Cardiovascular Engineering and Technology ( IF 1.6 ) Pub Date : 2023-12-18 , DOI: 10.1007/s13239-023-00703-0
Erica C Hord 1 , Melanie P Hager 2, 3 , Christina M Bolch 1 , Katherine Bonugli 4 , Lee-Jae Guo 4 , Egemen Tuzun 4 , John C Criscione 1, 2, 3
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Purpose
For pediatric patients, extracorporeal membrane oxygenation (ECMO) remains the predominant mechanical circulatory support (MCS) modality for heart failure (HF) although survival to discharge rates remain between 50 and 60% for these patients. The device-blood interface and disruption of physiologic hemodynamics are significant contributors to poor outcomes.
Methods
In this study, we evaluate the preclinical feasibility of a minimally invasive, non-blood-contacting pediatric DCC prototype for temporary MCS. Proof-of-concept is demonstrated in vivo in an animal model of HF. Hemodynamic pressures and flows were examined.
Results
Minimally invasive deployment on the beating heart was successful without cardiopulmonary bypass or anticoagulation. During HF, device operation resulted in an immediate 43% increase in cardiac output while maintaining pulsatile hemodynamics. Compared to the pre-HF baseline, the device recovered up to 95% of ventricular stroke volume. At the conclusion of the study, the device was easily removed from the beating heart.
Conclusions
This preclinical proof-of-concept study demonstrated the feasibility of a DCC device on a pediatric scale that is minimally invasive and non-blood contacting, with promising hemodynamic support and durability for the initial intended duration of use. The ability of DCC to maintain pulsatile MCS without blood contact represents an opportunity to mitigate the mortality and morbidity observed in non-pulsatile, blood-contacting MCS.
中文翻译:
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用于儿科心脏支持的微创直接心脏加压装置的临床前概念验证
目的
对于儿科患者,体外膜肺氧合 (ECMO) 仍然是心力衰竭 (HF) 的主要机械循环支持 (MCS) 方式,尽管这些患者的出院存活率保持在 50% 至 60% 之间。器械-血液界面和生理血流动力学的破坏是导致不良结果的重要因素。
方法
在这项研究中,我们评估了用于临时 MCS 的微创、非血液接触儿科 DCC 原型的临床前可行性。概念验证在 HF 动物模型中进行了体内验证。检查了血流动力学压力和流量。
结果
在跳动的心脏上进行微创部署是成功的,无需体外循环或抗凝治疗。在 HF 期间,设备操作导致心输出量立即增加 43%,同时保持搏动血流动力学。与 HF 前基线相比,该装置恢复了高达 95% 的心室每搏量。在研究结束时,该装置很容易从跳动的心脏中取出。
结论
这项临床前概念验证研究表明了在儿科规模上使用微创和非血液接触的 DCC 设备的可行性,在初始预期使用时间内具有有希望的血流动力学支持和耐用性。DCC 在没有血液接触的情况下维持搏动性 MCS 的能力代表了降低在非搏动性血液接触 MCS 中观察到的死亡率和发病率的机会。