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

BACKGROUND

Percutaneous left atrial appendage occlusion (LAAO) is conventionally performed under fluoroscopic guidance.

OBJECTIVE

This study aimed to evaluate the feasibility and safety of performing LAAO with the Watchman FLX device without the use of fluoroscopy.

METHODS

Since June 15, 2023, we have been performing LAAO procedures with the Watchman FLX device without the use of fluoroscopy. The procedures were performed under general anesthesia with transesophageal echocardiographic imaging. The key safety endpoint was the occurrence of death, ischemic stroke, systemic embolism, open heart surgery, or major endovascular intervention up to discharge or 7 days after the procedure, whichever came later. The key effectiveness outcome was assessed by the presence of peridevice leak, categorized as leaks of <3 mm, 3-5 mm, and >5 mm.

RESULTS

From June 15, 2023, to September 30, 2025, a zero-fluoroscopy LAAO procedure with the Watchman FLX device was attempted in 239 consecutive patients (mean age 79 years; 31% female; median CHA2DS2-VASc score 4), of whom 205 patients (85.7%) underwent a successful zero-fluoroscopy LAAO procedure and 34 (14.3%) required bailout fluoroscopy. The key safety endpoint occurred in 1 patient (in-hospital death at 165 days after the index LAAO procedure secondary to recurrent aspiration). No patient had a peridevice leak of >3 mm. At 45 days, a peridevice leak of <3 mm was noted in 16 of 218 patients (7.3%), and device-related thrombus in 1 patient (0.4%).

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.