Key result
WATCHMAN FLX reduced the combined clinical endpoint of adverse events by 59% compared to WATCHMAN V.2.5 at 3 months in patients with atrial fibrillation undergoing left atrial appendage closure.
Why the study?
Does the WATCHMAN FLX device improve echocardiographic outcomes and reduce adverse clinical events compared to the WATCHMAN V.2.5 device in patients with atrial fibrillation undergoing left atrial appendage closure?
Cohort (n=169)
No
Does the WATCHMAN FLX device improve echocardiographic outcomes and reduce adverse clinical events compared to the WATCHMAN V.2.5 device in patients with atrial fibrillation undergoing left atrial appendage closure?
The newer WATCHMAN FLX device demonstrates continued expansion over 3 months with reduced peridevice leakage and fewer adverse clinical events compared to the older WATCHMAN V.2.5.
INTRODUCTION: Interventional closure of the left atrial appendage (LAAC) has been established as an alternative treatment for patients with atrial fibrillation (AF) and an elevated risk of stroke. The WATCHMAN FLX (WM FLX) as the newest WATCHMAN LAAC device differs in several technical characteristics from its precursor, the WATCHMAN V.2.5 (WM V.2.5). METHODS: The data presented here are derived from a retrospective single-centre study. All patients in which an LAAC was performed between February 2017 and March 2021 with either a WM V.2.5 or WM FLX device were included. RESULTS: 169 patients were included in this study, of whom 95 had been treated with WM V.2.5 and 74 with WM FLX, respectively. Directly after implantation, only minor differences regarding membrane thickness and connector protrusion were noted, whereas no relevant differences were found regarding device sizing, device compression or peridevice leakage, respectively. However, at 3-month follow-up, device compression was significantly reduced in WM FLX indicating a continued device expansion which was paralleled by a reduced number of peridevice leakage in comparison to WM V.2.5. Additionally, the combined clinical endpoint of death, stroke/transistoric ischaemic attack, tamponade, device embolisation, device-related thrombosis or peridevice leakage was reduced in WM FLX. CONCLUSION: LAAC using the WM FLX device results in a continued device expansion over the first 3 months based on differences in radial force in comparison to WM V.2.5. This is accompanied by a reduction in adverse clinical endpoints.
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Sakriss et al. (2023) conducted a cohort in Atrial Fibrillation (n=169). WATCHMAN FLX vs. WATCHMAN V.2.5 was evaluated on Combined clinical endpoint (death, stroke/TIA, systemic embolism, pericardial tamponade, device-related thrombosis, or peridevice leakage) at 3 months (OR 0.41, p=0.04). WATCHMAN FLX reduced the combined clinical endpoint of adverse events by 59% compared to WATCHMAN V.2.5 at 3 months in patients with atrial fibrillation undergoing left atrial appendage closure.
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