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.