International Circulation: Do you believe TAVR will move on to moderate risk patients?
Dr. Leon: I think that we need to do the studies， look at the data， and see if the stroke rates are going down， as the primary endpoint is death from stroke. If TAVI is equivalent to surgery then we can discuss whether that will be an alternative for patients. Surgery for patients with AS is the best operation we do in cardiovascular medicine. I would never say that surgery is not a good thing. There will be a role for TAVR in the armamentarium of physicians and we are going to need to find that niche. As devices get better， as studies generate more data， we will try to understand whether or not it should drift to intermediate risk categories and other categories we are looking at， including patients with coronary disease， patients with failed bioprosthetic valves. There are many places where this technology can potentially provide an alternative benefit for patients.
《国际循环》：你认为TAVR会继续拓展到中危患者吗？
Dr. Leon：我认为，我们需要进行研究，看数据，观察卒中发生率是否在降低，因为主要终点是因卒中死亡。TAVI是否与外科手术相等，然后我们就可以讨论这对患者而言是否是一种替代选择。 对AS患者来说，外科手??术是我们在心血管医学中所能做的最好的操作。我从来不会说，手术不是一件好事。在医师的医疗设备中，TAVR将会发挥一定作用，我们需要找到其合适的位置。随着装置变得越来越好，随着研究产生更多的数据，我们会试着去了解它是否应当拓展到我们正在观察的中危类别和其他类别，包括冠心病患者，生物瓣膜失败的患者。在许多地方，这种技术可能为患者提供一种替代益处。
International Circulation: Are you worried that doctors may be being too forward and there may be a risk creep?
Dr. Leon: People have talked about that. There may be a risk creep in Germany， but talking to the doctors there， it turns out that it is a matter of judgment. They feel strongly that patients in their late 80s do better in non-surgical procedures and that the recovery is faster. We are not going to be able to show that their mortality is benefited， but the fact that they can be out of the hospital in days and back to a viable lifestyle in a week or two is meaningful for these patients. Some of us feel we should elevate some of the soft secondary endpoints and how they should be meaningfully incorporated into how people use this technology.
《国际循环》：你是否担心医生可能太过激进，有可能是一种风险蠕变？
Dr. Leon：人们已经讨论过这个问题。在德国有可能是一种风险蠕变，但与那里的医生探讨发现，结果证明这是一个判断的问题。他们强烈地认为，接近90岁的患者做非外科手术会更好，且恢复速度更快。我们不能证明其死亡率受益，但他们几天内就可以出院，一周或两周内就可以回到可以自理的生活方式的事实对这些患者来说是有意义的。我们中的一些人认为，我们应该提升一些软次要终点，在人们如何使用这项技术中这些软终点是有意义的。
上一页 [1] [2] [3] [4] [5] [6] 下一页