Objective: We assessed the suitability of two triple branch arch devices (aBranch) (Terumo aortic and Cook Medical) and a balloon-expandable covered stent (VBX, W. L. Gore & Associates, Johnson & Johnson) to incorporate the brachiocephalic trunk (BCT) in a cohort previously treated with hybrid thoracic endovascular repair (TEVAR). Methods: This is a single-center, retrospective, all-comers, preclinical suitability study. We conducted an analysis of preoperative computed tomography scans in surgical patients between 1999 and 2022 in a single vascular surgery unit. The primary outcome was the aortic suitability of aBranch devices and VBX as mating stent for BCT in previous hybrid TEVAR. Hybrid repair of the aortic arch included TEVAR, fenestrated or branched TEVAR associated with any surgical debranching of the supra-aortic trunks and chimney TEVAR with proximal landing in zones 0 to 2. Secondary outcomes included (i) suitability assessment when excluding minor instruction for use (IFU) criteria, (ii) a comparison of suitable and nonsuitable patients, (iii) risk factors analysis for nonsuitability, and (iv) a description of the exclusion causes. Results: During the study period, 120 patients were treated. Among elective patients (n = 73), the suitability of any aBranch was 82.2% (60/73) and VBX was suitable in 64.4% of BCTs (47/73). The aBranch suitable patients had a significantly longer sinotubular-BCT length (P =.017) and smaller distal ascending aorta (P =.043) as compared with nonsuitable ones. The suitability of Terumo Aortic and Cook Medical devices was 52.1% (38/73) and 46.6% (34/73), respectively. When minor IFU criteria were ignored, suitability increased to 82.2% (60/73) and 63.0% (46/73), respectively. Left common carotid artery diameter and sinotubular-BCT length were significant nonsuitability risk factors for Terumo Aortic aBranch in multivariable analysis. No associations were found for Cook Medical device. The outcomes were tested in the entire cohort demonstrating a global suitability of 82.9%, increasing to 86.3% when ignoring minor IFUs. VBX was anatomically suitable to use in BCT in 73.2% of patient BCTs. Conclusions: aBranch devices are anatomically suitable in a vast majority of patients (86%) undergoing hybrid TEVAR. The innominate artery seems eligible for incorporation with VBX in almost two-thirds of patients. This mating stent may help to overcome some minor IFU restrictions.

Leone N., Bartolotti L.A.M., Baresi G.F., Silingardi R., Resch T.A., Gennai S. (2024). Anatomical suitability for branched endovascular aortic arch repair and balloon-expandable bridging stent grafts in a cohort of patients previously treated with a hybrid approach. JOURNAL OF VASCULAR SURGERY, 79(2), 198-206 [10.1016/j.jvs.2023.11.011].

Anatomical suitability for branched endovascular aortic arch repair and balloon-expandable bridging stent grafts in a cohort of patients previously treated with a hybrid approach

Leone N.
Primo
Project Administration
;
Bartolotti L. A. M.;Baresi G. F.;
2024

Abstract

Objective: We assessed the suitability of two triple branch arch devices (aBranch) (Terumo aortic and Cook Medical) and a balloon-expandable covered stent (VBX, W. L. Gore & Associates, Johnson & Johnson) to incorporate the brachiocephalic trunk (BCT) in a cohort previously treated with hybrid thoracic endovascular repair (TEVAR). Methods: This is a single-center, retrospective, all-comers, preclinical suitability study. We conducted an analysis of preoperative computed tomography scans in surgical patients between 1999 and 2022 in a single vascular surgery unit. The primary outcome was the aortic suitability of aBranch devices and VBX as mating stent for BCT in previous hybrid TEVAR. Hybrid repair of the aortic arch included TEVAR, fenestrated or branched TEVAR associated with any surgical debranching of the supra-aortic trunks and chimney TEVAR with proximal landing in zones 0 to 2. Secondary outcomes included (i) suitability assessment when excluding minor instruction for use (IFU) criteria, (ii) a comparison of suitable and nonsuitable patients, (iii) risk factors analysis for nonsuitability, and (iv) a description of the exclusion causes. Results: During the study period, 120 patients were treated. Among elective patients (n = 73), the suitability of any aBranch was 82.2% (60/73) and VBX was suitable in 64.4% of BCTs (47/73). The aBranch suitable patients had a significantly longer sinotubular-BCT length (P =.017) and smaller distal ascending aorta (P =.043) as compared with nonsuitable ones. The suitability of Terumo Aortic and Cook Medical devices was 52.1% (38/73) and 46.6% (34/73), respectively. When minor IFU criteria were ignored, suitability increased to 82.2% (60/73) and 63.0% (46/73), respectively. Left common carotid artery diameter and sinotubular-BCT length were significant nonsuitability risk factors for Terumo Aortic aBranch in multivariable analysis. No associations were found for Cook Medical device. The outcomes were tested in the entire cohort demonstrating a global suitability of 82.9%, increasing to 86.3% when ignoring minor IFUs. VBX was anatomically suitable to use in BCT in 73.2% of patient BCTs. Conclusions: aBranch devices are anatomically suitable in a vast majority of patients (86%) undergoing hybrid TEVAR. The innominate artery seems eligible for incorporation with VBX in almost two-thirds of patients. This mating stent may help to overcome some minor IFU restrictions.
2024
Leone N., Bartolotti L.A.M., Baresi G.F., Silingardi R., Resch T.A., Gennai S. (2024). Anatomical suitability for branched endovascular aortic arch repair and balloon-expandable bridging stent grafts in a cohort of patients previously treated with a hybrid approach. JOURNAL OF VASCULAR SURGERY, 79(2), 198-206 [10.1016/j.jvs.2023.11.011].
Leone N.; Bartolotti L.A.M.; Baresi G.F.; Silingardi R.; Resch T.A.; Gennai S.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/957734
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