Results from a multicenter Italian registry on the use of a novel “custom/off the shelf” inner-branch device for endovascular repair of complex aortic lesions

OBJECTIVES This study aimed to describe the outcomes of a new custom-made inner-branch device, also suitable as off-the shelf stent graft, for the endovascular repair of complex aortic lesions and to evaluate the results also in narrowed patent aortic lumen (<25 mm) at the level of visceral aorta. METHODS This multicentre study (2021–2024) included patients treated with this new inner-branched device for complex aortic lesions. Endpoints were: technical success, early (<30 days) mortality and late (>30-day) survival, freedom from aorta-related mortality and aortic adverse events and target visceral vessels (TVVs) patency. RESULTS This study included 46 patients and 184 target vessels. Technical success was 100% and no cases of aortic related mortality (ARM) were recorded. Three cases (6.5%) of spinal cord ischaemia were registered. Overall 30-day mortality rate was 8.7%. The mean follow-up was 10.5 ± 9 months. Overall survival rate was 97.4% (95% CI: 76–99) at 3 months, 94% (95% CI: 71–98) at 6 months, 85.1% (95% CI: 54–96) at 12 months and 76% (95% CI: 41–92) at 24 months. Late deaths occurred in 3 patients (8.3%) after a median of 8 months (IQR, 4–12 months). No late aortic related mortality, type I or III endoleak were registered. The primary bridge-stent patency was 98.9% (95% CI: 73–99). No late spinal cord ischaemia (SCI) were registered. The subgroup characterized by narrow aortic patent lumen did not showed bridge-stent instability, reintervention, death and aortic related mortality. CONCLUSIONS Endovascular repair of TAAAs and complex aortic lesions with this new custom/off-the shelf stent graft was technically safe and effective with promising results both in elective and urgent cases.