title: Safety profile of multielectrode-phased radiofrequency pulmonary vein ablation catheter and irrigated radiofrequency catheter.
abstract: BACKGROUND
  Silent cerebral lesions with the multielectrode-phased radiofrequency (RF) pulmonary vein ablation catheter (PVAC(®)) have recently been investigated. However, comparative data on safety in relation to irrigated RF ablation are missing.
  
  
  RESULTS
  One hundred and fifty consecutive patients (58 ± 12 years, 56 female) underwent first pulmonary vein isolation (PVI) for atrial fibrillation (61% paroxysmal) using PVAC(®) (PVAC). Procedure data as well as in-hospital complications were compared with 300 matched patients who underwent PVI using irrigated RF (iRF). Procedure duration (148 ± 63 vs. 208 ± 70 min; P < 0.001), RF duration (24 ± 10 vs. 49 ± 25 min; P < 0.001), and fluoroscopy time (21 ± 10 vs. 35 ± 13 min; P < 0.001) were significantly shorter using PVAC. Major complication rates [major bleeding, transitoric ischaemic attack (TIA), and pericardial tamponade] were not significantly different between groups (PVAC, n = 3; 2% vs. iRF n = 17; 6%). Overall complication rate, including minor events, was similar in both groups [n = 21 (14%) vs. n = 48 (16%)]. Most of these were bleeding complications due to vascular access [n = 8 (5.3%) vs. n = 22 (7.3%)], which required surgical intervention in five patients [n = 1 (0.7%) vs. n = 4 (1.3%)]. Pericardial effusion [n = 4 (2.7%) vs. n = 19 (6.3%); pericardial tamponade requiring drainage n = 0 vs. n = 6] occurred more frequently using iRF. Two patients in each group developed a TIA (1.3% vs. 0.6%). Of note, four of five thromboembolic events in the PVAC group (two TIAs and three transient ST elevations during ablation) occurred when all 10 electrodes were used for ablation.
  
  
  CONCLUSIONS
  Pulmonary vein isolation using PVAC as a 'one-shot-system' has a comparable complication rate but a different risk profile. Pericardial effusion and tamponade occurred more frequently using iRF, whereas thromboembolic events were more prevalent using PVAC. Occurrence of clinically relevant thromboembolic events might be reduced by avoidance of electrode 1 and 10 interaction and uninterrupted anticoagulation, whereas contact force sensing for iRF might minimize pericardial effusion.
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Wasmer
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Foraita
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Leitz
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Güner
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Pott
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: P S
authors.initials: PS
authors.lastname: Lange
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Eckardt
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany moennig@uni-muenster.de.
authors.forename: G
authors.initials: G
authors.lastname: Mönnig
mesh_terms: D001281:Atrial Fibrillation / Q000453:epidemiology* / Q000601:surgery*; D017115:Catheter Ablation / Q000295:instrumentation* / Q000706:statistics & numerical data; D015897:Comorbidity; D004566:Electrodes; D004867:Equipment Design; D004868:Equipment Failure; D019544:Equipment Failure Analysis; D005260:Female; D006329:Heart Conduction System / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology*; D015995:Prevalence; D011667:Pulmonary Veins / Q000601:surgery*; D012189:Retrospective Studies; D012307:Risk Factors; D007507:Therapeutic Irrigation / Q000295:instrumentation* / Q000706:statistics & numerical data; D016896:Treatment Outcome
keywords: Atrial fibrillation; Irrigated radiofrequency ablation; Multielectrode-phased radiofrequency ablation; Pulmonary vein isolation; Safety