Lee Kirksey, MD  
Cleveland , OH

Specialties: Peripheral Arterial Disease, PAD

Interests: vascular, specialist, treatment options
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Treatment Resistant Hypertension and Renal Denervation

Dec 27, 2013 - 3 comments

Hypertension affects 78 million adults in the US. According to national data 82% of those with hypertension are aware that they have it. 75% are being treated but on 50% are under control. The degree of control is variable across different groups. Effective blood pressure control is essential to the successful reduction of heart attack, stroke and renal failure risks.

Importantly, of those control over 85% report having a usual source of health care and having insurance. Given the importance of this issue, the American Heart Association has made this a primary focus area of its 2014-17 campaign with a goal to reduce the death rate from heart attack and stroke by 20% in 2020.

Achieving this goal will require a mulipronged approach directed at systems changes, care provider education to ensure compliance with best evidence treatment approaches, and effective patient engagement to stimulate the highest level of patient education and participation.


Still, up to 20% of patients may have poorly controlled blood pressure despite being on three agents at maximally tolerated dosages, one of which is a diuretic. In this group of patients, the risk of heart attack, heart failure, stroke and renal failure are up to 3 times greater. Renal artery sympathetic ablation or renal denervation, represents a technology with potential benefit to better control blood pressures in this challenging group.

Research has shown that patients with this problem suffer from higher circulating levels of norepinephrine levels which are regulated by the nerves to and from the kidney. These nerves are also responsible for regulating salt and water absorption and blood vessel tone. Increased salt absorption and increase vascular constriction both elevate blood pressure.

Selectively interrupting these nerve pathways causes a reduction in blood pressure. The SimplicityI 1 Trial showed a reduction of 30/17 at one year which continued out to 3 years in a subset of patients followed out that far.
84% of patients responded.

The next level of studies will be better controlled with a placebo arm (patients not receiving the treatment to reduce the impact of the "placebo affect"). The trial will also have larger numbers.  The questions that remain to be answered include who it works in and just as important, who doesnt it work in. Are there any mid and long term side affects on artery integrity.

For a patient group that has limited options and significantly elevated stroke and heart attack risk--denervation trial enrollment represents an important immediate and future treatment option.

Renal Denervation for Severe Drug Resistant Hypertension

Dec 12, 2013 - 2 comments

lee kirksey md




drug resistant


renal denervation




Cleveland Clinic

High blood pressure or Hypertension is a leading cause of heart attack and stroke in the US and worldwide. The World Health Organization has identified hypertension as the most important risk factor for all cause mortality accounting for about 12% of the attributable hazard for death in the world. Currently, one third of American adults suffer from hypertension with that number expected to increase to one in two over the coming decade. Beyond the cardiovascular risks, end organ injury to the heart and kidneys can also result in systolic heart failure, chronic kidney disease and even end stage renal disease requiring dialysis.

It is estimated that up to 50% of those suffering hypertension have inadequate control. The causes of poorly controlled hypertension range from lack of access to healthcare, to patient noncompliance or physician noncompliance.

Other causes of poorly controlled hypertension are related to correctable secondary issues including:
Pheochromocytoma, Hyperaldosteronism, Cushing Syndrome, Hyperparathyroid, Hyperthyroid, Coarctation, Aortic Coarctation, Sleep apnea, NSAIDS, OCP.

Finally, an important and sometimes overlooked cause of hypertension is “white coat phenomena” in which patients experience high blood pressures while in the providers office only.  Typically, the patient can be evaluated with an ambulatory monitor for 24 hours which will verify that the blood pressure is normalized outside of the office.
As secondary causes of hypertension are evaluated and ruled out, most patients are placed on a heart healthy low sodium diet and optimized on a medication regimen if necessary. Despite these efforts a subgroup of hypertensive patients, from 5-20%, will continue to have suboptimal control of their blood pressure while maintained on 3 antihypertensive agents of different classes at maximal tolerable doses.  Studies suggest that this group of patients carries a long term higher risk of cardiovascular complications.

A growing body of recent research suggests that selective renal artery denervation using radiofrequency ablation causes reductions in blood pressure which may over time translate to fewer cardiovascular complications in affected patients.  Renal artery denervation is currently not FDA approved for use in the United States. Ongoing investigational trials (See ReduceHTN, Boston Scientific) hope to confirm earlier studies suggesting that the procedure is safe with a low rate of complication and the earlier data showing that reductions in blood pressure are consistent, reproducible and sustained.

Current renal denervation systems involve the catheterization performed from the groin region. Angiographic images are obtained of the renal arteries. A wire is then inserted into the renal artery and an ablative catheter threaded over that wire and carefully positioned with XRAY guidance in the blood vessel. The procedure is identical to commonly performed angioplasty.  

The catheter then delivers a safe degree of heat through electrodes positioned on the balloon at carefully selected locations.  The heat is able to destroy nerves that course along the outside and within the mid wall of the blood vessel-without causing any damage to the artery wall. The heat is delivered over 2 minutes. Because heat is applied, the patient is given intravenous sedation to minimize discomfort during the procedure.

Following the procedure, the patient is monitored and able to go home the following day.  The effect is not immediate. Over time however, the blood pressure begins to lower. Early studies show a reduction of 27/17 over 12 months and this reduction appears to be sustained in patients followed out to 3 years.
The important implication of this study is that in patients most severely affected by hypertension in which few options were previously available, an option now exists for reducing blood pressure. We know that reducing the blood pressure 20/10 can reduce that risk of heart attack and stroke by 50%.

In summary, renal artery denervation holds significant promise for reducing morbidity in drug resistant hypertensive patients. Further research is needed to determine in which patients the intervention works best in.

Do medical innovations always improve patients outcomes-Controlling healthcare costs

Jul 27, 2013 - 1 comments

Lee Kirksey


vascular surgery


Cleveland Clinic


Holistic Health




Heart Attack


limb salvage

The Medical device and healthcare industry like other industries in a capital market are driven by profit.  In the ideal scenario, the techology, provider and financial backer for a product or technology would be rewarded for  innovation which improves patient outcome. Unfortunately, that is increasingly less common and a new New York Times article suggests that up to 40% of established medical practices when studied show no benefit and may even be harmful.

In vascular surgery, one example is the use of arterial stents. It makes intuitive sense that if a patients has a study performed which reveals a blood vessel to be blocked--the blockage should be opened to make the patient better.  The reality is, that it requires clinical judgment. Merely the presence of the blocked blood vessel is less important than eliciting a careful history which discerns the symptoms, if any, that a patient is experiencing.

For example, a patient with none or very mild symptoms might be better off with serial monitoring and no procedure.  What's known is that the performance and durability of stents varies depending upon what blood vessel they are placed within.  In some vessels the risk for restenosis of occlusion of the stent within 12-24 months approaches or exceeds 50%. In some cases when this occurs, the patient may actually get worse symptoms than they started with. So in many cases it requires prudent judgment by the physician to determine if this procedure is actually warranted.  And in a situation where there is a perverse incentive for the physician to do more, the set up can predictably lead to more procedures. Especially as procedures become less invasive and less risk to perform, the threshold for doing them may be lowered.

In some areas, we see a rapid escalation in the number of procedures done as new technology is introduced and patient demand begins to drive the utilization. Many times before long term studies are performed in different patient types. This can lead to significant increased and wasteful healthcare expenses. All with no real long term benefit to the patient.

Unfortunately, sometimes referring physicians actually feed into this process by telling patients that they need a treatment or surgery without the referring physician necessarily understanding the nuances of the decision making process. The patient shows up saying " I trust my doctor and he said that I need this procedure"

One major benefit of the Cleveland Clinic physician compensation model is that all physicians are employed and not compensated on a per case productivity scale. In theory, I make as much money if I dont do a procedure so I dont have pressure to produce. I don't have to persuade myself subconciously that because something is minimally invasive, it should be done.

From the NY Times:

We usually assume that new medical procedures and drugs are adopted because they are better. But a new analysis has found that many new techniques and medicines are either no more effective than the old ones, or worse. Moreover, many doctors persist in using practices that have been shown to be useless or harmful.

Scientists reviewed each issue of The New England Journal of Medicine from 2001 through 2010 and found 363 studies examining an established clinical practice. In 146 of them, the currently used drug or procedure was found to be either no better, or even worse, than the one previously used. The report appears in the August issue of Mayo Clinic Proceedings.

More than 40 percent of established practices studied were found to be ineffective or harmful, 38 percent beneficial, and the remaining 22 percent unknown. Among the practices found to be ineffective or harmful were the routine use of hormone therapy in postmenopausal women; high-dose chemotherapy and stem cell transplant, a complex and expensive treatment for breast cancer that was found to be no better than conventional chemotherapy; and intensive glucose lowering in Type 2 diabetes patients in intensive care, which not only failed to reduce cardiovascular events but actually increased mortality. source

Healthcare system is missing the mark and failing with American Women

Jun 01, 2013 - 0 comments

lee kirksey md




Heart Disease


Cleveland Clinic


glenna crooks


disruptive women








vascular surgeon


healthcare reform

My good friend Glenna Crooks (see www.glennacrooks.com) is a well known health policy advisor and former member of the health policy team in the Reagan administration. Glenna actively blogs for disruptive women in healthcare at (disruptivewomen.net). Our careers intersect with our mutual interest in the rising impact of health disparities for American women.

Recents studies verify the women, especially those women in lower socioeconomic conditions with less education, have experienced an alarming decline in life expectancy since the early 1990's. This despite the fact that the medical community continues to make historic progress in medical treatments for problems such as heart disease, stroke and cancer.



The findings have been attributed to several issues including the recent economic downturn in the US which resulted in higher levels of unemployment and loss of health insurance as well as higher rates of smoking in American women. Or as former President Bill Clinton said in a speech that he delivers for his Clinton Global Initiative on Healthcare, some Americans people are dying of a "broken heart" from lack of access and opportunity.

One of the factors that may also play a role is the ongoing neglect and lack of understanding that the male dominated medical industry continues to display for women. Frankly we just have not done a good job in meeting women's healthcare needs in the public or private sector

1) Women represent more than 50% of the U.S. population and thus, companies have the potentially to as much as double their target market just by paying attention here.  No doubt virtually all healthcare companies have women in their customer base, but it is worth investigating what percentage that customer demographic represents.  If it is less than 50% and you sell a product that is not limited to use by men, then you have some obvious growth opportunities.

2) Women control the checkbook. If one actually believed the stereotypes that have perpetuated about women and our national economy, one would readily overlook these interesting facts:

■The average U.S. woman is expected to earn more than the average U.S. male by 2028
■51% of U.S. Private wealth is controlled by women
■Women account for over 50% of all stock ownership in the U.S.
■Women control more than 60% of all personal wealth in the U.S.
■Women control more than 80% of all U.S. spending
If those figures don’t make you want to figure out how to invest in sales and marketing programs to actively attract the attention of the female marketplace, you are not a very good CEO.

3) Women also influence or control much of how the other 50% purchase healthcare.  It is pretty obvious that women decide when and how their children will utilize healthcare services most of the time.  I am not saying that fathers never have a say or participate in that decision, but let’s get real.  It’s the moms that generally drag the kids to the pediatrician and buy them anti-colic drops at Whole Foods.  The global pediatric market is estimated at around $81 Billion by at least one group.  With expanded insurance coverage of children courtesy of the PPACA, that market is expanding markedly.  Appealing to the moms that control the bulk of that $81 billion is a good way to get your hands on it.  On a more global basis, it is estimated that moms represent a $2.4 trillion market.

Women also control or at least heavily influence much of the healthcare purchasing behavior related to the men in their lives.  For instance, Kaiser Permanente did a study a few years back that showed that, on average, 75% of health plan choices were made by women and that, overall, 80% of all family healthcare decisions were made by women.

4) Women live about 10 years longer than men.  As a result, they represent 10 more years of customer purchasing power than their male counterparts.  If the lifetime value of a customer is important to your product line because you have a recurring revenue model (and assuming your product is relevant to the over-50 market), understanding how to serve the female marketplace enables you to create about 10 more years of same store value than you can get out of your male customers.

5) Women are willing to spend money, and lots of it, on health and wellness and related verticals.  It is essential to recognize that women’s health does not equal medicine that is directed to areas covered only by a bikini.  Yes, women care about gynecology and breast cancer, but in the scheme of things the healthcare issues associated with those two categories are small potatoes.  Heart disease, lung cancer, diabetes, orthopedic problems, health insurance, choosing what provider/hospital to go to…those are the bread and butter of human healthcare purchases.   It is time to redefine women’s health as healthcare that happens to be for women.  When you open your mind to that definition, the market potential rises exponentially.  In fact, look at it this way:  the U.S. healthcare market is estimated at about $2.8 trillion in 2012.  If 80% of all that money is being influenced in some way by women, you should be paying better attention to your mom.  Of course this is not exactly the right way to look at it since so much of medicine is based on what physicians (majority: men) recommend to their patients, but no matter how you slice it, the number is large.  And women are the ones picking the family doctors, so marketing to doctors who appeal to women is a key part of the value creation chain.

6.    Women have the kind of customer loyalty that transmits real value in healthcare. It used to be believed that women are “more loyal” customers than men.  That theory has largely been altered to recognize that women and men exhibit different kinds of customer loyalty.  Whereas female customers are relatively more loyal than male customers to individuals such as individual service providers, males are relatively more loyal than females to groups and group-like entities such as companies.  When you are talking about an industry, such as healthcare, where purchases are extremely personal and largely made as the result of person-to-person, one-on-one relationships (e.g., through physician or pharmacist recommendation, broker sale, etc), attracting a female customer base can be a significant advantage in establishing long-term customer loyalty.    In fact, while it is often conventional wisdom that advertising should promote loyalty to company brand names (something we see a lot of in pharmaceutical marketing, hospital marketing, insurance plan marketing, etc.), it would seem that the smart money would be on promoting the personal experience/relationships between individuals (doctors, pharmacists, brokers, etc.) and consumers if women control 80% of healthcare spending.  Kaiser has been particularly sensitive to this, I note, in the development of advertising that emphasizes the individual physicians in their employ vs. the corporate brand itself.  These guys know where their bread is buttered.

Women use word-of-mouth marketing
7) Women communicate about their experiences.  Yeah, everyone knows women talk a lot.  But if you are the purveyor of a product or service and you want to proliferate its use, you want them to keep talking.  This is particularly so in the brave new world of social media, which the healthcare industry is desperately trying to figure out how to utilize to its advantage.  Women tend to do far more research and ask for referrals and advice than men when making a significant purchase decision, including a decision around service providers.  Research also shows that women tend to shop around longer and make more “wholistic” decisions about purchases, taking into account more lifestyle factors than do men.  It is worth noting that 78% of women in the U.S. use the Internet for product information before making a purchase and account for 58% of all total online spending; 22% shop online at least once a day.  Notably 92% of women pass along information about deals or finds to others.  When it comes to moms, the primary healthcare purchaser in our country, note that 63% read blogs online and that the average moms mention brands an average of 73 times/week vs. 57 times/week among males.  64% of moms ask other moms for advice before making purchases.  Women spend 2 more hours per week on social networking sites.  When you combine that statistic with the fact that people over age 55 represent the fastest growing segment of social media users, you know healthcare is going to be a major topic of their social communications.

Overall these statistics have significant ramifications for how marketing should be conducted in this age of social media.  If you fail to appeal to women in your efforts to market your healthcare product or service in this day and age, you are missing out on a true advantage of the medium:  free advertising through customer testimonial.    And perhaps more importantly, if you provide healthcare products and services to women that are not well-received, the blogosphere and everyone else in the world is going to know about it and fast.

In summary, healthcare may be a mans’ world, but it’s a woman’s marketplace.  If men want truly to maximize their market success while they still run the world, the way to do it is through walking a mile in our very attractive and uncomfortable shoes.  As for the women who aspire to leadership in the healthcare field, keep on keepin’ on and never give up.  At a minimum you will get your shot during those 10 years when you outlive your male colleagues.