Langenaeken Tom, De Meester Pieter, Verbrugghe Peter, Rega Filip, Lamberigts Marie, Van Hecke Manon, Van Hoof Lucas, Meuris Bart
Department of Cardiovascular Diseases, Research Unit of Cardiac Surgery, University Hospitals Leuven, Leuven, Belgium.
Congenital and Structural Cardiology, University Hospitals Leuven, Leuven, Belgium.
Interdiscip Cardiovasc Thorac Surg. 2023 Aug 3;37(2). doi: 10.1093/icvts/ivad142.
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.
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.
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.
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.
我们展示了在绵羊模型中，三叶瓣（Triflo）与双叶瓣（On-X）机械瓣膜在主动脉和肺动脉位置的长期结果。
将Triflo瓣膜植入21只雌性绵羊的主动脉（n = 8）和肺动脉位置（n = 13）。将On-X瓣膜植入7只雌性绵羊的主动脉（n = 1）和肺动脉（n = 6）位置。术后未给予任何抗血栓药物。在主动脉组中，生存队列分别为3个月和5个月。在肺动脉组中，生存队列分别为10周和20周。使用血液学、超声心动图和声学测量结合下游器官的尸检病理分析来评估瓣膜性能。
在肺动脉[4.30 mmHg（3.70 - 5.73）对6.80 mmHg（4.63 - 7.96），P = 0.012]和主动脉[5.1 mmHg（4.2 - 7.7）对10.7 mmHg（8.7 - 12.9），P = 0.007]位置，Triflo瓣膜的平均梯度均较低。在肺动脉[8.05 mmHg（6.75 - 10.23）对13.15 mmHg（9.20 - 14.76），P = 0.005]和主动脉[8.7 mmHg（7.5 - 12.5）对16.5 mmHg（14.2 - 19.6），P = 0.009]位置，Triflo瓣膜的峰值梯度均较低。在两个位置，瓣膜小叶和外壳表面在宏观和微观上均无任何沉积物，与未植入的对照瓣膜相当。外周器官未显示血栓栓塞损伤的迹象。生化和血液学指标与术前相当。Triflo瓣膜在主动脉[108.4声压级（102.0 - 115.7）对111.7声压级（105.5 - 117.0），P < 0.001]和肺动脉[103.6声压级（99.1 - 108.9）对118.5声压级（116.7 - 120.2），P < 0.001]位置的关闭喀喇音声压级均显著较低。
Triflo瓣膜在绵羊模型的主动脉和肺动脉位置的初步体内结果很有前景。出色的血流动力学、稳定的长期功能、低瓣膜噪音以及在未使用抗血栓药物的情况下无血栓栓塞事件，为未来的首次人体临床试验奠定了基础。
