Lifesaver or Billion-Dollar Industry?

Coronary artery bypass surgery took centre stage in 2004 when former US President Bill Clinton underwent emergency bypass surgery. Complaining of mild chest pain and shortness of breath, Clinton had an angiogram, which revealed blockages in his coronary arteries, and was rushed into quadruple bypass surgery.

If you followed any of the news coverage of Clinton's surgery, you'd think that surgery saved his life. The chief of cardiology at the hospital where Clinton had his surgery underscored the necessity for immediate intervention, and Clinton himself was quoted as saying that without the quadruple bypass, there was a 100-percent chance that he would have had a heart attack. Cardiologists interviewed on morning talk shows spouted off about the benefits of bypass, and newspaper articles detailed lifesaving breakthroughs in interventional cardiology.

The public bought it. Hospitals reported a jump in emergency-room visits by middle-aged men with chest pain, anxious to find out if they too needed bypass surgery. Imaging centres experienced a surge in appointments for heart scans and other screening tests for heart disease. Patients in record numbers consulted their physicians to see if bypass surgery or angioplasty, a less invasive means of opening blocked arteries, was their best course of action.

There's just one problem. Even though more than half a million bypass surgeries are performed in North America every year (most of them in the United States), there is virtually no scientific evidence showing that, except for a small subset of patients, those having surgery live longer or have fewer heart attacks than those who don't. Let's look at the evidence.

Lifesaving Surgery?

The first coronary artery bypass surgery was performed in the early 1960s. Because it helped relieve chest pain, it was assumed even though there were no scientific studies to support this assumption that it also prevented heart attacks and improved longevity, and over the next decade its popularity spread like wildfire.

The first study of bypass surgery, the Veterans Administration Cooperative Study, wasn't published until 1977, and its results ran 180 degrees counter to expectations. The study showed that, contrary to popular belief, bypass surgery did not save lives or prevent future heart attacks. In fact, it offered no significant benefits over treatment with medications.

You'd think that this would have ended the "bypass era." However, so many cardiologists and medical centres had jumped on the bypass bandwagon that this study was simply ignored. Eugene Braunwald, MD, of Harvard Medical School warned in an editorial in the New England Journal of Medicine that "an industry is being built around this operation…This rapidly growing enterprise is developing a momentum and constituency of its own, and as time passes it will be progressively more difficult and costly to curtail it materially if the results of carefully designed studies of its efficacy prove this step to be necessary."

Dr. Braunwald's words were prophetic. In 1983, the results of the most comprehensive, "carefully designed" study of bypass surgery ever done, the Coronary Artery Surgery Study (CASS), dramatically underscored the results of the earlier study. After five years of follow-up, bypass surgery neither improved longevity nor reduced heart attacks compared to nonsurgical treatment even in patients with blockages in three of their coronary arteries. The annual death rate of patients treated conservatively was so low (less than 2 out of 100 patients per year) that it was impossible for bypass surgery to improve on it.

The CASS researchers published follow-up data on study participants in 1990 and again in 1995, and again found that bypass surgery did not prevent heart attacks or prolong life, nor did it make a difference in terms of the presence of angina, use of medications, frequency of heart failure and hospitalization, and activity limitations.

Yet, as Dr. Braunwald predicted, none of these studies, which were far more damning of the procedure, stemmed the growing popularity of bypass surgery. Neither did the European Coronary Artery Surgery Study (the only other large clinical trial to date comparing bypass to conservative medical therapy), nor any of the handful of subsequent smaller studies reaching the same conclusions.

Follow the Money

On the contrary, a multi-billion-dollar industry has been built around the concept that large, cholesterol-filled blockages in the coronary arteries choke off blood flow and cause heart attacks. However, hundreds of scientific studies over the past decade make it clear that this concept is just plain wrong. The reality is that as many as 85 percent of all heart attacks occur when smaller plaques, destabilized by inflammation, rupture and attract a blood clot that blocks blood flow to the heart.

The diagnostic angiogram, or cardiac catheterization, that Clinton and well over a million other North Americans have every year, is great at picking up large, artery-narrowing plaques. But according to Steven E. Nissen, MD, director of cardiology at the Cleveland Clinic Foundation in Ohio, it misses the smaller, "vulnerable plaques" responsible for the vast majority of heart attacks.

Yet cardiologists continue to treat large stable plaques as public enemy number one, attacking them by the millions every year with bypass surgery and angioplasty. Yes, these procedures may reduce chest pain (although, in many cases, no better than medications and lifestyle changes). However, they do not contrary to what Bill Clinton and legions of cardiologists might claim prevent heart attacks or slow the progression of heart disease. Even worse, they have the potential of causing significant harm.

The Perils of Bypass Surgery

First, there is a risk of death with any surgical procedure, and for this surgery the in-hospital death rate averages 2.4 percent (greater than the risk of death without treatment, per the studies cited above). Then there are all the attendant risks of hospitalization, including medical mistakes, adverse reactions to drugs (which kill at least 106,000 hospitalized Americans every year), and infections acquired while hospitalized (which kill 88,000 annually).

There is also a serious risk of neurological damage. According to a 2001 editorial in the New England Journal of Medicine, 1.5 to 5.2 percent of patients have a stroke while on the operating table that results in damage to the brain, sometimes fatal and often permanent. Up to one-third have a period of disorientation known as postoperative delirium immediately following surgery, and more than half suffer less severe changes in cognitive function generally lasting less than six months after bypass.

Until recently, it was assumed that enduring neurological complications of bypass were rare. However, a 2001 study by researchers from Duke University Medical School revealed a high prevalence of lasting cognitive impairment after bypass surgery. Mark F. Newman, MD, and colleagues followed 261 bypass patients, administering tests of cognitive function before bypass, after discharge, and then six weeks, six months, and five years after surgery. More than half of the patients scored significantly worse a few days after surgery than they did before surgery. After six weeks, a third of them still exhibited deficits, and after six months a quarter remained affected. The bombshell of the study was that when these patients were retested five years after their surgery, an astonishing 42 percent showed signs of mental impairment.

The most likely culprit here is the heart-lung machine. During most bypass surgeries, the heart is stopped, and the patient is hooked up to a heart-lung machine that routes blood out of the body, oxygenates it, and pumps it back via the aorta, the large artery that directs blood into the arterial system. Problems arise when, during this procedure, small bits of plaque break off and lodge in the blood vessels of the brain, disrupting blood flow and oxygen delivery. Unfortunately, the very real potential for significant brain damage is rarely discussed with patients contemplating bypass surgery.

Furthermore, bypass surgery is far from a permanent fix. Researchers from the University of Bristol in the United Kingdom reported in 2004 that 15 percent of the saphenous vein grafts (veins taken from the legs of patients to bypass blocked coronary arteries) used in these operations become blocked within months to one year, and half of them are blocked by ten years, making the surgery a stopgap measure, at best.

Did This Patient Gamble With His Life?

I've been practicing medicine for more than 25 years, and during that time I've seen more than 5,000 heart patients for second opinions of their need for an angiogram (the first step on the slippery slope of invasive cardiology), bypass surgery, or angioplasty. In the overwhelming majority of cases, I concluded, based on clear-cut scientific criteria (see sidebar), that they were not appropriate candidates. I followed many of these patients for years, and contrary to their doctors' predictions that they were "a walking time bomb" or "about to have a heart attack" they did just fine with a more conservative course of regular exercise, a heart-healthy diet, a program of targeted nutritional supplements, and appropriate medications.

I want to tell you about one of these patients. I first saw Herman Ablon in June 1983, when he was 52 years old. He had been having chest pain while exercising, so his doctor ordered an angiogram. It revealed three blockages in his coronary arteries. Herman was referred to a cardiologist, who told him he needed immediate coronary artery bypass surgery. A second cardiologist concurred, and he was scheduled for surgery.

Just before Herman checked into the hospital, he decided to get a third opinion, so he came to my clinic. I evaluated him and concluded that he was no more a candidate for bypass surgery than I was. First, he had never had a heart attack, and his heart muscle was undamaged. Second, his heart was functioning well, as shown by the results of his exercise stress test, which measures the performance of the heart during exercise. And third, his doctors had never even tried treatment with medications or lifestyle changes to relieve his angina. Herman decided to pass on bypass and chose instead to follow my recommendations. Within months, he was exercising regularly, free of pain, and had no signs or symptoms of heart disease.

I didn't see him again for another 18 years, until June 2001. Herman, now 70, had recently been hospitalized for very high blood pressure, and once again, his doctor ordered an angiogram. Once again, a significant blockage was found, and immediate bypass surgery was recommended. And once again, he came to me for a second opinion.

This time around the recommendation for bypass was even more ludicrous. There were no signs of heart damage, Herman's heart function remained strong, and he had no chest pain. Yes, his blood pressure was high, but hypertension is no reason for bypass surgery - or for an angiogram, for that matter. I again advised Herman to forgo surgery and get back on his lifestyle program, which he had strayed from in recent years. The last time I saw Herman, a couple of years ago, he was exercising on a treadmill every day, adhering to his diet, and taking his supplements. He was feeling great, his blood pressure was under control, and he had been able to cut his blood pressure drugs by two-thirds.

How is it that Herman, who was told by his cardiologists that he was "gambling with his life" by forgoing bypass surgery, did so well all those years? What happened to the inevitable heart attack he was warned about?

A New Paradigm

It's time cardiologists come to grips with the new paradigm of heart disease. According to Peter Libby, MD, chief of Cardiovascular Medicine at Brigham and Women's Hospital and professor of medicine at Harvard Medical School, "we have a new therapeutic goal - the stabilization of lesions rather than [removing] them by surgery or angioplasty. We have also come to recognize that none of our high-technology therapies for treating ischemia [blood], including surgery and angioplasty, actually reduces the incidence of MI [myocardial] or prolongs life, except in selected subgroups of patients."

It's also time for patients to take control of their health. Do not be scared into bypass surgery. Research your options, get an unbiased second opinion, and take time to make your own decision.

Who Needs Bypass?

If a bypass, angiogram, or angioplasty is recommended for you, get a second opinion from an unbiased source outside your doctor's medical practice. The second-opinion protocol that I and many other doctors who pay attention to the medical literature use was developed by Harvard Medical School cardiologist Thomas Graboys, MD, and colleagues. They demonstrated how a patient's risk of heart attack could be accurately predicted, and how that risk could then be used to determine the necessity of surgery.

They defined a low-risk patient one who would do well on a conservative course of treatment rather than bypass as follows:

• absence of impaired ventricular function (a normal ejection fraction, indicating adequate ability of the left ventricle of the heart to pump blood)
• angina brought on by exercise or stress that could be relieved with medications (as opposed to unpredictable, uncontrollable angina)
• reasonable performance on exercise stress testing (monitoring for heart rate, blood pressure, and ventricular arrhythmia)
• ease of instituting a medical program that the patient would adhere to
• absence of critical blockage of the left main coronary artery.

The Graboys team then rendered second opinions based on this protocol to 88 patients who had been recommended to have bypass based on significant blockages seen on angiograms. They determined that 74 of the 88 patients did not need surgery. Sixty of these patients elected not to have surgery, and after two years, they were all alive.

This is not to say that nobody benefits from bypass surgery. There are a handful of valid reasons for a patient to undergo bypass. One is severe, incapacitating chest pain that limits activity, impairs quality of life, and is unresponsive to medications and lifestyle changes. Another is a significant blockage in the left main coronary artery, which branches into the two arteries that supply blood to a significant portion of the left heart muscle. Patients who have significant blockages in the proximal left anterior descending artery (an offshoot of the left main artery), accompanied by blockages in two other arteries, may also benefit. Blockages in three vessels warrant bypass surgery only if the patient has poor function of the left ventricle of the heart.

In virtually all other cases, a conservative course is warranted.

Alternative Rx Checklist for Heart Disease

• Eat a heart-healthy diet that includes nutrient-dense vegetables and fruits, salmon and other cold-water fish, nuts, and olive oil. Avoid processed carbohydrates and fats.
• Engage in a minimum of 30 minutes of moderate exercise daily. (Get an okay from your doctor before starting.)
• Take a daily multivitamin and mineral supplement that contains potent doses of vitamins C, E, and other antioxidants that protect against free radical damage.
• Add two to six fish oil capsules to your supplement program. Omega-3 fatty acids stabilize plaque and reduce the risk of sudden cardiac death.
• Beef up your magnesium intake to 1,000 mg a day. Magnesium relaxes the artery walls and reduces stress on the heart muscle.
• Boost your daily B-vitamin intake to a minimum of 800 mcg folic acid, 100 mg B₆, and 200 mcg B₁₂. This will help lower homocysteine, a primary contributor to atherosclerosis.
• Protect your heart with 100 to 200 mg of CoQ₁₀. In addition to its antioxidant properties, CoQ₁₀ energizes the heart muscle.
• Take one baby aspirin (81 mg) per day with a meal to further reduce inflammation and further stabilize plaque.
• Consider a course of enhanced external counterpulsation (EECP), a non-invasive therapy that dramatically increases blood flow to the heart and improves the health of the arteries. This "natural bypass" relieves angina and improves exercise tolerance.
• Also consider chelation therapy, an intravenous therapy that removes toxic metals from the body, enhances circulation, and improves the health of the arteries.