Left Ventricular Assist
A prospective multicenter clinical trial study of a domestic HeartCon third-generation magnetic and hydrodynamic levitation LVAD for the treatment of 50 cases of end-stage heart failure
Liu Xiaocheng, Wang Chunsheng, Zhou Xinmin, Yang Bin, Chen Liangwan, An Qi, Gu Tianxiang, Xu Zhiyun, Huang Jinsong, Kong Xiangrong, Shao Yongfeng
Published 2023-05-25
Cite as Chin J Thorac Cardiovasc Surg, 2023, 39(5): 273-278. DOI: 10.3760/cma.j.cn112434-20220915-00297
Abstract
ObjectiveTo analyze and evaluate the safety and efficacy of a Chinese domestically manufactured Heart Con-type implantable third-generation magnetic and hydrodynamic levitation left ventricular assist device(LVAD) for the treatment of end-stage heart failure(ESHF), by reporting the results of eleven-center clinical trial on 50 cases.
MethodsThis study was a multicenter clinical trial, designed by means of prospective, multicenter and single-group target value. 50 subjects with ESHF were competitively enrolled and treated with HeartCon as the LVAD in eleven centers. The primary efficacy measure was survival, defined as either the subjects experiencing the transition to heart transplantation(HT) or myocardial recovery assisted by the device within 90 days, or as successfully assisted by the LVAD for full 90 days after implantation. The target survival rate was 60%, other observations included implantation success rate, mortality, pump failure needing replacement or emergency heart transplantation.
ResultsAll enrolled 50 patients received LVAD implantation successfully, 46 survived with the pump for 90 days, 1 patient transitioned to heart transplantation, and 3 patients experienced pump thrombosis, within which 2 patients underwent pump replacement and continued to live with the pump for 90 days, and the other one received emergency heart transplantation. There were no dropout subjects. The survival rate at full 90 days after HeartCon implantation was 100%. The survival rates with pump in the full set analysis and the protocol set analysis were 96.00% and 95.92% respectively, which were higher than the target value of 60%. The differences were both statistically significant(P<0.05).
ConclusionThe results of the multicenter clinical trial with the largest sample size in China using domestically manufactured third-generation LVAD has demonstrated that, HeartCon is a safe and effective LVAD to treat ESHF patients.
Key words:
End-stage heart failure; Multicenter clinical trial; Left ventricular assist device; Domestically manufactured
Contributor Information
Liu Xiaocheng
Department of Cardiovascualr Surgery, TEDA International Cardiovascular Hospital, Tianjin 300457, China
Wang Chunsheng
Department of Cardiovascular Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China
Zhou Xinmin
Department of Cardiovascular Surgery, the Second Xiangya Hospital of Central South University, Changsha 410011, China
Yang Bin
Department of Heart Transplantation, Zhengzhou Seventh People’s Hospital, Zhengzhou 450000, China
Chen Liangwan
Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou 350001, China
An Qi
Department of Cardiovascular Surgery, West China of Sichuan University, Chengdu 610000, China
Gu Tianxiang
Department of Cardiovascular Surgery, the First Hospital of China Medical University, Shenyang 110001, China
Xu Zhiyun
Department of Cardiovascular Surgery, Changhai Hospital, Navy Military Medical University, Shanghai 200433, China
Huang Jinsong
Department of Cardiovascular Surgery, Guangdong Provincial People’s Hospital, Guangzhou 510080, China
Kong Xiangrong
Department of Cardiovascular Surgery and Department of Heart and Lung Transplantation, Tianjin First Central Hospital, Tianjin 300192, China
Shao Yongfeng
Department of Cardiovascular Surgery, the First Affiliated Hospital with Nanjing Medical University, Nanjing 210009, China
