Endovascular abdominal aortic aneurysm repair with a new stent graft:early results from a multicenter study.

Hong Peng Zhang; Xi Wei Zhang; Xiang Chen Dai; Min Tian; Bin Yang; Zhi Wei Wang; Xiao Jun Shu; Yu Hong Chen; Jian Jun Jiang; Jian Hua Huang; Chang Shu; Xiao Qin; Xin Wu LU; Hong Kun Zhang; Wei BI; Yong Liu; Bing Chen; Zhi Peng HU; Jian Zuo; Ping Fan Guo; Jun Luo; Xini Yuan Tong; Wei Guo

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Endovascular abdominal aortic aneurysm repair with a new stent graft:early results from a multicenter study.

Author: Hong Peng ZHANG ¹ ; Xi Wei ZHANG ² ; Xiang Chen DAI ³ ; Min TIAN ⁴ ; Bin YANG ⁵ ; Zhi Wei WANG ⁶ ; Xiao Jun SHU ⁷ ; Yu Hong CHEN ⁸ ; Jian Jun JIANG ⁹ ; Jian Hua HUANG ¹⁰ ; Chang SHU ¹¹ ; Xiao QIN ¹² ; Xin Wu LU ¹³ ; Hong Kun ZHANG ¹⁴ ; Wei BI ¹⁵ ; Yong LIU ¹⁶ ; Bing CHEN ¹⁷ ; Zhi Peng HU ¹⁸ ; Jian ZUO ¹⁹ ; Ping Fan GUO ²⁰ ; Jun LUO ²¹ ; Xini Yuan TONG ²² ; Wei GUO ¹
Author Information

1. Department of Vascular Surgery,the First Medical Center,People's Liberation Army General Hospital,Beijing 100853,China.
2. Department of Vascular Surgery, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029,China.
3. Department of Vascular Surgery,Tianjin Medical University General Hospital,Tianjin 300052,China.
4. Second Department of General Surgery,Yanan Hospital,Kunming 650051,China.
5. Department of Vascular Surgery,the First Affiliated Hospital of Kunming Medical University, Kunming 650031, China.
6. Department of Cardiovascular Surgery,People's Hospital of Wuhan University,Wuhan 430065,China.
7. Department of Vascular Surgery,the First Hospital of Lanzhou University,Lanzhou 730099,China.
8. Department of Cardiac and Vascular Surgery,Liuzhou People's Hospital,Liuzhou 545026, China.
9. Department of Vascular Surgery,Qilu Hospital of Shandong University, Jinan 250011, China.
10. Department of Vascular Surgery, Xiangya Hospital, Central South University, Changsha 410028, China.
11. Department of Vascular Surgery,Xiangya Second Hospital,Central South University,Changsha 410011, China.
12. Department of Vascular Surgery,the First Affiliated Hospital of Guangxi Medical University,Nanning 530021,China.
13. Department of Vascular Surgery, Ninth People's Hospital Shanghai Jiao Tong University School of Medicine, Shanghai 200011,China.
14. Department of Vascular Surgery,the First Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310003,China.
15. Department of Vascular Surgery,the Second Hospital of Hebei Medical University,Shijiazhuang 050004,China.
16. Department of Vascular Surgery,the Affiliated Hospital of Southwest Medical University,Luzhou 646099,China.
17. Department of Vascular Surgery,the Second Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310009,China.
18. Department of Vascular Surgery,Ningxia Medical University General Hospital,Yinchuan 750003,China.
19. Department of Cardiovascular Surgery,Xijing Hospital,Air Force Medical University,Xi'an 710032,China.
20. Department of Vascular Surgery,the First Affiliated Hospital of Fujian Medical University,Fuzhou 350004,China.
21. Department of Vascular and Thyroid Surgery, the First Affiliated Hospital of Xinjiang Medical University, Urumqi 830011,China.
22. Department of Medical Statistics, People's Liberation Army General Hospital, Beijing 100853, China.
Publication Type:Journal Article
MeSH: Humans; Middle Aged; Aged; Aged, 80 and over; Prospective Studies; China; Ischemia; Aortic Aneurysm, Abdominal/surgery*
From: Chinese Journal of Surgery 2022;60(12):1049-1056
CountryChina
Language:Chinese
Abstract: Objective: To examine the safety and effectiveness of a new stent graft system for endovascular repair of abdominal aortic aneurysm(AAA). Methods: This is a prospective,multi-center,single-arm clinical trial. The patients with AAA treated with a new stent graft system were enrolled at 21 centers from September 2018 to September 2019 in China. Follow-up was performed before discharge, and at 30, 180, 360 days after operation, respectively. The primary safety endpoint was the incidence of major adverse events(MAE) within 30 days. The primary efficacy endpoint was the success rate of AAA treatment at 360 days. Secondary safety endpoints were the incidence of perioperative access complications and acute lower limb ischemia,all-cause mortality, AAA related mortality and incidence of serious adverse events (SAE) at 180 and 360 days. Secondary efficacy endpoints were the incidence of type Ⅰ or Ⅲ endoleak,stent displacement,and conversion to open surgery or re-intervention at 180 and 360 days. Results: One hundred and fifty-six patients were enrolled,including 137 males and 19 females. The age was (68.9±6.9) years (range:48.2 to 84.6 years).Maximum aneurysm diameter was (50.8±11.2) mm (range:25.0 to 85.0 mm),diameter of proximal landing zone was (21.2±2.5) mm (range:17.0 to 29.5 mm),and length of proximal landing zone was (31.4±13.0) mm (range:11.0 to 75.0 mm).The incidence of MAE was 1.3% (2/156) at 30 days,both were all-cause death cases. The success rate of AAA treatment was 88.5% (138/156) at 360 days. No perioperative access complication and acute lower limb ischemia occurred. All-cause mortality was 2.0% (3/154) at 180 days and 2.6% (4/153) at 360 days,and there was no AAA related death. The incidence of SAE was 23.0%(35/152) at 180 days and 30.5%(46/151) at 360 days, and no device-related SAE occurred. The incidence of type Ⅰor Ⅲ endoleak was 3.4% (5/147) at 180 days and 3.5% (5/144) at 360 days. Conclusion: The new stent graft system is easy to operate,and early-term safety and effectiveness results are expected.