New Device Helps Stroke Victims with Hand Function Difficulties

Stroke victims often lose function of a hand. The road back to recovery involves months of physical therapy and work.

Last month the FDA approved the Neurolutions IpsiHand Upper Extremity Rehabilitation System for survivors of stroke trying to regain hand, wrist or arm function.  The system uses EEG electrodes to record your brain activity and then uses these messages to move an electronic hand brace according to the intended muscle movement. It essentially delivers your brain’s intended electrical message to the brace to retrain your limb to work.

This is a sophisticated device which will need to be fitted by stroke rehab professionals and then tailored for individual patient needs so it can be successfully used.

Making Sense of the New CDC Guidelines Here in Florida

There were almost 6,000 new cases of Coronavirus illness in Florida yesterday with the positivity rate of those tested being well above 5%. Fewer and fewer people are showing up for testing or to receive vaccine here in the Sunshine State.

The Center for Disease Control (CDC) has issued new less restrictive activity guidelines last week which suggest outdoor activities in low population densities do not require a mask. This makes great sense and I am in complete agreement. They go further and say small indoor gatherings with vaccinated individuals do not require a mask. This makes great scientific sense as well. What they do not want is thousands of individuals, whose vaccination or immunity status is unknown to be packed into a venue indoors or out without being masked. They additionally don’t recommend large private gatherings indoors of individuals whose immune status is unknown. This makes sense to me as well in Florida where the infectious positivity rate remains greater than 5%.

We know vaccinated individuals have a low probability of catching COVID if exposed. If they are unlucky enough to catch it (about 6,000 breakthrough cases are known in the USA with about 150 million already receiving vaccine) there is an even smaller chance of getting sick enough to require hospitalization or dying. They still are not sure if those infected can transmit it to those unvaccinated or those frail, immunosuppressed and vulnerable.

The Governor of Florida and his Attorney General have sued the CDC, NIH and Federal government demanding that they allow cruise ships to begin sailing again from Florida ports. My daughter and grandchildren depend on cruise industry revenue to pay their mortgage, feed and clothe the family and live. The cruise industry has gone to great expense to vaccinate its crews and restrict passenger access to those who can prove they have been vaccinated or prove they are not COVID Positive. They wanted a “vaccine passport” for passengers.

Florida responds by having its Surgeon General, pediatrician friend and political ally of the Governor with zero public health or infectious disease background declare if you are vaccinated you are not required to wear a mask anywhere anytime. The legislature, composed primarily of members of the Governors party, passes legislation forbidding businesses from barring individuals from their business based on their vaccine status. This comes well after they supported the Governor with legislation forbidding local municipalities from enforcing local ordinances requiring masks.

I want the ships to sail so my son-in-law keeps his job! The last thing we need is for Florida politics to permit a ship to go out to sea and become a center of infection, illness and death because Florida elected officials watered down the sensible guidelines the cruise industry developed to begin sailing again safely.

Florida is a gateway state encouraging visitors from Latin and Central America as well as US tourists. Brazil is embroiled in a COVID surge of infection and death . The poverty in Central America and the islands prevent knowing exactly what their status is. I am more concerned about the disease entering and leaving Florida via visitors and no rules than I am concerned with illegal immigrants bringing it in at the Texas and Arizona borders as the media and certain elements of the U S seem to be.

Vaccines have brought us so close to controlling the Pandemic. Why can’t we mask up and be patient for a few weeks more?

In my office we will continue to follow the CDC guidelines. We will wait to see if the relaxed mask recommendations of the CDC, plus the vaccine program, keep the infection rate down. Florida Surgeon General Scott Rivkes’ no mask for the vaccinated anywhere may be interpreted as no masks anywhere for everyone. It will take three to four weeks for the consequences of these announcements to make an impact. If the number of infected decreases, my physician associate and I will sit down and alter our approach based on the science. Until that time, we will require masks in our office!

I Was Wrong Regarding Athletes Post COVID-19 & Inflammatory Heart Disease

In a January 2021 blog post, I criticized college athletic departments for allowing their athletes who were infected with SARS-CoV-2  to resume training and competing in their sport without taking a cardiac MRI scan first. This was based on an article early in the pandemic from Italy citing the large number of inflammatory heart issues seen in 100 relatively mildly symptomatic COVID patients.  There was unexpected heart inflammation found in over 50% of these older nonathletic individuals.

The Big Ten Intercollegiate Athletic Conference published an article from the University of Wisconsin Department of Athletics a few months later. All their athletes recovering from COVID (182) received a cardiac MRI at the three-week mark and only two students had MRI evidence of myocarditis.  Based on this small study, other institutions decided that a history session, physical exam, electrocardiogram, echocardiogram and laboratory measurement of the athletes’ cardiac muscle troponin levels would be sufficient. Athletes with abnormalities on any of those tests were referred for a cardiac MRI which could cost $1500- $7500 per study.  I was extremely critical of that decision citing the large amount of income these athletes generated for their university and the potential cost in terms of long-term medical care, potential lawsuits and negative publicity from an athlete becoming seriously ill.  

Like most information regarding this pandemic over time, we learn more about the disease and how to diagnose and treat it. The more familiar we become with Sars2 coronavirus the more previous beliefs change.

This week researchers reported in the Journal of the American Medical Association Cardiology that very few elite athletes recovering from COVID-19 develop myocarditis.  They pooled medical data from May 2020 until October 2020 from Major League Baseball, Major League Soccer, the National Hockey League, the National Football League and the Men’s and Women’s National Basketball Association.

789 professional athletes tested positive for SARS-CoV-2 and entered the return to play protocol (RTP). Athletes who tested positive had a cardiac screening 19 days after their positive test without cardiac MRI imaging. From this group, only 30 athletes had abnormal results and were sent for additional screening. Cardiac MRI was performed on 27 of the 30 and inflammatory heart disease was found in 5 of them. This represents 0.6% of the original screened group. Three of the athletes had confirmed myocarditis and two had pericarditis. These athletes were held out of training and competition. The other 25 returned to training and competition.  None of those athletes who returned to competition had a cardiac illness related event as of December 2020.

In my blog I  tried to provide the ultimate safety evaluation and recommendation for athletes. My patients are older – not elite and anxious to resume their grueling workouts with their local personal trainers.  Given the knowledge base at the time I would make the same choice leaning towards safety, but the data proved me wrong. 

As we learn more about this disease previously held beliefs will be disproved. We have learned that hydroxychloroquine does not work in the treatment of the disease even though initial expectations were that it would. We learned that the virus does not last exceptionally long on surfaces but in the beginning a published article about the cleansing process on the cruise ship Yokahama Princess showed the virus survived 17 days on the ship’s surfaces. We learned that convalescent plasma does not save lives in severely ill patients. This is what happens in the field of science. The CDC and Dr Fauci do not flip flop and are not wrong. As information becomes available, they review the data and try and explain it to the rest of us. As the data changes over time, and the picture changes over time, they adjust their recommendations to be consistent with the facts. They tend to err on the side of caution and safety, as will I, as we move through this tragic pandemic.

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.

Caffeine Before Exercise Helps You Burn Fat

Researchers at the University of Granada have published a research article in the Journal of the International Society of Sports Nutrition showing that drinking a caffeinated beverage 30-minutes before exercising in the afternoon is the best way to burn fat. Morning exercise with caffeine, or without, was less productive at burning fat than afternoon exercise. Fifteen men, with an average age 32, each completed an aerobic exercise test four times with seven days in between testing. On the days tested, they were given either a caffeine dose equivalent to a strong cup of coffee or a placebo. They then rested for 30-minutes and then completed the aerobic exercise. Their meals were standardized on test days. Researchers measured the participants for fat oxidation, maximum oxygen uptake and exercise intensity.

Caffeine increased fat oxidation by 10.7 % in the morning and 29% in the afternoon. Caffeine increased exercise intensity by 11% in the morning and 13% in the afternoon. Maximum oxygen uptake was higher in the afternoon.

Recent literature has shown the benefit of tea in lowering systolic blood pressure. I think I might try a stiff cup of tea 30-minutes before my after-work exercise regimens. Come to think of it, Ii will try some coffee prior to my weekend morning workouts as well.

The Pandemic, Snail Mail & Credit Reporting

Not a day goes by that I do not receive an unsolicited email offer to run my credit report for free.  It never occurred to me that while the pandemic was raging, and millions of people were out of work without a true source of income, business as usual was occurring at the three major credit reporting firms.   I have been extremely fortunate in that my wife and I have been able to pay our bills on time.

The only negative issues we have run into is the dreadfully slow journey first-class mail takes today.  Bills and invoices for services rendered arrive late routinely if they arrive at all. I mail my payments when I receive a bill or invoice well in advance of the due dates.  Sometimes they arrive. Sometimes they disappear off the face of the earth. They all have my return address on them, but none have been returned. I mail them from the local post office these days putting on a mask and gloves and dropping them in the stamped mail slot inside the post office. 

Last month I ran out of first-class stamps, so I went to the nearby Post Office on Banyan Road and bought stamps directly from a postal employee inside because the automated machine was out of order. I stamped my three envelopes and handed them back to the postal worker behind the counter.  Those were payments to FPL, Florida Public Utilities (gas company) and to my homeowner’s insurer Tower Hill.  Those payments never arrived. Those checks never cleared.  USPS is so slow that several companies I purchase from refer to US mail as “snail mail.”

My children tell me to “… pay your bills online by setting up an automatic deduction from your bank account”.  This comes a few days after another major cyberattack and hack – this time to Facebook.  I used the email address and app Facebook provided to see if my credentials were part of the stolen data and yes, they were.  I subscribe to LifeLock for help in protecting my identity, so I know my data flows on the “Dark Web”. Last month someone tried to use that stolen data to obtain unemployment insurance in the state of Illinois.  I squashed that quickly.

Credit scores are used today to evaluate job applicants. They are used to determine if you qualify for all forms of insurance, and how much you need to pay, including life insurance, auto insurance, homeowner’s insurance and possibly health insurance.  I can see checking a credit report if you are trying to buy something and are trying to obtain financing or a loan to pay for it. Even in that arena, this summer I leased a car from Acura.  I have leased a car from Acura using their finance company for twenty-five years now.  Did they need to run a credit report to determine if I pay my auto lease?

I think there should be a moratorium on credit reporting just like there is a moratorium on home evictions.  It should start in May 2021 and run until at least April 15, 2022.  Millions of people will be trying to get back on their feet as the vaccines take hold and people return to the workforce. They deserve a chance to rebuild their lives and their credit rating without the discrimination against them caused by the pandemic’s effects on the economy.

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.