Scientific Reports, Media Reports and Ambiguity

Last week I read an article in a peer reviewed journal citing the benefits of a few eggs per week as part of a low carbohydrate dietary intervention for Type II Diabetes.  The information was so meaningful about a controversial food source of protein that I decided to write about it in my blog and pass it along to my patients.  Three days later the American Heart Association and American College of Cardiology discussed the increased risk of cardiovascular events and mortality in individuals consuming three or more eggs regularly. They talked about the detrimental cholesterol being concentrated in the yolk making egg white omelets look healthier than traditional omelets.

In the early 1970’s a VA study was published showing that veterans over 45 years of age who took an aspirin a day had fewer heart attacks and strokes and survived them better than those who don’t.  Fast forward almost 50 years and we have different recommendations for people who have never had an MI or CVA or evidence of cardiovascular disease compared to secondary prevention in individuals who have known coronary artery disease, cerebrovascular disease or diabetes. Throw in the controversial discussions of aspirin preventing colorectal adenomas from developing, aspirin preventing certain types of skin cancers and today’s report that suggests it may prevent liver cancer. Now three studies suggest that in older individuals (70 or greater) the risk of bleeding negates the benefits of cardio and cerebrovascular protection and aspirin may not actually prevent heart attacks and strokes in that age group.

We then turn to statins and prevention of heart attacks and numerous articles about not prescribing them to older Americans.  I saw articles on this topic covered by CNN, the Wall Street Journal, ARP Journal, AAA magazine and in several newsletters published by major national medical centers.  In each piece they caution you to talk to your doctor before stopping that medicine.

I am that seventy year old patient they all talk about.  I have never smoked. I exercise modestly on a regular basis, getting my 10,000 or more steps five or more days a week.  I battle to keep my weight down and find it difficult to give up sweets and bread when so many other of life’s pleasures are no longer available due to age and health related suggestions.

There are clearly no studies that look at patients who took a statin for 15 years and aspirins for over 20 years, stopped them and then were followed for the remainder of their lives.   How will they fare compared to patients who never took them?

I have this discussion every day with my patient’s pointing out the current guidelines and trying to individualize the suggestions to their unique lifestyle and issues. On a personal level, I still have no idea what the correct thing is to do even after discussing it with my doctors.  How can I expect my patients to feel any differently?

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Shared Decision Making. Science versus Art of Medicine.

My 80 year old patient presented with symptoms and signs of kidney failure. I hospitalized him and asked for the assistance of a kidney specialist. We notified his heart specialist as a courtesy. A complicated evaluation led to a diagnosis of an unusual vasculitis with the patient’s immune system attacking his kidney as if it was a foreign toxic invader.

Treatment, post kidney biopsy, involved administering large doses of corticosteroids followed by a chemotherapy agent called Cytoxan. Six days later it was clear that dialysis was required at least until the patient’s kidneys responded to the therapy and began working again.

You need access to large blood vessels for dialysis, so a vascular surgeon was consulted. He placed a manufactured vascular access device in the patient’s lower neck on a Monday in the operating room. The access was used later that day for a cleansing filtration procedure called plasma exchange. The patient returned to his room at dinner time with a newly swollen and painful right arm and hand on the same side as the surgical vascular access procedure.

The nurses were alarmed and paged the vascular surgeon. His after-hours calls are taken by a nurse practitioner. She was unimpressed and suggested elevating the arm. The floor nurses were not happy with that answer since they had seen blood clots form downstream from vascular access devices. They next called the nephrologist. He suggested elevation of the arm plus heat. This did not satisfy the charge nurse who requested a diagnostic Doppler ultrasound to look for a clot. The nephrologist acquiesced and it was done quickly revealing a clot or deep vein thrombosis (DVT) in an arm vein.

I am the patient’s admitting physician and attending physician (it is unclear to me what the difference is) but I was surprised I did not receive the first or second call regarding the swollen arm. I was the first however to receive a call with the result. My first knowledge that a problem was occurring came when an RN called, “Dr. Reznick, the patient in 803 came back from dialysis with a painful swollen right arm and hand. The vascular surgeon was called but his covering nurse practitioner wasn’t concerned. The nephrologist ordered the test after we encouraged him to. There is a clot in the right brachial vein. What should we do?”

This was a new complication occurring to a frightened patient just returning from surgery, plasma exchange and hemodialysis for the first time to treat a rare aggressive disease he and his children had never heard of. One of my cardinal rules of practice is when in doubt listen to the patient, take a thorough history of the events, examine the involved body parts, look at the diagnostic studies with the radiologist and explain it all to the patient and family. I changed my leisure clothes to my doctor clothes and headed to the hospital delaying dinner, something my wife is incredibly understanding and tolerant of.

One of the perks of teaching medical students is being provided free and total access to the medical literature using the school’s library and subscription access. I searched for anything related to upper extremity deep vein thrombosis after establishing vascular access and related to his vasculitis. Three items popped up including recommendations and guidelines for diagnosis and treatment from the American College of Cardiology and the American College of Thoracic Surgeons all within the last six months. They both suggested the same things, use intravenous blood thinners for five to seven days then oral anticoagulants for three to six months or until the vascular access is removed. The risk of the blood clot traveling to the lungs is lower than in leg and pelvic DVTs but it is still 5 – 6%.

I read this while the radiologist accessed the films and reviewed them with me. Next stop was the eighth floor where the patient and his out of town visiting adult child were. I asked them what happened. They showed me the warm swollen arm and hand. I checked for pulses which were present and then color and neurological sensation which were normal. I explained that when vascular access is inserted in the large neck veins it can increase the risk of a clot forming in the arm veins resulting in arm and hand swelling. I explained that the chances of a clot traveling back to his heart and out to his lung were 5 – 6% and significantly less than DVTs in leg or pelvic veins. The treatment was explained. His nephrologist concurred as did the cardiologist. Heparin was begun.

With elevation and soaks the swelling was down by morning. He returned from dialysis that afternoon with his chin and neck all black and blue. He was bleeding profusely from the upper portion of the surgical access site. Nurses were applying compression to the area after the blood thinner was stopped and it continued to bleed. Vascular surgery was furious that heparin or any blood thinner was used for the clot.

Repeated phone calls to the vascular surgeon resulted in him angrily arriving much later placing six sutures to stop the bleeding. Heparin can lower platelet counts when antibodies to heparin cross react with platelets. His platelet count of 80,000 was sufficient to prevent bleeding. A blood test for heparin induced thrombocytopenia was drawn and he received two more units of blood products to replace what he lost. After stabilizing the patient, we realized his drop in platelets was due to the Cytoxan having its peak effect not heparin.

The patient had no further bruising or bleeding. He was dialyzed or had plasma exchange on alternating days for another week. The nephrologist wanted this done in the hospital not as an outpatient. It took one week for the reference lab to return the negative HIT (heparin induced thrombocytopenia) results clearing the heparin of causing the bleeding and bruises.

Prior to discharge I reviewed the long term oral anticoagulation recommendations of the American College of Cardiology and Thoracic Surgeons with the patient, nephrologist, cardiologist and hematologist. The nephrologist was comfortable with administering a kidney failure lower dose of eliquis. The vascular surgeon and cardiologist felt it was not necessary. The hematologist initially agreed then changed his mind. I asked each of the naysayers to explain to me how this patient differed from the patients in the many studies who comprised the data for the recommendations? They said he did not. They said they had a feeling and discussed “the art of medicine in addition to the science”.

In a rare vasculitis disease which few of us have seen frequently, I prefer the data in multiple studies to one’s clinical intuition. At discharge, I prescribed the oral blood thinner. I reviewed the pros and cons of the drug. The patient and daughter told me that based on the ambivalence of the hematologist he would stick with his aspirin rather than the oral anticoagulant.

Shared decision making appropriately allows patients to decide for themselves. If the patient develops pleuritic chest pain coughing up blood with shortness of breath from a pulmonary embolus, I will be called to provide care not my colleagues because specialists don’t admit.

The Blood Pressure Guidelines Dilemma

The American College of Cardiology and American Heart Association recently published blood pressure control guidelines that suggest we should be treating blood pressure in 25 year olds the same way we treat it in 79 year olds and older patients. If you have any cardiovascular disease, or a 10% cardiovascular risk assessment over the next few years, they want your systolic blood pressure to be less than 130. They present excellent data explaining that as the blood pressure elevates above 130, the risk of a heart attack, stroke, vascular disease or kidney disease and, ultimately, death increase. No one is arguing these facts.

The American College of Physicians (ACP) along with the American Academy of Family Physicians (AAFP) recognizes this one size fits all in blood pressure control creates many problems. As we age, our arteries become less compliant or elastic. Stiffer arteries are more difficult to assess for blood pressure value. After we have exhausted the lifestyle changes of smoking cessation, weight loss, salt restriction and increased activity to control blood pressure; we are forced to use medications. We try to use low doses of medicines to avoid the adverse effects of the pills that the higher dosages can bring.

These medicines are costly. The more we prescribe the more patients don’t take them due to the cost. The more we prescribe, the more patients forget to take multiple pills on multiple schedules of administration. If we get the patients to take the medication we run into the problem of blood pressure precipitously dropping when patients change positions from supine to sitting to standing. If we are lucky, and the patient is well hydrated, then we may only be dealing with a brief dizzy spell. In other cases, we are left treating the consequences of a fall and injury from the fall. The more we strive to control your blood pressure to the new levels with medications the more we must consider drug interactions with prescription medicines being prescribed for other health problems seen in older Americans.

At this point, experts from the ACP Policy Board and noted hypertensive experts at the University of Chicago have suggested we follow the more liberal guidelines of the ACP individualizing our care based on the patient’s health issues. Personalizing care with individual goals makes sense to me, especially in my chronically ill patients battling blood pressure, weight control, age related orthopedic issues, and age related visual and urological issues plus other problems. We strive to do that in our practice allowing the time for discussion, questions and evaluation at each visit.

Are Diet Sodas Unhealthy for Your Heart?

SodaI was eating lunch reading a report from the American College of Cardiology meetings stating that women who drank two or more diet sodas per day of 12 ounces or more were 29% more likely to have a cardiac event than those who consumed a lower quantity of no more than 3 diet drinks per month. The report was prepared by Ankur Vyas, MD, of the University of Iowa Hospitals and Clinics. The 5% of women with the highest consumption of diet beverages in the Women’s Health Initiative also had 26 % elevated all-cause mortality. Cardiac deaths were 52% more likely with two or more diet sodas or other diet drinks per day.

Jeffey Kuvin, MD, vice chair of the program committee for the ACC meeting, called the results “provocative” but not yet compelling. Clearly these results are convincing enough to plan another study with a larger group and stricter design to determine if it is the caffeine, the artificial sweetener or some other constituent causing this increased risk? Could it be that the individuals drinking two or more diet beverages are already practicing a relatively heart unhealthy lifestyle and are overweight, less active, diabetic, hypertensive and or smokers? This all needs to be determined before we condemn diet beverages. Dr. Kurvin pointed out that sugary non diet beverages are well known to cause weight gain, diabetes and eventually coronary artery disease.

What does one drink then? I chose to have an old fashioned unhealthy sugary soda with my heart healthy lunch. While I was sipping that sweet delicious beverage, but feeling extremely guilty about it, my computer sent me a medical alert, “Soda associated with increased heart attack and stroke risk.”. The soda came flying out of my mouth and nose instantly as if had coughed and it splattered everywhere moments before I read the full message closely and noted that they were referring to cocaine not soda.

This study will surely raise questions from my patients in my practice. I will advise them to avoid diet beverages if possible, just like I advise them to avoid sugary beverages in large quantities if possible. Drink water or drink diet beverages in extreme moderation until the data is clear. Moderation would mean no more than 36 ounces per week.

Omega 3 Fatty Acid Levels and the Risk of Prostate Cancer

A recent well publicized research study known as “The SELECT Trail” showed that Vitamin E supplementation increased the risk of Prostate Cancer compared with placebo (NEJM JW Gen Med Oct 25 2011)  Researchers have now used data from that study analyzed separately now claims that individuals with a higher level of omega 3 fatty acids are at a higher risk of developing high grade prostate cancer. The results were published in the Am J Epidemiol 2011; 173:1429.

This was a case – control study in which researchers looked at the plasma omega 3 fatty acid levels in stored blood collected at the beginning of the SELECT trial. They compared the levels in 834 men with prostate cancer and 1393 controls without the disease.  The design of the study does not allow one to conclude that if you ingest omega 3 fatty acid supplements you will develop prostate cancer. The study just noted that individuals with prostate cancer as compared to men without had higher plasma levels of omega 3 fatty acids in their blood.

This particular study raised a great deal of media attention and concern especially with the American College of Cardiology advocating supplementation with fish oils for cardiac protection in recent years. This recommendation came despite two recent studies that indicated just the opposite ( NEJM JW Gen Med May 8 2013, and JAMA 2012; 308: 1024).   It is clear from this controversy that the exact role of omega 3 fatty acids, fish oils, omega 6 fatty acids and vegetable oils is still up for debate. I will advise my patients to eat fish in moderation consuming 1-2 fish meals per week if they enjoy fish.  Eating in moderation and allowing our bodies to use the nutrients they need seems to be the wisest course until more is known.

Inflammation and Vascular Disease

Heart, stethescopeI was privileged to hear Bradley Bale, MD and Amy Doneen, MSN, ARNP talk about the development of coronary artery disease and cerebrovascular disease in patients with low or few cardiac risk factors.  They cited American Heart Association studies looking at groups of men and women between ages 45 and 65 who have their first heart attack or stroke despite being in compliance with suggested lipid and blood pressure guidelines. They pointed out that the first Myocardial Infarct or Stroke occurred in 88% of women who met lipid guidelines and 66 % of men.  These are people who do not smoke, do not have untreated or uncontrolled lipid levels, are not diabetics and who lead an active life style.  They asked “why”?

Dr. Bale and Ms. Doneen work with the well respected cardiovascular Center of Excellence at the Cleveland Clinic program in Ohio, and believe that inflammation is the root of the problem.  They believe that soft plaque composed of lipids and other cells lurks beneath the endothelial cells lining blood vessels. In the presence of inflammatory stimulants, this soft plaque ruptures suddenly through the endothelial level into the blood stream. When it comes in contact with the blood flowing through the vessels the body believes we are bleeding and cut and chemical mediators are released that initiate the formation of a clot. When this clot occurs in a small coronary artery we have a heart attack or myocardial infarction or precipitate a lethal irregular heartbeat. When this clot occurs in the blood vessels of the brain, we have an acute stroke or cerebrovascular accident.

The key to prevention in the so called low risk patient is to detect the inflammation in advance, and treat it. They are firm believers in performing B Mode Duplex ultrasounds of the carotid arteries in the neck to look for the presence of soft plaque beneath the endothelial cell lining. This soft plaque is distinctly different from the safe but calcified plaque we can see on CT scans used for cardiac scoring studies.  They couple this imaging study with a series of complex blood tests which identify inflammation. These include a myeloperoxidase level, the Lp-PLA2 level, the urine microalbumen to creatinine ratio, a F2-IsoPs level and the cardiac specific CRP level.

These tests and studies in combination with a traditional history and exam, sugar and lipid levels and EKG can help us identify those “low risk” patients who actually are high risk for a heart attack or stroke. The cause of the inflammation is often difficult to spot and may be in your mouth with dental or periodontal disease or in your joints with inflammatory arthritis.  Patients with excellent dental hygiene and normal appearing gums may harbor specific inflammatory bacteria that put them at risk. While this seems a bit forward thinking, remember we once questioned the research that showed that bacteria (H Pylori) caused gastric ulcers and intestinal bleeding.

I have begun instituting the inflammatory blood marker panels in my practice. Labs are sent to the Cleveland HeartLab for this purpose. I will be initiating periodic carotid ultrasound studies for the appropriate patients in the coming year.

It is often difficult for clinicians to distinguish snake oil sold for profit from cutting edge science. I have tried to spare my patients from worthless but profit driven products. I am convinced the Cleveland Clinic is just ahead of the rest of us in offering these services and I will make them available to the appropriate patients and will do it in a financially structured manner that does not add out of pocket cost to the patient. It’s not about adding another profitable income stream to the practice. It’s about identifying individuals who shouldn’t have a heart attack or stroke before they do.

American Diabetes Association: Fish Oils Do Not Reduce Cardiovascular Event Risk

The American College of Cardiology now recommends that individuals take “fish oil” supplements in pill form to prevent coronary artery and vascular disease. The scientist who discovered that fish oils may have beneficial effects has publically come out and let it be known that he feels differently on the subject. While he once advocated eating two fleshy cold water fish meals a week to gain some degree of protection, he has most recently reduced that requirement to two meals a month. He has additionally scolded the nutritional supplement community for the promotion of fish oils in pill form when it can be safely and effectively obtained by eating a few cans of tuna fish or salmon per month.

Recently, at the annual meeting of the American Diabetes Association, Jackie Bosch, MSc, from McMaster University and Hamilton Health Sciences in Hamilton, Ontario presented data that suggested that fish oils did not reduce cardiovascular deaths or events.  The data was abstracted from the ongoing ORIGIN (Outcome Reduction with Initial Glargine Intervention) study of 12,536 patients with type 2 diabetes, impaired fasting glucose levels or impaired glucose tolerance. These study participants were composed of 65% men with a mean study age of 64 years who were followed for over six years. The study group received one gram daily of n-3-fatty acids.

The data showed that fish oils did not make a difference in the number of fatal or non-fatal heart attacks, fatal and non-fatal strokes, hospitalizations for heart failure, revascularization procedure numbers, and loss of a limb or digit due to poor circulation for any cardiovascular cause. The study additionally showed that the use of a long-acting insulin Glargine had no detrimental or beneficial effects on cardiovascular disease.  The story was covered and summarized in the online periodical of the University of Pennsylvania Medical School, MedPage.  Interestingly, the placebo group received one gram per day of olive oil.

Clearly this is another indictment against taking pills instead of acquiring nutrients in a well prepared balanced diet that includes cold water fleshy fish weekly.  Upon reading the study, I wondered if the use of olive oil by the placebo group was cardio-protective and fish oils were just no more cardio-protective than olive oil?  Once again, further research is needed. While the research is ongoing, eating cold water fleshy fish once a week as part of a nutritionally sound, well prepared diet rather than taking fish oil pills seems to make sense.