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 -2, P<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。
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.
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版权归中华医学会所有。
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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

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