A first-in-man study of an endovascular treatment for aortic arch aneurysms showed the less invasive approach was feasible and safe, results presented Jan. 27 at the Society of Thoracic Surgeons (STS) annual meeting in San Diego showed.
“This is truly disruptive technology,” said Robbin Cohen, MD, a cardiothoracic surgeon at the University of Southern California in Los Angeles and chair of the STS Workforce on Media Relations and Communications, at a press conference. “This is taking what traditionally have been our largest, most dangerous, biggest incision, longest ICU [intensive care unit] time operations and converting them to endovascular procedures.”
The study evaluated the technical success, patency and 30-day outcomes in 10 patients who underwent branched thoracic endovascular aortic repair at six sites. The researchers used a branched arch endograft (W.L. Gore) and a transfemoral approach for the procedures.
“Currently for the distal arch aorta, the most common form of revascularization is done through a small neck incision,” said lead investigator Himanshu J. Patel, MD, of the University of Michigan Medical Center in Ann Arbor. “The advantage is this is well tolerated but the disadvantages are it is an additional procedure and can be problematic when you have patients who present with rupture. The ideal solution would be to have a stent graft that has a branch along with it to maintain blood flow.”
He reported a 100 percent technical success rate, which included device delivery and branch vessel patency. There were no deaths, strokes or spinal cord ischemia in the study participants. The mean duration for hospitalization was 5.7 days.
Four patients experienced endoleaks; two resolved at one month and one at six months. One patient died from an aneurysm in another location that ruptured, Patel said. All side branches remained patent at six-month follow-up.
“We think aortic arch repair is a difficult procedure and it is often best treated with regular open surgery,” Patel said. But today’s stent grafting options may be limited by the challenging hemodynamics of the aortic arch and “the hostile environment anatomy that is present. This new graft is a very promising alternative.”
The study was sponsored by W.L. Gore. The endograft devise remains investigational.