Archive for the ‘Cardiac Surgery’ Category
Share Our Mission to Heal
Holy Cross Hospital is seeking studio audience members for A Mission to Heal, a new show all about the heart.
Needed: 75 audience members for each show; Mix of demographics. No children under 18; Community groups are encouraged to have representation in the audience, as well as community leaders.
Where
A studio in Davie, FL. Details will be provided to audience members upon selection.
When
September 30, 2010; Refreshments will be served.
The show is not “live” but it is being recorded “live” so it will be edited and shown at a later date. Audience members should dress comfortably for long periods of sitting. No white blouses, shirts, hats or sweaters.
Please email info@holy-cross.com and put A Mission to Heal in the subject field OR call 954-776-3244 if you are interested in being part of the studio audience.
Please provide your full name, phone number, e-mail address, age range (20s, 30s, 40s, 50+) and race/ethnicity. Someone will be in touch to let you know if you have been selected and provide additional information.
Do statins make you immortal?
My blogs over the past week have been concerned about the screening of asymptomatic patients for coronary artery disease and whether we make a difference in their morbidity and mortality if we find it.
That’s really all we are concerned with: Can we, as physicians, change a patient’s outcome by putting in place a medicine or a lifestyle? What good is it to find a problem if you can’t act on it?
To date, what we do when we find a patient who we believe to be at risk is tell them to stop smoking, control their blood pressure and their diabetes. And, we put them on statins. As those that read my blogs know, statins are our first line of defense against progression of coronary artery disease when a patient already has an infarct, angioplasty or coronary artery bypass surgery.
An article was published in Arch Intern Med 2010;170:1024-1031 which addresses this question. It is titled Statins and All-Cause Mortality in High -Risk Primary Prevention: A Meta-Analysis of 11 Randomized Controlled Trials involving 65,229 Participants.
This represents over 244,000 person- years of follow up. The average LDL cholesterol was 138 mg/dl and the results of giving statins yielded an average LDL of 94 mg/dl. An average of 3.7 years of follow up occurred in these studies and there was no evidence of benefit in these findings (7 fewer deaths for every 10,000 person years of treatment).
Although compelling, I believe that this study is flawed by the short follow up. Remember, this is not a randomized clinical trial which is the highest level of significance; it is a Meta-Analysis and only collates the data already collected in like studies.
Statins were approved because they were tested in randomized clinical trials against placebo and there was always a statistically significant reduction in a triple endpoint of unstable angina, myocardial infarction and death. Death however is usually the least affected because we are much better at preventing it if patients who are affected by an acute event present to hospitals. Patients who are found to be “at risk” will continue to be offered statins and the data shows that the lower the LDL is driven, the lower the vent rate. There seems to be no plateau. Every time a study drives the number lower, the event rate follows and some studies have the LDL as low as 50 mg/dl. The study known as TNT, or Treating to new targets,
showed this result in a study with over 10,000 patients.
The real study we want to do can not be done because it is not ethical anymore. Withholding statins from patients would never pass muster. It could be done in patients who refuse statins but the numbers would never be great enough. We will just have to accept the premise for the time being until science moves ahead of need.
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
Checking Up On the Doctor
I have often blogged about our guidelines. Guidelines are recommendations promulgated by my society, the American College of Cardiology, which are written by a committee made up of some of the most distinguished cardiologists today. The recommendations come from the research that is done and are powered into various groups with multiple large randomized trials, receiving the most weight and the strongest recommendation.
Over time these guidelines are adjusted as new information is developed and are not “secret” they can be viewed by anyone at the college’s web site at www.acc.org. They are not intended to replace patient-centered decision making by experienced clinicians. That being said it is interesting to see whether or not guidelines are being followed in certain areas.
The review chosen was my area of expertise cardiac catheterization and the choices made after cath; i.e. the recommendations for medical therapy, angioplasty or coronary bypass surgery based on the coronary anatomy identified. The study used the New York State Cardiac Diagnostic Catheterization database and was published in Circ 2009; 121: 267-275.
The findings were that 94% of those indicated for angioplasty received it. That 93% of the patients who needed bypass surgery or angioplasty, received angioplasty. However, in those patients that the guidelines indicated surgery, 53% had surgery and 34% received angioplasty. Of the patients that neither surgery nor angioplasty were indicated; 6% received surgery and 21% received angioplasty.
It seems that those of us with the “hammer,” the doctor, doing the cath often find the “nail,” the patient. These data don’t take into account the multiple other factors that come into play such as patient preference to not have surgery, status of the patients medical therapy and other co morbid issues, which may limit surgical options.
The group that received therapy when not indicated is the most troubling but a very small proportion of the total 10,333 patients in the study. What the study does show is that Interventional Cardiologists may be “growing the business” by pushing the limits of angioplasty. Many hospitals like Holy Cross have committees to review cases to help critique and improve the work done at the facility. I am proud of my profession in our ability to look at ourselves and present findings that may not reflect well on us. This is how we learn and continue to improve so we can perform in the best interests of our patients.
Do we have the COURAGE to change?
I have blogged about the COURAGE trial in the past and I frequently refer to many of the common misunderstandings that patients have regarding the various treatments for coronary artery disease. As I have often said, the treatment for coronary artery disease is medical and then when medical treatment fails to treat the symptoms adequately, and that varies from patient to patient, angioplasty and then coronary artery bypass surgery is called for, depending on the angiogram findings.
The COURAGE trial was published in the NEJM in 2007 and became a recent topic in the Wall Street Journal on February 11, 2010. Keith J Winstein writing in the WSJ suggests that cardiologists have not changed their practice to account for the COURAGE results and this has cost 5 billion wasted dollars. The total US healthcare system spends an estimated 15 billion dollars a year on stenting procedures.
Further, the article makes the point that neither Medicare nor private insurance companies have changed their payments in regard to this issue. This may change as time goes on.
One of the integral parts of this controversy is our (speaking as an Interventional cardiologist) inability to always determine that an individual lesion is important. Angiography at a cardiac catheterization is the “gold standard” to determine the extent of coronary artery disease but it does not provide a “functional test”. What is meant by this is, “does the lesion in the coronary artery provide a lack of blood flow to the distal cardiac muscle bed?” We have methods of determining this before the catheterization by nuclear stress testing and at the catheterization by fractional flow reserve which I have blogged about in the past. This component was not part of the COURAGE trial. This test can safely determine which lesions are “safe” to defer angioplasty in.
In my daily practice I am already impacted in my ability to treat people as I wish. I will not “name names” but many insurance companies routinely deny nuclear stress testing regardless of the reason for the test and make you appeal the decision. I often have to get on the phone and explain to someone why I’m ordering a test. Medications are changed for “cheaper “versions in spite of long term success for the individual patient ignoring the successful achievement of “goal” targets.
I have spent my professional life helping to develop guidelines for the treatment of the illnesses with which I deal. Medicine and health care are not linear fields, often its one step forward and two steps back. I firmly believe in the COURAGE trial results but it did not impact my practice because that it how I practiced before the trial. We need to continue to do these studies and then incorporate them into our daily practice. The time will soon be here that patients will be better served by us by adhering to “state of the art guidelines.”
The History of Coronary Angioplasty
It’s hard to believe but true. When I finished medical school in 1980 we as physicians still did not know what caused myocardial infarctions. It was the classic chicken and the egg question. Autopsies showed some people had clots in their heart arteries and some did not. Some people believed that the clots caused the myocardial infarctions and some people believed that the myocardial infarctions caused the clots.
It took a groundbreaking study by Dr. Marcus DeWood of Seattle and published in the N Engl J Med 1980 Oct 16;303(16):897-902 to solve the problem. He catheterized 322 patients within 24 hours of their infarction. Although that doesn’t sound so groundbreaking now, when he did it this was unheard of. Many of these people were very sick and there was nothing that could be done for them. Angioplasty was developed but not in widespread use and thrombolytic therapy was not yet known. Many of the patients were taken to emergency surgery for reperfusion.
Let me digress for a minute. I will relate a story that Dr Andreas Gruentzig the man who invented coronary angioplasty related to me. I was in a cath lab at Emory University with Dr. John Douglas, who is one of the Grand Masters of angioplasty. We were doing an angioplasty in a cath room because someone who was having a cath closed his artery on the table. This was not an infrequent occurrence in the early days of cath. As this was the “wrong” room Dr. Gruentzig poked his head in to see what was going on. When he came into the room he saw what was going on and told us this story.
Although history states that the first coronary angioplasty was done in Zurich Switzerland in September of 1977, the first angioplasty in a human occurred prior to that. It was in just such a case that a patient closed his left anterior descending artery after a cath and his colleagues called upstairs for him to “bring down his balloons.” He did and he opened the artery successfully. This was the first reperfusion therapy by balloon in history. Dr Gruentzig then told his colleagues not to stop the heparin, a blood thinner that we used at the time. They of course did not listen and soon after the artery closed again and the patient went to emergency surgery. Laughing 6 years later, he warned us not to stop the heparin and walked out of the room. It is so vivid to me because it was the last time I saw him. He died in a private plane crash 2 days later at the age of 46.
DeWood found that in 110 of 126 patients in the first four hours of a heart attack had a complete occlusion of the heart artery and that this percentage decreased the longer past four hours someone went. This was the answer as to why the autopsies sometimes showed clot in the artery and sometimes did not. The autopsies were never correlated to the length of time after the symptoms of heart attack started.
Next…what we are still learning.
Vote for the Blog of the Year
Did Dr. Niederman post a blog in 2009 that you found particularly helpful? Was there a blog that you could not wait to share with someone else? We’d love to receive your feedback.
Please comment on what you think was Dr. Niederman’s best blog in 2009.
Weighing Your Surgical Options
I have over the last several blogs pointed out how ideas, when they come to medicine, need to be rigorously tested. I want to travel back to the original question which is “who needs coronary bypass or angioplasty to manage their coronary artery disease?” It is important to remember as I have blogged before that management of this illness is medically based. Patients need to stop smoking, manage their cholesterol with statins and diet, exercise, control diabetes and high blood pressure. At times, it becomes necessary to provide revascularization because primarily chest pain or angina is life limiting. This means that your lifestyle is hindered. This equation is different for a 45 year old man than an 85 year old man and realistic goals need to be put in place.
Angioplasty can often be easily done but does not provide a mortality benefit or a prevention of myocardial infarction. It is a treatment of symptoms that do not respond to medical management. Surgery is much the same. However, if you have left main disease or poor heart function with three vessel disease you will live longer if you have bypass surgery instead of medical management alone.
The method of surgery should be discussed with your surgeon and depends on the placement of your arteries, and the condition of the segments needed for bypass targets and other technical concerns. Also important is the surgeon’s case level and whether he or she is comfortable with the procedures required.
The concept of “minimally invasive surgery” and robotic surgery is untested at this time and is purely a variation that requires a good hard look. It was widely felt that off pump surgery would be better but that is not the case. Robots are very expensive and it remains to be seen whether the whole idea is worth the trouble and expense.
One further point about the ROOBY study is that it again proved the point about getting a complete operation. What I mean by that is that all the vessels that need to be fixed need to be fixed. Although that sounds silly, angioplasty will often target only certain arteries and “manage” the others. Off pump did a poorer job of bypassing all the vessels needed. This approach leads to worse outcomes with increased need for reoperation, angina and death. As always you should have a thorough understanding of what is wrong and what your options are. If you don’t get the answers you need continue to ask until you do.
Off Pump Study Results Recently Revealed
Published in the New England Journal of Medicine earlier this month were the findings of the ROOBY study (NEJM 2009; 361:1827-37). The Randomized On/Off Bypass study group was comprised of 18 VA medical centers and was conducted from February 2002 to May 2008. More than 9,600 patients were screened for entry into the study; 7,460 were excluded because they had poor target vessels, would not give consent, or their surgeons were not a participant; 2,203 were randomized and 1,104 were assigned to off pump, while 1,099 were assigned to on pump randomly. Of the1,104 randomized patients to off pump, 137 needed the bypass machine for the operation to be completed. Interestingly, of the 1,099 patients who were randomized to on pump operations, 43 were converted to off pump.
The results showed there was no significant difference in the 30 day composite outcome–7.0% for off pump and 5.6% for on pump. The composite was death or the complications of reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure.
Further, the results for the one year outcome were worse: off pump 9.9% vs. 7.4 % for on pump. The 1-year composite was death from any cause, repeat revascularization procedure, or a nonfatal myocardial infarction.
Follow up angiograms revealed the overall patency rate of the bypass grafts was 82.6% in the off pump group and 87.8% in the on pump group. The off pump group had a higher proportion of arteries not able to be bypassed 17.8% vs. 11.1%. There were no differences in neurocognitive outcomes or short term use of major resources.
Overall, this study showed that patients who had the standard operation did better. This result is similar to the findings of a recent Meta analysis and of several other smaller studies. Single center and single surgeon studies fare better and reflect different surgical abilities but do not reflect “real world” outcomes. In this study, you needed to have done at least 20 off pump cases to be considered an investigator.
There are several problems with this study – the most glaring is that it is almost exclusively an all-male study. Remember it was done at the VA and in spite of the different composition of our armed forces at the present time most women who are veterans are not at the age to need this type of medical care. These results can not be generalized to women who often have poorer bypass targets and would be expected to have poorer outcomes.
Next…putting this information in context.
The History of Coronary Artery Bypass Surgery
Coronary artery bypass operations are again in the news. This operation is the most performed operation in the world and dates back to the early 1960’s. We are still trying to improve upon it and enhance the results we can achieve.
Open heart surgery dates back to the early 1950’s when Dr. John Lewis repaired an atrial septal defect (a hole between the top parts of the heart known as the atrium, a birth defect). He did this by cooling the 5 year old girl’s heart. At about the same time, the heart-lung machine was first used by Dr. John Gibbon also to repair an atrial septal defect.
In 1956, Dr. Walton Lillehei corrected a patient with mitral regurgitation under direct vision using the heart lung machine. He went on to develop some of the new artificial heart valves and the pioneering techniques for this type of surgery.
In 1946, Dr Arthur Vineberg developed a technique to implant the mammary artery directly into the myocardium, allowing it to collateralize the vessels to the front of the heart. Roughly 5,000 Vineberg procedures took place between 1950 and 1970.
Dr. Vasilii Kolessov, a Russian cardiac surgeon, performed the first internal mammary to coronary artery anastomosis in 1964. Dr Rene Favaloro, a physician at the Cleveland Clinic, performed the first saphenous vein operation by harvesting a vein from a patients leg and bypassing the right coronary artery in 1967. Soon after Dr. Dudley Johnson in Milwaukee used the vein grafts to bypass the left coronary arteries.
Bypass surgery was out of the gate and to this day has not changed much in technique. It is invasive and the heart lung machine is believed to be detrimental at times to patients. Over the years the ability of surgeons has increased so that they now routinely perform this operation on sicker and older patients and to continue to drive the mortality to the operation to 1.6%.
Can this operation be done in a safer manner? Are the alternatives better?
Next…the alternative.
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