- Thomas Bourdias, MD§,
- Vincent Dousset, MD§,
- Michel Haïssaguerre, MD§ and
- Thomas Arentz, MD⁎
- ↵⁎Reprint requests and correspondence:
Dr. Claudia Herrera Siklódy, Electrophysiology Department, Herz-Zentrum, Südring 15, D-79189 Bad Krozingen, Germany
Objectives We compared the safety of different devices by screening for subclinical intracranial embolic events after pulmonary vein isolation with either conventional irrigated radiofrequency (RF) or cryoballoon or multielectrode phased RF pulmonary vein ablation catheter (PVAC).
Background New devices specifically designed to facilitate pulmonary vein isolation procedures have recently been introduced.
Methods This prospective, observational, multicenter study included patients with symptomatic atrial fibrillation referred for pulmonary vein isolation. Ablation was performed using 1 of the 3 catheters. Strict periprocedural anticoagulation, with intravenous heparin during ablation to achieve an activated clotting time >300 s, was ensured in all patients. Cerebral magnetic resonance imaging was performed before and after ablation.
Results Seventy-four patients were included in the study: 27 in the irrigated RF group, 23 in the cryoballoon group, and 24 in the PVAC group. Total procedure times were 198 ± 50 min, 174 ± 35 min, and 124 ± 32 min, respectively (p < 0.001 for PVAC vs. irrigated RF and cryoballoon). Findings on neurological examination were normal in all patients before and after ablation. Post-procedure magnetic resonance imaging detected a single new embolic lesion in 2 of 27 patients in the irrigated RF group (7.4%) and in 1 of 23 in the cryoballoon group (4.3%). However, in the PVAC group 9 of 24 patients (37.5%) demonstrated 2.7 ± 1.3 new lesions each (p = 0.003 for the presence of new embolic events among the 3 groups).
Conclusions The PVAC is associated with a significantly higher incidence of subclinical intracranial embolic events. Further study of the causes and significance of these emboli is required to determine the safety of the PVAC.
Dr. Herrera Siklódy has received consulting and speaker honoraria from Medtronic and speaker honoraria from Biosense Webster. Dr. Hocini has received speaker honoraria from Biosense Webster. Dr. Miyazaki has received fellowship support from St. Jude Medical. Dr. Schiebeling-Römer has received fellowship support from St. Jude Medical. Dr. Haïssaguerre has received speaker honoraria from Biosense Webster. Dr. Arentz has received consulting honoraria from Medtronic. All other authors have reported that they have no relationships to disclose.
- Received January 23, 2011.
- Revision received March 21, 2011.
- Accepted April 27, 2011.
- American College of Cardiology Foundation