Nielsen Hans Henrik Møller
Department of Cardiothoracic Surgery, Aarhus University Hospital, Skejby, Brendstrupgårdsvej 100, 8200 Aarhus, Denmark.
Dan Med J. 2012 Dec;59(12):B4556.
Transcatheter aortic valve implantation (TAVI) was introduced experimentally in 1989, based on a newly developed heart valve prosthesis - the stentvalve. The valve was invented by a Danish cardiologist named Henning Rud Andersen. The new valve was revolutionary. It was foldable and could be inserted via a catheter through an artery in the groin, without the need for heart lung machine. This allowed for a new valve implantation technique, much less invasive than conventional surgical aortic valve replacement (SAVR). Surgical aortic valve replacement is safe and improves symptoms along with survival. However, up to 1/3 of patients with aortic valve stenosis cannot complete the procedure due to frailty. The catheter technique was hoped to provide a new treatment option for these patients. The first human case was in 2002, but more widespread clinical use did not begin until 2006-2010. Today, in 2011, more than 40,000 valves have been implanted worldwide. Initially, because of the experimental character of the procedure, TAVI was reserved for patients who could not undergo SAVR due to high risk. The results in this group of patients were promising. The procedural safety was acceptable, and the patients experienced significant improvements in their symptoms. Three of the papers in this PhD-thesis are based on the outcome of TAVI at Skejby Hospital, in this high-risk population [I, II and IV]. Along with other international publications, they support TAVI as being superior to standard medical treatment, despite a high risk of prosthetic regurgitation. These results only apply to high-risk patients, who cannot undergo SAVR. The main purpose of this PhD study has been to investigate the quality of TAVI compared to SAVR, in order to define the indications for this new procedure. The article attached [V] describes a prospective clinical randomised controlled trial, between TAVI to SAVR in surgically amenable patients over 75 years of age with isolated aortic valve stenosis. The study was terminated prematurely, as patients undergoing TAVI showed a statistically non-significant trend towards more complications than SAVR patients. Although non-significant the study was closed for ethical reasons. At present, scientific evidence supports TAVI as being superior to standard medical treatment, in patients who cannot undergo SAVR due to high- predicted risk. However, in patients who are surgically amenable, current publications suggest that TAVI using presently available devices is not competitive to SAVR, with regards to procedural safety and outcome.
经导管主动脉瓣植入术（TAVI）于1989年基于一种新开发的心脏瓣膜假体——支架瓣膜进行了实验性引入。该瓣膜由丹麦心脏病专家亨宁·鲁德·安德森发明。这种新型瓣膜具有革命性。它可折叠，能通过腹股沟处的动脉经导管插入，无需使用心肺机。这催生了一种新的瓣膜植入技术，比传统的外科主动脉瓣置换术（SAVR）侵入性小得多。外科主动脉瓣置换术安全且能改善症状并延长生存期。然而，高达三分之一的主动脉瓣狭窄患者因身体虚弱无法完成该手术。导管技术有望为这些患者提供一种新的治疗选择。首例人体病例发生在2002年，但直到2006 - 2010年才开始更广泛的临床应用。如今，在2011年，全球已植入超过40000个瓣膜。最初，由于该手术具有实验性质，TAVI仅用于因高风险而无法接受SAVR的患者。这组患者的结果很有前景。手术安全性可接受，患者症状有显著改善。本博士论文中的三篇论文基于斯基比医院在这一高风险人群中进行TAVI的结果[论文一、二和四]。与其他国际出版物一起，它们支持TAVI优于标准药物治疗，尽管存在人工瓣膜反流的高风险。这些结果仅适用于无法接受SAVR的高风险患者。本博士研究的主要目的是调查TAVI与SAVR相比的质量，以便确定这一新手术的适应症。所附文章[论文五]描述了一项针对75岁以上患有单纯主动脉瓣狭窄且适合手术的患者进行TAVI与SAVR对比的前瞻性临床随机对照试验。该研究提前终止，因为接受TAVI的患者出现并发症的趋势在统计学上虽不显著，但比接受SAVR的患者更多。尽管不显著，但出于伦理原因该研究停止。目前，科学证据支持在因预测风险高而无法接受SAVR的患者中，TAVI优于标准药物治疗。然而，在适合手术的患者中，目前的出版物表明，就手术安全性和结果而言，使用现有设备的TAVI与SAVR相比缺乏竞争力。
