Real-world clinical outcomes with a next-generation left atrial appendage closure device: the FLXibility Post-Approval Study.

ABSTRACT:

Aims

The FLXibility Post-Approval Study collected data on unselected patients implanted with a WATCHMAN FLX in a commercial clinical setting.

Methods and results

Patients were implanted with a WATCHMAN FLX per local standard of care, with a subsequent first follow-up visit from 45 to 120 days post-implant and a final follow-up at 1-year post-procedure. A Clinical Event Committee adjudicated all major adverse events and TEE/CT imaging results were adjudicated by a core laboratory. Among 300 patients enrolled at 17 centres in Europe, the mean age was 74.6 ± 8.0 years, mean CHA2DS2-VASc score was 4.3 ± 1.6, and 62.1% were male. The device was successfully implanted in 99.0% (297/300) of patients. The post-implant medication regimen was DAPT for 87.3% (262/300). At first follow-

SUBMITTER: Betts TR 

PROVIDER: S-EPMC10062328 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature