title: How to learn pulmonary vein isolation with a novel ablation device: learning curve effects using the endoscopic ablation system.
abstract: BACKGROUND
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors: Cardioangiologisches Centrum Bethanien, Agaplesion Markus Krankenhaus, Medizinische Klinik III, Frankfurt a.M., Germany.
authors: Laura
authors: L
authors: Perrotta
authors: Stefano
authors: S
authors: Bordignon
authors: Daniela
authors: D
authors: Dugo
authors: Alexander
authors: A
authors: Fürnkranz
authors: Kr Julian
authors: KJ
authors: Chun
authors: Boris
authors: B
authors: Schmidt
mesh_terms: D055011:Ablation Techniques / Q000193:education / Q000295:instrumentation; D000368:Aged; D001281:Atrial Fibrillation / Q000175:diagnosis / Q000601:surgery*; D006348:Cardiac Surgical Procedures / Q000193:education / Q000295:instrumentation*; D002983:Clinical Competence; D019723:Endoscopes; D004724:Endoscopy / Q000193:education*; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D005858:Germany; D006329:Heart Conduction System / Q000601:surgery*; D006801:Humans; D059032:Learning Curve; D008297:Male; D008875:Middle Aged; D011667:Pulmonary Veins / Q000601:surgery*; D016896:Treatment Outcome
keywords: atrial fibrillation; catheter ablation; endoscopic ablation; laser balloon; learning curve; pulmonary vein isolation