Custom-made versus off-the-shelf multibranched endografts for endovascular repair of thoracoabdominal aortic aneurysms

Abstract

Objective: This study compared early outcomes between the custom-made and the new off-the-shelf multibranched endograft (mbEVAR, t-branch; Cook Medical, Bloomington, Ind) for the endovascular repair of thoracoabdominal aortic aneurysms (TAAAs).

Methods: Between January 2010 and January 2013, 46 consecutive patients with TAAAs underwent endovascular aortic repair with mbEVARs. A custom-made device was used in 24 patients (group A, 52%), with Crawford classification type I, 2 (8%); type II, 4 (17%); type III, 9 (38%); and type IV/V, 9 (38%), and the a t-branch endograft was used in 22 patients (group B, 47%), with type II, 9 (41%); type III, 12 (55%); and type IV/V, 1 (4%). The main outcome measure was technical success, defined as successful target revascularization without occlusion of the bridging endografts or type I or III endoleak at the completion angiography. Secondary end points were mortality, unplanned reinterventions, branch occlusion, paraplegia, and persistent (after discharge) paraparesis.

Results: Technical success was 100% in both groups. The 30-day mortality was 8% in group A (n = 2) and 0% in group B (P = .51). Survival rates at 6 months were 71% in group A (mean follow-up, 13 ± 11 months) and 94% in group B (mean follow-up, 6 ± 3 months; (P = .04). There was only one procedure-related death caused by cerebral bleeding and herniation in group A. The freedom-from-reintervention rate at 6 months was 100% in group A (mean follow-up, 12 ± 11.5 months) and 90% in group B (mean follow-up, 6 ± 3.9 months; P = .07). No branch occlusions were observed in group A, whereas a branch occlusion occurred in three patients in group B (in all cases the bridging endograft for the renal artery). In two patients, the possible reason for branch occlusion was a thrombophilic disorder, whereas in one patient, the reason remains unknown. Paraplegia was observed in one patient in each group (group A: 4%; group B: 5%; P = .51) and persistent paraparesis in two patients in group A (8%) and in one patient (5%) in group B (P = .94).

Conclusions: The t-branch device, with the unique advantage of direct implantation without any delay for manufacturing, showed 100% technical success and comparable clinical outcomes to the traditional custom-made mbEVARs. Further long-term evaluation remains mandatory.