Implantation methods for commercially available heart valve prostheses require open-chest access to the heart to perform the suturing process. In order to alleviate this complicated surgical implant technique, a “stent-valve” design was developed that will provide a less cumbersome implantation method and therefore a less invasive access to the heart. The purpose of this study is to verify its hydrodynamic performance and migration characteristics to assess its feasibility for use as a replacement heart valve. Hydrodynamic evaluation of the novel stent-valve combination device was carried out using a Vivitro left heart simulator and by setting up a comparison with the same 19 mm trileaflet valve under a traditional implantation (suture) method. To assess implantation ability under normal physiological conditions, porcine aortic root tissue was mounted into the left heart simulator to replace the original glass sinus. A comparison experiment was conducted to study the change in the total compliance and resistance of the testing system using the modified Windkessel model. For the range of test conditions investigated, the stent-valve combination device produced an average pressure gradient of 41.2 mm Hg(±19.6 mm Hg), an average effective orifice area (EOA) of 1.06 cm2(±0.08 cm2), and an average regurgitation percentage of 4.5% (±3.3%), while the sutured valve produced an average pressure gradient of 48.7 mm Hg(±17.4 mm Hg), an average EOA of 0.88 cm2(±0.14 cm2), and an average regurgitation percentage of 0.8% (±0.4%). The total compliance and resistance of the system was 0.37 ml/mm Hg(±0.01 ml/mm Hg) and 1.1 mm Hg/ml/s(±0.29 mm Hg/ml/s), with the original Windkessel model, and 0.33 ml/mm Hg(±0.01 ml/mm Hg) and 1.1 mm Hg/ml/s(±0.24 mm Hg/ml/s) for the system with the aortic tissue. The stent-valve combination device has demonstrated favorable hydrodynamic performance when compared with the same trileaflet valve under the traditional suturing method, and the arterial stent makes it possible to secure the valve at its required position without migration.
One-Step Percutaneous Treatment of Heavily Calcified Left-Heart Valve Stenoses
