Baylor Scott & White The Heart Hospital — Plano recently performed the first endovascular repair of a type A aortic dissection in the North Texas region. The Heart Hospital is part of a physician-sponsored investigational device exemption (PSIDE) study in collaboration with Medtronic. The study is using specialized, physician-modified stent grafts for the endovascular repair of type A dissections in high-risk patients.
Surgeons on the medical staff performed the procedure on an elderly patient who did not qualify for traditional surgery due to age. The hospital is one of only two sites in the nation with this specific type of PSIDE.
“This is something that no other hospital is involved in in North Texas,” said William T. Brinkman, MD, medical director of thoracic aortic surgery at The Heart Hospital — Plano. “It’s potentially changing the approach to care to a less-invasive technique for high-risk patients. The use of an endovascular approach allows for the care of patients safely usually with a quicker recovery, decreased length of stay and increased outcomes.”
Type A aortic dissections have a high mortality rate, and the current care of patients with these aortic conditions is a complex open surgery. However, due to factors such as age or other comorbidities, some patients are considered a prohibitive risk for the traditional procedure.
“For patients where surgery is not a good option, this gives a second option to consider – enrolling them in the study to provide treatment through a less-invasive approach,” said Dennis R. Gable, MD, chief of vascular and endovascular surgery at The Heart Hospital — Plano. “If we can show the value of this approach as well as good outcomes, it could also eventually be an option for those who are high risk for a traditional operative approach.”
To qualify for the investigational device exemption, The Heart Hospital — Plano provided extensive background and supporting information to the FDA for approval. Ongoing data and results of the study will be shared with the FDA. If the approach is shown to be advantageous, the study may be expanded into a formal national clinical trial.
“This is a very exciting endovascular therapy, which has the potential to revolutionize the care of patients,” Dr. Brinkman said. “Much like the treatment of type B aortic dissection has been revolutionized, the care of patients with type A dissections will be changed through endovascular approach using stent technology.”