Newest Implanted Heart-Assisting Device Tested by
Newest Certified Heart Device Program
FDA approves HeartMate II tested at U. of Michigan
Cardiovascular Center
By Kara Gavin, Michigan State University
New Hope For Advanced-Stage
Heart Failure Patients
The HeartMate II Left Ventricular Assist System (LVAS)
is a small, quiet, next-generation blood pump shown to restore
hemodynamic function and improve patient outcomes and quality of
life. Through the rotary action of a single-moving part, the
HeartMate II LVAS can provide long-term circulatory support by
pumping blood from the heart to the body at up to 10 liters per
minute.
April 23, 2008 - Once upon a time, people whose
hearts were failing had two choices: hope that their own heart kept
pumping until they could receive a transplant, or face a certain death,
which they might fend off for a while using medicines.
But the last decade has brought incredible advances
in technologies that help a failing heart keep pumping. New devices
including one approved by the
U.S. Food and Drug Administration on April 21 are giving patients
a better chance at receiving a transplant, or even helping them survive
without getting a new heart.
The certification recognizes the broad range of
services and high quality of care for advanced heart failure patients at
U-M, which offers adults and children access to nearly a dozen
heart-assist devices and a full range of medical and surgical care.
Good news for treatment, scientific research and
testing of potentially new drugs
April
23, 2008 - Stem cells derived from material left over from open heart
surgeries have been used to grow large numbers of stem cells and create
new heart muscle cells. The Dutch researchers say it is a "breakthrough"
in stem cell research - previously it was necessary to use embryonic
stem cells to make this happen. It also means stem cell research is
advancing rapidly and may prove useful to today's senior citizens in
fighting a variety of diseases.
Read more...
U-M is one of the nations most experienced
programs offering such devices.
The certification comes from
the Joint Commission, which accredits health care organizations and
recently began certifying centers that offer ventricular assist devices,
or VADs the umbrella term for devices that help the heart pump blood.
Also this week, U-Ms heart team is celebrating the
FDA approval of the
HeartMate II, an implanted device about the size of a D-cell battery
that promises to help even more patients survive the wait for a
transplant.
U-M cardiac surgeon
Francis Pagani, M.D., Ph.D., helped lead the national clinical trial
that tested HeartMate II in hundreds of patients at 44 hospitals
nationwide including U-M, where 57 patients received the device
between 2004 and early 2008.
The results of that trial were published in August
2007 in a paper in the
New England Journal of Medicine, and were used in the FDA
application by Thoratec, Inc., which makes the HeartMate II as well as
its predecessor the HeartMate XVE.
Pagani welcomes both the FDA approval and the new
certification program as signs that heart-assist devices have come into
their own as an option in heart care.
When we first began implanting early long-term
devices in 1996, we dreamed of a time when we could have a technology to
suit every patient, no matter what their condition, he says. With
HeartMate II, and other devices now in clinical trials or already in
use, we are much closer to that dream. And the new certification program
can give patients and their families confidence that they will get the
best possible care from an experienced team before, during and after
their device implantation.
Pagani, associate professor of cardiac surgery at
the U-M Medical School, heads the
U-M Center for Circulatory Support, which includes surgeons,
cardiologists, intensive care specialists and nurses who focus on
patient care, research and education in mechanical circulatory support.
The U-M Center for Circulatory Support is also
working with the Ann Arbor-based Terumo Cardiovascular Systems
Corporation. TCSC is a sister company of
Terumo Heart Inc., also based in Ann Arbor, which makes an
experimental VAD called the DuraHeart. That device will have its first
test in a clinical trial that will begin later this year, with Pagani as
co-leader.
FDA Approves First Compact
Heart Assist Device
The U.S. Food and Drug
Administration on Monday, April 21, approved a heart assist
device with a novel design that is the first to mechanically
support the weakened heart of a small-sized adult man or woman
with heart failure who is at risk of dying while awaiting a
heart transplant.
Heart assist devices are
surgically implanted mechanical pumps that help the heart's
ventricle do its work of pumping blood to the rest of the body.
Previous models were too large to be placed in the upper abdomen
of some women and small-sized men.
But the Thoratec HeartMate
II Left Ventricular Assist System employs a first-of-a-kind
design. Instead of the standard pulsatile pump that simulates
the action of the heart, the device uses a continuous flow pump
that constantly moves blood with a single moving part, a
spinning rotor.
This allows the device to be
slimmed down to a mere three inches in length and a weight of
approximately one pound.
"The HeartMate II is an
important advance in mechanical heart technology," said Daniel
Schultz, M.D., director of FDA's Center for Devices and
Radiological Health. "Until now, some heart transplant
candidates have been underserved due to the large size of
previously approved heart assist devices."
An electrical cable that
powers the blood pump passes through the patient's skin to an
external controller that the patient wears on his or her waist.
The controller is powered either by batteries or connected to an
electrical power outlet.
Blood flow is set through
the pump based on the patient's need, and the controller
monitors pump performance, sounding alarms if it detects
dangerous conditions or a possible malfunction. The system can
operate on two external batteries, allowing the patient to move
freely for up to three hours.
In a clinical study of 126
patients at 26 transplant centers, 57 percent of patients with
the HeartMate II survived to heart transplant, which is
comparable to the survival of patients treated with currently
approved heart assist devices.
The product's manufacturer,
Thoratec Corporation of Pleasanton, Calif., is required to
conduct a post-approval study to further evaluate the HeartMate
II's performance during commercialization.
The HeartMate II is the latest in a string of VADs
and other devices to receive approval from the FDA. Smaller and lighter
than previous devices, it can be implanted in women, smaller men and
adolescents who were previously not able to receive the HeartMate XVE.
It connects through the skin to an external system controller that
regulates the speed of the rotary pump. A power cable connects the
device to a small monitor and power base unit, or patients can roam for
hours using a wearable battery pack.
The HeartMate II has allowed 77 percent of patients
to survive up to a year while they waited for a transplant, or while
they recovered without a transplant. It has also resulted in fewer
complications than previous devices, including infections, strokes and
surgical bleeding.
U-M also offers heart-assist devices for
cardiogenic shock, a severe acute condition that can kill quickly if not
treated, and for children whose hearts are failing due to congenital
defects or infections of the heart muscle.
One U-M patient, Maddie Shaw, recently celebrated
her fourth birthday on the same day that she observed her one-year
anniversary of living with an
Excor Pediatric device, also called a Berlin Heart. She received the
device under an FDA exemption, but more children may now receive it at
U-M and a handful of other centers through a new clinical trial.
Meanwhile, U-M offers certain adult patients the
CardioWest temporary total artificial heart (TAH-t), which completely
replaces the lower part of the heart and takes over all pumping
function.
U-M is one of only 11 U.S. hospitals that offers
this device, and may soon take part in a clinical trial of a portable
driver for the TAH-t that will allow patients to leave the hospital
while they wait for a heart. U-Ms first two TAH-t patients have both
received heart transplants and are doing well.
For more on the U-M Cardiovascular Centers
heart-assist device program, visit www.umcvc.org or call toll-free,
888-287-1082.
About heart failure and heart-assist devices:
Ventricular assist devices (VADs) and other
heart-assisting technologies are used to support the hearts of adults
and children with advanced heart failure, and patients in cardiogenic
shock.
More than 5 million Americans have some form of
heart failure, with 550,000 more diagnosed every year.
Each year about 2,200 Americans receive a heart
transplant, but many more are too sick to be listed for a transplant, or
die while waiting for one.
More than a dozen devices have been approved to
help failing hearts, or are in clinical trials.
The Joint Commission, which accredits health care
organizations such as hospitals, recently launched a program to certify
VAD centers that provide a broad range of high-quality care.
