Arrhythmias & electrophysiology

Zero-fluoroscopy left atrial appendage occlusion with the Watchman FLX device

Heart RhythmPublished Single-centre prospective case series

Authors' conclusion

In this proof-of-concept study, a routine approach of transesophageal echocardiography-guided, zero-fluoroscopy LAAO with the Watchman FLX device was safe and feasible.

Study context

Population
Patients undergoing left atrial appendage occlusion (LAAO) with the Watchman FLX device under general anaesthesia and TEE guidance, without fluoroscopy
Participants
239 consecutive patients
Outcome
Key safety endpoint: death, ischemic stroke, systemic embolism, open heart surgery or major endovascular intervention; key effectiveness outcome: peridevice leak (<3 mm, 3-5 mm, >5 mm)
Follow-up
Up to discharge or 7 days after the procedure, whichever came later
Methodological detailsconsecutive patients, proof-of-concept
  • Consecutive patients
  • Proof-of-concept

Main finding

As reported in the abstract

Key safety endpoint

1 patient

Peridevice leak >3 mm

0

Successful zero-fluoroscopy LAAO

205

85.7%

Bailout fluoroscopy required

34

14.3%

Observational data: associations, not effects.

Further findings

Peridevice leak <3 mm · 45 days

Peridevice leak <3 mm
16 of 218 patients (7.3%)

Safety

Device-related thrombus · 45 days

Device-related thrombus
1 patient (0.4%)

Original publication

Zero-fluoroscopy left atrial appendage occlusion with the Watchman FLX device. Heart Rhythm. Published 19 December 2025. doi:10.1016/j.hrthm.2025.12.028

Summarised from the published abstract; every number is checked against it

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