"The GORE TAG Thoracic Endoprothesis: Device Design and Clinical Experience "
-pdf
Abstract: Disease of the descending thoracic aorta (DTA) can
progress in an undetected state and increase a patient’s
risk of developing an aneurysm. In the US, 15,000-20,000
aneurysms of the DTA are reported annually with approximately
5,000 annual ruptures that lead to death. Conventional
treatment for this patient population involves open surgical
repair of the diseased segment of the aorta. These procedures
involve 4-6 hours of surgery with average hospital recovery time
of 10 days and are associated with high rates of mortality and
morbidity. Recent developments of endovascular stent graft
technology offers a promising new treatment option for this patient
population.
Figure 1. The GORE
Thoracic Endoprothesis deployed and constrained on a catheter.
The GORE TAG Thoracic Endoprothesis (Figure 1) consists of an
expanded polytetrafluoroethylene (ePTFE) main body with a fluoroethylene
propylene (FEP) medial layer to replace the longitudinal spine
and aid in lowering the permeability of the device. The
exoskeleton of the device has a self-expanding nitinol stent
attached in a sutureless fashion to the ePTFE main body. At
the proximal and distal ends of the device are flares for wall
apposition, an ePTFE sealing cuff, and a radiopaque gold band
marker. The TAG device is constrained on a 100 cm working
length catheter with an ePTFE deployment sleeve. The TAG
device is currently manufactured with diameter ranges from 26
to 40 mm and lengths from 10 to 20 cm.
The
GORE TAG Thoracic Endoprothesis pivotal clinical trial demonstrated
the TAG device group as compared to an open surgical control group
had: one-fifth the paraplegia/paraperesis rate (3% vs. 14%),
one-sixth the operative mortality rate (1% vs. 6%), 80% less procedural
blood loss on average (472 ml vs. 2,402 ml), lower aneurysm-related
death through 1 year (3% vs. 10%), shortened average ICU stay (1
day vs. 3 days), shortened average hospital stay (3 days vs. 10
days), two times faster return to normal activity (30 days vs.
78 days). These data were part of a regulatory submission
that resulted in FDA approval of the TAG device in March 2005 with
an indication for endovascular repair of aneurysms of the DTA.
|
