Data on procedural handling and complications of pulmonary vein isolation using the pulmonary vein ablation catheter GOLD

• Published in: Europace (London, England) England), 2016-05, Vol.18 (5), p.696-701
• Main Authors: Leitz, Patrick, Güner, Fatih, Wasmer, Kristina, Foraita, Philip, Pott, Christian, Dechering, Dirk Georg, Zellerhoff, Stephan, Kochhäuser, Simon, Lange, Philipp Sebastian, Eckardt, Lars, Mönnig, Gerold
• Format: Article
• Language: English
• Subjects: Aged; Antithrombins - therapeutic use; Atrial Fibrillation - therapy; Catheter Ablation - adverse effects; Catheter Ablation - instrumentation; Dabigatran - therapeutic use; Databases, Factual; Electrodes, Implanted - adverse effects; Equipment Design; Europe; Factor Xa Inhibitors - therapeutic use; Female; Hemorrhage - etiology; Humans; Ischemic Attack, Transient - etiology; Male; Middle Aged; Postoperative Complications - etiology; Pulmonary Veins - surgery; Retrospective Studies; Rivaroxaban - therapeutic use; Treatment Outcome
• ISSN: 1099-5129; 1532-2092
• DOI: 10.1093/europace/euv355

The second-generation multi-electrode-phased radiofrequency pulmonary vein ablation catheter (PVAC GOLD(®)) was redesigned with the intent to improve its safety and efficacy. 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. The PVAC GOLD(®) seems to have an acceptable safety profile. The handling is comparable with the previous generation PVAC(®).