Watchman FLXデバイスを用いたゼロ透視下左心耳閉鎖術
Tarun Chakravarty1, Sabah Skaf1, Uttam Singh1
1Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Background:
Percutaneous left atrial appendage occlusion (LAAO) is conventionally performed under fluoroscopic guidance.
Objectives:
The aim of the study was 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 started performing LAAO procedures with the Watchman FLX device without the use of fluoroscopy. The procedures were performed under general anesthesia with transesophageal echocardiographic (TEE) 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 post-procedure, whichever came later. The key effectiveness outcome was assessed by the presence of peri-device leak, categorized as leaks < 3mm, 3-5mm and >5mm.
Results:
From June 15, 2023, until September 30, 2025, zero-fluoroscopy LAAO procedure with the Watchman FLX device was attempted in 239 consecutive patients (mean age 79 years, 31% female, median CHADS-VASc score 4), of whom 205 (85.7%) patients underwent 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 peri-device leak > 3mm. At 45 days, a peri-device leak < 3mm was noted in 16/218 (7.3%) patients, and device-related thrombus in 1 (0.4%) patients.
Conclusions:
In this proof-of-concept study, a routine approach of TEE-guided, zero-fluoroscopy LAAO with the Watchman FLX device was safe and feasible.
