�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 ingrained in his chest, and
connected to his flunk heart, to help pump his blood and keep him animated.
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 erstwhile 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
inside the ice hockey puck-sized ingrained device never touches the walls of
the pumping chamber.
Instead, it levitates in the middle, suspended in a magnetic field and
push blood on. The battery-powered device pushes blood from the center
to the body, pickings over nearly of the function of the left side of a
severely weakened heart.
As a result, DuraHeart may cause less impairment to blood cells and be less
likely to allow unsafe blood clots to shape, compared with other
heart-assisting devices that use mechanical pumps. It has already been put-upon
in 70 patients in Europe, where it received approval for commercial exercise in
2007 after a clinical tribulation.
Now, spirit failure patients at U-M and other centers across the U.S.
will feature the chance to volunteer for a clinical trial of the
DuraHeart, which is organism 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 acquire how to implant the device.
"The DuraHeart gives us a new, third-generation option for patients
with advanced heart failure wHO need serve to leave them to survive until
they john receive a heart transplant," says Pagani, who leads the U-M Center
for Circulatory Support.
He has led early 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 run. U-M right away offers bosom
failure patients nearly a dozen different options to support their heart
social function, including heart transplants.
"This trial will test the DuraHeart's electric potential to overcome some of the
issues that take in been seen with other devices, including hemolysis caused
by fleece stress on red blood cells, and clotting jeopardy caused by blood that
does not circulate apace enough from all areas of the chamber," Pagani
explains. "It also clay to be seen if this device offers superior
durability, which might do it utilitarian 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
ticker attack and clogged arteries damaged parting of his heart muscleman, is one
of 5.3 trillion Americans with heart failure.
Although not all spunk 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 heel for a
heart transpose, but only 2,C people receive new hearts in the U.S. each
year because of a shortage of suitable donor organs. Hundreds of multitude
each year die patch waiting for a heart.
In the past 20 years, many devices receive been developed to aid the
pith pump. Most have been left-ventricular attend devices or systems,
sometimes referred to as LVADs or LVASs. But others have aided the right
side of the middle 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 feel
in implanting the devices and pickings care of patients before and after they
receive their device. This saltation, U-M became one of the first few such
accredited VAD centers in the land.
The DuraHeart was invented and highly-developed by a team light-emitting diode 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 tryout and the
trial in Europe, as well as a trial in Japan that may begin afterwards this
year. Pagani serves as an unpaid adviser to Terumo Heart.
The clinical trial will inscribe 140 patients in a prospective,
non-randomized fashion, and up to 40 hospitals may eventually take portion.
All of the devices are existence made in Ann Arbor at Terumo Heart.
To implant a DuraHeart device, the sawbones diverts blood flow from the
seedy 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 caparison. This pushes blood
into a flexible artificial blood vessel, which is connected to the large
blood vessel called the ascent aorta.
By assisting the weak left ventricle, which is the heart sleeping room most
ordinarily affected by heart failure, the DuraHeart allows the heart muscle
to rest. It also provides better blood menstruation to the body, brainiac and organs
than a weak heart ever could - which helps patients prepare for the toilsome
surgery of a heart transplant.
Devices such as the HeartMate II and its predecessor HeartMate XVE, and
potentially the DuraHeart, may suit substitutes for heart transplants
over clip. They crataegus oxycantha allow patients to live for days with help from the
device, or to recover enough center function that they no longer need either
a device or a transplant. The HeartMate XVE is already sanctioned for this
type of "destination" use, and the HeartMate II is presently in a clinical
run for this purpose.
The DuraHeart may hold the same potential drop, says Pagani, but number one it
must be tested as a bridge to transplantation. With Anthony Shannon as the
pioneer, that test has now begun.
University of Michigan Health System
http://www.med.umich.edu
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