A Beam of Light –
A Beam of Hope
New Laser Procedure Promises
to Reduce the Risk of Amputation
by Christina DiMartino
J
immy Smith, like millions of Americans, has diabetes. Also like many, he
has no feeling in his feet and, therefore,
cannot feel pain when he gets a blister or
other wound. Because he doesn’t feel pain,
he may not notice these wounds until they
are already in bad shape. And, to make
matters worse, because the blood supply
to his lower legs and feet is restricted, his
wounds do not heal properly. This, in turn,
leads to gangrene – the dreadful, silent
fiend that ultimately leads to amputation
for thousands of people each year. Smith
has already had two toes on his right foot
amputated and is at high risk for losing
more toes and possibly his feet.
Smith’s scenario represents a real and
common situation for people at high risk
of amputation resulting from vascularrelated conditions caused by diseases
like diabetes. These people could have a
bypass or balloon angioplasty similar to
the heart procedure used to clear blocked
arteries. Unfortunately, arteries in people
who are in advanced stages of vascular
disease are generally blocked in so many
16
inMotion Volume 13, Issue 2 March/April 2003
Although this exciting technology
is still in development, and has not
yet been approved by the FDA, this
promising experimental research is
being received with enthusiasm by
medical professionals and patients
alike. With diabetes spiraling in
epidemic proportions nationwide,
the laser beam may soon become
a beam of hope for people with
diabetes. inMotion will follow
this research carefully and report
future outcomes as they develop.
places and are so small that surgeons have
little access into and through the arteries.
In addition, the bypass failure rate is high
because arteries do not remain open for
long periods.
A new procedure called LACI (Laser
Angioplasty for Critical Ischemia), however, is showing strong evidence that
ischemia, or a lack of blood supply in the
limb, can be addressed giving people a
much greater chance of saving their feet
in the future. Study results on LACI were
released in late January of this year and
successes on patients involved in the
study are generating excitement among
the medical community and patients.
Although LACI hasn’t been approved
yet by the Food and Drug Administration
(FDA), it is currently under review.
The Spectranetics Corporation in
Colorado Springs, Colorado, which
develops single-use medical devices used
in minimally invasive surgical procedures
within the cardiovascular system, is also
the developer of the excimer laser used
in the LACI study. “LACI relates to
tissue removal for critical limb ischemia,”
explains Mary de Sousa, the firm’s marketing manager. “In the procedure, the
cardiologist sticks the femoral artery in the
groin and snakes a wire through the artery.
The small guide wire is guided through the
legs. He then snakes a fiber-optic catheter
over this wire to the site of the blockages.
When he reaches a blockage, he presses
a foot pedal and fiber-optic energy is
emitted through the fiber-optic threads
in the catheter, which are about the size
of a human hair. This thrusts forward the
plaque in the artery, and blood is immediately restored to the area.”
In most procedures that involve clearing the arteries, plaque breaking off and
passing through the bloodstream to major
organs is a dangerous risk. The LACI procedure, de Sousa says, dissolves the plaque
into a liquid or gas form that is smaller
than a blood cell so that it cannot form a
clot that can obstruct blood flow.
when using the excimer laser to treat this
challenging patient group, which included
diabetics and patients with hypertension
and coronary artery disease.”
The trial, Dr. Laird says, enrolled 145
patients, including 155 limbs, at 14 domestic and several European sites.
“The control group was comprised of
789 patients with critical limb ischemia
treated with a variety of standard therapies,” he says. “Additionally, significant
adverse events in treated patients were
nearly one-half that of the control group,
at 33 percent and 60 percent, respectively.”
“We hope to receive FDA approval
to market the product before the end of
Study Results Just In
2003,” de Sousa says. “In the meantime,
The research data on LACI was submitwe have requested that the FDA allow us
ted to the FDA on January 21, 2003, with
to proceed with the study so we can coninput from medical professionals directly
tinue to help patients avoid amputations.
involved with the study.
Although we don’t have data regarding
Third World
countries,
research indicates that 7,000
amputations
per day take
place in the
Western world
due to conditions related
to vascular
disease. That is
150,000 people
each year who
Same foot three months after intervention
face losing some
part
of
their
foot
and
lower
leg.”
“The successful treatment of critical
Enrollment
for
the
study
began in
limb ischemia is measured by the relief of
April
2001.
Patients
considered
for the
pain during rest, the healing of ulcers and
the avoidance of major amputations,” says study were considered to be poor surgical
candidates with circulatory problems of
John R. Laird, MD, of the Washington
Hospital Center in Washington, D.C., and the lower leg evidenced by leg pain, nonhealing ulcers on the foot or lower leg, or
principal investigator of the LACI trial.
areas of necrotic, gangrenous tissue on the
“We are impressed with the improved
foot or lower leg that would require minor
limb salvage rate and the greatly reduced
amputation.
incidence of significant adverse events
Heel wound before treatment
Forefoot wound before treatment
Six months after intervention
To support the ACA or to become a member, call 1-888/267-5669
17
“The 145 patients chosen for the study
were not randomized, because you cannot
randomize people with amputation risk,”
de Sousa says. “But these patients were
not candidates for surgery. Our patients
stayed in the hospital an average of 21⁄2
days. In 93 percent of the cases, they were
able to avoid amputation. Patients who
underwent bypass surgery remained in
the hospital an average of 20 days, and
their amputation limb salvage rate was 87
percent. Complication percentages were
also considerably different between the
two groups. The LASI participants had a
complication rate of 30 percent compared
to 60 percent reported by those who had
bypass surgery.”
David Cohen, MD, FACC, is in private
practice at Cardiology Associates in West
Paterson, New Jersey. He led the study at
St. Joseph’s Hospital and Medical Center
in Paterson, one of the sites where the
LACI study was conducted.
“I enrolled seven patients in the actual
study, but I continued the work beyond the
study group on people who did not fit the
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inMotion Volume 13, Issue 2 March/April 2003
rigid criteria the study defined,” Dr. Cohen
says. “It is a fabulous technique and one I
think will make a tremendous difference
for people at high risk of amputation. The
procedure is intense and takes several
hours. It takes some practice to master,
but once you do, it is an amazing experience. When a surgeon is able to open an
artery that otherwise would be impossible
to clear, and he witnesses the blood flow
returning to a person’s limb, it is truly awesome.”
Dr. Cohen agrees that bypass surgery is
not a good alternative for most patients
who suffer with vascular problems, especially those in advanced stages.
“It is a difficult procedure requiring a
lengthy recuperation process,” he says.
“The results are not gratifying - grafts
generally do not remain open. Therefore,
we rarely suggest bypass for these patients.
They end up going to podiatrists who care
for the wounds as best they can, but many
eventually face amputation. Multiple
amputations - first a couple of toes, then
a part of a foot, then the entire foot and
even part of a leg - are generally what
defeat these people physically and in spirit.
What is worse is when a patient loses one
foot and soon afterward faces losing the
other. Many die as a result of the effects of
continual and radical amputation procedures.”
The main challenge in the LACI procedure, Dr. Cohen says, is to train doctors
everywhere to perform it. “Doctors from
major New York City university hospitals
came here to view the procedure,” he says.
“They would typically say, ‘If you get that
artery open I’ll be shocked.’ Their jaws
dropped in amazement as they witnessed
the artery opening and blood flowing freely
through the leg. This procedure allows us
to do things that, until now, we thought
were impossible. It is minimally intrusive,
not painful, has minimal resulting complications, and it eliminates the risk of
infection. If the artery blocks up again, the
procedure can easily be redone.”
No one knows yet if the LACI procedure has any magical qualities related to
permanency because it is so new, but Dr.
Cohen says it allowed him to open arteries
that could not have been opened by any
other procedure.
“It converts what would have been a
completely unsuccessful prognosis into
success for patients who have no other
resources remaining - and for them, it
is a miracle,” he says. “At this point, it is
imperative that the public and medical
community learn about LACI as expediently as possible. Without this procedure,
people who are now on a downhill course
with their vascular problems will face
amputation and unnecessary early mortality. It can save gross numbers of people
from suffering with major disabilities and
social burdens. Diabetes is an epidemic
today, and, to date, these people have had
no effective treatment. This is the first
procedure that shows promise.”
Dr. Cohen says he will continue to participate in the study if the FDA permits its
continuance. 