NEWS
RELEASE
FOR IMMEDIATE RELEASE
Contact: Bobbie Boyd, Director of Public Relations
& Community Outreach
Advanced Cardiac Specialists
Cell Phone: (602) 570-7069 E-mail:
bobbie.boyd@acs-im.com
NEW FDA APPROVED DEVICE PROVIDES TREATMENT OPTION FOR
LIFE-THREATENING RUPTURE OF THORACIC AORTIC ANEURYSM
First Procedure in Phoenix East Valley
Phoenix
(August 11, 2005) - An aortic aneurysm is a diseased, weakened and bulging
section of the wall of the main artery carrying blood from the heart. Approximately 15,000 people are diagnosed
with thoracic aortic aneurysms every year.
Because three out of four people have no symptoms, there is a concern
that this life-threatening condition may be under-diagnosed. Once diagnosed, patients have been faced
with a dilemma. An untreated thoracic
aortic aneurysm can rupture resulting in death within minutes due to internal
bleeding.
Traditional
surgery to repair the aneurysm carries significant risk of complications,
including bleeding, paralysis, stroke and kidney failure. It involves a hospital stay of five to seven
days, with two to three months for a complete recovery.
March 23, 2005 the Food and
Drug Administration approved release to market of the GORE TAGä Thoracic Endoprosthesis, the first and only device
approved for treatment of patients with aneurysms of the descending thoracic
aorta. On July 19, 2005 at Mesa General
Hospital, M.L. Eckhauser, M.D. performed the first procedure in the Phoenix
East Valley utilizing this new device, outside of clinical trials. Dr. Eckhauser used three GORE stent grafts
to cover the aneurysm. The procedure
was successful and the patient was discharged within 72 hours of the
procedure. He is expected to make a
full recovery and allowed to return to full activities within two to four
weeks.
The new GORE TAGä device provides a “minimally invasive” alternative
to open surgery. In the GORE TAGä Device Pivotal Study, compared to open surgical
repair, patients treated with the device demonstrated lower rate of paraplegia,
lower operative mortality, significantly less procedural blood loss, shorter
time in ICU, shorter hospital stays, reduced aneurysm-related death and no
aneurysm ruptures for two years. In
addition, clinical studies indicate fewer complications and twice as fast
return to normal activity.
With
this new alternative, a sheath is inserted through a small incision in the
groin. The GORE TAGä Device, a tube shaped stent-graft made of
biocompatible material, is inserted into the catheter. The graft is then positioned inside the
diseased aorta to seal off the aneurysm and create a new path for blood
flow. The device remains in the aorta
permanently, creating a tight fit and seal against the wall of the aorta. The procedure takes about one to three hours
and recovery time is minimal.
Before
the availability of this device, if medications were not effective, the only
treatment option for patients with thoracic aortic aneurysms was open surgery,
something many with complex pre-existing conditions could not endure. For those able to withstand traditional
surgery, the procedure requires an incision around the chest, large enough for
a synthetic graft to be inserted while the blood flow through the aorta is
literally stopped. Then, the graft is
sewn in place with sutures and blood flow is restored. The procedure usually takes from two to four
hours with two to three months recovery time.
Patients are at high risk for severe complications or death.
The
thoracic aorta, which flows through the thorax or chest, is the body’s main
circulatory vessel, carrying oxygen-filled blood from the heart. A thoracic aortic aneurysm may be caused by
vascular disease, hardening of the arteries (atherosclerosis), high blood
pressure, injury, infection or hereditary (genetic defect) creating a weakening
in the wall of the aorta. Continuous
high blood pressure can further this weakening, resulting in an aneurysm, or
thinning and enlarging of the artery.
Early identification of an
aneurysm is a key factor. People who
have high blood pressure, diabetes, high fat diet, family history of thoracic
aortic aneurysms (TAAs) or who smoke may be at high risk and should be checked
regularly. Most often, aneurysms are
discovered during a medical test such as a CT (computed tomography or CAT scan)
or MRI (magnetic resonance imaging scan).
Other testing may include IVUS (intravascular ultrasound), TEU
(transesophageal ultrasound) or cardiac catheterization (angiogram). Once detected, the physician will evaluate
treatment options based on the size and growth rate of the aneurysm. Ideally, risk factor modification will be an
option for initial treatment. However,
the size and growth rate may warrant medications or ultimately surgery.
M.L. Eckhauser, M.D.,
vascular and endovascular surgeon, is one of a handful of surgeons in the state
trained and experienced in performing this procedure. Dr. Eckhauser practices with Advanced Cardiac Specialists, a
statewide Cardiology and Internal Medicine practice based in Phoenix with Medical
Director and Chief of Cardiovascular Services, Robert M. Siegel, M.D. Additional information is available by
calling (480) 926-6990. The GORE TAGä device is a product of Gore Medical Products
Division, based in Flagstaff, Arizona.