The American Society for Preventive Cardiology 30 Years and Counting

ASPC CVD PREVENTION

July 30, 2015 marks the start of the ASPC’s Annual meeting, taking place once again at the spectacular Boca Raton Resort. This year, in addition to our world-class faculty, new elements will be added to the meeting – poster presentations to be published in Clinical Cardiology as well as a Level 1 Expert’s Course in Preventive Cardiology. Over the next three months I will certainly write more about the conference and I hope many of you will avail yourselves of its offerings. (For more complete information please visit www.aspconline.org).

Today however, on the heels of the Dallas Cardio-Metabolic Health Congress (CMHC) I am compelled to write this brief note about the ASPC. The reason is simple. As I sat in the speaker’s row with my friends and colleagues Drs. Jamie Underberg, Amit Khera, and Michael Miller it became clear that the thirty-year-old organization is now firmly entrenched in mainstream education. You see, Dr. Underberg sits on the ASPC’s Board of Directors while Dr. Khera is the Secretary; I am the President Elect, and Dr. Miller is a Past President. It was truly heartwarming to have us all gathered together for the sole purpose of helping to educate our colleagues about issues such as Familial Hypercholesterolemia (FH), Hypertriglyceridemia, Lipid and Cholesterol Guidelines, and the future of HDL research and therapies.  The ASPC is growing at a gratifyingly rapid rate, as more and more physicians, ARNPs, and other healthcare practitioners embrace the doctrine that cardiovascular disease prevention must preempt intervention in order for our nation and the world at large to be able to truly enjoy optimal health. If you are not already a member of the ASPC, please consider becoming one. Also, I encourage everyone interested in prevention to join us in July. I promise you will not be disappointed.

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

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An Update From the 2014 American Society for Preventive Cardiology (ASPC) Annual Meetings

Two weeks ago was the ASPC’s Annual meeting in Boca Raton, FL. The event was superb. Internationally recognized experts in a variety of disciplines convened in Boca Raton for the three–day-event. Nearly 200 healthcare practitioners from around the country came to listen to Professors from Northwestern, Harvard, NYU, The Mayo, Columbia University, The Miami Miller School of Medicine, Emory, Ohio State, UCLA…  Topics such as the somewhat controversial 2013 ACC/AHA Cholesterol and Obesity Guidelines, the enormously under-recognized disorder Familial Hypercholesterolemia, and the vast sex differences in CVD presentation and treatment were discussed.

My lecture was entitled, “The Omega-3 Fatty Acids DHA and EPA: Caution when interpreting the Trials. It’s time to get back to the basics.”  The talk highlighted enormous limitations inherent in recent omega-3 studies. It is not only clinicians and laypeople who must understand such issues, but the press as well. Too many reporters – and even physicians in the news – misinterpret clinical studies, oftentimes sending not just misleading messages to the pubic, but potentially damaging ones as well.

DHA and EPA are the essential fatty acids found in fish, NOT flax, Chia, or olive/canola oil. These fatty acids have been studied in a variety of disorders ranging from heart attacks to dementias, ADHD, eye disease, inflammatory bowel disorders, and Rheumatologic ailments. The list is actually even more extensive than this. Their benefits are legion – anti-inflammatory, anti-oxidant, anti-arrhythmic, and anti-thrombotic to name a few. Scientists across the globe are spending their entire careers evaluating the myriad biological effects of these fatty acids. Although we still do not know precisely how DHA and EPA will fit into our medicinal armamentarium, we do know that they have an important role to play. More studies and clinical trials are needed. One thing is clear however. DHA and EPA are here to stay. They represent a component in our diets that should be emphasized, not neglected. Nearly daily fatty fish or fish oils should be a part of most people’s dietary habits.

Beyond the value of DHA and EPA is an even more important message though. The media, in their unbridled attempt to produce quick and enticing stories, often critically misses the mark. Consequently we all must be very careful about how we interpret what we read or hear. We must always be vigilant when drawing conclusions about our health as well as other consequential matters.

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

For more information more about essential vitamins and supplements visit www.vitalremedymd.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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New AHA / ACC Cholesterol Guidelines – Controversial but not to be Feared

Last week four guidelines were released by the AHA and ACC. A tremendous amount of controversy surrounded the Cholesterol Guidelines as they deviated in fundamental ways from prior standards. The writers of the guidelines took a strict Evidence Based Medicine (EBM) slant, limiting extrapolation and thereby altering the traditional approach to cholesterol management. For example the format of all prior clinical trials did not specifically address cholesterol goals. Thus they were excluded from the guidelines. That does not, however, mean that it is wrong to continue to try to “get our patients to goal”. It simply means that in the strictest view of EBM, there is insufficient evidence to do so. The American Society for Preventive Cardiology (ASPC, of which I am Treasurer) and several other organizations endorsed the document. The National Lipid Association (NLA) did not. It is critical for practitioners to understand two things when trying to utilize this document as effectively as possible. First, the guideline was meant to be a living work, one that will be updated at regular intervals. Second, and perhaps far more consequential, it is essential that practitioners ardently adhere to a single paragraph from the guidelines which follows:

“Guidelines attempt to define practices that meet the needs of patients 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. As a result, situations might arise in which deviations from these guidelines may be appropriate.”

In sum, we most always remember that guidelines are just tools to help practitioners understand the most recent evidence in medicine. They are not laws. Clinical judgment must always reign supreme.

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

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