Page 17 - Journal of Structural Heart Disease Volume 1, Issue 3

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Original Scientific Article
Figure 18: The TriGuard Cerebral Protection Device. The device consists of a nitinol mesh and a nitinol frame with two stabilizers that anchor the device in the brachiocephalic trunk and at the inner curvature of the aortic arch.
day period after TAVR ranges from 3% to 7%, with the majority of patients experiencing ‘major’ strokes [11]. The observation that most cerebrovascular events occur within the first days after device implantation, implies that the stroke has a thromboembolic origin [44]. In order to minimize the risk of thromboembolic cerebrovascular accidents during TAVR, cerebral pro- tection devices are currently being developed.
Embrella Embolic Deflector
The Embrella Embolic Deflector system (Edwards Lifesciences, Irvine, Ca, USA) consists of an oval-shaped nitinol frame covered with a porous polyurethane membrane that is positioned at the level of the aortic arch with the purpose of deflecting embolic debris generated during TAVR procedures [45] (Figures 16 and 17). The device is inserted via the right radial or brachi- al approach using a 6 Fr delivery system. The frame of the device has two opposing petals that are positioned along the greater curvature of the aorta, covering the ostia of both the brachiocephalic and the left common carotid arteries. In a pilot study recently published, the Embrella Embolic Deflector system was used in 41 pa- tients during TAVR, compared to 11 patients that under- went TAVR without embolic protection [45]. The system was successfully deployed at the level of the aortic arch
Figure 19: The Montage Dual Filter system. The conically shaped filters consist of a nitinol frame and polyurethane laser-drilled filter membrane with 140 μm-diameter pores. The filters are ad- vanced to the brachiocephalic trunk and the left common carot- id arteries before valve deployment.
in all patients with no complications. The use of the sys- tem was associated with a lower cerebral lesion volume demonstrated with diffusion weighted magnetic res- onance imaging (DW-MRI) compared with the control group (p=0.003).
TriGuard
The TriGuard Cerebral Protection Device (Keystone Heart Ltd, formerly SMT Research & Development, Caesarea, Israel) is introduced via the femoral artery. The concept is similar to that of the Embrella device with some notable differences. A 9 Fr sheath is usually used for delivery and retrieval and allows additional placement of a pigtail catheter for procedural guid- ance. The device itself consists of a nitinol mesh and a nitinol frame with two stabilizers that anchor the de- vice in the brachiocephalic trunk and at the inner cur- vature of the aortic arch [46] (Figure 18). Initial clinical experience in 15 patients demonstrated successful placement of the embolic protection device in all of them without procedural complications [47]. No pa- tient developed new neurological symptoms except one patient who suffered from TIA two days after the procedure. DW-MRI showed 3.2 new cerebral lesions per patient, compared to 7.2 new lesions per patient in a historical control group without the device. The
Abramowitz, Y. et al.
TAVR Devices