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.
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.
Authors: Hitesh C Patel; Paramdeep S Dhillon; Felix Mahfoud; Alistair C Lindsay; Carl Hayward; Sabine Ernst; Alexander R Lyon; Stuart D Rosen; Carlo di Mario Journal: Clin Res Cardiol Date: 2014-05 Impact factor: 5.460
Authors: S Kochhäuser; H H Lohmann; M A Ritter; P Leitz; F Güner; S Zellerhoff; C Korsukewitz; D G Dechering; J Banken; N M Peters; L Eckardt; G Mönnig Journal: Clin Res Cardiol Date: 2014-10-22 Impact factor: 5.460