Current Devices in TMVI and Their Limitations: Focus on Tendyne

Figures

• 

  Figure 1. Different anchoring mechanisms for catheter valves in mitral position. Please see text. From Central illustration, Regueiro et al. (7).

• 

  Figure 2. Tendyne™ valve. The Tendyne valve is a tri-leaflet porcine bioprosthetic valve with an outer and inner frame. The valve is anchored by a tether secured by an apical pad. Courtesy of Abbott.

• 

  Figure 3. The history of Tendyne: The company was founded in 2010. First implant done in acute studies in 2013 and first compassionate use case in 2014 before first EFS case was done in 2014. In 2015 Tendyne was acquired by Abbott Laboratories. The Tendyne system became the first TMVI system to receive CE Mark approval in January 2020. Courtesy of Abbott.

• 

  Figure 4. Pre-procedural planning by CT reconstructions. (A) Measurements for sizing are done both in systole and diastole to calculate for the best fitting. (B) Simulation of the selected valve to evaluate the neoLVOT and sealing of the valve (C). Neo LVOT is calculated in systole and diastole. (D) Calculation of off table angles for delivery sheath. (E) The best coaxial puncture point (green) is generally slightly different from the anatomical apex (F). Papillary muscles are not in the path of the delivery sheath to avoid damage. Courtesy of T Vilkama (Abbott) and P Blanke (Univ. British Columbia and St. Paul's Hospital).

• 

  Figure 5. The Tendyne valve is in 13 sizes, 8 standard profile (SP) and 5 low profile (LP). The size is calculated according to the anterior-posterior (AP) diameter, the inter-commisural (IC) diameter and the perimeter (PER). Courtesy of Abbott.

• 

  Figure 6. The frame of the Tendyne valve is in two designs, the Standard profile and the Low profile. The low profile enhances the neo LVOT area but also has a smaller effective orifice area and sealing body. Courtesy of Abbott.

• 

  Figure 7. The Tendyne valve placed in the left ventricle. Courtesy of Abbott.

• 

  Figure 8. Apical pad in two sizes. Courtesy of Abbott.

• 

  Figure 9. Simulator for Tendyne implant that includes a human-like 3D printed plastic mitral valve and echo imaging. Courtesy of Abbott.

• 

  Figure 10. Experience of Tendyne in MAC. First Presented by Sorajja et al. (20). Left: Representative Patterns of Severe MAC in Patients With Symptomatic MR Images from gated, contrast-enhanced cardiac computed tomography are shown. (A,B,D) are from unique patients, whereas (A,C) are from the same patient. Some patients had large spicules arising from the anterior horn of the mitral annulus (A, arrowhead) or invading the myocardium (B, arrowheads). Ao, aorta; LA, left atrium; LV, left ventricle; MAC, mitral annular calcification; MR, mitral regurgitation; MV, mitral valve. Right: Tendyne implanted in MAC.

• 

  Figure 11. The SUMMIT trial design that includes randomization between Tendyne and MitraClip. Separate cohorts enroll patients with severe MAC or are otherwise not suitable for MitraClip and therefore are in the single-arm non-randomized cohort where all subjects are treated with Tendyne. Courtesy of Abbott.

• 

  Figure 12. Tendyne concomitant to AVR and TAVI. First experience presented at Paris PCR 2019 (23).