June 2, 2008 - Heart transplants save the lives of
more than 2,100 Americans every year. But many more patients are still
waiting for a new heart to become available, and hundreds will die
without ever getting a second chance at life. Meanwhile, tens of
thousands more people aren’t sick enough to need a transplant, but
struggle every day with severe
heart failure that limits all aspects of their lives.
Could technology be the solution – whether
temporary, or permanent – for many of these people? Could
heart transplants ever become a thing of the past?
The answers are “yes” - and “perhaps,” says a
University of Michigan heart surgeon who has dedicated his career to
helping patients through both heart-assisting implanted technology and
lifesaving heart transplants.
But until machines are good enough to make
transplants obsolete, says
Francis Pagani, M.D., Ph.D., we can harness technology to help many
people with severe heart problems survive and even thrive.
Patients like Tim Cusatis, a 50-year-old Michigan
man who had never felt sick until Super Bowl Sunday 2006 — the day
doctors told him his heart was failing fast. A few weeks later, they
told him that he’d die within weeks without a new heart.
Pagani and his team implanted it in Cusatis’ chest
and attached it to his heart, and then helped him adjust to life as a
“bionic man.” The HeartMate II is about the size of a D-cell battery,
with a tube that pokes through the skin and connects to a battery pack.
And it helped pump blood throughout Cusatis’ body, taking over for the
left side of his failing heart and helping him get stronger while he
waited for a transplant.
At the time, the device was still experimental. The
HeartMate device has since been approved for use by the
Food and Drug Administration (FDA) in April of 2008.
Lucky for Cusatis, a donor heart that matched his
own became available just seven weeks later – two years ago this week.
But he knows many other people wait many more months than he did,
waiting for chance, and the generosity of a grieving family, to save
their lives.
The device that Cusatis received is one of the
latest in a series of technologies that have been tried in the past 25
years, ever since the first truly successful use of a heart-assisting
device.
Pagani and his colleagues at the
U-M Center for Circulatory Support – cardiologists, nurses, surgical
team members and therapists – have helped test all of the new devices as
they have been developed over the years. The U-M team has been helped by
hundreds of patients who have volunteered for clinical trials of new
devices.
U-M now offers nearly a dozen options for adults
and children with heart failure. Most of the devices help the left side
of the heart, the powerful pumping chamber known as the left ventricle,
so they’re called left-ventricular assist devices or LVADs.
In fact, the HeartMate II is the cousin to the
larger HeartMate LVAD that has been available for several years. That
device was developed to help patients survive until a transplant, but
later it was shown that even non-transplant candidates could get years
of high-quality life with help from it.
It’s larger and louder than a HeartMate II – when
he saw it, Cusatis compared the HeartMate to the water pump from an old
Ford truck. Indeed, the HeartMate was too big to be used in some
patients, including most women, which is part of what makes the
HeartMate II an important advance.
Now, U-M and other hospitals are planning a study
that will see if the HeartMate II could also be used in people with
heart failure who aren’t good candidates for a transplant. That’s a
question that will take several years and hundreds of volunteers to
answer. In the meantime, the HeartMate II is mainly for people who are
waiting for a new heart.
Amazingly, the new device may even help some
patients avoid a heart transplant. In a small minority of patients, the
device gives the heart muscle such a break that the muscle can actually
start to heal and get stronger. The U-M team is now studying a drug that
might help accelerate this process.
But as exciting as today’s technology is, there’s even more hope on the
horizon, Pagani says.
“Over the past 15 years the technology has
dramatically improved. The pumps are now very small, but there’s even
newer technology that is coming into clinical testing within the next
year that offers dramatic improvements in the durability of these
devices,” he says. “We believe that some of the devices coming into the
research area now will likely have five- to ten-year durability, and
that they will start competing practically with heart transplantation.”
These “third generation” devices use magnetic
fields to keep the pumping components suspended within the implanted
device, to reduce friction and wear, and improve the life of the device.
A clinical trial of the first of these devices, called the Duraheart,
may begin this summer.
“I think the technology is improving to such a
point that we see dramatic changes in patients’ lifestyles, compared
with when they had advanced heart failure,” says Pagani. “The major
issue now is reducing the side effects associated with this therapy,
using transplantation as the benchmark and trying to achieve the
outcomes that we can achieve with a transplant. If we can do that
successfully with this technology, then it’s going to have much, much
wider application.”
For Cusatis, there’s no question that having the
HeartMate II and then a transplant has transformed his life. He now
knows that he has to take an active role in keeping himself healthy, and
has done so ever since getting the HeartMate II. He quit smoking, lost
weight, and exercises every day. He reads food labels carefully, looking
for lower-salt options and lower-fat choices. He ran his first
five-kilometer race last fall and just ran his third one, five minutes
faster than his last time.
“It’s amazing what a piece of equipment will do,”
he says. “When I look back at before the LVAD, and how sick I was, I can
see that it was a stepping stone to getting better. It was a bridge to a
new life.”
More on heart failure and left-ventricular assist
devices:
About 5.3 million Americans have heart failure, and
284,000 will die of it this year. While most heart failure patients will
not benefit from current heart-assisting technology, a sizable
percentage might.
Heart-assisting technologies are best suited for
patients who are waiting for a heart transplant; between 2,000 and 4,000
Americans are on transplant waiting lists at any time.
Only 2,100 heart transplants take place in the
United States each year, and hundreds of people die while waiting for a
heart.
Donor hearts can only come from people who have
signed up for donor registries before their deaths, and whose families
give permission for their hearts to be donated at the time of death.
Other factors, including the cause of death and the overall health of
the person at the time of death, also affect whether or not a heart can
be used for a transplant.
In 1984, the first successful heart-assisting
device was used. In the years since, a number of new devices have been
tried in thousands of patients nationwide. The HeartMate
left-ventricular assist device was approved for use in transplant
candidates in 2001, and as a “destination therapy” for long-term use in
2003.
The HeartMate II device was approved on April 21,
2008 for use in transplant candidates, and may soon be tested as a
“destination” option.
Other devices to assist the heart in pumping are
also available or in clinical trials, for both adults and children.
Later in 2008, a clinical trial of a
third-generation device called the DuraHeart may begin. It uses
magnetically levitated pump components to reduce friction and wear.
For information on heart failure treatment and
heart-assisting devices at the U-M Cardiovascular Center, call toll-free
888-287-1082 or visit
www.med.umich.edu/cvc.
Original written by Kara Gavin, University of
Michigan
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