The Apex bileaflet mechanical heart valve

Abstract

Mechanical Heart Valves (MHVs) are known for their excellent lifespan and feasibly are the most reliable and stable valves amongst all prosthetic valves. Successful bileaflet MHVs such as the St. Jude Medical (SJM) are known for providing central blood flow and minimal pressure drop across the valve. However, due to their non-physiological flow conditions, they still suffer from hemodynamic complications, that is, red blood cell (RBC) lysis and/or thrombogenicity, to date. Our hypothesis is that the design of MHVs can be improved so that their hemodynamics can be comparable to those of tissue valves. In this study, a new concept for the design of MHVs is proposed. To accomplish this, we identified the major design limitations of bileaflet MHVs, such as the gold standard SJM valve as well as the believed contributing factors to their thrombogenicity. We developed a novel design architecture for bileaflet MHVs that addressed these limitations, and from it, the Apex Valve (AV). Our experimental assessment of the AV found that its hemodynamics were closer to that of a bioprosthetic valve than of a bileaflet MHV. This design has been filed as a US Provisional Patent.

Keywords:

• Mechanical heart valves
• SJM valve
• novel design
• closing volume

Acknowledgements

The authors would like to thank the NSERC/DG for financially supporting this study and Larry Scotten for performing the in-vitro experiments on the valve and for making the Leonardo apparatus available for this study. The authors also thank Dylan Goode, the Heart Valve Performance Laboratory’s manager, for his editorial contribution.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The present work was financially supported by Natural Sciences and Engineering Research Council of Canada.