Technology landscape of pediatric mechanical circulatory support devices: A systematic review 2010-2021.

Technology landscape of pediatric mechanical circulatory support devices: A systematic review 2010-2021.
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DOI:
10.1111/aor.14242
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发表时间:
2022-08
期刊:
影响因子:
2.4
通讯作者:
--
中科院分区:
工程技术3区
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--
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机械循环支持(MCS)装置,例如心室辅助装置(VAD)和全人工心脏(TAH),已成为治疗成年患者终末期心力衰竭的重要治疗选择。对于儿科患者来说,此类治疗选择仍然受到限制。临床医生最初针对儿科患者调整或扩展了现有的成人设备;然而,这些成人设备的设计并不是为了支持该人群所需的解剖结构和不同的流量能力,并且通常以“非设计”方式操作,这存在溶血和血栓形成等并发症的风险。专为儿科人群设计、旨在解决这些缺点的设备现已出现并获得 FDA 批准。为了分析儿科 MCS 设备的竞争格局,我们进行了系统的文献综述。详细研究了大约 27 种设备:8 种已确定或先前批准的设计,19 种正在开发中(11 个 VAD、5 个 Fontan 辅助装置和 3 个 TAH)。尽管取得了重大进展,但仍然没有一种儿科泵技术能够满足支持儿科患者的独特且独特的设计限制和要求,包括患者体型的广泛性、随着生长而增加的心血管需求以及先天性心脏病的解剖和生理异质性。需要具有前瞻性的设计解决方案来克服这些挑战,并确保为儿科患者转化新的 MCS 治疗设备。
Mechanical circulatory support (MCS) devices, such as ventricular assist devices (VADs) and total artificial hearts (TAHs), have become a vital therapeutic option in the treatment of end-stage heart failure for adult patients. Such therapeutic options continue to be limited for pediatric patients. Clinicians initially adapted or scaled existing adult devices for pediatric patients; however, these adult devices are not designed to support the anatomical structure and varying flow capacities required for this population and are generally operated “off-design”, which risks complications such as hemolysis and thrombosis. Devices designed specifically for the pediatric population that seek to address these shortcomings are now emerging and gaining FDA approval. To analyze the competitive landscape of pediatric MCS devices, we conducted a systematic literature review. Approximately 27 devices were studied in detail: 8 were established or previously approved designs, and 19 were under development (11 VADs, 5 Fontan assist devices, and 3 TAHs). Despite significant progress, there is still no pediatric pump technology that satisfies the unique and distinct design constraints and requirements to support pediatric patients, including the wide range of patient sizes, increased cardiovascular demand with growth, and anatomic and physiologic heterogeneity of congenital heart disease. Forward-thinking design solutions are required to overcome these challenges and to ensure the translation of new therapeutic MCS devices for pediatric patients.
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