In-vivo experience with the Triflo trileaflet mechanical heart valve

Area of Science:

• Biomedical Engineering
• Cardiovascular Research
• Medical Device Development

Background:

• Evaluating the in-vivo performance of the novel Triflo trileaflet mechanical heart valve.
• Gathering site-specific safety data in an ovine model for regulatory approval.
• Assessing device safety prior to clinical trials for a new mechanical valve design.

Purpose of the Study:

• To evaluate the in-vivo performance and safety of the Triflo trileaflet mechanical valve.
• To compare the Triflo valve's performance against a standard bileaflet mechanical valve.
• To gather data for regulatory approval for clinical trials.

Main Methods:

• Implantation of Triflo trileaflet valves (29-mm mitral, 21-mm aortic) in 26 sheep.
• Allocation of animals into 150-day and 365-day survival cohorts.
• Assessment of valve performance using angiography, echocardiography, and pathology.

Main Results:

• Triflo mitral valve pressure measurements were within established ranges; mild regurgitation observed.
• No significant infection or hemolysis; thromboembolic events noted in 4-20% of kidneys.
• Mild to moderate fibrous tissue formation at inflow orifice; comparable to St. Jude Medical bileaflet valve.

Conclusions:

• Triflo valve demonstrated safety comparable to standard bileaflet valves in aortic and mitral positions.
• Trileaflet design may reduce outflow tract obstruction and patient-prosthesis mismatch.
• Triflo valve emulates native tissue valve hemodynamics, combining tissue valve function with mechanical durability.