What does this research mean for the field?

Only 46% of patients received the mandated post-WATCHMAN implantation follow-up TEE, highlighting poor adherence to FDA guidelines. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

What question did this study set out to answer?

The aim is to assess adherence to FDA imaging guidelines following WATCHMAN device implantation in patients across multiple centers.

February 8, 2026

Adherence to imaging guidelines post WATCHMAN implantation in the real world: lessons from a multicenter prospective registry of high-volume operators in the US

Key Result

Only 46% of patients post-WATCHMAN implantation underwent follow-up TEE, with 29% having cardiac CT, indicating imperfect adherence to FDA imaging mandates.

Key Points

The aim is to assess adherence to FDA imaging guidelines following WATCHMAN device implantation in patients across multiple centers.
Conducted a prospective registry at six high-volume centers
Enrolled patients scheduled for WATCHMAN device implantation
Collected data on follow-up imaging types and adherence rates
46% of patients had follow-up transesophageal echo (TEE)
29% had follow-up CT imaging within one year after implantation
Adherence to imaging guidelines was found to be imperfect, with significant reliance on cardiac CT rather than TEE

Structured PICO

Population

1,994 patients scheduled to undergo implantation with a WATCHMAN FLX or WATCHMAN FLX Pro device from six high-volume centers in the US

Intervention

WATCHMAN FLX or WATCHMAN FLX Pro device implantation followed by local standard of care

Outcome

Adherence to FDA mandate for follow-up imaging (TEE at 45 days and one year post implant)

In a real-world US registry, adherence to FDA-mandated post-WATCHMAN TEE imaging was imperfect, with only 46% receiving TEE and 29% receiving cardiac CT up to one year.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

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 one year post implant, however clinical experience varies across centers and countries. We sought to evaluate the adherence to this FDA mandate in 1994 patients from six high volume centers in the US. 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 All patients had a TEE or intracardiac echo (ICE) guidance at time of the procedure. Of those with follow-up imaging, 46% (916/1994) of patients had follow-up TEE and 29% (577/1994) of patients had follow-up CT up to one year after device implantation.(Graph 1) Conclusion Despite clear FDA mandate to perform post-procedure imaging at 45 days and 1 year post WATCHMAN implant, adherence to these mandates remains imperfect with a significant number having cardiac CT rather than TEE. Further studies are needed to explore the geographic, clinical, healthcare resources as barriers to re-image patients to optimize performance of the LAA occlusion devices for stroke prevention.

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