<International Circulation>: Can you walk about Edwards and the CoreValve for a second and compare the advantages and disadvantages?

　　Prof. Cribier: Well actually if you put in your hands an Edwards valve and a CoreValve you will be absolutely amazed by the difference， the concepts are totally different.  To tell you the truth， when I started， I am more or less responsible for the Edwards valve and at that time my goal was clear， it was that I wanted to mimica surgical valve prosthesis.  It means that I always thought that the device should be implanted in a very small spot which is located between the coronary arteries and the mitral valve insertion.  It means that the device has to be relatively small and short in height.  From the studies I have computed that the device should be， after delivery， between 14 and 17 mm.  We could not have more than that.  Also for me， the second criteria was that the device had to be circular and round.  This is very important and all of the sudden I thought if the frame is not circular then you have another wrapping of the leaflets and that could create a lot of problems in the long term， so this was my goal and this is what we had with the Edwards.  I had the feeling that this was the only way to consider implanting a valve trans catheter.  However I must say that I was very surprised that the compound had another feeling， so probably wanted to make things equal and if you take a CoreValve you will be surprised by the fact that it is a 15 mm height so it started with the idea that we would implant the valve in the annulus but just over the coronary arteries and suprannularimplantion in the aorta.  It is self expanding， it means that the tube for self expanding in the stent which is not stainless steal as originally.  It is thinner so I would say there is less resistance to put pressure and so if you take the two devices， the mechanism of action is totally different.  With the Edwards valve， if you take the insertion of the valve， the differences are the leaflets are inserted at the levels of the annulus.  The leaflets on the CoreValve are inserted at both the annulus.  The CoreValve is implanted in the right position because in many cases they are putting it too low so this is a place where the stent and the meeting of the frame can be distorted.  If the stent is distorted， for example the frame is less good， so as a matter of fact， not only are the valves are different in their physical properties and the mechanism of action， but also their results a little different.  If you take the acute results as a whole， acute results are comparable.  You can put any kind of valve in place and then you will have to see the acute results: same area， same low gradients， and same complications except for the pacemakers.  So one of the differences in the two devices is that the CoreValve， because it is implanted lower it is creating a block， but it is significant.  So of course one can say that having your pacemaker when you are a non patient is not a big deal and that there is no effect on mortality but they are much more concerned about the problem that if the valve is inserted too low， not only are you applying some force against the septum creating the block but you are also contacting the anterior mitral valve reflux which is just in front.  So my concern with CoreValve is that the risk of injury of the mitral valve reflux is here.  After millions and millions of beats， we could have some destruction of the valve or creation of mitral valve insufficiency and so on.  Today， we do not have any randomized comparison of the two valves so it is very difficult to say one is better than the other.  We can just take into consideration the results of the registries and again as we are saying， if you are satisfied with the acute results， then the results are very comparable except with pacemaker.  Now the problem when we are implanting a valve is that we are not implanting a valve for two years， we are implanting a valve that should be durable for many years， especially if you want to compare with a surgical valve. So we will see with more experience if there is a difference with the long term results with the two devices.

　　《国际循环》：您认为Edwards和CoreValve两种人工瓣膜各有哪些优缺点？

　　Cribier教授：事实上，如果你将Edwards和CoreValve两种人工瓣膜放在手上时，你将对两者的差异感到惊讶。其concept是完全不同的。实话告诉你，我开始的时候或多或少地更倾向于Edwards瓣膜，那时我的目标非常明确就是我想取代外科瓣膜植入术。这意味着我始终认为，瓣膜需要从冠脉与二尖瓣之间的一个很小的点植入，因而瓣膜需要相对较小，长度较短。通过研究计算我发现，瓣膜植入后需要在14~17 mm。不能再比这更长。同时，对于我来说，第二个标准就是瓣膜需要是圆形的。这一点非常重要，我认为如果其框架不是圆形的，就需要换另一种支架，长期以往会引发很多问题。这就是我的目的，而Edwards瓣膜能有效的解决这些问题。我感觉这是经导管植入瓣膜的唯一方法。但是我必须说，我非常惊讶这种化合物还给人另一种感觉。如果你选用CoreValve瓣膜你将会惊讶其长度为15 mm。开始时我们认为其需要放置于冠状动脉环及主动脉环之上。它能够自我扩张，但支架内自我扩张的导管最初并不是不锈钢的。它非常薄，因此阻力非常小。这两种瓣膜的作用机制是完全不同的。就瓣膜植入位置而言，Edwards瓣膜放置于纤维环的水平。而CoreValve支架则放置于两个动脉环处。CoreValve瓣膜需要放置于正确的位置，很多病例中其放置位置都太低了以至于支架及其框架会发生弯曲。如果框架不是太好，支架发生弯曲，不但瓣膜的物理特性、作用机制不同，其所甙类的结果也会多少有些不同。就急性结局而言，是相当的。你可以选择任何一种瓣膜，其除心脏起搏器外，狭窄面积、低梯度、并发症等急性结局都是相同的。

　　因此，两种瓣膜的区别之一在于CoreValve因植入位置更低以发生堵塞。当然正常人应用起搏器不是个大问题，起搏器不会对死亡率造成影响。但是如果瓣膜位置太低的话，你不但会对室间隔产生一些压力造成堵塞，还会二尖瓣前瓣的回流相冲突。对CoreValve瓣膜我担心的是其具有影响二尖瓣回流的风险。数百万次的冲击后，瓣膜将被破坏或是导致二尖瓣关闭不全。目前，尚无有关两种瓣膜的随机对比试验，因此很难说其中一种优于另一种。我们只能根据注册研究的结果说，如果你满意其急性结局，那么其结果就与起搏器相媲美。目前我们植入瓣膜时所面临的问题是，瓣膜植入事件不够2年，而我们需要植入能应用多年的耐用瓣膜，尤其是如果你想将其与外科瓣膜相媲美时。因此，如果两种瓣膜的长期结局存在差异的话，我们将拥有更多的经验。

　　<International Circulation>:  So you mentioned the use is a little more difficult to implant the valve than the other.  In terms of from the surgeons perspective is there a preference for the valves?

　　Prof. Cribier: Well you are talking in terms of the Edwards and the CoreValve?

　　《国际循环》 ：你的意思是很难说一直瓣膜优于另一种。外科医生更偏向于哪一种瓣膜？

　　Cribier教授：你指的是Edwards 瓣膜和CoreValve瓣膜？

　　<International Circulation>: Yes.

　　Prof. Cribier: Well the surgeons you know are not so much concerned with the CoreValve because the CoreValve is not supposed to be implanted very often surgically， so now the Edwards， if you take the Edwards Sapien， which is in use in the United States for example， you have 50% of patients implanted transfemoral and 50% of patients implanted transapical so the surgeons are very much concerned with that.  Now if you take the Edwards second XT， the new generation model， we have more or less 85% of the patients who are going to be transplanted transfemoral so the surgical part is narrowing.  Now concerning CoreValve， the surgeons initially were just involved when they have to cut down the subclavian artery as an alternative to the transfemoral approach， now the surgeons are can also implant the valve transaortic like we do with the Edwards so now concerning the surgical feeling about these two valves， I am not a surgeon so I cannot say but I have the feeling that the surgeons prefer in general， implanting a valve which is comparable to the device that they used to implant surgically so it means that the device is to be on the coronary arteries.  So I have this feeling and when I discuss with my colleagues in general as far as implanting， they prefer the concept of an expandable short than the self expanding because this is not something they are used to.

　　《国际循环》：是的

　　Cribier教授：你知道外科医生并不是太喜欢应用CoreValve瓣膜，因为CoreValve瓣膜不应该是由外科手术植入，以在美国应用的Edwards瓣膜来说，植入该瓣膜的患者有50%经股动脉植入，50%经心尖植入。因此，外科医生更多应用的Edwards瓣膜。而新一代Edwards XT瓣膜，其应用者则有85%采用经股动脉植入，故其外科应用空间就变小了。而对CoreValve瓣膜而言，外科医生最初只是在经股动脉途径失败而选择经锁骨下动脉途径时选用。但现在外科医生也会像应用Edwards瓣膜时一样经主动脉途径植入。就外科医生对两种瓣膜的喜好而言，因为我并不是外科医生，因此我无法解答。但是我感觉一般来说外科医生更喜欢应用与他们外科手术所用瓣膜更具有可比性的瓣膜。也就是说，哪些放置于冠状动脉上的瓣膜。我感觉是这样的，我与我的同事进行讨论时发现，与其不经常用的自我膨胀式瓣膜相比，他们更喜欢可扩张的、短瓣膜。

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