Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH 44195, USA.
Curr Cardiol Rep. 2010 Sep;12(5):393-403. doi: 10.1007/s11886-010-0126-5.
Aortic stenosis affects a significant number of patients worldwide, and carries a dismal prognosis once symptoms develop. Unfortunately, a large number of patients present a prohibitive risk for surgical aortic valve replacement. Therefore, transcatheter aortic valve implantation has emerged as a promising technology for providing treatment to this group of patients. Currently available valves include the balloon-expandable Edwards SAPIEN valve (Edwards Lifesciences, Irvine, CA), which is usually implanted via a transfemoral or transapical approach, and the self-expanding CoreValve ReValving system (Medtronic, Minneapolis, MN), which uses only the transfemoral route. Early experience with the procedure performed on a compassionate-use basis was encouraging, and led to a number of first-in-man and feasibility studies. These trials demonstrated the safety and efficacy of valve implantation and led to CE (European Conformity) mark approval of both valves in Europe. Use of the SAPIEN valve in the United States is limited to the recently completed PARTNER (Placement of Aortic Transcatheter Valve) randomized trial comparing transcatheter and surgical aortic valve replacement in high-risk patients, and its post-trial registry. The CoreValve is not yet available in the United States. With improved device technology, better understanding of patient selection and pre- and periprocedural imaging, and greater procedural experience, widespread diffusion of transcatheter aortic valve implantation is expected.
主动脉瓣狭窄影响了全球大量患者,一旦出现症状,预后极差。不幸的是,大量患者因手术主动脉瓣置换而面临禁忌风险。因此,经导管主动脉瓣植入术已成为为这组患者提供治疗的有前途的技术。目前可用的瓣膜包括球囊扩张的 Edwards SAPIEN 瓣膜(Edwards Lifesciences,加利福尼亚州欧文),通常通过经股或经心尖途径植入,以及自扩张的 CoreValve ReValving 系统(美敦力,明尼苏达州明尼阿波利斯),仅使用经股途径。基于同情使用的该手术的早期经验令人鼓舞,并导致了许多首例人体和可行性研究。这些试验证明了瓣膜植入的安全性和有效性,并导致这两种瓣膜在欧洲获得 CE(欧洲符合性)标志批准。在美国,SAPIEN 瓣膜的使用仅限于最近完成的 PARTNER(经导管主动脉瓣置换术)随机试验,该试验比较了高危患者的经导管和手术主动脉瓣置换术,以及其后的试验注册。CoreValve 尚未在美国上市。随着设备技术的改进、对患者选择以及术前和围手术期成像的更好理解,以及更广泛的手术经验,经导管主动脉瓣植入术的广泛应用有望实现。