Comparing learning curves of two established “single-shot” devices for ablation of atrial fibrillation

• Published in: Journal of interventional cardiac electrophysiology 2018-12, Vol.53 (3), p.317-322
• Main Authors: Leitz, Patrick, Mönnig, G., Güner, F., Dechering, D. G., Wasmer, K., Reinke, F., Lange, Philipp S., Eckardt, L., Frommeyer, G.
• Format: Article
• Language: English
• Subjects: Ablation; Atrial Fibrillation - surgery; Cardiology; Catheter Ablation - adverse effects; Catheter Ablation - instrumentation; Catheter Ablation - methods; Complications; Cryosurgery - adverse effects; Cryosurgery - instrumentation; Cryosurgery - methods; Equipment Design; Female; Fibrillation; Fluoroscopy; Humans; Learning; Learning Curve; Learning curves; Male; Medical instruments; Medicine; Medicine & Public Health; Middle Aged; Outcome and Process Assessment (Health Care); Paralysis; Phrenic nerve; Polyvinyl acetates; Postoperative Complications - epidemiology; Postoperative Complications - etiology; Pulmonary Veins - surgery; Retrospective Studies; Tamponade; Time Factors
• ISSN: 1383-875X; 1572-8595
• DOI: 10.1007/s10840-018-0361-z

Purpose We compared the contour of learning curves of two “single-shot” devices used for pulmonary vein isolation (PVI) for safety and procedural data. Methods We performed a retrospective analysis comparing the first 60 PVI performed at our center using a pulmonary vein ablation catheter (PVAC) array (39 male, mean age 57 years, 42 paroxysmal AF) to the first 60 first PVI using the Cryoballoon (44 male, mean age 59 years, 22 paroxysmal AF). Both groups were further divided into tertiles, where T1 regroups the first 20 ablations, T2 the following 20, and T3 the last 20 ablations. Results The mean total procedure time was reduced by 24 min between T1 and T3 for the PVAC and 15 min for the Cryoballoon ( p  = 0.01). Fluoroscopy increased by 5 min, total ablation time was reduced by 7 min for PVAC ( p  = 0.02), and both times decreased respectively by 7 and 1 min for the Cryoballoon ( p  = ns). In the PVAC group, a mean rate of 0.16 (T1: n  = 5; T2: n  = 2; T3: n  = 3) complications was observed while a rate of 0.16 (T1: n  = 2; T2: n  = 3; T3: n  = 4) occurred in the CRYO group ( p  = ns). Severe complications defined as stroke, pericardial tamponade with need of pericardiocentesis and phrenic nerve palsy occurred in n  = 4 in both groups (6.6%). Conclusions With either of the systems, no significant differences in the effect of the learning curve on the occurrence of adverse events were observed. However, the PVAC array seemed to have a steeper learning curve for procedure, as well as fluoroscopy time.