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JULY 7, 2005
By John Carey, with Amy Barrett Is Heart Surgery Worth It? [Page 2 of 2] DIET AND LIFESTYLE. A better way to lower heart-attack risk is to fight the unstable plaque with aggressive cholesterol-reducing drug 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." The surgeries do 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." MAJOR PLACEBO EFFECT. 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, 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. CLOTS AND STENTS. 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. 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. SURGERY VS. DRUGS. 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 stentmakers 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 cholesterol-reducing drugs and other 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." VITAL INFORMATION. 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 overtreating 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. 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. MEDICINE'S LIMITATIONS. 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.
 Carey is a senior correspondent for BusinessWeek in Washington, and Barrett is BusinessWeek's Philadelphia bureau chief
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