Race is on to market HeartSaver
Monday 25 January 1999
Ottawa's artificial heart project promises to draw much attention --as long as doctors can keep the technology here. Maria Bohuslawsky reports.
Maria Bohuslawsky
The Ottawa Citizen
The metal and plastic heart in Dave the Dummy's gaping chest pumps with a surprisingly loud wheeze. WEE-hee, WEE-hee, WEE-hee.
The high-pitched sound fills the fifth-floor lab in the University of Ottawa Heart Institute. This is where scientists are developing the world's first fully implantable artificial heart.
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Dave's noisy heart, known as the HeartSaver, is cutting-edge technology that promises to restore a near-normal life to thousands of people dying of heart failure.
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The HeartSaver is bringing international attention to Ottawa, and its makers are in a fierce race to get it to market in 2001. It is expected to eventually create up to 5,000 high-tech jobs and earn $1 billion a year. And yet Canada nearly lost this wondrous technology to big American or Japanese biomedical companies when the program was denied research funding in 1995.
"This technology was in danger of dying or being taken over by other countries," says Dr. Tofy Mussivand, 54, director of the cardiovascular devices division at the institute.
"Many times Dr. (Wilbert) Keon, and myself were approached
to take the technology and move elsewhere."
Terminal heart failure is the last untreatable form of heart
disease. It is caused by viral infections, alcohol abuse or
damage by repeated heart attacks. The heart can't pump
enough blood to keep the patient alive.
Each year, about 25,000 Canadians die prematurely of heart
failure; around the world five million succumb to the disease.
About 40 per cent of the deaths occur in patients younger than
65.
"Ultimately I think it can extend people's lives indefinitely so
they would not die prematurely of heart disease," says Dr.
Keon, 63, director of the heart institute and originator of the
idea. "You might not be able to do extensive downhill skiing,
but you'd be able to shop and take care of your children and
play golf. You won't know you have it."
The HeartSaver is about the size of a man's hand and weighs
500 grams. It is called an electrohydraulic ventricular assist
device (EVAD). That's where the name Dave comes from --
EVAD spelled backwards.
The device is designed to lie next to a patient's diseased organ
and take over its pumping functions. It does the work of the
damaged left ventricle, the largest pumping chamber.
The heart institute expects to begin clinical trials in humans
in December, starting with six local patients for a five-year
study that will eventually extend to dozens of patients,
worldwide.
"When somebody's heart muscle dies, the only choice we have
is to transplant them," says Dr. Keon. "But there are so few
donors available."
About 200 heart transplants a year are performed in Canada
and the number of available hearts is declining due to fewer
car accident fatalities. There are 11 people waiting for a
transplant at the heart institute, a wait that can last a year to
18 months.
Heart transplants are a successful treatment but are costly and
require long-term anti-rejection medication. Dr. Mussivand
would rather have a HeartSaver beating in his own chest.
About 2,000 to 5,000 Canadians a year could benefit from the
device, with about 425,000 potential recipients worldwide.
Across from Dave's muscled torso is a glass box that contains
the first version of the heart. It has been continuously
pumping since October 1992.
Still there are many unknowns. How long will it pump? How
will the materials react in the human body?
The HeartSaver is now in its sixth incarnation, each time
getting smaller, quieter and more durable. It is made of
titanium and polyurethane and houses a turbine and an energy
converter.
The turbine moves hydraulic liquid, which in turn forces
blood to flow through the heart's cavity.
Power to run the HeartSaver is transmitted from a small
battery-powered coil taped to the chest. Another coil is
implanted beneath the skin. A patient wears a battery on a
belt, which can be recharged in a wall outlet or a car's cigarette
lighter.
An internal battery that looks like a metal cigarette case is
implanted under the skin and used as a backup power source.
By itself, it can keep the heart beating for up to an hour, to
allow a person to swim or shower.
Artificial hearts now in use are heavy and cannot be entirely
contained within the body, thus reducing a patient's freedom
of movement. With the Heartsaver, a patient will not be tied
to large machines by wires and tubes protruding through open
flesh, which increases risk of infection and results in a
miserable quality of life.
"All of our competitors have got somebody carrying a suitcase
or pushing a cart," said Dr. Keon. "Our patients will walk
around with nothing."
Another big difference is that the HeartSaver simulates the
action of the normal heart and generates a pulse.
Non-pulsatile machines lead to complications in other organs.
Despite such hard-won attributes, the program has had to
fight to survive funding cuts. The lowest point came in 1995
when the newly elected Harris government cancelled a
$7-million loan that had been promised by the previous
provincial government.
"That was almost my whole budget," recalls Dr. Mussivand,
who was forced to lay off 30 staff. "It was awful."
Foreign companies began to court him and Dr. Keon. But they
resisted and kept "begging" governments and the private
sector.
"I'm a Canadian," said Dr. Mussivand. "This is the work of
many Canadians."
He even told his troubles on the Discovery channel and was
touched by donations from viewers, including $5 from an
American man on welfare.
Finally, the federal government lent the program $5.5 million
at 10 per cent interest. The heart institute must repay it once
it begins earning royalties.
"We survived by producing even in hard times," said Dr.
Mussivand. "Many people supported us with their time, money
and prayers."
Over the past 10 years, the project has cost about $35 million,
which has come from international grant agencies,
governments, foundations and the public. Only about 25 per
cent has been from government sources.
During that bleak time, a connection was made with Ottawa
Senators owner Rod Bryden and Corel Corp. chairman
Michael Cowpland.
These high-tech powerhouses formed WorldHeart Corp. in
1996 to manufacturer and market the device in partnership
with the heart institute. Dr. Mussivand is now president of the
Nepean-based company and Dr. Keon is vice-president.
WorldHeart projects its first profit of about $13 million U.S.
in 2001.
The cardiovascular devices division and WorldHeart each have
about 60 paid employees. In addition, Dr. Mussivand relies on
an extensive volunteer network of scientists, electronics
experts and engineers.
The HeartSaver is expected to last at least five years. It would
then have to be replaced. It could be implanted permanently or
temporarily until a transplant became available.
There will be no shortage of volunteers for the clinical trials,
predicted Dr. Keon. "They have no choice."
Candidates must not have other serious health problems like
cancer, kidney disease or psychiatric illness. "Their health
must be strong enough to stand the physical and emotional
trauma of this undertaking."
The device will sell for $50,000 U.S. and will be covered by
provincial health plans once approved.
"We're not suggesting this is the ultimate end product," warns
Dr. Keon. "This is the beginning of totally implantable
artificial hearts."
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