University of Maryland, Baltimore
The goal of this prospective, non-randomized trial is to determine the safety and technical success of a novel modification to a U.S. Food and Drug Administration (FDA)-approved hybrid frozen elephant trunk (FET) device (Thoraflex Hybrid, Terumo Aortic). The modification is intended to enable supra-aortic vessel stenting in patients undergoing aortic arch replacement for aortic aneurysm or dissection.
Surgical repair of the aortic arch has evolved significantly over the past several decades in response to persistent challenges related to cerebral protection, operative time, and the complex anatomy of the thoracic aorta. The classic elephant trunk technique allowed for a two-stage repair of extensive aortic disease by leaving a free-floating Dacron graft in the descending thoracic aorta to be addressed during a subsequent operation. While foundational, this staged approach was associated with inter-stage mortality and incomplete aortic remodeling. In response, the frozen elephant trunk (FET…
Inclusion Criteria: 1. Age 18 years or older. 2. Willing and able to give written informed consent, or the patient's legally authorized representative has given written informed consent. 3. Expected life expectancy of more than two years after repair. 4. Aortic pathology requiring repair or replacement of multiple damaged or diseased segments of the thoracic aorta, with at least one of the following: (a) thoracic aortic aneurysm at increased risk for rupture or complications; (b) acute aortic dissection requiring urgent repair; (c) aortic pseudoaneurysm at risk for rupture or complications; (…
The proposed SA-FET procedure consists of a hybrid frozen elephant trunk (FET) device (Thoraflex, Terumo) with up to three reinforced fenestrations on the proximal endograft segment. Each fenestration is sized from 4 to 13 millimeters (mm) based on the size of the targeted supra-aortic vessel and wire-reinforced circumferentially using continuous watertight anastomosis-type suturing with polyester suture, as is done in commercially available fenestrated aortic endografts. The reinforcement provides an anchoring point against the radial force of the branch stents to maintain a seal and prevent tearing of the aortic endograft, and also provides a radiopaque marker. The fenestration is then pre-wired to allow delivery of a branch stent graft (Gore Viabahn). After deployment of the fenestrated graft, the supra-aortic branch stent grafts are deployed. The branch stent may be additionally secured to the fenestration using interrupted or continuous suturing with polypropylene suture.
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