August 2, 2005
As Their Use Soars, Heart Implants Raise Questions
By BARRY MEIER
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A little-known heart device, an implantable defibrillator, has been under a
spotlight after the recent disclosure that a producer, the Guidant
Corporation, did not tell doctors for years that one of its models had a
defect that could render it useless. But well before that, medical experts
had been increasingly debating other aspects of the device, namely its
benefits and its costs.
No one disputes that many heart patients need a defibrillator, a device that
sends out an electrical jolt to interrupt a chaotic heart rhythm that can
cause sudden cardiac arrest, which is often fatal. But some doctors say the
units, which are fast becoming one of the most costly medical devices in use
today, are being implanted in many other patients who may not need them
because they are either too well or too sick.
Both the medical and financial consequences of that debate have been growing
as use of the device has soared. Last year, an estimated 135,000 devices
were implanted in patients in the United States alone, a near tripling of
the number in 2000. Meanwhile, the three major device producers, Guidant,
Medtronic and St. Jude Medical, have reaped a financial bonanza as domestic
sales rose during that same period to $3.5 billion, from $1.3 billion,
according to Harris Nesbitt, an investment firm.
The overuse or inappropriate use of medical treatments is a familiar theme.
But defibrillators pose unique issues because they are increasingly being
used as a standard piece of safety equipment, like an air bag in an
automobile, in an ever-growing number of heart patients whose individual
need for the device is not clear. Defibrillator prices are also like those
found on a new car, ranging from about $20,000 to $35,000 each.
"They are expensive and in theory almost anyone in the country could
benefit," said Dr. Mark Hlatky, a professor of health research and policy at
Stanford University School of Medicine. "So where do you draw the line?"
The dilemma reflects a growing medical conundrum. Defibrillators were first
used in the 1980's only in patients who had survived an episode of sudden
cardiac arrest. But since then, studies largely funded by the industry have
resulted in a steady expansion of the device's use to ever-broader pools of
heart patients with varying degrees of risk of cardiac arrest.
The problem, however, is that medical researchers have not figured out how
to tell which patients in these broader groups are at high risk and which
ones are at low risk. The result: they all qualify for a unit.
The problem is no small matter. Experts agree that many, if not the
majority, of defibrillator candidates are at a low risk of cardiac arrest.
"We can identify groups at risk, but we cannot really identify the
individuals in those groups who are at higher risk," said Dr. Douglas P.
Zipes, a cardiology professor at Indiana University School of Medicine.
Meanwhile, physicians like Dr. Zipes and health policy experts say that
manufacturers have used a variety of strategies to increase profits by
keeping device prices high. For example, rather than offering a low-cost
unit that does the basic job of stopping a bad heart rhythm, defibrillator
makers are engaged in a sort of medical arms race in which producers turn
over models by adding new features like different ways to measure heart
rhythms. Some of these additions are valuable, while others are just "bells
and whistles," experts say.
"These companies don't compete on price, they compete on features," Dr.
Doctors and patients also have no reason not to go for a top of the line
model, said experts like Dr. Hlatky. Many physicians acknowledge that they
do not consider product prices when deciding which model of defibrillator is
best for their patient. And patients have little reason to care about cost
because insurers like Medicare cover the cost of an implant procedure, which
includes the device, regardless of its cost.
As in other areas of medicine, there have been claims that device makers
retain the loyalty of physicians by providing them with consulting
arrangements and other financial incentives. The companies insist that they
have done nothing wrong and that their prices are fair. They also say they
are responding to doctors' suggestions by producing the devices they want.
In January, both the financial and public policy stakes involving
defibrillators were heightened when Medicare dramatically expanded the types
of heart patients who qualify to receive a unit. The agency's ruling means
that hundreds of thousands of heart patients each year will likely get a
unit, compared with 135,000 last year.
The Medicare decision followed a clinical trial, sponsored by Medtronic and
a division of the National Institutes of Health, which showed that patients
with heart failure who got both a defibrillator and heart drugs had a 7
percent higher survival rate than patients who were treated with just drugs.
Heart failure is a progressive weakening of the heart caused by coronary
disease or other factors.
However, that study also raised the troubling possibility that the sickest
heart patients might not be helped by a defibrillator and might even be
harmed if a device, as happens, misreads a rhythm and emits an unneeded
shock. That possibility is currently just a theory, but Dr. Gust H. Bardy,
who led the study, said he hoped to further research the issue.
A defibrillator is implanted under the skin near the collarbone in a
procedure that takes about an hour. The device, which is about the size of a
pager, sends out an electrical charge when it senses a chaotic heart rhythm
known as a ventricular fibrillation. That rhythm can cause sudden cardiac
arrest by effectively shutting off blood flow from the heart.
Most defibrillators can also treat an abnormally fast heart rhythm, known as
ventricular tachycardia, which can deteriorate into ventricular
fibrillation. No one is suggesting that anyone be denied a device without
better ways of selecting which patients face little risk. And there are many
heart patients who could benefit from a defibrillator who have not gotten
But the steady broadening of the device's use - from high-risk groups like
patients who survived a cardiac arrest to those at relatively lower risk
like heart attack patients or patients with heart failure - has also led to
a situation where more patients are receiving devices to find the one who
will benefit. "We have gone from six, to seven, to eight, to ten, to twelve
people" needing to have device implanted to save one patient's life, said
Dr. Zipes of Indiana University.
In just two years, defibrillator-related costs to both Medicare and private
insurers are expected to reach $10 billion, with Medicare covering about a
half of that expense, according to an estimate by Sanford C. Bernstein &
Company, an investment firm. That would make defibrillators one of
Medicare's biggest surgery-related costs.
With costs soaring, there is an increased urgency to find a way of both
discriminating between high-risk patients and low-risk ones and hold down,
or even reduce, the price of a device.
In an unusual move, Medicare is requiring doctors and hospitals to submit
detailed information about both the health condition of patients with
defibrillators and the type of device they received. Agency officials say
the goal is to create a database that will make sure the right patients are
getting units as well as potentially serve as a way of identifying the types
of patients who do not need them.
"We want to see if we can better define who is not benefiting so that in the
future we may be able to change the criteria," Dr. Steve Phurrough, the
director of the coverage and analysis group at the Centers for Medicare and
Medicaid Services, said in a recent interview.
Medicare officials are also reviewing one method of assessing a patient's
risk of cardiac arrest using a kind of stress test. Two heart device makers,
Medtronic and St. Jude Medical, said they were conducting clinical trials to
look at this same method as well as other markers that might help better
detect patient risk. Guidant declined to respond to written questions.
For now, however, experts have not agreed on a method. "It is an exciting
area potentially, but there may be a limit to what we can do," said Dr.
Michael Domanski, the head of the clinical trial group at the National
Heart, Lung, and Blood Institute, a part of the National Institutes of
The price of a defibrillator, like other medical devices, follows its own
unique economics, experts say. For example, while the prices of other
high-technology devices like computers and digital cameras have plunged, the
price of a standard defibrillator has remained steady or declined slowly,
industry analysts said.
"You can get a lot of high-end stuff in a low-cost digital camera today,"
said Dr. Charles D. Swerdlow, a cardiologist in Los Angeles.
Many cardiologists like Dr. Swerdlow say they have long lobbied major
producers, without success, to make a less-costly defibrillator that
performs the device's basic function of saving a life.
Daniel Schaber, a vice president at Medtronic, said it was unfair to compare
defibrillators with consumer products like computers because the market for
heart devices was tiny relative to computer sales. And both he and Dr. Eric
Fain, an executive at St. Jude Medical, said that the technological features
added to the devices might be costly but were in response to what doctors
"We have said to our advisers, 'What would you be willing to go back to in
terms of functionality?' " said Dr. Fain, referring to doctors who serve as
St. Jude consultants. And those consultants, he said, have routinely
rejected changes that would result in loss of certain features.
Two years ago, the American division of a German defibrillator maker,
Biotronik, offered a basic defibrillator for $10,000, about $6,000 less
expensive than the least costly units offered by the three major producers.
There was so little interest, the company dropped it.
Some doctors insisted that if one of the big producers, rather than
Biotronik, offered such a device, they might use it. But while one producer,
Medtronic, said in response to an inquiry that it does market such a product
- a unit called the Onyx - the company has not widely publicized it. Dr.
Zipes of Indiana University, who has consulted for Medtronic for three
decades, said he had never heard of it.
Separately, a hospital consulting firm, Aspen Healthcare Metrics of
Englewood, Colo., said last year in court papers as part of a lawsuit
initiated by Guidant that the device maker kept doctors loyal to its brand
by giving them "clinical research grants, consulting arrangements and other
The charges came in counterclaims to a lawsuit filed by Guidant against
Aspen in which Guidant charged that the consulting firm had, among other
things, illegally gathered confidential Guidant price data. Under federal
law, providing such inducements to doctors can be illegal. Aspen has denied
Guidant's claims and Guidant has denied Aspen's charges.