Some doctors say it may be time to give bypass operations a second look. They include even some cardiologists who specialize in the far more popular alternative — using stents
to keep coronary arteries open.
No one is predicting a sudden surge back to bypass, which is still a far more invasive and initially riskier way to treat plaque-clogged heart arteries, a condition that afflicts millions of Americans.
But in light of new safety concerns over the long-term risks of stents, as well as accumulating data indicating that the sickest heart patients may live longer if they receive bypass surgery instead, some well-known stent specialists say the pendulum may have swung too far away from bypass surgery.
“We as cardiologists have probably pressed forward on stent technology a little faster than we should have,” said Dr. Kirk Garratt, the director of research into stents and related heart therapies at Lenox Hill Hospital in New York, one of the nation’s leading stenting centers.
It is a remarkable acknowledgment, considering the medical and financial stakes in play. In the last decade, the number of bypass surgeries in this country has fallen by a third — to about 365,000 last year. Meanwhile, the number of patients receiving stents has soared, to nearly a million in 2006.
To some extent, the stent preference has been propelled by patients themselves, who have an understandable aversion to major surgery.
“Most of the time that I recommend bypass surgery, the patient begs me to put in stents instead,” said Dr. Ralph Brindis, senior cardiovascular adviser for the network of Kaiser Permanente hospitals and clinics in Northern California.
And cardiologists, the specialists who are most likely to diagnose artery disease, are in many cases also the doctors who implant stents. Their judgment heavily influences which patients get referred to surgeons.
Meanwhile, as Medicare and other insurers have curbed their payments for bypass surgeries, the cost of stenting has risen with the introduction of newer devices. Surgery and stent procedures are now comparably priced for patients with multiple blockages — an average of around $30,000, according to the American College of Cardiology and the American Heart Association
. Both procedures are generally covered by insurers.
But Mr. Goodman says he expects the number of bypass surgeries to begin rising this year, although he declines to forecast by how much.
What has changed most recently in the stents-versus-surgery calculus is new evidence that surfaced in clinical trials last year. The data disclosed a previously undetected risk with stents, which are tiny mesh cylinders that are placed in arteries via filament-thin catheters threaded from a tiny incision in the thigh.
Bypass surgery is the recommended treatment for such patients, according to the guidelines of the American Heart Association and the American College of Cardiology. But some doctors say too many patients never hear about those recommendations from their cardiologists.
A joint committee of the heart association and cardiology society expects to release new guidelines within the next month that could clarify the proper boundary between stenting and surgery, according to Dr. Sydney C. Smith Jr., the head of the committee.
Dr. Robert A. Guyton, the chief of cardiothoracic surgery at the Emory University
School of Medicine in Atlanta, argues that as many as 200,000 such patients who get stents each year should be having bypass surgery instead. He bases that conclusion on studies using data from nearly 40,000 patient cases in New England and New York and at Duke University
Stenting and bypass surgery are both meant to relieve symptoms like chest pain and shortness of breath, which are caused by a buildup of arterial plaque that may eventually lead to heart attacks and gradual heart failure.
Neither stents nor bypass surgery can halt the buildup of plaque. But surgery, by bypassing an entire section of diseased artery with a vessel taken from elsewhere in the body, can restore more blood flow and the benefits may last longer.
And while bypass surgery still typically involves the trauma of sawing through the breastbone to open the chest, the operation is getting gentler. Blood vessels for grafting can be harvested from arms and legs through much smaller incisions than in the past, for example.
And about 20 percent of the operations no longer require stopping the heart and attaching patients to an external pump, thus eliminating a step believed to increase the risk of strokes in the sickest patients. Some bypasses now can even be performed using a robotic tool through small incisions between the ribs.
Most of the debate over stents versus surgery focuses on complex patients like Edgardo Hilario, 59, a Kmart shelf stocker from Spotswood, N.J. After he was hospitalized last fall with severe chest pain, his doctors found that he had four severe blockages in three arteries.
Mr. Hilario was operated on last month at St. Michael’s Medical Center, a 337-bed teaching and referral hospital in Newark.
The chief of cardiac surgery there is Dr. Mark W. Connolly, a nationally known heart surgeon who was named physician of the year in 2006 by the American Heart Association. Well-regarded among stent specialists, he was invited to speak last fall at their national meeting.
Dr. Connolly, who says he has performed more than 4,000 bypass surgeries, operated on Mr. Hilario and another patient, Francisco Tobio, that day. Both patients probably would have received stents in many other hospitals.
In fact, Mr. Tobio had arrived at St. Michael’s expecting to have a stent procedure performed by Dr. Fayez Shamoon, who had previously treated Mr. Tobio’s wife. But the X-rays of Mr. Tobio’s blockages led Dr. Shamoon to consult with Dr. Connolly, and the two doctors together advised him to have surgery instead.
“Dr. Shamoon put three stents in my wife, so I trusted him,” Mr. Tobio said.
All hospitals expect both cardiologists and surgeons to consult with heart patients when the form of treatment is in question. But with few patients demanding the chance to talk to a surgeon, it is usually up to a cardiologist like Dr. Shamoon to initiate such a meeting.
How often that happens may depend on the degree of respect and collaboration between a hospital’s cardiologists and surgeons, many doctors say.
Another factor, cardiologists say, is the unwillingness of some surgeons to take on complex cases, especially in states like New York and California that now report performance statistics for each doctor.
“They started sending cases back to us because of reporting,” said Dr. Robert Jesse, the top cardiologist for the Veterans Health Administration.
The data suggesting that patients may be suffering as a result of such trends is hardly ironclad. Little of it comes from randomized clinical trials, which are considered the highest level of evidence in medicine. Instead, the pro-bypass case rests mainly on data from registries that track long-term outcomes for every patient treated at a single major hospital or across large regions.
Such registries can offer a more accurate picture of how medicine is really practiced than clinical trials, which focus on preselected patients. But many researchers say that because registry data tends to be collected more haphazardly, it is better at identifying issues for further study than guiding medical practice.
Two major clinical trials now under way will try to directly compare stents and bypass surgery in patients with the most serious forms of artery disease. One trial, sponsored by Boston Scientific, randomly assigns 1,500 patients to either surgery or stenting. The other, sponsored by the National Heart, Lung and Blood Institute, compares stenting to bypass surgery in diabetic
patients with multiple coronary blockages.
But the first results, which will come from the Boston Scientific trial, are not expected before the second half of next year. And those near-term results cannot be conclusive about the main stent safety issue now worrying doctors — the long-term risk of potentially fatal blood clots.
Moreover, by the time the trials’ longer-term results are available in 2012, they may have little applicability to medical practice at that time.
Despite the forces now favoring stents, Mr. Goodman, the consultant, says he expects the number of bypass surgeries to begin rising this year. Concerns about stent safety will play a role, he said, but another inducement will come from patients who received stents in recent years and now need follow-up care.
That is what happened to Joseph Gubernick, 72, the chief marketing officer for a division of the Estée Lauder Companies.
Mr. Gubernick had four bare-metal stents implanted in 2000 at Lenox Hill Hospital, after suffering a heart attack on a business trip to Japan. Last fall, when he began feeling symptoms he feared were signs of a new blockage, Mr. Gubernick called Dr. Connolly at St. Michael’s.
A St. Michael’s cardiologist, Dr. Jonathan Goldstein, took X-ray images of the arteries, and told Mr. Gubernick, “The time for stents is past.”
Dr. Connolly did the bypass operation on Dec. 20.
“I’m back at work and feeling terrific,” Mr. Gubernick said on Thursday.