Posterior peri-device leaks were most common at both baseline (66.7%) and follow-up (44.4%), with a noted increase in anterior leaks over time.
Posterior peri-device leaks are the most common anatomical location following WATCHMAN implantation, both at baseline and 45-90 day follow-up, which may guide procedural planning and imaging strategies.
Absolute Event Rate: 0% vs 0%
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 3 mm or ≥3 mm. Locations were recorded as posterior, anterior, inferior, mitral, limbus, or through-face. A clock-face model was used for visualization. Results At baseline (N=67 with PDLs, 6.9% (67/974)), 57 patients (85.1%) had leaks 3 mm: 38 posterior (66.7%), 8 limbus (14.0%), 5 inferior (8.8%), 5 anterior (8.8%), and 1 mitral (1.8%). Among 10 patients (14.9%) with leaks ≥3 mm, 5 were posterior (50.0%), 3 limbus (30.0%), and 1 inferior (10.0%). At first follow up (N=221 with PDLs characterized, out of 228 with PDLs, 24.9% (228/916)), 153 patients (69.2%) had leaks 3 mm: 68 posterior (44.4%), 30 anterior (19.6%), 29 limbus (19.0%), 15 inferior (9.8%), and 9 through-face (5.9%). Among 68 patients (30.8%) with leaks ≥3 mm, 31 were posterior (45.6%), 14 anterior (20.6%), 10 limbus (14.7%), 9 inferior (13.2%), and 4 through-face (5.9%). (Figure) Conclusion Posterior PDLs were most frequently observed at both time points, particularly among leaks ≥3 mm. Anterior, inferior, limbus, and through-face leaks were also identified, with greater prevalence of larger leaks first follow up. While the overall distribution pattern was consistent over time, a relative decrease in posterior leaks and increase in anterior leaks was noted from baseline to follow-up. These spatial patterns may guide procedural planning and follow-up imaging strategies.
Motairek et al. (Thu,) reported a other. Posterior peri-device leaks were most common at both baseline (66.7%) and follow-up (44.4%), with a noted increase in anterior leaks over time.