[ACC2013]心房颤动伴合并症的治疗——美国梅奥诊所Douglas L. Packer教授专访
<International Circulation>: Thank you very much. My next question is, I am aware that you are currently involved in a clinical trial. How do you suggest we take what we know about atrial fibrillation and put it into practice? What do you see as some of the major outcomes of the trial and what are some of the problems today with antiarrhythmic agents and why is there a trial going on the test the difference between drug therapy or ablation theory?
《国际循环》:非常感谢。我的下一个问题是,我知道您目前参加了一项临床试验。您认为我们应当如何将房颤知识用于临床?您如何看待试验主要结果,目前抗心律失常药问题包括哪些,为什么目前有研究探索药物治疗和消融治疗之间的差别?
Prof. Packer: CABANA was designed to answer the question whether drug therapy or ablation therapy would be better for the treatment of fibrillation. CABANA chose to ask an even tougher question as to which drug or ablative approach will prevail in patients who mortality is the endpoint. So that set CABANA apart from other studies. What will ablation do to the mortality rate, decrease it? Heart failure, heart failure hospitalization, stroke, major and minor and strokes, and in fact if you look at major and minor strokes, CABANA gives us the chance to look at the effect of therapy on dementia and other problems. Ablation has come along but there’s no long term data. And the data might say there was a success and you have been following them for one year. From the recurrent data it looks like the success rate might be as low as 30-50%. So, simply because there was success for one year doesn’t necessarily point to the long-term outcome. So then you look back at drugs and you find 30-40% of drug-treated patients do well over two or three years. So the outcomes of both get a little close together. Drugs can have pro-arrhythmic effects and drugs can also have toxic effects. Also drugs can affect the thyroid and the liver and lungs and skin and etc. so drugs may not be optimal but in the time being we are spending a lot of money and we don’t know which approach is better. That’s what we hope CABANA will tell us and we also hope that CABANA will tell us more about the quality of life and cost of health care. It may be that we can’t afford ablation.
Packer教授:CABANA研究被设计用来回答药物治疗和消融治疗哪种治疗房颤更好这个问题。CABANA还回答一个更难的问题,即哪一种药物或消融方法可降低患者死亡率。这使得CABANA研究和其他研究不同。消融能够降低死亡率吗?能够减轻心衰,降低心衰住院率,减少卒中和小卒中吗?如果专注卒中和小卒中,CABANA为我们提供了关注治疗对痴呆和其他问题的效果。消融术目前还缺乏长期数据。本研究提供了手术是否成功及术后随访1年的数据。从复发率来看,成功率可能只有30%~50%。这只是1年成功率,而不一定代表长期结果。而药物治疗患者大约有30%~40%在2~3年内效果良好。因此两种治疗结果相近。药物治疗可能会有致心律失常和毒性作用。药物还可能影响甲状腺、肝脏、肺和皮肤等。因此药物治疗可能并非最佳选择,目前我们花费了很多钱来研究,但是仍不知道哪种治疗更好。这是我们希望CABANA研究能告诉我们的。我们还希望CABANA研究能够告诉我们更多关于生活质量和医疗费用问题。结果也许是我们无法承担消融术。
<International Circulation>: So at what point does ablation become economical?
《国际循环》:那么什么时候消融术可以是经济的?
Prof. Packer: The honest answer to that question is we really don’t know. It depends on who’s paying for it and which country you go to. In the United States it costs 50,000 USD and you would need to know the health care costs for patients over the next five or six or seven years. And there are relatively few “good” health costs in health care economics studies. CABANA is spending a lot of time and effort to try and answer this exact question.
Packer教授:对这个问题,诚实的答案就是我们并不知道。这取决于谁来支付费用,在哪个国家。在美国手术会花费50 000美元,并且需了解术后5~7年内医疗开支。而且在卫生经济学研究中相对来说很少有“好”的卫生开支。CABANA花费了很多时间和努力来回答这个问题。
<International Circulation>: How much experience does the physician need to have? How significantly does the physician’s experience impact the outcome of ablation?
《国际循环》:医生需要多少经验?医生的经验对消融的结果有多大的影响?
Prof. Packer: There’s a lot of data from studies beginning ten to fifteen years ago. We look at the first ablation registry and we found a substantial difference in labs where they have done fewer than fifty to a hundred cases and once they hit about three hundred cases then the outcomes were substantially better. They recently looked at that in California in Medicare clients and they found that the more procedures that had been done the higher the success rate and the lower the risk. I think in virtually every aspect of health care you will find this. What’s the magic number? We don’t know and it also depends on technology. But here’s where we get back to the original question of outcome morbidity. In patients that have heart failure, patients that have hypocardia cardiomyopathy, patients that are fluid overloaded and have other underlying congenital disease are substantially harder to deal with. A third or fourth time we do it is substantially harder to do. So in those cases it makes it even harder to do and experience is important.
Packer教授:10~15年来有很多研究数据。我们分析第一个消融术注册研究,发现不同导管室之间有很大不同。和病例数只有50~100例以内的导管室相比,病例数达到300例以上的导管室治疗结果更好。他们最近还研究了加利福尼亚州医保患者数据,发现手术量越大,成功率越高,风险越小。我认为在医疗方面,每个领域都会有这种规律。病例数字的作用在哪里?我们并不知道。而这也取决于技术。这就回到了我们原来的问题,即结果和合并症的问题。合并心衰、心肌病,有体液潴留的患者及有其他潜在先天性疾病的患者治疗难度更大。大约1/4~1/3患者治疗难度更高。对于这些病例,经验就更加重要。
<International Circulation>: Thanks. What are some of the newer developments in catheter ablation technology or techniques?
《国际循环》:谢谢。导管消融技术方面有什么新进展?
Prof. Packer: Irrigation Tip Ablation, I think, has emerged as the gold standard so everything is being compared against that. The STOP-AF coagulant study will be out this month and that looked at drug therapy and showed the effectiveness of ablation over drugs. New technologies Laser blooms. Different kinds of surgical approaches which use different kinds of bi-polar clamps. We are working on using photonic energy and carbon particles to ablate atrial fibrillation without going in through catheters. There is a number of using better imaging, using four or five D to understand the target. Genetics is getting better. Instead of being four or five mutations we are aware of now we have ten or fifteen we are aware of. So maybe we can go about that approach instead of having to resort to ablation. Robotics started off strong and has had some issues concerning long-term outcomes and complications. So, there will always be new technology and we welcome it but it needs to be directed at physiologically. Going after rotors is refreshing because it looks at physiology. It looks at new physiology and a new way of thinking. So, I think the new technology that is physiologically-based will in the end ultimately win the day.
Packer教授:我认为盐水灌注消融已成为金标准,所有研究都是与它比较。STOP-AF凝血研究本月将公布,该研究探索药物治疗,并且显示消融效果优于药物。新技术在不断出现。有使用不同双极系统的外科手术方法。我们还在研究使用光能和碳粒子消融房颤,而不用通过导管。还有一些影像学方面进展,使用4D或5D技术来研究治疗目标。基因学方面也取得进展。过去发现4~5个相关突变,而目前则有10~15个突变。因此,也许我们可通过这些方法而不用进行消融。机器人技术起步迅速,并且引起关于远期结果和并发症的担忧。因此,总是有新技术出现,我们欢迎新技术。基于生理新技术会在将来取得成功。
<International Circulation>: OK, that’s it for my questions. Thank you.
《国际循环》:感谢您回答我的问题。
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