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
10.3760/cma.j.cn112434-20220915-00297
- VernacularTitle:国产HeartCon第三代磁液悬浮左心室辅助装置治疗50例终末期心力衰竭的前瞻性多中心临床试验研究
- Author:
Xiaocheng LIU
1
;
Chunsheng WANG
;
Xinmin ZHOU
;
Bin YANG
;
Liangwan CHEN
;
Qi AN
;
Tianxiang GU
;
Zhiyun XU
;
Jinsong HUANG
;
Xiangrong KONG
;
Yongfeng SHAO
Author Information
1. 泰达国际心血管病医院心外科，天津 300457
- Keywords:
End-stage heart failure;
Multicenter clinical trial;
Left ventricular assist device;
Domestically manufactured
- From:
Chinese Journal of Thoracic and Cardiovascular Surgery
2023;39(5):273-278
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To 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.Methods:This 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.Results:All 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). Conclusion:The 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.
