Five Year Outcomes of the Fabulous Stent System in the Management of Complicated Type B Aortic Dissection: A Prospective Multicentre Study

Chengkai Hu; Yuchong Zhang; Jue Yang; Yulong Huang; Wei Wang; Xiangchen Dai; Xinwu Lu; Hongpeng Zhang; Weiguo Fu; Lixin Wang

doi:10.1016/j.ejvs.2025.07.020

Five Year Outcomes of the Fabulous Stent System in the Management of Complicated Type B Aortic Dissection: A Prospective Multicentre Study

Eur J Vasc Endovasc Surg. 2025 Jul 11:S1078-5884(25)00680-X. doi: 10.1016/j.ejvs.2025.07.020. Online ahead of print.

Authors

Chengkai Hu¹, Yuchong Zhang¹, Jue Yang², Yulong Huang³, Wei Wang⁴, Xiangchen Dai⁵, Xinwu Lu⁶, Hongpeng Zhang⁷, Weiguo Fu⁸, Lixin Wang⁹

Affiliations

¹ Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Vascular Surgery Institute of Fudan University, Shanghai, China.
² Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Vascular Surgery Institute of Fudan University, Shanghai, China; Department of Vascular Surgery, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, China.
³ Department of Vascular Surgery, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, China.
⁴ Department of Vascular Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.
⁵ Department of Vascular Surgery, Tianjin Medical University General Hospital, Tianjin, China.
⁶ Department of Vascular Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
⁷ Department of Vascular Surgery, Chinese PLA General Hospital, Beijing, China.
⁸ Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Vascular Surgery Institute of Fudan University, Shanghai, China; Department of Vascular Surgery, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, China. Electronic address: fu.weiguo@zs-hospital.sh.cn.
⁹ Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China; Vascular Surgery Institute of Fudan University, Shanghai, China; Department of Vascular Surgery, Zhongshan Hospital (Xiamen), Fudan University, Xiamen, Fujian, China. Electronic address: wang.lixin@zs-hospital.sh.cn.

PMID: 40653301
DOI: 10.1016/j.ejvs.2025.07.020

Abstract

Objective: This study aimed to assess the 5 year follow up results from a prospective, single arm, multicentre study evaluating the efficacy of the Fabulous stent system (DiNovA Meditech, Hangzhou, China) in the treatment of complicated Stanford type B aortic dissection (cTBAD).

Methods: From December 2017 to October 2019, 144 patients from 14 centres in China were prospectively enrolled. Primary outcomes were freedom from all cause death and long term aortic related adverse events. Secondary 5 year outcomes were the changes in the false lumen (FL) and true lumen (TL) in the bare stent and distal bare stent segments.

Results: The 5 year freedom from all cause mortality was 86.6%, and imaging follow up was completed by 64 patients (mean age 54.4 years; 89.1% male). From pre-procedure to the 5 year follow up there was a consistent increase in the minimum diameter of the TL (13.01 ± 6.52 mm pre-procedure; 23.16 ± 5.37 mm 1 year follow up; 24.68 ± 5.27 mm 5 year follow up) and a simultaneous reduction in the maximum diameter of the FL within the bare stent segment (28.69 ± 7.09 mm pre-procedure; 9.08 ± 12.84 mm 1 year follow up; 7.67 ± 12.51 mm 5 year follow up). The proportion of patients with complete FL thrombosis in the bare stent segment increased from 64% to 81%. During the 5 year follow up, three patients developed retrograde type A aortic dissection and three patients underwent a second intervention.

Conclusion: Following endovascular treatment using the Fabulous system, the 5 year outcomes of the cTBAD cohort demonstrated encouraging results regarding TL expansion and FL thrombosis. These results should enhance understanding of the application of the Proximal ExTension To Induce COmplete ATtachment (PETTICOAT) technique in cTBAD.

Keywords: Aortic remodelling; Bare stent; Fabulous; PETTICOAT; Type B aortic dissection.