Key result
The Triflo trileaflet mechanical valve demonstrated significantly lower mean gradients compared to the On-X valve in both pulmonary (4.30 vs 6.80 mmHg, P=0.012) and aortic positions in a sheep model.
Why the study?
Does a trileaflet mechanical heart valve improve hemodynamics and reduce noise compared to a bileaflet valve in an ovine model?
Does a trileaflet mechanical heart valve improve hemodynamics and reduce noise compared to a bileaflet valve in an ovine model?
Absolute Event Rate: 4.3% vs 6.8%
p-value: p=0.012
The Triflo trileaflet mechanical heart valve demonstrated superior hemodynamics, lower noise, and no thromboembolic events without antithrombotic therapy compared to a standard bileaflet valve in a preclinical ovine model.
OBJECTIVES: We present the long-term results of a trileaflet (Triflo) versus bileaflet (On-X) mechanical valve in both aortic and pulmonary positions in a sheep model. METHODS: The Triflo valve was implanted in 21 female sheep in aortic (n = 8) and pulmonary position (n = 13). The On-X valve was implanted in 7 female sheep in aortic (n = 1) and pulmonary (n = 6) positions. No antithrombotic medication of any kind was given postoperatively. In the aortic group, survival cohorts were 3 and 5 months. In the pulmonary group, survival cohorts were 10 and 20 weeks. Valve performance was assessed using haematology, echocardiography and acoustic measurements combined with post-mortem pathology analysis of the downstream organs. RESULTS: The mean gradients were lower for the Triflo valve in both pulmonary [4.30 mmHg (3.70-5.73) vs 6.80 mmHg (4.63-7.96), P = 0.012] and aortic [5.1 mmHg (4.2-7.7) vs 10.7 mmHg (8.7-12.9), P = 0.007] positions. Peak gradients were lower for the Triflo valve in both pulmonary [8.05 mmHg (6.75-10.23) vs 13.15 mmHg (9.20-14.76), P = 0.005] and aortic [8.7 mmHg (7.5-12.5) vs 16.5 mmHg (14.2-19.6), P = 0.009] positions. In both positions, leaflets and housing surface were free from any deposits macro- and microscopically and comparable to nonimplanted control valves. Peripheral organs showed no signs of thrombo-embolic damage. Biochemical and haematological were comparable to preoperative. The closing click sound pressure level of the Triflo was significantly lower in both aortic [108.4 sound pressure level (102.0-115.7) vs 111.7 sound pressure level (105.5-117.0), P < 0.001] and pulmonary [103.6 sound pressure level (99.1-108.9) vs 118.5 sound pressure level (116.7-120.2), P < 0.001] position. CONCLUSIONS: Preliminary in vivo results of the Triflo valve are promising in both aortic and pulmonary positions in an ovine model. Excellent haemodynamics, stable long-term function, low valve noise and no thrombo-embolic events in the absence of antithrombotic medication lay the foundation to a future clinical first-in-man trial.
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Langenaeken et al. (2023) studied Mechanical heart valve implantation (n=28). Triflo trileaflet mechanical valve vs. On-X bileaflet mechanical valve was evaluated on Mean gradients (pulmonary position) (p=0.012). The Triflo trileaflet mechanical valve demonstrated significantly lower mean gradients compared to the On-X valve in both pulmonary (4.30 vs 6.80 mmHg, P=0.012) and aortic positions in a sheep model.
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