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In accordance with Title 17 U.S.C. Section 107, the material below is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

 An article from Business Week

Is Heart Surgery Worth It?
Physicians are questioning whether bypasses and angioplasties necessarily prolong patients' lives

 By John Carey, with Amy Barrett in Philadelphia

Copyright © 2005 Business Week July 18, 2005, pp 32-36
www.businessweek.com

You start breathing hard after climbing stairs, and your chest hurts. You go to your doctor. Scans reveal that arteries feeding your heart are severely narrowed. Your doctor sends you to the hospital for coronary bypass surgery or angioplasty to restore the blood flow to your heart. Despite the trauma of surgery, you're glad the blockage was caught in time, saving you from a potentially fatal heart attack.

There's just one problem with this happy tale of modern medicine: More and more doctors are questioning whether such heart procedures are actually extending patients' lives. One of them, Dr. Nortin M. Hadler, professor of medicine at the University of North Carolina at Chapel Hill and author of The Last Well Person, is urging the U.S. medical Establishment to rethink its most basic precepts of cardiovascular care. Bypass surgery in particular, he says, "should have been relegated to the archives 15 years ago."

That is an extreme view that is disputed by cardiac surgeons. "The reason thousands and thousands of bypass surgeries have been done is that [the procedure] is successful," says Dr. Timothy J. Gardner, co-editor of Operative Cardiac Surgery and a cardiothoracic surgeon at Christiana Care Health System in Wilmington, Del.

Nevertheless, the data from clinical trials are clear: Except in a minority of patients with severe disease, bypass operations don't prolong life or prevent future heart attacks. Nor does angioplasty, in which narrowed vessels are expanded and then, typically, propped open with metal tubes called stents. "People often believe that having these procedures fixes the problem, as if a plumber came in and fixed the plumbing with a new piece of pipe," explains Dr. L. David Hillis, professor of cardiology at the University of Texas Southwestern Medical School. "But it fundamentally doesn't fix the problem."

With doctors doing about 400,000 bypass surgeries and 1 million angioplasties a year—part of a heart-surgery industry worth an estimated $100 billion a year—the question of whether these operations are overused has enormous medical and economic implications. "It is one of the major issues in cardiology right now," says Dr. David Waters, chief of cardiology at the University of California at San Francisco.

It is also part of a far broader problem—what some health-care experts call the medicalization of life. "None of us will live long without headache, backache, heartache, heartburn, diarrhea, constipation, sadness, malaise, or other symptoms of some kind," argues Hadler. Yet under relentless bombardment by messages from the pharmaceutical and health-care industries, Americans increasingly believe that these symptoms—and many others—are conditions that can and should be cured. "We have an image of ourselves as invincible and powerful and able to overcome all odds," Hadler says. "And the lay press is too quick to talk about the latest widget and gizmo without asking what it is and does it work."

HIGHER COST, BIGGER RISK

Indeed, there is compelling evidence that more health care and more aggressive treatment across the complete spectrum of illnesses is not necessarily better. When Dr. Elliott S. Fisher, professor of medicine at Dartmouth Medical School, first looked at regional differences in health-care spending in the U.S., he assumed that people in areas with lower expenditures would have worse health than people in regions where spending was 1 1/2 to 2 times as high because they were failing to receive needed care. It turned out that the opposite was true. "Patients have a substantial increased risk of death if cared for in the high-cost systems," he says. Why? For one thing, additional doctor visits and testing often lead to unnecessary procedures and hospitalizations, which carry risks. "My data suggest that we are wasting 30% of health-care spending on stuff with no benefit and perhaps causing harm," says Fisher.

International comparisons support his reasoning. The U.S. spends 2 1/2 times as much as any other country per person on health care, but that doesn't translate into better outcomes, according to studies that compare such indicators as fatality rates after a heart attack and length of survival after a kidney transplant. That suggests that "the investment in health care in the U.S. is just not paying off," says Gerard Anderson, director of the Center for Hospital Finance & Management at Johns Hopkins Bloomberg School of Public Health and co-author of a 2004 study that looked at 21 different health-quality indicators in five nations.

SSimilar comparisons can help pinpoint dubious treatments. The classic case: tonsillectomy. In the early 1970s, Dr. John E. Wennberg, now director of the Center for Evaluative Clinical Sciences at Dartmouth Medical School, showed that some hospitals removed tonsils 10 times as often as others. But the children in areas with low rates weren't worse off, so the operation fell out of favor. More recently, Dr. James N. Weinstein, chair of orthopedic surgery at Dartmouth-Hitchcock Medical Center, found that people with back pain are up to 20 times as likely to have back surgery in some parts of the country as in others. Yet it's not clear that they do better as a result. Weinstein is comparing the outcomes in patients who get different treatments, from rest and physical therapy to spinal fusion. Meanwhile, he says, "billions of dollars are being spent without good information."

This is of obvious concern to those who pay for health care, from the government to private insurers, which are struggling to better balance costs and benefits. And nowhere are the financial and health stakes higher than in the area of cardiac surgery. /span> U.S. patients and insurers will spend $3.4 billion this year on drug-coated stents from suppliers Boston Scientific Corp and Johnson & Johnson, according to Citigroup. At many hospitals, cardiac units have become major profit centers. "We've shown that it is a lucrative area for hospitals," says Paul B. Ginsburg, president of the Center for Studying Health System Change. But are heart procedures always the best path for patients who currently get them?

TThe answer seems to be no. As Hadler describes in his book, data from bypass-surgery clinical trials in the late 1970s show that the procedure extends life or prevents heart attacks only in a small percentage of patients -- those with severe disease. More recent trials with angioplasty show it reduces deaths mainly just in emergencies. "For people in the throes of heart attacks, opening the artery definitely prolongs life," says UCSF's Waters. Not so for patients with stable chronic disease. "The overwhelming number of heart procedures done these days do not affect patients' life span at all," says Hillis.

The latest thinking on heart attacks may explain why not. In the traditional view, the slow accumulation of plaque inside arteries gradually narrows the vessels. Reduced blood flow causes chest pain, or angina. Eventually the arteries are blocked, bringing on heart attacks. Newer evidence, however, pins the blame not on this gradual narrowing but on unstable plaque that breaks off and causes clots. The clots are what obstruct the arteries, causing the heart attacks—which is why so many such events are unexpected and why "there is no evidence that opening chronically narrowed arteries reduces the risk of heart attack," says Waters.

 DIET AND LIFESTYLE

 A better way to lower heart-attack risk is to fight the unstable plaque with aggressive therapy, diet, and lifestyle changes, many cardiac physicians say. That can be a tough sell to patients who want a quick fix, says Hillis. "Medical therapy is just not as sexy as doing a procedure," he explains. "The assumption our society makes is that the more aggressive your medical care is, the better it is. It's not true. But if I explain to a patient why he doesn't need surgery, 9 times out of 10 he will go across town and find someone who will do the procedure/span>."

The surgeries may relieve angina symptoms—and for some doctors that's a slam dunk. Emory University cardiologist Dr. Robert A. Guyton, co-chair of the American College of Cardiology and the American Heart Assn. committee that wrote the current bypass-surgery guidelines, points to patients disabled by pain and shortness of breath who, a month after bypass surgery, "are walking around as healthy as you or I," he says. "To say the whole operation ought to be scrapped is nuts." Similarly, angioplasty eases the often crippling pain of angina. "There is quite a lot of good evidence for symptom relief," says Dr. Robert Henderson, a cardiologist at Nottingham City Hospital in Britain and co-investigator for a key angioplasty clinical trial.

Critics such as Hadler, on the other hand, emphasize the risks. Not only is there a 1% to 2% chance of dying during a bypass operation [or angioplasty], he explains, there is a high risk of complications and a 40% chance of cognitive deficits. The healthy, active post-surgery patient is an "urban legend," he says. "An alarming number never return to the workforce or describe themselves as well again."

Recent studies even raise questions about whether surgery causes the symptom relief. In June, Harvard Medical School associate professor of medicine Dr. Roger J. Laham reported on follow-up results of a randomized trial looking at laser surgery to improve blood flow. Patients who got the surgery had significantly less pain and improved heart function. But so did patients who had a sham operation—the equivalent of a placebo. After 30 months the placebo effect was still there. Scans and other tests showed physiological gains in blood flow among only those who thought they had been operated on. A similar large placebo effect might explain "most of the benefits that we've seen so far with balloon angioplasty and bypass surgery," Laham says.

There are also fresh concerns about the safety of drug-coated stents, now widely used in angioplasty. When doctors first tried to open clogged arteries with a balloon, they found that arteries soon closed again. So they began inserting metal mesh stents to hold them open. When arteries continued to clog up again, companies devised stents impregnated with drugs that slow the growth of cells, reducing chances that patients would have to have their arteries opened again.

First approved in April, 2003, drug-coated stents account for 88% of the stents used in the U.S. But when pathologist Dr. Renu Virmani, medical director of CVPath, a research service of the International Registry of Pathology, examined the hearts or heart vessels of 39 patients who died after getting the new stents, she found clots in 11 cases that developed more than 30 days after the procedure/span>. The sample is small, and it's not clear that the clots caused the deaths. But it's a big jump from her experience with patients who died after getting bare-metal stents. Just 12.5% of them had late-developing clots.

What worries some doctors is that people getting the new stents might have a higher risk of clots, which then could cause heart attacks more than a month after the procedure.. "Out of 100 patients who get a drug-coated stent vs. a bare-metal stent, maybe 10 will avoid a repeat procedure," says Dr. Eric J. Topol, chief of cardiology at the Cleveland Clinic Foundation. "But how many will wind up with a heart attack or death? Maybe one in 1,000? We just don't have that nailed down yet." Drug-coated stent-makers Boston Scientific and Johnson & Johnson say their clinical trials show no such increased risk of late-developing clots.

Cardiac surgeons readily admit there are big unanswered questions. "We can handle the criticisms, and we should be accountable," says cardiothoracic surgeon Gardner. "But there is plenty of hard work going on to try to determine the appropriate patients for whom such treatments are necessary." There are also large clinical trials under way comparing surgery with medical treatment, which will provide better answers. If the trials show no benefit to surgery compared to medicine, "it will be a serious challenge to the coronary-intervention industry," says Dr. Robert H. Jones, distinguished professor of cardiothoracic surgery at Duke University Medical Center. His prediction? "I'm a surgeon, so I think surgery will hold up."

The answers still may not be definitive, however, because medicine continues to advance. "Every time these studies come out and show that revascularization [improving blood flow] doesn't do much, cardiologists say: 'Well, that study was started four years ago, and now we have shinier stents, and the results are better,"' notes UCSF's Waters. "But medical therapy [with drugs] is getting much, much better, too." Harvard's Laham suggests that as many as 400,000 of the angioplasties done in the U.S. each year may be medically unwarranted. "I'm sure we are way over-treating our patients," he says.

Some scientists argue that the rational solution is to let patients decide for themselves. But that requires providing detailed information about the risks and benefits of medical procedures, such as coronary surgery—including the unknowns. /span> In trials where one group gets the information and the other group receives no special attention, the well-informed patients opt for more invasive, aggressive approaches 23% less often, on average, than the other group. Without this full information, "patients typically don't understand that they have options, and even if they do, they often wildly exaggerate the benefits of surgery and wildly minimize the chances of harm," says Annette M. Cormier O'Connor, clinical epidemiologist at Ottawa Health Research Institute and a leader in this field of so-called decision aids.

It's a model approach for medicine in general. As Hadler argues, the exaggeration regarding benefits goes far beyond heart surgery. Too many common conditions are viewed as diseases needing treatment, and too many treatments of uncertain benefit are used too often. "What Hadler does is question the soundness of that thinking in a very profound way," says Dr. Glenn D. Pomerantz, senior vice-president for global innovation at Cigna. Hadler hopes that enlightening people about the limitations of medicine will help them worry less and stay well longer. It also could help cure an ailing health-care system, making it more rational. In the end, few doctors will object to the basic prescription: Avoid drastic procedures that probably won't help and might actually do harm.


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In accordance with Title 17 U.S.C. Section 107, this material below is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

An article from Discover Magazine

The Doctor Who Doesn’t Check His Cholesterol

"Bypass Surgery belongs in the medical archives. . .No Western European nation has as high a rate of bypass surgery and angioplasty as we do—and they live longer."

Norton Hadler, M.D., Professor of Medicine, University of North Carolina Chapel Hill

 Interview by Susan Dominus
 Copyright © 2005 Discover Magazine, June 2005

For three decades Dr. Nortin Hadler, a Professor of medicine at the University of North Carolina at Chapel Hill, has been rigorously examining statistics generated by his medical colleagues' practices and arriving at startling conclusions about their effectiveness. To take just one example, Hadler is credited with leading a complete rethinking about the treatment of back pain, which he finds excessive. He wrote the editorial accompanying a landmark study in The Journal of the American Medical Association two years ago suggesting that the benefits of surgery for back pain are over-rated.

He has also taken on heart treatment, testifying before Congress and the Social Security Advisory Board and publishing papers arguing that very little data back up the value of modern treatments like bypass surgery and angioplasty. He took his case about cardiac care and other health issues to the public in The Last Well Person: How to Stay Well Despite the Health-Care System (McGill-Queen's University Press, 2004).

Your book makes the case that too many people are having bypass surgery without much advantage. Under what circumstances do you think bypass surgery is appropriate?

H: None. I think bypass surgery belongs in the medical archives. There are only two reasons you'd ever want to do it: one, to save lives, the other to improve symptoms. But there's only one subset of the population that's been proved to derive a meaningful benefit from the surgery, and that's people with a critical defect of the left main coronary artery who also have angina. If you take 100 60-year-old men with angina, only 3 of them will have that defect, and there's no way to know without a coronary arteriogram. So you give that test to 100 people to find 3 solid candidates—but that procedure is not without complications. Chances are you're going to do harm to at least one in that sample of 100. So you have to say, "I'm going to do this procedure with a 1 percent risk of catastrophe to find the 3 percent I know I can help a little." That's a very interesting trade-off.

 So you believe the vast majority of those who have had this major surgery have suffered through it for no reason? That seems so counterintuitive. Everyone seems to know a father or uncle who's been given a new lease on life after their bypass surgery, with more energy and less chest pain.

H: This analysis is upsetting for people to hear—feel free to yell at me if you need to. I'm really asking people to rethink common sense. But people don't realize that angina is an intermittent illness. It comes and goes. You can have it for months and then months off. Classic cardiologists used to help people handle the symptoms by treating it like a chronic illness. Well into the 1960s and 1970s, they helped people cope with the anticipation of pain, prescribing drugs like nitroglycerine and helping patients learn to wait until things calmed down a little bit.

But for those people bypass surgery helps, it's not intermittent—it makes the pain go away altogether. Isn't that worth something?

H: You have to consider how much of that relief is a function of natural history and placebo effects. In one controlled trial of surgery for angina, half the people with the condition underwent an operation in which doctors merely made a skin incision and closed it up; in the other half, the patients had a particular kind of bypass. The numbers from each group whose symptoms were significantly alleviated were about the same. Angina is particularly susceptible to the placebo effect because the anticipation of pain adds to the intermittency of it. FDA-approved pharmaceuticals for alleviating angina have about a 55 percent effectiveness level in randomized controlled trials; the placebo runs about 45 percent. Even if surgery could be proved to alleviate the discomfort, you'd have to consider if that offsets the risks of bypass surgery—about half the patients suffer severe depression after the surgery, a third suffer measurable memory loss, and many never go back to work again. Then there are the added risks of any major surgery.

  You analyze the definitive studies and find that the number of people whose lives are saved by bypass surgery, angiograms, and cholesterol-lowering drugs Is statistically insignificant—and yet life expectancy has risen since the advent of all three of those treatments. If it isn't better cardiac care that's extending lives, what Is?

H: The start of the rise in longevity kicked in long before cardiac intervention became popular. Looking at life-course epidemiological studies, the secret lies in two questions: Are you comfortable in your socioeconomic status, and do you like your job? With regard to socioeconomic status, the central question relates to relative wealth—in other words, the smaller the income gap in a given area, the better the longevity. Where the income gap is larger, the poor die sooner. These are powerful associations. The answer does not lie in modern medicine but in modern society.

  Let's say we could come up with a magic pill that would dramatically reduce deaths by heart attack—then do you think we'd see an even further rise In lib span?

H: We'd still die at around age 85 of something. When people die of heart disease at that age, it's not just heart disease they're dying of, even though that might be the official diagnosis—it's usually multi-system disease, or as ft's more commonly known, frailty. That's the most common cause of death.

Surgery is obviously Invasive, but why do you object to the widespread prescription of statins, the cholesterol-lowering drugs?

H: In men with normal cholesterol levels, the risk of death for those between ages 45 and 65 over the course of the next five years is only a fraction of 1 percent lower than it is for men with high serum cholesterol in the same category. The most thorough study to date had some 3,000 men with "high" cholesterol levels take a statin every day for five years, while 3,000 similar men took a placebo. When all was said and done, there was no difference in cardiovascular deaths between the two groups. Statins do reduce the risk of heart attack in those who have a strong family history of people in their family having heart attacks very young—but that's a small percentage of the population. You could argue, looking at the data, that they're helpful for people who've already had one heart attack. But for everyone else, the possible advantage is marginally and clinically insignificant.

You're 62—do you get your cholesterol checked?

H: I don't want to know. We have data that tell me if you stigmatize me by labeling me somehow, it will change my sense of well-being. I have nothing to gain from that in this case. I would be infuriated if any doctor checked my cholesterol without my asking and told me if it was up or down. I would think that would be an abuse of science that offered me a chance of feeling less well for no good reason.

 If the data are not prompting so much interventional cardiology, what is?

H: Money. Interventional cardiology is what supports almost every hospital In America—it's an enormous part of our gross domestic product. Every year in this country we do about half a million bypass grafts and 650,000 coronary angioplasties, with the mean cost of the procedures ranging from $28,000 to $60,000. There are a lot of people involved in this transfer of wealth. But no Western European nation has such a high rate of those procedures—and their longevity is higher than ours.

Do you think your book will have any impact on the decisions cardiologists make?

H: I want it to start a dialogue, the way we did with back surgery 10 years ago, to shift the debate so that people are not just talking about how good you are at doing an angioplasty but if it should ever be done.

  So what are patients supposed to take away from your critiques?

H: I think the patient's job is really to find the right person, the right doctor. You need a relationship with a physician who can listen to your experience of illness and consider with you the benefits and risks of all options. The system is not set up to benefit you in this fashion, because it's set up as part of an enormous business model. There's too much that we're doing that doesn't help. That doesn't mean we don't need physicians or that many aren't caring people. But if I had my way, cardiologists would no longer take care of hearts. They'd take care of people with heart disease, and if they were doing that, they shouldn't be doing angioplasties

  The kind of statistical analysis you do is laborious and often yields results people don't want to hear. Why have you made this form of research your sideline?

H: I pursued medical training as a young man in order to serve in what I saw as a ministry, a calling—that's what I felt. And I sought out and received some elegant education on how to implement the classic Greek warning to "do no harm," to be sure that what you're doing is good. We now have the wherewithal, thanks to issues in statistics and experimental design, to actually put meat on this question: Am I doing better or worse with the common practice or the not-so-common practice? It's the theme of my life as an educator.

  Your arguments seem to demand a major rethinking of how we practice modern cardiac care. Has the response from the medical community, many of whose practices you condemn, been fierce?

H: Not really. The book review in The Journal of the American Medical Association, about as establishment a journal as you can find, was so positive I'm convinced my mother wrote it.

Copyright © 2012 Elmer M. Cranton, M.D., all rights reserved
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