David R. Holmes Jr教授   美国明尼苏达州梅奥诊所

　　<International Circulation> : What kind of atrial fibrillation patients should be given priority when it comes to atrial appendage closure?

　　Prof. David Holmes: I think that the patients who are would be have number 1， are at higher risk for bleeding because I think with the new anti-coagulants they will be at high risk， they may be at somewhat less risk with warfarin but they will still be high risk and that would be one group.  The second group of patients would be those who it is very difficult to control their anticoagulant parameters.  That would be a very important group.  The third would be a group of patients who are faced with a lifelong use of anticoagulant therapy and would rather not have that.  And then the final group would be a group of patients who are going to need to have dual antiplatelet therapy plus anticoagulant therapy and they are probably the highest risk group that we deal with at the present time.

　　《国际循环》：哪些房颤患者可应先考虑应用左心耳封堵术？

　　David Holmes 教授：我认为第一类患者是应用新型抗凝剂存在较高出血风险的患者，虽然其应用华法林的出血风险会相对较低，但仍具有较高的出血风险。这是第一类患者。第二类患者是抗凝治疗效果不好的患者，这一个非常重要的人群。第三类是需终生行抗凝治疗但不愿意终生治疗的患者。最后一类是需要行双联抗血小板治疗加抗凝治疗的、我们目前需要处理的极高危患者。

　　<International Circulation> : So a lot of the data for the safety and efficacy of this closure comes from the PROTECT AF trial， but with the emergency of new anticoagulants， what function does LAA closure still have to offer?

　　Prof. David Holmes: The information on the only two randomized trials that have been completed were pieces of information that related to the fact that the device was compared with orphan therapy because when Protect AF started we did not have the new anticoagulants.  People thought the new anticoagulants would dramatically change both the safety as well as the efficacy of anticoagulants therapy and a couple of pieces of information about that.  Number one， there has been variability in the results in terms of decreasing major bleeding with the new agents.  Not all the agents reduced major bleeding.  The agents are better than warfarin at preventing stroke.  That is true but major bleeding winds up still being a problem for those patients.  Second piece of information is that is if there is an absolute or a relatively contraindication to warfarin therapy， it probably is going to be the same in terms of absolute or relative contraindication to some of the new agents by virtue of if they have had a past history of GI bleed， they are going to bleed about as much on the new anticoagulants as they did on warfarin.

　　《国际循环》：左心耳封堵术安全性及疗效的数据主要来源于PROTECT AF试验，但是随着新型抗凝剂的出现，您如何看待左心耳封堵术的作用？

　　David Holmes教授： 已经完成的有关左心耳封堵术的随机试验仅有两项，都是将其与orphan 治疗相比较，因为Protect AF试验开始的时候新型抗凝剂还未问世。人们曾认为新型抗凝剂将极大地改善抗凝治疗的安全性及疗效，但其存在以下问题。其一，新型制剂降低主要出血事件的相关结果存在变异，并不是所有的新型抗凝剂均能降低主要出血事件。虽然与华法林相比，新型抗凝剂对卒中的预防效果更好，但主要出血事件仍是其应用过程中的重大挑战。其二，如果患者存在华法林治疗的绝对或相对禁忌证，则很可能也存在某些新型抗凝剂的绝对或相对禁忌证。例如，如果患者既往有胃肠道出血史，，则其应用新型抗凝剂时将会出现与应用华法林同样多的出血事件。

　　<International Circulation> : In previous studies， patients still need to take oral anticoagulation after LAA closure but with the new oral anticoagulants， do you think LAA closure is going to be a supplement or a substitute?

　　Prof. David Holmes: I think it will be a substitute.  I think that the information and the thrust of this technology is number one， to identify a strategy that prevents the need for taking long term anticoagulant therapy.  Number two， that can be used in patients who cannot take anticoagulant therapy， and indeed in those patients you would want to make sure that it was as good as if they could take anticoagulant therapy but without the need to take anticoagulant therapy.  The data， at least on warfarin， and from the PROTECT trial as well as the PREVAIL trial， is that at six months or a year， about 95% of patients who would have been treated with warfarin before， can be off the warfarin and yet not suffer any harmful effects.

　　《国际循环》：既往研究中，患者在左心耳封堵术后仍需要行抗凝治疗，随着新型抗凝剂的问世，您认为左心耳封堵术是抗凝药物治疗的补充，还是能取代抗凝药物治疗？

　　David Holmes教授：我认为其有望替代抗凝药物治疗。我认为，要想用其替代长期抗凝治疗，首先需要对该技术的信息进行宣传或推广。其次，它能够用于无法接受抗凝治疗的患者。实际上，对这些患者而言，你需要确定，如果他们能进行抗凝治疗，左心耳封堵术的疗效与抗凝治疗的疗效同样好。PROTECT 试验及PREVAIL试验的数据显示，随访第6个月或1年时，有95%的既往曾接受华法林治疗的患者可停用华法林，且不受任何不良影响。