Table 2. Major studies for different types of LAAO devices: Amplatzer Cardiac Plug and Amulet.
Characteristics | Tzikas et al.20) | Koskinas et al.25) | Berti et al.24) | López Mínguez et al.27) | Kleinecke et al.26) | Urena et al.23) |
---|---|---|---|---|---|---|
Study type/device used | Retrospective/ACP | Prospective/ACP 408, Amulet 92 | Prospective/ACP 91, Amulet 17 | Prospective/ACP | Retrospective/Amulet | Retrospective/ACP |
Population | 1,047 | 500 | 108 | 167 | 50 | 52 |
Implantation success rate (%) | 97.3 | 97.8 | 100 | 94.6 | 98 | 98.1 |
CHA2DS2-Vasc score | 4.5 | 4.3 | 4.3 | 4 | 5.2 | 5 (median) |
HAS-BLED score | 3.1 | 2.9 | 3.4 | 3 | 3.5 | 4 (median) |
Anticoagulation used | 16% treated with warfarin, otherwith variable combinations of aspirin, clopidogrel, LMWH | DAPT with aspirin for 5 months plus clopidogrel for 1–6 months | - | DAPT with asprin and clopidogrel. Aspirin for 6–12 months and clopidogrel for 3–6 months | DAPT with clopidogrel × 3 months and aspirin for at least 6 months | DAPT or single APT for 1–6 months followed by single APT |
Annual Ischemic stroke (%) | 2.3 | - | 2.2 | 3.9 | 6.1 | 1.9 |
Annual hemorrhagic stroke (%) | 2 | - | 1.1 | - | - | - |
Major bleeding (%) | 1.2 | 3.2 | 0.9 | 5.7 | 4 | 3.8 |
Pericardial effusion/tamponade (%) | 1.24 | 3.2* | 2.7 | 1.2 | 4 | 1.9 |
Device embolization (%) | 0.7 | 2 | 0 | - | 2 | 1.9 |
Procedure related stroke (%) | 0.8 | 1 | - | 1.2 | - | 0 |
ACP = Amplatzer Cardiac Plug; APT = antiplatelet therapy; DAPT = dual antiplatelet therapy; LAAO = left atrial appendage occlusion; LMWH = low molecular weight heparin.
*Hemodynamically significant pericardial effusion.