title: Data on procedural handling and complications of pulmonary vein isolation using the pulmonary vein ablation catheter GOLD®.
abstract: OBJECTIVE
  The second-generation multi-electrode-phased radiofrequency pulmonary vein ablation catheter (PVAC GOLD(®)) was redesigned with the intent to improve its safety and efficacy.
  
  
  RESULTS
  Using a prospectively designed single-centre database, we retrospectively analysed 128 consecutive patients (102 paroxysmal and 43 female) who underwent their first pulmonary vein isolation with the PVAC GOLD(®). The analysis focused on procedural data as well as in-hospital complications. Baseline characteristics of the patient collective were as follows: mean age 57.9 years, mean CHA2DS2-VASC was 1.73 ± 1.30; structural heart disease was present in seven patients. The PVAC GOLD(®) exhibited procedure durations of 123.1 min ± 27.9, duration of energy delivery was 18.3 min ± 11.4, and fluoroscopy duration was 16.0 min ± 7.7. The redesigned catheter shows major complication [major bleeding, transitory ischaemic attack (TIA), and pericardial tamponade] rates of 2.3% (n = 3). The overall rate of adverse events was 5.4% (n = 7). Bleeding complications were observed in three patients (2.3%), in particular there were two cases (1.6%) of minor bleeding and one case (0.8%) of major bleeding. Two patients suffered pericardial effusion, but there was no need for pericardiocentesis. Besides one TIA, there was no other thrombo-embolic event. Furthermore, one case of post-procedural fever was observed. No deaths, stroke, or haemorrhagic shock occurred. Of the 510 pulmonary veins, 508 could be reached with the PVAC GOLD(®) device using a non-steerable long sheath.
  
  
  CONCLUSIONS
  The PVAC GOLD(®) seems to have an acceptable safety profile. The handling is comparable with the previous generation PVAC(®).
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany patrick.leitz@ukmuenster.de.
authors.forename: Patrick
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: Fatih
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: Kristina
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: Philip
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: Christian
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: Dirk Georg
authors.initials: DG
authors.lastname: Dechering
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Zellerhoff
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: Simon
authors.initials: S
authors.lastname: Kochhäuser
authors.affiliation: Division of Electrophysiology, Department of Cardiovascular Medicine, University of Muenster, Albert-Schweitzer-Campus 1, Building A1, 48149 Muenster, Germany.
authors.forename: Philipp Sebastian
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: Lars
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.
authors.forename: Gerold
authors.initials: G
authors.lastname: Mönnig
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000628:therapy*; D017115:Catheter Ablation / Q000009:adverse effects / Q000295:instrumentation*; D000069604:Dabigatran / Q000627:therapeutic use; D016208:Databases, Factual; D004567:Electrodes, Implanted / Q000009:adverse effects; D004867:Equipment Design; D005060:Europe; D065427:Factor Xa Inhibitors / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology; D011667:Pulmonary Veins / Q000601:surgery*; D012189:Retrospective Studies; D000069552:Rivaroxaban / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: Atrial fibrillation; Pulmonary vein isolation; Safety; Second-generation multi-electrode-phased radiofrequency ablation