The Heart Valve Society

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Towards A Warfarin-free Mechanical Heart Valve Substitute
Walter Dembitsky, Sr.1, Penelope Leyland, Mrs2, Stefano Mischler3, Angelo Casagrande, PhD3, Michele Gaffuri, PhD2, Bernhard Vennemann, PhD4, Dominik Obrist, PhD5, Jean Geringer, PhD6, Thierry Carrel, MD7, Gilles Dreyfus, MD8, Didier Lapeyre, MD9.
1Sharp Hospital,, San Diego, CA, USA, 2EPFL, Lausanne,, Switzerland, 3EPFL, Lausanne, Switzerland, 4ETHZ, Zurich, Switzerland, 5ARTORG Center, Bern, Switzerland, 6Ecole des Mines, Saint-Etienne, France, 7Inselspital, University of Bern, Bern, Switzerland, 8Cardiothoracic Centre of Monaco, Monaco, Monaco, 9Triflo Medical Switzerland, Neuchatel, Switzerland.

OBJECTIVE: There is a huge underserved need for more durable and less thrombogenic heart valves. Many patients born with a bicuspid valve will require valve surgery early in adulthood. Rheumatic disease in young patients remains endemic in many threshold countries. Current mechanical heart valve were designed in the early 70s with the assumption that damage to blood and subsequent activation of thrombosis occurs during the forward flow. Recent experimental, numerical and bio-molecular hematological studies have demonstrated that it is not the forward flow phase nor the material but rather the non-physiologic closing mode that wounds the blood and is responsible for thrombolism and the need for life-long anticoagulation.
METHODS: Projected Dynamic Valve Area (PDVA), Digital Particle Imaging Velocimetry (DPIV), Computational Fluid Dynamics (CFD) and Platelet-Shear Flow Interaction (PSFI) diagnostic technologies were used to compared in head-to-head cardiac output, heart rates and systemic pressure conditions tissue valves (Carpentier Edward Perimount and Medtronic Intuity) and mechanical valves (St-Jude Regent and Medtronic Open-Pivot) to the Lapeyre Triflo Furtiva tri-leaflet hingeless mechanical valve using a low density bio stable and biocompatible rigid polymer for the leaflets (Vesta Keep PEEK, Evonik).
RESULTS: The Triflo mechanical heart valve demonstrates the same physiologic closing mode of tissue valves with similar opening and closing flow patterns, low closing volume, no shape transition in the pivoting spaces of the leaflets and no platelet activation in this critical area (the Achilles' heel of current mechanical heart valves). These physiologic haemodynamic profiles drastically differ from that of current bi-leaflet mechanical valves. Validations of the structural performances of the valve are on-going in compliance with ISO 5840.
CONCLUSIONS: The innovative Lapeyre-Triflo Furtiva mechanical tri-leaflet design operates physiologically like tissue valves, with same flow patterns during the opening and closing phases, no pathologic shear stress in the pivoting spaces, low risk of life-threatening occlusive thrombosis. It may thus function without requirements for anticoagulation, no risk of structural degeneration and meet the need of the large population of young patients that are not candidates for tissue valve replacement


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