First U.S. Patient to Receive New Heart-Assist Device Doing Well After Surgery at...

First U.S. Patient to Receive New Heart-Assist Device Doing Well After Surgery
at University of Michigan

National trial aims to help heart failure patients survive until transplant,
and may offer lower clot risk and less blood damage than earlier heart devices

ANN ARBOR, Mich., Aug. 5 /PRNewswire-USNewswire/ -- Anthony Shannon made
history on July 30. That's when he became the first person in the United
States to receive a new type of experimental and very high-tech heart-assist
device. Called a DuraHeart, it was implanted in his chest, and connected to
his failing heart, to help pump his blood and keep him alive.

Shannon, a 62-year-old from Livonia, Mich., is doing well less than one week
after the operation, which was performed by a team led by surgeon Francis
Pagani, M.D., Ph.D. at the University of Michigan Cardiovascular Center.
Shannon is the former director of homeland security and emergency management
for Wayne County, Mich., and holds a Ph.D., in public administration.

The DuraHeart, made by an Ann Arbor, Mich.-based company called Terumo Heart
Inc., uses advanced magnetic-levitation technology. This "maglev" approach, as
it is called, means that a crucial, constantly revolving part within the
hockey puck-sized implanted device never touches the walls of the pumping
chamber.

Instead, it levitates in the middle, suspended in a magnetic field and pushing
blood along. The battery-powered device pushes blood from the heart to the
body, taking over most of the function of the left side of a severely weakened
heart.

As a result, DuraHeart may cause less damage to blood cells and be less likely
to allow dangerous blood clots to form, compared with other heart-assisting
devices that use mechanical pumps. It has already been used in 70 patients in
Europe, where it received approval for commercial use in 2007 after a clinical
trial.

Now, heart failure patients at U-M and other centers across the U.S. will have
the opportunity to volunteer for a clinical trial of the DuraHeart, which is
being co-led by Pagani and by Yoshifumi Naka, M.D., Ph.D., from Columbia
Presbyterian Hospital in New York. U-M is the national training center for the
trial, which is funded by Terumo Heart, and teams from Columbia and the
University of Louisville have already traveled to Ann Arbor to learn how to
implant the device.

"The DuraHeart gives us a new, third-generation option for patients with
advanced heart failure who need help to allow them to survive until they can
receive a heart transplant," says Pagani, who leads the U-M Center for
Circulatory Support.

He has led other national clinical trials of heart-assist devices, including
the HeartMate II, which in April received approval from the U.S. Food and Drug
Administration after a clinical trial. U-M now offers heart failure patients
nearly a dozen different options to support their heart function, including
heart transplants.

"This trial will test the DuraHeart's potential to overcome some of the issues
that have been seen with other devices, including hemolysis caused by shear
stress on red blood cells, and clotting risk caused by blood that does not
circulate rapidly enough from all areas of the chamber," Pagani explains. "It
also remains to be seen if this device offers superior durability, which might
make it useful as a destination therapy that could remove the need for a heart
transplant."

Shannon, whose heart has been weakening for nearly 20 years after a heart
attack and clogged arteries damaged part of his heart muscle, is one of 5.3
million Americans with heart failure.

Although not all heart failure patients are candidates for a heart-assist
device or a heart transplant, tens of thousands could be. At any given time,
as many as 4,000 Americans are on the waiting list for a heart transplant, but
only 2,100 people receive new hearts in the U.S. each year because of a
shortage of suitable donor organs. Hundreds of people each year die while
waiting for a heart.

In the past 20 years, many devices have been developed to help the heart pump.
Most have been left-ventricular assist devices or systems, sometimes referred
to as LVADs or LVASs. But others have assisted the right side of the heart or
both sides - collectively, such devices are called VADs.

The therapy has become common enough that hospitals can now apply for
accreditation as certified VAD centers, an indication of their experience in
implanting the devices and taking care of patients before and after they
receive their device. This spring, U-M became one of the first few such
accredited VAD centers in the nation.

The DuraHeart was invented and developed by a team led by Chisato Nojiri,
M.D., Ph.D., the chief executive officer of Terumo Heart. More than a decade
of research and development has led to this clinical trial and the trial in
Europe, as well as a trial in Japan that may begin later this year. Pagani
serves as an unpaid consultant to Terumo Heart.

The clinical trial will enroll 140 patients in a prospective, non-randomized
fashion, and up to 40 hospitals may eventually take part. All of the devices
are being made in Ann Arbor at Terumo Heart.

To implant a DuraHeart device, the surgeon diverts blood flow from the ailing
left ventricle of the heart into a titanium tube that leads into the pumping
chamber. The magnetically levitating impeller, a flat magnetic disc, acts as a
paddlewheel, turning constantly as it is magnetically attracted to the turning
motor within the pump housing. This pushes blood into a flexible artificial
blood vessel, which is connected to the large blood vessel called the
ascending aorta.

By assisting the weak left ventricle, which is the heart chamber most commonly
affected by heart failure, the DuraHeart allows the heart muscle to rest. It
also provides better blood flow to the body, brain and organs than a weak
heart ever could - which helps patients prepare for the arduous surgery of a
heart transplant.

Devices such as the HeartMate II and its predecessor HeartMate XVE, and
potentially the DuraHeart, may become substitutes for heart transplants over
time. They may allow patients to live for years with help from the device, or
to recover enough heart function that they no longer need either a device or a
transplant. The HeartMate XVE is already approved for this type of
"destination" use, and the HeartMate II is currently in a clinical trial for
this purpose.

The DuraHeart may hold the same potential, says Pagani, but first it must be
tested as a bridge to transplantation. With Anthony Shannon as the pioneer,
that test has now begun.

For information on the U-M Cardiovascular Center, visit www.umcvc.org or call
1-888-287-1082. For more on the DuraHeart trial, visit
www.umms.med.umich.edu/engage/detail_pub_study.do?id=3158.

SOURCE University of Michigan Health System

Kara Gavin of the University of Michigan Health System, +1-734-764-2220,
kegavin@umich.edu; or Carmen Fox of Terumo Heart Inc., +1-734-741-6345,
carmen.fox@terumomedical.com