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    In: Journal of Cardiovascular Electrophysiology, Wiley, Vol. 25, No. 12 ( 2014-12), p. 1293-1298
    Abstract: Novel ablation devices for pulmonary vein isolation (PVI) need a careful evaluation of its efficacy and safety beyond clinical studies in a real world situation. The endoscopic ablation system (EAS) was recently approved for PVI in Europe. We sought to determine the safety, efficacy, and learning curve effects of EAS‐PVI in a large volume single center. Methods and Results Between June 2010 and March 2013, all EAS guided PVI procedures were analyzed and 150 consecutive patients were divided in tertiles (T). Clinical follow‐up of 12 months assessed freedom from atrial fibrillation (AF) using 72 hour‐Holter ECG recordings. In total, 497 of 583 PVs (85%) were isolated by visual guidance only. In T 2 and T 3, visually guided PVI rates increased from 73% to 91% (P 〈 0.001). After gap mapping, 96% and 99% of all PVs were isolated in T 1–3, respectively (P = 0.018). Total procedure and fluoroscopy time significantly declined over time. All major periprocedural complications occurred in the first T. In 3 patients (2 in 1st and 1 in 2nd T), phrenic nerve palsy was observed (2%). At 12‐months follow‐up, 103 of 133 patients (77%) remained in stable sinus rhythm without significant differences between Ts. Conclusion With EAS even first time users may achieve acute PVI in a high number of patients with favorable clinical outcomes after 1 year. Yet, acute procedural efficacy and safety are further improved after passing a learning curve of 50 patients.
    Type of Medium: Online Resource
    ISSN: 1045-3873 , 1540-8167
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2014
    detail.hit.zdb_id: 2037519-0
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