Archive for the ‘Cardiac Health’ Category

Acquired Brain Injuries: Causes and Impact

Tuesday, May 17th, 2011

On the heels of Jason Penn’s blog regarding calling “911″ for signs of a possible stroke, I decided to introduce a variety of acquired brain injuries for further discussion in future blogs since damage to the brain results in some of the most catastrophic injuries possibly sustained by the human body with significant “collateral damage” for all of the friends and family involved in the individual’s life.

What is an “acquired brain injury”?

Wikipedia defines acquired brain injury as damage to the brain occurring after birth but not including neurodegenerative diseases, such as Parkinson’s or Alzheimer’s, that occur later in life.  These injuries can further be divided into traumatic and non-traumatic acquired brain injuries.

Traumatic brain injuries are a result of some kind of trauma to the cranium/brain, but the actual causes can vary significantly. Trauma, in general, is the leading cause of death in the young-adult age group. An obvious example of a significant head trauma is the gunshot wound to the head sustained by Arizona Representative Gabrielle Giffords earlier this year. Other examples are assaults with blows to the head, falls with blows to the head, car or bicycle accidents with head injuries, sports-related head injuries/concussion, childhood playground head injuries, and even damage sustained during brain surgery. The degree of damage and permanent sequellae obviously varies as well, ranging from fully recoverable within a few days to catastrophic permanent deficits and even death. Interestingly, the amount of external damage (or lack thereof) does not necessarily reflect the damage inside the cranial vault.

Non-traumatic acquired brain injuries, on the other hand, have a wide range of etiologies not related to head trauma that have just as wide of a range of catastrophic effects and recovery times. One of these causes is a stroke, as described by Jason Penn; however, strokes can be either ischemic (blockage of blood flow to the brain by, for example, a blood clot) or hemorrhagic (when a blood vessel in the brain ruptures), and each is treated very differently!  Other possible causes are infections, brain tumors, failure of other body organs (liver, kidney), loss of oxygen delivery to the brain (heart attack, blood clot in lungs), other chemical or drug ingestions with toxic effects, aneurysm rupture, and build-up of carbon dioxide in the blood stream from other lung pathology, including smoking!

A Virtual Tour of the Brain

Described as the most complex organ in the human body, the brain has been the subject of numerous educational videos, which attempt to give the layman a better understanding of the parts and functions of the human brain. YouTube has numerous “brain anatomy” videos for you to peruse. Here’s one from the University of Bristol that does a good job of providing the basics of this incredible organ.

httpv://www.youtube.com/watch?v=9UukcdU258A

Effects of Brain Damage

The brain is the body’s 3-pound computer that controls every conscious and unconscious function of the body. Different areas of the brain control different cognitive, behavioral and emotional functions as well as the everyday metabolic functions of the body. Damage to specific areas of the brain result in specific functional losses, which is why someone with a “stroke” might experience numbness and weakness of one side of the body or no weakness but loss of balance or loss of vision. Larger injuries result in more brain tissue damage and more functional deficits. The object of “the game” is to rapidly diagnose the problem and rapidly treat the problem in order to minimize the amount of brain damage, and thus, minimize the functional deficits. Many acquired brain injuries progressively worsen due to different “normal” pathophysiologic mechanisms. It is imperative to intervene sooner whenever possible.

A Personal Story

My uncle had a stroke 1 month ago while working in the yard.  ”911″ was called immediately, and he was transported to the closest hospital.  He apparently had an undiagnosed abnormal heart rhythm (atrial fibrillation) that caused a large blood clot to form in the heart. This clot ultimately got pumped out into the carotid artery and lodged itself at the beginning of the middle cerebral artery on right side of his brain.  He was initially unconscious, but he later “came to”, only to deteriorate into unconsciousness again as the brain swelled from the blocked artery and infarcted brain tissue. He was transferred to another hospital that was capable of performing brain surgery, and he had back-to-back brain surgeries on 4/10 and 4/11 to try to minimize the damage. They actually had to remove a large part of his skull to allow for the brain swelling to occur without the brain’s tissue being compressed against the skull so as to prevent herniation of the brain.

He was in a coma for several days, but he is slowly making some recovery. In the meantime, he needed a tracheostomy and feeding tube in his stomach, both of which he still has. His entire left side remains completely paralyzed. It is difficult for him to stay awake, although he does seem to know who is around at any given time. My aunt, God bless her, has spent the last month at the hospital, 8 hours or more every day, and she is just exhausted. It is unclear when he will be going home or even if he will be going home. We are hoping and praying for the best recovery possible, but the future remains uncertain.

Collateral Damage

In addition to the person affected by acquired brain injury being functionally limited, whether temporarily or permanently, there is often collateral damage to himself/herself as well as to friends and family members. Emotional issues often arise, whether through mood disorders like depression and anxiety, or with actual personality changes. Those affected can become more belligerent or difficult, angry, withdrawn, and a host of other characteristics, making it very difficult on the person caring for the affected individual. The physical demands alone can overwhelm the care-provider (like bathing, toileting, feeding, transporting to appointments, etc.) and lead to care-provider stress and mood disorders.  Financially, these injuries are often devastating. Marriages end; relationships among family members suffer; sometimes, physical abuse and neglect can even occur when frustrations become overwhelming.

There are support groups available many of which can be accessed through local hospitals, associations or your health department.

Locally, you may want to visit the Brain Injury Association of Maryland and the Brain Injury Association of Washington, D.C.

Stay posted for more details on some of these causes of acquired brain injury specifically. In the meantime, do you have a story to tell?

 

Image from neuroskills.com

Follow-up Blog: Important questions and answers on Pradaxa

Monday, January 10th, 2011

Some months ago, we published a blog to announce what we thought was important medical news about a new product called Pradaxa. That blog, entitled A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?, was widely viewed by many readers since October, 2010. Following our posting, a number of those readers have sent us questions about this new drug. To better serve our readers, we have invited Dr. Steven M. Davis to be our guest blogger on Pradaxa, and to answer some of these important questions.

Dr. Davis is the Associate Professor of Pharmacy at the Campbell University College of Pharmacy and Health Sciences in Buies Creek, NC. He is also the Clinical Coordinator for Pharmacy Services at Wake Forest University Baptist Medical Center in Winston Salem, NC. Dr. Davis has a PharmD with a specialty certification in geriatric pharmacology.

Below are the most frequently asked reader questions:

  1. How does Pradaxa differ chemically to Coumadin (Warfarin)?
  2. Do things with high Vitamin K (like spinach, lettuces, and broccoli) interfere with Pradaxa?
  3. If one were to start Pradaxa, how long would it take the blood to thin? If one were already taking Coumadin (Warfarin), what is the recommended method of switching to Pradaxa?
  4. How long would it take to reverse the effects of Pradaxa? I have been told Coumadin (Warfarin) stays in the body and before any surgery a patient has to wait 5 days.
  5. Why doesn’t the blood coagulation need monitoring if Pradaxa thins out the blood? Why wouldn’t the blood protime (PT) need monitoring with Pradaxa?
  6. How would someone adjust Pradaxa to keep the protime (PT) at a desired level?
  7. Are there any restrictions to other medications such as Aspirin?

Dr. Davis’ responses are listed below:

Question 1: Pradaxa (Darbigatran) is a direct thrombin inhibitor.  Thrombin is one of many clotting factors in the body necessary for coagulating blood.  Coumadin (Warfarin) works by a completely different mechanism. Coumadin/Wafarin prevents the activation of 4 clotting factors that depend on Vitamin K .

Question 2: Since Pradaxa works by directly inhibiting the clotting factor thrombin, the amount of vitamin K in the diet does not matter.

Question 3: When switching from Coumadin to Pradaxa, a physician will usually wait for a patient’s INR to drop below 2 before starting Pradaxa.  In most patients taking Pradaxa, blood will be appropriately thinned 2 to 3 days after starting the medication.

Question 4: Pradaxa is still a blood thinner and care must be used before surgery.  Pradaxa has a shorter life in the body (that is why it is dosed twice daily) and it is cleared from the body quicker than Coumadin (Warfarin).  It is recommended that a patient discontinue Pradaxa 1-2 days before surgery if they have normal kidney function and 3-5 days if they have impaired kidney function.  Of course you would NEVER stop this medication without consulting your physician first.

Question 5: Prothrombin time (PT) and INR measure the ability of Coumadin (Warfarin) to prevent the activation of the Vitamin K dependant clotting factors.  Again, since Pradaxa does not affect these factors, the prothrombin time does not change and, therefore, does not need to be monitored.

Question 6: The biggest advantage to Pradaxa is that there are fewer drug interactions, less food/drug interactions (Vit K containing foods), and thus no need to monitor prothrombin time or INR.

Question 7: Combining Pradaxa with aspirin will increase a patient’s risk of bleeding.  Both medications are used together frequently but ONLY under the direction of a physician.

Dr. Davis offers the following advice to patients considering taking or taking the drug Pradaxa.

This is a new medication and as with all new medications, it has not been used in a large population of patients yet.  New side effects and drug interactions may be discovered as this drug is used more frequently.  The Food and Drug Administration (FDA) monitors these reports and will issue statements as necessary.

From Brian Nash: I want to take this opportunity to thank Dr. Steven Davis for providing us with this information for our readers.

To our readers: Please keep in mind that we, at Nash & Associates, are not physicians. While Dr. Davis was so kind to provide the information he did regarding Pradaxa, this is not the usual approach we would take to our blog postings. From time to time we try to make you aware of important and/or interesting medical news. However, if you have questions about Pradaxa, we strongly urge you to speak with your personal physician.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

DARVON AND DARVOCET WITHDRAWN FROM U.S. MARKET – WHAT SHOULD YOU DO IF YOU ARE TAKING THESE MEDICATIONS?

Tuesday, November 23rd, 2010

Last week, the manufacturer of Darvon and Darvocet, Xanodyne Pharmaceuticals, agreed to withdraw these drugs from the market in response to FDA requests.  The FDA has also requested that generic drug manufacturers also stop marketing propoxyphene-based pain killers like Darvon and Darvocet. These drugs were withdrawn from the U.K. market almost six years ago. About a year and a half ago, the European drug agency also placed a ban on propoxyphene-based pain killers. An estimated 10 million Americans are taking propoxyphene-based drugs.

Although propoxyphene was always associated with a number of complications, the FDA’s request was prompted by new studies revealing the drug’s serious cardiovascular side-effects. The FDA was petitioned on a number of occasions to pull propoxyphene off the market. The latest petition came from the public interest group Public Citizen in 2006.  The FDA submitted the petition to an expert advisory committee that voted in favor of withdrawing the medication in 2009 (14 to 12 ).

The FDA did not request that the medication be removed from  the U.S. market in 2009. Instead, it requested that the manufacturer of the drug, Xanodyne Pharmaceuticals, Inc., conduct research to study the effects of the drug on the heart. This new research revealed that people taking propoxyphene (Darvon, Darvocet and  the like) can develop abnormal or fatal heart rhythm.  These findings prompted the FDA to request the withdrawal of the medication. Propoxyphene is also associated with the following cardiovascular complications:

  • Tachycardia
  • Cardiac/respiratory arrest
  • Congestive heart failure
  • Myocardial infarction
  • Hypotension

Some other side effects include:

  • Drug overdose/toxicity
  • Drug dependence/withdrawal
  • Anxiety
  • Nausea
  • Vomiting
  • Drowsiness/ dizziness
  • Hives
  • Difficulty breathing
  • Chest tightness
  • Swelling of the face, mouth, lips or tongue

The Public Citizen group has claimed that about 2000 people in the U.S. have died as a result of propoxyphene in the last six years. The good news for those taking Darvon, Darvocet or a similar drug is that the cardiovascular side effects of these drugs are not cumulative. Therefore,  the risk of developing cardiovascular problems should go away once the drug is stopped.

If you are taking Darvon or Darvocet, DO NOT stop taking the drug until you talk to your doctor. Sudden interruption of the medication can lead to serious withdrawal symptoms.  If you are taking propoxyphene-based medications, contact your doctor immediately so that you may be transitioned to a safer pain killer.

Photo: pharmer.org

High-paying Jobs for Women Cause Women to Pay a Price in Cardiovascular Health

Thursday, November 18th, 2010

High-paying jobs typically equate to high-stress jobs for most individuals, that is, fast-paced jobs with a lot of responsibilities and little creativity.  As women have entered the workforce and fought for equality in all types of employment situations, they have slowly and gradually been successful in most venues; we have yet to see a female President of the USA.  Some jobs are much more creative allowing the expression of individual skills while others require strict adherance to company policy (or parent company policy), little decision-making ability, and productivity-driven payscales.  These latter types of jobs, regardless of the gender of the employee, often lead to job strain, a type of psychologic stress that seems to have potent effects on an individual’s health.

This week, the great city of Chicago (a bustling hub-bub of big corporations and highstress jobs) hosted the American Heart Association’s annual meeting.  Abstract 18520 was presented; it was titled, “Women with High Job Strain Have 40 Percent Increased Risk of Heart Disease.”  The study elaborates on details related to job security and the types of cardiovascular ailments.  This was a landmark study, funded by the National Institutes of Health (NIH), called the Women’s Health Study, and it followed 17, 451 women and their development of cardiovascular disease over a 10-year period.  Previous studies related to stress and cardiovascular disease have focused on men.

Women with high job strain were at a 40% increased risk overall of heart attack, ischemic stroke, coronary artery bypass surgery, balloon angioplasty/stent and even death!  The increased risk of heart attack alone in these women was 88%! The study further delineates that even women in high stress jobs who have significant control over decision-making are also at an increased risk long-term of cardiovascular disease.  Women who suffer job insecurity (fear of losing one’s job) are at risk for particular risk factors that contribute to cardiovascular disease (high blood pressure, high cholesterol, obesity), but no direct correlation to the end-effects of cardiovascular disease could be statistically supported.  This truly supports the notion that psychological stress plays a role in the development of cardiovascular disease.

The National Women’s Health Information Center is a government-sponsored organization that collects information on all types of women’s health topics and offers up-to-date information and advice on the topics.  In the Heart Health and Stroke section, the statistics are numbing; coronary artery disease is the number 1 killer amongst women while stroke is the number 3 killer of women.  In other words, women are 4 to 6 times more likely to die of heart disease than of breast cancer according to the American Academy of Family Physicians (AAFP).

Interestingly, breast cancer has much more awareness and publicity as compared to women and heart disease.  This is surprising since the symptoms of heart attack or angina pectoris in women are often atypical, much like the silent growth of microscopic cancer cells in women’s breasts.  Women, for whatever reason, do not necessarily experience the “crushing chest pain” that most people equate with a heart attack; they might develop generalized fatigue or weakness, lightheadedness, back pain, upper abdominal discomfort or simply a feeling of nervousness or anxiety.

Hmm- try being a highly-stressed 48-year-old female executive telling an ER doctor that you are feeling anxious and a little short of breath; you will be given paper bag for breathing and a Valium pill to take instead of an EKG, aspirin, oxygen and nitroglycerine.  A male would most likely get the second treatment!  Litigation involving this aspect of medicine often involves a failure to diagnose the disease.

Now, let’s get back to this landmark Women’s Health Study.  There is finally a long-term study that reports some very frightening statistics for women.  It is time for women to start advocating for themselves and performing primary interventions such as exercise, healthy weight maintenance, smoking cessation, low-fat/high fiber diets, and routine physical exams.  Both the AAFP website (linked above) and the U.S. Food and Drug Administration website offer tips for reducing women’s risk of heart attack and stroke; they will soon have to incorporate job-related stress as potential risk prevention interventions.  Employers, as well, might need to re-examine work policies and provide stress-relief activities for their employees, especially of they do not want to lose them to premature death and disability.

Another abstract presented at these same American Heart Association Scientific Sessions in Chicago addressed a controversial but nonetheless seemingly stroke-protective intervention.  From men’s and women’s  studies, mild to moderate alcohol consumption on a daily basis is associated with a reduction in risk of heart attack, but women were limited to one alcoholic beverage per day.   Abstract 19870 titled, “Alcohol Consumption and Risk of Stroke in Women,” concluded that women who consumed moderate amounts of alcohol on  a daily basis were not at an increased risk of stroke and may be healthier overall in the long-term.

The women in our office got a good laugh when these studies were placed side-by-side since our conclusion was that the boss should sponsor a happy hour on a weekly basis! All kidding aside, these new data offer both  some chilling reality checks and some hope that more research regarding modern women’s health topics will be on the horizon.  One thing is for sure — there needs to be more awareness, advocacy and primary prevention!

What programs do you have at your workplace for stress reduction?

Photo from the-invisible-gym.com

Editorial Comment (Brian Nash): To all employees (especially the women!), there will not be a firm-sponsored, weekly Happy Hour. Nice try, though.

A New Blood Thinning Drug is Approved – Pradaxa – better than Coumadin?

Friday, October 22nd, 2010

This week’s press release by the US division of the German based Boehringer Ingelheim pharmaceutical company is certainly a breakthrough for patients. The company announced the FDA approval of their drug Pradaxa (dabigatran etexilate). This is the first new oral anticoagulation drug approved in the US in more than 50 years.The drug was approved for stroke and systemic embolism prevention in people who have atrial fibrillation not caused by a failing/defective heart valve.

The press release touts impressive results. National studies have shown when Pradaxa 150mg was taken twice daily, there was a 35% reduction in stroke and embolism when compared with the traditional drug known to most as Coumadin (Warfarin). In addition, at the same dosing level both types of stroke (embolic/clot and hemorrhagic/bleeding) were greatly reduced when compared to Coumadin. More good news for patients taking the drug…

  • Very few drug interactions,
  • No more dietary restrictions, and
  • No more routine blood testing and dosing changes as required when taking Coumadin.

WHAT IS ATRIAL FIBRILLATION AND WHY DO YOU NEED TO TAKE BLOOD THINNING DRUGS?

Atrial fibrillation is a heart rhythm disorder caused by a malfunctioning electrical conduction system within the heart – see video.  It is usually identified by an irregular rapid heart rate that begins in the upper heart.The smaller 2 upper heart chambers, known as the atria, begin to contract quickly and in an irregular fashion. As electrical signals leave the atria and enter the 2 lower heart chambers known as the ventricles, they too begin to contract quickly and in an irregular fashion.  This irregular and rapid heart rate is unable to pump the blood through the heart and out to the body in a strong, efficient manner. Thus blood can pool in the heart and the lower extremities allowing clots to form. These clots dislodge and travel to the heart, lungs, and brain leading to a stroke. Therefore it is important to prevent the clots from forming by correcting the abnormal heart rhythm,  and by lowering the blood’s ability to form dangerous clots.

The press release noted an estimated 2.3 million Americans have atrial fibrillation and the number is expected to increase to 5.6 million by 2050. A large US-based managed care organization used their data to show 95% of all persons with atrial fibrillation have no heart valve problems. Atrial fibrillation increased the risk of stroke 5 times, and is an underlying condition in 15% of all US strokes. Atrial fibrillation related strokes are twice as likely to be fatal or severely disabling when compared to strokes from other causes.

MedicineNet.com today reported recent studies by the New England Journal of Medicine and the American Heart Association found Pradaxa was also more effective in preventing clots in patients experiencing acute coronary syndrome. Sweden reports the drug can be safely used in conjunction with Plavix and Aspirin drug therapies.

WHAT ARE THE DOWNSIDES?

With the good news, comes the drug’s downside. The company is forthcoming in reporting Pradaxa when administered in 150mg doses results in a higher rate of gastrointestinal bleeding related complications when compared to Coumadin. This dose was reported to also cause an increase in adverse GI reactions such as dyspepsia, abdominal and gastric pain, GERD, esophagitis, gastritis, and ulcer. Importantly, in patients older than 75 years of age, the risk of bleeding complications may be greater than Coumadin. Also noteworthy is the finding that the risk of myocardial infarction was greater in studies with patients taking the 150mg dose than those taking Coumadin.

The company warns patients taking other blood thinners, non-steroidal anti-inflammatory medicines, St. John’s Wort, and any drug that can cause abnormal bleeding reactions need to be avoided. Over the counter medications are included in this warning. The company’s public package leaflet notes the drug will interact with Amiodarone and Verapamil and Pradaxa dosing will need to be reduced. The drug may also affect the liver but not more then Coumadin. It is contraindicated in patients who are in kidney failure, liver failure, and pregnancy. Some report a Quinidine interaction.

The FDA has approved dosing in capsule forms of 75mg and 150mg twice a day. Those persons taking larger doses of 150mg need to be fully informed of the above possible complications before switching from Coumadin to an easier life with Pradaxa.

EASIER TO LIVE WITH, BUT WHAT WILL IT COST?

It will take 3 to 6 months before distribution begins and pricing is not known. As with any new drug introduced in the US, speculation is the cost will be just short of prohibitive. Canada Pharmacies online sell Pradaxa 60 capsules both 75mg and 150mg doses at approximately $350.00 each. Generic Coumadin 100 pills at variable doses sell for approximately $34.00 to $50.00. The high drug price for US patients may offset the life style improvements for many who pay out of pocket for drugs. It is not known if prescription drug plans will approve partial or full payment for the drug.

It is generally reported that Coumadin is not a popular drug. Consumers and physicians alike resound with the same low opinion of the drug.  It is a difficult drug for physicians to manage, and it has a great impact on quality of life for patients. If Pradaxa continues to show its improved lifestyle value with no hidden serious side effects, patients will be the winners. Hopefully over time competitors will surface and prices will be driven into an affordable range for the growing US atrial fibrillation patient population.

UPDATE: Interesting piece by Dr. Wes on Pradaxa just posted today. Thought you may want to read. The comments have been coming in fast and furious on this new “wonder drug.”  Here’s the post by Dr. Wes – Pradaxa, Your Days are Numbered

Related Post:

Follow-Up Blog: Important Questions and Answers on Pradaxa

To breathe or not to breath: Lancet study show chest compressions may be as good as CPR.

Friday, October 15th, 2010

Physician’s First Watch published a summary of an online posting by The Lancet this morning regarding a meta-analysis of outcomes for chest-compression-only versus standard cardiopulmonary resuscitation. This analysis related solely to “out-of-hospital” cardiac arrests.

The author of Physician’s First Watch gives the following summary of the Lancet study:

Researchers combined data from three randomized trials of dispatcher-assisted CPR for adults with out-of-hospital cardiac arrest and found that survival was significantly higher with chest compressions alone than with compressions plus rescue breathing (14% vs. 12%). Analysis of data from seven observational studies, however, found no difference between the methods (these studies did not examine dispatcher-assisted CPR).

The authors conclude: “Emergency medical services dispatch should instruct bystanders to focus on chest-compression–only CPR in adults with out-of hospital cardiac arrest. However, whether chest-compression–only CPR should be recommended for unassisted lay bystander CPR is unclear.”

The readers of our blog, Eye Opener, may recall that we recently did two pieces on automated external defibrillators (AED’s) – one relating to 24,000 defective AED’s, which were the subject of an FDA MedWatch Safety Alert, and the other premised on a reader’s comment to the first posting. It would be most interesting if there was data regarding the effectiveness of these devices versus either chest-compression-only and CPR interventions.

I’m not sure what the intent of The Lancet piece is other than what is listed in its “interpretation” summary:

For adults with out-of-hospital cardiac arrest, instructions to bystanders from emergency medical services dispatch should focus on chest-compression-only CPR.

I just hope that, if I ever find myself in a position of having to attend to someone who has suffered an out-of-hospital cardiac arrest, there is an EMS or someone with ACLS certification standing in the crowd.

Stent Wars – The Decade Begins

Tuesday, June 22nd, 2010

On June 10th, we did the first in a series of articles regarding the basic medical issues involved in the St. Joseph Medical Center/Dr. Mark Midei stent scandal. This second installment begins in the year 2000 – a period in time the cardiology industry calls the STENT WARS.

The early part of this decade was a period when interventional cardiologists, such as Dr. Midei, were aggressively seeking to demonstrate a short and long term successful alternative to open cardiac bypass surgery for patients. While there is no doubt that these specialists were seeking better approaches for their patients by avoiding, if possible, open heart bypass surgery, it is also evident that these endovascular procedures were quite lucrative for interventional cardiologists as well.  It was reported that drug eluting stents generated a world market revenue of $5 billion annually in the early 2000′s.  In 2001, more then 500,000 procedures involving stents and balloon angioplasty were being performed in the United States annually. The “war” for market position was on. Who would win top position among manufacturers and grab this pot of gold?

The STENT WARS were also being fought around the globe and included familiar company names: Cordis, Boston Scientific, Medtronic, Abbott, Conor MedSystems, OrbusNeich, Biosensors, and Xtent.  Mergers, acquisitions, partnerships abounded.  As you can imagine, clinical trials were also proliferating throughout the medical world. Investment money was flowing. Interventional cardiologists invested in their own technology and made money on both the procedures and their investments. During this period of enormous expansion, Dr. Midei became co-founder of a large cardiology practice in the Baltimore metropolitan region. In the latter part of 2007, he was recruited away from his group practice and hired by St. Joseph Medical Center as its Director of Interventional Cardiology (Cardiac Catheterization).

So what was stent research showing?  What was the science that gave Dr. Midei an open door to placing numerous unnecessary stents at the cost of $10,000 – $15,000 a stent.

Early clinical trials were positive for the industry.  Data revealed drug-eluting stents (DES) reduced re-stenosis (i.e. re-narrowing of the cardiac blood vessel) from 20-30% to single digits and continued to show better outcomes than bare metal stents (BMS) and balloon angioplasty.  These favorable results led to the official FDA approval of two drug-eluting stents in 2003 and 2004 for use in the USA although clinical trials had been underway in major cardiac centers for several years. The stent type, coating of the stent with a particular drug, and key decisions made by the interventional cardiologist during stent placement were reportedly all factors necessary for favorable outcomes.  Using coronary angiography, the interventional cardiologist determined the proper stent length and diameter needed to repair a blocked artery and was able to ensure proper stent placement within the artery.  There was  enough new scientific research data for the American College of Cardiology and the American Heart Associated to update and publish clinical practice guidelines  for both hospitals and cardiologists in 2001.

Landmark studies during this time were also revealing more new information about progressive heart disease.  Research studies demonstrated coronary artery atherosclerosis usually affected more then one vessel and was, therefore, often a diffuse disease.

While these results led to the positive development of conjunctive drug therapies, they also opened the door for exploitation.

An interventional cardiologist, seeking to line his/her own pockets and/or gain a position of power within an organization for whom he/she worked could place many stents in multiple coronary vessels regardless of size or complexity. In other words, stents could be placed in symptomatic large blockages, and stents could also be placed in those small areas that MIGHT, in the so-called clinical judgment of the operator, develop into a blockage. Clinical practice guidelines were silent as to what should be done to lesser size lesions.  In the absence of data, the cardiologist could choose to be aggressive or conservative.  However, clearly an avenue for financial abuse and gain was opened for some interventional cardiologists to push acceptable judgment boundaries.

You might ask: weren’t there provisions and systems in hospitals to prevent such exploitation if it were to occur.  Unfortunately, nether the ACC nor AHA 2001 clinical practice guidelines contained any recommendations for peer review or oversight of this burgeoning stent industry. It was left to hospitals to establish their own monitoring guidelines to oversee the conduct of their physicians.

Join our next blog to learn more about the introduction of peer review guidelines that were finally published four years later in 2005.

Investigation into unnecessary stent procedures broadens in scope.

Sunday, June 6th, 2010

Stent Fraud Investigation

As I notified our Facebook followers earlier today, the Baltimore Sun published an exclusive lead article on a broadening ‘stent investigation.’ What started out as a scandal involving one cardiologist (Dr. Mark Midei) at one

hospital (St. Joseph Medical Center), now has the potential to encompass the activities of other interventional cardiologists at other area hospitals.

I have been reporting on this since early in the St. Joseph investigation. Keep in mind, I have also advised our readers that our firm is now part of the class action litigation team with the Murphy firm and by extension the Angelos law firm. While I can not share with you any details of what our investigation has revealed to date, I will keep you informed of developments in our ongoing investigation and those being conducted by the news media and Maryland agencies as they progress and become public.

What is at the center of today’s report in the Baltimore Sun is the investigation by Maryland health officials.

Several cardiologists in the state have performed a suspiciously high number of the same invasive cardiac stent procedures that Dr. Mark G. Midei is accused of over-performing at St. Joseph Medical Center, according to an analysis of data from the state’s Health Services Cost Review Commission.

Investigators plan to review the work of the other cardiologists — who were not identified to The Baltimore Sun — going back five years. Sources also said they expect the investigation to eventually expand to include inquiries into other medical specialties and procedures.

Without revealing any confidential information, suffice it to say that based on our investigations to date, this news comes as no surprise. Keep in mind also that when St. Joseph conducted its own internal review and issued letters to 585 patients advising them that their stents were not medically indicated, this was based on an investigation for less than a two year period of time while Dr. Midei was a full-time employee of St. Joseph Medical Center. Dr. Midei took on this position with the hospital in January 2008. He was previously an employee of MidAtlantic Cardiovascular Associates. One might wonder if Dr. Midei’s performance of unnecessary stent procedures was isolated to his new position at St. Joseph.

For the present, let me leave you with some food for thought. These stent procedures costs usually in excess of $10,000 per procedure. As the Sun reports, in the last fiscal year alone, stent procedures brought in $220,000,000 to Maryland hospitals alone. Just how many people needed stents in one year in one state?

There were supposed to be review systems in place in-hospital and at the state agency level to guard against any fraud in the performance of unnecessary  procedures for monetary gain. How well do you think those systems worked? Hospitals have what is known as peer review committees to monitor the conduct of doctors, patient care, outcomes and the like. How did Dr. Midei’s conduct escape detection? As the Sun points out in its “St. Joseph timeline”:

May 2010: State regulatory documents indicate that Midei was able to avoid St. Joseph’s peer review process because, as a department head, he chose which cases would be reviewed. (emphasis all mine!)

Well that makes sense – sort of. We’ll see just how much attention was being paid to Dr. Midei’s (and perhaps others’) conduct by the hospital itself as the dollars came flowing in. Is this somewhat like putting the fox in charge of the hen house? We’ll just have to see. Discovery in our class action lawsuit is just starting. Stay tuned!

If you have any questions or need additional information, please contact: Lisa Bennett, 410-951-8811 or 410-940-8590
Lisa.Bennett@murphypa.com

Cardiac Health: Implantable Cardiac Devices – number of procedures on the rise, but is the technology really there to handle this boom?

Wednesday, May 26th, 2010

It is reported that an estimated 650,000 people in the United States currently have implanted cardiac devices (ICD’s) designed for defibrillation (cardiac electro-shock therapy) or combination defibrillation and heart pacing.  For you  Baby Boomers rounding (or having passed) the 60’s bend, these numbers are expected to grow exponentially.  Cardiovascular Business posted an article on April 20 advising that hospital admissions for implantation of ICD’s increased ten-fold from 1990 to 2005.

This same article was quite alarming in its lack of scientific data on factors that determine the best results.  While it may be comforting to know that several large patient-studies have recently shown that centers performing the greatest numbers of procedures have the lowest rates of procedural complications, it is important to also note that authorities in this area of medicine warn that more data and study are needed on individual operator volume, specialty identification, training, performance and outcomes.

Cardiovascular Business News released a feature on April 20, 2010, citing an article published in 2009 by the Journal of the American Medical Association.  The data suggest that your odds of having procedural complications were greater if the device was implanted by a non-electrophysiologist. In short, does this mean you have better odds with an electrophysiology cardiologist? What about a general cardiologist? Or a thoracic surgeon? The study data apparently did not adjust for underlying health conditions or patients who are more ill. Why not? Are we to assume the latter groups of patients may have merely been more prone to complications? Or do the non-electrophysiologists just have less experience and training in implanting ICD devices? As of this time, Boomers, the medical profession has not published answers to these questions.

Perhaps we should be encouraged that Medicare is requiring implant and performance outcome data. As of June 2009, the agency had collected information on more then 380,000 implants.  Yet almost a year later, with many more procedures entered into that same database, the medical specialty communities are still unable to let us know which are the safest specialists and hospitals performing ICD implant procedures.  Physicians say longer term outcomes are needed.

In the meantime, are Medicare and other payors paying for all procedures regardless of the quality of practitioner or hospital performance?

More alarming, on May 17, 2010, Dr. Westby G. Fisher, a cardiologist at North Shore University Hospital Health System wrote in medcitynews.com that the medical system currently can no longer sustain the volume to maintain the implanted devices safely. He complains that physicians are unable to re-program ICD devices remotely.  Is this true? Due to the growing volume of implanted devices now occurring, technicians with no medical degree are programing patient devices from remote locations with sometimes no documentation or notification to the patient’s physician. Physicians are supposed to be overseeing the process according to Dr. Foster. However, he is of the opinion that due to the high maintenance these devices require, along with the growing number of patients, managing the technology will be of great concern to the boomer population and their physicians.  Once again, how are the pressing issues of quality, safety, and cost going to be timely addressed in this burgeoning aspect of our healthcare?

Finally, perhaps we can be comforted by the recent news release from the Heart Rhythm Society. Apparently, the medical profession had never previously determined parameters on how and when to stop these devices at the end of one’s life.  The study cited a dying patient whose defibrillator went-off  greater than 12 times, causing the patient needless suffering. Several groups of medical societies have now have published a consensus statement outlining ethical and legal issues, a decision-making algorithm for withdrawing/deactivating the device(s), and rights/responsibilities for those physicians who have ethical conflicts. The Heart Rhythm Society is encouraging and educating physicians and patients on what needs to happen in this algorithm for ending ICD-sustained life.

One can only hope that a physician is not placed into a remote call-waiting voicetree for dying boomers when the time comes to deactivate. It’s bad enough that we don’t yet know how to choose the best physician and/or hospital to have these devices implanted. Now there is growing concern that simple but critical issues of maintenance, remote re-programming and the like will get out-of-hand due to the ever increasing volume of these devices being implanted.

Contributor: Sharon M. Stabile