Heart Failure

Who decides what's "appropriate" (Part 3)

In my previous blogs, I have attempted to provide a brief overview of the process and reasons why Appropriate Usage Criteria (AUC) has been developed.  One paper published last week and one study presented last week at the American College of Cardiology meeting in New Orleans again highlight the problems we as physicians face in straightening out what we do and why we do it.

In 2009 before the AUC was published, a group of 85 cardiologists from 10 United States institutions were sent 68 of the clinical scenarios that were used from the formulation of the AUC.  The purpose was to see whether independent cardiologists came up with the same answers.  Be careful what you ask for.  As published in J Am Coll Cardiol, 2011:57:1546-1553 and titled Concordance of Physician Ratings with the Appropriate Use Criteria for Coronary Revascularization, this study found that agreement between the groups was 84%.  Those procedures deemed appropriate were agreed upon 94% of the time, those procedures uncertain were agreed upon 73% of the time and those inappropriate were agreed upon 70% of the time.

As I have described, acute work for myocardial infarction and unstable angina is easy.  This work has shown clear benefit to prolonging and sustaining life.  It’s the elective work that is problematic as documentation is often poor and both stress tests and medication is often used in inadequate ways.

At the American College of Cardiology meeting, a study of 500,000 cases were examined from the data base that we use called the National Cardiovascular Data Registry (NCDR) from July 2009 to July 2010.  Some of the cases could not be evaluated but of those that could be, 84.6% were deemed appropriate, 4.1% were inappropriate and 11.2% were deemed uncertain.  The acute work was deemed 98.6% appropriate.  Of the 29% of the cases that were elective, only 50% were deemed appropriate, 38% were deemed uncertain and 11% were deemed inappropriate.

11% may seem like a small number, but would you fly in a plane that had an 11% chance of a problem?  The cost of these procedures is high and the benefit small.   Further and perhaps most concerning is that the rate of inappropriate procedures varied from hospital to hospital.  In other words, it’s not chance.  Some hospitals just do more inappropriate procedures.  The variation is from under 10% to over 30% in some hospitals.

In response, the NCDR will be sending score cards to hospitals starting this year with a detailed reporting of the rates of appropriate, uncertain and inappropriate along with a report of all the cases that were deemed inappropriate.  You can bet they will also be published in some form.  Holy Cross hospital reports to this data base and so we will receive ours also.

As you can see, even though these criteria are not universally agreed upon, they are being placed into use both by the government and payers’.  This information will help in our, and most hospitals', goal of providing top care in a safe manner.  17 doctors decided all of this, and I hope they were right.  This is the beginning of a new era in accountability, and I for one welcome it.

Who decides what's "appropriate?" (Part 2)

Almost a decade ago, the Rand Corporation was interested in healthcare, and they developed a way to achieve consensus documents.  The participants provide numerical assessments and then try to move to “the middle” and achieve a document which satisfies everyone (this is usually followed by joining hands and singing Kumbaya).  Sometimes when endpoints are fixed (i.e. length of stay or mortality) the process is easy.  What about “appropriateness?"  Can a consensus be reached amongst doctors on anything?  I have often said that if you put 10 doctors in a room you get thirteen opinions.

Much of medicine is gray.  Some things are black and white but the middle, gray, needs the most work and would help the most in steering both doctors and patients to a proper course.  This of course is the most difficult area in which to work and get consensus.  The fear is that the use of these documents will become de facto answers for payment or liability.  These decisions would then be published and become tools with which doctors could be judged.

The document titled Appropriateness Criteria for Coronary Revascularization was published concurrently by multiple societies.  The American College of Cardiology published it in JACC 2009; 53:530-553.  The panel was composed of 17 doctors divided into 4 cardiovascular surgeons, 8 cardiologists, 4 interventional cardiologists and 1 medical officer from a health plan.  180 clinical scenarios were created and scored 1-9.  Those scored 7-9 were appropriate and likely to improve health or survival. Those scored 1-3 were deemed always inappropriate and unlikely to improve health or survival; those 4-6 were deemed uncertain to improve health or survival.

As readers of my blog know, I have made a point of defining when angioplasty is useful.  In general you need symptoms unrelieved by maximal medical management, which is defined by two classes of anti-angina medications or significant ischemia either unstable angina or a severely abnormal stress test.  These are the 7-9 scoring scenarios.  Asymptomatic patients or low risk stress tests and minimal medications received the 1-3 scores.  Those patients who have no symptoms and were given a stress test that was mildly positive would not be expected to undergo catheterization and certainly not angioplasty under this scheme.  All the rest of the patients make up the “gray middle.”

The results are published in the referenced article, and I would refer you to it.  I attempted to add them to this blog but was unable to.  Symptoms drive the decision and medical management is essential.   The more symptomatic the patient is, the more disease the patient has the likelier that angioplasty is appropriate.

By now you are asking who cares besides doctors.  Patients should care because stenting is forever, and inappropriate stenting can lead to surgery that would not have been necessary if the procedure was not performed in the first place.  In my next blog I will reveal why this topic comes up now.

What happens if there is no consensus amongst the 5000 members of the American College of Cardiology on what is “appropriate?"

Maybe it really doesn't matter (Part 3): How the trigger was pulled on Gravitas

I have been going over the strange yet wonderful story of Plavix which to put it another way is an example of I’d rather be lucky than smart.  For sometime now, we as physicians have been inundated with material about how we should prevent stent thrombosis.  Studies have been started and published.  First go one way -- no that’s wrong -- go the other.  Well, it is probably all over but the shouting.

GRAVITAS was a study of a test result produced by a machine known as VerifyNow produced by the company Accumetrics.  The theory was that by using this machine in the cath lab after patients had been appropriately loaded with Plavix, we as physicians could document who had low Plavix reactivity and -- by treating them with more Plavix -- could prevent poor outcomes.  Guess what?  It doesn’t work.  It made no difference what your platelet reactivity was or if you took one or two Plavix.  The outcomes were the same.  This is another example of my dictum that just because it makes sense doesn’t mean Mother Nature will care.

The other side of the coin, just use a “better more potent drug,” didn’t work either.  The role out of the new antiplatelet agent prasugrel has been a disaster for Eli Lilly and Daiichi Sankyo the companies that produced it.  TRIGGER-PCI was supposed to show that prasugrel (Effient) was more effective than clopidogrel (Plavix).  The study was to enroll 2150 patients and follow them for six months.  432 patients were enrolled and 250 reached six months.  Why recruitment to this study was so slow is an ongoing question.  The predicted event rate was 7% when the study was started and when the data underwent interim analysis the event rate was 2.3% even lower than GRAVITAS.  Whoopsie, that was the end of the study, as it would never reach significance.

What does this tell us?   Basically with the new generation stents that are used today, and with aspirin and Plavix, stenting has become predictable and safe as an operative treatment for stable coronary artery disease that fails medical management.   It is still undecided whether there is an additional benefit inferred by changing up the paradigm in unstable angina or myocardial infarction patients as those patients have “more active platelets."  TRILOGY ACS is ongoing comparing clopidogrel and prasugrel in unstable angina or non-ST elevation myocardial infarctions.  Prasugrel was approved for use in those patients and never tested in “stable” patients but the hope was that doctors were to ignorant to know that and they would just use the “better” drug.

One question remains: how long do you continue the Plavix?  We are divided into two basic camps.  One camp believes that Plavix should be continued forever (my personal favorite) and one camp believes it can be some finite date yet to be determined but presently located at one year.  The ongoing DAPT study or dual antiplatelet therapy study plans to study the date out to three years from the present one year.  At one year patients will be randomized to Plavix/Effient (whichever they were on initially) or placebo and followed.  All the patients continue aspirin.

Do you want to bet on the outcome after reading these three blogs?

Maybe it really doesn't matter (Part 2)

Let’s talk about platelets.  Nothing else in the body is so small and can create such chaos.  They were discovered by a German named Max Schultze and described in 1865.  Platelets are cell fragments which mean they do not have a nucleus and cannot reproduce.  They are formed in the bone marrow and die with a life span of 5-9 days so there is a constant production of platelets.

When the endothelial layer of arteries is injured, platelets respond as the first line of defense to stop the bleeding or if internal to clot the artery.  This in the heart leads to heart attacks.  Cigarette smoking makes platelets more activated, hence the reason that smokers are at greater risk.  This clotting is caused by the reconfiguration of the platelet.  Instead of its normal shape, it changes into a sphere with little sticky pseudo pods that look like old water mines in WWII.  These water mines were round with protuberances on them and exploded the mine if they were struck.  The pseudo pods grasp other platelets and attract thrombin to form a clot.  Aspirin blocks the activation of one pathway, and Plavix blogs the activation of the other main pathway.  Together, they render platelets relatively useless in forming clots.  I say relatively because all of this can be overcome in most circumstances.  The effect is enough to protect the stents which do not have endothelial material on them for a period of time but not strong enough to cease clotting.

When it was determined that patients responded in variable ways to Plavix an attempt was made to measure who was “protected” and who was not by measuring the aggregation ability of platelets after exposure to various reagents.  Here is where it really goes off the rails.  Different reagents will give different platelet activation times.  Therefore, no one test has been developed to document exactly what platelets do and when they are not functioning properly.  I’m not kidding.  This stuff fills up Journals and will make your eyes spin.  A company came on the scene that decided that they had “cracked the code."  This device in the cath lab would allow us as doctors to decide who was and who was not sensitive to Plavix and by extension stop stent thrombosis.  There was only one problem:  no study had been done to prove that this had any clinical significance.

Further, there was only one drug, so if Plavix didn’t work, you were just stuck taking two.  When Effient or prasugrel came on the scene as the second drug, many people (mostly investors in Lilly) thought that we as doctors would just move everybody to Plavix.  Well, they forgot that doctors are notoriously slow on the uptake.  When Dr. Semmelwies in 1847 discovered that mothers would not die if doctors washed their hands between births, he was run out of the profession and died at age 47 of sepsis.  This has come around again 164 years later as posters on all hospital walls admonish us to wash our hands and nurses wear buttons saying “ask me if I washed my hands."  I told you we were slow on the uptake.

Yeah, I’m getting to the point.  Two studies have been released which probably put this whole issue to rest, and they are the subject of my next blog.

Do we dare tell the truth?

heartclockEver since the fable about the Emperor having no clothes, there has been reluctance to speaking the truth at times.  In this era of the intersection of both political correctness and over share, we often don’t know what to say or when.

In general doctors are loath to tell patients that they are responsible for their own problems.  Somehow people who smoke, have high blood pressure, high cholesterol and diabetes are surprised to find out that they need coronary artery bypass surgery and we cannot say, “I told you so" (or in my case, “why didn’t you read my blog?”).

Over the past several years, a movement to address acute management of myocardial infarction has led to the dictum of having the artery that is blocked and causing the event open within 90 minutes of presentation to the hospital emergency room.  This is referred to as the “door to balloon time."  The whole hospital team had to come together to accomplish this goal, and considerable improvement in attaining this 90 minute window has been achieved a remarkable number of times.

However, those of us who do this on a regular basis have been troubled that we in the hospital do not seem to be the biggest part of the problem.  If a patient waits six hours before coming to the hospital, then 90 minutes or less of an opening time doesn’t really improve on the vast amount of damage already done.  The “heart muscle clock” starts ticking as soon as the artery is closed and doesn’t stop until it is opened.

Recently, the unspeakable was spoken and the subject of "how do we get patients to the hospital sooner" was broached in public.  This discussion came at the Cardiovascular Research Technologies conference in Washington D.C. This discussion revealed that only half the population in the United States has a coordinated response system in place for the treatment of ST segment elevation myocardial infarctions.  Only one third live in an area that has a set transfer protocol to handle this emergency.  Only some hospitals are configured to do this work, and EMS had no dedicated plan to bring patients with an ST elevation myocardial infarction to those hospitals, bypassing the ones who can not.

In this era of over communication, it seems downright retro that ECG’s taken in the field cannot routinely be transmitted to Emergency Rooms with any consistency.  This process saves many valuable minutes when the ECG is diagnostic alerting the cath lab to mobilize earlier.  At this conference, an iPhone app was unveiled to do this.  I believe that makes it the 1,000,000,000th.  At least they finally stopped updating Angry Birds.

Along with the process of communicating vital information is an equally important process of public education.  Listen up guys!  That “heartburn” that is making you short of breath and profusely sweaty and will not go away with multiple TUMS is not indigestion.  Unfortunately, most guys won’t go to the Emergency Room unless someone else calls EMS or they fall down from the attack.  If you wait, you will be sorry.

Save your heart muscle…Save your life.  Maybe that should be the public message.  Maybe we should spend more money on the now and not worry about some of the other things with which we seem to be so obsessed.  In the long run, we would even save some money and bring down the long term health care costs.  Our societies need to make the message clear and loud.  Red Dresses to support cardiac care in women is a good start but not enough.  We need to wage war, and the battle needs to begin now.

We have been set up to fail

Last year, the American Heart Association presented their concept of “cardiovascular health."  This concept consisted of seven components of “ideal cardiovascular health” (the quotation marks are not mine).  I’m not sure who figured this out but here they are:

Lifestyle
Not currently smoking
Body Mass Index<25 kg/m2 (pesky isn’t it)
Physically “very active”
Eating three or more servings of fruits and vegetables (does wine count?)
Health
Total Cholesterol<200 mg/dl untreated
Systolic BP<120 mm HG and diastolic BP<80 Hg untreated
Fasting plasma glucose<100 mg/dl untreated

Who dreams this stuff up?

First and foremost, I have a problem with the word "health."  I believe that health is what your genetic potential leads to with a shove from your lifestyle.  Plenty of people are grossly overweight and have normal coronary arteries.  Trust me I see it all the time.  Others have severe coronary artery disease and run and bike and so forth.  The difference is genetic.  As Jim Fixx showed us you can not outrun your genes.

I digress; who is Jim Fixx?  In 1977 his book, The Complete Book of Running, was the bible to those of us who ran.  I was running long distances and had completed several marathons until my knees gave out.  I was fascinated by the book and more so by the back story.  Mr. Fixx, 10 years before he took up running, was 240 pounds and smoked two packs a day.  He was 35 years old.  The publication of his book made him an overnight sensation as he “had become healthy."  He did not smoke and lost 60 pounds.

The problem with this was that his dad died at age 43 with a myocardial infarction.

Poor Jim lasted until he was 52, and on July 20, 1984, he died of a myocardial infarction after a run.  Autopsy showed severe three vessel disease. (Note to people who profess ever lasting life with a life style: don’t get autopsied.)  Supposedly, as was reported at the time, he was running with increasing angina, but I don’t know whether that is true or apocryphal. So the question is, was he healthy?  I would bet he would have met all the seven criteria.

Well I know you, my readers, know the answer to this question.  How many in a 2,000 patient group of middle aged community-dwelling individuals met all seven of the goals?  That’s correct -- one.  Yup, only one made it.  But wait, there’s more… 2.0% met the lifestyle criteria and 1.4% met the health criteria.

No kidding people, this was published in Circulation.  I can’t make stuff like this up.  (Circulation 2011; 123:850-857.)  What good is an ideal if it impossible to obtain?  If we obtain it what do we get?  How long do we have to have it to get the benefit?  How many more years of life?  Any randomized studies?

This is the kind of drivel that moves people away from the message.  We, as physicians, want people to keep their blood pressure and cholesterol down, to improve their eating habits and to lose weight.  Our names are not Walgreen’s or CVS.  We do not get anything for giving out prescriptions to patients.  They get the money for the drugs.  We have serious problems in this country, but The 2020 Impact Goal issued by the American Heart Association is not helping.  I suggest they go back to funding basic research.

Ancient History and an Answer We Never Had: Part II

Ancient history and an answer we never had...

...until now.

The common assumption is that if obesity has an increase in cardiovascular events -- and death from them -- then it is because of a toxic brew of hypertension, increased lipids and diabetes.  Well, you know what assume really stands for?  Assume stands for the contraction makes an a** out of u and me.  Until the group of patients in the WOSCOPS study was followed, no randomized study answer was at hand.

Even the answer that WOCCOPS found is interesting.  As published online (on Valentine’s Day no less) at Heart 2011; DOI:10.1136/hrt.2010.211201 the researchers excluded any subject with an event in the first two years.  After 14.7 years of follow up 1027 nonfatal cardiovascular events occurred and 214 fatal cardiovascular events occurred.

The groups were analyzed in two ways.  The first included age and statin treatment and the second included all known risk factors plus BMI with the reference being a BMI of 25 to 27 kg/m2.  The researches found that the risk of nonfatal events did not matter what your BMI was.  However, fatal cardiovascular events were significantly increased in those white men with a BMI of 30 to 39.9 kg/m2.

Remember, this study was done in white men so these results are not transferable to any other group.  This however is the first published randomized long term follow up of any group that shows an increased cardiovascular mortality of any sort and represents a milestone and who knows if it will ever be repeated or if another group is right behind this.

If it is not diabetes, lipids or hypertension what causes this increase?  This is pure speculation but one man’s speculation is another man’s results.  The authors speculate that obesity leads to an increase in inflammation and that this increase in inflammation causes this effect.  We have many studies which center on this phenomenon and the drug Crestor was the subject of a study showing a decrease in cardiovascular events in those patients with “normal” LDL and an increase in CRP, which many physicians believe is a marker of generalized inflammation.  The treatment of patients with statin and aspirin often reduces the CRP level.  I blogged about this study in the past and it is known as the Jupiter trial.

I doubt that we have the basic research knowledge to figure this out at the present time.  This, like the genetics of cardiovascular disease is most likely for the future.  What this data does is provides another basis to urge patients and people in general to start losing weight in an effective and long term way.  Recently as I have blogged about in the past every new drug that has come to FDA for approval that had to do with weight lose was turned down as too toxic for widespread use.  Gastric bypass and gastric lap banding seem to be the best options.

I am fond of saying “it’s not nice to fool with Mother Nature."  There are often unpredictable results when we attempt to fool the body into doing something it doesn’t want to do.  We are left with the unpleasant and often spoken ugly truth that we just have to EAT LESS.

Oh my.  What is a lover of Veal Parm to do?  Maybe just eat two bites?  Statins won’t protect you.  It’s apparently up to each and every one of us to make the best of it.

Good Luck.

We Will Crush the Earth!

Three papers published in The Lancet (Lancet 2011; DOI: 10.1016) highlight the fact that we in the United States know all to well.  It turns out that the whole world is getting fatter except for one very surprising group.

Table 1: The International Classification of adult underweight, overweight and obesity according to BMI
table1_crush

chart1_crush

A graph of body mass index is shown above. The dashed lines represent subdivisions within a major class. For instance the "Underweight" classification is further divided into "severe", "moderate", and "mild" subclasses.
Based on World Health Organization data here.

The Tables above are from the World Health Organization.  BMI is a value derived by dividing your mass or weight in kg/height in meters 2.  As you can see if you are smaller you cant’ weigh much before you are overweight.  Be 5’7’’ and weigh 190 and you are obese.

We in the United States have the highest BMI of high income countries at 28.3 kg/m2.  (yeah we are the best at something again!)  We are increasing 1.1 kg/m2 per decade in men and 1.2 kg/m2 per decade in women.  Women in France, Italy, Greece, and Switzerland all come in below the underweight cutoff.  Hard to believe but apparently true.  The lowest BMI for men is the Democratic Republic of Congo at 19.9 kg/m2.
9.8% of men and 13.8% of women worldwide are obese.  (are you listening Lane Bryant?)

Just for kicks, do yours.  Alright it’s not that bad.  Just stop eating.  What the women in Italy are doing beats me.  No pasta?   Who knows about France?

All this data means just one thing.  We will crush the earth if we don’t stop eating.  The consequences of all this obesity are likely to be increasing health care expenditures at a time when no country on earth can afford it.

Although weight seems to be going up we seem to be doing better at controlling cholesterol and blood pressure.  This is not uniform as blood pressure has increased in the Baltic countries and in Africa.  Cholesterol has declined in high income countries but is rising in Japan, China, and Thailand.

The reasons for these discrepancies will be combed through as these issues are receiving major hand ringing amongst many organizations.  We must find a way to control the increases in some countries and provide food for those that are in need.  Drugs to counteract the weight are not the issue.   Your mother used to say “finish the food on your plate there are children starving."   The fault seems to be putting too much on our plate and not donating the money saved to aid organizations.

The Good, the Bad, and Why It Doesn't Seem to Matter What they Pay Us (Part 2)

In my last blog I outlined how poorly we as physicians treat certain conditions that are defined and that we have relatively good medications for.  One concept that has been floated is the proposal to “pay for performance."  Now I for one take great exception to the whole principle.  The concept that I wouldn’t do my best to care for my patients but if you pay me more I will do better is anathema.  It is hard for me to believe that governments think that by increasing payments for certain things I, and we, will do better.

To prove my point, an article about the British attempt to pay for performance appeared in the British Medical Journal. (BMJ 2011; DOI:10.11.1136/bmj.d108)  This article discussed the British program to improve the treatment of hypertension.  The government allocated 1.8 billion British Pounds but spent twice as much as 99% of the physicians participated.  470,725 patients were studied and the findings were that there was no change in blood pressure control or monitoring and no change in the incidence of stroke, myocardial infarction, renal failure or all cause mortality, in other words, just a complete waste of time and money.

Again we face the dilemma of how to do better.  It’s really a two sided problem.  On the one side, we have physicians who don’t have enough time to spend with patients to truly educate them about what hypertension is and what it will do to you.  On the other hand, we have patients who take an ever widening array of add on medications; for instance, four or five diabetic medication that they have “drug fatigue,” and the last thing they want to do is take a drug that makes them feel worse than when they had high blood pressure.

One suggestion would be to “extend” the doctors reach by the use of other professional personnel. Nurses, Nurse Practitioners, Physician Assistants, Pharmacists all have a role to play in this battle.  The doctor may be the best in choosing the medications and the overall plan of attack, but other individuals may have better success in monitoring and achieving goals.  These models have their best effect in Lipid and Hypertension clinics set up for those purposes.

However we attempt this, it’s about time that we stop wasting time and get to work.  We have identified how poorly we do.  We have identified how much it costs and how little is obtained.  What we need now is the ability for doctors to fashion their own solution and then have the agencies pay for it.  This is not going to be a one size fits all solution.  Different cultures and communities need different approaches, and as long as it is dictated how we do things, it will not work.

More flexibility needs to be allowed by the governing bodies, and we must be allowed to attempt and document the success or failure of our own ideas.  With the rise of the Internet checking on patients and having group web chats should be possible.  Patients want to be involved with their care and most want to be feeling better and protect their future well-being.  It’s time to think outside the box.  If the government wants to pay me for that I’m all for it.

The Good, the Bad, and Why It Doesn't Seem to Matter What They Pay Us (Part 1)

stethoscopeThe keeper of much of the information regarding the health, or the lack of it, in the United States is the CDC (Centers for Disease Control).  Using the NHANES or the National Health and Nutrition Examination Survey an attempt is made to obtain a “snapshot” of how we, as a people, are doing health-wise and by inference how we, as a group of doctors, are doing in caring for you.  The data related is from the 2005-2008 survey and is contrasted with the 1999-2002 report.

I have blogged about some of this information before, but it again comes into play in a recent analysis of both blood pressure control and lipid control.  It has often been mentioned that for all we pay for health care, we as a people are not very healthy, and we don’t get the best care.  As I have quoted people in the past, we as a nation are wonderful in providing “rescue” care but we do a very poor job in providing continuum of care and long term care, such as blood pressure and lipid control.

You would think that providing blood pressure and lipid control would not be that difficult.  Apparently that is not the case.  Hypertension adjusted for all variables effects roughly 30% of us.  About 70% of those affected receive some sort of treatment.  Roughly 46% of patients report that their blood pressure is controlled.  Mind you this is better than previous years but hardly anything to be satisfied with. If you are a Hispanic patient only 37% achieved control, Blacks 43% and Whites close to 48%.

If you received medical care only twice a year, you had a 20% chance of success.  Four or more visits achieved better care at 50%.  Medicare recipients and private insurance achieved the same success at 47%.

Roughly 35% of the population has high LDL-C based upon the National Cholesterol Education Program Adult Treatment Panel III guidelines.  Of those patients, 50% state they receive treatment.  If you were covered by Medicare and received more than four visits a year, you had the best chance of being treated at >60%.  This discussion does not address how “well” you were treated or to what level LDL-C was driven.

All in all, 90% of the patients with uncontrolled hypertension and 83% of uncontrolled LDL-C patients have insurance. If patients have insurance then what is the problem?

Are we as physicians not explaining ourselves?  Have we not made patients understand the medical issues?  Do patients just not care?

Can we pay doctors to do better?