| Literature DB >> 33377326 |
Carola Gianni1, Domenico G Della Rocca1, Andrea Natale1,2,3,4, Rodney P Horton1,5.
Abstract
Closure of the left atrial appendage using percutaneous transcatheter occlusion devices is used for stroke prevention as an alternative for patients with a high risk or contraindications for long-term oral anticoagulation use. Herein, we will discuss the practical aspects of five among the available devices used for interventional left atrial appendage occlusion: Watchman, Amulet, WaveCrest, LAmbre, and Lariat.Entities:
Keywords: Left atrial appendage occlusion; Stroke
Year: 2021 PMID: 33377326 PMCID: PMC7779816 DOI: 10.4070/kcj.2020.0416
Source DB: PubMed Journal: Korean Circ J ISSN: 1738-5520 Impact factor: 3.243
Left atrial appendage occlusion devices, main characteristics
| Device | Manufacturer | Design | Sizes (mm) | Approval |
|---|---|---|---|---|
| Watchman | Boston Scientific | Single lobe | 5 sizes: 21, 24, 27, 30, 33 | CE mark |
| FDA approved | ||||
| Watchman FLX | Boston Scientific | Single lobe | 5 sizes: 20, 24, 27, 31, 35 | CE mark |
| FDA approved | ||||
| Amulet | Abbott | Distal lobe and proximal disc | 8 sizes: 16, 18, 20, 22, 25, 28, 31, 34 | CE mark |
| Ongoing FDA approval trial | ||||
| WaveCrest | Biosense Webster | Single lobe | 3 sizes: 22, 27, 32 | CE mark |
| Ongoing FDA approval trial | ||||
| LAmbre | LifeTech Scientific | Distal lobe and proximal disc | 11 sizes: 16, 18, 30, 22, 24, 26, 28, 30, 32, 34, 36 | CE mark |
| FDA approval trial planned | ||||
| Lariat | SentreHeart | Non-absorbable suture | 2 sizes: 40, 45 | CE mark |
| FDA 510(k) cleared for soft tissue approximation/ligation |
CE = Conformité Européenne; FDA = Food and Drug Administration.
Figure 1Principal devices for left atrial appendage closure.
Left atrial appendage occlusion devices, main studies (feasibility, safety)
| Device | Author, year (study name) | Design | Number (device) | Procedure-related complications* | Follow-up (average; months) | Incomplete closure* |
|---|---|---|---|---|---|---|
| Watchman | Holmes et al., 2009 | RCT | 463 | 7%† | 18 | 32% at 1 year |
| Holmes et al., 2014 | RCT | 269 | 5% | 18 | NA | |
| Watchman FLX | Doshi et al., 2020 | Prospective observational | 400 | 1% | 12 | 11% at 1 year |
| Amulet | Landmesser et al., 2017 | Prospective observational | 1,078 | 6%† | 11 | 2% |
| WaveCrest | Stone, 2017 | Prospective observational | 69 | 4% | NA | NA |
| LAmbre | Huang et al., 2017 | Prospective observational | 153 | 6% | 12 | 16% |
| Lariat | Price et al., 2014 | Retrospective observational | 154 | 10% | 4 | 20% |
NA = not available; RCT = randomized controlled trial.
*Definition varies among studies; †Approximate number (reported events include non-periprocedural device-related events, which might not always be discerned from peri-procedural ones).
Figure 2Transesophageal echocardiography for sizing of intravascular LAAO devices. Examples of different LAA measurements on a 90° TEE view. Solid and dashed lines represent LAA landing zone and depth, respectively; grey solid line represents the anatomical ostium while the red dashed circle is the left circumflex coronary artery. Reproduced with permission from Gianni et al.19)
LAA = left atrial appendage; LAAO = left atrial appendage occlusion; TEE = transesophageal echocardiography.
Figure 3Importance of a low mid-to-anterior transseptal puncture. For LAAO the transseptal puncture should be low, in the mid to anterior septum to facilitate engagement of the LAA. On ICE (rightmost), the LAA and MV should be in view. Reproduced with permission from Gianni et al.19)
IAS = interatrial septum; ICE = intracardiac echocardiography; LAA = left atrial appendage; LAAO = left atrial appendage occlusion; MV = mitral valve.
Figure 4Watchman FLX deployment. Step-by-step procedure as seen on fluoroscopy. See text for description.
Figure 5Watchman deployment. Step-by-step procedure as seen on fluoroscopy. See text for description. Reproduced with permission from Gianni et al.19)
Figure 6Amulet deployment. Step-by-step procedure as seen on fluoroscopy. See text for description. Reproduced with permission from Gianni et al.19)
Figure 7WaveCrest deployment. Step-by-step procedure as seen on fluoroscopy. See text for description. Reproduced with permission from Gianni et al.19)
Figure 8Lariat deployment. Step-by-step procedure as seen on fluoroscopy. See text for description.