I'm going to look at a special population which has hypertension in the disparate manner of the burden of cardiovascular mobility and mortality, but paradoxically, we have some questions about how best to apply renal denervation. Here are my disclosures. This is data that showed the downward trend, the top dotted line all forms of cardiovascular disease mortality panel D, a non Hispanic white adults panel he non Hispanic black adults. Pay attention to the fact that the downward trend we see in all forms of cardiovascular disease, both the non Hispanic white adults and non Hispanic black adults and started to slow. And some recent data has suggested an uptick in cardiovascular mortality, you know that hypertension is the most prevalent and potent risk factor. The other thing I would like to bring to your attention if you look at panel D, and compare it to panel, he is a real white black mortality gap for cardiovascular disease. And it's primarily driven by disparate degrees and poor control of high blood pressure. Now when we look at patients who have a parent treatment resistant hypertension. We know the American Heart Association scientific statement in 2017 high blood pressure guidelines just using three classes of medicines. Yes, black or long acting calcium channel blockers preferably amlodipine and a thighs I typed are you ready, but in more difficult patients. The use of core salad though, or in data might have been shown to be beneficial, especially in patients who have moderate renal insufficiency, and the addition of an old national antagonist from lacto has outcomes data control in more difficult to treat patients is similar, especially useful in men who have breast tenderness and dynamic master. This analysis is from the Jackson Heart Study Framingham South, we call it, and a study called regards it's a large cohort study mainly in the southeast by racial population. cohort less patients had ideal lifestyle factors, only about 6% were using for $1 or a double mind, and only about 10% using sperm lactone or pill alone but still have poorly controlled blood pressure. So that brings us to the question of renal denervation the trial that has the best data in the African American population is simplicity three. You heard that it was a negative study. When you look at this subgroup analysis, there's actually a trend for a benefit statistically significant 0.1 in African American know versus African American, yes, suggesting that those patients who were defined self defined or investigated as African American actually did not have benefit whereas those who were not defined as African Americans may have had benefit. Now does this drive the poor outcomes in terms of sham versus intervention and simplicity three it's difficult to say, but here's a bar diagram that shows what I just described non African Americans, the p value reaches statistical significance and remember this is subgroup analysis so it doesn't necessarily give any positivity to the study the study was negative overall, but in the African American population in the maroon or dark red. There actually was a better benefit. Again, trend, not statistically significant for the sham procedure. One of the things that you often should do when you look within studies and you see these type of subgroup analysis. What are the confounders, we know that to a large extent race is not a biological scientific category. health seeking behavior diet. A lot of factors unrelated to skin color itself. So looking within the 26% of the simplicity three cohort would define as African Americans, we see that there was a statistically significant higher degree of diastolic blood pressure. They tend to have more female than male and this has been described also the literature, worse outcomes in African American women body mass index didn't reach statistical significance but a strong trend, you know that obesity is more common especially in black and a higher rate of comorbid prior stroke or history of heart failure. These may be predictive of poor outcome with innovation simplicity three it's hard to say, but it's interesting that in that particular population. This was not a significant large population only 26% of the overall cohort. There were some differences in the physiology. Looking, then within the trial one other thing that pops out very clearly in the middle you see the African Americans who were taking at least one medication, three or more times a day in the sham, and they had a very robust lowering of the blood pressure. What this suggests is that these were patients who once they were in a clinical trial previously have been taking multiple medicines multiple times a day. We're now having a better control. The name of this would be the heart phone in fact, it comes from a suburb of Chicago, where Western Electric was able to observe that their employees when they were told that we're in the study actually performed better patients who in clinical trials in general better than usual conventional care, and in simplicity three, those African Americans who are taking three or more medicines, multiple times a day, seem to do better, perhaps because now they were having better adherence it's unclear why. So, to get back to the main point we now know that uncontrolled hypertension, or resistant hypertension but not just resistant but uncontrolled it's a significant medical problem, especially in black adults. So, it's not going to just be renovation, it's going to be a combination that we call in New Orleans a gumbo lifestyle changes combining three agents, effective diuretics, moderate Reno's fish support valid on that for my rest blocking agent calcium and a significant number of patients are actually taking this can be beneficial. What's the future potential for real innovation in this patient population. Well we need further analysis of the recently reported trials and ongoing trials, so that we don't have a type one error, you can have adequate sampling and have a greater confidence that we move innovation will be beneficial in this population. Thank you. I think we left time so you can have a little discussion.

cardiovascular disease

hypertension

African American population

renal denervation

Simplicity 3 trial