IYSC14 - 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 ( < 25mm) at the level of visceral aorta.

Methods: This multicenter 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 ischemia 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 ischemia (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.