VentrAssist is third-generation heart assist device
to support patients until they receive heart transplant
April 2, 2009 - Patients with severe heart failure
can be bridged to eventual transplant by a new, smaller and lighter
implantable heart pump, according to a just-completed study of the
device, which is now looking for clinical trial participants. Results of
this third-generation heart assist device were reported at the 58th
annual meeting of the American College of Cardiology on March 30.
The blood pump, a left ventricular assist device (LVAD),
is the latest generation of heart assist devices. The LVAD was tested at
five main sites: Washington University School of Medicine in St. Louis,
the University of Minnesota, Mt. Sinai School of Medicine, Inova Fairfax
Hospital and the University of Pittsburgh.
"LVADs have allowed us to support patients until
they can receive a heart transplant, so they are called a bridge to
transplant," says Gregory Ewald, M.D., a Washington University
cardiologist at Barnes-Jewish Hospital and medical director of the Heart
Failure, Cardiac Transplantation and Total Artificial Heart Program.
"For patients whose hearts are failing and are
awaiting transplantation, these devices can be lifesavers. Washington
University is the only medical center in the region where patients can
receive these devices at this time."
In addition to Ewald, associate professor of
medicine, lead investigators in the trial included Nader Moazami, M.D.,
associate professor of surgery and surgical director of the Cardiac
Transplantation and Total Artificial Heart Program at Washington
University, and Andrew Boyle, M.D., associate professor of medicine at
the University of Minnesota and medical director of Heart Failure,
Cardiac Transplantation and Mechanical Circulatory Support. Boyle
presented the findings at the ACC meeting.
VentrAssist™ LVAS
VentrAssist™ is a new third generation cardiac
assist system primarily designed as a permanent alternative to heart
transplants for patients suffering heart failure.
It is a blood pump that connects to the left
ventricle of the diseased heart to help the ailing heart’s pumping
function and assist in restoring a better quality of life.
It can also be used as a bridge to heart transplant
and possibly as a bridge to recovery, where it may allow a deteriorating
heart an opportunity to recuperate.
VentrAssist™ has only one moving part – a
hydrodynamically suspended impeller. It has been designed to have no
wearing parts or cause blood damage.
It weighs just 298 grams (10oz) and measures 60mm
(2.5 inches) in diameter, making it suitable for both children and
adults.
The implanted parts of the VentrAssist™ system use
materials which are fully biocompatible including titanium alloys. Its
components are light, strong, non-toxic and highly resistant to
degradation within the body.
The VentrAssist™ is an outstanding advance over
older heart assist devices.
Its unique combination of features and benefits
include:
Features
● small size
● patented hydrodynamicaly suspended impeller
● diamond-like carbon coating on blood contacting
surfaces
● fully redundant back-up motor drive, controller
and processor
Benefits
● outstanding biocompatibility
● assists the natural heart which is not removed
● no wearing parts
● advanced information management allows remote
monitoring and logging of critical data
>> New Home Page for VentrAssist under construction
–
click here
An LVAD is implanted inside the chest cavity near
the heart and is connected to the heart's left ventricle (pumping
chamber). It assists the patient's weakened or damaged ventricle in
pumping blood through the body. By restoring a normal blood flow, the
device improves patients' health. Because it is powered by portable
battery packs, patients usually go home while they wait for a heart
transplant.
The LVAD used in this study, the VentrAssist, is
termed a third-generation heart assist device. Measuring 2.5-inches
across and weighing 10 ounces, the pump is considered an improvement
over earlier devices because its size and light weight make it suitable
for small adults and children. In addition, its pumping mechanism has no
contacting parts for improved durability.
Patients who received the LVAD in the study were
approved and listed for cardiac transplantation. The study considered
the device successful if a patient survived until heart transplantation
or survived at least 180 days after the device was implanted and
remained qualified for heart transplantation. Eighty-five percent of
patients met this measure of success.
Out of 98 patients who received the device, 60 were
transplanted, 19 continued to be supported with the device and 19 died.
The median time on LVAD support was 131 days.
Adverse events reported
during the trial included stroke and bleeding, and the number and type
of adverse events was similar to other LVADs but better than that of
first-generation VAD devices.
Answering standardized questionnaires for patients
with heart failure, they reported a significantly improved quality of
life after receiving the device, indicating that their heart failure was
less apt to interfere with everyday activities such as housework,
hobbies or sleeping or to affect their mood, ability to concentrate or
energy level.
"Before implantation of the device, 80 percent of
these patients were rated class four on the New York Heart Association
scale — they were short of breath at rest," Ewald says.
"But by six
months, 84 percent were in class one or two, meaning their heart failure
symptoms were minimal or mild. All of them were able to go home with the
device, and that allowed them to rehabilitate themselves — their
nutrition improved and they were in better shape, making them better
candidates for heart transplantation."
The VentrAssist device pumps blood in a continuous
flow in contrast to earlier heart assist pumps that pumped blood in
pulses. It contains a spinning rotor that is suspended by blood within
the pump housing and magnetically rotated.
Since the impeller blades
don't touch any part of the pump, the chance of damage to blood cells is
lessened. With only one moving part, the pump is resistant to wear.
The positive results from this clinical study mean
the VentrAssist will be submitted to the U.S. Food and Drug
Administration for approval for use as a bridge to heart transplant. In
the interim, Washington University School of Medicine will continue to
provide the device to patients as part of a clinical trial.
Doctors here are continuing to enroll patients in a
trial of the device as a bridge to transplantation, and they are also
testing the device as "destination therapy" to see if the device can
function as an alternative to heart transplant by permanently assisting
failing hearts.
For information about enrolling in the trials call
314-454-7687.
Information Source:
Boyle AJ, Moazami N, John R, Ewald GA, Anyanwu AC,
Pinney SP, Desai SS, Burton NA, Teuteberg JJ, Kormos RL, Ascheim DV,
Gelijns AC, Parides MK, Joyce LD. The VentrAssist U.S. Pivotal Bridge to
Cardiac Transplantation Trial. Presented at 58th annual meeting of the
American College of Cardiology, March 30, 2009.
VentrAssist is made by Ventracor. Ewald, Moazami
and Boyle report no financial interest in Ventracor.
Funding from Ventracor supported this research.
Washington University School of Medicine's 2,100
employed and volunteer faculty physicians also are the medical staff of
Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine
is one of the leading medical research, teaching and patient care
institutions in the nation, currently ranked third in the nation by U.S.
News & World Report. Through its affiliations with Barnes-Jewish and St.
Louis Children's hospitals, the School of Medicine is linked to BJC
HealthCare.
Original report by Gwen Ericson, Assistant Director
of Research Communications, Washington University at St. Louis
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April 2, 2009 - Patients with severe heart failure
can be bridged to eventual transplant by a new, smaller and lighter
implantable heart pump, according to a just-completed study of the
device, which is now looking for clinical trial participants. Results of
this third-generation heart assist device were reported at the 58th
annual meeting of the American College of Cardiology on March 30. 