My office telephone has been ringing with patients who have heard about former President Bill Clinton's surgery this month and wonder if they might need cardiac bypass themselves. What I tell them is that careful screening for heart disease is essential, but the bypass operation, which involves sawing open the chest, is a 40-year-old procedure that is usually unnecessary.
Bypass has been shown to save lives only in certain cases, and it has never been proven to directly prevent heart attacks. It has unique risks, such as chest wall inflammation, depression and impaired thinking that may persist long-term. And though surgical technique has advanced over the years with the use of the patient's own mammary arteries and more recently with operations on the beating heart, coronary stenting and medications have also advanced greatly and have largely replaced the need for surgery.
My patient Neal Johnston is a 64-year-old man with severe heart disease who had a heart attack 10 years ago and has since had two stents placed. He takes a cholesterol-lowering statin drug and a daily aspirin. He has refused bypass surgery several times and he continues to do well without it.
He is not alone. Another patient I know has had four coronary balloon angioplasties -- tiny inflations of blocked arteries -- over the past 15 years, the last one in 1997 with a stent that has kept the artery open ever since. He has never suffered heart damage, he remains quite active, and he, too, has refused bypass surgery on several occasions. This man is my father.
According to Fred Feit, director of interventional cardiology at New York University Medical School, the goal these days is to "come with the treatment that is least invasive." Feit said that over a recent two-day period, he catheterized 17 patients, snaking a tiny tube from the groin up into the coronary arteries. He sent only one for bypass; the rest received stents. Stents are tiny mesh cylinders are made of metal and coated these days with a drug that retards clogging. They are floated into the artery with a catheter and then snapped into place. With the latest technology, each stent appears to have less than a 10 percent chance of closing up over the first six months.
In the United States, 500,000 bypasses are still done each year, compared with more than 1 million angioplasties. But each year there are fewer bypasses and more angioplasties with stents. Over the past year, in fact, New York state has seen three times more stent procedures than coronary bypass operations.
Feit says stent placement is safer, with an in-hospital mortality rate of only 0.7 percent, compared with 1.4 to 2.1 percent for bypass surgery. In addition, bypass surgery poses other risks: heart attack immediately after surgery (3 percent), wound infection (3 percent), bleeding (3 to 5 percent) and heart arrhythmias (30 percent).
In contrast, in a 2002 study, 94 percent of the patients who were given a stent coated with the drug Rapamune, which prevents clots from forming, were free of any adverse heart events, and none experienced reclosure. The patients were followed for eight months, and follow-up data a year later continued to show open vessels in more than 90 percent of patients. Other studies have confirmed the same results.
Even most surgeons recognize that the wave of the future is away from bypass surgery, says Feit. The latest conventional wisdom on heart disease, he says, calls for a "combination of limited intervention and medication, an improved understanding of the disease process, aggressive risk factor modification and intensive medical therapy."
In fact, 15 million to 20 million people in the United States now take cholesterol-lowering statin drugs, which have just been shown to retard the development of coronary blockages or plaques to the point where a patient with clogged coronaries who seemed a sure candidate for bypass may never require any procedure at all. Lowering LDL cholesterol by 25 to 30 percent over a 10-year period has been shown to reduce the risk of cardiac events by at least 25 to 30 percent over the same period of time. Recent studies have shown that many heart patients who kept their LDL cholesterol as low as 70 with the help of the statin Lipitor actually showed some improvement in their coronary plaques.
Bill Clinton was clearly not such a patient. While he exercised regularly and appeared vigorous, he also smoked cigars regularly, had bad eating habits and was hardly compliant. His surgeon, Craig R. Smith, chief of cardiovascular surgery at New York-Presbyterian Hospital, told me in an interview that Clinton had had chest pain on exertion for quite some time, probably indicating heart disease, and that he had high blood pressure and was on a cholesterol-lowering drug -- which he stopped taking when his cholesterol level dropped. (That last is a common patient mistake, said lipid expert John Larosa, president of SUNY Downstate Medical Center in Brooklyn: "Patients get a good report, so they think they can stop the medicine. That's wrong. You haven't cured the problem. You're just managing it.")
With all of his risk factors, Clinton was clearly at high risk for a heart attack.
What that says to me is clear: Clinton should hardly be our poster boy for proper assessment and treatment. His bypass operation doesn't indicate that others require one. His severe case is the exception rather than the rule.
Larosa indicated that current thinking is not to wait until a patient develops severe heart disease, but to treat everyone based on their "global risk." Ways to recognize and combat risk are available at the American Heart Association Web site, www.americanheart.org.
But New York-Presbyterian Hospital, which is affiliated with Columbia and Cornell universities, is known for its aggressive treatment of heart disease.There were 15 deaths from coronary bypass there in 2001. Smith, who was one of five doctors who reviewed each of those deaths, said that the number of deaths from the procedure has since decreased. The recent addition to the Columbia faculty of an elite group of interventional cardiologists should mean that the number of bypasses performed there will decrease as the number of stent procedures goes up.
"The decision to operate on President Clinton was made by his medical doctors," said Smith, in a manner he described as standard. "He had 20 minutes of rest pain [chest pain without activity] the day before he came. He was on Plavix (a blood thinner), so we waited a few days before operating, but we could have done it any time if we'd needed to." Smith said that Clinton received "the same treatment that anyone else would have received in a similar situation." By this he meant that all patients with heart disease as advanced as Clinton's would have received a bypass operation.
"A diagonal branch off one of the heart's main arteries was quite diseased," Smith said, and "very close to the branch point of the artery." Attempts to use a stent there could well have led to an incomplete result where at least one essential artery was still clogged.
Clinton didn't question his doctor's advice. Smith said that Clinton was "upbeat, a delight to work with. He made it very easy for us." But Smith admitted that other doctors have since subjected his choices to tremendous scrutiny.
After recommending surgery, Smith had a second major decision to make: whether to operate on a beating heart. That was his initial preference because of the lower risk of complications. But after Smith opened Clinton's chest, he reversed his decision after discovering that one of the arteries he had to bypass was buried within a thickened heart muscle. Stopping the heart allowed him better access. Cooling and potassium-containing solution stops the heart, and the patient is kept alive by filtering the blood through a heart lung machine until the heart is restarted with a shock.
Clinton's heart received two mammary arteries and a leg vein. The arteries were swung down from their origin deep in the chest and connected to the two major arteries on the left side of the heart; the vein was lifted out of the leg and tied in two places to the right coronary artery. Mammary arteries continue to do the work of arteries, secreting substances that keep the blood moving.
Accomplishing all of this requires a longer operation -- four hours in Clinton's case -- with more potential complications than a stent placement. A stent can be placed in 15 minutes and the heart is never stopped.
Thirty years ago, a prominent multi-center study shocked the heart world with the information that cardiac bypass surgery did not prolong life except for those with very weak hearts.
Since that time, there has been no evidence presented that heart patients won't do equally well or better with coronary stents or medical management alone, especially given the advances in these fields and the risks of surgery. Recent studies have shown that stented patients develop no more heart attacks or strokes in the months after the procedure than patients who have undergone bypass.
At the same time, there is still no evidence that cardiac bypass surgery directly prevents heart attacks.
This is because severe narrowing, as in Clinton's case, is often longstanding and relatively stable. In fact, almost half of all heart attacks occur in vessels without significant narrowing, where an unstable plaque develops quickly and a blood clot suddenly closes a vessel. Victims of these sudden heart attacks are often saved when their vessels are reopened by stents, while there is no time for bypass surgery to be considered.
Clinton received the Cadillac of operations, and it appears to have been indicated by the severity of his disease and the technical difficulty his case presented. But for the vast majority of patients with heart disease, medications are preferable to surgery, and if trouble occurs, a stent is now the first choice. If my patients -- or even my father -- start asking for cardiac bypass surgery just because of Bill Clinton's successful outcome, I will tell them emphatically "no."
Marc Siegel is a clinical associate professor of medicine at New York University Medical School. His book "False Alarm: Profiting From the Fear of Epidemic" is scheduled for publication in 2005.