The concept of a novel transcatheter aortic valve

Introduction Recently published studies comparing transcatheter aortic valve implantation (TAVI) with surgical aortic valve replacement (SAVR) are very encouraging. The PARTNER 3 study revealed that TAVI showed an advantage over the surgical procedure in terms of composite endpoints in a 30-day and 1-year follow-up. The Evolut Low Risk Trial showed that TAVI is not inferior to SAVR in a 2-year follow-up. Currently, Sapien 3 and Evolut R are approved by the FDA for use in low-risk patients [1, 2]. As a result, the indications for TAVI will most likely be extended in future recommendations. It will also mean that TAVI will be used in ever-younger patients. As younger patients are qualified for the procedure, the importance of access to coronary arteries will increase. Access to coronary arteries depends both on anatomical factors and the applied procedure [3]. The compatibility of the new commissures with the native commissures constitutes another issue. Surgical valves are compatible with the new commissures in 96% of cases, and the valves implanted using TAVI are fully or partially compatible only in 47% of cases [4]. Proper orientation of the new commissures in relation to the native ones reduces valve coverage of the coronary ostia, facilitating access to the coronaries in future interventions [4]. It can also impact valve durability by reducing central regurgitation and transvalvular shear stress [5].

Assumptions of the concept of the novel aortic valve

1. The valve is made of Nitinol 2. It is self-expanding, repositionable, retrievable, rotatable 3. The shape of the valve frame with three arms ensures free access to coronary arteries (Figure 1 A) 4. The shape of the base is cylindrical in order to ensure predictable oversizing at the annulus level (Figure 1 A) [6] 5. Additional markers with different shapes at the base ensure correct positioning of the valve during implantation, in alignment with the native commissures (Figure 1 A, 2 A) 6. Correct implantation of the new valve requires determination of the position of the X-ray tube, in which the lower markers are visible in the correct order, in a single line and at equal distances from each other 7. The height of the stent is relatively low (12 mm from the base to the lowest point of the area between the arms of the stent) (Figures 2 C–E) 8. The valve can be used in patients with a bicuspid aortic valve 9. The valve is resistant to deformation during resuscitation...


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