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      Clinical Results and Aortic Remodeling After Endovascular Treatment for Complicated Type B Aortic Dissection With the “Fabulous” Stent System

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          Abstract

          Objective

          To report the clinical outcomes and aortic remodeling after the implantation of a self-developed, biomechanically optimized, two-stage thoracic stent system named Fabulous.

          Background

          Given the efficacy of the PETTICOAT concept, the benefits of Fabulous and the behavior of remodeling in different segments need further investigation.

          Methods

          This is a prospective and multicenter study. From 2017 to 2019, 145 patients (mean age, 56.6 years; 88.3% male) from 14 centers were included in this cohort. The clinical results and core laboratory results were from a central electronic data capture system. Computed tomographic angiography was performed preoperatively, 1 month, 6 months and yearly thereafter and was used for volumetric analysis by 3mensio (Bilthoven, The Netherlands). After the 1-year follow-up, 97.2 and 87.6% of the clinical and imaging results of the eligible patients were available.

          Results

          Both stent grafts and bare stents were successfully delivered in place in 100% of the patients. The 30-day mortality and 1-year freedom from all-cause mortality were 2.1 and 96.6%, respectively. The incidence of entry flow was 11.7% at 30 days and 6.2% at 365 days. No cases of stent-induced new entry (SINE) or reintervention were observed. After the 1-year follow-up, the true lumen/overall volume ratio reached 88%. The following subdivided segment volume changes were recorded: stent graft segment TL +56%; FL −92%, bare stent segment TL +32%; FL −75%, and there were no significant changes in the visceral segment.

          Conclusions

          These outcomes indicated that there were favorable clinical benefits of Fabulous stent system. This device achieved a low short-term mortality and a low incidence of reintervention. In addition, patients undergoing Fabulous stent system implantation showed remodeling both on descending aorta and on the distal aorta. The volume changes in the TL and FL varied in the different segments. The long-term follow-up is still ongoing.

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          Most cited references24

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          Editor's Choice - Management of Descending Thoracic Aorta Diseases: Clinical Practice Guidelines of the European Society for Vascular Surgery (ESVS).

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            Interdisciplinary expert consensus document on management of type B aortic dissection.

            An expert multidisciplinary panel in the treatment of type B aortic dissection reviewed available literature to develop treatment algorithms using a consensus method. Data from 63 studies published from 2006 to 2012 were retrieved for a total of 1,548 patients treated medically, 1,706 patients who underwent open surgery, and 3,457 patients who underwent thoracic endovascular repair (TEVAR). For acute (first 2 weeks) type B aortic dissection, the pooled early mortality rate was 6.4% with medical treatment and increased to 10.2% with TEVAR and 17.5% with open surgery, mostly for complicated cases. Limited data for treatment of subacute (2 to 6 weeks after onset) type B aortic dissection showed an early mortality rate of 2.8% with TEVAR. In chronic (after 6 weeks) type B aortic dissection, 5-year survival of 60% to 80% was expected with medical therapy because complications were likely. If interventional treatment was applied, the pooled early mortality rate was 6.6% with TEVAR and 8.0% with open surgery. Medical treatment of uncomplicated acute, subacute, and chronic type B aortic dissection is managed with close image monitoring. Hemodynamic instability, organ malperfusion, increasing periaortic hematoma, and hemorrhagic pleural effusion on imaging identify patients with complicated acute type B aortic dissection requiring urgent aortic repair. Recurrence of symptoms, aortic aneurysmal dilation (>55 mm), or a yearly increase of >4 mm after the acute phase are predictors of adverse outcome and need for delayed aortic repair ("complicated chronic aortic dissections"). The expert panel is aware that this consensus document provides proposal for strategies based on nonrobust evidence for management of type B aortic dissection, and that literature results were largely heterogeneous and should be interpreted cautiously.
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              Stent graft-induced new entry after endovascular repair for Stanford type B aortic dissection.

              Stent graft-induced new entry (SINE), defined as the new tear caused by the stent graft and excluding those arising from natural disease progression or iatrogenic injury from the endovascular manipulation, has been increasingly observed after thoracic endovascular aortic repair (TEVAR) for Stanford type B dissection in our center. SINE appears to be remarkably life threatening. We investigated the incidence, mortality, causes, and preventions of SINE after TEVAR for Stanford type B dissection. Data for 22 patients with SINE were retrospectively collected and analyzed from 650 patients undergoing TEVAR for type B dissection from August 2000 to June 2008. An additional patient was referred to our center 14 months after TEVAR was performed in another hospital. The potential associations of SINE with Marfan syndrome, location of SINE and endograft placement, and the oversizing rate were analyzed by Fisher exact probability test or t test. We found 24 SINE tears in 23 patients, including SINE at the proximal end of the endograft in 15, at the distal end in 7, and at both ends in 1. Six patients died. SINE incidence and mortality reached 3.4% and 26.1%, respectively. Two SINE patients were diagnosed with Marfan syndrome, whereas there were only 6 Marfan patients among the 651 patients. The 16 proximal SINEs were evidenced at the greater curve of the arch and caused retrograde type A dissection. The eight distal SINEs occurred at the dissected flap, and five caused enlarging aneurysm whereas three remained stable. The endograft was placed across the distal aortic arch during the primary TEVAR in all 23 patients. The incidence of SINE was 33.33% among Marfan patients vs 3.26% among non-Marfan patients (P = .016). There was no significant difference in mortality between proximal and distal SINE (25% vs 28.6%, P > .99), incidence of SINE between endograft placement across the arch and at the straight portion of descending thoracic aorta (23 of 613 vs 0 of 38, P = .39), and the oversizing rate between SINE and non-SINE patients (13% ± 4.5% vs 16% ± 6.5%, P = .98). SINE appears not to be rare after TEVAR for type B dissection and is associated with substantial mortality. The stress yielded by the endograft seems to play a predominant role in its occurrence. It is important to take this stress-induced injury into account during both design and placement of the endograft. Copyright © 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
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                Author and article information

                Contributors
                Journal
                Front Cardiovasc Med
                Front Cardiovasc Med
                Front. Cardiovasc. Med.
                Frontiers in Cardiovascular Medicine
                Frontiers Media S.A.
                2297-055X
                14 February 2022
                2022
                : 9
                : 817675
                Affiliations
                [1] 1Department of Vascular Surgery, Zhongshan Hospital, Fudan University , Shanghai, China
                [2] 2Vascular Surgery, Yantai Yuhuangding Hospital Affiliated With Qingdao University , Yantai, China
                [3] 3Department of Vascular Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University , Hangzhou, China
                [4] 4Department of Vascular Surgery, Peking University People's Hospital , Beijing, China
                [5] 5Department of General Surgery, Tianjin Medical University General Hospital , Tianjin, China
                [6] 6Department of Vascular and Endovascular Surgery, Henan Provincial People's Hospital, Zhengzhou University , Zhengzhou, China
                [7] 7Department of Vascular Surgery, The First Affiliated Hospital of USTC , Hefei, China
                [8] 8Department of Vascular Surgery, Jiangsu Province Hospital , Nanjing, China
                [9] 9Department of Vascular Surgery, School of Medicine, Second Affiliated Hospital, Zhejiang University , Hangzhou, China
                [10] 10Department of General and Vascular Surgery, Xiangya Hospital, Central South University , Changsha, China
                [11] 11Department of Vascular Surgery, The First Affiliated Hospital of Guangxi Medical University , Guangxi, China
                [12] 12Department of General Surgery, Hainan Province People's Hospital , Haikou, China
                [13] 13Department of Vascular Surgery, Shanghai Ninth People's Hospital , Shanghai, China
                [14] 14Department of Vascular and Endovascular Surgery, Chinese PLA General Hospital , Beijing, China
                Author notes

                Edited by: Julie A. Phillippi, University of Pittsburgh, United States

                Reviewed by: Duanduan Chen, Beijing Institute of Technology, China; Ding Yuan, West China Hospital, Sichuan University, China; Domenico Spinelli, Università degli Studi di Messina, Italy

                *Correspondence: Yi Si si.yi@ 123456zs-hospital.sh.cn

                This article was submitted to Atherosclerosis and Vascular Medicine, a section of the journal Frontiers in Cardiovascular Medicine

                †These authors have contributed equally to this work and share first authorship

                Article
                10.3389/fcvm.2022.817675
                8882966
                35237674
                bc1a596b-4b66-4adc-9c49-75747d12e321
                Copyright © 2022 Wang, Kan, Yang, Zhang, Zhang, Dai, Zhai, Hu, Zhang, Chen, Huang, Qin, Xiao, Lu, Guo, Si and Fu.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 18 November 2021
                : 14 January 2022
                Page count
                Figures: 2, Tables: 6, Equations: 0, References: 25, Pages: 9, Words: 7078
                Funding
                Funded by: National Key Research and Development Program of China, doi 10.13039/501100012166;
                Categories
                Cardiovascular Medicine
                Original Research

                aortic dissection,aortic remodeling,composite device,thoracic endovascular aortic repair (tevar),bare stent

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