Customized Stent-Grafts
for Abdominal Aortic Aneurysms
May / June 2002
In early 1998, Penn's Division
of Vascular Surgery was the
first center in the region to participate in early FDA clinical
trials to repair abdominal aortic aneurysm (AAA) utilizing
fabric covered stent-grafts. As a result of these clinical
trials, the FDA approved two devices. Since then, Penn vascular
surgeons have trained hundreds of physicians in the region
to perform stent-grafting using these devices.
Now Penn vascular surgeons are investigating new stent-graft
technology that allows surgeons to customize a graft to meet
a patient's individual anatomy and offer treatment to many
patients who were too frail for conventional repair or were
not appropriate for existing devices.
"Until now, stent-grafts were only available in certain
restrictive sizes and therefore only applicable to a limited
subset of patients," says Ron
Fairman, MD, chief of vascular surgery at the University
of Pennsylvania Health System.
"Penn is involved in every investigational stent-graft
clinical trial that is currently sanctioned by the FDA,"
adds Dr. Fairman, who, with his colleagues in the division
of vascular surgery, has developed one of the largest endovascular
programs in the country and has performed more than 400 stent-graft
repairs for AAA.
The ability to customize stent-grafts will enable endovascular
surgeons to treat more than 80 percent of patients with AAA,
compared to the currently approved devices that are applicable
in only 40 to 50 percent of patients. AAA is diagnosed in
approximately 150,000 Americans each year.
The less-invasive stent-graft repair requires unilateral
or bilateral groin cutdowns which allow for the insertion
of guidewires and catheters into the femoral arteries. Using
a catheter-based delivery system, the aneurysm is repaired
by deploying a fabric-covered, self-expanding stent from within
the aorta.
Conventional repair requires a large abdominal incision,
a blood transfusion, a seven-to-10 day hospital stay and is
not an option for many frail, elderly patients with existing
medical conditions, such as advanced emphysema and coronary
artery disease.
"Essentially, most of the risks of an abdominal operation
are avoided. The endovascular approach has the magnitude of
a hernia repair. The main advantage is that patients who are
the most frail are able to have their aneurysm repaired,"
explains Dr. Fairman. "Stent-graft results are excellent
when the devices are deployed in patients with suitable anatomy,
but consistent and long-term patient follow-up is essential."
Conventional repair is still the treatment of choice for
many patients and Dr. Fairman recommends discussing both options
with patients so an individualized decision can be made.
"We recognize that many physicians in our region are
now using this technology very successfully. We would like
to remain a resource for physicians who may have patients
that cannot be treated with one of the two FDA-approved
devices,"
adds Dr. Fairman, who expects that one or two of the investigational
stent-grafts will be available commercially in the next
year.
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