Clinical trials for new minimally invasive technologies have the potential for improved recovery times and reduced pain for patients with aortic arch conditions. Baylor Scott & White The Heart Hospital – Plano is the major center for clinical trials for diseases of the aorta in North Texas, and their work has put them at the forefront of minimally invasive therapies.
“In the area of thoracic aortic disease, Baylor Scott & White The Heart Hospital – Plano is involved in research around cutting edge therapies in the ascending aorta, aortic arch, and abdominal aorta, giving patients access to these innovative trials that no one else in Texas offers,” says William Brinkman, MD, a cardiovascular surgeon and Director of the Thoracic Aortic Clinic. “In fact, we’re the only site in the Dallas/Fort Worth area offering access to some of the minimally invasive aortic arch treatments we have underway right now,” explains Dr. Brinkman.
“Team Aorta” is the group that evaluates patients with aortic problems and offers a full range of treatments. Patients who are at high risk for traditional open surgical approaches are considered as candidates for clinical trials. Team Aorta is comprised of vascular, cardiothoracic surgeons, nurse practitioners and imaging specialists. A weekly clinic allows patients to be assessed by multiple practitioners, thereby accomplishing in one clinic visit what would normally take multiple appointments. “If patients want access to information about these innovative devices and trials, they can come to our weekly thoracic aortic clinic to be evaluated by the team and get comprehensive advice from all specialties. It’s really quite a unique way to evaluate patients,” describes Dr. Brinkman.
Team Aorta is working on two major clinical trials for innovative devices.
Dr. Brinkman serves as a site principal investigator (co-PI) along with William Schutze, M.D. in the key clinical trial in the early feasibility phase called, “A Prospective, Multicenter, Non-Blinded, Non-Randomized Early Feasibility Study of the Relay Branch Thoracic Stent-Graft System in Subjects With Thoracic Aortic Pathologies Requiring Treatment Proximal to the Origin of the Innominate Artery (NCT03214601).” The main objective of this study is to assess the safety and effectiveness of this branched stent in treating aneurysms and dissection of the aortic arch at the index procedure and at 30-day follow-up. The study will evaluate the delivery and deployment of the device, patency of branches and branch vessels, and exclusion of the aortic pathology. These data will help determine if modifications need to be made to the device, the procedural steps, operator technique, or the indications for use.
The other early feasibility study is looking at a novel endovascular stent for the treatment of Type A aortic dissections, or dissections that involve the ascending aorta. The current standard of care for type A dissection involves open surgery with sternotomy. This trial is another example of a larger movement in research which explores endovascular treatments for this very high- risk population.
“These are just two examples of what’s going on at Baylor Scott & White The Heart Hospital – Plano. It’s amazing all the clinical trials happening here to move the field forward and offer patients truly better and better options for treatments,” Dr. Brinkman adds.
Dr. William Brinkman is a cardiovascular surgeon and Director of the Thoracic Aortic Clinic. Dr. Brinkman specializes in the treatment of thoracic aortic disease, cardiac valve repair, and minimally invasive surgical techniques for cardiac surgery. He focuses on hybrid approaches to the management and treatment of thoracic aortic disease valve-sparing aortic root surgery and the employment of stroke and spinal cord protection technologies, to improve the quality of heart surgery.