Data On Procedural Handling And Complications Of Pulmonary Vein Isolation Using The Pulmonary Vein Ablation Catheter Gold((R))

EUROPACE(2016)

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Abstract
The second-generation multi-electrode-phased radiofrequency pulmonary vein ablation catheter (PVAC GOLD(A (R))) 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((R)). 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 CHA(2)DS(2)-VASC was 1.73 +/- 1.30; structural heart disease was present in seven patients. The PVAC GOLD(A (R)) 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((R)) device using a non-steerable long sheath.The PVAC GOLD(A (R)) seems to have an acceptable safety profile. The handling is comparable with the previous generation PVAC((R)).
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Key words
Atrial fibrillation,Pulmonary vein isolation,Safety,Second-generation multi-electrode-phased radiofrequency ablation
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