How Tightly Should We Control Blood Pressure in the Elderly?

A recent publication in a fine peer reviewed medical journal of the SPRINT study proved that lowering our blood pressure to the old target of 120/80 or less led to fewer heart attacks, strokes and kidney failure.  There was no question on what to do with younger people but to lower their blood pressure more aggressively to these levels. Debates arose in the medical community about the ability to lower it that much and would we be able to add enough medication and convince the patients to take it religiously or not to meet these stringent recommendations?

There was less clarity in the baby boomer elderly growing population of men and women who were healthy and over 75 years of age. The thought was that maybe we need to keep their blood pressure a bit higher because we need to continue to perfuse the brain cells of these aging patients.

A study performed in the west coast of the United States using actual brain autopsy material hinted that with aggressive lowering of the blood pressure, patients were exhibiting signs and symptoms of dementia but their ultimate brain biopsies did not support that clinical diagnosis. In fact the brain autopsies suggested that we were not getting enough oxygen and nutrient rich blood to the brain because of aggressive lowering of blood pressure.  Maintain blood pressure higher we were told using a systolic BP of 150 or lower as a target.

A recent study of blood pressure control in the elderly noted that when medications for hypertension were introduced or increased a significant percentage of treated patients experienced a fall within 15 days of the adjustment in blood pressure treatment.  This all served as an introduction to a national meeting on hypertension last week during which the results of this same SPRINT (Systolic Blood Pressure Intervention Trial) strongly came out in favor of intensive lowering of blood pressure to 120/70 to reduce heart attacks, strokes and mortality in the elderly and claimed even in the intensive treated group there were few increased risks.   On further questioning however by reclassifying  adverse events in the SPRINT trial to “ possibly or definitely related to intensive treatment, the risk of injurious falls was higher in the intensive vs conventional treatment group.”

What does this mean in the big picture to all of us?  The big picture remains confusing.  It is clear that lowering your blood pressure aggressively and intensively will reduce the number of heart attacks and strokes and kidney disease of a serious nature.  It is clear as well that any initiation or enhancing of your blood pressure regimen puts you at risk for a fall. You will need to stay especially well hydrated and change positions slowly during this immediate post change in therapy time period if you hope to avoid a fall.  Will more intensive control of your blood pressure at lower levels lead to signs and symptoms of dementia due to poor perfusion of your brain cells?  With the SPRINT study only running for three or more years it is probably too early to tell if the intensive therapy will lead to more cognitive dysfunction.

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How Much of Yourself Can You Give to Others?

I have been practicing general internal medicine for over 35 years in the same community. I have many patients who started with me in 1979 and are now in their late eighties to early nineties.  Predictably and sadly they are failing.  Not a week goes by without one or two of them moving from general medical care to palliative care, very often with the involvement of Hospice for end of life care.   Medicare may now compensate for discussion of end of life issues but anyone practicing general internal medicine or family practice has been discussing end of life issues appropriately for years with no compensation. It just comes with the territory.

Most of us still practicing primary care thrive on being able to improve our patient’s quality of life and our major compensation can be hearing about their interactions and social engagements with family and friends.  It is an accomplishment to see you’re 90 year old with multisystem disease for years, dance at her great grandchild’s wedding.  No one who cares for patients longitudinally for years is that dispassionate that they do not give up a piece of their heart and soul each time they lose a patient or have one take a turn for the worse.   When I lose a patient, if time permits, I will attend the funeral or family grieving gathering during the mourning period.  Everyone gets a personal hand written letter. Completion of the circle of life and then moving on is part of the process.

I think physicians’ families take the brunt of this caring and I am sure mine does. As much as you want to have time and patience and sympathy and empathy for your loved ones, the work truly drains your tank and reserve. When you answer the questions of the elderly and their families over and over, often the same questions, it drains you.  Unfortunately, I believe my elderly failing mother is cheated the most by this process. Last weekend when making my weekly visit she was complaining again about the same things, asking the same questions that have repeatedly and compassionately been addressed by my brother and I. My wife interjected that I sounded angry and annoyed. I was. I told her that unfortunately all the compassion and understanding in me had been drained already today and I needed time to recharge.

I saw the widow of a patient who expired last month in his nineties. I had offered to make home visits and they were declined several times by the patient and his spouse. His last week of life he asked to receive Hospice care and they assumed his care.  I called the surviving spouse and wrote what I considered a personal letter of condolence.  His wife told me she was disappointed in me for not coming up to see him one last time. I apologized for not meeting their needs but wondered inwardly, how much can I give and still have something left for myself and my loved ones?

Changes Coming to Medicare Soon

CMS (Center for Medicare Services) is determined to eliminate fee for service medicine. Fee for service medicine is the system where patients see a physician or “provider” for a visit or service and the “physician or provider” bills the patient or Medicare for each service provided.  CMS argues that “providers” are seeing too much volume and providing too many services thus driving up the cost of health care and the percentage of the Gross National Product that healthcare consumes.  To contain costs they have come up with the public relations mantra of the “Triple Aim.”  The triple aim includes improving the global health of the US population while improving quality and reducing overall costs.  The true emphasis is on reducing overall costs!

To reach their goals, CMS is changing the way it pays for health care and services. By 2019, less than three years from now, CMS hopes to pay one flat fee per beneficiary to large health care organizations ( think HMOs) thus fixing their costs. That large organization will then be responsible for providing total care to a local population.   Hospitals and large health care systems have been purchasing physician practices and employing the doctors in organizations known as Accountable Care Organizations (ACO’s). These health systems believe that by employing the doctors they will control their ordering and spending habits and reduce costs to the overall system. They hope to drive an aging private community physician population into early retirement or at least to stop coming to the hospitals to care for their own patients. They still want these patients to come to their hospital for care but want their employed physicians to provide the care.

If you look around the community you will notice that the major hematologic and oncology groups are now owned by Boca Raton Regional Hospital, as is the major surgical group, several cardiology groups and a host of internists and family practitioners.  The hospital has additionally partnered with its contracted emergency room physicians to open numerous walk in clinics in young population centers to capture that business. At the same time that our local regional hospital is purchasing practices and discouraging local private physicians from continuing to practice, they have introduced a residency training program in internal medicine and surgery. By the fall of 2017 we can expect 100 internal medicine physicians and up to 45 surgical physicians fresh out of medical school and beginning their training, to be serving as a cheap physician labor force for Boca Regional Hospital.  The hope is that ultimately, the Charles Schmidt College of Medicine at FAU will attract and develop a clinical faculty worthy of a university and academic medical center that will enhance medical care in our area but until then we will always wonder, as anesthesia puts us to sleep, who actually is performing our surgical procedures?   Additionally one wonders if you become ill with a serious illness, will you be permitted and covered to see the best physician at the best institution for your problem or will you be required to stay in a narrow network of local providers contracted with the local health entity?

If physicians choose not to join a large health system organization as an employee they will be required to be part of a merit based payment system.  Government administrators, employers and private insurers are certain they can define and quantitate “quality care.”  It is unclear whether there is any meaningful evidence of what “quality care” really is.   Quality care will include parameters like patient satisfaction ( if you are not given an antibiotic for your viral illness or a narcotic pain medicine for your injury appropriately based on the illness or injury will the provider be given a low patient satisfaction grade?), did you counsel an obese patient to lose weight?  Did you counsel a tobacco smoker to stop?  Did you intervene to control a patient’s blood pressure?  All the data entry will require the physician to spend time in front of the computer screen checking more boxes and less time in face-to-face patient care.  Computers will need to communicate with each other from the office to the hospital to the lab etc. but it is unclear who will pay for this? At the end of each year the doctors will be required to send all their patient care data electronically to CMS for review.

Many physicians will choose to just leave or “opt out” of the Medicare system. They will contract privately with patients and be able to order tests and studies at approved institutions but they will not be reimbursed by Medicare for their services nor will the patient be reimbursed by Medicare for the cost of those doctors’ visits and services.  In most areas of the country where the population is not overwhelmingly composed of senior citizens 65 years of age or older, doctors have stopped seeing Medicare patients for just this reason. This may become the norm rather than the exception in South Florida as well.

For the moment my concierge practice is not changing anything. We continue to participate in all the CMS quality programs such as Meaningful Use and PQRS , vaccine registry and Eforcse (a controlled substance prescribing data base) despite the cost and time involved just to leave our future options open. I remain committed to giving my patients longer quality visits and following them where possible into the hospital when they need hospital services. As patients and citizens it is urgent that you become familiar with what CMS and the Federal Government are doing with your taxes and health care options and hold them accountable to your wishes!  If you have questions about this give me a call or set up a special time to discuss this face-to face.

Increased Dementia Risk in Senior Citizens Due to Proton Pump Inhibitors (PPIs)

Brittany Haenisch, PhD of the German Center for Neurodegenerative Diseases in Bonn, has reported in JAMA Neurology, a study from health insurance data suggesting that taking Proton Pump Inhibitors (PPIs) such as Aciphex (omeprazole), Protonix (pantoprazole), Nexium (esomeprazole), and Prevacid (lansoprazole), was associated with a markedly increased risk of developing dementia. The correlation was stronger in men than women with a slightly increased risk for those taking Nexium.

The study, conducted from 2004 through 2011, looked at 73,679 people age 75 years or older and who were free of dementia at “baseline”.  It revealed 29,510 patients (40%) developed dementia and, of these, almost 3,000 (average age of 84) were taking a PPI medication. The authors concluded that avoiding PPIs may prevent dementia.

All of these medicines are now freely sold over the counter not requiring a prescription. Their use has dramatically increased. There is belief from animal studies that PPIs cross the blood brain barrier and effect the production of amyloid and tau protein associated with dementia. In humans, B12 levels can be lowered effecting cognitive ability. None of this data shows a clear cause and effect relationship so we cannot say PPIs hasten the onset or cause dementia. Newer well designed controlled and blinded studies will be needed for this purpose.

In the interim, I will ask my patients to reduce or avoid these medications. We can treat heartburn and indigestion with products such as antacids, weight loss, eating smaller portions and staying upright after those meals, loosening your belt at the waist and avoiding those foods that reduce lower esophageal sphincter muscle pressure leading to reflux.

There will be some with conditions such as Barret’s Esophagus, which is precancerous, and recent bleeding ulcers which require the use of PPIs for eight or more weeks and then switch to Tums, Rolaids, Gaviscon or Carafate. Some patients will need the PPIs for symptom relief beyond eight weeks and they will need to make a tough decision between symptom relief and increased dementia risk while the researchers search for the answer.

How Often Do Screening Colonoscopies Result in a Complication?

Harlan Krumholz, MD is the director of the Yale Center for Outcomes Research and Evaluation (CORE). His team at Yale is being paid extraordinarily well to determine what works and what doesn’t in Medicare. Their data will theoretically allow Medicare to issue payment for services based on success rates of care without complications. His group is part of a national program promoted by the Center for Medicare Services (CMS) to spend less for more effective high quality care. This in my humble opinion is “voodoo” health care policy.

One of their areas of interest is trips to the emergency room or hospital within 7 – 14 days of a colonoscopy. They developed a formula to look at this problem and applied it to Medicare claims data in the year 2010 in NY, Nebraska, Florida and California. They found 1.6% of healthy individuals going for screening colonoscopy ended up at the hospital within seven days. They found wide variations in this rate coming from different facilities and different doctors. When the data is extrapolated to the 1.7 million Medicare beneficiaries undergoing screening colonoscopy annually it indicates there will be at least 27,000 unplanned hospital visits within seven days of the procedure.

Determining what causes complications of a screening procedure so we can determine a root cause and then prevent it is a good thing. However; the research needs to be done by independent groups not receiving funds from CMS which has a clear and strong conflict of interest!

We need to be looking at complications related to the choice of preparation, choice of colonoscopy, choice of anesthesia and whether polyps were removed and or biopsies taken. We additionally need to assess the definition of “low risk patient.”

Within the recommended age group for screening colonoscopies of 50-75 years old, very few patients are not taking prescription medications as well as supplements. The research needs to look at procedures such as CT Scan virtual colonoscopy and fecal immunochemical human occult blood testing as well for efficacy and complication rate.

There are currently DNA analysis tests of columnar epithelium colon cells sloughed during a normal bowel movement. Pre-cancerous polyps and colon cancer have distinctive DNA patterns that can be detected by looking at fecal material. There is no prep but the cost of $500 makes determining if it works and under what circumstances important. If it works then shouldn’t it be the screening test to determine who needs to have a colonoscopy? Yes, the research must be done but it must be done by agencies not affiliated with CMS with their stated goal of spending less for better service and better quality.

Vitamin D in Senior Citizens: How Much is Enough?

Vitamin D levels are the most popular blood test being billed to CMS Medicare and private insurers. The World Health Organization considers 20 ng/ml to be a normal level of 25-hydroxyvitamin D which contrasts with 30ng/ml in the USA. Vitamin D is made by the kidney when our limbs get exposed to sufficient sun light. It is low in severe and chronic states. Supplementing Vitamin D does not improve the illness except possibly in multiple sclerosis but can return the serum level to normal.

Experts in fall prevention hoped that supplying adequate vitamin D will preserve muscle function and reduce falling. About one in three elderly experience a fall annually with one fracture per five falls. In the USA this amounts to 250,000 hospital admissions for hip fracture each year. The research hope was that by raising the Vitamin D level to 30 we would reduce falls and fractures.  Unfortunately individuals 70 years or older who took 2000IU of Vitamin D a day or 60,000units per month, had more falls and a higher risk of falls than seniors who had lower serum levels and less supplementation. Their muscle function improved with higher dose vitamin D but so did the falls.

The Institute of Medicine, an independent US advisory panel advises taking 800 IU per day or 24,000 IU per month with a goal of a serum level of 21-30 and less frequent Vitamin D level monitoring.

Does Tdap Protect You From Whooping Cough?

Within the past few years an epidemic of whooping cough swept through and injured youngsters in California and Arizona. There were tragic childhood mortalities in the frail not yet vaccinated pediatric population. The researchers from the Center for Disease Control and National Institute of Health swooped in and concluded that adults, primarily grandparents, were transmitting the disease to their newly arrived and not yet immunized grandchildren. They reasoned that the adults’ immunity from their childhood vaccinations with DPT had worn off and they were unknowingly transmitting it to the youngsters after a mild adult upper respiratory tract infection with bronchitis.  We were told that in adults, Bordetella pertussis produced bronchitis indistinguishable from a viral bronchitis. This was just the type of illness health care leaders were telling physicians not to prescribe an antibiotic for in their international campaign for the prevention of antibiotic resistance developing.  Little did they know at first that in adults, the bronchitis is a mild illness but in children it is aggressive and is often lethal.  They were not originally aware that long after our adult mild bronchitis resolved we could still transmit the bordetella pertussis to our grandchildren.

Their solution was to re-immunize adults with a pertussis booster in combination with your next tetanus shot. The combination was called Tdap.  A national information campaign was undertaken to get primary care physicians to spread the word to their adult patients.  The question is does it really work? In a recently published study led by Dr. Nicola P. Klein of the Kaiser Permanente Vaccine Study Center in Northern California which appeared in the Journal Pediatrics, it seems that the vaccine is only effective for a short time in the very healthy and robust 11 and 12 year children.  Their study showed that Tdap protected young adolescents 69% of the time in the first year, 57% in the second year, 25% in the third year and only 9% in the fourth year.  The vaccine was given during an epidemic in California in whooping cough in the hopes of averting a greater infection rate.

 

The failure of the vaccine to provide long term benefits in adolescents and teenagers will lead to different immunization strategies. Tdap is already a milder form of a former vaccine, scaled down to prevent some of the rare side effects seen when it was administered.  A possible return to that previous vaccine or whole cell preparation may be needed. Another proposal calls for vaccinating pregnant women hoping that their maternal antibodies will pass to the fetus and provide long term protection.

The real question with no answer is what about the millions of adults who received Tdap with immune systems far less robust and protective than adolescents?  Are they immune and for how long?  No one knows because the research has not been done or published yet.  Still the CDC and the NIH and the American College of Physicians call for adult immunization with Tdap.  The Kaiser Permanente Study will surely establish the need for an adult efficacy investigation. Until then we will give the Tdap while we wait for answers. It does raise the question of whether our approach to adult bronchitis should include an antibiotic that treats Bordetella pertussis until a quick test is developed to distinguish it from run of the mill viral pneumonias.