International Circulation: I would first like to ask how we can predict response to renal denervation， especially when determining responders and non-responders?
Professor Michael Bohm: We have determined clinical predictors of response in about 450 patients. The best and only predictor of response is the height of the blood pressure at base line: the higher the blood pressure， the greater the response. There is no interaction with age， renal function， obesity， and diabetes， which we had initially thought. It came out that these are no the true predictors. Another point is heart rate. Patients with a higher heart rate have a better response beyond blood pressure. They respond according to blood pressure and heart rate.
《国际循环》：我们应该如何预测患者对肾脏去神经术的反应，尤其是识别有反应者和无反应者？
Bohm教授：我们在450例患者中确定了对RND有反应的临床预测因子。最佳也是唯一的预测因子是基线时血压水平。血压越高，反应越强。年龄、肾功能、肥胖、糖尿病与之均无交互作用，这与我们原来的设想不同，这些都不是真正的预测因子。心率是另一个因素，心率快的患者在血压之外有更好的应答。患者根据血压和心率水平对RND应答。
International Circulation: Can denervation be used for other syndromes? Some research has suggested it may help EGFR and therefore might help improve outcomes for CDK.
Prof. Bohm: There are some ongoing pilot studies. We have already tried denervation therapy in patients with renal impairment， with a GFR between 10 and 40. They have the same response concerning their blood pressure reduction. They have no increased or marked worsening of renal function， so it appears to be safe in this population. Furthermore， there are ongoing pilot studies on heart failure. There will be a big heart failure trail looking at clinical endpoints. At the end of the day， it will be necessary to have endpoint trials here as well.
《国际循环》：RND可以用于其他疾病吗？一些研究提示它可能改善EGFR，因此可能改善慢性肾病的转归？
Bohm教授：有一些预试验正在进行之中。我们已经在肾功能不全，GFR 10～40的患者中使用RND。就血压降低程度而言，与其他患者一致。他们的肾功能没有改善，也没有恶化，因此RND在这个人群中看上去是安全的。心力衰竭的预试验也正在进行中。有一项大型心力衰竭试验观察临床终点。最终，我们需要临床硬终点试验。
International Circulation: What are your opinions on the SIMPLICITY-3 trial? What will this trial add to the conversation in places like Europe where this procedure is already in use?
Prof. Bohm: My personal opinion is that the SIMPLICITY 3 trial will confirm SIMPLICTY 1 and 2. However， it is important that we have at least one set of data using a sham-operated group. It is not really possible in some countries， because doing a sham-operation and analgesia in patients without performing the intervention is a little questionable.
《国际循环》：您对SIMPLICITY-3试验如何平均，它会对欧洲RND的临床实践产生什么影响？
Bohm教授：我个人的观点是SIMPLICITY-3将确SIMPLICITY-1和2的结果。不过，重要的是我们至少能有一组假手术的数据。在某些国家，这样的数据是不可能获得的，因为对患者实施麻醉和假手术，而不做干预会产生问题。
International Circulation: But you do feel that the sham procedure is important?
Prof. Bohm: I believe that the trial results will be similar because the sham-procedure is simply trying to rule out the placebo effect. However， there is a blood pressure reduction over 36 months， which would make it the longest placebo effect known. It is not a placebo effect. Still， it is important to have at least one data set showing that this is indeed important.
《国际循环》：您认为假手术很重要吗？
Bohm教授：我相信临床试验的结果将会是相同的，因为假手术只是为了排除安慰剂效应。然而，（试验显示）血压降低的效益持续超过36个月，这会是我们所知的最长的安慰剂效应？当然这不可能是安慰剂效应。尽管如此，能够有一组数据表明这不是安慰剂效应仍然是非常重要的。
International Circulation: Do you think we’re ever going to start seeing some harmful side effects from the procedure such as stenosis? Are there adaptive features that we do need?
Prof. Bohm: There are also studies addressing these. There is no evidence that we develop chronotropic incompetence or reduce exercise tolerance because the sympathetic nervous system is reduced. This has been vigorously studied in a paper and came out in JACC there is no sign of orthostatic dysreguatlion， which was another concern and which was a big problem in these operations done in the 50s. This is not the case. There is no worsening of renal function， in fact， there is improvement in renal function due to unloading of the kidney. Renal artery stenosis can occur: we have seen 2 patients out of 450. However， this renal artery stenosis occurred nine-months after the procedure. The question is whether this happened by chance or is a natural response of atherosclerotic disease of the kidneys to develop stenosis. There is so far no evidence that stenosis is significantly and causally related to procedure.
《国际循环》：您认为我们会开始见到RND的不良反应，例如再狭窄？我们需要适应性的
Bohm教授：有一项研究正在探讨这个问题。没有证据表明，由于交感神经切除，导致变时性机能不全无力或运动耐力的降低。JACC的一篇文章非常严格地进行了研究，没有直立性血压调节的问题，这个问题在50年代手术切除交感神经时很严重。肾功能没有恶化，实际上由于肾脏负荷的减少，肾功能还有所改进。肾动脉狭窄可能发生，在我们的450例患者中，有2例出现这样的问题。然而，肾动脉狭窄发生于术后9个月，这是偶然发生的还是动脉粥样硬化的自然病程的体现，仍然不清楚。到目前为止，没有证据表明肾动脉狭窄是RND引起的，是有显著意义的。
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