In Vitro Hydrodynamic Assessment of a New Transcatheter Heart Valve Concept (the TRISKELE)

Abstract

This study presents the in vitro hydrodynamic assessment of the TRISKELE, a new system suitable for transcatheter aortic valve implantation (TAVI), aiming to mitigate the procedural challenges experienced with current technologies. The TRISKELE valve comprises three polymeric leaflet and an adaptive sealing cuff, supported by a novel fully retrievable self-expanding nitinol wire frame. Valve prototypes were manufactured in three sizes of 23, 26, and 29 mm by automated dip-coating of a biostable polymer, and tested in a hydrodynamic bench setup in mock aortic roots of 21, 23, 25, and 27 mm annulus, and compared to two reference valves suitable for equivalent implantation ranges: Edwards SAPIEN XT and Medtronic CoreValve. The TRISKELE valves demonstrated a global hydrodynamic performance comparable or superior to the controls with significant reduction in paravalvular leakage. The TRISKELE valve exhibits enhanced anchoring and improved sealing. The valve is currently under preclinical investigation.

Impact of aortic root geometry on hydrody-namic performance of transcatheter aortic valve prostheses

“…Thus, higher regurgitant fractions were measured in comparison to our experiments. Rahmani et al developed a model of the aortic root including a valve and tested commercial heart valves in the same test bench as we did [3]. Measured regurgitant fractions and EOA were comparable to our measurements, although absolute values were slightly higher (regurgitant fraction: 23.9% to 33.0%, EOA: 1.7 cm² to 2.1 cm²) depending on prosthesis type and test condition [3].…”

“…In the past, a variety of pulse simulating devices and mock circulation systems have been developed and were described in literature for the measurement of the in vitro performance of artificial surgical as well as transcatheter heart valves [1][2][3]. In general, pulse simulating devices, so called pulse duplicators, are hydraulic models of the left human heart and the left circulatory system.…”

“…In general, pulse simulating devices, so called pulse duplicators, are hydraulic models of the left human heart and the left circulatory system. Furthermore, these devices are wellestablished testing benches to obtain comprehensive information about the complex hydrodynamic properties of prosthetic heart valves [1][2][3].…”

Design, Analysis and Testing of a Novel Mitral Valve for Transcatheter Implantation

“…In the current application, the valve distal loops (Fig. 2a, portions 1 and 2) are engaged by a set of tethers, used to pull the valve into the catheter from the side at the outflow 45. Nevertheless, the resulting geometry of the crimped wireframe in the numerical simulations resulted visually accurate.…”

Tissue Engineering—Bridging the Gap

“…The challenges in translating the data from pre-clinical and clinical pilot trials that will ultimately be faced by all tissue engineering projects are also reviewed [4]. The experimental studies in this issue address a variety of topics within the heart valve field including two papers on the development of decellularised valves [5,6], the chemical fixation of bovine pericardium and the assessment of a new transcatheter heart valve [7,8]. Within the vascular field, there are two papers, the first addresses the use of an in vivo approach that utilises the host reaction to an implanted biomaterial for the generation of completely autologous tissues, while the second examines the use of intravascular echo as a tool to evaluate the changes within tissue-engineered valves implanted into sheep [9,10].…”