Safety & Efficacy of Lowering Lipids in the Elderly

I am bombarded regularly by older patients, their adult children and various elements of the media with complaints that elderly are taking too many medicines. Poly pharmacy is the word they use and the first prescription medications they want eliminated are their cholesterol lowering drugs – either a statin (Lipitor, Zocor, Pravachol, Crestor , Livalo or their generic form), Zetia ( Eztimebe) or the newer injectable PCSK9 inhibitors Repatha and Praluent. Is there an age that we should stop these medications? Is there benefit in the elderly to continue taking them? Should we start these medications in the elderly if we discover they have high cholesterol and vascular disease?

A recent study was published in the prestigious Lancet medical journal. The authors looked at 29 trials with 244,090 patients. From this pool there were 21,492 patients who were at least 75 years old. Half of them were on oral statin drugs and the others were on Eztimebe or PCSK9 inhibitors. They were followed from 2 – 6 years.

The results showed that for every reduction of LDL cholesterol of 1mmol/L there was a 26% reduction of in major adverse vascular events. These numbers were similar to those in younger patients. The data also pointed out that these patients had a significant reduction in cardiovascular deaths, myocardial infarction (heart attacks), strokes and the need for heart surgical revascularizations. It was extremely clear that if you are on a cholesterol lowering drug you should stay on that medication despite your age!

A study in JAMA internal medicine, authored by LC Yourman, answered the question of whether you are too old to start on a cholesterol lowering drug. They found that it took 2.5 years before the cholesterol lowering medicine reduced your risk of a major cardiovascular event. Their conclusion was that if you are 70 or older, and your lifespan appears to be greater than 2.5 years, you should start the medicine.

A New Device To Protect the Brains of Athletes From Head Impact

As a parent of athletic girls who played competitive soccer and other sports that involved using your head to control a kicked or thrown ball, I always knew that studies of the brain of European professional soccer players showed much of the same brain injuries seen in professional boxers. We also saw several goalies diving to prevent a ball from entering the goal collide and hitting their heads with the goal’s metal side supports or with an opposing player. Several of the team parents and I tried to design a protective helmet for youth soccer but we never came up with anything that FIFA, the soccer world’s governing body, would allow to be worn during a game.

I played high school football, and a year in college, once suffering a concussion requiring an overnight hospital stay. Later in life as a physician I have followed the discovery of traumatic brain injuries and long-term permanent brain damage in football players, hockey players, soccer players and our military in combat. I wondered when the same creative humans who can send men to the moon and back would design items to protect the brains of competitive athletes.

Q30 Sports Science, LLC apparently has. They received FDA approval for their Q Collar which is designed to prevent deep tissue brain injury from head impacts. The Q Collar is already being marketed and used by athletes in Canada.

The Q Collar is a neck brace worn for up to four hours a day. It was designed after looking at woodpeckers head battering rams and trying to determine why, with all the head trauma they sustain, they do not develop CTE or other permanent traumatic brain injuries. Human brains are suspended in protective fluid inside a bony skull. The force of our head neck and shoulders colliding with a person or object allows our brains to slosh around unrestrained inside the skull and often hitting the extremely hard bony skull bones.

The Q collar increases the blood volume in our internal jugular veins causing a much tighter fit of the brain within the skull and preventing the movement or slosh. By reducing the movement of the brain within the skull it protects the brain from head impact injuries.

The collar was tested on a high school football team who wore state of the art football helmets plus an accelerometer which measured every impact the head sustained during play and practice. There were 284 participants with 139 athletes wearing the Q collar and 145 did not. Each athlete underwent a preseason specialized MRI study of the brain and a post season study. This allowed researchers to look to deep tissue brain injury that occurred over the course of that season. Significant changes were found in the deep tissue of brains on 106 of the 145 (73%) of the participants in the non-Q collar groups. No significant changes were found in 107 of 139 (77%) of the group who wore the Q collar.

The Q collar can be worn for four hours at a time and should be replaced every two years. No pricing data have been released but the intention is to sell the device directly to consumers. The National Institute of Neurological Disorders and Stroke states that in any year there are 1.6 million to 3.8 million traumatic brain injuries related to competitive and recreational sports.

As a parent I would want my child to be wearing this type of device when they engaged in sports that had head impact injuries as a potential side effect. It will remain to be seen just how effective this type of device will be in other recreational activities such as skiing, snowboarding, biking, riding scooters or skating and; will it have an impact in the military on blast injuries? Will insurance companies require such a device for contact sports?

Put on a Mask and Just Stay Home!

I listened to the Governor of my home state, Florida, declare our state the freedom state because all the businesses are open and running full tilt.  He cited his success in keeping deaths from coronavirus low while keeping the economy running and jobs available.

I bring this up because on my way to visit my fully vaccinated adult children last weekend I passed by at least 20 overhead electronic road signs proclaiming, “Miami Beach Curfew 8PM – 6 AM Causeways Closed!”  Yes, here it was springtime with Passover and Easter on the horizon and the famed Miami Beach was closing at night.  We are at a critical point in the fight against the Sars2 COVID-19 coronavirus. We are trying to vaccinate enough people quickly so that the virus does not enter a vulnerable host and mutate to a form that the vaccine is less effective against.   We are so close to controlling this pathogen but human nature and failure to be able to delay gratification, and put off travel and group activities, is leading to a potential fourth surge of COVID-19 related illness and death.

My cell phone rang twice with patient calls on the 60-minute trip southward. The first was from a patient whose adult children came to visit him. His unvaccinated eighteen-year-old grandson was with them. After spending four days together they received a phone call that the grandson’s girlfriend was sick and tested positive for COVID-9. The next two calls were from patients who had been to two different Passover seders. One was outdoors, the other indoors with 20 plus guests. Both had been exposed to a person who called the next day to say they were COVID-19 positive.

I watched the director of the Center for Disease Control and Prevention (CDC), an experienced infectious disease and critical care physician, beg Americans to wear a mask and social distance while she was brought to tears by the thought of another wave of illness, death and prolonged restrictions. I listened to the President of the United States plead with state governments to maintain mask restrictions a bit longer to save lives and control the disease. I listened to the Vatican public relations division discuss not holding an Easter Service in St. Peters Square this coming weekend and wondered what it will take to convince people that we just are not ready to resume full activities.

The Governor of Florida is correct. Deaths are down due to vaccinations and the elderly staying home. I suspect if he tracks the cell phones of the tourists and spring breakers to their home states and countries three weeks from now, he will see an increase in hospitalizations and deaths.  Florida’s economy may boom but we certainly are maintaining it at the cost of illness and death elsewhere.

An Oral Medication To Stop Coronavirus?

Researchers have produced a pill that, taken twice a day at the 800 mg dosage for five consecutive days, seems to stop SARS-CoV-2 virus from multiplying and causing clinical symptoms. The work is quite early and needs to proceed through stage 2 and 3 clinical trial phases before it can be presented to the FDA for emergency utilization authorization.

The drug is called molnupirvir. It could be taken in the first few days of infection to prevent advancement to severe disease much like Tamiflu is used with influenza. In initial human trials, the virus was eliminated from the nasopharynx of 49 infected individuals.

Wendy Painter, MD, of Ridgeback Biotherapeutics presented the data at the Conference on Retroviruses and Opportunistic Infections. The drug works by interfering with the virus’s mode of reproducing and mutating – overloading the virus with replication and mutation until the virus burns itself out and can no longer make effective viral copies.

Their method of testing the drug was to administer it, or a placebo, to humans who were infected and in the early stages of symptomatic disease. They used three different dosages and swabbed the participants’ nose and cultured for the virus at different times during the experiment.

At day 5, after the onset of symptoms, there was no detectable infectious virus in the nasopharynx of participants who were treated with molnupiravir. Dr. Painter reminded everyone that the next test will be given to patients who are actually sick with COVID-19 and see if it works. This preliminary data should encourage us that when scientists are given the time and resources, they solve problems. Imagine in the near future a vaccinated society that has at its disposal accurate and reliable quick tests for COVID-19 and the availability of a pill taken twice a day, for five days, to prevent the disease from becoming severe and requiring hospitalization.

Obstructive Sleep Apnea Surgery vs. CPAP? Daytime Anti-Snoring Device?

Obstructive sleep apnea is now epidemic in a population where it runs hand-in-hand with obesity, which is also an epidemic. The consequences of untreated sleep apnea include daytime somnolence, cardiovascular, neurological and endocrine complications.   One of the hallmark signs of obstructive sleep apnea (OSA) is snoring. 

The US Food and Drug Administration (FDA) recently approved an oral device to be worn during the daytime to reduce and/or eliminate snoring. The device is called eXciteOSA made by Signifier Medical Technologies.  The device is a prescription item which will be used by sleep specialists, dentists and ENT physicians.  It has four electrodes that deliver a series of electrical stimuli to the tongue with rest periods in between. The stimulation over time improves tongue function preventing the tongue from collapsing backward into the airway and obstructing it during sleep.  The device is used for 20-minutes once a day, while awake, for six weeks and then once a week thereafter. It is designed to be used in adults 18 years of age or older with snoring and mild OSA. Think of it as physical therapy for the tongue.

The device was tested on 115 patients, 48 of whom had mild obstructive sleep apnea plus snoring. The others were all snorers. The snoring was reduced in volume by more than 20% in 87 of the 115 patients. In the group of patients with the diagnosis of OSA and snoring, the apnea-hypopnea index score was reduced by 48%

It is recommended that a thorough dental exam be performed prior to trying this device. The major side effects noted from its use were excessive saliva production, tongue discomfort or tingling, metallic taste, jaw tightening, tooth filling sensitivity.  No mention of the cost was included in the printed review.

The online journal Practice Update reviewed a JAMA Otolaryngology publication on the use of surgery to treat Obstructive Sleep Apnea versus using a CPAP machine. There are many patients who just can not wear the CPAP mask which is the first-line “gold standard” for treating OSA.  Most patients who spend 90-days adjusting to the mask sleep far better and look forward to using the device to obtain a restful night’s sleep. The study looked at patients who were at high risk for not being able to adhere to a CPAP use regimen. Soft tissue surgery to the uvula was found to reduce the rates of cardiovascular, neurological and endocrine systemic complications compared with prescriptions for CPAP in patients less likely to adhere to or use the CPAP mask. 

The takeaway message is clear. When a patient is unlikely to adhere to CPAP mask use offering soft tissue oral surgery should be offered early while treating the disease.

Tea Can Help Lower Your Blood Pressure

Researchers at the University of California, Irvine, led by George Abbott PhD and Kaitlyn Redford, published their findings in Cellular Physiology and Biochemistry explaining why and how tea lowers your blood pressure. They found that two flavonoid type compounds found in green and black tea activate a specific type of ion channel protein named KCNQ5 which allows potassium ions to diffuse out of cells to reduce cellular excitability. The two catechin type flavonoids acting on KCNQ5 in the smooth muscle of blood vessels relax these blood vessels.

Scientists have previously found that tea can reduce blood pressure by a small amount. Their discovery of the role of the KCNQ5 protein now gives pharmaceutical developers a target for future medications. Hypertension is present in one third of adults in the world.

Tea has been consumed for over 4,000 years and two billion cups a day are consumed worldwide. Next to water it is the most common liquid consumed on the planet. It all comes from the leaves of the evergreen species Camellia sinensis with a difference in the fermentation process producing either green, oolong or black teas.

In much of the world, tea is consumed with milk mixed in. Dr Abbott’s group found that in the laboratory when milk was added to the teas it negated the effects of the KCNQ5 protein. They additionally found different temperatures of the tea resulted in different effectiveness of the KCNQ5 protein. Professor Abbott noted however that in humans’ digestive tracts our stomach and intestines separate out the milk products from the active KCNQ5 protein allowing it to work. He also noted that with our body temperature being about 37 degrees centigrade, the positive effects of the tea continued to work independent of whether you consumed hot tea or iced tea.

The message from this research is that a cup or two of tea per day will help lower your blood pressure.

Foreign Dependence on the Drug Supply Chain

I have written often about the problems we have as a nation being dependent on foreign nations for the raw materials and manufacturing of common everyday drugs and supplies. The COVID-19 pandemic has only amplified that problem as the U.S. compete for supplies against nation states for needed drugs to treat the infected and prevent transmission. I have addressed how many common drugs are manufactured in China, India and Israel and, due to financial cutbacks for FDA inspections, production plants have not been inspected for years.

I have also addressed how a hurricane that destroyed Puerto Rico left the only intravenous solution producing factory in North or South America unable to function – leaving hospitals and the military short of vital materials for health care. We witnessed the shortage of personal protective materials including masks, face shields, gloves, sanitizers, etc. as the coronavirus spread through the Americas with businesses and states bidding against nations for a limited supply of products, preferentially kept in the nation they were manufactured in.

This past Wednesday, President Biden issued and signed an Executive Order directing Federal agencies to study ways to secure the supply chain for pharmaceutical goods and manufactured goods. The Executive Order will direct 100-day reviews for supply chains for pharmaceutical goods, computer chips, large capacity batteries like those used in electrical cars to prevent dependence on foreign governments. The studies call for “consulting with experts in private industry, academia, workers and communities”.

The hope is we will create manufacturing diversity and redundancy bringing some manufacturing home but insuring that one nation or one site will not be responsible for the total production of any vital product. In my view, this is a long overdue step in the right direction based on what has transpired in the recent past.

Vitamin D & Cardiovascular Health

The online journal Practice Update reviewed a publication in the Journal of the American College of Cardiology which basically says excessive calcium supplementation may harm your healthy heart. It was published at a pertinent time because it came while I was trying to convince my post-menopausal wife that between her Vitamin D pearls, calcium, Vitamin D pills and her multivitamin she was taking too much Vitamin D. Her measured 25-hydroxy Vitamin D level came back at 63.

Vitamin D is a fat-soluble vitamin like vitamins A and K. Extra doses of fat-soluble vitamins are stored in the body’s cells and can reach harmful and toxic levels. The normal level of Vitamin D measured by a standard blood test is considered to be 20 or greater by the World Health Organization. In North America it was originally higher at 28 then raised to 30. The Covid-19 Pandemic has raised issues about low levels of Vitamin D being a risk for catching the disease, and developing complications, but no one has defined what levels are considered unsafe.

The National Academy of Medicine, after reviewing this data, has set these limits and levels:

1. Deficiency is less than or equal to 12ng/ml
2. Inadequacy is 12-20 ng/ml
3. Adequate is 20-50 ng/ml
4. Risk of Adverse Effects occurs at > 50ng/ml

The data suggest avoiding supplementation unless the 25-hydroxy Vitamin D level is <20 and probably best reserved for <12 ng/ml.

Calcium is best absorbed when accompanied by Vitamin D .  Taking smaller doses like 500 mg plus 1000 of Vitamin D3 works. For osteoporotic patients they suggest 600mg of Calcium plus 1000 IU of Vitamin D3 daily. They want you to eat a diet that supplies another 600 mg of calcium a day plus walk for weight bearing exercise and get 15 or more minutes of sunlight daily. Of interest was the statement that calcium supplements may harm your heart, but any calcium obtained naturally through foods does not.

The article was reviewed and commented on by David Rakel, MD, FAAFP with the take home message being, “Eat a high-fiber, plant-based diet with some fish and go outside and play.”

Can Smartphones & Fitbits Interfere with your Pacemaker or Defibrillator?

The February 8^th edition of Medpage Today, an online magazine, published the concerns of cardiologist and electrophysiologist Joshua Greenberg, MD, about the magnet arrays in the new Apple iPhone 12 interfering with the function of pacemakers and defibrillators.

When a patient goes to their doctor, cardiologist, electrophysiologist, etc., and the physician wishes to turn off their pacemaker to look at the heart’s normal electrical activity, they normally place a magnet over the implanted device to deactivate it. The new iPhone 12 apparently uses an array of magnets around a wireless charging coil.

Dr Greenberg used the iPhone 12 to disable a Medtronic ICD. Once he brought the phone over the patients left chest the device deactivated. His findings were published in January in a letter to the editor of the journal Heart Rhythm. “This is a big deal because if the patient were to go into ventricular tachycardia or fibrillation during this time, they would just drop dead without receiving a life-saving shock from the ICD.”

Separately, electrophysiologist M. Eskander, MD tweeted a video showing an iPhone12 shutting off a pacemaker as well as if a magnet had been placed over it. Wristband magnets in Fitbit and Apple iWatches have been reported to deactivate Medtronic ICDs from 0.9” away due to their wristband magnets.

Phil Mar, MD , an electrophysiologist at Saint Louis University School of Medicine agrees that this is a previously unrecognized issue that needs to be dealt with. He suggests patients with implanted pacemakers and ICDs avoid purchasing an iPhone with magnets. He encourages their spouses or bed partners to follow the same advice to prevent deactivation when they roll over and get close. He emphasizes that this was not an issue with earlier model iPhones which didn’t have an array of magnets and was not seen in Apple iWatches without the magnetic wrist bands for charging. He is concerned that any cell phone, wrist band or watch using wireless charging may cause the same deactivation.

The author of the article, Anthony Pearson, MD made the suggestion that patients with pacemakers and ICDs should have their cardiologist or electrophysiologist routinely test their cell phones, Fitbits and iWatches’ effect on their devices at a planned routine visit and certainly immediately after implantation. He reminded us this does not occur in devices that do not have a magnet array which is most cell phones and watches.

There has always been a recommendation that if you have a pacemaker or AICD you use your cellphone in the ear opposite your pacemaker or device pocket and never bring it within six inches of the device.

Blood pressure measurement, its importance in reducing vascular disease & remote patient monitoring

An article published in the prestigious journal Hypertension looked at following blood pressure over a decade and the reduction in heart attacks, strokes and deaths if you were able to keep blood pressure under control. It talked about extending your life by over four years and the preventing vascular disease from developing for at least five years.

The authors looked at multiple blood pressure trials and noted the difficulty in relying on one office visit measurement periodically. They too noticed that certain patients were always higher in the office than at home and noted the problems with home blood pressure monitors including trying to decide if they were accurate and being recorded correctly. The result was that whatever reading they obtained at your visit, when looked at over a 10-year period, influenced your survival and cardiac events.

We too have struggled with this issue in our office. We ask patients to bring in their home blood pressure equipment so we can correlate the readings they get in our office on our equipment and their equipment. Just last night a patient with no symptoms and feeling well took his blood pressure and found it elevated. Rather than contact me or his cardiologist he ran to the Emergency Room. He waited hours, had multiple tests and by that time his blood pressure lowered they referred him to his doctors without intervening at all.

When needed, we have a patient use a 24-hour ambulatory blood pressure monitor. They wear it on their arm like a blood pressure cuff and it inflates six times per hour during daytime and four times per hour during sleep while measuring their pressure. There is a small recording device worn on their belt. After 24 hours, it is returned to our office and we print out the readings and obtain averages to help us determine just what your blood pressure really is. The equipment has a diary so the patient can note when stressful events occur and we can correlate it with the readings. The minor drawbacks to the equipment are its bulkiness, the need to keep it dry and the disturbance to sleep it causes as the cuff inflates and deflates.

To improve measurements, as well as capture other health metrics, we are introducing a remote monitoring smart wristband. We have identified a vendor who will supply you with the high-tech wrist band at no out-of-pocket expense to you. The wristband interacts with your iPhone or android phone.

The device measures and captures pulse, heart rhythm, blood pressure, blood oxygen level, and steps.  It even has built-in fall detection. The 2021 model, which will be introduced in a few months, has an EKG component to help us follow patients who get dizzy, faint or have documented heart issues. It will also capture body temperature. There is an optional blood glucose sensor monitoring device. The wristband is water resistant so you may shower with it.

Due to the Pandemic, and development of tele-health, Medicare pays for the monitoring if you wear the device a minimum of 16 days each month. Patients are asked to identify emergency contacts so that if you fall or if you have an arrhythmia, abnormal blood pressure, abnormal blood sugar, the monitoring call center contacts your emergency contact on record.

Your physician can view all the data on our computers. Certain private insurances pay for these services as well as Medicare. I will start wearing one and my wife will as well.

I will personally discuss this with each of you whom I feel will benefit from wearing the wristband as remote monitoring is proven to reduce hospital admissions and ER visits. If you have a chronic condition, disease or certain risk factors; it’s likely I will encourage you to wear the band.

Some patients have asked if the band has a panic button for you to push if you feel you need to such as after a fall. The technology senses if you fell and have not gotten up or if you are ill and calls your emergency contacts but it does not have a unique panic button to push.

We look forward to introducing this new remote high technology to improve your health, safety and peace of mind.