Dworakowski R, Wendler O
Department of Cardiothoracic Surgery King's College Hospital/King's Health Partners London, UK -
Minerva Cardioangiol. 2013 Aug;61(4):471-82.
Last year was the 10th anniversary of the first transcatheter aortic valve implantation (TAVI) performed by Alain Cribier using the Cribier-Edwards transcatheter heart valve (THV). The Edwards SAPIENTM THV (Edwards Lifesciences, Irvine, CA, USA) was the first commercially available balloon-expandable THV to receive CE-Mark certification in Europe for transfemoral and transapical aortic valve implantation in 2007/2008. Outcome of the prospective randomized PARTNER-US trial resulted in FDA approval for TAVI using the Edwards SAPIENTM THV in patients unsuitable for surgery in 2011 and high-risk patients in 2012. This experience, together with results from the SOURCE Registry and National Registries, has resulted in further modifications of valve design and delivery systems, but also improvement in patient selection and procedural techniques. In this manuscript we review the changes made to the newest model of the Edwards SAPIENTM and its delivery systems over time with an emphasis on the SAPIEN XTTM. We also summarize the recent experience presented on the Edwards SAPIENTM and SAPIEN XTTM, new access routes and lessons learned for patient assessment, as well as opportunities for future development of the device.
去年是阿兰·克里比耶使用克里比耶-爱德华兹经导管心脏瓣膜（THV）进行首例经导管主动脉瓣植入术（TAVI）的10周年纪念。爱德华兹SAPIEN™ THV（美国加利福尼亚州尔湾市爱德华兹生命科学公司）是首款于2007/2008年在欧洲获得CE标志认证，可用于经股动脉和经心尖主动脉瓣植入的商业化球囊扩张式THV。前瞻性随机PARTNER-US试验的结果使得爱德华兹SAPIEN™ THV在2011年被FDA批准用于不适于手术的患者，2012年被批准用于高危患者。这一经验，连同SOURCE注册研究和国家注册研究的结果，不仅促使瓣膜设计和输送系统得到进一步改进，也推动了患者选择和手术技术的提高。在本手稿中，我们回顾了随着时间推移爱德华兹SAPIEN™及其输送系统最新型号所做的改变，重点是SAPIEN XT™。我们还总结了有关爱德华兹SAPIEN™和SAPIEN XT™的最新经验、新的入路途径以及患者评估的经验教训，以及该设备未来的发展机遇。
