Anatomical distribution of peri-device leaks on TEE following WATCHMAN implantation: a multicenter core lab analysis

Abstract Background The FDA recommends transesophageal echocardiography (TEE) at 45 days and 1 year following WATCHMAN implantation to assess peri-device leak (PDL) and device-related thrombus (DRT) before stopping anticoagulation. While PDLs have been well characterized in trials, little is known about their anatomical distribution in real-world practice. We aimed to characterize PDL size and spatial localization at implant and first follow up (45-90 days) using core lab–adjudicated TEE. Purpose To characterize the size and anatomical localization of PDLs at implant and 3-month follow-up using core lab–adjudicated TEE from a multicenter registry. Methods Patients undergoing WATCHMAN FLX or FLX Pro implantation were enrolled in a prospective multicenter registry and followed per local standard of care. TEE was performed at implant and/or first follow up (45-90 days) and reviewed by a central core lab. PDLs were defined by color Doppler flow and classified as