OBJECTIVE: In this prospective US investigational device exemption trial, we assessed the safety and 1-year clinical outcomes of the Thoraflex Hybrid device (Terumo Aortic) for the frozen elephant trunk technique to repair the ascending aorta, aortic arch, and descending thoracic aorta.
METHODS: For the trial, which involved 12 US sites, 65 patients without rupture were recruited into the primary study group, and 9 patients were recruited into the rupture group. All patients underwent open surgical repair of the ascending aorta, aortic arch, and descending thoracic aorta in cases of aneurysm and/or dissection. The primary end point was freedom from major adverse events (MAE), defined as permanent stroke, permanent paraplegia/paraparesis, unanticipated aortic-related reoperation (excluding reoperation for bleeding), or all-cause mortality.
RESULTS: In the primary study group, 2 patients were lost to follow-up at 1 year. Freedom from MAE at 1 year was 81% (51/63). Seven patients (11%) died (including 2 before 30 days or discharge), 3 patients (5%) suffered permanent stroke, and 3 (5%) developed permanent paraplegia/paraparesis. Twenty-six patients (41%) underwent planned extension procedures, including 22 endovascular procedures within a median of 122 (interquartile range, 64-156) days. In the aortic rupture group, 2 patients were lost to follow-up at 1 year. Freedom from MAE at 1 year was 71% (5/7). One patient (14%) died, 2 patients (29%) had permanent stroke, and none had permanent paraplegia/paraparesis. No extension procedures were performed in the rupture group.
CONCLUSIONS: One-year results with the Thoraflex Hybrid device are acceptable. Long-term data are necessary to assess the durability of these repairs.

The hybrid SPIDER-graft consists of a proximal descending aortic stent graft and a conventional six branched Dacron graft for open abdominal aortic repair. Technical feasibility with regard to avoiding thoracotomy and extracorporeal circulation (ECC) during thoraco-abdominal aortic hybrid repair and peri-procedural safety of this novel device are unknown.
This was a feasibility and safety study in domestic pigs (75-85 kg). The abdominal aorta including iliac bifurcation, left renal artery, and visceral arteries were exposed via retroperitoneal access. The right iliac branch was first temporarily anastomosed end to side to the distal aorta via partial clamping. During inflow reduction and infra-coeliac cross-clamping, the coeliac trunk (CT) was divided and the proximal stent graft portion of the SPIDER-graft was deployed into the descending aorta via the CT ostium. Retrograde visceral and antegrade aorto-iliac blood flow was maintained via the iliac side branch. The visceral, renal, and iliac arteries were sequentially anastomosed, finally replacing the first iliac end to side anastomosis. Technical success, blood flow, periods of ischaemia, and peri-procedural complications were evaluated after intra-operative completion angiography and post-operative computed tomography angiography.
Six animals underwent successful thoracic stent graft deployment and distal open reconstruction without peri-operative death. The median thoracic graft implantation time was 4.5 min, and the median ischaemia times before reperfusion were 10 min for the CT, 8 min for the superior mesenteric artery, 13 min for the right renal artery, and 22 min for the left renal artery. Angiography demonstrated appropriate graft implantation and blood flow measurements confirmed sufficient blood flow through all side branches.
In this translational pig model, thoraco-abdominal hybrid repair using the novel SPIDER-graft was successful in avoiding thoracotomy and ECC. Technical feasibility and safety appear promising, but need to be reassessed in humans.