Safety and effectiveness of the sutureless integrated stented graft prosthesis in an animal model
Lu Dai,
Chenyu Zhou,
Liang Zhang,
Juntao Qiu,
Shen Liu,
Jiawei Qiu,
Rui Zhao,
Enzehua Xie,
Jian Song,
Cuntao Yu
Affiliations
Lu Dai
Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, Beijing, China
Chenyu Zhou
Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, Beijing, China
Liang Zhang
Department of Aortic Surgery, Anhui Chest Hospital, Hefei, Anhui, China
Juntao Qiu
Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, Beijing, China
Shen Liu
Department of Cardiac Surgery, Peking University International Hospital, Peking University Eighth Clinical Medical School, Beijing, China
Jiawei Qiu
Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, Beijing, China
Rui Zhao
Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, Beijing, China
Enzehua Xie
Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, Beijing, China
Jian Song
Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, Beijing, China
Cuntao Yu
Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, Beijing, China; Corresponding author. Department of Aortic Surgery, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College/National Clinical Research Center for Cardiovascular Diseases, No. 167 North Lishi Road, Xicheng District, Beijing, 100037, China.
Background: Prolonged circulatory arrest time is an independent risk factor for postoperative adverse events of type A aortic dissection (TAAD) surgery. Further reduction of the circulatory arrest time is essential to improve surgical outcomes. This study aimed to evaluate the safety and effectiveness of the novel Sutureless Integrated Stented (SIS) graft prosthesis in an animal experiment. Materials and methods: Straight type of the SIS graft prosthesis was implanted into the descending aorta of 10 adult male sheep, and the use of the device was scored on a scale of 1–10. Aortic digital subtraction angiography (DSA) was performed at 4, 14, and 26 weeks to investigate the prostheses. After 26 weeks, the animals were sacrificed for histological analysis. Results: The immediate success rate of the surgery was 100 %, and the overall mean score of the use of the device was 9.65 ± 0.99. Three animals died from non-device-related causes during follow-up. Aortic DSA showed filling defects in 5 animals. Histological analysis revealed that all prostheses were intact. Except for 2 early deaths, the other 8 prostheses were endothelialized with mild inflammation, foreign body reactions, and intimal fibrosis. The mean cross-sectional area of the sutureless region was reduced by 26.4 % (range, 1.3–39.1 %). Conclusions: The safety and effectiveness of the novel SIS graft prosthesis were acceptable, and the delivery system exhibited a promising performance. Using the SIS graft prosthesis in TAAD surgery was expected to simplify the procedures and shorten the circulatory arrest time. Further large-scale clinical trials are required to verify these findings.
