Key result
WATCHMAN peri-device leaks increase to ~25% at follow-up in real-world practice.
Why the study?
Understanding of peri-device leak and device-related thrombus post-WATCHMAN implantation relies on clinical trials, whereas real-world experience is lacking.
What is the real-world incidence of peri-device leak at implant and follow-up after WATCHMAN FLX or FLX Pro implantation?
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%).
Real-world PDL rates rise substantially post-WATCHMAN; leaves open optimal surveillance frequency and management thresholds.
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.
No takes yet. Share an insight, caveat, or question.
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.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: