International Circulation: You’ve recently published about vascular complications. From that data or from your own experience， would you have any tips for practicing cardiologists?
Dr. Leon: That was the first generation system of very large-profile catheters. The reality is we have to respect the anatomy and respect the fact that careful， CT angiographic sizing of the peripheral vasculature is required to decide whether or not these patients undergo the procedure from a trans-femoral approach. Much better screening and using CT angiography is one issue. The second issue is low-profile devices. These are being developed rapidly right now. I believe with best clinical practices—careful screening， good technique， and low-profile devices—there is a small likelihood of increased vasculature complications in the future. There is a series coming out of Vancouver from John Webb， were he applied all of those criteria: complete percutaneous access enclosure， low-profile devices (with “pre-close”)， and careful vascular screening with CT angiography. His vasculature complication rate was literally a few percent in a consecutive series of patients. This suggests we will be able to overcome that problem with iterative technology， better technique， and better understandings.
《国际循环》： 您最近发表了有关血管并发症的文章。根据这些数据或者您自己的经验，你对执业心脏医师有何提示？
Dr. Leon：这是第一代极大尺寸的导管输送系统。现实是，我们必须尊重解剖，尊重下述事实，即需要谨慎的CT血管造影了解外周血管大小以决定这些患者是否接受经股动脉途径的手术。更好的筛查和利用CT血管造影是一个问题。第二个问题是小尺寸鞘管。这些装置目前正在迅速开发中。我认为，鉴于最佳临床实践--仔细的筛查、良好的技术和小尺寸鞘管--未来血管并发症增??加的可能性较小。有一个来自温哥华John Webb的系列研究，他应用了所有这些标准：完全的经皮入路闭合，小尺寸鞘管（伴有“预闭合”）和用CT血管造影进行仔细的血管筛查。在这个连续的系列患者中，其血管并发症发生率的确很小。这提示，借助更好的技术以及更好的了解，我们将能够克服这个问题。
International Circulation: For physicians new to TAVR， what are the best ways to predict patient response?
Dr. Leon: There are a lot of things that we are considering. There are few definitive scores that proven helpful. There was score from a German registry， called GARY， which was a way of looking at a variety of risk factors to see if the risk algorithms could better predict outcomes than the conventional scores， which are either STS or EuroSCORE. We are still struggling with that. We are the midst of study of over 8000 patients. This is a collaboration between the United States and Europe， with both the PARTNER and SOURCE data and some high-brow bio-statisticians to come up with a TAVI score to predict patient outcomes. This way， we can better tell our patients what our expectation is with regard to their likelihood of improvement. We have learned some things about important criteria， for instance， gender. Women do much better with this procedure than surgery. We believe that is one patient population group that tends to do better if they are high-risk. We have also learned that if you are too much in the way of comorbidities—a high STS score， extremely frailty， evidence of dementia—patients may fall into a category that we call “futility.” In this case， it may not be a good idea to perform this procedure because there are many issues beyond the aortic stenosis. To invest all the effort in a procedure is not going to make the patient feel better because of other co-morbid situations.
《国际循环》：对新接触TAVR的医师，预测患者反应的最佳方法是什么？
Dr. Leon：有很多我们正在考虑的事情。明确证明有帮助的评分很少。有来自德国注册研究的评分系统－GARY，该评分考虑各种危险因素以观察风险算法是否较传统评分STS或者EuroSCORE评分更好地预测结果。在这一点上我们仍然在努力。我们正在进行一项包含8000多例患者的研究。这是美国和欧洲之间的合作，合并了PARTNER和SOURCE的数据，由一些高水平生物统计学家共聚一堂形成一项TAVI评分来预测患者结果。通过这种方式，我们可以更好地告诉我们的患者，就其改善的可能性而言，我们的预期是什么。有关重要标准，我们已经有所了解，例如，性别。女性采用这种介入手术比外科手术要好得多。我们认为，如果他们是高危患者，那么这是一个往往会做得更好的患者群体。我们还了解到，如果你有太多合并症--高STS评分，极其脆弱，痴呆症患者的证据可能会归入一个我们称之为“无效”的类别。在这种情况下，进行这种手术可能不是一个好主意，因为在主动脉瓣狭窄之外还有许多问题。由于其他并存疾病，将所有的努力都投入在手术上并不会使患者感觉更好。
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