Comparison between surgical and Non-Surgical treatment

In the two centuries since a classical description of angina pectoris as a symptom of coronary heart disease first appeared in the medical literature, there has been little for physicians to offer patients in the way of effective treatment. Only recently have effective therapies become available.
The coronary arteries provide blood and energy to the muscle of the heart―the pump. That pump must contract 70 times per minute or so to propel blood throughout the body. It cannot stop to rest, like other muscles, or death will occur in minutes. If the flow of blood to that muscle is partially restricted by atherosclerotic plaque in the coronary arteries, the heart continues to pump, but it hurts, similar to a leg cramp. That type of pain is called angina pectoris, which is Latin for "chest pain"―commonly shortened to angina.

   
 

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Angina is often triggered by stress or exertion, because the heart must then work harder to pump more blood. The discomfort can also be dull, as a pressure sensation. It can radiate to the arms, neck, back or upper abdomen and may even mimic indigestion. Angina is usually relieved by rest. One variation of angina can even come on at rest.  If the blockage is severe, a part of the heart muscle may die, causing a so-called heart attack―in medical terms, a myocardial infarction.

Right through the end of the 1940s, nitroglycerin was the standard treatment for this type of pain. At the onset of an angina episode, a victim placed a tiny white pill under the tongue and waited for the uncomfortably tight, strangling sensation and pain to subside. But because the condition underlying angina is usually progressive, pain became more frequent and severe, and less amenable to nitroglycerin relief.

The seriously afflicted had little choice but to learn to live (or die) with their condition. Since exertion predictably triggered frightening discomfort, many were forced to adopt curtailed lifestyles, giving up former work and play activities.

In 1950, a seemingly miraculous remedy captured attention. Surgeons developed a new operation called internal mammary artery ligation, which involved surgically tying off the mammary artery, which carries blood to the exterior chest wall. Because this artery is located near the heart, surgeons hoped this action would force more blood to flow through other arteries in the vicinity (including coronary arteries) and ease the pain of angina.

Results exceeded the most optimistic expectations. Remarkably, up to 90 percent of patients reported either total pain relief or dramatic symptom improvement. The operation, hailed as a miraculous advance, was widely advocated by many members of the medical profession. Enthusiasm mounted; angina victims lined up; surgeons maintained three-month waiting lists. The operation's effectiveness went unquestioned and untested, for almost ten years.

But then, as now, there were skeptics within the medical community. There was too much enthusiasm to suit some discerning physicians who doubted the procedure deserved such universal acclaim, inasmuch as it had a dubious scientific rationale. The doubters arranged to verify the surgery's effectiveness with a research protocol, which would be unacceptable under today's more rigid ethical standards.

They set out to test the procedure by dividing surgical candidates into two groups, each equally afflicted with angina. All subjects were told they were to undergo ligation surgery, and went through identical hospital protocols with only one important difference: One group did have the ligation operation while the control group was taken into the operating room, anesthetized, and then subjected to a sham operation. Their chests were opened, then closed. When they awoke, they were told their operations had been successful.

To the astonishment of the entire medical community, the surgeons included, both groups reported relief from pain of angina and increased tolerance to exercise. But, the group that had undergone the sham surgery fared better than those who had undergone the genuine operation. It was the first time medical researchers proved that placebo effect extends to surgery; and, not surprisingly, when word got out, the number of operations plummeted.

Unlike the well-documented time sequence of placebo effect, patients don't experience full benefit from EDTA chelation therapy until three months after therapy is completed. And benefit continues for many months or years thereafter, even without further therapy. This is very unlike any placebo effects ever reported. Placebo effects occur at once and last only a few months at most. The time when placebo effect would fade is when relief from chelation therapy reaches its peak. I have never seen reports of placebo effect that lasted as long as six months.

What has this to do with current methods of treating angina?

More than one leading scientist has expressed the belief that, in many cases, coronary artery bypass graft (CABG) surgery, one of the most common major operations performed in the United States today, is the current equivalent of the sham surgery of the 1950s. Said one, "My own suspicion is that a placebo might do just as well, and not cost $50 thousand, the usual price tag of a coronary bypass operation." According to the American Heart Association, in 1995, the latest yearly figures they publish, there were 1,460,000 angiograms performed at an average cost of $10,880 per procedure. This resulted in 573,000 bypass surgeries at an average cost of $44,820, and 419,000 percutaneous transluminal (balloon) coronary angioplasties (PTCAs) at an average of $20,370 each. The total bill in 1995 was $50 billion, or $137 million per day―$5.7 million per hour. That's big business! The total annual cost of cardiovascular disease in the United States, including medications and disability, is approximately $274 billion per year.

Despite the commotion surrounding the bypass procedure, it has never been conclusively proven to do much more than relieve the pain of angina (except for some slight additional benefit in approximately 15 percent of patients who meet very specific selection criteria). As with any symptom-relieving treatment, there is a real possibility that the placebo effect is at least in part responsible

The scientific references listed at the end of this chapter were used to gather source material for the following.

Heart bypass may serve as a type of "surgical beta blocker," with an action paralleling that of a group of drugs that diminish pain by interfering with nerve impulses, which can trigger arterial spasm in the coronary arteries and increase heart muscle contraction, resulting in angina. Although not widely known, it is impossible to perform the operation without partially disrupting the nerves that stimulate the beta receptors on arteries and heart muscle. Nerves that transmit the pain of angina are also transected.

Is bypass surgery, like the operation that preceded it by some 20 years, undeservedly popular?

When the Office of Technology Assessment was commissioned by the United States Congress to review the case for surgery for coronary artery disease, it was not greatly impressed. A panel of government consultants, which included leading academicians from the nation's most prestigious medical schools, reported to Congress:

"For more than half a century, surgeons have believed that an efficacious surgical approach to coronary artery disease is possible. Prior to the modern bypass operation, five different operations were developed and advocated enthusiastically. Although all five operations were ultimately abandoned as of no value, initially they were alleged to be efficacious, with reports in the medical literature claiming 'objective' evidence of benefits."

Noting that "coronary bypass surgery seems to give excellent symptomatic relief from angina pectoris . . . but the improvement diminishes with time," the government panel of experts cautioned that there was an historical lesson to be heeded, pointing out that "the possible placebo effect (of bypass surgery) needs to be kept in mind because: the initial results are similar to previous operations; nonsurgical treatment also produces good results; and, the methods of evaluation of symptomatic relief are experiential."

The chief of cardiology at the Montreal Heart Institute, Dr. Lucien Campeau, is a cardiovascular specialist who suspects long-term relief of angina pain results from what he calls a "pain-denial placebo effect." Dr. Campeau came to this conclusion after studying 235 patients angiographically three years after their coronary artery bypass operations, discovering that even in cases where grafts had reclosed, patients unexpectedly reported being improved or angina-free.

A report in the Journal of the American Medical Association (JAMA) once again documented angina pain relief in 75 percent of patients who have bypass surgery. Shortly thereafter, an article in the New England Journal of Medicine stated 75 percent of angina patients' pain is also relieved with non-surgical therapy. In effect, these two highly authoritative articles are saying bypass surgery works no better than non-invasive therapies using prescription medicines.

Many patients who opt for this operation have a real need to believe in its effectiveness. They have a huge emotional as well as financial investment in a successful outcome, often having been scared into believing that this surgery is the only way to save their lives.

Claims that the operation prolongs life to any significant degree are still being debated. When the Harvard University School of Public Health put coronary bypass surgery to the test, they concluded that surgery is often unnecessary. The Harvard study involved 142 men who had all "flunked" a treadmill exercise test and had other evidence of extensive coronary atherosclerosis. Each had been advised to undergo the bypass operation.

But, when this group of surgical candidates was referred to Harvard specialists for a second opinion, surgery was rejected in favor of medication, diet, and exercise. After keeping tabs on these 142 men for anywhere from 20 months to 12 years, the Harvard researchers found their death rate exactly what would have been expected had the men been operated on (provided, the study pointed out, they survived the operation, which has an operative mortality of two to three percent, more in some centers).

Contrary to the claims of cardiovascular surgeons, bypass surgery does little to improve the outlook for survival, according to the Harvard report.

A study by Dr. Wilbert Aranow at the University of California comparing atherosclerotic heart patients treated surgically with those treated medically revealed no evidence of increased survival or lowered heart attack risk. Nor did studies conducted by Duke University Medical Center find reason to suggest that coronary surgery prolongs life when compared with medical management.

An analysis of 1,101 consecutive patients with coronary artery disease was made by the Division of Cardiology at Duke―490 had surgery, 611 were treated non-surgically. At the end of four years, there was no significant difference in the survival rate between the surgically treated and the medically treated: survival was 82 percent for the first group, 78 percent for the second.

In a study reported in the New England Journal of Medicine by Paulin, et al, 686 patients with stable angina were followed for 22 years. Of that number, 322 received bypass surgery and 312 were treated medically, without surgery. Long-term survival rates were comparable in both treatment groups. At 22 years, the cumulative survival rate was 25 percent in the medically-treated group but only 20 percent in patients who had received bypass surgery.

Brain damage is a common complication of bypass. In another article published in the New England Journal of Medicine, Roach, et al, reported on mental impairment following bypass surgery: "Adverse cerebral outcomes after coronary bypass surgery are relatively common and serious; they are associated with substantial increases in mortality, length of hospitalization, and use of intermediate- or long-term care facilities." Five years after bypass, 23 percent of patients showed an abnormal mental decline in ability to make sense of spatial relationships and an additional 16 percent had persistent impairment in their ability to remember words. Six percent of bypass patients suffered more serious brain injury, including dementia, stupor, stroke, and epileptic seizures.

The Newark Star-Ledger reported in March, 1999, that the statewide New Jersey death rate as a complication of bypass surgery was 3.37 percent, and that in some hospitals it was as high as eight percent.

One important study of long-term results following bypass was the Coronary Artery Surgery Study (CASS), in which 780 patients were followed for more than 12 years.

When that long awaited ten-year, government-funded study was released, it offered little encouragement for advocates of cardiovascular surgery. The study was conducted at 11 prominent medical centers: the University of Alabama, Alabama Medical College, Boston University, the Marshfield (Wisconsin) Clinic, Massachusetts General Hospital, Milwaukee Veterans Hospital, New York University, St. Louis University, Stanford University, Yale University, and at the Montreal Heart Institute. Seven hundred eighty volunteer patients with coronary heart disease were divided into two groups. Half had bypass operations; the other half had non-surgical treatment consisting of prescription drugs and advice to start exercising sensibly and avoid risks like smoking, overeating, and consuming too much fat in their diets.

After many years of follow-up, results now show that the most severely diseased 15 percent of patients who submit to bypass surgery actually did get a measurable benefit. But even for those few, the death rate was higher during the first two years following surgery because of surgical complications.

The 15 percent of patients who did get small but statistically significant benefit from bypass fell into the following three categories: (1) high-grade obstructions of the left main coronary artery system, including the left anterior descending artery, without adequate collateral flow around those blockages; (2) high grade blockages of all three major coronary arteries without adequate collateral flow; and, (3) patients with greatly reduced pumping action of the heart. Patients who met one or a combination of those criteria eventually experienced a small increase in survival rate lasting a few years. In that small group, from the second to fifth years the death rate was only about ten percent lower when compared to patients who do not have surgery. That advantage was lost from the fifth to the tenth year and, indeed, from the tenth year on.

In other words, 15 percent of patients had a ten percent lowering of death rate five years after surgery, which amounts to a 1-1/2 percent overall lowering in death rate following bypass surgery, as it is now performed. Remember, from two percent to eight percent (depending on the hospital) die immediately as a complication of surgery, and surgery therefore results in an overall increase in death rate during the first two postoperative years. I doubt that many patients would agree to undergo bypass if those statistics were clearly presented to them in advance?

It is, nevertheless, true that some patients―those who have been carefully selected and who suffer severely impaired quality of life from coronary heart disease―do experience dramatic improvements following either surgery or balloon angioplasty. I'm not opposed to those procedures. I refer patients when I think they need that kind of therapy. It is always a judgment call, the risks of surgery versus the risk of no surgery―assessing the so-called risk-reward ratio. But, for patients whose condition is stable and not worsening at a dangerous rate, I'm definitely opposed to immediately and aggressively resorting to invasive, expensive and potentially fatal procedures, without first trying treatments that involve less risk, and much lower cost, including EDTA chelation therapy.

A very significant finding of the CASS study is the fact that the death rate for patients who did not have surgery or angioplasty was only two percent per year. That is quite a low death rate for patients with such serious heart disease, and seems hardly to justify the three to four percent risk of immediate death from complications from surgery or invasive procedures.

After six years, 92 percent of surgical patients and 90 percent of the medical patients were still alive. The researchers concluded that tens of thousands of bypass operations every year were unnecessary and could be eliminated. That's fine as far as it goes. But the real question to be asked is, did the scientists speak out boldly enough?

Many think not. There is good reason to suspect they were extremely conservative in their estimate of the annual number of unneeded operations and downplayed their statements concerning the percentage of bypasses that could safely be avoided.

As Dr. Eugene Braunwald, professor of cardiology at Harvard Medical School, pointed out in the New England Journal of Medicine, the data were already obsolete when the CASS study came out, inasmuch as it was collected before the advent of newer calcium-channel blockers and improved beta blockers. "Non-surgical therapy has not stood still during the last six years," Dr. Braunwald noted, challenging the validity of findings that exclude recent advances in nonsurgical cardiovascular treatment. And, in my opinion, had EDTA chelation been compared to bypass, surgery would have come out a poor second.

Were the researchers too kind to proponents of surgery? If, in the majority of cases, bypass surgery is no better than less drastic treatments, does it do any harm?

There is no question that bypass surgery and angioplasty can often relieve symptoms of angina and is suitable for patients whose quality of life is greatly impaired by coronary heart disease not relieved by medicine. They must be willing to accept the risk of greater than a two percent chance of death and the 25 percent incidence of other serious complications from those invasive procedures.

A U.S. government pamphlet entitled "Medicine for the Layman―Heart Attacks," published by an agency of the U. S. Government, noted clinical investigations have yet to determine whether bypass surgery improves or impairs heart function. As stated by this booklet, "There is no evidence yet that bypass surgery makes the heart pump better―some evidence bypass surgery may actually decrease efficiency."

Medical authorities are increasingly critical of bypass surgery. Thomas A. Preston, M.D., Professor of Medicine at the University of Washington School of Medicine and Chief of Cardiology at the Pacific Medical Center, Seattle, Washington, once wrote about coronary artery bypass surgery, "As it is now practiced, its net effect on the patient's health is probably negative. The operation does not cure patients, it is scandalously overused, and its high cost drains resources from other areas of need." He further says, "A decade of scientific study has shown that, except in certain well-defined situations, bypass surgery does not save lives or even prevent heart attacks. Among patients who suffer from coronary artery disease, those who are treated without surgery enjoy the same survival rates as those who undergo open-heart surgery. Yet many American physicians continue to prescribe surgery immediately upon the appearance of angina or chest pain."

A Veterans Administration Cooperative study was also published in the New England Journal of Medicine. That study included 486 victims of atherosclerotic heart disease of the most critical kind with unstable angina pectoris. Half were subjected to bypass surgery, and the other half were treated without surgery. The overall results were very similar to the CASS study and showed minimal benefit from surgery.

Both studies, however, were conducted prior to the use of calcium channel blockers, although beta blockers were administered to half of the CASS patients. Both types of prescription medicine have been shown to reduce the incidence of heart attacks, decrease death rate in heart disease and relieve angina without surgery. It is therefore not possible, without further research comparing bypass surgery with present-day medicines (including EDTA chelation therapy), to conclude whether patients would not do equally as well or even better without surgery.

An interesting report in the New England Journal of Medicine showed that coronary blood vessels increase in size as blockages occur. When a plaque grows to approach 50 percent of the inside diameter of a coronary artery, the artery simultaneously enlarges to compensate. The diseased artery may therefore continue to allow almost the same flow of blood as a healthy artery.

Only when plaque blockage exceeds 50 percent, and then only with strenuous exercise, does blood flow decrease enough to cause symptoms. At that point, collateral branches will often grow in from nearby arteries to maintain an adequate supply of blood, even if a major vessel becomes totally blocked.

With 75 percent blockage from atherosclerotic plaque, compensatory enlargement can cause total overall blood flow to remain equal to that in a healthy artery with only a 50 percent blockage. Furthermore, animal experiments show that substantially more than 50 percent blockage of a normal coronary artery is necessary to decrease heart function, even under maximum physical stress. More than 75 percent blockage of a healthy artery, without time to compensate or form collaterals, is needed to reduce heart function at rest. Nonetheless, bypass surgery is aggressively recommended in many instances with plaque blockage of 75 percent, despite adequate coronary blood flow.

An editorial in that same issue of the New England Journal of Medicine stated, "Those . . .who perform coronary arteriography have made one serious mistake. It consists of the unfortunate adoption of a grading system for stenoses expressed as a percentage of the arterial lumen that is compromised. This grading system implies a degree of accuracy that coronary angiography cannot achieve." It is not possible to accurately predict the three-dimensional flow of blood in an artery from two-dimensional x-ray shadows. That editorial goes on to point out that 75 percent blockage of a diseased coronary vessel is often necessary to compromise the heart under maximum physical exertion and considerably more than a 75 percent plaque blockage is necessary to reduce function without physical exertion.

Conclusions in that report stated, "The preservation of a nearly normal lumen cross-sectional area, despite the presence of a large plaque, should be taken into account in evaluating atherosclerotic disease with the use of coronary angiography." That recommendation is often ignored at medical centers, which seem to have become dependent on financial income generated by bypass surgery for survival. Even the American Medical Association has published in its flagship journal (JAMA) that 44 percent of all bypass surgery in the United States is done for inappropriate reasons.

Arterial spasm can cause anginal pain and heart attack, even without atherosclerotic plaque; and spasm is properly treated without surgery. Reversible spasm can also be triggered by irritation from the injected dye and reduced oxygen transport during angiograms, which can closely mimic blockage by plaque. Arteries are encircled by bands of muscle, like a belt around the waist. If that muscle contracts in spasm, like tightening a belt, blood flow is cut off.

Why then are patients so often told that they must have bypass surgery because arteriograms show 75 percent blockage of an artery, with no consideration for heart function, collateral branches or total blood flow? Overall cardiac efficiency and blood flowing past and around a blockage can be measured with isotope imaging prior to recommending surgery. Non-invasive imaging of the heart using radioisotopes or ultrasound will often indicate adequate pumping action and coronary blood flow, despite extensive plaque on the arteriograms. Is it possible that isotope studies are not routinely done because they do not show the surgeon where to operate and because surgery might be canceled if blood flow were thus shown to be adequate?

Arteriograms are a major marketing tool for bypass surgery and balloon angioplasty (and now sometimes for laser vaporization or plaque removal by rotating blades). Results of catheterization and arteriograms can frighten patients into accepting unnecessary, dangerous and expensive surgery or angioplasty, when non-surgical treatment might be equally as effective or even more so, with much less danger and expense. The risk of harm or death to patients from the preliminary catheterization and arteriograms, although small, is still significant. I believe that arteriograms should be resorted to only when a decision is made to consider surgery or angioplasty, based on severity of symptoms and lack of response to non-surgical treatments, including chelation therapy.

Another reason to delay surgery, whenever possible, is a recent report of accelerated atherosclerosis in arteries after they have been subjected to bypass. Plaques grow faster in bypassed arteries after surgery.

When an artery is bypassed beyond a point of high-grade obstruction, a region of back-flow and stagnant flow is created between that partial obstruction and the site of the implanted bypass. Clotting and total blockage of the original obstruction up to the point of bypass can then more easily occur, causing total dependence on the thin-walled and weaker vein graft. If that vein graft fails, the patient becomes worse off than before surgery.

One risk of surgery is the very real possibility of suffering a heart attack while still on the operating table or before they leave the hospital. A number of reports suggest that that happens to as many as three percent of all patients and more than 10 percent of some high-risk patients, depending on the surgeon and medical center. In rare instances, the heart may refuse to resume beating when taken off the bypass machinery.

Not to be overlooked is the psychological trauma. It would be difficult to find anyone who is not terrorized by the operation. Bypass patients must also face the possibility that one operation won't do it. Reports indicate that 15 to 30 percent of vein grafts become occluded within one year of surgery.

Angioplasty has an even worse reclosure rate. As many as 50 percent of coronary arteries forced open by balloon angioplasty close up again within one year. The use of stents may improve those odds, but long-term follow-up studies have not been completed.

The ultimate damage, death.

While few deny the bypass operation involves serious hazards, there is enormous disagreement on mortality rates, reported at anywhere from one to 42 percent, depending on where the procedure is done, who performs the surgery, on which group of patients, and on how data is collected. The National Heart and Lung Institute has reported the risk of death following coronary artery bypass surgery to be between one and four percent in the best of circumstances and ten to 15 percent in the worst.

Surgical candidates are understandably quoted the most optimistic view, even though their chances of survival depend to a large degree on their age, general health status, degree of disease, and the skill and experience of the surgeon and surgical team.

The testing procedures upon which surgical decisions are based are also open to criticism. Each new diagnostic device that comes along is tacked on the ever-growing checklist. Physicians may become so captivated with space-age diagnostics that they sometimes fail to remember they're treating patients, not tests. Coronary arteriograms, electrocardiograms, radionuclide studies, nuclear ventriculograms, thallium scans, digital subtraction arteriography, ultrasound imaging, treadmill stress tests, echocardiography, ultra-fast CT scans, EBCT, and PET scans can all be useful, but are overused, according to no less an authority than Dr. George Burch, professor of cardiology at Tulane University School of Medicine.

As Dr. Burch points out, "It has yet to be demonstrated that the new information, expensively gotten, will change the way we treat patients."

What he failed to mention is how often such diagnostic procedures merely serve as an excuse to speed a patient into surgery.

The Harvard University report, previously mentioned, specifically challenged the over-reliance of many heart specialists on exercise tests. The researchers noted that stress tests suggesting clogged arteries are an insufficient basis by themselves for the decision to undertake such procedures as coronary angiography as a prelude to surgery, the common current practice.

Exercise stress tests are not only inconclusive, but also carry some small risk. A study of 170,000 such tests revealed that for every 10,000 persons tested, one may die and two or three may require hospitalization. Occasionally, emergency treatment is needed. While the risk of death is very low, 0.01 to 0.04 percent, that still seems to me significant enough to avoid indiscriminate use, considering, in many cases, that test results may be vague or misleading.

For almost 30 years, the coronary angiogram has been the diagnostic tool most revered by vascular surgeons, the one they invariably rely on for evidence of need for surgery.

In principle, the angiogram (also called an arteriogram) provides a filmed visualization of dye injected into the arteries, enabling skilled radiologists to pinpoint the precise location and extent of blockages (expressed in percentages). In actuality, that's not what happens.

Have patients gone to surgery on the basis of misinterpreted arteriograms?

"Without question," according to Dr. Arthur Selzer, cardiopulmonary lab chief at San Francisco's Presbyterian Hospital, who told a reporter he had "always been skeptical about angiographic readings, especially when expressed in percentages. That implies the evaluator is measuring something when he's just giving a visual impression of an obstruction." Radiological readings are rarely challenged. If the angiographer reports a 75 percent occlusion of the so-called "time-bomb artery" (the left main coronary, or its major branch, the left anterior descending artery), the necessity for a bypass is considered confirmed.

It was not until the National Heart, Lung and Blood Institute (NHLBI) undertook an investigation of angiogram reliability that cardiologists were given hard evidence that coronary angiography is more art than science.

The NHLBI report, presented at an American Heart Association meeting in Anaheim, California, revealed that inaccurate assessments of arteriograms are commonplace and that when experienced radiologists evaluate the same arteriograms, they have conflicting opinions almost half the time.

The NHLBI conducted a three-pronged probe. In one study, three arteriographers, working independently, examined films of 28 patients who had died within 40 days of cardiac catheterizations. When their readings of the amount of occlusion of that all-important left main artery were compared with actual autopsy findings, it turned out they were more often wrong than right. In a whopping 82 percent of their judgments, the degree of narrowing was significantly under- or over-estimated.

In the second stage of the research project, 30 films with distinct pathology were circulated among radiologists at three first-rate medical centers to discover how often first, second, and third opinions might agree. The discouraging results: only 61 percent of the time did two or more of the three groups reach the same conclusion.

Finally, in the third study, three months later, the same 30 films were recirculated to the same experienced radiologists, who did not know, of course, they were being asked to re-evaluate films they had seen before. This time, the radiologists not only disagreed with each other, they also disagreed with themselves! In 32 percent of the readings, their second evaluations differed from their first.

One conclusion made from that study is that angiograms are, at most, accurate only to within 25 percent of the actual degree of arterial closure.

Exploding the myth of angiogram reliability has "profound implications for the diagnosis and treatment of coronary disease," declared Dr. Harvey G. Kemp, Jr., cardiology chief at St. Luke's Medical Center in New York, who directed one segment of that research. Especially, he noted, since the evaluations had been conducted under the most favorable circumstances. "We had some of the best people reading the best quality angiograms available," he pointed out.

And how did the cardiovascular community respond to research that clearly indicated patients were being scheduled for surgery based on erroneous diagnoses? They didn't. Nothing's changed.

Despite findings to the contrary, the coronary angiogram remains the "gold standard" of cardiovascular diagnosis and is still considered the final word when it comes to determining if bypass surgery is indicated. Angiograms continue to be performed daily, by the hundreds of thousands every year.

To refer to the angiogram, which costs about $3,500 (about as much as a full course of chelation) and sometimes requires hospitalization, as a diagnostic test, is in itself misleading when, in fact, it is an operation to get the patient ready for an operation. The recommendation for surgery seems often to be a foregone conclusion.

Occluded arteries are to be expected. Remember, atherosclerotic plaque begins accumulating before the third decade of life, and many men and women who are symptom-free and considered healthy have been found to have 75 percent or more arterial blockage when autopsied after accidental death from causes unrelated to arterial disease.

Of all the diagnostic procedures, the angiogram is often the one patients fear most, they are awake during the procedure―"Worse than the surgery which followed," some report―increasingly so now that balloon angioplasty and placement of stents are commonly performed at the time of the initial angiogram. It can be an uncomfortable procedure, involving threading a long catheter through a large puncture in an artery in the arm or groin, which is then threaded up into the heart. Dye is injected through the catheter directly into the patient's coronary arteries. X-ray films of the dye flow through blood vessels ostensibly show the location, pattern, and extent of blockages, but as we've already learned, error-ridden readings of those films degrade their accuracy and limit their diagnostic value.

It's customary for a cardiologist to get a patient's permission to proceed at once with balloon angioplasty and placement of synthetic mesh stents within arteries at the time of the angiogram, with no wait for the patient to recover and participate in that decision. Angioplasty is itself almost as risky as bypass surgery and can require emergency bypass if complications occur during the procedure. Recent data show that patients whose conditions are stable after a myocardial infarction (MI) and who are nonetheless treated with angiography and invasive procedures have a 71 percent higher mortality rate at hospital discharge, a 60 percent increase in death rate 30 days after discharge, and a 30 percent increased death rate at 44 months follow-up, compared to MI patients treated conservatively.

There are other risks associated with angiography. It can trigger a heart attack or stroke, either immediately or several months later; and result in torn arteries, infection, or allergic reaction to the dye. Plaques can be disrupted by the catheter, releasing small pieces, called plaque emboli, which flow downstream to block smaller blood vessels.

Finally, angiograms too often lead to a hazardous operation. Once the cardiologist requests an angiogram, the patient is frequently on the final lap of the surgical track. Angiograms can be very useful and they do have their place, but they act as such good marketing tools for subsequent surgery or angioplasty that they are utilized excessively, in my opinion.

If bypass surgery is an expensive, high-risk, limited-benefit procedure, as research indicates, why then does it continue to be the uncontested winner of the "Most Popular Operation of the Year" award? Why do almost one million Americans each year submit to surgery and other invasive coronary artery procedures, costing as much as $50,000, which will not cure their underlying disease and has a chance of making them worse? Good question.

Bypass surgery, a dramatic operation with lots of pizzazz, has been the beneficiary of considerable media "hype." In the early 1970s, it represented the ultimate in sophisticated medical technology, made possible by newly perfected heart-lung bypass machinery. Newspapers, magazines, and TV, always eager to sensationalize science with "soap opera" appeal, zoomed in to capture every heart throbbing (pun intended) moment of what was hailed as a medical marvel.

The general public responded as might be expected. People with angina and other heart-related problems began seeking out cardiac surgeons, sometimes without even consulting their family physician. The medical community reacted just as naively. It's not just the average man in the street who learns what's new in medicine from the television news and other news media, surveys have shown many doctors also rely on lay publications to be informed of current medical issues. Unperturbed by the lack of proven advantages over other therapies, cardiovascular specialists embraced the new technology with questionable enthusiasm.

Almost overnight, bypass surgery became a medical fad. An experimental procedure when first introduced, balloon angioplasty and stents soon followed. They have since become the treatment of choice for almost a million Americans each year. Indeed, in certain social circles, the sternum splitting scar is a status symbol.

"What, you haven't had your bypass yet?" one executive asks another in the locker room. The intimation is clear: only an administrator unworthy of having a key to the executive washroom would have escaped the inevitable consequences of being dedicated to one's job. More recently, the question has changed somewhat, from, "Have you had your bypass?" to "How many arteries?" In several large metropolitan cities, being scheduled for cardiovascular surgery opens the door to the local "Zipper Club."

A prestigious procedure? Of course. It has a glamorous image since so many really important, famous people have had it―former Secretaries of State Henry Kissinger and Alexander Haig, King Khalid of Saudi Arabia, comedian Danny Kaye, late night talk show host David Letterman, Larry King of CNN's Larry King Live, and top country music singer Marty Robbins. This two-time Grammy winner, by the way, had two bypasses: first a triple bypass; then an eight-hour quadruple bypass 12 years later. He died one week after the second operation.

The latest wrinkle among the elite is to have bypass surgery preventively. I'm not sure what that means, but when a 49-year-old governor of Kentucky, John Y. Brown, Jr., suffered chest pains while barbecuing the family's dinner, he was rushed to King's Daughters Hospital and 24 hours later underwent a triple bypass. His doctors told the press the operation was "preventive," emphasizing the governor had not had a heart attack, giving the unfounded impression the surgery would certainly ward one off.

All of which serves to prove that the rich and famous often get no better medical advice than the less privileged.

Would coronary bypass surgery have proliferated so rapidly and enjoyed such unwarranted popularity if it weren't so enormously profitable? Many critics believe it is a procedure that has gotten out of hand, primarily because of the big bucks involved.

"Every time a surgeon does a heart bypass, he takes home a new sports car," quipped one cynic, referring to the $15,000 or more surgeon's fee that has provided some cardiovascular surgeons with incomes of $1 million per year, and more.

Nor are surgeons the only beneficiaries. Coronary artery bypass surgery and balloon angioplasty are now an estimated $50 billion a year industry, providing a financial windfall to hospitals, drug and equipment manufacturers, and guaranteed employment to a small army of highly specialized, highly paid surgical and post-surgical coronary care teams.

With medical insurance companies picking up a large part of the tab, "some non-surgical measures may be overlooked in the rush to get cases into the operating room," according to the executive director of Maryland's Health Services Cost Review Commission. "Less expensive treatments would get greater play if patients were uninsured and had to form 'first' opinions about their own money, instead of spending someone else's," he added.

Balloon angioplasty was introduced in the early 1980s as a way to avoid costly and dangerous bypass surgery. Instead, the number of bypass operations has increased from 200,000 in 1984 to 573,000 in 1995, at a time when angioplasty procedures increased from 46,000 to 419,000 per year. Angioplasties often fail in less than a year, leading to repeated angioplasties or bypass surgery. Six percent of all angioplasty procedures require emergency surgical interventions because of complications.

In a study reported in the medical journal Lancet in 1997, 1,018 patients were randomized into two groups. One group received percutaneous transluminal coronary balloon angioplasty (PTCA), and the other group was treated medically. These patients were then followed for 2.7 years. The study revealed that only those patients with the most severe angina had improved pain relief and also showed that improvement was often lost beginning a few months after PTCA, with no improvement at two years, presumably from reblockage, when compared to the medically-treated group. Death and non-fatal myocardial infarction occurred in 6.3 percent of PTCA patients, compared with only 3.3 percent of medically-treated patients. There was one death and seven non-fatal myocardial infarctions at the time of PTCA.

A three-year follow up of this same group of patients was reported in the March 15, 2000, issue Journal of the American College of Cardiology. Patients in the balloon angioplasty group with the most severe angina had significantly greater improvements in physical functioning, vitality and general health at both three months and one year, but not at three years. Those conclusions were related to breathlessness, angina grade and treadmill exercise time.

Lange and Hillis reported in an editorial in a 1998 issue of the New England Journal of Medicine that after reviewing four recent large prospective, randomized studies comparing invasive, aggressive therapy with conservative, non-invasive, medical management of acute coronary syndromes (angina, ischemia, and infarctions): "...studies show that routine angioplasty and revascularization [bypass] do not reduce the incidence of non-fatal myocardial infarctions or death..." They go on to state that despite the fact that adverse events are similar or even greater in patients managed aggressively, physicians in the U.S. continue to choose the more aggressive and invasive approaches. Angioplasty and bypass are performed less than half as frequently on similar patients in Canada, although the incidence of myocardial infarction and death in three years of follow up was similar. In their editorial the authors ask, "Why are coronary angiography and revascularization [bypass and angioplasty] often performed in patients with acute coronary syndromes in the United States, even without an obvious indication?"

Will criticism from within or without the medical community stem the flood to the surgical suites?

"Not likely," said one of San Francisco's leading cardiologists. "There's too much money involved. It's become a self-perpetuating industry."

Perhaps the surgeons have gotten carried away, but that's no reason for patients to play along.

Should you be advised to submit to bypass surgery or angioplasty before other treatments are fairly tried, or even considered, first ask this question first: "What are my other alternatives?"

The following references from the scientific literature support the opinions and statements  written above.

REFERENCES

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