Ronald M. Fairman, MD, Chief of Penn's Division of Vascular Surgery is the primary investigator for the nation-wide "VALOR" trial, which is taking place at 35 sites across the country with Penn as the only site in the Philadelphia region. Joseph E. Bavaria, MD, Director of Penn's Thoracic Aorta Surgery and Lung Transplantation Programs, serves as co-investigator at the Penn site.
"This is an extremely important trial, as we will be exploring the safety and effectiveness of a device that could significantly increase the number of treatment options for thoracic aneurysm patients," said Fairman. "In most instances, treatment options are limited and, as a result, mortality rates high. I'm hopeful that we can establish that this stent is both safe and effective, ultimately providing patients with a new option that could save their lives."
The procedure involves introducing the stent graft through a small opening in the femoral artery of the leg, and advancing it under fluoroscopic guidance to the site of the thoracic aortic aneurysm or dissection, where it is then deployed. Once placed, the stent graft expands to fit the diameter of the aorta, thereby excluding the aneurysm by providing a new path for blood.
It is estimated that there are more than 21,000 patients diagnosed with thoracic aortic aneurysms yearly in the U.S. A number of these patients also have serious co-morbidities such as coronary artery disease, emphysema, high blood pressure and diabetes that make it difficult - if not impossible - for them to survive open surgical repair, which is the current standard of care. Open surgery is a risky, taxing procedure that can lead to death in many frail and elderly patients and can also be associated with severe complications, such as paraplegia. For those patients considered ineligible for open surgical repair, conservative medical management or "watchful waiting" is often used as a treatment option and can lead to increased mortality and morbidity in many elderly patients.
Study to Cover Three Distinct Thoracic Aortic Conditions
The TalentTM Thoracic Stent Graft System has been approved for over five years in Europe and has been implanted more than 6,000 times worldwide. The VALOR study is a prospective, non-randomized, multi-center, consecutive trial enrolling patients in three separate study arms: Patients will be divided into three categories: those diagnosed with thoracic aortic aneurysms who are considered candidates for open surgical repair and who are of low- to-moderate risk of major complications; those patients with Type B thoracic aortic dissections, aneurysms associated with dissections, and pseudoaneurysms; and high-risk/non-surgical candidates: including patients with traumatic thoracic aortic aneurysms - incurred through emergencies such as car accidents - who do not have a complete severing of the aorta.
"The standard operation for thoracic aortic aneurysms is difficult for the patient, requires a lengthy recovery period, and can only be done when absolutely necessary," said Bavaria. "This new therapy is revolutionary and allows much greater access to aneurysm repair in the chest with better outcomes."
Editor's Notes: Drs. Fairman and Bavaria have no financial interest in Medtronic, Inc.
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