Results from a Multicentre 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, late (>30-days) survival, and freedom from aorta-related mortality (ARM), 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 ARM were recorded. Three cases (6.5%) of spinal cord ischaemia (SCI) 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 (interquartile range [IQR], 4-12 months). No late ARM, type I or III endoleak were registered. The primary bridge-stent patency was 98.9% (95% CI, 73-99). No late SCI were registered. The subgroup characterized by narrow aortic patent lumen did not showed bridge-stent instability, reintervention, death, and ARM. Conclusions: Endovascular repair of thoraco-abdominal aortic aneurysms (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.