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

全球每年约有130万例心脏瓣膜置换手术；由于人口老龄化，预计到2050年，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，都是不完美的。生物瓣膜是由硬质框架上手工缝合的动物组织制成的，它们的耐用性有限，只有10-12年。机械瓣膜通常用于较年轻的患者，因为它们的使用寿命较长，但它们需要使用华法林进行终身抗凝，这会显著影响患者的生活质量，引发妊娠期间的畸形，并导致每年3-4%的血栓栓塞/出血事件。我们已经开发出新一代心脏瓣膜假体；我们创新的聚合物心脏瓣膜结合了出色的耐用性和血液相容性，确保了植入物的长期使用而不需要抗凝。我们的瓣膜代表着所有年龄段患者的理想治疗，同时在重复手术、再次住院、药物管理等方面降低了医疗成本。我们已经在剑桥的实验室、模拟真实心脏操作的设备中测试了原型瓣膜，并在加速台架测试中展示了与同类最好的生物瓣膜相当的流体力学，以及超过10亿次循环(相当于人体使用25年)的耐久性。布里斯托尔还在三只绵羊身上进行了小型急性试验，表明该瓣膜易于缝合，没有机械故障，没有跨瓣返流，跨瓣压差低，以及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.