Impact of Operator's Experience on Peri-Procedural Outcomes with Watchman FLX: Insights from the FLX-Spa Registry

Objectives: This study compares peri-procedural results of left atrial appendage occlusion (LAAO) with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX devices. Background: The Watchman FLX is a device iteration of the Watchman 2.5 that incorporates several design enhancements intended to simplify LAAO and improve procedural outcomes. Methods: Prospective multicenter "real-world" registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5 device. A further stratification of centers according to whether or not they had performed {less than or equal to}10 or >10 Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of both groups of institutions were compared. Results: A total of 359 patients (mean age 75.5{plus minus}8.1, CHA2DS2-VASc 4.4{plus minus}1.4, HAS-BLED 3.8{plus minus}0.9) were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9 (2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the center´s previous experience with Watchman 2.5 device and procedural volume with Watchman FLX existed. Conclusions: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operator´s experience with its previous device iteration or the number of Watchman FLX implants performed.