International Circulation: One highlight of EuroPCR 2009 are the many live cases and lectures about percutaneous valve implantation. What is your opinion about the current situation and developmental trends of this technique? What are the inclusion and exclusion criteria for percutaneous valve implantation?
Prof. Grube: It is a great honor and pleasure to speak about interesting topics at EuroPCR as it relates to China. Obviously one of the most important topics is percutaneous valve implantation and you can see that by the large crowds in the rooms during the talks. This is a fairly new technology if we compare it to the standard of care of the treatment of aortic stenosis. The first valves were implanted in 2002 by Dr. Cribier and then was followed in 2004 by the CoreValve prosthesis. The attraction of this approach to treatment of aortic stenosis is widely accepted by the interventional community in terms of physicians, patients, and referring physicians. We believe that in 2009 we have emerged from infancy to a more mature state of development. The two valves currently available for this treatment are the Edwards Sapien valve and the Medtronic CoreValve and more than 5,000 implants have been done altogether with these two valves. We believe that we interesting and promising intermediate results with the percutaneous implant of these prostheses. The patients are doing better, the hemodynamic data are improving, and now we are awaiting longer term results in order to get different indications and longer term results regarding the durability of the valves. Presently the indications are the elderly patient population, mainly 70 years or older, with a high risk of traditional operative procedures. The no option patient and the high risk patient indications will probably last for another 1~2 years and when we have more experience the indications will probably be expanded to the lesser risk group.
International Circulation: One highlight of EuroPCR 2009 are the many live cases and lectures about percutaneous valve implantation. What is your opinion about the current situation and developmental trends of this technique? What are the inclusion and exclusion criteria for percutaneous valve implantation?
《国际循环》:EuroPCR 2009的一个亮点是关于经皮瓣膜植入的许多现场病例和演讲。请您简单介绍一下这种技术的现状和发展趋势,以及经皮瓣膜植入术的选择和排除标准。
Prof. Grube: It is a great honor and pleasure to speak about interesting topics at EuroPCR as it relates to China. Obviously one of the most important topics is percutaneous valve implantation and you can see that by the large crowds in the rooms during the talks. This is a fairly new technology if we compare it to the standard of care of the treatment of aortic stenosis. The first valves were implanted in 2002 by Dr. Cribier and then was followed in 2004 by the CoreValve prosthesis. The attraction of this approach to treatment of aortic stenosis is widely accepted by the interventional community in terms of physicians, patients, and referring physicians. We believe that in 2009 we have emerged from infancy to a more mature state of development. The two valves currently available for this treatment are the Edwards Sapien valve and the Medtronic CoreValve and more than 5,000 implants have been done altogether with these two valves. We believe that we interesting and promising intermediate results with the percutaneous implant of these prostheses. The patients are doing better, the hemodynamic data are improving, and now we are awaiting longer term results in order to get different indications and longer term results regarding the durability of the valves. Presently the indications are the elderly patient population, mainly 70 years or older, with a high risk of traditional operative procedures. The no option patient and the high risk patient indications will probably last for another 1~2 years and when we have more experience the indications will probably be expanded to the lesser risk group.
Prof. Grube:与主动脉狭窄的标准治疗方法相比,经皮瓣膜植入术是一个相当新的技术。随着这种方法被介入群体广泛接受,我们相信2009年这种技术会向更成熟的阶段发展。目前可用的两种瓣膜分别是Edwards公司的 Sapien瓣膜和Medtronic公司的CoreValve瓣膜,超过5000例植入术使用这两种瓣膜。目前适应证主要是70岁以上传统手术风险很高的老年患者、没有其他选择的患者和高风险患者,随后,这些适应证可能会扩大至低风险患者。如果试图将其应用于更年轻的患者,就必须证明这种治疗模式的耐用性等同或优于传统手术。 International Circulation: Professor Dai, what is the current situation in China regarding percutaneous valve implantation?
《国际循环》:戴教授,中国经皮瓣膜植入术的现状如何?
Prof. Qi Ming Dai: In China this technique is not currently being employed. We do not have any experience in this technique.
戴启明教授:目前这种技术还没有得到中国政府批准,中国目前还没有应用,我们没有这方面经验。
International Circulation: Professor Grube, you mentioned the two different valves. Are there any differences between the Sapien and the CoreValve?
《国际循环》:Prof. Grube,您提到两种不同的瓣膜Sapien和CoreValve,它们有什么不同?
Prof. Grube: There are very distinct differences between the two valves. The Sapien valve is balloon expandable, which means it must be deployed with a balloon, as opposed to the self-expanding CoreValve. The tissue leaflets are different. The CoreValve has porcine leaflets and the Edwards has bovine leaflets. Most importantly, the size of the catheter is very different. Currently Edwards has 26 French and CoreValve has 18 French, which allows for different access. CoreValve can be implanted via transfemoral and subclavian. The Edwards valve, due to the size, can be implanted by transfemoral, provided the size of the vessel allows it, and preferably transapical. The results of both valves are promising, the hemodynamic results are good, and we believe that as technology evolves, apart from the differences that I just mentioned, that we will not have many clinical or hemodynamic differences.
Prof. Grube:两种瓣膜存在明显的差别。Sapien瓣膜是球囊扩张的,必须用球囊展开,与自扩CoreValve瓣膜相反。组织小叶也不同:CoreValve是猪组织小叶瓣膜,Sapien是牛组织小叶瓣膜。最重要的是,导管的大小不同:Sapien瓣膜大小为26 F,CoreValve为18 F。可以允许不同的入路:CoreValve瓣膜可以经股动脉和锁骨下动脉植入;Sapien瓣膜由于尺寸是原因,可以选择经心尖植入,假如血管条件允许,经股植入的途径更好。两者的结果都很乐观,血液动力学结果很好。
International Circulation: We know that you are a leading interventional cardiologist and a pioneer in medical devices. Would you give us an introduction to your present research, especially in new devices not yet available on the market?
《国际循环》:我们知道您是国际一流的心脏病专家和医疗器械先驱。您能否给我们介绍一下您目前的研究,特别是目前没有上市的新的医疗设备?
Prof. Grube: The valve technology is the most interesting and exciting field now. There are the next generation valves being developed now. The Sadra valve and the Direct Flow valve, which are going first in man. This technology will be entering the second generation stage. As far as coronary heart disease is concerned, we have to see that there is an improvement and a change of paradigm of the stent technology. We are shifting from permanent polymers to bioabsorbable polymers and no polymer solutions. These no polymer and bioabsorbable polymer solutions are very attractive, very prominent here at EuroPCR 2009, and hopefully they will be able to maintain the same efficacy but reduce the risk of late stent thrombosis. Furthermore, various dedicated bifurcation stenting devices are out now. There are reports about these stents and very new promising results are being published. The last remaining field that is very important is chronic total occlusions. Chronic total occlusions are mainly being worked on by our Japanese and Chinese colleagues. We are hearing more positive reports with existing wire and balloon technology in order to cross totally occluded vessels.
Prof. Grube:瓣膜技术是现在最有趣和最令人兴奋的领域,下一代的瓣膜正在研究开发中。Sadra瓣膜和直接流量瓣膜首先在人身上运用,并且即将进入第二代。支架技术也在发展和变化:永久性聚合物向生物可降解聚合物和无聚合物方向转变。无聚合物和生物可降解聚合物极具吸引力,在这次会议上非常突出,有希望可以保持相同的有效性但降低迟发支架血栓形成的风险。此外,此次会议上有关于各种专用分叉支架装置的报道,最新可喜的成果也即将发表。另外,还有一些其他的技术,比如利用现有的导丝和球囊技术打通完全闭塞的血管等。
International Circulation: What type of work is being done in China in the area of bioabsorbable polymers?
《国际循环》:中国生物可降解聚合物相关领域的工作有哪些? Prof. Qi Ming Dai: In China, one example is the Excel stent. It is becoming more and more widely used.
Prof. Dai:在中国,生物可降解聚合物应用的一个例子是Excel支架,其运用越来越广泛。 Prof. Grube: The Excel technology in China is very promising also using sirolimus or ‘olimus drugs and a bioabsorbable stent on a metal platform. The same thing is happening in China as elsewhere that we are hoping these changes transfer to more safety with these technologies.
Prof. Grube:Excel技术在中国非常有希望,金属支架方面包括西罗莫司或‘olimus药物和生物可降解性支架。
International Circulation: Yesterday the results from the Nevo trial were presented here. What is your view on this reservoir technology Professor Grube?
《国际循环》:昨天在这里公布了Nevo试验的结果。Prof. Grube,您对储存槽技术有什么看法? Prof. Grube: The results are very interesting and very good with a very low late loss, which we expected. The reservoir technology is very interesting because you can do many things with it. You can use different reservoirs with different drugs; you can co