Peri-device leaks were present in 6.9% at implantation and increased to 24.9% at follow-up after WATCHMAN device implantation in real-world practice.
What is the real-world incidence of peri-device leak at implant and follow-up after WATCHMAN FLX or FLX Pro implantation?
In a real-world US registry, peri-device leaks after WATCHMAN implantation were low at implant (6.9%) but increased significantly by follow-up (24.9%).
Abstract Background The FDA approved the WATCHMAN device in March 2015 with the caveat that follow-up transesophageal echo (TEE) be performed at 45 days and 1 year post implant to assess peri-device leak (PDL) and device-related thrombus formation (DRT) as an important step before interruption of anticoagulation. However, our understanding of these PDLs and DRTs relies on well designed and published clinical trials. The real-world experience regarding these issues is lacking. We sought to evaluate the PDL incidence at implant and follow-up as adjudicated by a central core lab to minimize variability in reporting. Methods Patients were eligible for enrollment in this prospective registry if they were scheduled to undergo implantation with a WATCHMAN FLX or WATCHMAN FLX Pro device. Enrolled patients were implanted with a WATCHMAN device and followed per local standard of care without interference from the central core lab or study leadership. There were no pre-specified endpoints, but analyses include procedural success, procedural complications, and leak and thrombus rates as adjudicated by a central imaging core lab. Results At time of implant, 6.9% (67/974) of patients had a PDL on TEE. Leaks 3.0mm were detected in 5.9% (57/974) of patients and leaks 3.0mm were detected in 1.0% (10/974) of patients (Graph 1). At follow-up, 24.9% (228/916) of patients had a PDL on TEE, including 15.9% (155/974) of patients with leaks 3.0mm and 7.5% (73/974) of patients with leaks 3.0mm (Graph 1). Conclusion As observed in well-controlled clinical studies, PDLs remain low at time of implant, and is more observed on follow-up. Mechanisms behind this dynamic change in PDL are poorly understood and will be explored further in this registry.
Saliba et al. (2025) studied this question. Peri-device leaks were present in 6.9% at implantation and increased to 24.9% at follow-up after WATCHMAN device implantation in real-world practice.