On Feb. 14, Drs. Dean and George Arnaoutakis, M.D. performed the first Bolton dual branch endograft deployment in the Southeast together. This was the 16th such implant in the entire United States.
This device involves leading-edge technology designed to treat aneurysms of the aortic arch in a less invasive fashion than traditional complex open heart surgery. An aneurysm is a potentially life threatening outpouching of the aorta, which can be prone to rupture. The dual branch endograft involves an implantable stent-graft device placed within the patient’s aortic arch via the arteries in the groin, avoiding any incisions in the chest. The stent graft treats the aneurysm by relieving the pressure on the weakened aortic wall.
“We’re very excited to be one of the 10 sites in the United States to be selected for this early feasibility clinical device trial,” said Dean Arnaoutakis, M.D., MBA, an assistant professor in the division of vascular surgery and site principal investigator for aortic stent graft trials at the University of Florida College of Medicine. “I think it speaks to the innovation, skillset, and cross-disciplinary collaboration in UF Health’s Department of Surgery that we were selected as a site.”
An aging population is often synonymous with a decline in cardiovascular health. Occasionally, ailments such as heart disease can exist alongside different comorbidities that make traditional open surgical repair of aortic aneurysm very risky. Similarly, the anatomy of the aortic arch itself prevents the use of commercially available stent grafts because the aortic arch has branches going to the brain and arms. This novel technology involves a stent graft that has branches to preserve blood flow the brain and arms.
“Ideally, this investigational device and others like it will allow us to perform operations that were previously not feasible and offer patients the prospect of a speedier recovery with potentially less risk,” said George Arnaoutakis, M.D. an assistant professor in the division of thoracic and cardiovascular surgery in the College of Medicine and UF site principal investigator for the Bolton Dual Branch Early Feasibility Trial.
The standard method of treating aortic arch aneurysms requires an incision in the middle of the breastbone (also known as a sternotomy incision), stopping the heart with the aid of the heart-lung machine, and replacing the entire diseased aorta with a synthetic Dacron graft material. This operation is the gold standard treatment, but requires four to six hours of open surgery, a seven- to 10-day hospitalization and six to eight weeks for complete recovery. Patients who receive the dual branch endograft undergo a much less invasive operation than conventional surgery and typically are in the hospital less than a week, with minimal recovery time.
Patients appropriate for consideration in the dual branch stent graft trial include those with aortic aneurysm disease, penetrating atherosclerotic ulcer (PAU), or chronic Type B aortic dissection. The Relay®Branch in particular is intended to treat aortic diseases whose repair would require the coverage of innominate and left common carotid arteries. Consequently, the dual branch endograft includes a graft with a proximal landing zone for the proximal aorta, as well as branch grafts that extend into the innominate and left common carotid arteries. The branch graft’s exoskeleton is constructed out of a polyester vascular graft fabric that covers the self-expanding stents made of nitinol.
“It’s rewarding to see patients with such a complex problem be effectively treated and yet recover so quickly,” Dean Arnaoutakis said. “The innovation behind the procedure and success of the implants are promising.”