Endovascular aortic repair in patients with challenging anatomies: the EXTREME study

Abstract

Aims: The aim of this study was to report the 30-day technical and clinical success with endovascular repair using the ultra-low-profile Ovation stent graft in patients judged to be outside the instructions for use (IFU) for conventional endografts, while amenable to treatment within the IFU for Ovation.

Methods and results: One hundred and twenty-two patients (78.65±7.67 years; 111 male) were enrolled. Patients were evaluated as being outside the IFU for standard endografts because of the absence of a suitable proximal aortic neck in 109 cases (89.3%), of inadequate access vessels in 13 (10.7%), or both in 111 (90.9%). Mean aneurysm (abdominal aortic aneurysm [AAA]) diameter was 52.96±10.1 mm; mean aortic neck length was 7.75±6.05 mm. Technical success (98.4%) was achieved in all but two patients due to a type Ia endoleak. At completion angiography, 15 (12.3%) patients presented a type II endoleak. All patients underwent 30-day follow-up. Primary clinical success at one month was 96.8%, assisted clinical success 98.4%. There were no type I endoleaks, while 12 (9.8%) type II endoleaks were still evident, in the absence of sac expansions. Two patients (1.6%) presented an asymptomatic limb occlusion.

Conclusions: Our experience suggests that, in a selected population of patients with challenging anatomy outside the IFU for conventional endografts, endovascular aneurysm repair (EVAR) using the Ovation stent graft can be performed safely with satisfactory immediate outcomes.

Figure 1

Type Ia endoleaks following EVAR procedure. A) Multiplanar reconstruction of the postoperative CTA showing a type Ia endoleak. B) Axial postoperative CTA image showing infolding of the proximal sealing ring due to excessive oversizing. C) Intraoperative lateral image with coils placed between the two rings, exactly where the infolding was responsible for the leakage.