How to Learn Pulmonary Vein Isolation With a Novel Ablation Device
How to Learn Pulmonary Vein Isolation With a Novel Ablation Device
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 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.
In Europe, approximately 85% of all catheter ablation procedures for atrial fibrillation (AF) are carried out with radiofrequency current. With intent to simplify pulmonary vein isolation (PVI) and to improve its clinical outcome, several novel ablation devices have been introduced in the past years. The endoscopic ablation system (EAS; HeartLight™, CardioFocus, Marlborough, MA, USA) is a balloon based ablation system and offers the theoretical advantage of optimal tissue contact and precise lesion deployment with little need for extensive catheter manipulations. Recent studies suggested a steep learning curve for EAS with considerable shortening of procedure times after only 15 cases, but did not investigate its influence on safety or efficacy.
When adopting novel technologies, operators and centers need to pass an individual learning curve. Since initially this may be associated with longer procedure times, higher complication rates, and lower clinical success, the time course of learning and the effects of procedural changes are of profound clinical importance. This is particularly true for the large number of low volume centers performing <50 cases per year.
We, therefore, sought to describe the learning curve with EAS implemented into clinical routine at our center with particular interest in procedural characteristics as well as safety and efficacy endpoints.
Abstract and Introduction
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 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.
Introduction
In Europe, approximately 85% of all catheter ablation procedures for atrial fibrillation (AF) are carried out with radiofrequency current. With intent to simplify pulmonary vein isolation (PVI) and to improve its clinical outcome, several novel ablation devices have been introduced in the past years. The endoscopic ablation system (EAS; HeartLight™, CardioFocus, Marlborough, MA, USA) is a balloon based ablation system and offers the theoretical advantage of optimal tissue contact and precise lesion deployment with little need for extensive catheter manipulations. Recent studies suggested a steep learning curve for EAS with considerable shortening of procedure times after only 15 cases, but did not investigate its influence on safety or efficacy.
When adopting novel technologies, operators and centers need to pass an individual learning curve. Since initially this may be associated with longer procedure times, higher complication rates, and lower clinical success, the time course of learning and the effects of procedural changes are of profound clinical importance. This is particularly true for the large number of low volume centers performing <50 cases per year.
We, therefore, sought to describe the learning curve with EAS implemented into clinical routine at our center with particular interest in procedural characteristics as well as safety and efficacy endpoints.
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