In September 2011, the Department of Health and Human Services (DHHS), the Centers for Disease Control (CDC), and the Centers for Medicare and Medicaid Services (CMS) jointly announced the Million Hearts Initiative.1,2 The goal is to prevent 1 million heart attacks and strokes over the next five years. Other groups such as the American Heart Association, the American College of Cardiology, the American Pharmacy Association, and Walgreens drug stores quickly joined the effort.
Unfortunately, the action plan to achieve this lofty goal as published is likely to fail. Nevertheless, those of us in integrative medicine should embrace the overall goal and use all our skills to formulate a plan to prevent even more heart attacks and strokes than the efforts put forth by these prestigious organizations. This article analyzes the strengths and weaknesses of the Million Hearts Initiative (MHI) and shows how we can make it dramatically better.
Cardiovascular Disease as the Leading Cause of Death
In the US there are about 2 million heart attacks and strokes each year, with 800,000 fatalities. Not only are they the leading cause of death, but also the overall medical cost of these diseases is estimated to be $450 billion per year. From 1980 to 2000, there was a significant reduction in the death rate from cardiovascular disease, most of which was due to lifestyle changes and preventive medicine. Yet cardiovascular disease is still by far the leading cause of death. DHHS Secretary Kathleen Sebelius states that heart disease is responsible for 1 of every 3 deaths in the US.
The MHI Plan to Prevent Heart Attacks and Strokes
The clinical interventions put forth by the MHI consist of four potential categories of drugs. The treatment acronym is the ABCS of prevention: Aspirin for high-risk patients, medications to control Blood pressure, Cholesterol management, and Smoking cessation if needed (varenicline, nicotine patches, etc.). In addition, the MHI calls for improved nutrition through a reduction in the intake of sodium and trans fats. The MHI hopes to coordinate activities with Obama's Affordable Care Act. Electronic health records and quality recognition programs offered by both the government and various private insurance plans should also be useful for recruitment of patients to participate.
At present, only 47% of patients at risk take aspirin, 46% have blood pressure under control, and 33% have LDLs below 100. The specific goals of the MHI are to increase all of these numbers to 65% by 2017. A fourth clinical goal is to reduce smoking prevalence from 19% to 17%.1
Emphasizing four interventions that might require drug therapy certainly makes one wonder about the influence of the pharmaceutical industry in this effort. There are at least 30 million people in the US whose blood pressure and/or cholesterol are not under control. That is a pretty large target population, just with these two factors. Overall, Forbes estimates that the MHI seeks to put half of our adult population on drugs prescribed by doctors.
One of the strengths of the MHI plan is that it does not depend on intensive care by cardiologists and vascular surgeons. In fact, several popular blogs written by these specialists have complained that cardiologists are being left out of the campaign. Perhaps there is a reason for this omission. The OAT trial in 2006 demonstrated that opening totally occluded arteries with stents after uncomplicated myocardial infarctions involving those vessels actually increased the mortality rate when compared with medical management.3 Soon afterwards, the COURAGE trial showed that angioplasty and stents for stable coronary artery disease were no more effective than proper medical management.4 Before the COURAGE trial, 85% of all stents in the US were surgically placed in patients with stable coronary artery disease. Both of these important studies have been virtually ignored in clinical practice. Vascular specialists continue to place unnecessary stents in many patients each year. A recent JAMA editorial described this practice as an "expensive placebo."5 The authors further commented that "some entire medical subspecialties (might be) based on little evidence." No doubt there are valid indications for revascularization procedures and complex drug therapy. Cardiologists are necessary. Many of them would be more effective, however, if they focused more on nutritional biochemistry.
Of great interest is the study by Canto and associates that analyzed 542,008 patients who had heart attacks from 1994 to 2006.6 For those patients who suffered their first heart attack, the in-hospital mortality was inversely proportional to the number of traditional risk factors identified. The risk factors that they examined were hypertension, smoking, dyslipidemia, diabetes, and family history of heart disease. Obviously, other factors were contributing to the increased mortality for these patients. If we are to succeed, we must do a more thorough job of identifying risk factors and modifying them safely.
Criticism of the MHI Plan
The most obvious deficit in the MHI plan is that it does not include three commonly recognized lifestyle factors for the prevention of cardiovascular disease: regular exercise, stress coping measures, and weight reduction if needed. Exercise alone is probably more effective than any drug. By excluding these important lifestyle factors, it becomes highly unlikely that the MHI will succeed in real life.
The MHI appropriately states that we must reduce trans fats and sodium in our diets, but it could say much more. At the very least, patients at risk should avoid foods that are high on the glycemic index, aspartame, high-fructose corn syrup, processed foods, and fried foods. We also could eat organic raw vegetables as much as possible. The use of unrefined salt would add beneficial trace minerals. Not surprisingly, the potential benefits of nutritional and herbal supplements are not mentioned in the MHI.
Diabetes is another prominent risk factor for cardiovascular disease. Weight control and low-carbohydrate diets are important for prevention and treatment of diabetes. Diet, exercise, and supplements are often sufficient to achieve control of type 2 disease without medications.
Poverty and inequality are factors that have been shown to increase cardiovascular disease. Not only do these factors cause economic stress, but they also result in poor-quality food and increased smoking as a stress-coping measure. Such socioeconomic factors make it more difficult for the ABCS of the MHI to succeed. A more comprehensive approach as I describe is required to overcome the twin risk factors of poverty and inequality.
The MHI is careful to note that aspirin and statin drugs for cholesterol management are to be used only for high-risk patients. However, that might serve to be the "fine print" that nobody reads. Recent reports show that for primary prevention of cardiovascular disease, the "number needed to treat" to prevent one heart attack with aspirin is 163 and for statin drugs is 200.7 The "number needed to harm" for both of these interventions is much lower. Thus the use of these drugs for primary prevention is highly questionable. However, many physicians still prescribe them when not indicated, which is a waste of resources and the potential source of serious complications.
If we are going to succeed in saving a million hearts with our current socioeconomic and lifestyle stresses and our failure to change our therapies in response to definitive evidence, we should look at additional risk factors, especially ones whose remedies are much less likely to cause complications than the proposed drugs. We should emphasize powerful lifestyle changes and safe, optimal supplements instead of diverting our attention toward aspirin, antihypertensive drugs, and statins. For this, we can rely on and offer our patients the insights and experience of integrative medicine.
Let's Get Serious About Saving a Million Hearts
Obviously, we cannot save a million hearts and strokes all by ourselves. But we can save far more than our share. First, we should identify the hearts that need saving (although the case can be made that all hearts need saving). We can determine if patients' hearts are at risk mostly by performing a history and physical exam and gathering basic lab and other tests, some of which might have been previously been performed. If patients have a history of documented vascular disease, hypertension, hyperlipidemia, diabetes, smoking in the previous 5 years, or a family history of heart attacks or strokes, they automatically qualify.
Computerized risk assessments, usually based on the Framingham Risk Assessment, might or might not be helpful. They provide striking graphic displays that demonstrate the effect of improving basic risk factors. However, they don't include the cumulative effect of a comprehensive risk factor plan like we are discussing. If patients are at least 50 years old or the physician suspects high-risk lifestyles, one or more screening tests to determine if they are beginning to develop plaque in their arteries is indicated. If a resting EKG has nonspecific ST/T-wave changes, their hearts might be at risk. A stress EKG can have false positives and false negatives, especially in women. A stress echocardiogram is more accurate in females. An ultrafast CT scan for calcium score is a good screening test. A carotid intima media thickness (CIMT) ultrasound test by CardioRisk (www.cardiorisk.us) is also a very sensitive screening test that can be done by that company periodically in your office. The ankle/brachial index is a reasonable screen for peripheral artery disease, although not very sensitive, in my experience. If positive, however, there is an increased risk for heart attacks and strokes.
If we determine that a patient is at risk, a comprehensive cardiovascular risk factor evaluation is indicated. For our patients who join the MHI, we often recommend a VAP cholesterol panel, including Lp(a), HbA1C, ferritin, fibrinogen, CRP sensitive, red cell magnesium, 25 [OH] vitamin D3, and homocysteine test.8,9 Virtually all of these tests and more are included in a comprehensive cardiovascular blood panel. Two companies that offer such panels are Doctors Data (www.doctorsdata.com) and Atherotech (www.Atherotech.com). We also do a EDTA challenge test for heavy metals, with special attention to lead.10 If available, heart rate variability testing frequently detects high sympathetic activity that is not balanced by parasympathetic output, even when the patient is unaware of excessive stress. A saliva test strip for nitric oxide (www.advancedbionutritionals.com) can detect low NO levels, which at least theoretically can be improved with nutritional support. Other tests for nutritional factors can certainly be ordered, but they are beyond the scope of this article.
In our report of findings, we estimate how much risk we think each patient has and how we think we can improve that risk with various interventions. Our individual patient database is considerably larger than that of the MHI. Our recommended treatment interventions include more aggressive lifestyle measures, nutritional supplements, herbal therapies, and other treatments as indicated.
Integrative Treatment Plan
Start with the ABCS. Instead of or in addition to aspirin, to reduce platelet aggregation, we can use fish oils, garlic, vitamin E (mixed tocopherols especially gamma), nattokinase, and/or lumbokinase. Donating blood several times a year is another way to decrease blood viscosity. One study showed an 88% reduction in the risk for myocardial infarction for 153 middle-aged men who donated blood in the previous 24 months.11 That study has been criticized, but a more recent study delineated a more complex mechanism and confirmed that blood donation might reduce the risk of vascular disease.12 In addition to reduced blood viscosity, the resulting decrease in elevated ferritins substantially lowered free radical activity. Rheologics (610-524-5427) makes a machine that measures blood viscosity.
The blood pressure might respond to garlic, potassium, magnesium, and other phytonutrients. I have found rauwolfia with sandalwood and other herbs (BP Natural Relief; www.natrelief.com) to be particularly effective. Weight loss can often lower the blood pressure significantly. These measures might be sufficient by themselves, or they can be used in conjunction with medications to achieve good control.
For cholesterol, HDL, and LDL management, low-carbohydrate appears to be the most effective diet, especially if the triglycerides are high.13 But this remains controversial. The DASH, LEARN, Ornish, and Mediterranean diets are alternatives. Red yeast rice is a natural statin that can effectively lower cholesterol and LDL, with much fewer side effects than the drugs. As with statin drugs, the main beneficial effect from red yeast rice might be to reduce arterial inflammation rather than to reduce LDL. Always replace coenzyme Q10 when prescribing any kind of statin. Both muscle inflammation and congestive heart failure have been attributed to low levels of CoQ10, which is depleted by the statins. Fish oils can help reduce cholesterol and so can cinnamon, niacin, berberine, and lecithin. Intravenous essential phospholipids from lecithin have been used in Europe to treat coronary artery disease. Proteolytic enzymes might also be effective to reduce inflammation. Food allergies can be important, especially gluten and casein sensitivity. A therapeutic trial of an elimination diet can be very helpful.
To stop smoking, hypnosis and acupuncture are somewhat effective. The medication varenicline (Chantix) might have its place, but the incidence of side effects is troubling.
For better fitness compliance, an exercise prescription is mandatory, depending on the patients' physical capacities. People often need to have specific goals to get the best results. Al Sears's PACE program with brief periods of intense exercise makes sense to me. It is backed by the Harvard Professional Lifestyle Study.14 Adequate fitness, however, can usually be achieved by walking for 30 minutes 5 days per week.
Always be aware of how important stress can be for cardiovascular disease.
One of the best-documented treatment programs is HeartMath, a home tutorial using biofeedback.15 Yoga, meditation, progressive relaxation, visualization, deep breathing, Emotional Freedom Technique, prayer, and acupressure are procedures that can be utilized. All patients in the MHI should form a plan to improve their stress-coping activities, especially if their heart rate variability results are abnormal.
Nutrient deficiencies are frequently detected with the comprehensive cardiovascular risk profile, particularly magnesium. Antioxidants are indicated if an increased amount of oxidized LDL is detected. Linus Pauling's admonition to treat patients who have elevated Lp(a) levels with vitamin C, proline, and lysine still rings true. The optimal level of 25(OH) vitamin D3 is 60 to 100 ng/ml, although the listed normal is usually as low as 30 ng/ml. Calcium might be given to lower the risk of osteoporosis or colon cancer, but always balance it with at least half of the milligram dose of magnesium. Do not prescribe the ultra-high doses of 1500 to 2000 mg of calcium a day. Studies have shown that high-dose calcium can lead to calcification of the arteries. CoQ10, D-ribose, and L-carnitine are helpful adjuncts, especially for congestive heart failure and fatigue. Medium-chain triglycerides from coconut oil are useful to preserve brain function. The herb apoaequorin (Prevagen) is particularly good to preserve memory, in my experience. The physician formulation of apoaequorin is four times as strong as the product available over the counter.
For many years, integrative physicians have found intravenous EDTA chelation therapy to be very effective in treating and preventing cardiovascular disease. This is especially true if a buildup of toxic metals is detected. Lead is the best-documented toxic heavy metal.10 It has been linked to heart disease, cancer, and autoimmune problems. If mercury is found, DMPS or DMSA might be needed in addition to EDTA. The published intravenous EDTA protocol appears to be effective, even if heavy metals are not found. The author and associates demonstrated a dramatic decrease in subsequent cardiac events in high-risk patients who had received chelation therapy.16 The results of the Trial to Assess Chelation Therapy (TACT) are due to be published this summer.
An underappreciated advantage of enrolling a patient in a course of chelation therapy is that the treatments are given once or twice a week during the basic course. That means that each week, the nurse has a teaching opportunity to reinforce diet, exercise, stress-coping, supplement compliance, and habit control, all of which are important for saving hearts. Our staff helps the patient set goals and identify barriers to reaching the goals. As with any class or program, repetition is key. It often helps to bring a friend. When patients share their experiences and goals with others, results can be better than trying to follow the program by themselves. Group visits to deal with risk factors and lifestyle might be a useful service to offer.
Monitoring and maintenance are two key concepts for a successful program. The risk factors identified must be monitored often enough to assure that interventions are effective. Too often the patient and the physician identify risk factors, correct them temporarily, but fail to be sure that the factors remain under control. Noninvasive vascular tests should be repeated to monitor progress. Lab biomarkers should be repeated at specified intervals. The CIMT and the heart rate variability are particularly good monitoring tests. However, the ultra-fast CT scan is not.
A summary of the integrative approach in seven steps is outlined in Table 1.
Table 1. Seven Steps for an Integrative Million Hearts Initiative
Step 1 Identify and enroll patients
Patients eligible if they have at least one:
__Documented vascular disease
__Have been a smoker within the last 5 years
__Have a strong family history of heart disease or stroke
__Your doctor identifies you as high risk due to lifestyle or other factors
Step 2 List noninvasive cardiovascular test(s) that have been done
Step 3 Detailed risk factor testing
__ Comprehensive Cardiovascular Risk Panel (VAP cholesterol,
__ homocysteine, CRPsens, HbA1c, Ferritin, Fibrinogen, Red cell
__ magnesium, and additional tests)
__ 25 [OH] vitamin D3
__ EDTA challenge test for toxic metals
__ Heart rate variability
Step 4 Treatment
Treat the ABCS
__For aspirin and platelet aggregation, may substitute phytonutients
__Consider regular blood donation
__For blood pressure control, use medications and/or phytonutrients
__For cholesterol management, use statin drugs (+coQ10) or natural
__statins and other supplements
__Refrain from smoking
Treat additional lifestyle factors
__Healthy diet or specific diet for lipids or weight loss
__Specific measures to better cope with stress
Step 5 Chelation should be presented as an option
__For heavy metals if indicated, or
__Vascular protocol for prevention or treatment of cardiovascular disease
Step 6 Additional phytonutrients as indicated
Step 7 Monitoring and maintenance
__Noninvasive tests of CV disease
__Risk factor tests that were abnormal
__Reinforce lifestyle measures
Research and New Frontiers
Several avenues of research are currently taking place, including genomics, molecular targeting, stem cell biology, and regenerative medicine.17 Both conventional and integrative medicine are active in these areas of interest. Progress is anticipated within the five-year target period of the MHI. For example, stem cells harvested from autologous bone marrow are being tested to treat myocardial infarction.18 Initial results were not impressive, but the authors were optimistic that revisions in protocol might yield better results. Mikirova and associates recently showed that chelation of heavy metals improved the number of stem/progenitor cells in circulation.19 Our version of the MHI should be a fluid plan that can be improved as new evidence emerges.
One criticism of integrative medicine is that there are few large clinical trials to support the therapies that are utilized. Harvard professors Groopman and Hartzband in their book, Your Medical Mind, point out that too often the larger the clinical trial, the less significant the results.7 Their reason is that it takes a large study to have sufficient statistical significance to prove a minimal effect. Smaller studies with larger effects are often more useful.
How much effort is required to prevent a heart attack or a stroke? How about a million heart attacks and strokes? We applaud the conventional medical community and government for setting the MHI as a lofty goal. Unfortunately, it is unlikely that goal will be reached with the plan that has been put forth. On the other hand, utilizing a comprehensive, integrative approach, we can make a huge impact for those 1 million individual hearts and brains that we want to save. Not infrequently, hypertension and hyperlipidemia can be controlled by detoxification of heavy metals, exercise, a healthful diet, and stress management without the use of medications that might cause more adverse affects than beneficial ones. Nutritional and herbal supplements, as needed, can be added with greater safety than many medications, with similar benefits.
Patients must be presented with all the evidence in an unbiased manner. Then it is their responsibility to choose the therapies that suit them best. Individual treatment plans are more effective than rigid guidelines. Our goal is to reduce their chances of having heart attacks or strokes over the long term to the lowest incidence possible. With this effort, I am confident that we will prevent many heart attacks and strokes, while helping patients live longer. Many patients will have a better quality of life as well. Let's start immediately, by providing comprehensive plans for our patients and letting the word spread, wide and far.
1. US Department of Health and Human Services. New public-private sector initiative aims to prevent 1 million heart attacks and strokes in five years [online press release]. www.hhs.gov/news/press/2011pres/09/20110913a.html. Accessed Jan. 19, 2012.
2. Frieden TR, Berwick DM. The "million hearts" initiative—preventing heart attacks and strokes. N Engl J Med 2011;365:e27. September 29, 2011.
3. Hockman JS, Lamas GA, Buller CE, et al. Coronary intervention after persistent occlusion after myocardial infarction. N Engl J Med 2006; 355:2395–2407.
4. Boden WE, O'Rourke RA, Teo KK, et al. COURAGE trial research group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007;356:1503–1516.
5. Prasad V, Cifu A, Ioannides JP. Reversals of established medical practices: evidence to abandon ship. JAMA 2012;307:37–38.
6. Canto JG, Kiefe CI, Rogers WJ, et al. Number of coronary risk factors and mortality in patients with first myocardial infarction. JAMA 2011;306:2120–2127.
7. Groopman J, Hartzband P. Your Medical Mind. New York: Penguin Press; 2011.
8. McAna JF, Goldfarb NI, Couto J, et al. Improved cardiac management with a disease management program incorporating comprehensive lipid profiling. Popul Health Manag. 2011;15:1–6.
9. Wang TJ, Pencina MJ, Booth SL, et al. Vitamin D deficiency and risk of cardiovascular disease. Circulation 2008;117:503–511.
10. Menke A, Muntaer P. Batuman V., et al. Blood lead below 0.48 micromol/L (10 microg/dL) and mortality among U.S. adults. Circulation 2006;114:1388–1394.
11. Meyers DG, Strickland D, Maloly PA, et al. Possible association of a reduction in cardiovascular events with blood donation. Heart 1997;78:188–193.
12. Zheng H, Cable R, Spencer B, et al. Iron stores and vascular function in voluntary blood donors. Arterioscler Thromb Vascular Biol 2005;25:1577–1583.
13. Gardner CD, Kiazand A Alhassen S, et al. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women. JAMA 2007;297:969–977.
14. Harvard Medical School. Walking: your steps to health. Harvard Men's Health Watch. August 2009. Available at: www.health.harvard.edu/newsletters/HarvardMensHealthWatch/2009/August/Walking-Your-steps-to-health.
15. Lemaire JB, Wallace JE, Lewin AM, et al. The effect of a biofeedback-based stress management tool on physician stress: a randomized, controlled clinical trial. Open Medicine 2011;5:154–162.
16. Chappell LT, Shukla R, Yang J, et al. Subsequent cardiac and stroke events in patients with known vascular disease treated with EDTA chelation therapy. Evid Based Integrative Med 2005;2:27–35.
17. Nabel EG, Braunwald E. A tale of coronary artery disease and myocardial infarction. N Engl J Med 2012;366:54–63.
18. Hare JM. Bone marrow therapy for myocardial infarction. JAMA 2011;306: 2156–2157.
19. Mikirova N, Casciari J, Hunninghake R. Efficacy of oral DMSA and intravenous EDTA in chelation of toxic metals and improvement of the number of stem/progenitor cells in circulation. Transl Biomed. 2011;2. Available at http://www.transbiomedicine.com.
Terry Chappell, MD, is a board-certified family physician from Bluffton, Ohio, who has served as president of ACAM and ICIM. He has published widely on chelation therapy.