论著
ENGLISH ABSTRACT
国产高流量介入式左心辅助装置在心脏术后低心排血量综合征患者中的应用——预试验结果报告
陈良万
解启莲
戴小福
丘智煌
李虔桢
方冠华
卢衡
吴青松
肖军
张兆锋
作者及单位信息
·
DOI: 10.3760/cma.j.cn112434-20250215-00038
Application of domestic high-flow percutaneous left ventricular assist device in patients with low cardiac output syndrome after cardiac surgery: a preclinical trial report
Chen Liangwan
Xie Qilian
Dai Xiaofu
Qiu Zhihuang
Li Qianzhen
Fang Guanhua
Lu Heng
Wu Qingsong
Xiao Jun
Zhang Zhaofeng
Authors Info & Affiliations
Chen Liangwan
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
Xie Qilian
Anhui Tongling Bionic Technology Co., Ltd., Hefei 230000, China
Dai Xiaofu
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
Qiu Zhihuang
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
Li Qianzhen
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
Fang Guanhua
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
Lu Heng
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
Wu Qingsong
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
Xiao Jun
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
Zhang Zhaofeng
Department of Cardiovascular Surgery, Fujian Medical University Union Hospital, Fujian Heart Medical Center, Fuzhou 350001, China
·
DOI: 10.3760/cma.j.cn112434-20250215-00038
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摘要

目的报道国产高流量介入式左心辅助装置(percutaneous left ventricular assist device,pLVAD)用于心脏术后低心排血量综合征(低心排)患者的预试验结果。

方法6例心脏直视术后低心排患者接受国产高流量pLVAD植入。观察植入后患者的血流动力学改变、并发症发生和生存率等临床效果。

结果4例患者在心导管室植入pLVAD,另2例经食管超声心动图引导植入。植入过程简单、快速、顺利,均未见出血和心律失常等。pLVAD开始辅助的流量为3.8~5.0(4.22±0.44)L/min,撤泵流量为1.0~1.3(1.18±0.15)L/min;辅助时间16.5~165.0(101.3±60.65)h。pLVAD使用后血流动力学立即得到改善:平均动脉压从(62.67±4.46)mmHg(1 mmHg=0.133 kPa)上升至(80.50±18.96)mmHg, P=0.049;心输出量从(2.45±0.66)L/min上升至(4.35±1.32)L/min, P=0.01;心脏指数从(1.95±0.21)L·min -1·m -2上升至(2.77±0.33)L·min -1·m -2P<0.001;肺动脉舒张压从(27.50±1.87)mmHg下降至(18.33±4.18)mmHg, P=0.001;左心室射血分数从0.27±0.04上升至0.37±0.06, P=0.004。辅助过程中未见肉眼血红蛋白尿,未发生恶性心律失常、脑部并发症等。1例患者过渡至外科植入式左心室辅助装置植入治疗,另5例均顺利撤除pLVAD出院。3个月后6例患者均生存,心功能Ⅰ-Ⅱ级。

结论国产高流量pLVAD植入可为心脏术后低心排患者提供一种安全有效的辅助治疗。

高流量介入式左心辅助装置;低心排血量综合征;心脏外科手术;预试验结果
ABSTRACT

ObjectiveTo report the preclinical trial results of the application of a domestic high-flow percutaneous left ventricular assist device (pLVAD) in patients with low cardiac output syndrome (LCOS) following cardiac surgery.

MethodsSix patients who developed LCOS after direct cardiac surgery were implanted with a domestic high-flow pLVAD. Clinical outcomes, including hemodynamic changes, complications, and survival rates were observed post-implantation.

ResultsFour patients underwent pLVAD implantation under digital subtraction angiography (DSA) guidance, while two patients had the procedure performed under ultrasound guidance. The implantation process was straightforward, rapid, and uneventful, with no instances of bleeding or arrhythmias. The flow rate at the initiation of pLVAD support was 3.8-5.0 (4.22±0.44)L/min, and the flow rate during pump removal was 1.0-1.3(1.18±0.15)L/min. The duration of pLVAD support was 16.5-165.0(101.3±60.65)h. Hemodynamic parameters showed immediate improvement following pLVAD support: mean arterial pressure increased from (62.67±4.46)mmHg to (80.50±18.96)mmHg (1 mmHg=0.133 kPa, P=0.049), cardiac output increased from (2.45±0.66)L/min to (4.35±1.32)L/min( P=0.01), cardiac index improved from (1.95±0.21)L·min -1·m -2 to (2.77±0.33)L·min -1·m -2( P<0.001), pulmonary artery diastolic pressure decreased from (27.50±1.87) mmHg to(18.33±4.18)mmHg( P=0.001), and left ventricular ejection fraction improved from 0.27±0.04 to 0.37±0.06 ( P=0.004). No visible hemoglobinuria was noted during the support period. No malignant arrhythmias or cerebrovascular complications occurred. One patient required transition to surgical LVAD implantation, while the other five patients had the pLVAD successfully removed and were discharged. Three months later, all six patients were alive, with functional status classified as New York Heart Association (NYHA) Class Ⅰ-Ⅱ.

ConclusionThe implantation of a domestic high-flow pLVAD provides a safe and effective therapeutic option for patients with LCOS following cardiac surgery.

High-flow percutaneous left ventricular assist device;Low cardiac output syndrome;Cardiac surgery;Preclinical trial
引用本文

陈良万,解启莲,戴小福,等. 国产高流量介入式左心辅助装置在心脏术后低心排血量综合征患者中的应用——预试验结果报告[J]. 中华胸心血管外科杂志,2025,41(03):177-182.

DOI:10.3760/cma.j.cn112434-20250215-00038

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低心排血量综合征(low cardiac output syndrome,LCOS)是心脏直视术后的严重并发症,发生率2.0%~28.0% [ 1 , 2 ]。虽然传统的药物治疗和短暂机械辅助[如主动脉内球囊反搏(IABP)和体外膜肺氧合]得到很大发展,但LCOS的病死率仍高达40%~80% [ 3 , 4 ]。最新研究表明,早期外科植入左心辅助装置能明显降低心脏直视术后并发LCOS患者的病死率 [ 5 ]。然而,目前常用的外科植入式左心辅助装置(surgical left ventricular assist device,sLVAD)常规用于LCOS治疗受到明显限制,主要原因是价格昂贵,难以常规备用;且需要手术技术过硬和完善的手术团队等。最新报道显示,植入高流量(5.0 L/min)介入式左心室辅助装置(percutaneous left ventricular assist device,pLVAD)进行短期辅助,有助于心脏直视术后并发LCOS患者的心肌收缩力恢复或桥接至sLVAD治疗,病死率明显降低 [ 6 ]。同时,该装置能简单、快速地植入和移除,且较sLVAD价格便宜。目前,全球仅有美国Abiomed公司生产的高流量pLVAD(Impella 5.0)获得FDA批准上市 [ 7 ]。但是进口Impella 5.0价格昂贵,国内患者一般难以承受。为了更好满足国内患者的临床需求,安徽通灵仿生科技有限公司生产出国产高流量pLVAD(TeleHeart P50),在动物试验阶段表现出良好的有效性及安全性。本研究探讨该装置应用于6例心脏直视术后LCOS患者的临床预试验结果,报道如下。
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备注信息
A

陈良万:实验设计,实验实施,文章起草;谢启莲:研究实施,数据采集,文章审阅;戴小福:实验设计,实验实施,文章审阅;丘智煌、李虔桢、方冠华、卢衡:研究实施,文章起草;吴青松、肖军、张兆锋:数据采集、分析,文章起草

B
美国国立卫生研究院(NCT06127927)
C
U. S. National Institutes of Health(NCT06127927)
D
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