Heart Pump Saves Lives, and Raises Questions
By: Sheryl Gay Stolberg
NY Times, July 2, 2002
Sherri Selph, who has
had a heart pump for three years,
wears a battery pack
that attaches to the pump
through a line from her abdomen.
SUMTER, S.C. ≈ With tens of thousands of Americans dying of heart
failure each year, and a dire shortage of donated human hearts,
cardiologists have long dreamed of a device that could be permanently
implanted in people too old or sick for a heart transplant. Now, the Food
and Drug Administration is considering just such a machine.
It is a $60,000 heart pump that experts say may extend the lives of as
many as 100,000 people a year. But the decision is generating social and
economic questions: who should get the costly pumps, who should pay for
them, and are they worth the expense?
Called left ventricular assist devices, or LVAD's, the implantable
pumps have been used since 1998 to keep transplant patients alive while
they await donor hearts. The F.D.A. is deciding whether to approve them as
permanent implants, for what cardiologists are calling "destination
therapy."
Approval by the agency, which the pump's manufacturer expects within
several months, would open a huge market for the devices and, proponents
say, offer dying patients the closest thing to an artificial heart. But
the pumps are hardly perfect; they often break, and some patients who
receive them suffer fatal infections, while others die before ever leaving
the hospital.
"What are we willing to pay for an extra year of life, and what
quality of life are we giving these people?" asked Dr. Steven Nissen,
a cardiologist at the Cleveland Clinic, who recently served on a committee
of experts that voted 8 to 2 to recommend that the agency approve the
devices.
The vote was based on a study that found that the implants kept dying
heart patients alive for 408 days, as opposed to 150 days for patients
receiving conventional drug therapy. But the committee also raised
questions about the pumps' reliability.
"I'm troubled by this," said Dr. Nissen, who cast one of the
two dissenting votes, "and a lot of people are troubled by it."
One person who is not troubled is Sherri Selph, a 49-year-old patient
who learned about the heart pump on the Internet and talked her way into
the clinical trial. Three years ago, too weak from heart failure even to
dress herself and too overweight to receive a donated heart, she signed
what she calls "my death warrant," an order for doctors not to
revive her if her heart gave out.
Today, the heart pump ticks away, 80 beats a minute, inside Mrs.
Selph's chest. During the day, she wears a battery pack slung around her
shoulders, holster style, that attaches to the pump through a line
protruding from her abdomen. She plugs into a power charger at night. Her
friends call her "the electric lady."
Most of Mrs. Selph's fellow study subjects have died, and Mrs. Selph is
on her second pump; the first one broke. "Sure, it cost $100,000 to
have the surgery to get this," she said. "But I've had almost no
medical bills, compared to what I had before the pump. And it's kept me
alive."
At a time when lawmakers in Washington are debating how to provide
prescription drug coverage to Medicare recipients, the pump controversy
suggests that medical devices will also affect the cost of health care in
the coming years.
"Everyone is concerned with the cost of drugs," said Dr.
Roger Evans, a health care consultant and expert in the economics of organ
transplants. "But that could be trivial compared to what we could do
with devices."
Dr. Evans and other experts say the pump controversy recalls the debate
in the early 1970's over whether Medicare should cover kidney dialysis, a
treatment that has helped thousands of patients in what the government
calls its end-stage renal disease program.
The program began in 1974 with about 600 patients. Once the government
decided to pay for dialysis, its use skyrocketed. Over time the technology
improved, extending people's lives for decades. Today, Dr. Evans said, the
program covers more than 300,000 people, at a cost to taxpayers of roughly
$12 billion a year, about 5 percent of what Medicare spends.
Should the heart pumps come into widespread use, Dr. Evans has
calculated that insurers, including Medicare, would pay $15 billion to $24
billion a year for them, along with a relatively small amount for heart
transplants.
Sensing the parallels to the dialysis debate, Dr. Eric Rose, chairman
of the department of surgery at Columbia University and the heart study's
principal investigator, took the unusual step of including a cost-benefit
component in his experiment. Experts say that if this analysis finds heart
pumps comparable in cost to dialysis, it will offer a compelling argument
for coverage.
"The skeptic would say, `Look at end-stage renal disease ≈
it costs society a fortune,' " Dr. Rose said. "I would argue
that the end-stage renal disease program is an absolute triumph of
humanity."
To Dr. Rose, there is no question the pumps help patients. His study, a
nationwide clinical trial, enrolled 129 patients from May 1998 through
July 2001 in 20 cardiac transplant centers around the country. Sixty-eight
patients received the pumps, while 61 were treated with medicine. At the
end of two years, 23 percent of the pump patients were still alive,
compared with 8 percent of those on drugs.
The study was partly financed by the National Institutes of Health,
which has been investing heavily in heart device research since the early
1960's. The research has proceeded along two tracks: artificial hearts,
which are now the subject of a continuing experiment, and the heart pumps,
which work by taking over the left ventricle of the heart, its main
pumping chamber, that pumps oxygen-rich blood from the lungs throughout
the body.
"People have been paying their taxes to do this research for 40
years," Dr. Rose said. "Now that we have made progress are we
going to turn our backs on it? It makes no sense."
Also at issue is which hospitals and which doctors will be able to
offer the pump surgery, said Dr. Robert Kormos, director of the artificial
heart program at the University of Pittsburgh. "This is a very
complex procedure," Dr. Kormos said. "If you haven't got the
background, you shouldn't dabble in it."
In the United States, three pumps are on the market as
bridge-to-transplant devices. The one closest to receiving Food and Drug
Administration approval for destination therapy is made by the Thoratec
Corporation. Another company, the World Heart Corporation, will seek
approval for a similar device.
The current European and American market for bridge-to-transplant pumps
is $125 million to $150 million a year, said D. Keith Grossman, Thoratec's
chief executive. If the devices come into widespread use as permanent
implants, Mr. Grossman estimated, the market will grow to $6 billion to $8
billion a year.
Mr. Grossman said that even if Thoratec got only 1 percent of that
business, its revenues would roughly double. "I think it will be a
very, very big opportunity for this company," he said.
Anticipating F.D.A. approval, the company is waging an intense campaign
to persuade Medicare officials to reimburse hospitals for the pumps,
relying in part on recipients who by their very survival are making the
case better than any medical expert.
Among them is Mrs. Selph, who told of her experience over a glass of
iced tea one recent afternoon in the modest brick house where she lives
with her husband, Danny, and the grandson they are rearing, Keith.
In 1994, Mrs. Selph, then a district manager for a chain of convenience
stores, learned she had congestive heart failure. Doctors recommended a
heart transplant, but she said she was nervous and not convinced that she
needed one. As her condition worsened, she put on weight, and by 1999, she
said, she weighed 233 pounds, 43 pounds over the limit for a new heart.
"At that point, they didn't give me six months," Mrs. Selph
said.
On Oct. 29, 1999, a Friday, surgeons at the University of Alabama at
Birmingham sliced Mrs. Selph's chest open, from neck to navel, and
implanted the device. By Tuesday, she said, "I was walking up a
flight of stairs, just to see if I could do it."
Still, she is not back to normal. Mrs. Selph can no longer go camping,
which she loves, or swim in her backyard pool, or bowl ≈ her arm
gets caught on the battery pack when she tries to release the ball. She
cannot leave the house alone for fear her batteries will go bad and she
will not be able to get help. It takes her "a good 30 minutes and a
lot of aggravation" to get ready for the shower, she said.
But these, she says, are minor inconveniences.
"I feel like this is the reason I'm here, to test this pump,"
Mrs. Selph said. "It's like that was my calling."
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