The Annals of thoracic surgery · 2024
Outcomes of a Novel Single-Branched Aortic Stent Graft for Treatment of Type B Aortic Dissection.
СтатьяКлиническое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
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Desai Nimesh D, Wang Grace J, Brinkman William, Coselli Joseph, Taylor Bradley, Patel Himanshu, Dake Michael, Fleischman Fernando, Panneton Jean, Matsumura Jon, Sweet Matthew, DeMartino Randall, Leshnower Bradley, Sanchez Luis, Bavaria Joseph E
Аннотация
BACKGROUND: Intervention on type B dissection frequently requires landing the proximal edge of the stent graft between the left common carotid artery and left subclavian artery (LSA). The GORE TAG thoracic branch endoprosthesis is a technology that allows LSA preservation with a single internal branch.
METHODS: This study was a prospective nonrandomized single-arm clinical trial of patients with type B aortic dissection who were treated with the single-branched device. Patients with operative indications for acute, chronic, or residual type B dissections that originated distal to the origin of an LSA suitable for branch graft placement were eligible for the study. Native aortic and surgical graft proximal landing zones were eligible.
RESULTS: Of the 132 patients, there were 25 (18.9%) acute type B dissections, 79 (59.8%) chronic type B dissections, and 28 (21.1%) residual dissections after previous open type A repair. Percutaneous access was used in 105 (79.5%) patients. Overall, 30-day mortality occurred in 6 patients (4.5%). The overall 30-day stroke rate was 2 of 132 (1.5%), and the 1-year freedom from stroke was 96.8%. Device technical success and procedural success were achieved in 129 of 132 (97.7%) and 110 of 132 (83.3%) patients, respectively, and there was 1 instance of loss of side branch patency. No persistent antegrade false lumen flow was observed.
CONCLUSIONS: In this study of a novel branched endograft device to preserve the LSA in patients with type B dissection undergoing thoracic endovascular aortic repair, we demonstrate acceptable safety and efficacy outcomes at 1 year.
METHODS: This study was a prospective nonrandomized single-arm clinical trial of patients with type B aortic dissection who were treated with the single-branched device. Patients with operative indications for acute, chronic, or residual type B dissections that originated distal to the origin of an LSA suitable for branch graft placement were eligible for the study. Native aortic and surgical graft proximal landing zones were eligible.
RESULTS: Of the 132 patients, there were 25 (18.9%) acute type B dissections, 79 (59.8%) chronic type B dissections, and 28 (21.1%) residual dissections after previous open type A repair. Percutaneous access was used in 105 (79.5%) patients. Overall, 30-day mortality occurred in 6 patients (4.5%). The overall 30-day stroke rate was 2 of 132 (1.5%), and the 1-year freedom from stroke was 96.8%. Device technical success and procedural success were achieved in 129 of 132 (97.7%) and 110 of 132 (83.3%) patients, respectively, and there was 1 instance of loss of side branch patency. No persistent antegrade false lumen flow was observed.
CONCLUSIONS: In this study of a novel branched endograft device to preserve the LSA in patients with type B dissection undergoing thoracic endovascular aortic repair, we demonstrate acceptable safety and efficacy outcomes at 1 year.