Heart Failure

New drugs new problems

I have blogged about atrial fibrillation and the need for anticoagulation in the past.  Some blogs have gone over the history of Coumadin, and more recently, the development and approval of Pradaxa.  Also, there have been blogs about some of the more novel issues' with Pradaxa.

Perhaps the most novel element about Pradaxa is the fact that you can not reverse the effect of the drug.  If you have a bleeding issue on the drug, you have to allow it to wear off and support the problem.  Pradaxa, unlike warfarin or heparin, cannot be reversed.

Pradaxa is only one alternative to warfarin that is now being developed.   One other new drug, rivaroxaban, is going to be available soon.

Pradaxa is a direct thrombin inhibitor, and rivaroxaban is an oral direct factor Xa inhibitor.  Trust me, you don’t want to know anymore.  It will make your head explode.  The only reason I bring it up is so you understand that the clotting pathway of our bodies is being interacted in different places by these two drugs and so presents two different opportunities.

On September 8, 2011, the FDA advisory committee voted to approve the drug for the use in atrial fibrillation to prevent stroke.  A large study demonstrated it to be non inferior to warfarin when given once a day.  This drug is an oral compound which does the same thing as Lovenox, a drug most people who have been hospitalized recently are aware of.  Lovenox is the drug they inject in your abdomen to prevent blood clots from forming in your legs.

This drug will be known as Xarelto.  Don’t ask; I certainly don’t know how they came up with that.  The interesting thing about this drug, and the purpose of this blog is this: this drug, which is not yet approved here in the United States, appears to have a reversal agent.

Published in Circulation on September 6, 2011 (Circ2011;DOI: 10.1161/circulationaha.111.029017), this article reports on the use of PCC, or prothrombin complex concentrate, in volunteers who are test subjects.  They do not have the illness that is being treated.

This study compared rivaroxaban and dabigatran.  When given both drugs, it prolongs the PT or prothrombin time.  We can test to see whether someone is taking Pradaxa with the PT, but the intensity of the effect is not measured unlike warfarin and the INR.  When PCC was given to the volunteers, the rivaroxaban was reversed but not the Pradaxa.  So PCC may be a useful drug to immediately reverse the effect of the drug in the case of a bleeding emergency or if emergency surgery is needed.

This is a small study, and more work will need to be done before this is accepted, but it is provocative and useful information.  It may well be a great selling point between these two drugs in addition to Xarelto being used once a day.

Progress.  Slow, not always steady, but always toward better patient care.

Five years and one million heart attacks and strokes Part II

In my last blog I documented the problem and some of the proposed fixes in a planned attempt to lower the stroke and heart attack rate.  Some good news is that there is finally a realization that often patients don’t get or take medications in the way we want them to because they simply don’t have the money to buy them.  One of the goals of this plan is to reduce or eliminate co-pays or deductibles for these medications.  Indeed one of the provisions of the Affordable Care Act, if it survives, is the elimination of the “doughnut hole."  The “doughnut hole” was another attempt by the Bush administration to get something without paying for it.  Everything has to be paid for at one point.  We as a nation should be able to decide what is important and figure out how to pay for it.  We went to the moon.  We have no excuse.

Medicare is planning to waive patient co-pays for blood pressure and cholesterol screening.  Smoking cessation work will also be waived.  In addition there is a new annual wellness visit in which these issues will be prominently featured.

Now let’s touch on the fun parts.  They, and you, know who “they” are are going to go after, our beloved french fries.  This has already happened to a great extent.  It is now almost impossible to smoke unless it is in your car and probably a sensor is being developed so that if you are smoking in your car the motor will turn off.  First it's texting, then it's talking and now smoking.  Soon cars will only be used to get from place to place.

Trans fats have already gotten the axe and have been virtually removed from food.  Salt is next up.  Soon, no salt will be allowed anywhere.  Reducing salt is definitely good for your blood pressure and certainly helps with fluid retention, and I am a big fan of avoiding pickles.

Part of this is of course missing the point.  It doesn’t matter if the french fries or potato chips don’t have trans fat.  You shouldn’t be eating them anyway.  And, if you are, you might as well have something that tastes good.  Is the government really supposed to be our mother?  Is effective health policy really run from McDonalds?  The figures quoted to date are that the reduction of trans fats in food is estimated to reduced 50,000 deaths per year, but I am not familiar with how that number is derived.  Perhaps we just eat smarter.

Don’t get me wrong.  I am enthusiastic that finally the problem maybe getting the attention it needs.  I write about these issues every week.  Many of our problems are self inflicted.  I, like most everyone else, eat too much, exercises too little and don't get enough sleep.

No matter how much government does, we ourselves need to take control of our own destiny.  We have to control what we eat, we have to monitor our own blood pressure and take responsibility for our own health.  It’s your problem.  Own it.  If your doctor won’t help, you find another; there are enough to go around.

Wait till you get a load of this one (Part I)

We have before us another example of our Congress at work.  I actually heard about this about two years ago.  I couldn’t believe it then, and it is now coming to a closure.  Perhaps.  What happened?

First some background.  For years, we in Interventional Cardiology and others had only one drug to use for the angioplasty procedure.  That drug was heparin.  When angioplasty started in 1977 Dr. Gruentzig and all the others used a dose of heparin that was fixed at 10,000 units.  Every hour that the procedure went on another 5,000 units of heparin were given.  As procedures back in those days commonly lasted several hours, patients often received significant amounts of the drug, and the consequences was often severe; at times fatal bleeding occurred.

In today's practice we use a lower dose that corresponds to how much someone weighs and then measure the effect.  None of these tools were available to us when angioplasty started.  I have always disliked heparin.  The dosing is too variable, and the wait for the answer whether the proper dose was given often took longer than it took to do the angioplasty.

An aside.  In our lack of knowledge at the beginning of angioplasty, we thought that the heparin would keep the artery from clotting when we worked in it.  It turns out that it's the platelets in the bloodstream and their antagonism that counts.  That is why Plavix and drugs like Integrilin are so important.  We could do angioplasty without heparin as long as we kept the catheters clear like when we do angiography.  This was actually done in a study at Duke, but it is too difficult for the average Joe.

Back to the story.  Besides being sourced in China (see previous blogs), heparin is a real pain to use.  Its one redeeming feature is that it is incredibly cheap.  When a new anticoagulant drug was developed from our old friend the leech, a great deal of excitement was generated.  I participated as an Investigator in the original large scale testing of the drug bivalrudin.  The drug was found to be safe and then went on to be tested in two large trials, and by the end, was found to be safer than heparin because it caused less bleeding.  The Angiomax as it is called is given as a bolus and drip, and when it is stopped, you can pull out the sheath we use to work in without testing after two hours.  We do not have to wait for a test to see whether we have enough in the patient to work safely, we can just proceed with the angioplasty.  It is a hospital's worst nightmare.  A drug which is hundreds of times more expensive without any real benefit except we like it because it makes our job easier.

This is really what is driving the cost of medical care.  I am simplifying things a bit but not much.  Soon we were all using it, and the company that produced it, a small company called The Medicines Company, was getting rich.  Roughly $200 million a year.  Not Lipitor numbers, but the number of patients is much less.

What happened next was a surprise and a disaster...

Five years and one million heart attacks and strokes (Part I)

The problem is very real but are the solutions?  The first job is defining the problem.  Once that is done, solutions can be offered for a try at correcting the identified problem.  Echoing my recent blog on September 8th comes news of a vast new initiative from the federal government to prevent heart attacks and strokes.

Let’s first identify the problem.  As I have blogged about numerous times the problem is very real.  2 million people a year have a stroke or a heart attack.  800,000 die.  This is far and away the leading cause of death in the United States.  The cost is staggering and estimated at $450 billion dollars a year.  Ominously, just the medical costs are projected to triple in the next twenty years.

Our Department of Health and Human Services is leading a coalition of other federal, state, regional, private sector stake holders to promote and implement these proposed actions.

These actions are divided into two areas.  The first is clinical which is the part I and others like me do.  The second is what they plan on doing to you, my readers.

What we need is a cute phrase.  The best example I know was “Whip Inflation Now” or WIN as it was known in President Gerald Ford’s days.  If my memory serves me this campaign had buttons and all.  A button today would probably be a collectors item.  The program lasted about a week.

Our new cute phrase for the clinical side is “ABCS."  I guess they figure that we can’t remember what we are supposed to do without a phrase.  It stands for aspirin for high risk patients, blood pressure control, cholesterol management and smoking cessation.  The feds must finally be reading my blog.

Now scroll back, my September 8th blog which describes in frightening detail just how poorly we do with the “ABCS."  62% get aspirin, 66% get statins, 50% get ACE and 40% beta blockers, both of which are primarily used for blood pressure management.  Want to guess how many people are told not to smoke?  Less than 25% of those patients who want to quit get advice from their healthcare provider.  I can’t understand it because I think I sound like a broken record telling people over and over to quit.

Here is the rub.  50% of American adults have high cholesterol, uncontrolled BP or smoke.  Many have more than one problem.  It is estimated that 100,000 lives a year can be saved by just adhering to our guidelines.

How are they going to accomplish this?  Well some of the proposals make sense and some are fantasy.  It is good, however, to have goals.  Two important parts are in play.  The first is the feds want to “document” what I do so they can track it better.  If they can measure it, and I meet or exceed my goal, I get a lollipop.  How this is supposed to work when the plan is to cut all doctor fees by 30% January 1st is not clear to me.

This is the real purpose of the Electronic Health Record.  Now I know that you thought that the EHR (or EMR) was for you so that you could finally read what I wrote, but in truth, it is for “data mining” so the feds and insurance companies can keep track of how we are doing.  The problem is that people are made up of multiple spinning plates, and our job is to keep them all spinning like the guy on the Ed Sullivan show.  Som times you can not do something even if you want to.

Some things don’t lend themselves to data basing very well.  I have blogged about these issues before.  The results will of course be published and on the Web so you can see how we are doing.  Kind of like the sports page.  Maybe we will just get another section in the papers.  Oops I forgot.  Newspapers are so yesterday.

Don’t worry there is plenty more for next time.

Good news we are all bad

I’m sitting here in London when I should be in Paris where the European Society of Cardiology is meeting.  I have been trying to get them to send me to this meeting as it is held in far better places than Atlanta, but so far I have had no luck.  I am stuck across the channel but am still excited or dismayed about the news from the meeting.

As I have blogged about before, the Europeans have stolen our thunder, or our fire if you are a fan of Prometheus, in the publication of new ideas.  We in the United States have become fossilized for many reasons, but we have at this point ceded the high ground to the Europeans.  Our meetings are basically a rehash of the European data.  Face it, the Europeans have been implanting aortic valves percutaneously for five years, and we haven’t started.  Is this any way to run  a country?

Dr. Yusef, who is the father of large studies based in Canada, has now presented a study showing how poorly we all do in many countries just providing the medication which has been proven to reduce disability and death after the first coronary event.

Really.  Is it so hard to just follow directions?  Do we really think that somehow this work doesn’t apply to us?  Why can’t we just do the right thing?  These investigators looked at 153,996 patients in 13 countries.  They found 5650 patients with coronary disease and 2292 patients with stroke.  They then looked to see whether the patients were taking the classes of drugs which we know help to prevent secondary problems.  These drugs are antiplatelet drugs, beta blockers, ARB’s or ACE inhibitors and statins (my personal favorite).

Antiplatelet drugs were used in 62% of high-income countries and 8.8% of low income countries.  Now considering that this means using aspirin, which is cheap as dirt, I for one cannot understand why this number is not close to 100%.  There will be some patients that cannot take these drugs secondary to ulcers and allergies but really, this low?

ACE was used 49.8% v 5.2%, beta blockers 40% v 9.7%, and statins 66.5% v 3.3%.  I guess the moral is don’t get sick in a third world country, but what about the rest of us?  If you have an MI in the US, is 66% OK?

This is actually worse than it seems since, in many places, the cost of these drugs is minimal.  They simply are not being provided or written for.

This is an enormous problem as it represents a significant burden on all health care systems.  Clearly the drug costs here are significantly less than the human cost or the cost to the healthcare system.  We as physicians are the ones who need to change.  This goes for us in the United States as well as the third world countries.  At these numbers, we have nothing to be proud of.

Thanks to Dr. Yusef for calling us out.  These drugs can -- and do -- reduce disease.  We as physicians need to do better, and you as patients need to understand that we are trying to help you stay well.  This is shared responsibility and we need to communicate these issues better to achieve patient compliance and satisfaction.

All catheterizations are not created equal Part II

In my last blog, I wrote about the rates of normal catheterizations and the overall importance of this to hospitals, patients and our healthcare system.

Roughly 175,000 patients with no known coronary disease are subjected to cardiac catheterization each year.   On the face of it one would think that it should be easy to avoid normal catheterizations with the use of noninvasive testing, but the tests we presently have are all subject to important technical issues as well as interpretation issues.

Stress testing with echo is valuable but depends on a certain body shape to allow for rapid visualization of the heart at peak exercise.  This, in some women, is difficult as well as in patients who are significantly overweight.  Nuclear stress testing also suffers from weight limitations and breast artifact leading to erroneous reports of “anterior wall ischemia."  CT angiography is our best tool to proclaim someone free of any atherosclerosis but has difficulty distinguishing between significant and moderate disease at times.

The cited study shows that by evaluating baseline cardiac risk, chest pain characteristics, non invasive test results and an adequate trial of medications, rates of normal catheterizations, which in this study ranged from 0%-77%, depending on the hospital could be reduced to perhaps 12%-24%.  Let’s move back to the rate.  The median rate, that which is the number in the middle of both ends, was 45%.  91 hospitals (13%) had diagnostic yields of significant coronary disease of <35%.  On the better side, 82 hospitals had yields > 75%.

How is it possible for some hospitals and doctors to get something right only 35% of the time?  Wait, there’s more.  One would think that if analysis was done, and I doubt any was, a change would be put into place which would identify and correct the hurdles in doing something right only 35% of the time.  The rates however did not change, and in 2005, the rate of finding obstructive coronary disease was 44.4% and in 2008 it was 45.6%.  No change at all.

What are the causes of this continued problem?  Reimbursement is now so low for cardiac cath that the operator performing it actually is better off financially doing something else.  Cardiac cath is necessary and useful in the proper sequence.  The exclusion of coronary disease is useful in some cases but having a “normal cath” does not stop ER visits or admissions for chest pain.  There are of course legal issues, but these should be, and can be, dealt with by precise documentation and noninvasive testing.  There is patient persistence; some will go to doctor after doctor until they get what they consider to be what they need.  Generally, discussion stops this but in our era of “speed doctoring,” when your two minutes are up, you need to proceed to the next patient.

The real “problem” with this study is that it now sets a bar with which to guide Medicare and Insurance companies to wield the stick.  I believe it is correct and that good documentation should allow for payment of caths that are normal if multiple signs pointed to illness.

In the United States, 83 per 10,000 patients undergo cardiac catheterization.  Comparable rates in the Netherlands are 12 per 10,000 and in Great Britain 26 per 10,000 with 62% of the angiograms deemed appropriate and 33% uncertain.  Do we have more disease?  Are we out of control?

I have seen the enemy and he is us.

All catheterizations are not created equal Part I

In keeping with recent assaults on our skill set as physicians, we now have the results of a study again using our database which shows that we as cardiologists are not very good at deciding which patients benefit from a cardiac catheterization and which patients do not.  This seems to be true whether we compare ourselves to each other or to other countries.  In fact, as this study shows, we maybe the worst in the world. As reported in our Journal of the American College of Cardiology JAm Coll Cardiol, 2011; 58:801-809 there is a significant number of cardiac catheterizations done in the United States that are normal and in some hospitals that seems to be the norm. The “Oracle,” our NCDR or the National Cardiovascular Data Registry, was queried for catheterizations on individuals who had no previous knowledge or indication of cardiovascular conditions yet needed a cardiac catheterization for some reason.  This yielded 565,504 patients between the years 2005-2008. Let me digress for a moment.  Science is based on forming a hypothesis that is then tested in some way to prove or disprove it.  This in turn leads to other hypothesis and eventually to a better understanding of the problem, and hopefully in the case of medical care, better care.  Measuring things is what science does so that observations can be formed to provide a rational basis for our daily actions. This often means that although we as physicians do things now, they will be found to be “best practice” in the future.  It also means that if we record what we do in large databases and then analyze those data bases, we often have enough information to finally decide that one way is better than another and provide better patient care.  This is the moving target of medical care and the paradigm of constant improvement that we attempt to provide our patients. Cardiac catheterization in today’s practice of Cardiology in most cases should be limited to patients with moderate to high pretest probability of having coronary disease.  Ideally, patients have multiple risk factors, symptoms compatible with the diagnosis and non invasive testing, such as CT coronary angiography or myocardial perfusion imaging, which warrants an invasive test.  If this paradigm is followed, most patients will have coronary disease.  Patients on the other hand should not have none of those characteristics and be subjected to cath as the yield is very low. Occasionally, very occasionally, cardiac cath need to be done to reassure someone who has persistent chest discomfort and negative non invasive testing.  Our job is to provide reassurance at times and with it, guidance.  Catheterization is also done for acute coronary syndromes, but that is not the discussion here. The “negative cath rate” may become a quality metric in the near future.  Obviously, it matters to hospitals, patients and insurance companies (Medicare) if a center has too many negative catheterizations.  What is that number?  Well, this study makes it clear, and it is not pretty. Next...what they found.

What not to do during an MI Part II

In my last blog I went through a brief history of angioplasty and MI.  Published in J Am Coll Cardiol, 2011; 58:692-703 is a Meta-Analysis titled Culprit Vessel only vs. Multivessel and Staged PCI for Multivessel Disease in Patients Presenting with ST-Segment Elevation Myocardial Infarction.

This article details that 40%-65% of patients presenting with myocardial infarction have other significant disease.  40,280 patients were included in this analysis.  After analysis it was clear that culprit only angioplasty lead to far less mortality than multivessel angioplasty at the same setting.  In fact it is a 60% increase in long term mortality when multivessel PCI is performed in the setting of an MI.

In a second article in the same journal, the one year mortality was 9.2% vs 2.3%, and the stent thrombosis rate was 5.7% vs. 2.3% when a combined procedure was performed.

If that is the case, how come it’s still commonly done?  In several recent published studies, 9.9% to 18.5% of patients underwent multivessel PCI in the setting of an MI.  What happens in private practice is anyone's guess.

A great deal of work has been done which shows that other vessels and lesions that are identified at the time of the acute infarct may look much worse than they truly are.  This is because of circulating compounds that can worsen the appearance of a lesion and make it look more severe than it truly is.  Lesions, unlike some dates, often look better the morning after.

We have a device and a procedure that I have blogged about before.  This device, known as a flow wire, measures the pressure gradient over a lesion during maximum vasodilatation generated by an IV adenosine infusion over three minutes.  If a lesion looks as if it needs to be fixed by utilizing this procedure, the physician can see that a lesion need further work or not.  This can then be “staged” or determine whether the lesion is symptomatic with angina or stress testing and then return to the cath lab and repair it.  This method avoids recathing a patient only to find out that the lesion is “gone.”

The only reason to perform multivessel angioplasty at the time of infarct is because of cardiogenic shock, which is rare in today's setting.  Even shock can often be treated with the advanced methods that most of us have at our disposal, such as the Impella which I have blogged about before.  Honestly, shock and multivessel MI is at times best treated by opening the infarct artery and proceeding to surgery.  I have many patients alive and well today following that advice.  I saw one such patient just two days ago back in my office for follow up.  In spite of his young age, 38, he presented in shock and had a prolonged resuscitation.  After an hour we stabilized him enough to get some angiograms, and it was off to the OR.  Today he is without limitations and has a normal cardiac function on minimal medications.

The best treatment is defined by the patient and not a single method.  Experience counts in this setting, and Holy Cross is privileged to have many experienced Interventional Cardiologists and Cardiac Surgeons.

Just do it

walkdogA question that I am often asked is, “How much exercise should I do?”  The answer is simple and is again brought to the forefront by a recent meta analysis published online in Circulation which is the journal of the American Heart Association.  It was published at Circ 2011;DOI: 10. 1161/CIRCULATIONAHA.110.010710 and is titled “Dose response between physical activity and risk of coronary disease."

Let me back up a moment.  Exercise has many purposes and benefits.  I have blogged about them before.  It can ease depression and help relieve stress, and in doing so, reduce blood pressure which is a leading cause of the cardiac problems patients have.  There is a benefit both before and after a myocardial event.  Exercise will help a patient lose weight and maintain that weight loss.  The exercise can be solitary or group exercise, and it can lead to lasting friendships.
It does not need to be vigorous.  Patients just have to start.

The patients that tend to ask me about exercise the most are those who need it the most, and they are often the ones least capable of exercise.  This is generally because of weight issues that have led to severe musculoskeletal issues and degenerative joint disease.

This study shows that all you need is 150 min/week of moderate intensity exercise to lower your risk of heart disease by 14%.  Add 150 minutes for a total of 300 min/week and you lower you risk by 20%.  Add anymore and the incremental value is minimal.  The “sweet spot” is 150 minutes and for those of us who have nothing better to do at 6 am 300 minutes is all you need.  Sleep the rest of the week.

This is not a study of the rehabilitative effect of exercise.  It simply compares those who do to those who do not.  Also, it is not a study of post cardiac event therapy.  It relates to primary prevention.  If you have never had a problem and want to reduce your risk by 14%, get up off your a** and do something.  It seems that something is anything.  Walk the dog for 150 minutes a week, and you are all set.  The dog is probably happier also.  Think of all those great new smells.  What is required is the time and that the exercise be of moderate intensity.  Moderate intensity exercise is any exercise that you can “perceive” as causing mild shortness of breath.  In other words, try and break a sweat.

I would like to add two more notes.  The first is that stretching before exercise doesn’t seem to add much to the prevention of injuries.  That said, however, one of the hallmarks of advancing age is loss of flexibility.  Flexibility is not something that can be achieved through once in a while activity.  it is something that needs to be achieved through active effort.  The best way to achieve flexibility is yoga.  It is not “new age,” it is “old age,” and it can achieve a significant increase in overall flexibility and well being.  It certainly fits into the 150 minutes a week scheme.  There are many places that it can be learned and there are classes for all levels.  We have several at our Wellness Center, and I urge you to be able to touch your toes.

What not to do during an MI Part I

mi

Photo from: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001246/

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In the almost 30 years I have been performing angioplasty, much has changed.  Then again even though techniques have improved in some cases, not much has changed.

I was present at the beginning.  In 1983 the first TIMI study was performed, and I helped with the study.  Much of my enthusiasm for research dates back to those days.  TIMI stands for Thrombolysis in Myocardial Infarction, and we were testing a new compound -- the first in fact that had been created by a new company Genentech.  This compound was the synthetic version of a real protein, and this had never been achieved before.  The compound was tPA or tissue plasminogen activator.

This compound is found in the endothelial cells that line blood vessels and is part of the yin and yang that keeps blood from clotting in our vessels.  We used it in a study against a substance which breaks down clot known as streptokinase.  Patients with acute myocardial infarctions were randomized to either streptokinase or tPA to see which drug would open more arteries by giving it intravenously.  This went on in many variations with different compounds over the years.  The work I did at Emory set the stage for  my continuing research work here in Fort Lauderdale.

If the vessel was not open at 90 minutes then PTCA occurred trying to get the artery open.  We had no stents, and this worked at times and did not work at others.  As time went on we realized that it was the platelet stupid and not so much the dissolving of the clot.  New agents, such as Reopro and then Integrilin, were platelet antagonists that would literally dissolve clot before our eyes.  It was breath taking at times and nothing short of a miracle for some patients.  Angioplasty by default became the treatment of choice for acute MI and now is routinely done in 90 minutes from the time patients enter appropriately structured hospitals.  It is rare now that patients get tPA for MI, and it has moved to being the treatment for acute stroke.  The treatment of choice for myocardial infarction has become urgent angioplasty with mostly drug eluting with the help of anti-platelet drugs.

But what about the other vessels?  When we are taking the angiograms and snooping around, we often find in the other coronary arteries severe lesions that we believe require angioplasty also.  Everything that needs to be done should be done at once right?  Why put the patient through another procedure?  Save time and money by doing it all at once.  So we thought and often did in the early days.  Soon it became clear that maybe this wasn’t such a great idea as angioplasty was still a hit or miss situation, and at times we fixed one artery that was an infarct artery only to butcher a second artery and cause enough trouble that surgery was required for we had no stents and no way out.

Second vessel angioplasty as it was called soon became a Class III no no.  Class III are guidelines that mean don’t even think about it.  As stents became more prevalent, this concept again raised its head but it seems now that it maybe doomed for a long time.  I never thought it was a great idea to begin with but now three articles published in JACC document it’s demise.

More next blog.