PoliValve: Improving patients’ quality of life and reducing healthcare costs through next generation heart valves

全世界每年约进行130万例心脏瓣膜置换；预计到2050年，由于人口老龄化，这一数字将增加4-5倍。目前临床上使用的人工心脏瓣膜，无论是生物的还是机械的，都是不完善的。生物瓣膜是由动物组织手工缝合在坚硬的框架上制成的，它们的耐用性有限，只有10-12年。机械瓣膜通常用于年轻患者，因为其使用寿命较长，但需要终生使用华法林抗凝，这严重影响患者的生活质量，在妊娠期间引发致畸，并导致每年3-4%的血栓栓塞/出血事件。我们开发了下一代心脏瓣膜假体；我们创新的聚合物心脏瓣膜结合了优异的耐用性和血液相容性，确保植入物长期使用而不需要抗凝。我们的瓣膜代表了所有年龄段患者的理想治疗方法，同时降低了重复手术、住院再入院、药物管理等方面的医疗成本。我们已经在剑桥实验室的设备上模拟了真实心脏的操作，并证明了与同类最佳生物瓣膜相当的流体动力学。结合在加速台架测试中超过10亿次循环（相当于人类使用25年）的耐久性。在布里斯托尔也进行了一项在三只羊身上进行的小型急性试验，表明瓣膜易于缝合，无机械故障，无瓣膜反流，瓣膜压力梯度低，具有良好的生物相容性和血液相容性。

About 1.3 million heart valve replacements are undertaken each year worldwide; this number is estimated to increase 4-5 times by 2050 due to population aging. Prosthetic heart valves currently used in clinical practice, either biological or mechanical, are imperfect. Biological valves are made from animal tissue sutured by hand on rigid frames, and they have a limited durability of only 10-12 years. Mechanical valves are often used in younger patients as they last longer, but they require life-long anticoagulation with warfarin, which significantly affects patients' quality of life, triggers teratogenicity during pregnancy and causes 3-4% thrombo-embolic/haemorrhagic events/year.We have developed the next generation heart valve prosthesis; our innovative polymeric heart valve combines excellent durability and hemocompatibility, ensuring a long-lasting implant without the need for anticoagulation.Our valve represents the ideal treatment for patients of all age, while reducing healthcare costs in terms of repeated surgeries, hospital readmissions, medication management etc.We have already tested prototype valves in the lab in Cambridge, in equipment simulating the operation of a real heart, and demonstrated hydrodynamics equivalent to best in class biological valves, combined with durability in excess of one billion cycles (equivalent to 25 years of use in a human) in accelerated bench testing. A small acute trial in three sheep has also been performed in Bristol, demonstrating that the valve is easy to stitch in, and shows no mechanical failure, no trans-valvular regurgitation, low trans-valvular pressure gradients, and good biocompatibility and blood compatibility.