International Circulation: You have previously mentioned that stroke is not an unmanageable complication for TAVR. How would do you go about managing the risk of stroke?
Dr. Martin Leon: “Not unmanageable” is a relative statement. In the early studies， there was a two-fold higher stroke in randomized surgical trials. This was with elderly and very sick patients， with a proto-type device that had not been used previously by anyone in 19 or the 22 sites enrolled in the study. That was our early data. When we looked at the continued access data， which comes after the randomized trial， the stroke rates in the later 2000 and more patients were much less. With more experience and better understanding of how to manage the native aortic valve with limited balloon dilatation and with lower profile devices， we think the intrinsic stroke rate will decrease. We also learned that， for example， adjunctive pharmacology and nuances in atrial fibrillation are other contributors to delayed stroke. We also think that a better understanding of how to manage those problems pharmacologically could also further reduce the stroke rates. Ultimately， there are devices called embolic protection devices that are being developed by multiple companies that are relatively easy to implant and deploy. These are temporary devices that can protect the brain during the procedure. For all of those reasons， the stroke issue is not one that I would ignore， but it is manageable in the context of evolutionary developments of technology in this space.
《国际循环》：您先前提到过，对TAVR，卒中并非难以控制的并发症。你会如何进行卒中风险管理？
Dr. Martin Leon： “非难以控制”是一种相对的说法。在早期研究中，随机手术试验中卒中风险升高2倍。这是对高龄和病情严重的患者，该研究在19或22个中心纳入患者，采用了以往未被任何人使用过的原型设备。那是我们的早期数据。当我们审阅来自随机试验后的连续访问数据，在后来的2000例以及更多患者中卒中发生率要低得多。随着经验的增加以及更好地了解如何以有限的球囊扩张和小尺寸鞘管来处理自体主动脉瓣，我们认为卒中发生率会降低。我们还了解到，辅助药物治疗和心房颤动对迟发卒中也有影响。如何使用药物更好应对这些问题还可以进一步降低卒中发生率。最后，多家公司正在开发易植入和展开的所谓栓子保护装置，这是在手术期间可以保护大脑的临时装置。基于上述所有这些原因，卒中问题是一个我不会忽略的问题，但在这一领域的技术发展的背景下，它是可以控制的。
International Circulation: Pharmacologically， do problems still exist in the management of stroke during TAVR?
Dr. Leon: We are definitely not there. We do not have a precise adjunctive pharmacological therapy. We used dual anti-platelet therapy， but we are sure of which are the best agents， or for how long to use them in these high-risk， elderly patients. A lot of these patients have atrial fibrillation and should be on warfarin or warfarin-like drugs. We are not sure if it should on that plus one or two other anti-platelet drugs. A European trial， pro TAVI， is a 2 by 2 factorial randomized study looking both embolic protection and different adjunctive pharmacology therapies to see if any combinations will have an important impact on stroke rates.
《国际循环》：从药物治疗方面看，在TAVR期间卒中的管理上是否仍然存在问题？
Dr. Leon： 我们绝对还没有达到那种境界。我们没有确切的辅助药物治疗。我们使用双重抗血小板治疗，但我们不确定哪种是最佳药物，或者在这些高风险的老年患者中要用多久。这些患者中很多有心房颤动，应该接受华法林或类似药物治疗。我们不确定是否应该接受这种药物再加一种或两种其他抗血小板药物治疗。欧洲试验PRO TAVI是一项2×2析因随机研究，观察栓子保护和不同的辅助药物治疗组合是否会对卒中发生率产生重要影响。
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