Objective
We present the long term results of a trileaflet (Triflo) vs. bileaflet (On-X) mechanical valve in both aortic and pulmonary position 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) position. 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 hematology, echocardiography and acoustic measurements combined with postmortem pathology analysis of the downstream organs.
Results
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) position. 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) position. 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 hematological were comparable to preoperative. The closing click sound pressure level (SPL) of the Triflo was significantly lower in both aortic (108.4 SPL (102.0-115.7) vs. 111.7 SPL (105.5-117.0), p < 0.001) and pulmonary (103.6 SPL (99.1-108.9) vs. 118.5 SPL (116.7-120.2), p < 0.001) position.
Conclusions
Preliminary in vivo results of the Triflo valve are promising in both aortic and pulmonary position in an ovine model. Excellent hemodynamics, stable long term function, low valve noise and no thromboembolic events in the absence of antithrombotic medication lay the foundation to a future clinical first-in-man trial.