Service de cardiologie, hôpital Charles-Nicolle, université de Rouen, Rouen, France.
Arch Cardiovasc Dis. 2012 Mar;105(3):146-52. doi: 10.1016/j.acvd.2012.01.005. Epub 2012 Mar 16.
The development of transcatheter aortic valve implantation (TAVI) by our group has been a 20-year odyssey. In 1993, postmortem studies validated the concept of intravalvular stenting in calcific aortic stenosis. The first prototypes of balloon-expandable valves were tested in an animal model in 2000. The first-in-man implantation was performed in Rouen in 2002, rapidly followed by two prospective series in compassionate cases in our centre. TAVI took flight in 2004 in the hands of Edwards Lifesciences, with major improvements in devices and approaches. At the same time, the self-expanding CoreValve was launched. Thousands of high-surgical-risk patients were enrolled in feasibility studies, leading to the Conformité Européenne (CE) mark being granted in 2007 for the two devices. A number of postmarketing registries have shown dramatic improvements in procedural and midterm results and decreased complication rates, with more experience and improved technology. The results of the randomized PARTNER study in the USA recently confirmed the important place of TAVI in non-operable and high-surgical-risk patients. To date, more than 50,000 patients have benefited from TAVI worldwide (2300 patients in 33 centres in France in 2011) and the number is consistently increasing. An optimal multidisciplinary collaboration and formally trained experienced physicians are the keys to success. An extension of indications to lower-risk patients might be expected in the coming years but should be cautiously investigated. Ten years after the first-in-man case, TAVI is here to stay and the future is promising.
我们团队在经导管主动脉瓣植入术(TAVI)方面的发展经历了 20 年的历程。1993 年,尸检研究验证了钙化性主动脉瓣狭窄瓣内支架的概念。2000 年,我们在动物模型中测试了第一批球囊扩张瓣膜的原型。2002 年,我们在鲁昂进行了首例人体植入,随后在我们中心进行了两例同情病例的前瞻性系列研究。TAVI 在 Edwards Lifesciences 的手中于 2004 年起飞,设备和方法都有了重大改进。与此同时,自扩张的 CoreValve 也问世了。数以千计的高手术风险患者参加了可行性研究,导致这两种设备于 2007 年获得了 CE 标志。一些上市后注册研究表明,手术和中期结果有了显著改善,并发症发生率降低,这得益于更多的经验和改进的技术。最近,美国的随机 PARTNER 研究结果证实了 TAVI 在不能手术和高手术风险患者中的重要地位。迄今为止,全球已有超过 50,000 名患者受益于 TAVI(2011 年法国 33 个中心的 2300 名患者),而且这个数字还在不断增加。最佳的多学科合作和经过正式培训的有经验的医生是成功的关键。预计未来几年可能会将适应证扩展到低风险患者,但应谨慎进行研究。首例人体病例 10 年后,TAVI 已经到来,未来充满希望。