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Medical Insider Blog

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.


From bad to worse (Part III)

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

So we have a conundrum.  Which is better: utilizing a new drug that works all the time and is easy to use but has a major drawback or an old drug that does not have the drawback but is impossible to use?   The answer is, "Who knows?"  I will  lay out the facts.

As I have mentioned before, only about 60% of the patients who are "supposed to be anti coagulated" because they have atrial fibrillation are actually anti coagulated.  Surprisingly, the use of the newer anticoagulants has not altered that number. Let me list some of the reasons that this happens.  At times doctors just don't realize that it is important. Sometimes there is a disagreement between doctors as to how to proceed, and the patient becomes confused.  Sometimes the patient refuses to use the drug regardless of their doctor's request.  You can do anything you want as long as you understand the issue and the possible consequences. Many of these patients are older and frail and have many co-morbities that make it almost impossible to anti coagulate them properly.  We as physicians just basically give up as the hassle for everyone just doesn't make sense.  If you the patient are trying, but we the physician never get you anti coagulated, you are not protected anyway.

Even in the best of hands anticoagulation is only correct 60% of the time.  How do I know this?  That is how often the "experts," who did the work of drug approval on these drugs, got it right.  This number has been replicated many times, and so it is not exact but pretty darn close.  How can people take a drug that is only dosed right 60% of the time?

Further, as reported in the Archives of Internal Medicine (Arch Intern Med 2012; DOI:10.1001/archintmed.2012.4485) in an article titled "Persistence with therapy among patients treated with warfarin for atrial fibrillation,"  more that 60% of the people who started taking warfarin stopped after five years.  It gets better.  8.9% didn't fill their second prescription.  31.8% stopped after one year.  43.2% stopped after two years.  61.3% stopped by five years.  More to the point, the mean stop time was 2.9 years.  That means that half the people had stopped by that time.  This group of people were in Ontario and were 66 years or older.  They all had insurance.  In this country I'm sure the numbers would be worse.

What to do?  My opinion, the one that I share with my patients, is that these new drugs are far easier to use than warfarin and provide a stable effect.  I prefer Xarelto because the pills are not fragile, and it is taken once a day.  The risk of difficulty when someone bleeds is real, but we as physicians make choices all the time that play the odds.  You can't live life worrying about all the "what ifs."  If you really need to be anti coagulated, then you should take the best drug possible to avoid the strokes associated with the condition.  I believe that patients who have had bleeds, or have a condition that might lead to bleeding, should not receive these newer drugs.

It is early in the game, and these real issues will be worked out over time.  No one is going to spend the money to find an antidote that no one will use.  Progress in this field will allow us to modify the bad effects and retain the better treatment results.

Progress in medicine is not a straight line.


From Bad to Worse (Part II)

  • Posted Nov 08, 2012
  • Alan Niederman, MD, FACC, FACP

Pradaxa is once again in the news.  Two very different stories about the drug were published on November 2, 2012.  The first was published in the New York Times, written by Katie Thomas and is entitled "A Promising Drug With a Flaw."  The second is a FDA Drug Safety Communication regarding Pradaxa.

The FDA undertook a review of the bleeding episodes of Pradaxa to follow-up on a FDA Safety Communication of December 7, 2011.  This new safety study concludes that "the results of this Mini-Sentinel assessment indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the large clinical trial used to approve Pradaxa (the RE-LY trial)."

The data according to the FDA report shows that intracranial hemorrhage, which is the most dreaded bleeding complication, occurs 1.8 to 2.6 times higher in new users of warfarin than Pradaxa per 100,000 patient days at risk.  The rates of gastrointestinal hemorrhage were 1.6 to 2.2 times higher for new users of warfarin than Pradaxa per 100,000 patient days at risk.  The excess bleeding in warfarin users is likely due to physicians' inability to control the effect of the drug on patients and the multiple interactions of warfarin with other drugs that patients are often given without a full understanding of their medical conditions.

So what is the problem that has the New York Times so spun up?  The problem is that Pradaxa has no way to be reversed.  It just has to "wear off," and in that time, the bleeding may not be controllable, and the patient can die.  Some conditions like intracranial hemorrhage are so devastating and unpredictable that it often doesn't matter what we do.  Further, although there is an antidote for warfarin, let me lead you through the steps.

First ,we have to figure out that you are on warfarin and that you are actually anti-coagulated. The data shows that this only happens about 60% of the time.  Second, you have to be "typed and crossed" to find out what blood type you are.  Third, the fresh frozen plasma needs to be unfrozen.  It can't be placed in a microwave.  It is put in a warm water bath and gently rocked back and forth.  I am not kidding.  You can hop up and down all you want, but you the doctor and you the patient  are not getting the fresh frozen plasma until the blood bank is good and ready to give it to you.  Then you have to administer it.  All of this takes precious time.  In the meantime, physicians do what we can, just like always, to support the patient.

The data to approve Pradaxa and Pradaxa itself need to be better understood.  First, we physicians give Pradaxa to any patient, but the oldest patient in the study to approve Pradaxa was around 80 years old.  The mean age in the RE-LY  study to approve was 71.4 +/- 8.6 years.  The older you are, the more likely you are to have a poor outcome.  Second, as I have blogged about before, the FDA made up the 75 mg dose.  The RE-LY study used both a 150 mg does and a 110 mg dose.

More - and there is plenty more - next week.


From bad to worse (Part I)

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

I have blogged recently about the disaster of contaminated drugs and about Pradaxa; both topics remain in the news. First, the contaminated drugs: this event is nothing short of a disaster. The company New England Compounding Center and its sister company, Ameridose, are both shut down. When the FDA tested 50 vials from one of the lots of the drug, all 50 vials were contaminated. In one lot, 83 of 321 vials had visual contamination of "greenish black matter," and 17 vials had "white filamentous matter." 29 patients have died, and a total of 404 cases have been identified. Most of these relate to injection of the material in the spinal column, but some relate to injection of the material into other joints like knees and shoulders.

Now a second problem has been added to the devastation of the first one. This problem is the development of an abscess at the site of injection. This abscess can extend into the space around the spinal cord known as the epidural space. This is a devastating problem. Perhaps not fatal but it can lead to paralysis and chronic pain. It is possible that some of these patients may need treatment the rest of their lives as the fungus may be controlled but never cured. This second infection seems to be occurring in at least 30% of the cases.

Further complicating the picture is that these secondary sites are occurring in patients who have been receiving treatment for the fungus, which is called Exserohilum. These infections can only be identified by MRI scans. Not much has been heard from the FDA, and there is speculation that the reason is pending Federal indictments. Certainly, this problem will require hearings and new legislation to mandate further protection of the public who rely on medication. This is another cautionary tale for those people who believe that States and not the Federal government should take care of their own.

In my blogs last month on trying to expand the use of Pradaxa, I mentioned that a study was underway to evaluate the use of Pradaxa in the anticoagulation of mechanical valves. This study, known as RE-ALIGN, has two arms. The first arm randomized patients immediately after surgery, and the second arm three months or later after surgery. The first arm has just been discontinued after an excessive number of strokes occurred.

The second arm continues. No new patients are being enrolled. This work is taking place in Europe and Canada. The dose of Pradaxa is the same dose that is being used for atrial fibrillation. This may not be the proper dose. When we use warfarin for the purpose of anti-coagulating valves, the INR level we use is 3-4. The level for atrial fibrillation is 2-3. The dose of Pradaxa used may simply be too small. Although not done clinically, the levels of Pradaxa in your bloodstream can be identified. The levels found in the first arm were lower than those compared to the atrial fibrillation group. This is what research is about. Entering the maze and trying to find your way out. Next...more "bad" press for Pradaxa.


Transcatheter Aortic Valve Replacement (TAVR) at 10 years (Part II)

  • Posted Nov 01, 2012
  • Alan Niederman, MD, FACC, FACP

This transformational technology has now been carried out and followed for three years in the United States and longer in Europe.  In PARTNER B, which randomized patients to either TAVR or medical therapy at one year, the TAVR group had a mortality of 43.3% and the medical therapy group was 68%.  Cardiac death was TAVR 31% and medical therapy 62.4%.

PARTNER A was a randomization of TAVR vs. SAVR or surgical aortic valve replacement.  This revealed at two years that the all cause death rates were similar.  This meant that either approach was beneficial.

At the recent TCT meeting in Miami Beach, the three-year data were presented from the PARTNER B group.  At three years, 80.9% of the medical therapy group had died.  54.1% of the TAVR group had died.  The value over time went from a 20% reduction in death at one year, to a 25% reduction at two years, to a 26.8% reduction after three years.

Nonetheless, this is a very sick group of patients:
Rehospitalization:  75.7% vs. 42.3% \
Mortality or Rehospitalization: 93.1% vs. 66.3 %
Mortality or stroke: 80.9% vs. 57.5%

The take home message is that even with the benefit of this treatment, these patients are sick and need aggressive follow-up care.  The patients who are "too sick for TAVR" may represent a group of patients for which a new treatment model should exist, which is primarily that of comfort care.

This therapy continues to expand.  There are more than 10 new valves which are under development in Europe.  Some of these are quite innovative.  The largest technical hurdle is preventing leaks around the new valve because the "fit" of the new valve in the old valve is imperfect.  At open surgery, the leaks around the valve are minimal or nonexistent because the surgeon has exact control.  When the valve is implanted without that the imperfect fit, it sometimes causes problems.  This is being adjusted by a bigger "skirt" around the bottom of the valve.  This valve is undergoing trials in Europe (of course) and should be available here in the United States in two to three years.

Most recently, the second approach to the valve site has been approved in the United States.  Of course, they have been doing it this way in Europe for five years.  The standard approach is through the leg, but the patient needs an artery that is 9 mm or greater.  In elderly petite patients, who often have the problem of aortic stenosis, the arteries are just too small.  We are now allowed to implant the valves directly through the heart.  The tip of the heart, or apex, lies right under the breast, and a small one- to two-inch incision is made on the chest to access the tip of the heart.

Sutures are then placed in the heart while it is beating, the delivery device is placed directly in the heart, and the new valve is implanted.  The delivery device is removed and the sutures pulled tight.  This procedure has been around for several years and both delivery approaches are well-understood.  The patients who get the transapical approach tend to be sicker than the transfemoral cohort.

In one last example of our inadequate system, there are more elegant ways to implant the valve, but they are not allowed by Medicare.  Eventually, but not now.

At Holy Cross Hospital, we are allowed to perform TAVR in both ways.  We have had excellent results in our first 13 patients.  We have had no deaths, strokes or vascular problems.  We have an excellent team of surgeons and interventional cardiologists who are spending a great deal of time to ensure that we provide to best service to our community.  Our Valve Clinic is run by a full-time Nurse Practitioner who is dedicated to this group of patients. After 10 years, this technique is becoming available to a wider selection of patients.  I will continue to update you as we continue to advance this technique.


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About Holy Cross Hospital

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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