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  

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

作　　者：刘晓程[1] 王春生 周新民[3] 杨斌[4] 陈良万[5] 安琪[6] 谷天祥[7] 徐志云 黄劲松[9] 孔祥荣[10] 邵永丰 Liu Xiaocheng;Wang Chunsheng;Zhou Xinmin;Yang Bin;Chen Liangwan;An Qi;Gu Tianxiang;Xu Zhiyun;Huang Jinsong;Kong Xiangrong;Shao Yongfeng(Department of Cardiovascualr Surgery,TEDA International Cardiovascular Hospital,Tianjin 300457,China;Department of Cardiovascular Surgery,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Cardiovascular Surgery,the Second Xiangya Hospital of Central South University,Changsha 410011,China;Department of Heart Transplantation,Zhengzhou Seventh People’s Hospital,Zhengzhou 450000,China;Department of Cardiovascular Surgery,Union Hospital,Fujian Medical University,Fuzhou 350001,China;Department of Cardiovascular Surgery,West China of Sichuan University,Chengdu 610000,China;Department of Cardiovascular Surgery,the First Hospital of China Medical University,Shenyang 110001,China;Department of Cardiovascular Surgery,Changhai Hospital,Navy Military Medical University,Shanghai 200433,China;Department of Cardiovascular Surgery,Guangdong Provincial People’s Hospital,Guangzhou 510080,China;Department of Cardiovascular Surgery and Department of Heart and Lung Transplantation,Tianjin First Central Hospital,Tianjin 300192,China;Department of Cardiovascular Surgery,the First Affiliated Hospital with Nanjing Medical University,Nanjing 210009,China)

机构地区：[1]泰达国际心血管病医院心外科,天津300457 [2]复旦大学附属中山医院心外科,上海200032 [3]中南大学湘雅二医院心血管外科,长沙410011 [4]郑州市第七人民医院心脏移植中心,郑州450000 [5]福建医科大学附属协和医院心血管外科,福州川350001 [6]四川大学华西医院心脏大血管外科,成都阝610000 [7]中国医科大学附属第一医院心脏外科,沈阳110001 [8]海军军医大学附属长海医院心血管外科,上海200433 [9]广东省人民医院心外科,广州1510080 [10]天津市第一中心医院心外科心肺移植科,天津300192 [11]南京医科大学第一附属医院心脏大血管外科,南京210009

出　　处：《中华胸心血管外科杂志》2023年第5期273-278,共6页Chinese Journal of Thoracic and Cardiovascular Surgery

摘　　要：目的通过报道11个医疗中心完成的50例临床试验结果,分析和评价中国制造的HeartCon型植入式第三代磁液悬浮左心室辅助装置(LVAD)用于治疗终末期心力衰竭(ESHF)的安全性和有效性。方法本试验系依前瞻性、多中心和单组目标值法设计的多中心临床试验。50例ESHF受试者竞争入组,在11个中心接受HeartCon辅助治疗。主要有效性指标为生存率。受试者在植入HeartCon后90天内出现过渡到心脏移植或心功能恢复停止辅助、使用HeartCon辅助满90天情况之一被认为生存,目标生存率为60%。其他观察指标包括植入成功率、病死率、泵失功或因失败需更换或紧急心脏移植。结果50例均成功接受LVAD植入手术,其中46例带泵满90天,1例过渡到心脏移植,3例发生泵血栓(其中2例接受血泵置换术继续带泵生存满90天,另1例接受紧急心脏移植)。无脱落受试者。植入HeartCon后满90天的生存率为100%。用全集分析和符合方案集分析的带泵生存率分别为96.00%和95.92%,均高于目标值60%,差异均有统计学意义(P<0.05)。结论本研究是中国最大宗样本量的应用国产第三代LVAD治疗ESHF患者的多中心临床试验,结果表明HeartCon是一种安全有效的LVAD。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.

关 键 词：终末期心力衰竭 多中心临床试验 左心室辅助装置 国产 

分 类 号：R654.2[医药卫生—外科学]