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.
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