Abstract
Purpose
To evaluate the feasibility of one-step implantation of a new type of stent-based mechanical aortic disc valve prosthesis (MADVP) above and across the native aortic valve and its short-term function in swine with both functional and dysfunctional native valves.
Methods
The MADVP consisted of a folding disc valve made of silicone elastomer attached to either a nitinol Z-stent (Z model) or a nitinol cross-braided stent (SX model). Implantation of 10 MADVPs (6 Z and 4 SX models) was attempted in 10 swine: 4 (2 Z and 2 SX models) with a functional native valve and 6 (4 Z and 2 SX models) with aortic regurgitation induced either by intentional valve injury or by MADVP placement across the native valve. MADVP function was observed for up to 3 hr after implantation.
Results
MADVP implantation was successful in 9 swine. One animal died of induced massive regurgitation prior to implantation. Four MADVPs implanted above functioning native valves exhibited good function. In 5 swine with regurgitation, MADVP implantation corrected the induced native valve dysfunction and the device’s continuous good function was observed in 4 animals. One MADVP (SX model) placed across native valve gradually migrated into the left ventricle.
Conclusion
The tested MADVP can be implanted above and across the native valve in a one-step procedure and can replace the function of the regurgitating native valve. Further technical development and testing are warranted, preferably with a manufactured MADVP.
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Acknowledgments
The technical assistance of ELLA-CS, Hradec Králové, Czech Republic, who provided materials according to our calculations and requirements, is greatly appreciated. This work was supported by a CIRSE/FIRE research grant and by the Institute for Clinical and Experimental Medicine (MZO 00023001).
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Šochman, J., Peregrin, J.H., Roček, M. et al. Percutaneous Transcatheter One-Step Mechanical Aortic Disc Valve Prosthesis Implantation: A Preliminary Feasibility Study in Swine. Cardiovasc Intervent Radiol 29, 114–119 (2006). https://doi.org/10.1007/s00270-005-0029-9
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DOI: https://doi.org/10.1007/s00270-005-0029-9