On October 3, 2022, an AdventHealth Heart, Lung and Vascular Institute (HLVI) team under the leadership of cardiothoracic surgeon Ahmad Zeeshan, MD, became the first in Florida to successfully implant the Thoraflex™ Hybrid Frozen Elephant Trunk (FET) device in a 73-year-old patient with a complex aortic arch dissection that involved the aortic root, ascending aorta and the aortic arch.
Terumo Aortic’s Thoraflex™ Hybrid device is indicated for the surgical treatment of complex aortic aneurysms and dissections. It has been used in Europe for a while, and after the U.S. Food and Drug Administration’s (FDA) approval in April 2022, the device is now commercially available in the U.S. It is made of a polyester graft section that reinforces a weakened section of the aorta. A connected stented section (nitinol wire frame on polyester graft material) keeps the descending aorta open and allows better blood flow through the true lumen. The polyester graft and stented portions are coated with a bovine gelatin to seal the implant and prevent unnecessary blood loss from the graft pores. The gelatin-coated woven polyester graft replaces the remaining diseased aorta.
“This first-of-its-kind surgical device significantly enhances treatment of aortic arch pathology,” explains Dr. Zeeshan. “Complex aortic arch reconstruction is an unusual surgical procedure that requires placing the patient under deep hypothermic circulatory arrest. Because of its hybrid design, the Thoraflex™ device decreases the duration of implant time; hence, the duration of deep hypothermic circulatory arrest time, resulting in fewer complications. Additionally, the device facilitates stage 2 of the elephant trunk procedure when needed.”
The results of a multi-center U.S. clinical trial were recently published in the Journal of Thoracic and Cardiovascular Surgery. The study found that use of the Thoraflex™ Hybrid device resulted in 81% freedom from major adverse events at one year.
“This is an exciting milestone,” says Dr. Zeeshan. “Prior to the availability of the Thoraflex™ Hybrid device at AdventHealth HLVI, Central Florida patients had to be referred out for complex aortic arch surgery. Now, they can receive this care closer to home.”
AdventHealth HLVI remains committed to combining technical ability with the latest technology to bring advanced cardiovascular care to patients.