Copyright
©The Author(s) 2019.
World J Cardiol. Feb 26, 2019; 11(2): 57-70
Published online Feb 26, 2019. doi: 10.4330/wjc.v11.i2.57
Published online Feb 26, 2019. doi: 10.4330/wjc.v11.i2.57
Device | Study | Year of Introduction | Description | Approach | Approval |
Atriclip Device System (Atricure) | EXCLUDE study[33] | 2008 | Self-closing, sterile, implantable clip, with a reusable deployment tool applied pericardially. | Epicardial | CE Mark |
Tiger Paw System (Terumo Cardiovascular Systems) | Slater et al[34] | Introduced in 2009 and recalled in 2015 | Implantable fastener of titanium connectors that staples the LAA tissue plus rims of silicone that seal the puncture sites. | Epicardial | Recalled |
Lariat device (SentreHEART) | Bartus et al[36]; Massumi et al[37]; Dar et al[38] | 2009 | Multicomponent system including: transvenous and epicardial balloon catheters, magnet tipped guidewires, and suture delivery system | Epicardial and transvenous | FDA approval for soft tissue closure not LAAO CE mark |
PLAATO (Appriva Medical) | Sievert et al[43]; Ostermaye et al[44]; Bayard et al[45]; Park et al[46] | Introduced in 2001and discontinued in 2007 | Self-expanding nitinol cage covered with polymeric membrane (ePTFE) designed to be placed in the orifice of the LAA | Transvenous, trans-septal | Discontinued |
Watchman (Boston Scientific) | Pilot study[47]; PROTECT AF study[48-50]; PREVAIL study[51,52]; CAP 1 registry[53]; CAP 2 registry[54]; EWOLUTION registry[55-57]; RELEXAO Registry[72]; ASAP study[58]; ASAP TOO study[59] | 2005 | Self-expanding nitinol frame structure with fixation barbs and a permeable polyester fabric that covers the atrial facing surface of the device | Transvenous, trans-septal | FDA approved and CE Mark |
ACP (St. Jude Medical) | Urena et al[67]; Gloekler et al[60]; Abualsaud et al[61]; Korsholm et al[64]; Berti et al[65]; RELEXAO; Registry[72] | 2008 | Self-expanding distal lobe (6.5mm in length) and proximal disc (4-6mm larger than distal lobe) nitinol mesh with articulating waist | Transvenous, trans-septal | CE Mark |
Amplatzer Amulet (St. Jude Medical) | Gloekler et al[60]; Abualsaud et al[61]; Landmesser et al[62]; Tzikas et al[63]; Korsholm et al[64]; Berti et al[65]; Kleinecke et al[66]; RELEXAO; Registry[72]; | 2013 | Self-expanding distal lobe and proximal disc nitinol mesh with articulating waist, and more anchors | Transvenous, trans-septal | CE Mark |
Study/reference | Regimen |
PROTECT AF trial[48-50] | Warfarin for 45 d followed by aspirin and clopidogrel for 6 mo, then aspirin indefinitely |
PREVAIL trial[51] | Warfarin for 45 d followed by aspirin and clopidogrel for 6 mo, then aspirin indefinitely |
EWOLUTION registry[56] | warfarin in 16%, NOAC in 11%, DAPT in 60%, SAPT in 7%, and no therapy in 6% |
RELEXAO registry[72] | OACs in 28.8%, SAPT in 36.2%, DAPT in 23.2%, OACs plus DAPT in 4.3%, and no therapy in 7.5%. |
ASAP trial[58] | DAPT for 6 mo followed by aspirin indefinitely |
EHRA/EAPCI expert consensus[75] | DAPT for 1 to 6 mo followed by aspirin indefinitely |
Complication | Incidence | Treatment |
Pericardial effusion/tamponade that require intervention[47,48,50,51,53,56-58,63,76] | 1.2% to 5% | Pericardiocentesis |
Device embolization[47,48,50,51,56-58,63,76] | 0% to 3.7% | Transcatheter removal or surgery |
Device related thrombus[47,56-58,63] | Up to 14% | Anticoagulation |
Persistent ASD[77] | 11% at 6 mo and 7% at 12 mo | Usually small no need for treatment |
Cardiac perforation[51] | 0% to 0.4% | surgery |
Procedure related stroke[47,48,51,53,56-58,76] | 0% to 1.1% | Stroke management |
- Citation: Moussa Pacha H, Al-khadra Y, Soud M, Darmoch F, Moussa Pacha A, Alraies MC. Percutaneous devices for left atrial appendage occlusion: A contemporary review. World J Cardiol 2019; 11(2): 57-70
- URL: https://www.wjgnet.com/1949-8462/full/v11/i2/57.htm
- DOI: https://dx.doi.org/10.4330/wjc.v11.i2.57