Key result
TRIFLO mechanical valve yields favorable hemodynamics and no thrombosis in sheep, potentially eliminating long-term oral anticoagulation.
Why the study?
Current mechanical heart valves require lifelong oral anticoagulants due to flow-related thrombosis, prompting the need for a tri-leaflet design that eliminates high-shear flow and rapid closing.
Does the TRIFLO tri-leaflet mechanical valve prevent thrombosis and structural failure without long-term anticoagulation in an adult sheep model?
Does the TRIFLO tri-leaflet mechanical valve prevent thrombosis and structural failure without long-term anticoagulation in an adult sheep model?
The novel TRIFLO tri-leaflet mechanical valve demonstrated favorable hemodynamics and absence of thrombosis without long-term anticoagulation in a preclinical sheep model, suggesting potential as a major innovation in valve surgery.
Answers are grounded in this paper and cite their sources.
Does not support changing anticoagulation practice; leaves open need for human trials to confirm thrombosis resistance.
The aortic valve is the most frequently diseased valve and aortic stenosis (AS) is the most prevalent valvular heart disease in developed countries. The diseased native aortic valve can be replaced by either a biological or mechanical valve prosthesis. The main concerns relate to durability, the need for oral anticoagulants and the incidence of complications related to this medication. Experimental, computational and biomolecular blood flow studies have demonstrated that the systolic forward flow but also the reverse flow phase at the end of the systole and leakage during the diastolic phase is mainly responsible for platelet activation and thrombosis. Better design of mechanical prosthetic heart valves must ensure smooth closing during flow deceleration and must eliminate high-shear hinge flow during diastole to prevent life-threatening thrombosis. A novel tri-leaflet valve should combine the favorable hemodynamics and the durability of existing mechanical heart valves and eliminate the less favorable characteristics, including the extremely rapid closing. In this paper, we discuss some issues of current mechanical heart valve prostheses and present a new valve design with the potential for significant innovation in the field. The TRIFLO Heart Valve, is a rigid, three-leaflet central flow heart valve prosthesis consisting of an alloyed titanium housing, and three rigid polymer (PEEK) cusps. This valve has a physiological operating mode. During the forward flow phase, the intraventricular pressure opens the leaflets so that blood can freely flow through with little obstruction, and with the deceleration of the blood flow, the leaflets close early and smoothly, minimizing blood flow regurgitation, blood cell damage, and activation of the coagulation cascade. Pre-clinical studies have shown pretty favorable results and a first-in-man study should start very soon.
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Carrel et al. (2023) conducted a review in Aortic valve disease. TRIFLO tri-leaflet mechanical valve vs. Current mechanical and biological valves was evaluated. The TRIFLO tri-leaflet mechanical valve demonstrated favorable hemodynamics and no thrombotic deposits in pre-clinical sheep models, suggesting a potential to eliminate long-term oral anticoagulation.
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