Clinical outcomes of Watchman vs. Amplatzer occluders for left atrial appendage closure (WATCH at LAAC)

Abstract

Aims This study compares clinical outcomes of Watchman vs. Amplatzer devices for left atrial appendage closure (LAAC). Methods and results Of two real-world registries, the Watchman registry Lichtenfels, Germany, and the Amplatzer registry Bern-Zurich, Switzerland, 303 and 333 consecutive patients, respectively, were included. After a 1:1 propensity score matching, 266 vs. 266 patients were compared by use of the predefined primary efficacy endpoint of stroke, systemic embolism and cardiovascular/unexplained death, the primary safety endpoint of major peri-procedural complications and major bleeding events at follow-up, and the combined hazard endpoint, a composite of all above-mentioned hazards. Mean age was 75.3 ± 7.8 (Watchman) vs. 75.1 ± 9.9 (Amplatzer) years, CHA2DS2-VASc score 4.5 ± 1.7 vs. 4.5 ± 1.5, and HAS-BLED score 3.2 ± 1.0 vs. 3.2 ± 1.0. At a mean follow-up of 2.4 ± 1.3 vs. 2.5 ± 1.5 years and 1.322 patient-years, the primary endpoints of efficacy [40/646, 6.2% [Watchman] vs. 43/676, 6.4% [Amplatzer]; hazard ratio (HR), 1.02; 95% confidence interval (CI), 0.66–1.58; P = 0.92] and safety (33/646, 5.1% vs. 30/676, 4.4%; HR, 0.57; 95% CI, 0.29–1.11; P = 0.10), as well as the combined hazard endpoint (69/646, 10.7% vs. 66/676, 9.8%; HR, 0.80; 95% CI, 0.55–1.12; P = 0.26) were similar for both groups. Conclusion This study suggests comparable efficacy and safety of the Watchman and Amplatzer devices.

Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry

“…The authors evaluated the long-term efficacy of LAAO procedure in primary and secondary stroke prevention and reported comparable efficacy outcome during a mean follow-up of 50 months. The 6.2% rate of TIA/stroke in the WD group, observed in our study, correlated well with data from the PREVAIL trial (6.4%) [ 16 ] and the aforementioned European registries (6.4%) [ 14 ].…”

“…In our study, no major adverse events occurred in the WD group, which correlated well with data from the EWOLUTION registry [ 13 ]. The analysis of two European real-world registry data, performed by Kleinecke et al [ 14 ] reported a comparable periprocedural major complications rate for the WD and Amplatzer group devices (4.1% vs. 6.0%, p = 0.32). A recent meta-analysis of six studies also confirmed the comparable safety outcomes for the WD and Amplatzer groups [ 15 ].…”

Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience.

“…13-16, 29,31 However, only few retrospective data reported a head-to-head comparison of clinical outcomes of Amplatzer and Watchman devices and especially industry-independent data are lacking. [23][24][25][26][27][28] In our real-world study, the incidence rate of periprocedural MACCE for our cohort was 6.6%, with an incidence of 2.7% in the Watchman group and 10.6% in the Amulet group. In the previously published Watchman studies, the rates of 7-day procedure-related serious adverse events were 8.7% in PROTECT-AF trial, 4.2% in the PREVAIL trial, and 2.8% in the EWOLUTION study.…”

Percutaneous occlusion of the left atrial appendage: the state-of-the-art

“…Except for the Amulet IDE and Wavecrest2 trial, comparing respectively, Amulet and WaveCrest® with the Watchman™ (both still in the recruitment phase), there are no randomized head-to-head trials comparing devices. Among the few registries published on the subject, there were no significant differences in success rates, complications, residual leak or late stroke when comparing the ACP to Amulet, 37 Watchman™ to ACP/Amulet 38 or Watchman™ to ACP/Amulet to LAmbre™, 39 suggesting that LAAO has a class effect, which does not depend on the device implanted, as long as the anatomical requirements are respected.…”