Archive for May, 2010
One Pill Cures All
It has long been a goal of doctors, not drug companies, to make a pill that combines multiple medications that can be taken once a day. When I was in school, we named it “Wonderall.” This concept vastly increases compliance and it is hoped would prevent “events.”
The drugs in these pills are generic drugs that we have been used for years and are proven to do the jobs they are supposed to. The drawback is the doses chosen may not be enough for a particular patient. In medicine, one size generally does not fit all.
It is very easy for a patient to have to take more than 10 different medications several times a day. If you have heart disease, diabetes, lung problems, the list gets long indeed. Besides, the cost is just not practical and leads to many problems.
These pills contain 75 mg of aspirin, 40 mg simvastatin, 50 mg of atenolol and 10 mg of lisinopril. There has been some discussion about removing the aspirin because of the recent difficulties that I have blogged about. If you survived a stroke, you get a pill with 12.5 mg hydrochlorothiazide instead of the atenolol.
The study to take place in Great Britain, Ireland and the Netherlands and is known as UMPIRE or Use of a Multidrug Pill in Reducing Cardiovascular Events and will enroll 2000 subjects. To be enrolled they have had to have sustained a stroke, myocardial infarction or be at high risk. The primary end point is compliance but events will be monitored.
Another study which is starting is known as TIPS 2, which uses a pill containing 25 mg hydrochlorothiazide, 100 mg atenolol, 10mg ramipril, 40mg simvastatin and 200mg aspirin. This study will enroll 500 subjects and will be presented at the American College of Cardiology meeting in 2011.
Sadly none of these studies will take place in the United States. What’s up with that? Are we afraid of making it too easy for our patients? It’s really a disgrace, if you ask me. We should be at the forefront of this work to give possibly better, certainly easier care to our patients. Are we as physicians so enamored with 20 medications on a patient’s list? Do we get a prize for the most medications prescribed? Can we get with the program?
Anyone Want a Used Pacemaker?
In our land of plenty, one could spend a considerable amount of time bemoaning the waste that goes on in medicine. One of the areas where this is least apparent is that of devices and what their “shelf life” is. We all know that milk expires and generally doesn’t taste good. Meat spoils and lettuce wilts, but what about a stent or a pacemaker?
When the original drug coated stents arrived, they were in short supply. This problem was worsened by a decision that was originally made that had nothing to do with science. That decision was how long the shelf life should be, and this was determined by the testing of the drug by the FDA at a point in time. The time chosen was 6 months. So a stent was deemed good and could be implanted for up to six months after manufacture and if not used, it had to be destroyed. This had nothing to do with the actual time that it could have stayed on the shelf, perhaps up to a year or more. The same issue occurs with any sterile device. After their expiration date, they must be destroyed. I can not tell you the amount of money that is wasted by the manufacture and destruction of devices but I am sure it is an astounding amount.
What about a pacemaker or defibrillator that has just been implanted and two weeks later must be removed and replaced? What do we do with it? Well, in the United States it is generally thrown out. Does it need to be?
At the recent Heart Rhythm Society meeting in Denver, a paper was presented about this issue. I applaud these Investigators as they have done a great service for many patients. In brief they explanted 17 devices had them cleaned, yes it is possible, just not allowed in the United States, and then they were implanted in patients who need them in Managua, Nicaragua.
Holy Cross sponsor’s medical missions in Nicaragua under the Sponsorship of the Sisters of Mercy and Dr. Ed Coppersmith have led many of these missions. I have been on two and many of the physicians at Holy Cross have participated, so I am familiar with the circumstances of medical care there. Neither Holy Cross nor any of its physicians have participated in this project that I am reporting.
To be accepted the devices had to have > 70% of the battery power left. They were checked at discharge, four weeks later and every six months there after. The mean follow up was 68 months. These devices performed as if they were new. No patient who was asked to donate a device refused. No infections were found.
The organ donation campaign uses the slogan “don’t send your organs to heaven.” Maybe we as cardiologists should start are own campaign “don’t throw your devices away.”
Now We Can Do It!
The use of the Impella device has significantly expanded what can be done in the cath lab, while at the same time significantly increasing the safety of some angioplasty procedures.
Let me give you some examples of recent cases that I have done with the help of my surgical colleagues. An 88-year-old man, who I have known for sometime, presented to Holy Cross Hospital with disabling angina. He is known to have advanced coronary disease and was recently turned down for cath at another facility. This individual has a totally occluded left anterior descending artery, in other words, the artery to the front of his heart. In addition, he has a totally occluded artery to the bottom of his heart the right coronary artery. He is living on collaterals and his one remaining artery, the artery to the back of his heart the circumflex.
He was completely active before this occurred but has been getting more symptomatic over time. After discussion about how to proceed, he underwent catheterization and was found to now have in addition to his other lesions, a new lesion in his circumflex of 95%.
It is just not possible to work in someone’s last remaining heart artery because the heart doesn’t tolerate having no blood going to its muscle and conduction system. My surgical colleagues were not anxious to operate given his age and the distal bypass targets. The Impella device provided the answer. After being placed, I was able to take the time necessary to perform the angioplasty and at the conclusion of the procedure, he was so stable that I was able to remove the device in the cath lab.
A second recent case was a 52-year-old patient who was 18 years post surgery and had a severely low ejection fraction. He presented with unstable angina and cath showed him to have a 99% lesion in his vein graft to a very large right coronary artery territory. As this area of his heart was the area working best any problems with the graft would have caused hemodynamic collapse and likely his death, as we would not have been able to get him to surgery in a stable condition. After placing the Impella, I was able to proceed with the angioplasty with complete control of the situation and if the worst happened he would have a chance of getting into the operating room.
This blog does not do this device justice. Although I have tried to relate to you the importance of this device in providing us a measure of safety in our procedures it has remarkably expanded our ability to spare patient’s surgery, which in these cases is generally followed by a long and arduous recovery. Its ease of use and placement is a testimony to the company which developed it. It is American medicine at its best.
An Important Advance
Medicine in general moves slowly in fits and starts until the rough spots are smoothed out. At times, physicians can use a drug for years, and only after it’s been around for so long that it’s almost off of patent, we come to find out we don’t even know how to dose it, Plavix anyone? At other times, a change is so important as to open up areas of patient care that we have been struggling with for the beginning of angioplasty.
Stents are an example. The effect was so striking that it arguably rescued angioplasty, which although it worked, would never have the acceptance that it does today. The goal of full cardiovascular support for failing hearts has been a dream for many years and multiple companies have tried and failed to provide physicians with a machine to do the job. Many of these companies were destroyed in the process.
Physicians now have such a device. This device is known as an Impella and was developed by Abiomed. The more powerful version of this device, the 5.0 Liter is used by the cardiovascular surgeons and the interventional cardiologists use the 2.5 Liter version.
The 2.5 liter device can be placed in a leg artery in a standard fashion for us, and the resulting incision can be easily closed in spite of its diameter. The larger 5.0 must have a surgical placement. The 2.5 device gives a patient a cardiac output of 2.5 liters, which is more than enough to hemodynamically stabilize a patient in shock from any cardiovascular condition. The device is placed through the aortic valve over a wire just like we place any catheter and then sucks blood out of the heart with a spinner which creates a venturi flow which propels the blood through the body.
The surgeons can completely support a failed heart with the 5.0 machine and this allows the heart to rest and recover while the kidney, liver and brain sustain maximum support. This allows coronary bypass and some valve operations to be performed that were not possible before this development.
Only a handful of these machines and the doctors that can use them are in South Florida. We at Holy Cross were the first in Florida to have the 5.0 device because of our experience with the 2.5 version.
Next…what we do with it in the cath lab
More On Calcium Scores
My last blog concerned the use of calcium scores to determine whether a patient did or did not have coronary artery disease. An article has been published that I would like to share with you because it compares the Framingham risk calculator and the use of calcium scoring to determine which is better in defining patient illness.
This article titled “The detection of any coronary calcium outperforms Framingham risk score as a first step in screening for coronary atherosclerosis” was published in the Am J Roentgenol 2010: 194:1235-1243. The study details that 1416 men and 707 women were included. The mean age of the men equaled 51.4 years, and the mean age of the women equaled 56.9 years.
In those patients who had a presence of a segment plague score of 4 or higher, any calcium was 98% sensitive in men and 97% sensitive in women. In the same population if you had a Framingham risk score of 10% or higher, it correlated with the findings only 74% of the time in men and 36% of the time in women.
If your plague segment score was 3 or higher, the presence of calcium was 97% sensitive in men and 92% sensitive in women. In contrast, the Framingham score of 10% or greater was found in 88% of men and 35% in women.
This is not really surprising as I explained before that the presence of any calcium infers that the patient has the illness and needs to be treated. It does not mean that they have symptomatic disease but the data can be used to propel the patient to “make the right decision” and stop smoking, control their blood pressure and take statins. In much the same way the Framingham calculator does that because you input the blood pressure, the smoking status and the LDL level as some of the information to achieve a score. By “manipulating” the data, one can point out that lowering numbers or stopping smoking reduces risk considerably.
Why the disparity in women and men scores is so great, I do not know. It is widely understood that the diagnosis of coronary disease in women lags behind men, although equal numbers of men and women die each year. Perhaps women should have scoring and men the Framingham test and then the numbers would be more reflective of need.
Technology may help us lead the way to better patient care in both men and women.
What Does a Calcium Score Mean?
Technology now aids cardiologists in making decisions as to which patients may or may not have coronary artery disease. In the past, this was quite difficult and led to many needless tests and the repetition of tests that provided no value to patient care. As the readers of my blogs know, many pieces of a patients illness can be placed into risk calculators and then a risk can be assigned that will help cardiologists in decision making. The Framingham calculator is one such tool. The higher the score the more risk and the more concern with a work up. There is no one right way to do it.
It has become more and more difficult to do this without substantial interference from insurance companies. Many now require pre authorization before any work up and this includes cardiac cath. They are essentially practicing the medicine of NO. It is very complicated and time consuming to accomplish any sort of work up and this is likely to be the tip of the iceberg.
Now an article in the J AM COLL Cardiol 2010 55:1110-1117 has been published discussing the technique of calcium scoring and its usefulness in both determining who is at risk and when they would need to be tested again. As it is claimed in the article “what is the warranty for a negative score?”
When atherosclerosis starts in an artery, the artery first gets larger in a process known as positive remodeling. Only when this process stops does the obstructive phase of atherosclerosis begin so in general angina caused by blocked arteries is a very late phenomenon in the illness. Calcium is deposited and can be visualized in coronaries early on and this is what is seen on the CT scans. Using high speed scanners and one pass of the gantry a score can be assigned from zero to over a 1000. The higher the score
The more risk there is. If your score is zero, then you are likely to remain free of coronary events for four years according to the article.
This kind of work is useful for both determining the burden of illness and the limiting of downstream tests in an individual patient. It should in theory allow us to control costs in a meaningful way. That is if the insurance companies let us.
This is Really Something
Ever since Star Trek introduced us to the concept of nano particles and technology, we have seen some examples but we are still awaiting the first real use in medicine. It has become the vogue to try and target cells for destruction with chemotherapeutic agents to “spare” healthy cells, something that we do not have control over now but today the success is limited.
A report has appeared of a novel use of nano technology to possibly help in the war on cholesterol deposits in the coronary arteries. We do not have a good model of human atherosclerosis because we are the only species to suffer from it. Researchers can give other species a semblance of coronary disease but it doesn’t do ours justice, just try cracking an atherosclerotic coronary artery plaque with 18 times atmospheric pressure and watch nothing happen to it.
Researchers in Russia and the Netherlands have developed a method of delivering silica- gold nanoparticles to the plaque in coronary arteries and when these particles are exposed to infrared light from outside the body the particles heat up to 50- 150 degrees centigrade and “burn” the plaque while the surrounding tissue is not effected.
The effect is hoped to produce inflammation, which in turn leads to healing. This has already been done in a small group of patients in several different ways. 97% of the plaque was destroyed in a small group when the cells were delivered by circulating progenitor cells, which are similar to stem cells. A laser catheter was then used to deliver the energy. This led to the revascularization of the patient by the opening of the artery much like angioplasty.
One year later the arteries were still open in the patients treated. The field of cardiology continues to test the boundaries of our knowledge. When Dr. Gruentzig started most people believed angioplasty would never work. In multiple ways researchers are looking for better and easier ways to stop the progression of coronary disease. I am hopeful for our future.
The Perfect Storm for Health Care
I knew things were bad, but recent data released from the National Health and Nutrition Examination Survey (NHANES) report that what I have been blogging about lately takes the cake (Excuse the pun.) The report is published @ Fryar CD, Hirsch R, et. al. Hypertension, high serum cholesterol, and diabetes: Racial and ethnic prevalence differences in U.S. adults, 1999-2006. Hyattsville, MD: National Center for Health Statistics, 2010.
In brief, the report outlines 45% of individuals who are 20 years or older have hypercholesterolemia, hypertension, or diabetes. 3% had all three, and 13% had two most commonly; hypertension and hypercholesterolemia.
In 15% of all US adults, these conditions are undiagnosed. The levels used in these studies are not as “stringent “as the levels with which we cardiologists work with, which would undoubtedly would lead to an increase in these issues.
This brings up many points. The first one is people are going to have to take more responsibility for their health. Weight loss is the primary goal, as it will lead to a decrease in all three of these events. If you are at your “ideal” weight (and who among us are), then medications are warranted to prevent the long term consequences of these illnesses. As I have blogged about before, these illnesses start early and progress silently over time until the myocardial infarction or stroke occurs. It doesn’t really do much good the hose the burning barn down. It is far better to protect the barn.
Data has shown and I have blogged that as your LDL cholesterol drops the event rate for stroke and myocardial infarction drops. There is no plateau. An LDL of 70 is better than 80 and an LDL of 50 is better than 70. If you are taking cholesterol medication, get the maximum benefit and take the maximum amount. There is no significant increase in side effects and that is well documented. One scary event that is occurring is the constant switching of medications by insurance companies for no other reason than price. The statin drugs are not the same and to reach “goal” the amounts that patients need vary widely. Don’t get lulled into the amount you are taking. If you don’t take the “right” amount, you are risking the side effects without the full benefit.
Hypertension is more controversial. As we have recently seen and I have blogged about the ACCORD trial shows that lower is not necessarily better. You should strive to keep your systolic numbers below 140 and your diastolic numbers below 90.
The biggest benefit comes from exercise, which will help with diabetes, hypertension, and cholesterol. As Nike says Just Do It.
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