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Acute Aortic Disease.. - Index of

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Endovascular Thoracic <strong>Aortic</strong> Stent Grafting 277<br />

Figure 8 Demonstration <strong>of</strong> the possible maximum (hollow arrow) and minimum (long<br />

solid arrow) course that stent graft may be positioned.<br />

RESULTS OF TEVAR IN DESCENDING THORACIC<br />

AORTIC ANEURYSMS<br />

Three United States clinical trials have examined the use <strong>of</strong> endovascular aortic<br />

stent graft technology in the treatment <strong>of</strong> descending thoracic aortic aneurysms.<br />

The three devices (Medtronic Talent, Gore TAG, and Cook Zenith TX2) have also<br />

been used extensively worldwide. Results from the U.S. clinical trials as well as<br />

results from the worldwide experience have been encouraging, prompting investigators<br />

to expand the role <strong>of</strong> TEVAR to acute thoracic aortic pathologies. The three<br />

U.S. trials will briefly be discussed.<br />

VALOR Trial<br />

The Medtronic VALOR trial is a prospective, multicenter, nonrandomized, observational<br />

trial evaluating the use <strong>of</strong> the Medtronic Talent thoracic stent graft system<br />

in the treatment <strong>of</strong> thoracic aortic pathology. One-year data for the VALOR trial is<br />

expected soon. The trial consists <strong>of</strong> three groups: (i) the test arm, (ii) the registry<br />

arm, and (iii) the high-risk arm. The test arm consists <strong>of</strong> patients with the diagnosis<br />

<strong>of</strong> thoracic aortic aneurysms who are considered surgical candidates for traditional<br />

open repair with low to moderate risk [based on society <strong>of</strong> vascular surgery (SVS)/<br />

international society <strong>of</strong> cardiovascular surgery (ISCVS) criteria]. At least 20 mm <strong>of</strong><br />

normal aortic neck at the proximal and distal landing zone is required. Enrollment<br />

<strong>of</strong> 195 patients is complete, and one-year follow-up data (rate <strong>of</strong> mortality and<br />

successful aneurysm treatment) is awaiting accrual prior to FDA disclosure. The

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