European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2026
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.
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Di Stefano Lucia, Zacà Sergio, Massara Mafalda, Volpe Pietro, Speziali Sara, Dorigo Walter, Pulli Raffaele, Massi Francesco, Filippi Federico, Parlani Gianbattista, Attolini Stefano, Sante Cucci Andrea, Palermo Dario, Angiletta Domenico, RAN Collaborators
Аннотация
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.
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.