International Circulation: Current PFO (Patent Foramen Ovale) closure devices typically have components that remain within the heart forever and that may cause unfavorable adverse events like thrombosis， device fracture and erosion， embolization， etc. Are there any new findings or new therapy options for treatment of PFO in recent years?

国际循环: 目前卵圆孔未闭（PFO）封堵装置典型地含有会永久留在心脏内部的零件，这可能会导致恶化的不良事件，例如血栓、装置断裂或糜烂、栓塞形成等。近年来是否有关于治疗PFO新的发现或新的治疗观念？

Professor Sommer: I think it’s a very important point. We have in general used these devices for upwards of two decades now. We know that the issues that occur with these devices late after the implant， such as thrombosis， erosion， and infection， those kinds of issues， are pretty much limited to the first few months after the procedure. Once the skin of the heart—the endothelium covers the device completely， then it’s really no longer an issue. So， for most of the patients， once they get past 3-6 months， we really feel very comfortable that there aren’t going to be any late issues. That being said， there are still issues that occur in the first few months after the procedure. So there is a trend now， especially in the research areas of this field to develop less permanent implants or closing the holes without implants at all. There are several companies that are using non-implant technologies. Sutura is a company that now has a device that you can stitch the hole closed through a catheter， mimicking what the surgeons would do. CoAptus is a company that’s developed a radio frequency energy application that should weld the two pieces of the PFO together. So， there would be no device left with either of those technologies. NMT Medical， who makes the CardioSEAL and the STARFlex devices， which have been used for a long time already， has their two latest versions of the device. One of them is the BioSTAR， which has a metallic frame that remains behind， but we eliminate the Dacron with that device and use instead a porcine collagen material， which is rapidly reabsorbed. The fourth generation device， the BioTREK， will be completely reabsorbable after the endothelium has covered the device. All of those options are much more attractive to both physicians and patients than leaving a permanent implant， but the truth is that the current devices work very well.

 Sommer教授：这是一个非常重要的问题。我们使用这些装置已有20年以上。我们知道植入这些装置后发生的事件，如血栓、糜烂、感染，这些事件通常在植入术后头几个月发生。一旦内皮完全覆盖装置，就不再会出现这些事件。所以，对大部分患者来说，一旦他们平安度过3～6个月，那么我们就可以放心不会有任何迟发事件。那就是说，在植入术后的头几个月，不良事件仍然有可能发生。所以目前在相关研究领域的一个趋势就是，开发非永久性植入体或不需植入器械即可闭合卵圆孔。有一些公司正在使用非植入技术：Sutura公司目前有一个装置可以通过导管来缝合卵圆孔，模拟外科医生；CoAptus公司开发一种射频能量，用于封闭卵圆孔。这两种技术都不会有装置遗留。NMT医药公司研制的CardioSEAL 和 STARFlex 装置已经在临床应用很长时间，两种最新版本的装置也已经推出。一个是BioSTAR，一种可吸收装置。第四代的装置——BioTREK， 在内皮覆盖装置后可以完全被重吸收。所有这些新技术都比残留永久性植入体更能吸引医生和患者，但事实上目前的装置效果非常好。

International Circulation: So you feel some of these upcoming devices might overcome these shortcomings?

国际循环: 所以您觉得这些即将面市的装置中有一些可以克服这些不足？

Professor Sommer: I think if we look down the road 5-10 years we are going to be moving away permanent implants to devices that are either non-implant oriented or bio-absorbable.

Sommer教授：我想再过5～10年，永久性植入体将会被非植入的或可生物吸收的装置所替代。

International Circulation: You just mentioned bio-absorbable devices. How do you feel about the use of bioabsorbable stents?

国际循环: 您刚刚提到生物可吸收装置。您对生物可吸收支架的使用有什么看法？

Professor Sommer: I can only really give you my input on that from the congenital side since I am not a coronary expert. Stents are widely used in pediatric cardiology and in adults with congenital heart disease. For adults， it’s less of an issue for stenting areas like the coarctation of the aorta， or blockages in the branch pulmonary arteries， or in conduits that have been surgically placed， because the adults are fully grown and so you can put in a device that will remain at that size and in that position for a long duration. In children， however， the potential of using a bio-absorbable stent is really exciting and there is really not a lot of work being done here yet because these stents are still very new. The idea of being able to open up a stent， let’s say in the aorta， in a small child， and having that stent resorb so that the vessel can continue to grow normally， as apposed to the current stent， which would guarantee that child would have to come back for future interventions， is a very exciting prospect.

Sommer教授：因为我不是冠状动脉方面的专家，我仅仅能从先天的方面给予我的看法。支架在儿科心脏病学和有先天性心脏病的成年患者中广泛应用。对于成年患者来说，放置一个装置可以保持尺寸和位置长时间不变，因而放置永久性支架的影响不会非常严重。而对于儿童患者，显然使用生物可吸收支架是更让人兴奋的，但目前为止这方面的研究还不多。例如在幼龄儿童主动脉放置支架后，支架可以再吸收，那么血管可以继续正常生长，这是一个令人兴奋的展望。

 International Circulation: Are there any new studies on the safety and efficacy of the new techniques for treating PFO?

国际循环: 在PFO治疗新技术的安全性及有效性方面有没有一些新的研究？

Professor Sommer: All of those are experimental at this point. The radio frequency idea has been around for a few years already. The CoAptus Company that I already mentioned has gone through a prior iteration of their device， which was great at closing holes in pigs， but didn’t do so great in people. Similarly， another company had developed an RF frequency device and that also didn’t work very well. So， we are learning as we go and all of these things are the still in the process of being developed. In fact， in the United States， there are no approved devices yet for PFO closure and the only bright side here is that the CLOSURE I trial， which is the big study sponsored by NMT for preventing recurrent stroke by closing PFOs， has just finished its enrollment. So within a year to 18 months， I expect that we will have results of that trial， which could change the landscape of PFO closure totally.

Sommer教授：目前所有这方面的研究都是实验性的。射频的想法已经出现一段时间了。CoAptus公司曾表示，该装置关闭猪的卵圆孔效果很好，但用于人体的效果不甚理想。相似地，另一家公司开发的射频装置效果也不是很好。所以，所有这些装置目前都只是在开发研制阶段。事实上，在美国还没有被证实可用于PFO的装置，但我们正在进行CLOSURE I研究（通过闭合卵圆孔预防卒中复发）已完成注册。在12～18个月内，我想这项试验会有结果，将会改变PFO的治疗。

International Circulation: What is your opinion of the effectiveness of the STARFlex Septal Repair Implant?

国际循环: 您对STARFlex中隔修复植入的有效性有什么看法？

Professor Sommer: I don’t think the issue with any of these devices is their effectiveness. All of them work really pretty well to close the holes. The real issue here is that we are still trying to assess in these studies is can these devices prevent recurrent stroke better than staying on blood thinner therapy， or in the case of the migraine population， can c