Destination
Therapy:
Alternative to Heart Transplant
July / August 2004
Penn Cardiac Care surgeons are utilizing mechanical ventricular
assist devices (VAD) as destination therapy for patients
with
heart failure who are not eligible for heart transplant.
Approved by the FDA in October 2003 for destination therapy,
VADs are
mechanical aids to heart function that help restore blood
flow to the damaged heart.
Approximately 20 to 25 percent of people on the heart transplant
recipient list die waiting for a heart each year. Over a decade
ago, early trials of VAD demonstrated that these individuals
could survive until the transplant was available by relying
on a VAD. Even though this surgical procedure carries a 20
to 30 percent mortality, 60 to 70 percent of patients who
utilize a device as a bridge to transplant would not have
survived on their own long enough to obtain a transplant.
In the late 1990s, the success of the REMATCH (Randomized
Evaluation of Mechanical Assistance for the Treatment of Congestive
Heart Failure) trial led to the consideration of using mechanical
assist devices as destination therapy. REMATCH compared standard
medical destination therapy with VAD destination therapy in
patients who were not transplant candidates. The REMATCH trial
clearly showed that survival and quality of life for patients
on the device was much better than for patients on standard
medical therapy.
Ineligible for Transplant
Regardless of the number of donor hearts available, many patients
are not candidates for a heart transplant for a variety of
reasons including cancer, personal reasons, blood clotting
problems, debilitating health and more. To be eligible for
destination therapy, patients must have a very high mortality
(upwards of 75 percent in one year) and be ineligible for
a heart transplant.
It is anticipated that these patients will not only live
longer, but also experience improvement in their quality of
life. “Our first patient was so short of breath that
for the last few years he spent most of his time sitting around.
Two months after receiving the device he was able to dance
and play with his nieces and nephews,” says Rohinton
J. Morris, MD, clinical associate professor of surgery
and associate director of heart transplantation and the mechanical
assist program in the Penn Transplant Center. “The results
have been encouraging, but the long-term function of the device
has not been studied. While there are many patients who wait
for a heart transplant, there are few who have sustained two,
three or four years.”
Improving Quality of Life
To date, the Thoratec™ HeartMate Left Ventricle Assist Device™ (LVAD) is the only FDA-approved device for destination
therapy
but experts expect more devices to be approved in the next
two to three years. At Penn, cardiothoracic surgeons are
investigating
a totally implantable VAD, a small axial-flow pump (which
may only require a tiny incision in the left chest), a
totally
artificial heart, and other LVADs. As of April 2004, two
patients at Penn received the HeartMate for permanent assist
and approximately
50 patients nationwide have received destination therapy.
“What’s exciting is the technology continues
to improve. In the future, instead of receiving a heart transplant,
patients may receive a device as an elective procedure before
they start getting so sick,” explains Dr. Morris. “Right
now this is an expensive proposition, but it can be even more
costly to have a patient repeatedly admitted to the hospital
for heart failure.”
An Accepted Treatment
Each year, approximately 400,000 people die of heart failure.
It is estimated that 10 to 25 percent of these patients could
have benefited from surgical interventions including:
- the investigational girdling jacket to limit or reverse
ventricular remodeling
- high-risk valve repair surgery
- heart transplant
- destination therapy
The future for caring for patients with heart failure is
a focus of intense research. In Europe, trials have found
that patients who were awaiting a heart transplant and on
a device for one or two years actually showed an improvement
in heart function and had the device removed. “Although
I don’t anticipate this will happen for the majority
of patients, the device does allow the heart to rest and heal,”
adds Dr. Morris. “For now, destination therapy is in
the early stages of becoming an accepted treatment for patients
with heart failure but the number of people obtaining this
technology should grow rapidly.”
The Penn Transplant Center performs approximately 50 to
55 cardiac transplants yearly and is one of the top five
busiest
heart transplant centers in the United States. Penn’s
one- and five-year survival rates are consistent with United
Network of Organ Sharing (UNOS) and national norms.
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Referring Physicians: To speak with a Penn physician
or refer a patient, contact PennHealth through the secure online
referral form or by calling
1-800-789-PENN
(7366). |
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