Heart Failure

Gimmee a Pill!

 pill

When I was a child I had four great-grandparents.  Two were from Russia and two were from Poland.  My grandparents were actually born in the United States.  My last great-grandparent died at the age of 96 when I was 31 and in training after medical school.  She was someone I knew as a full person and not just as a grandparent.  Interestingly enough she actually came to the United States not once but twice.  She returned to Russia because she did not like the conditions in New York City when my maternal grandmother was five years old.  She quickly returned to the United States when she got back to Russia.

 

My great grandmother suffered from congestive heart failure and loved to eat anything salty.  Pickles, lox you name it she ate it and then she would call me up and complain she was short of breath.  She wanted no part of diet restriction and all she would say was “Gimmee a pill”.  Then she would infer that I wasn’t as smart as I should have been because I didn’t have a pill to solve her problem.

 

We as a population have become much like my great grandmother.  Maybe she was on to something.  The area of life which comes to mind the fastest is that of weight loss.  No one wants to hear or deal with the knowledge base we have.  Eat less, actually a great deal less, and get some exercise, actually a great deal of exercise, and guess what?  You will lose weight and keep it off.  Whoa that’s just not going to cut it. “Gimmee a pill” screams America and what America wants is big Pharma to continue to serve up.

 

What is a significant weight loss induced by pills?  Give up?  One would hope it would be 20-30 pounds, or in the case of gastric bypass or the Biggest Loser TV show, at least an entire person worth.  You will find out that’s not the case.

 

Should drugs even be used in what is generally a self induced problem?  Obesity is epidemic in this country, and childhood obesity has become a national disaster that will dwarf all health care spending deficits.  As you will see in my next blog, approving these drugs is not an easy task, and as most people will remember the diet drug combo known as Phen-Fen was removed from the market only when its serious side effect of heart valve problems became an issue.  This has made it even harder to approve these drugs as the heart problems did not become evident for many years after the drugs were marketed.  What is “reasonably safe” and is this a problem for which there is a “medical solution”?

 

I will discuss these issues in my next blog.  Until then I’m going for ice cream.

 

 

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No “right” answers

When it comes to prescribing drugs, doctors must weigh the risk of giving any drug versus the benefits of those drugs.  Common drugs that we use today have significant and at times fatal reactions. 

Guess the drugs that correspond to the following side effects:

Side effects: Anaphylactic shock and death. Drug: Penicillin. 

Side effects: fatal bleeding, anaphylactic shock and asthma with severe respiratory distress.  Drug: Aspirin.

Side effect: respiratory depression with cessation of breathing. Drug: morphine. 

I could go on and on.

This is the practice of medicine.  You have a disease and need a treatment.  Doctors try and find a treatment which is not worse than the disease.  The drugs reported on in this study were being used in the disease of congestive heart failure.  Congestive heart failure, when it is Class 3 or 4, has almost 100% mortality at five years.  This class of drugs when used in this disease state significantly increases your chance of living and improving your quality of life.  Is it worth it to take the drug?

It is true that the same benefit is received when you take angiotensin converting inhibitors but many patients have side effects from those drugs.  The angiotensin converting enzyme blockers are better tolerated.  They are also much more expensive and many patients are given angiotensin converting enzyme inhibitors first and then when they are not tolerated switched over.

What this study really does is to provide a starting point for further evaluation.  There is a wealth of data that the FDA has and these studies are meant to serve as a means of impelling them to review their data or providing it to people who will.

In the next weeks the public will hear about the diabetic drug Avandia which has been in the news over the past year.  It is very possible that this drug which already carries a “black box” warning, which is the highest level of warning the FDA has, maybe removed from the market.  We will have to wait and see.

In the meantime, if you are taking these drugs continue them and discuss this with your doctor.  If you really don’t want to get lung cancer don’t smoke.  In London, the cigarette packages say smoking kills in large print.  Better than our warnings.

One year and continuing

heart-xrayIt has been one year and 104 blogs since I started this dialogue with you and I hope you are enjoying it.  I have learned a great deal and I look forward to continuing it this year.

I would like to thank the people behind the scenes Christine Moncrieffe and Lidia Amoretti who edit and post them for me and allow the administrative functions of the blog to work.

If there are topics you would like to me to blog on please send them on.  I appreciate the support and the growth of our readers.

And now for year Two…  Not a good week for cardiology.  Congress adjourned without changing the payment cuts, so on June 1st every physician got a 20% pay cut.  This is on top of the 41% pay cut that cardiologists received January 1st for ancillary testing i.e. stress tests and echoes.

Further, two studies were published recently stating that overtime work leads to heart attacks.  Since I have no overtime I have to work until I finish I guess it doesn’t apply to me.  Honestly, it doesn’t apply to me since I have never for one day considered what I do work.  Also, this week brought news that cardiology is responsible for much of this health care crisis anyway.  Let me explain.

At the recent American Heart Association meeting in Washington, DC that I have blogged about recently a study was presented regarding the “Increasing use of cardiovascular devices and rising health care costs.”  This study presented by Dr. Peter Groeneveld of the VA Medical Center Philadelphia found that stents and ICDs, implantable cardioverter defibrillators,  represented 29% of the total increase in the cost of taking care of those two patient populations.

The study found that from 2003 to 2006 the cost of caring for coronary artery disease increased from $13,558 to $14,215.  For every 1% increase in drug-eluting stents, the cost increase was $394.  On the heart failure side, the costs rose from $18,930 to $20,235.  For every 1% increase in ICD implants an extra $627 was added to the bill.  During the years 2003 and 2006 Medicare spent $4.97 billion on drug eluting stents.  This accounted for 89% of the total costs for coronary artery patients. On the heart failure side The ICD cost was $893 million or 29% of the total cost.

That is a considerable amount of money but not a complete analysis in that it is not matched by outcome data.  These are the types of discussions that were not heard during the recent health care legislation discussion.  We are going to have to make choices as we cannot afford this type of expense indefinitely.  I have no answers but I know that the answers can not be imposed from above.  We are all going to need to become active in the debate before it is to late.

One Pill Cures All

pillIt has long been a goal of doctors, not drug companies, to make a pill that combines multiple medications that can be taken once a day.  When I was in school, we named it “Wonderall.”   This concept vastly increases compliance and it is hoped would prevent “events.”

The drugs in these pills are generic drugs that we have been used for years and are proven to do the jobs they are supposed to.  The drawback is the doses chosen may not be enough for a particular patient.  In medicine, one size generally does not fit all.

It is very easy for a patient to have to take more than 10 different medications several times a day.  If you have heart disease, diabetes, lung problems, the list gets long indeed.  Besides, the cost is just not practical and leads to many problems.

These pills contain 75 mg of aspirin, 40 mg simvastatin, 50 mg of atenolol and 10 mg of lisinopril.  There has been some discussion about removing the aspirin because of the recent difficulties that I have blogged about.  If you survived a stroke, you get a pill with 12.5 mg hydrochlorothiazide instead of the atenolol.

The study to take place in Great Britain, Ireland and the Netherlands and is known as UMPIRE or Use of a Multidrug Pill in Reducing Cardiovascular Events and will enroll 2000 subjects.  To be enrolled they have had to have sustained a stroke, myocardial infarction or be at high risk. The primary end point is compliance but events will be monitored.

Another study which is starting is known as TIPS 2, which uses a pill containing 25 mg hydrochlorothiazide, 100 mg atenolol, 10mg ramipril, 40mg simvastatin and 200mg aspirin.  This study will enroll 500 subjects and will be presented at the American College of Cardiology meeting in 2011.

Sadly none of these studies will take place in the United States.  What’s up with that?  Are we afraid of making it too easy for our patients?  It’s really a disgrace, if you ask me.  We should be at the forefront of this work to give possibly better, certainly easier care to our patients.  Are we as physicians so enamored with 20 medications on a patient's list?  Do we get a prize for the most medications prescribed?  Can we get with the program?

More On Calcium Scores

My last blog concerned the use of calcium scores to determine whether a patient did or did not have coronary artery disease.  An article has been published that I would like to share with you because it compares the Framingham risk calculator and the use of calcium scoring to determine which is better in defining patient illness.

This article titled “The detection of any coronary calcium outperforms Framingham risk score as a first step in screening for coronary atherosclerosis” was published in the Am J Roentgenol 2010: 194:1235-1243.  The study details that 1416 men and 707 women were included.  The mean age of the men equaled 51.4 years, and the mean age of the women equaled 56.9 years.

In those patients who had a presence of a segment plague score of 4 or higher, any calcium was 98% sensitive in men and 97% sensitive in women.  In the same population if you had a Framingham risk score of 10% or higher, it correlated with the findings only 74% of the time in men and 36% of the time in women.

If your plague segment score was 3 or higher, the presence of calcium was 97% sensitive in men and 92% sensitive in women.  In contrast, the Framingham score of 10% or greater was found in 88% of men and 35% in women.

This is not really surprising as I explained before that the presence of any calcium infers that the patient has the illness and needs to be treated.  It does not mean that they have symptomatic disease but the data can be used to propel the patient to “make the right decision” and stop smoking, control their blood pressure and take statins.  In much the same way the Framingham calculator does that because you input the blood pressure, the smoking status and the LDL level as some of the information to achieve a score.  By “manipulating” the data, one can point out that lowering numbers or stopping smoking reduces risk considerably.

Why the disparity in women and men scores is so great, I do not know.  It is widely understood that the diagnosis of coronary disease in women lags behind men, although equal numbers of men and women die each year.  Perhaps women should have scoring and men the Framingham test and then the numbers would be more reflective of need. 

Technology may help us lead the way to better patient care in both men and women.

Correcting Urban Legends in Medicine

Urban legends are situations or things that are thought to exist but don’t.  Their power is such that they can lead to excessive attempts to change behavior that didn’t need to be done in the first place. 

Urban legends in medicine lead to an overuse of resources and an enormous increase in the overall cost of medical care in spite of contrary evidence.  I don’t claim to know how to stamp it out.  Education is one way, but people and physicians are incredibly resistant to it.

One such “Urban Medical Legend” is preoperative cardiac risk evaluation.  The legend holds that it is possible to identify and then rectify the condition of patients who are at risk for cardiovascular incident and death before they have an operation.  This is the so called cardiac clearance for surgery.  It comes in two flavors the “emergency clearance” and the classical “elective clearance.”

Although there are Guidelines published by The American College of Cardiology in conjunction with The American Heart Association, neither are closely followed by most practitioners.  The guidelines suggest that patients who have no evidence of angina or congestive heart failure are at no adverse risk for any surgery.  In the process of screening for “problems” patients are generally subjected to nuclear stress tests and these tests identify those lesions that are “significant.”  However, significant lesions cause angina and not myocardial infarctions and many myocardial infarctions are from lesions that are not considered significant.

 The most important study done on this was a study that identified these patients and then randomized them to medical therapy and “corrective” therapy, either angioplasty or coronary artery bypass surgery.  This study revealed that the “corrected group” had a statistically significant worse outcome than the medically treated group because of the incidents that occurred during the correction.  This included the data for the surgery that they then went for after they were cleared.

The medical therapy most often applied is the use of preoperative beta blockers.  These are drugs like Toprol and atenolol which control heart rate and blood pressure.  This too has been called into question in that the routine use of these drugs can have important consequences for patients.

There is no perfect answer but what we presently do is unjustified by the data.  The use of selective functional testing and the selective correction and treatment is evidence based but not necessarily the current standard of practice.  This arises from legal concerns, compensation from testing and procedures and possibly from surgeons.

We as physicians need to do better.  This is one area that we can make a difference in the quality and cost of health care.  Beware of clearance that requires testing that you would not have gotten without the pending surgery.

Many Changes Bring the Hope of Better Care for Heart Failure

In my last blog, I discussed our abysmal record in treating heart failure.  A great deal of effort is being directed to this health care challenge as it represents a great economic opportunity.  The opportunity is on both sides of the equation with biomedical and drug companies on one side, hospitals and provider organizations on the other.

Medicare is relaxing some of the antitrust and Stark rules that govern the interaction between hospitals and doctors to allow for pilot projects that allow the division of money that is saved between participants.  This topic alone is the subject of many very large books and I can not do it justice. 

In brief, the projects allow for the joining of divergent groups to participate in clinical practice that is accountable for outcomes.  In other words, you just can’t save money by denying care; you have to save money by doing it better.  This process will allow for innovation to flourish, and let’s face it, innovation does better if there is reward at the end of it.  All sides will be winners the hospitals will not lose as much money, practitioners will be compensated and patients won’t end up in the endless and damaging spiral of repeated admissions and hopefully will achieve a better quality of life.

Some of the biomedical companies have provided unique tools for our use and are now in the approval phase of them.  The approval of these devices is interesting in itself.  Since the devices do what they say they do i.e. measure something and that is not at issue the FDA requires that the “measuring” has some clinical benefit.  To that end studies have been set up to determine whether by measuring “something” patients can obtain better treatment, have a better quality of life, and stay out of the hospital.

Now we as practitioners use a patient’s daily weight as a measure of whether a patient is stable in their condition.  The increase in a patient’s weight signals a worsening of their condition and the need for intervention.  That seemed pretty reasonable until it was shown that the weight gain comes 10-14 days after the worsening of the condition begins, so not only is it delayed but almost to late when it arrives.

In my next series of blogs I will detail the innovation that the medical industry is bringing to the problem.

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Health Care Reform and the Treatment of Heart Disease

There have been endless hours of discussion regarding “Health Care Reform.”  I once heard that you didn’t want to see sausage being made, but it sure tasted good.  That certainly holds true for our process in Washington.  Unfortunately, what the Congress and Senate are arguing about is not “Health Care Reform” but insurance reform and how we pay for our medical care, which as it is often pointed out, is very technical and expensive but it often doesn’t accomplish much.

Recently this phenomenon was again pointed out to me in an unsettling way.  An article was published in Circulation: Heart Failure on November 10, 2009, detailing our United States failure in the treatment of heart failure.

This article detailed the startling fact that 25% of heart failure patients discharged were back in the hospital within 30 days.  This was not occurring in isolated areas but was the figure across Medicare.  Since Medicare recipients have insurance and drugs as well as ancillary care, the figure for non Medicare patients is likely higher.

Further, this readmission rate figure is consistent from year to year.  It occurred in each of the years from 2004 to 2006.  So not only are we doing a poor job; but we don’t even know how to fix it.  This was documented by the statistic that half of the hospitals in the United States had risk standardized readmission rates within 1.5% of one another indicating that none of them had a better idea.

Part of the problem is that our present system rewards poor performance and stagnation.  I do not mean that doctors don’t try to make a patient truly better from their chronic condition but if they “fail” and the patient is readmitted, they get paid again.  If you had a car which didn’t work, how many times would you take it back to the same place to try again?

Although the problem can be identified in a blog, an entire book could be written on this issue.  This is a major issue as it accounts for the major expense to the Medicare system.  People do not realize that the mortality of patients with the diagnosis of congestive heart failure over five years is close to 100%.  As heart disease is the leading cause of death in the United States, the amount of money being spent is truly astounding.

This is a topic I will blog about continuously this year.  The medical system is moving on many fronts to confront and solve this problem and to define systems that work and can be put into place.  Technology is now available to help and I will detail much of this in coming blogs.

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High Levels of a Substance Found in Ventricular Myocardium May Lead to Atrial Fibrillation

I have blogged about atrial fibrillation before and now a study arrives, which sheds new light on perhaps a marker of who might develop atrial fibrillation in the future.  This study reviewed the data of 5,445 patients followed from 10 to 15 years.  The authors used a marker know as BNP.

BNP is a substance found in the ventricular myocardium and since the weight of the left ventricle is so much greater than the right ventricle, it is used as a marker of left ventricular failure.  When patients present to the hospital or office with signs of congestive heart failure, such as shortness of breath on exertion or fluid retention one can measure the level of BNP in their blood.  The higher the level of BNP the more likely the diagnosis of heart failure is.

This substance is also present in acute coronary syndrome, which is a prelude to myocardial infarctions and is also present in myocardial infarctions.  Physicians can measure it and get a sense of how important the attack is based on how high the BNP is.  In practice, BNP is measured as NT-proBNP.

Past studies have used the Framingham Heart Study, which I have blogged about in the past and would actually be the subject of a long book.  Elevated levels of BNP were found to be predictive but only 68 subjects were found.  This study, the Cardiovascular Health Study Circ 2009; 120:1768-1774 utilized 5,445 patients.  There were 1,126 cases of atrial fibrillation.  Among those with the highest levels of BNP, there was a fourfold increase in the risk of atrial fibrillation compared to the lowest levels.

This study found that BNP was the strongest predictor of atrial fibrillation in comparison to other historic variables such as age, sex, medication use, blood pressure, echocardiographic variables, diabetes and heart failure.

Having a marker that may predict atrial fibrillation would allow us to aggressively treat those patients in an attempt to alter the disease course.  I am sure that these studies are in progress or being planned given the expected explosion of these cases as the population continues to age.