One-year outcomes of a prospective, non-randomised, feasibility trial evaluating the treatment of aneurysms involving the proximal descending thoracic aorta indicate that total repair can be achieved by using a single branched endograft (TAG Thoracic Branch Endoprosthesis, Gore).
Presenting the findings at the Vascular Annual Meeting (9–11 June, National Harbor, USA), Mark F Fillinger, Dartmouth-Hitchcock Medical Center, Lebanon, USA, reported that the one-year results showed a technical success rate of 100%, with 0% 30-day/hospital mortality and 0% device-related mortality. “The device used was designed for lesions requiring a zone 2 proximal landing zone with perfusion of the left subclavian through a side branch graft,” Fillinger told the audience.
Thirty patients at six US sites were enrolled in the study, 12 (40%) with fusiform aneurysms and 18 (60%) with saccular aneurysms. The mean diameter of treated aneurysms was 55mm (range 40–77mm) and total mean treatment length was 18cm (range 10–33cm).
At one-month follow-up there was 100% patient survival and primary procedural endpoints (successful access, successful deployment and side branch primary patency) were achieved in 100% of patients. At one month, there was one case of stroke and one case of spinal cord ischaemia.
At 12 months, there had been no further cases of stroke and one further case of spinal cord ischaemia, which resolved following intervention. Within the 365-day follow-up period there were two deaths, as well as two further deaths in ongoing follow-up, none of which were device-related. Fillinger also told the audience that there were no core lab-determined device events out to 12 months.
“Four patients had type I endoleaks that were detected during the procedure or immediately post-operatively,” Fillinger said. “All of these resolved spontaneously without reintervention by the one-month CT imaging follow-up. There was one site-reported side branch occlusion at six months with no reported associated adverse events, with no reintervention performed. There was one reintervention due to deployment inaccuracy requiring an additional branch device to be placed in zone 0—the reintervention was performed 133 days after the initial procedure.”
Stable (n=8, 53%) or shrinking (decrease of ≥5mm from baseline, n=6, 40%) aneurysms were achieved in 93% of cases, with only one patient exhibiting an aneurysm growth of ≥5mm from baseline at one year.
“This study will continue to evaluate longer-term safety and efficacy of this device,” Fillinger concluded. “A parallel feasibility study is evaluating the graft in the treatment of zone 0/1 aortic arch aneurysms, and future studies are planned to evaluate its safety and efficacy in a larger multicentre pivotal trial and, potentially, for additional pathologies.”