Baylor Scott & White The Heart Hospital – Plano is currently the only hospital in North Texas offering the GORE® TAG® Thoracic Branch Endoprosthesis (TBE) as part of a pivotal study to evaluate its safety and efficacy. The TBE device is the first of its kind – designed for the endovascular treatment of aortic arch and descending thoracic aorta lesions in patients who are high risk for traditional surgery.
The new TBE device takes a previously evaluated and approved thoracic endoprosthesis device and adds a side branch component. With both an aortic and a side branch component, the TBE device provides perfusion into a single aortic arch vessel.
“With this device, we’re taking a high-risk population and treating them with an endovascular approach,” said William T. Brinkman, MD, medical director of thoracic aortic surgery at Baylor Scott & White The Heart Hospital – Plano, who is principal investigator for the study. “In many ways, the approach is similar to what was done with TAVR and valve replacement – treating high-risk patients in a minimally invasive way.”
Traditionally, lesions of the aortic arch and descending thoracic aorta – including aneurysm, trauma and dissection – require an open operation. Because of the complexity of these procedures, there is an increased risk of complications, and patients with factors that make them a high operative risk may not be candidates for traditional surgery.
“This device is important for people who would have a hard time recovering from open surgery, such as those with other medical problems or those who are frail or older in age,” Dr. Brinkman said. “That’s the population where we believe this will be a great approach.”
Because of the need for an alternative to traditional surgery for these patients, the TBE device is among the first devices in the United States to receive an FDA Expedited Access Pathway (EAP) designation. This new pathway is only for medical devices that show the potential to address unmet medical needs for life-threatening diseases – like complex aortic lesions.
The endovascular approach not only provides a new option for patients considered high risk for surgery but also provides them the benefits that come with minimally invasive treatment. Endovascular techniques have been shown to decrease the risk of complications and decrease recovery time.
“It offers the opportunity to have an aneurysm of the aortic arch or the descending thoracic aorta fixed with minimal morbidity,” Dr. Brinkman said. “Typically, it allows them to get back to living their life within a week or two, rather than recovering for months.”