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轴流泵式左心室辅助装置(LVADs)耐久性和可靠性的比较技术分析

Comparative Technological Analysis of Durability and Reliability in Axial-Flow Pump Left Ventricular Assist Devices (LVADs).

作者信息

Khorshid Savar Amin, Wang Hongrui, Chen Nuo, Cheng Yunzhang

机构信息

Shanghai Interventional Medical Device Engineering Technology Research Center, University of Shanghai for Science and Technology, Shanghai, China.

出版信息

Cardiovasc Eng Technol. 2025 Apr 30. doi: 10.1007/s13239-025-00778-x.

Abstract

PURPOSE

This study addresses the critical gap in the literature regarding the comparative analysis of axial flow left ventricular assist devices (LVADs). Despite technological advancements, there is a notable lack of integrated studies focusing solely on axial flow pumps and comparing multiple models with the same technology. This gap limits developers' access to comprehensive technical information essential for innovation in mechanical design, flow efficiency, and thrombus prevention.

METHOD

A systematic review of 27 low-risk studies was performed on four axial flow LVADs: HeartMate II, DeBakey, Berlin Heart INCOR, and Jarvik 2000. The analysis evaluated durability and reliability using key metrics, including actuarial survival rates, device exchange rates, pump thrombosis rates, and freedom from adverse events, while considering technical factors such as rotor design, flow dynamics, and material innovation.

RESULTS

HeartMate II achieved a 79% actuarial survival rate at 1 year and a 6.3% thrombosis-related exchange rate. DeBakey had a higher exchange rate of 33.3% due to mechanical issues, indicating a need for better material durability. Jarvik 2000 offered long-term support with a 5-year duration and an 8.3% thrombosis rate, benefiting from its spiral cable design. INCOR showed high reliability with low energy consumption and minimal driveline infections, highlighting the advantages of advanced coatings and reduced friction.

CONCLUSION

Axial flow LVADs are crucial for patients with small chest spaces, especially children. Enhancements in rotor design, materials, and real-time monitoring are essential for improving durability and reliability. These findings provide valuable insights for developing more durable and reliable axial flow pumps.

摘要

目的

本研究填补了文献中关于轴流左心室辅助装置(LVAD)比较分析的关键空白。尽管技术不断进步,但明显缺乏仅专注于轴流泵并对多种采用相同技术的型号进行比较的综合研究。这一空白限制了开发者获取机械设计、流动效率和血栓预防创新所需的全面技术信息。

方法

对四种轴流LVAD(HeartMate II、德巴基、柏林心脏INCOR和Jarvik 2000)进行了27项低风险研究的系统综述。分析使用关键指标评估耐久性和可靠性,包括精算生存率、装置更换率、泵血栓形成率和无不良事件发生率,同时考虑转子设计、流动动力学和材料创新等技术因素。

结果

HeartMate II在1年时的精算生存率为79%,血栓相关更换率为6.3%。德巴基由于机械问题更换率较高,为33.3%,这表明需要提高材料耐久性。Jarvik 2000凭借其螺旋电缆设计提供了为期5年的长期支持,血栓形成率为8.3%。INCOR显示出高可靠性,能耗低且传动系统感染极少,突出了先进涂层和降低摩擦的优势。

结论

轴流LVAD对胸腔空间较小的患者至关重要,尤其是儿童。转子设计、材料和实时监测方面的改进对于提高耐久性和可靠性至关重要。这些发现为开发更耐用、可靠的轴流泵提供了有价值的见解。

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