Treatment of Gastroesophageal Reflux with Magnet Device

Gastroesophageal reflux disease causes heartburn and regurgitation of food and digestive enzymes. Treatment includes weight loss, wearing loose clothing not binding at the waste, dietary restriction and medications. The main class of medications used have been the protein pump inhibitors (PPI’s) such as Nexium, Protonix, Aciphex and Pepcid. Most recently this class of medications has come under major criticism from researchers believing they may be responsible for increased risk of community acquired pneumonia, malabsorption of nutrients resulting in bone disease and even dementia and cognitive decline. Physicians have been trying to limit the use of these medications but recurrent and persistent symptoms have made that very difficult.

Last month at Digestive Disease Week, a meeting sponsored by the American Association for the Study of Liver Diseases, The American Gastroenterological Association, The American Society of Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract; a paper was presented demonstrating the success of a magnetic band placed with laparoscopic surgery around the lower esophageal sphincter (the juncture of the esophagus and stomach).

Reginald Bell, MD of the SurgOne Foregut Institute in Denver, Colorado along with MedPage reported that at six months post procedure, 92.6% of the patients with the magnetic device LINX, had relief of regurgitant symptoms compared with 8.6 % taking a double dose of PPI’s. Only one surgical complication had occurred and it was corrected. The research was done at 22 different locations enrolling 150 patients with moderate to severe regurgitation despite once-daily use of a PPI treatment.

The improvement numbers are dramatic and if this stands over time will change the way we treat this disease. The publication did not reveal the cost of LINX and we certainly want to observe these patients for more than six months before endorsing a new and promising treatment.

Telemedicine and Acute Stroke Treatment

My community hospital is holding its quarterly physician staff meeting and one of the items on the agenda will be a bylaw change which will permit outside physicians, not credentialed or vetted by our hospital credentials committee, to perform video consults on patients within our hospital. Hospital administration is pushing this bylaw change, and since there has been a quiet coup which has transferred medical staff power from the community’s practicing physicians to the hospital employed and paid physicians, it is a foregone conclusion that it will easily pass.

The bylaw change is being requested because the hospital would like to continue to reap the benefits of being an ischemic stroke comprehensive treatment center and offering the health benefits to the community despite not being able to meet the criteria. If a patient presents to the emergency department within four hours of developing ischemic stroke symptoms they must be offered the administration of a “clot busting “drug Alteplase (t-pa). The patient must not have any bleeding tendencies and no evidence of active bleeding or a mass or tumor on head CT scan and must be examined by a neurologist within 45 minutes of arrival.

The problem is that most community based neurologists with outpatient office practices and hospital staff privileges cannot and will not drop everything they are doing and run to the emergency department to evaluate a new patient each time a stroke protocol patient arrives. When given an ultimatum by the hospital administration, that they must take call and be available within 45 minutes, our community neurologists en masse relinquished their hospital privileges.

The hospital countered by bringing in several research oriented academic neurologists and neurosurgeons to man the beautiful new Neuroscience Institute and provide coverage of the ED for the stroke protocol. Few if any of these physicians were able to develop and maintain a practice within the community and they have since left. The Emergency Department is staffed by employed board certified emergency physicians who are well qualified to diagnose an ischemic stroke and administer t-pa. They refuse to do so citing the liability of a poor outcome as the reason. Despite data indicating the benefits of t-pa administration in these situations, the 6 out of 100 chances of a bleed in the brain plus the 1 in 6 chance of death is enough to deter their participation.

You would think that since the hospital hires these physicians the logical choice would be to fire them and hire a group that will provide the state of the art care in a timely fashion. This has not occurred. You would think that the state legislature would grant the ED physicians sovereign immunity from medical malpractice suits if the patient meets the criteria for the ischemic stroke protocol and the patient is given appropriate informed consent for the procedure but this common sense legislation has not been developed or passed.

The hospital has chosen a different pathway. They are opting to hire neurologists from a university medical center who will provide video consults on ischemic stroke patients from an offsite location. Robots will actually examine the patient and televise the data back to the telemedicine center after an emergency department physician performs a brief initial evaluation. The neurologist off site will then provide the needed neurology consult to proceed with the injection of the clot buster.

I suspect the mechanism will work like this. A patient or family member will call EMS via 911 and be taken to the Emergency Department. A triage nurse will ask all the questions to qualify the patient for the t-pa protocol; a robot will examine the patient and transmit via TV the data to an offsite neurologist while an ER physician does an exam. A CT scan of the head and brain will be performed. If no bleed is discovered or tumor or mass that could bleed, t-pa will be administered by the pharmacy and nursing staff. Further intervention by an interventional radiologist and or neurosurgeon may then occur.

At no point in this protocol does it call for the patient’s primary care doctor or cardiologist or usual neurologist to be called. We will be called once the procedure is complete because neither the ER physician or the neurosurgeon or the interventional radiologist will want to admit the patient to neurology ICU. While our surgical ICU and Medical ICU/CCU are covered 24 hours per day by an outsourced hired intensivist group, the neuro ICU does not have that type of coverage.

I can hear it now, my phone ringing and upon picking it up I hear the voice of a clerk in the Emergency Department, “Hello Dr Reznick, Dr. Whateverhisorhername wishes to speak to you about patient Just Had A Stroke.” I get put on hold for five minutes and then in a flat nasal voice, “Hello Steve your patient came in earlier by EMS with symptoms of an acute ischemic stroke. They met the t-pa ischemic stroke criteria and were treated. Unfortunately, they had a major hemispheric bleed with mass effect and edema and are now unresponsive and intubated on a ventilator. We need you to come in and admit him and care for him.”

I will vote in protest against this bylaw. I will lobby for recruiting neurologists who are hospital based who will actually see the patient and care for them. I will lobby for a new state law to provide sovereign immunity for ED physicians treating ischemic strokes according to the internationally recognized protocol. I will lobby for our medical and surgical residents on site and in the hospital to be permitted to administer t-pa after meeting the appropriate criteria. I will not support out of the area physicians making the final call and leaving our local physicians to deal with their results.

Water versus Diet Drinks for Dieting and Weight Loss

Water and many diet beverages quench your thirst and are listed as providing no energy or calories to your daily intake. With this in mind, researchers at the University of Nottingham in the United Kingdom set up a definitive study to assess the effect of water on weight loss after a meal versus a diet beverage’s effect on weight loss.

Ameneh Madjid, PharmD and associates looked at 81 overweight and obese women with Type II Diabetes Mellitus. Members of the group were either asked to continue drinking diet beverages five times per week after lunch or substitute water for the diet beverages. The researchers found that over a 24 week period, the water group had greater decreases in weight, body mass index, fasting plasma glucose, fasting insulin homeostasis and two hour post-meal glucose readings compared with the diet beverage group.

A similar study published in the American Journal of Clinical Nutrition looking at 89 obese women found that after six months the water group had lost an extra three pounds compared to the diet beverage group.

As a clinician, the idea of putting water into your body as opposed to diet drink chemicals makes great sense. There have been some researchers who felt that diet beverages eliminated calories in soft drinks but that users consumed more dietary food and calories when drinking diet beverages as opposed to water.

I will suggest to my patients that they try water instead of diet beverages but remind them that an occasional diet beverage probably will not hurt their long term goals.

To Floss or Not To Floss? Making Recommendations Without Data

The U.S. Department of Health has announced that there is no data that flossing your gums has any benefit.  This has led to an Associated Press review of the paucity of randomly controlled trials with evidence that flossing is beneficial. The result is a new recommendation that flossing daily is not necessary. We are living in an era where the only justification for research and observational studies seems to be to justify saving money by not teaching patients something or encouraging them not to do something. Cost containment is the key as the US Government tries to lower the percentage of dollars spent on health care as a percentage of the Gross National Product.

Experts at the Cleveland Clinic spurred on by the “Bale and Doneen” philosophy that inflammation in arterial vessels leads to acute heart attacks and strokes have pushed for greater periodontal care and health. Flossing is part of that philosophy. Cleaning in-between your teeth with hand held pics or water pics provides cleaning of the gums and spaces between teeth as well.  There are few or any studies on this subject because the benefit is so obvious that there has been no need to perform them.  Dentists assure me that proper tooth and gum care is essential to your general health and wellbeing.  This is common sense like not crossing a busy street against the light, not drinking alcohol and driving a car or truck or not jumping out of an airplane without a parachute. It’s time for our dental schools to organize and perform these studies but I suggest you keep caring for your gums and teeth while the data is being accumulated.

Pneumococcal Vaccine in Development May Fight All Strains of the Disease

Community acquired pneumonia (CAP) plus other infections attributable to the Pneumococcus bacteria account for 15 million infections per year including pneumonia, meningitis and bronchitis. The organism is the leading cause of death in children less than five years old.  Over the last 30 years pharmaceutical companies have developed Pneumovax 23 which covers 23 unique bacteria that cause CAP in adults and Prevnair 13 which covers 13 pneumococcal bacterial strains.  Twelve of the bacteria in Prevnair 13 are identical to the Pneumovax 23 with only one unique bacterial type included.

A group at the State University of New York at Buffalo led by Blaine Pfeifer, specializing in chemical and bacterial engineering; has developed a new approach to pneumococcal vaccination. Working with computer modeling and animals to this point, they have developed a successful vaccine that attacks pathogenic pneumococcal bacteria while leaving the beneficial and non-pathogenic subtypes alone. The vaccine reads proteins on the surface of the bacterial cells and destroys only those that show aggressive activity. The vaccine has been 100% effective against the 12 most virulent pneumococcal bacterial strains existing in animal studies.    The vaccine is being prepared for human testing in the near future.  The preliminary work was discussed in the medical magazine Medical Economics

Zika Update

Zika is an infectious virus introduced to Florida by individuals who traveled to South and Central America plus the Caribbean Islands and were infected by the bite of an aegypti mosquito or a close relative of that mosquito. They then brought the infection back to the USA. The disease has an incubation period of less than two weeks and generally produces a mild illness that most adults do not even know they have. Fever, aches and pains, a fleeting rash, headache and conjunctivitis are common symptoms. Once infected the disease can be transmitted from human to human by body fluids during sexual activity. It can additionally be transmitted when an infected individual is bitten by a mosquito and then it bites a human being. Fortunately the mosquitoes have a flight range of about 100 yards. It is the mobility of infected human beings causing the geographical spread of the virus more than mosquitoes. The virus infects a male’s semen and can remain infectious for about six months. This has led to the suggestion that infected men use condoms when having sex for six months post infection.

The disease is mild in adults but the body’s response to infection has produced a neurological ascending paralysis known as Guillan Barre Syndrome (GBS) at three times the expected rate of this diseases occurrence.  GBS is painful and can affect our respiratory muscles necessitating the use of mechanical respirators and ICU care for survival. The disease is most dangerous in pregnant women causing permanent brain and developmental damage and death in developing fetuses.

At the current time treatment is supportive. There are lab tests to detect an infection using blood and urine specimens. A vaccine to prevent infection is under development with early success noted in rhesus monkeys. Prevention at this point involves practicing safe sex, avoiding mosquito bites using repellant and appropriate clothing.  The mosquito spreading Zika bites during daylight hours. Spraying to reduce the mosquito population is an ongoing strategy being hampered by poor funding. An experimental project to introduce sterile genetically engineered female mosquitoes is being hampered by lack of funding and citizen concern about potential dangers of releasing mutated mosquitoes.

President Obama asked Congress last spring for 1.9 billion dollars to fight Zika but Congress adjourned without providing any funds. The CDC used other funds to begin the research and fight against Zika but is rapidly running out of funds.

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.