I’ve Been Invited to Join the Board of Directors of The FH Foundation

“The mission of the FH Foundation is to raise awareness of FH (familial hypercholesterolemia) through education, advocacy, and research. Our goal is to save lives through increasing the rate of early diagnosis and encouraging proactive treatment. If left untreated this life-threatening genetic disorder leads to aggressive cardiovascular disease in men, women, and children.”

I am proud to have been invited to serve on the Board of Directors for this very impactful organization. It is a wonderful opportunity to help make a difference.

For the full press release announcing Seth’s appointment click here.

Please learn more about preventive cardiology at www.preventivecardiologyinc.com.

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My New Year’s Wish: Disband Debate and Let 2014 be the Year of the Dialectic

Socrates and Plato believed truth to be the highest virtue. In search of absolute truth they employed the dialectic, a discourse between people holding opposing viewpoints. The critical distinction between dialectic and debate is that in dialectic the two individuals (or groups) engaged in a disagreement have no emotional investment in the outcome of their discourse. They both seek the truth; being “right” or “wrong” has no relevance. Victory is achieved if the truth is identified and acknowledged by both parties during their thoughtful interchange. In debate, winning is everything. Emotional appeal, persuasive arguments, and even distorted reasoning can win the day. The truth is not the prize, rather it is victory in argument that opponents seek.

Today we are bombarded by hostile media-reporting. On both “sides of the aisle” respect and honor appear to have vanished. News is rarely if ever reported in an unbiased fashion; there are always elements of editorializing. The right and left are polarized; they report the news to win their “argument.” Though I believe the populace yearns for objective, uncensored reporting, it seems to be a thing of the past. We the people consequently distrust our media. They fail to give us what we need; a window to the truth. Compounding the disillusionment and despair felt by so many Americans is the fact that we have also lost faith in our elected officials. My patients – some nearing one hundred years old – tell me they have never witnessed such discord in our nation. Something must change for us to get back on our prior track. We need to reclaim an America where Kennedy’s inspiring words, “Ask not what your country can do for you, but what you can do for your country” become once again cause for resounding applause.

So my 2014 New Year’s wish is simply this: Let’s reach back through the ages and heed the advice of the fathers of philosophy, Socrates and Plato. United, let’s use dialectic not debate to find our way. No more polarizing-politics, name-calling, character-assassinating, or skirting real issues. Instead let’s try to find the truth where we can, so America can once again become a nation of greatness and an object of emulation.

Wishing everyone a very happy and healthy New Year!

Please learn more about preventive cardiology at www.preventivecardiologyinc.com.

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Cleveland Heart Lab’s “Heart” Award

My thanks to Cleveland Heart Lab for awarding me the 2013 CHL “Heart Award”.

When Jake called to inform me that I had been selected to receive the 2013 CHL Heart Award, I was – and remain – honored and proud. Receiving such an accolade from Jake Orville and Marc Penn, two of the most industrious proponents of avant-garde cardiovascular prevention I know, validates my own CVD prevention efforts. As you all know, it is not always easy to staunchly stand for something that some “experts” decry. But it’s undeniably worth the struggle. The tools afforded me by CHL have enabled my patients to achieve far better levels of health and in so doing potentially avert adverse outcomes such as heart attacks, strokes, and even death.  The real prize therefore goes to all of you at CHL. Your genuine belief in the utility of CVD biomarkers coupled with your tireless efforts to “spread the word” have enabled doctors like me to practice the brand of medicine we believe in our heart of hearts to be the best for our patients. Thank you, the entire CHL team, for your contribution to CVD Prevention in America.

Learn more about preventive cardiology at www.preventivecardiologyinc.com.

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From the Ivory Tower to the Trenches: A Practical Approach to the 2013 ACC/AHA Cholesterol and Risk Assessment Guidelines

The distillation of well over one hundred pages of two guidelines into a pragmatic and accessible tool for the practicing clinician is of course a monumental task. It is essential to do so though. Clinicians require clear guidance in helping them manage patients in harmony with scientific developments. To think though that science is simply and solely a regurgitation of large randomized double blind placebo-controlled trials would be foolhardy to say the least. Science – especially medical science – is so much more. The fast-paced evolution of science keeps us all on our toes. And there are so many levels to consider: clinical trials of all forms, basic science of multiple disciplines, clinical acumen borne of clinical experience, and of course good old-fashioned common sense. So the Guidelines’ authors’ use of just a single facet of science, the Randomized Clinical Trial (RCT), a priori limits the utility of the recent guidelines. Still, they must be addressed and reckoned with. Indeed like most other things in life, they are not “all bad.” Before distilling the Guideline’s into a practical approach that I personally intend to follow, let’s first put the premise of the RCT as “King” in a real-world context by examining a typical doctor’s approach to patients.

In medical schools, residencies, and fellowships all physicians are trained how to diagnose and manage patients. Take a hypothetical case. A new patient awaits your expertise as you enter the exam room. The patient has dutifully completed a multi-page questionnaire, the modern-day equivalent of a Review of Systems (ROS), Past Surgical History (PSH), Past Medical History (PMH), List of Allergies and Current Medications, and History of Present Illness (HPI). You’ve read the document prior to entering the room but you spend time clarifying the issues and creating this patient’s cohesive medical story. Then you examine him; from his right, just as you were taught in medical school. Your exam has morphed of course, emphasizing those aspects relevant to your particular specialty but still incorporating features from other areas of interest. After all, it is a whole person you are seeing, and ailments oftentimes breach systems’ boundaries as they are not constrained by artificial barriers. You examine his blood work as well as any other pertinent tests that have been performed prior to the visit. Then you think. You place the pieces of his particular puzzle in an orderly fashion; you make diagnoses; and then you create a plan. Reflecting on every single aspect of this fundamental, age-old doctor-patient interaction, consider how much of it is truly based upon solid RCT evidence. I will spare you the agony of this exercise as I’ve already done it countless times. The answer is essentially none. Where are the RCTs validating our ROS, HPI, examination from the right…? They simply do not exist. Yet, this is how we all practice medicine. And, it has worked out rather well for our patients. None of us should be handcuffed by RCTs when we evaluate and treat patients; we are all free to use any and all of the countless tools at our disposal. And frankly, the more tools in our chest, the better off are our patients. So, rule number one in addressing the guidelines is, “Remember that they are not rules.” Guidelines are not a part of the Ten Commandments. Even the authors of the 2013 ACC/AHA Guidelines acknowledge this when they state, “Guidelines attempt to define practices that meet the needs in most circumstances and are not a replacement for clinical judgment. The ultimate decision about care of a particular patient must be made by the healthcare provider and patient in light of the circumstances presented by that patient.” Translation: You the doctor should treat each and every individual patient in the manner you deem most appropriate. You must not feel shackled by these or any other “Guidelines.” With this in mind, I will now review the Cholesterol and Risk Assessment Guidelines to present an approach I will utilize in my practice. The views that follow emanate from experience garnered through practicing Clinical Lipidology and Preventive Cardiology, in addition to my personal interpretation of the literature as a whole.

Four groups qualify for statin therapy in the new guidelines, and I agree; they should all be treated. They are:

  1.  Patients with clinical atherosclerotic cardiovascular disease (ASCVD), defined as acute coronary syndromes (ACS), myocardial infarction (MI), stable or unstable angina pectoris, coronary or other arterial revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial disease (PAD) presumed to be of atherosclerotic origin. These patients are to receive high-intensity statins.
  2. Primary elevations of LDL-C > 190 mg/dL (consistent with Familial Hypercholesterolemia, or FH). These patients are to receive high-intensity statins.
  3. Diabetic patients between the ages of 40 and 75 with LDL-C 70 to 189 mg/dL and no history of ASCVD. Patients with 10 year risk > 7.5% receive high-intensity statins while others receive moderate-intensity statins.
  4. Patients without clinical ASCVD or Diabetes Mellitus between the ages of 40 and 75, having an LDL-C 70 to 189 mg/dL and 10 year ASCVD risk of > 7.5%. These patients are to receive moderate-to-high intensity statins.

A few problems with this construct are:

  1. The Risk calculator is still shrouded in uncertainty. Many issues remain to be resolved, not the least of which is the fact that a strong Family History of premature ASCVD fails to impact risk in this system. Also, only 24,000 patients were evaluated to construct this tool which sits at the center of these guidelines and is meant to be used to determine therapy for hundreds of millions of people. Therefore, for now, when I opt to do a 10 year risk assessment I will still use Framingham Risk Scoring. I do so with the understanding of the limitations of this scoring system and the concomitant need for methods to further risk reclassify patients.
  2. The intention is to treat patients with high-intensity statins and assume an LDL-C reduction of > 50%, and moderate intensity statins to achieve a reduction of 30 to 50%. LDL-C goals are now passé in this paradigm. However, we all know that each patient is unique. Some respond very well to statin therapy; others do not. I will therefore continue to measure LDL-C (as well as LDL-P) on drug and I will continue to get my patients to goals at least as stringent as those in ATP3. There are ample data supporting the “lower is better” hypothesis. For example, the Cholesterol Treatment Trialists (CTT) study showed in both phases one and two that lower is better. The fact that we do not have RCTs that have used titration of statins to LDL goals as a primary endpoint in no way negates the overwhelming body of literature showing better outcomes at lower LDL-C , apo B, and LDL-P levels across a range of different statins. I will continue treat to targets.
  3. The high-dose-statin-absent-adjunctive-therapy (or-even lipid/lipoprotein-follow-up) concept is to me “pie in the sky.” We all know that from an LDL-C – but even more so LDL-P or apo B – standpoint by prescribing statins alone we will fall woefully short of what we have been accustomed to achieve. We also know that lower is better. Thus, by adhering to the guidelines’ advice we will very possibly see worse future outcomes. Additionally, we know from several trials that statin-related Diabetes Mellitus is dose related. JUPITER found that 20 mg of Rosuvastatin reduced 2.5 ASCVD events or deaths for every one excess in DM. Thus there is a trade-off for uptitration of statins. For me, I will use statins as a base and other therapies such as cholesterol absorption inhibition and bile acid sequestration as adjunctive therapy.
  4. ASCVD includes the presence of PAD but it does not include the presence of subclinical disease in the coronary or carotid arterial trees. This is counterintuitive. There is ample evidence that the presence of a high Coronary Artery Calcium score (CAC) or age-and sex-inappropriate Carotid Intimal Media Thickness (CIMT) predicts higher risk of ASCVD events. Even absent the copious data we have accumulated, doesn’t it make physiologic sense to ascribe as much value to disease in the vascular beds that are direct culprits for the very events we are attempting to thwart as we do to distant arteries in the legs? I will continue to use CIMT and CAC (and coronary CT angiography) in intermediate risk patients as tools to risk reclassify patients.
  5. The age limits of 40 to 75 are problematic. What do we do with a 35 year old woman with no other ASCVD risks except an LDL-C of 180 mg/dL and a powerful family history of premature ASCVD? Her 10 year risk is only 1.6% but she is too young to be treated by the new guidelines regardless of her risk score. I would unequivocally treat this woman.
  6. The absence of a significant lipoprotein and triglyceride discussion relegates the guidelines to be strictly statin/LDL-C documents. They do not attempt to be comprehensive and the authors acknowledge this fact. Thus, we should not be misled to believe that lipoproteins and triglycerides are suddenly unimportant. They are not. I will continue to assess them and manage them in a patient-centric, individualized manner. Again, every patient is different. Each one deserves his or her unique assessment and management. “One size fits all” has no place in modern medicine.
  7. Biological markers like Lipoprotein Associated Phospholipase A2 (LpPLA2), myeloperoxidase (MPO), oxidized LDL, Lp(a), and urine microalbumin have numerous studies either validating their position as ASCVD risk factors or at least implicating them in ASCVD. Though de-emphasized in these guidelines, biological markers are helpful tools in understanding our patients’ risks as well as motivating our patients to adjust their lifestyles and take their medications. I will continue to utilize them in my practice of “Interventional Prevention.”

In summation let us remember that these guidelines are not law. They are based entirely upon a mere 25 “highest level” clinical trials, ignoring thousands of “lower level” trials, human biology and physiology, and clinical acumen. To some extent I would say they are so limited in scope by inappropriately-stringent data-entry criteria that they have become Ivory Tower, clinically-blind advice. Their very construct diminishes their real world relevance.  Ironically the system suggested in the guidelines has itself never been validated by the very type of RCT evidence demanded by the guideline authors. Something is surely wrong with that. Yet on a positive note the new guidelines are simpler than ATP3. Reliance more upon Global (Total) Risk rather than individual risk factors makes it easier for clinicians to make recommendations. Still, simple is not always good. As outlined above, I intend to use the guidelines as a foundation upon which to build a more dynamic and plastic way to approach the patients in my clinical practice. I refuse to await trials that may never appear. Instead, I will continue to avidly follow the literature, eagerly learn from my colleagues, and diligently incorporate a wide gamut of data to render the well-considered recommendations I ultimately share with my patients.

Please read more about preventive cardiology at www.preventivecardiologyinc.com.

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Caution: When choosing your health insurance remember to look to the future!

The country is in the midst of a monumental healthcare debate. Physicians like me treat individual patients, not populations. Thus this note of caution is meant for you, the individual who now must determine what health insurance plan best suits you and your loved ones. This blog in no way addresses the merits or lack thereof of the Affordable Care Act (ACA). I have been a practicing Cardiologist for over twenty years. During that time, my practice has run the gamut from intervention to prevention. Although it would be hyperbole to say “I have seen it all”, my varied experience has afforded me the opportunity to participate in the most intimate and meaningful aspects of a great many patients’ lives during so many different types of medical trouble. I have also myself unfortunately been a patient with life-threatening ailments on more than one occasion. To say I am an expert in the medical arena is therefore not hyperbole.

Now that many Americans must examine their health insurance with a new perspective I want to raise a single note of caution: When choosing your plan, always look to the future. It is one thing to keep your current doctor; that is indisputably important. Possibly even more consequential though is the fact that many of us ultimately develop complex, serious, and even rare medical disorders. We do this “in the future”, and to make matters worse, we never know when the axe will fall. Sadly but irrefutably we are all vulnerable to this fate. When this occurs, patients invariably and appropriately want to “see the best”. To do so often requires long trips to a variety of places in America (as an aside, it is ALWAYS in America where you will find “the best”). I have patients and loved ones who have traveled to Nebraska and Texas for the treatment of Lymphoma; Sloan Kettering for Neuroblastoma and other cancers; the Brigham and Women’s, Massachusetts General Hospital, Columbia Presbyterian, the Mayo Clinic and Cleveland Clinic for Cardiovascular issues; and many other centers of excellence for a host of other ailments as well. Every time patients travel afar to see the experts they do coordinated research with their physicians in order to identify the doctor and institution best suited to manage a particular condition. This is always a difficult and emotionally challenging task. Now consider this. The majority of plans under the ACA do not have contracts with most of the aforementioned hospitals. In fact, it is my understanding that perhaps the finest cancer center in America is not on ANY of the ACA plans. So, when choosing your health insurance, please focus on what you don’t know. Give the future as much attention as the present. Being unable to see a true expert to treat the disease you have not yet developed (but sadly will most likely afflict you or your loved ones at some point in your life) would be a catastrophic event. Buy your plan with your eyes wide open. Know what you’re getting for now, as well as for the days that lie ahead.

Please read more about preventive cardiology at www.preventivecardiologyinc.com.

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