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Medical Insider Blog

Bits and pieces

  • Posted Dec 18, 2012
  • Alan Niederman, MD, FACC, FACP

Bits

I always attempt to keep you my readers ahead of the curve.  On July 7, 2011 I published a blog post about a device and iPhone App that I believed would help many patients with their heart rhythm issues.  Many patients have episodic rhythms which trouble them but are very hard to capture.  The blog detailed what could change all that.

I urge you to go back to it: Something to do with your iPhone4.  In brief, Dr. David Albert is a physician and inventor who developed a back case for the iPhone 4 and 5.  This case allows you to touch your skin and record your heart rhythm.  You can then store the information or cut and paste it.  This information can then be sent to your healthcare provider.

Well, eventually the worm turns, and the FDA has finally allowed it on the market.  I cannot adequately explain why it takes a year and a half,  but it obviously does.  Known as the AliveCor monitor, it is already available for animals, although I'm not quite sure why you would want to know what Fido's or Fluffy's  heart rate is.  The information obtained can also be stored in the ubiquitous cloud and then downloaded by your doctor.

As I said in my blog post, this is going to be a game changer for everyone. But wait, there's more.  Now comes the second idea on how to use your phone for more than Angry Birds.  Who makes phone calls these days anyway?   This new App uses the camera and flash.  You place your finger on the flash and the camera records the changes in color.  A program in your phone then determines the "chaos" and can determine whether you are in normal rhythm or atrial fibrillation.  The study was done using two minutes, but it seems that one minute is sufficient.  These results were actually published in the journal Heart Rhythm (HeartRhythm 2012;DOI:10.1016/j.hrthm.2012.12.001).

It looks like soon I will not have to get out of bed to practice cardiology.  I will see you on Sykpe, and you can send me all the info on the iPhone apps.  Now, if I can only find a way to have you open up your own heart artery during a heart attack at 3am.

And Pieces

An interesting set of facts was published by David Leonhardt of the New York Times on December 15, 2012.  The facts relate to Medicare and its funding, and they are very important.  As an example, he uses a married couple, 66 years old.  They had "average earnings"; this is not defined.  The total amount of Medicare taxes paid in over their lifetime was $122,000.  They will use an average of $387,000 in Medicare funds.  Oops.  Who pays the rest?

In 25 years the Medicare percentage of Gross Domestic Product will rise from 3.7% this year to 6.7%.  This is an estimate and could very well be higher.  At that level we will not be able to afford to live.  As I have mentioned in other blog posts, when Medicare started in 1964, the average life expectancy was 75 years.  Now it is 20 years up from 16 years in 1980.  The longer we live, the more it costs.

We have to face the facts.  We as workers need to pay in more in taxes to Medicare.  We need to "means test" monthly premiums when we reach Medicare age.  We need to fix the payment system to pay for "quality," whatever that is, and not quantity.  We need to gore everyone's Ox equally.

We need to get to work.


Aspirin...again

  • Posted Dec 13, 2012
  • Alan Niederman, MD, FACC, FACP

I have blogged about aspirin many times dating back to September 19, 2009.  Yes I have been doing this for a long time.  What is old is new again in an article published in Circulation online last week.  Entitled "Drug Resistance and Pseudoresistance: An Unintended Consequence of Enteric Coating Aspirin" (DOI: 10.1161/CIRCULATIONAHA.112.117283), this article helps to dispel yet another Urban Legend, that of the concept that certain people do not respond to aspirin appropriately.

This is actually a big deal if it was true.  Taking aspirin after a myocardial event decreases your risk of death by 20%.  Like the discussion of "more taste, less filling" or the tooth fairy, you either believe in aspirin resistance or you don't.  A great deal of money is spent on testing for something that most people feel doesn't exist.  This article is just one in a long line of articles.  This article also helps disspell another myth, that of enteric coating.

Just because it should work doesn't mean it does work.  Enteric coating was promulgated to reduce the risk of GI bleeding.  This "proof" was, however, incorrectly done.  What enteric coating does is reduce the risk of visible stomach lining lesions.  The proper study, never done, would have been to assess for all bleeding not only for those visibly seen.  This is because the bleeding is based on the prostaglandin function of aspirin and not the irritative function of aspirin.  You can get GI bleeding from aspirin by giving it rectally. Similarly, Plavix causes GI bleeding and it is not based on an irritative basis.

What is the science?  We believe that approximately 50 mg of aspirin is needed to inhibit the platelet receptor in question.  This, however, requires the aspirin to be perfectly absorbed from the stomach.  This definitely does not happen all the time.  Therein lies the problem with the enteric coating.  When the 400 healthy subjects in this study were given enteric coated aspirin, none were found to be aspirin resistant by common tests.  49% did not have proper activation at 4 hours, and this dropped to 17% at 8 hours.  Of the 17%, after one week of aspirin therapy, none were found to be resistant.

What have we learned?  Enteric coating does little to protect you from GI bleeding in aspirin use.  It does however interfere with the acute use of aspirin such that in emergency situations, regular aspirin should be used and preferably chewed.   It does not seem to help if you chew enteric coated aspirin. Good luck with finding regular aspirin in a hospital, however, since most - if not all - of the aspirin has been replaced with the enteric coated aspirin.  Long term administration of any form of aspirin eradicates the apparent resistance.

The naysayers have already appeared.  This study utilized healthy people, and their conjecture is that "sick" patients are different.  This may or may not be true.  It has yet to be determined but probably never will be because it takes time and money to do this work, and it is unlikely to get funding.

I can guarantee we have not seen the last on this topic.  Over 150 years and we still do not understand the "simple drugs."


Angels do walk the earth

  • Posted Dec 11, 2012
  • Alan Niederman, MD, FACC, FACP

This is a true story. It is a story about a patient, but it reflects the best that health care can do, and it brings several important issues into focus. The first issue is, "what is a hospital?" This simple question is not really defined in the American public's mind. People seem to think that hospitals are like banks and that they are all the same. They are not the same, and the differences in hospitals are real and may cost you your life if you go or are taken to the wrong one at the wrong time. This is becoming more acute a problem as techniques and advances become more sophisticated and require increasing expertise, which is often not available in every hospital.

A hospital is more than just a building. It is made up of doctors, nurses, allied personnel and equipment. That equipment is very expensive, and the doctors require more and more training and expertise. Like heart attacks that have to be treated in a timely fashion, strokes are a devastating and often fatal occurrence. Also, like heart attacks, the treatment for strokes has advanced since the time not long ago when doctors just pursed our lips and offered condolences and comfort to the patient and their family.

Much of the advance in stroke therapy is borrowed from Interventional Cardiology and are techniques which we pioneered in the coronary arteries. Much has been devised by the pioneers in the field of neuro-interventional radiology. The first hurdle was the belief that you could not work in the brain. Gruentzig faced the same prejudice when he started working in the heart arteries. No one believed it could be done until he proved it. Not being a Cardiologist, he was never subjected to the false understanding of what could and couldn't be done.

At Holy Cross Hospital, we are blessed by an Administration who has spent the money to buy the equipment to allow those of us with the expertise to better serve our patients and our community. Our hybrid operating room is an example. The Administration has also obtained the services of doctors with unique skill sets to serve unmet needs in our community. One such physician is Dr. Laslo Miskolczi.

Dr. Miskolczi and his team of angels apply their skills to save patients brains after they have a neuro event. They serve as our Code SERT or brain attack team. One of my patients is a 69 year-old female who developed cardiac symptoms and underwent coronary CT angiography, another advanced test that Holy Cross offers, with great expertise because of the radiologists that read our tests. They are among the best in the world, led by Dr. Claudio Smuclovisky - an innovator in this field.

My patient then underwent cardiac cath and was found to need coronary bypass surgery. Given that she was fit and otherwise without medical problems, it was predicted to go very easily for her, and it did until day four when she had a brief episode of atrial fibrillation that can occur in over 70% of patients with coronary artery bypass surgery. This was ended in about four hours. Two hours later while with a nurse in the bathroom, she suddenly collapsed and could not move the entire right side of her body or speak. A Code SERT was called, and she was immediately taken to CT scanning which showed a severe lack of blood flow to her left brain.

Minutes later, Dr. Miskolczi and his angels had her in the neuro interventional lab, and the following picture was obtained.

Soon after, Dr. Miskolczi worked his magic, and he and his team had the artery opened.

She was recovered from anesthesia, could speak a few words and began to move all of her extremities. By the next day she was speaking better and moving better. She is now on the Rehab floor at Holy Cross Hospital and working her way to what will hopefully be a full recovery. The ability to resolve what would have been a devastating or fatal stroke is a gift, and we at Holy Cross and our community are lucky to have this physician and his skill. We the medical staff, the nurses and allied personnel of Holy Cross Hospital are here for you, our community. Learn more about Dr. Miskolczi by visiting his online physician profile: Laszlo Miskolczi, MD

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A stake through the heart (Part II): The rise of Gdufa

  • Posted Dec 06, 2012
  • Alan Niederman, MD, FACC, FACP

Who or what is Gdufa?

Is Gdufa the answer to the problem of generic drug manufacturing and the lack of transparency and accountability in the entire process?  Can we return to a time of naivety when we never thought or worried about this subject?  Should we return to that time?

Gdufa stands for Generic Drug User Fee Amendments of 2012.  It actually goes by Gdufa, and if you type that into Google, the information about the act is what shows up.  I will summarize its purpose and what it hopefully means for everyone.  First, some surprising numbers.

Since 1984 over 8,000 generic drugs have been approved by the FDA.  In 2011, 78% of all drug prescriptions were for generic drugs, and the estimated cost savings was $931 billion.  Almost a trillion dollars in one year alone.  I, and others like me, would have thought that somehow this savings should be protected as well as the public's safety.  Isn't that what the FDA does?

It seems that isn't the case.  Why?  The same reason things usually don't get done: money.  In the era of deficits and "small government," the protection of the American public took a backseat to expediency.  The system got a trillion dollars in savings and you got...who knows.  Somehow Afghanistan can be billed to us the taxpayers but drug protection...not so much.

Well our problem is solved.  The money to do what is needed is coming from the foxes guarding the hen house.  The generic drug manufactures are going to provide $299 million a year in inflation adjusted dollars. This represents one half of 1% of generic drug sales.  What did the drug manufacturers get?  Currently it takes 31 months on average to approve a new generic drug.  Seriously, I'm not making this up.  2,500 applications were awaiting approval at the time of the bill passage.  This time will be significantly shortened, and the FDA will have to be accountable to Congress.  The FDA promises to review 90% of the new applications within 10 months of the submission date by the 5th year of the agreement.

What did we, the people, get?  Currently the FDA inspects foreign drug manufacturers once every seven to 13 years.  I'll bet that scares them.  Now they will be inspected every two years with the riskiest sites being inspected more frequently.  Further, all facilities that manufacture drugs and their components will now be identified.

Certainly this is a good start.  Execution will be the problem as always.  It is hard for me, and I'm sure for you, to understand how this was not always the way it was.  Is glass in generic Lipitor the only problem?

One final note: the bill strives to create an improvement in, as they call it, "regulatory science."  Basically this refers to testing and maintaining the generic drugs to ensure they meet the potency and same activity that the formal product has.  When there were just a few drugs and manufacturers, this was not such a problem.  If 15 companies make the same generic Lipitor, are they all the same?  Can we choose or does the pharmacy just give us the pills and tell us, as my mother used to say, "take your medicine"?

I can guarantee you that this event, the finding of glass in generic Lipitor, is just the first in what will be a long line of problems.  We must as a country solve this problem and devise ways to protect patients from drugs that do not work or are harmful.


A stake through the heart (Part I)

  • Posted Dec 04, 2012
  • Alan Niederman, MD, FACC, FACP

There appears to be no bottom to it.  I have attempted to inform you, my readers, about a problem that no one has an answer to and very few people seem to care about.  It's almost as if the phrase "what I don't know can't hurt me" has infected our entire national psyche.  The what we don't know is what is in our drugs.

Of all the drugs that patients waited to become generic, Lipitor stood out.  It was necessary for so many patients, and it was expensive.  Insurance companies would wrongly point patients to other less expensive, but  not as powerful, drugs like it was OK.  But, as it became clear to us that those that suffer from coronary disease need LDL levels less than 70, the power of Lipitor became more apparent.  Lipitor was the largest selling drug in the world year after year, after year: $16 billion a year.

How is it possible that the company that brought the generic to market could be so careless as to have it tainted?  Not only does it show just how broken the system is, but now the company has completely shut down production of atorvastatin.  Does no one care?  Are we doomed?  Is this the new normal?

How does glass get into a drug?  Why can't we document and secure our drug sources?

Let's take a look at the company.  As reported in the New York Times on November 29, 2012, Ranbaxy Pharmaceuticals was in a heap of trouble before this incident.  Ranbaxy is a subsidiary of a large Japanese pharmaceutical company called Daiichi Sankyo.  As an interesting factoid, Daiichi Sankyo was the company that found the substance in Red Rice Yeast that became lovasatin.  Second factoid: lovasatin is also found in oyster mushrooms.  Yes, all my friends who only want to take "natural" drugs, that's what lovastatin is - natural.

Anyway, I digress.  Ranbaxy is operating under a consent decree issued on January 25, 2012.  I quote from the decree:
"These problems include failure to keep written records showing that drugs had been manufactured properly; failure to investigate evidence indicating that drugs did not meet their specifications; failure to adequately separate the manufacture of penicillin drugs from non-penicillin drugs in order to prevent cross-contamination; failure to have adequate procedures to prevent contamination of sterile drugs; and inadequate testing of drugs to ensure that they kept their strength and effectiveness until their expiration date."

What did the government do?
I quote: "Among other things, the consent decree prevents Ranbaxy from manufacturing drugs for the U.S. market at certain of its facilities until those facilities can do so according to U.S. standards. To remove false data contained in Ranbaxy’s past drug applications and to prevent Ranbaxy from submitting false data to FDA in the future, the consent decree requires Ranbaxy to take actions such as:  hire an outside expert to conduct a thorough internal review at the affected facilities and to audit applications containing data from those facilities; withdraw any applications found to contain false data; set up a separate office of data reliability within Ranbaxy; and hire an outside auditor to audit the affected facilities in the future."

So...they manufactured the active drug in India at a plant that was not shuttered in India and assembled the drug here in the United States.  One would think that they would be extra careful, but apparently they don't think like one.  Ranbaxy had 43% of the market in October.

Folks, as Joe Biden would say, "If this is so screwed up, we are all in trouble.  Can Gdufa save us?" Read my next blog.


FREEDOM (Part IV)

  • Posted Nov 29, 2012
  • Alan Niederman, MD, FACC, FACP

Will this blog never end?  I am spending so much time on this topic because it impacts cardiology thinking in such an important way.  In addition, I write the blog to educate you, my readers, about what I think you should know.  You need to see how the "sausage is made" to understand why cardiologists recommend some things and why we don't recommend others.  Medicine is a moving target, and we physicians are responsible to understand the movement so that we can provide the best care for our patients.

The use of the SYNTAX score allowed us to understand a very important fact that was not clear until year four of the study.  If you have a SYNTAX score of 0-22, you can have either CABG or PCI and you will do the same.  If your SYNTAX score was 23-32 you double the risk of death16.1% for PCI vs. 8.4% for CABG.  MI is 9.3% vs. 3.9%.  In the highest risk group SYNTAX Scores 33 and over death/stroke/MI is 22.7% vs 14.6% with CABG.  Further, you have a 17% need for repeat procedure.  Overall the total risk was 40% vs 23% for CABG.

Does this finally end the story?  If you have complex disease defined not because I think it but by a scoring system, then you need CABG.  If you have diabetes, even more so.  You should be evaluated by both a surgeon and a cardiologist, and your SYNTAX score should be known.  This approach has already been codified into the European Society guidelines.

But... we cardiologists are not done yet.  Now we have FREEDOM. Folks listen to me, as Joe Biden would say.  This should be the last time that this question is asked and the answer is the same.  Somehow in my gut I know that it won't be but it should be.  FREEDOM stands for Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management.  It was published in the New England Journal of Medicine on November 4th (2012DOI: 10.1056/NEJMoa121585).

From April 2005 until April 2010, 32,966 patients were screened.  3,309 were eligible and 1,900 agreed to do the study.  Mean age was 63.9 years. 83 % had three vessel disease, and the SYNTAX score mean was 26.2.  All had diabetes.

At five years, the risk of death with PCI is 16.3% vs 10.9% with CABG.  If you look at death, MI or stroke, then the risk is 26.6% vs 18% in favor of CABG.

It has taken us 17 years to come back to the same place we started.  After BARI, the National Heart Lung Blood Institute issued a clinical alert regarding the results.  It said that if you have diabetes and three vessel disease, you need surgery.  It may not be what you want to hear, but it is the best treatment.  Now the answer is starkly before cardiologists.  The question is will we listen and act or continue to "do what the patient wants," which is always PCI and just happens to be what we do.

Mark my words, the next step is a Class I indication in our guidelines and the follow through will be no payment will be made for these patients unless they get what they need.  There will be full review, and heads will roll.  This is what it will take for "the right choice " to be made.  It has happened already for ICD implantation, and it will happen here.

It's too bad that this is what it takes.  Judge Fenton would be proud of us.


FREEDOM (Part III)

  • Posted Nov 27, 2012
  • Alan Niederman, MD, FACC, FACP

Now, we cardiologists had a bright idea.  The reason that angioplasty was not better than bypass surgery was that we were comparing apples to oranges.  The reasoning went that if we compared "like" patients that angioplasty would be superior. So, off we went to do another study.

This one is named SYNTAX. SYNTAX stands for SYNergy Between PCI With TAXUS and Cardiac Surgery.  I bet you can already figure out what the problem will be.  This study was started in March 2005 and enrolled 1,800 patients.  It ended April 2008, and the final data was done this year.

Feeling our "oats" we went after the big Kahuna.  To get into the study, you needed to have three vessel disease, Left Main disease or Left Main equivalent with or without one, two or three vessel disease.  In other words, these patients had a large burden of disease including the big no-no that is left main.  We were so sure of ourselves that we went for broke.

The main difference between this study and the previous trials to answer this question is the SYNTAX score.  This score is very useful but very complicated.  Even the study sites often got it wrong.  The score was always "overhead," so it was corrected before a patient could be entered in the study.  The score uses the coronary tree diagram and then weighs the lesion for importance.  I will not go into it further because the exact way it was done is not the point.  The point is that the score allowed us to differentiate between low risk, medium risk and high risk.

The study was an "all comer" study.  A surgeon and a cardiologist had to agree that the patient could technically be done either way.  The only exclusions were previous interventions, acute MI or need for other cardiac surgery like valve replacement.  Two groups were then formed, one for Left Main and one, two 0r three vessel disease, and one for all other lesions.

At the end of the study, 897 patients had CABG (coronary artery bypass grafts), and 903 had PCI (percutaneous coronary intervention).  Two registries were formed for those patients who were considered for the trial but could only be done one way.  The CABG registry had 1,077 patients, and the PCI registry had 198 patients.  In each of the two study groups, 28% had diabetes and 71% did not. The primary endpoint was 12 months.

All cause death
CVA/Stroke
Myocardial infarction
Any repeat PCI or CABG

Average age was 65,  78% male, average SYNTAX score was 29, left main was 34% in each group, number of stents implanted in PCI group 4.6, number of bypass grafts 2.8 average with 3.2 distal attachments. At 12 months, all cause death was the same roughly 4%.  Higher strokes were seen in the CABG group 2.2% vs. 0.6%. Higher MI's in the PCI group 4.8% vs 3.2%.  All cause death/MI/CVA equal at 7.7%. Need for repeat revascularization PCI 13.7% vs 5.9% for CABG.  This drives the results in favor of CABG 12.1% vs 17.8% for PCI.

So, the final answer was that in this trial, both PCI and CABG could be done, but the cost is a higher redo rate for PCI.  However... the real results did not come out until four years later.


FREEDOM (Part II)

  • Posted Nov 22, 2012
  • Alan Niederman, MD, FACC, FACP

Cardiologists did not get the answer that we wanted the first time. In fact, even worse, we found that we were actually quite misinformed about what we were doing to patients, especially those with diabetes. Why is that so important?

A few factoids from the BARI 2D site
More than 24 million people in the United States have diabetes. 65% of those people die from either a stroke or heart disease. If you have diabetes, you have two to four times the risk of dying from heart disease than those patients who do not have diabetes. As mentioned in my last blog post, BARI took place between 1988-1991 and so did not represent "contemporary" medical practices. The 10 year survival rate of patients who had diabetes and angioplasty was only 44.1% vs 57% survival rate for those patients that had bypass surgery. This difference is statistically significant. Let me give you the real wake-up call. 10 year survival without diabetes was roughly 77% in both the angioplasty and surgery groups. Diabetes is a bad actor. This data made it very difficult for cardiologists to recommend angioplasty to patients, but because the study did not include drug eluting stents, which we were certain would save the situation, no real practice changes occurred.

BARI2D was set up to address the issue of strategies for myocardial ischemia and the treatment of diabetes. Full disclosure: I was an Investigator in this study. BARI2D studied intensive medical management of diabetes and the revascularization strategy. The goal was to achieve a hemoglobin a1c below 7.0%. Cardiologists then selected the choice of angioplasty or coronary bypass surgery before the patient was randomized. Recruitment began January 1, 2001, and the study ended November 30, 2008. Of the 2,368 patients only 30% were female. The mean age was 62.4 years. The patients were equally divided into one, two and three vessel disease. The duration of diabetes was 10.4 years. Hemoglobin a1c was 7.7% at baseline.

In those patients that had single vessel disease, 90% were intended to get angioplasty. If you had two vessel disease, 66% for angioplasty. If you had three vessel disease, 45% angioplasty. Remember that, one, cardiologists were making the choice, and two, the mortality for diabetics with angioplasty was 20% higher than surgery. Yet we were still willing to "water the tree of liberty." After three years, we lowered the LDL from 96 to 80. Hemoglobin a1c went from 7.8 to 7.5 in those patients taking insulin and from 7.8 to 7.2 in those patients taking non insulin management. At five years, either angioplasty or surgery took place in 42% of those patients that had their procedure deferred. In other words, nothing but medical management need to be done in the majority of patients who had their procedure deferred. Again, coronary disease is a medically treated illness in most cases. All cause mortality was 88% among the two groups. Those that got "fixed" early and those that got "fixed" late. Death/MI/Stroke was 76% in both groups. If you were intended to have surgery and received it, you had no difference in survival than if you had medication alone. If you add MI and stroke into the number, you did better if you had the surgery. Still, we cardiologists did not get the answer we wanted. So, we did another study!


Freedom (Part I)

  • Posted Nov 20, 2012
  • Alan Niederman, MD, FACC, FACP

Thomas Jefferson once said, "The tree of liberty must be refreshed from time to time with the blood of patriots and tyrants."  Is the same thing true of patients?  Must we physicians do the same work over and over again while we use "the blood of our patients" to prove a point which is known to be inaccurate.

In the Clint Eastwood movie Hang 'Em High, Pat Hingle plays Judge Adam Fenton.  Fenton is a Judge in the Oklahoma territory in the late 1880's.  Fenton was Judge, jury and executioner.  In much the same way, cardiologists are unique in having the patient, testing the patient and then making the decision for the patient as to what is to be done.  There is some discussion, or not, depending on the circumstances.  Same sitting angioplasty, the repair of the artery in the same procedure that is known as Ad Hoc angioplasty, does not allow for any discussion.  This is usually in the best interest of the patient.  In fact, Medicare reduces my payment by doing angioplasty and catheterization at the same time.

Let me break it down piece by piece.  I have blogged about our organization's documents known as appropriate use.  Those documents say in general that no patient should go to cardiac catheterization unless they are having a heart attack, have unstable angina, have a very large defect on nuclear stress testing or who are believed to have angina and are taking adequate medical management. This then leads to the second part of the equation.  The patients that receive catheterization need something done if possible after the cath because that's what it is for.  Angioplasty and bypass surgery are to relieve symptoms.  Except for special circumstances, they do not lead to longer life.  As my patients know, most of what is done in cardiology is done to prolong life.  That is the reason that people take statins.

So, the question becomes which is better at prolonging life and reducing symptoms, angioplasty or bypass surgery?  This question has been asked multiple times, and the answer is always the same.  No matter what we cardiologists do, no matter which drugs we have, and no matter what covers our stents surgery provides more benefits than angioplasty.

Several new wrinkles have been added.  The worst patients are the most common.   Those with diabetes, which as you know is endemic in our society, have the worst disease.  Diabetics develop more advanced and complex disease than patients without diabetes.  Our stents are excellent, and surgeons have different techniques.

Since the beginning of angioplasty, the limits of the procedure were tested.  The results of the procedures were tabulated in certain centers in a database held by the National Institutes of Health (NIH).  The topic of "which is better long-term" then became more formalized.  The first study was the BARI study which was published in the New England Journal of Medicine (N Engl J Med 1996; 335: 217-225).  This study was all comers - those with and without diabetes.  Five-year survival for surgery was 89.3%.  Five-year survival for angioplasty was 86.3%.  However, if you had diabetes, then the five-year survival with surgery was 80.6%.  The five-year survival with angioplasty was 65.5%.

So what did we cardiologists do?  We did another study!!


Vindication

  • Posted Nov 15, 2012
  • Alan Niederman, MD, FACC, FACP

One more urban legend dies.  Since I have been practicing cardiology, now 25 years, I have championed the process of drawing random lipid panels.  The lipid panel is the most important non invasive test I have.  Most of my patients have coronary artery disease or some other manifestation of cholesterol damage.  The guidelines are now stricter than ever, and in my constant striving to practice evidence-based medicine, I require my patients with disease to have a LDL cholesterol of 70 mg/dl or less.  The lower the LDL goes, the happier I am.  If you do not have any evidence of cholesterol damage. the level for LDL is > 100 mg/dl.

This has allowed me for 25 years to have the same discussion over and over again.  The discussion goes like this: I want to draw your lipid panel.  You tell me that you have eaten, and I tell you that I don't care.  The reason I don't care is that I'm not interested in your "best" fasting number.  I'm interested in your worst number.  You don't fast all day, so why would I care about the fasting level?  The only real use of the fasting tests are in a research setting because the sampling needs to be uniform.  Having to go to the doctor's office is a hassle in itself.  Having to go twice for a fasting specimen is unfair.

Also, for the millionth time, what you eat is not responsible for your cholesterol level.  Your parents are.  Your triglyceride level is more associated with fasting.  This does affect the LDL level at times since the standard LDL level is inexact anyway since it is calculated not measured.  We have a way to measure LDL known as Direct LDL, but it is more expensive and generally not necessary.  All the "gobbledygook" on the special cholesterol panels is interesting, but why get it if you can't do anything about it?  After you get the advanced panel, the answer is still take more statin.  These panels are a waste of money and just produce noise. I usually prevail in my discussion, and I get the test.

Now an article has been published supporting what I have said all along.  Published in the Archives of Internal Medicine is an article entitled "Fasting time and lipid levels in a community based population" (Arch Intern Med 2012;DOI:10.1001/archinternmed.20122.370).  This article used 209,180 specimens.  Fasting times ranged from one hour to 16 hours.  The difference between the fasting and non fasting specimens were less than 10% for LDL.  The sample is so large that it doesn't matter if you are on statins or not.  The differences in the entire population wash out.

So, it maybe possible to eventually eliminate the practice of obtaining fasting specimens.  I am usually "whistling in the wind" when I try to explain things to my peers, but I will keep trying.  I am going to hand out copies of this blog to my patients so that maybe I can save my voice for some of my other favorite conversations.


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Holy Cross Hospital is a nonprofit, Catholic hospital in Fort Lauderdale, Florida, dedicated to innovative, high quality and compassionate care. For nearly six decades, Holy Cross has continuously expanded its services to provide leading-edge care for their patients in Florida and for those from elsewhere in the United States. Holy Cross also offers an International Services program to ensure that patients from outside the U.S. receive the care they need.

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