How to learn pulmonary vein isolation with a novel ablation device: learning curve effects using the endoscopic ablation system.
J Cardiovasc Electrophysiol
; 25(12): 1293-8, 2014 Dec.
Article
in En
| MEDLINE
| ID: mdl-25065945
ABSTRACT
INTRODUCTION:
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 ANDRESULTS:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pulmonary Veins
/
Atrial Fibrillation
/
Endoscopes
/
Endoscopy
/
Heart Conduction System
/
Cardiac Surgical Procedures
Type of study:
Diagnostic_studies
/
Guideline
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Journal:
J Cardiovasc Electrophysiol
Journal subject:
ANGIOLOGIA
/
CARDIOLOGIA
/
FISIOLOGIA
Year:
2014
Type:
Article
Affiliation country:
Germany