Abstract
Background: Evidence supporting the clinical superiority of the Watchman FLX with respect to its previous iteration, the Watchman 2.5, is still sparse.
Aims: We aimed to compare the Watchman FLX and Watchman 2.5 in terms of device-related complications and clinical outcomes.
Methods: All consecutive left atrial appendage closures (LAACs) completed with implantation of a Watchman device at two high-volume centres between July 2018 and January 2023 were considered. Based on the type of implanted device, patients were assigned to either the Watchman FLX or Watchman 2.5 group. The study endpoints included device-related thrombus (DRT) and peridevice leak (PDL), as evaluated by transoesophageal echocardiography (TOE), and stroke rate at the longest available follow-up. Propensity score matching (PSM) analysis was used to minimise baseline differences between groups.
Results: After performing PSM, 1,128 patients were included in each group. In the TOE follow-up, performed at a mean of 2.3 months, both DRT (0.2% vs 3.1%; hazard ratio [HR] 0.35, 95% confidence interval [CI]: 0.21-0.38; p=0.017) and PDL (21.0% vs 30.6%; HR 0.68, 95% CI: 0.59-0.77; p=0.031) were significantly lower in the Watchman FLX group compared with the Watchman 2.5 group. At a mean of 1.6 years of follow-up, the stroke rate was numerically lower in the Watchman FLX group compared with the Watchman 2.5 group (3.4% vs 5.1%; HR 0.56, 95% CI: 0.15-1.69; p=0.078).
Conclusions: In a large dual-centre cohort of consecutive, successful LAAC procedures using two iterations of the Watchman device, the Watchman FLX was associated with significantly lower rates of both DRT and PDL compared to the Watchman 2.5.
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