Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics, Comprehensive Center for Pediatrics, Medical University of Vienna, Vienna, Austria.
J Med Syst. 2023 May 3;47(1):58. doi: 10.1007/s10916-023-01950-3.
Despite recent design improvements, human factors issues continue to challenge left ventricular assist device (LVAD) therapy. The aim of this study was to evaluate user experience of former non-HeartMate 3 (HM3) LVAD patients post heart transplantation (HTX) and laypersons (LP) with HM3 LVAD peripherals in simulated everyday and emergency scenarios.
This single center cohort study included untrained HTX and LP. Seven scenarios, including battery exchanges (without alarm, advisory alarm, dim light, consolidated bag), change of power supply, driveline dis-/reconnection and controller exchange were simulated. Subjects' gaze behavior was recorded using eye tracking technology. Success rate, pump-off-time, duration to success (DTS), percental fixation duration per areas of interest and post-scenario-survey results were defined as outcome measures.
Thirty subjects completed 210 scenarios, initially solving 82.4% (HTX vs. LP, p = 1.00). Changing power supply revealed highest complexity (DTS = 251 ± 93s, p = 0.76): 26.7% succeeded at first attempt (p = 0.68), 56.7% at second attempt, with significantly more LP failing (p = 0.04), resulting in 10 hazards from driveline disconnections (pump-off-time 2-118s, p = 0.25). Comparison on initial success showed differences in fixation durations for seven areas of interest (p < 0.037). Decreasing DTS during battery exchanges (p < 0.001) indicate high learnability. Exchanging batteries within the bag took longer (median DTS = 75.0 (IQR = 45.0)s, p = 0.09), especially in elderly subjects (r = 0.61, p < 0.001). Subjects with less initial success were more afraid of making mistakes (p = 0.048).
This eye tracking based human factors study provided insights into user experiences in handling HM3 peripherals. It highlights unintuitive and hazardous characteristics, providing guidance for future user-centered design of LVAD wearables.
尽管最近的设计有所改进，但人为因素问题仍然给左心室辅助装置（LVAD）治疗带来挑战。本研究旨在评估接受心脏移植（HTX）后的前非 HeartMate 3（HM3）LVAD 患者和 HM3 LVAD 外周设备的非专业人员在模拟日常和紧急情况下的用户体验。
这是一项单中心队列研究，包括未经训练的 HTX 和 LP。模拟了七种情况，包括电池更换（无警报、警告警报、光线昏暗、合并袋）、更换电源、驱动线断开/重新连接和控制器更换。使用眼动追踪技术记录受试者的注视行为。成功率、泵停时间、成功时间（DTS）、每个关注区域的固定时间百分比和场景后调查结果被定义为结果测量。
30 名受试者完成了 210 个场景，最初成功率为 82.4%（HTX 与 LP，p=1.00）。更换电源的复杂性最高（DTS=251±93s，p=0.76）：首次尝试成功率为 26.7%（p=0.68），第二次尝试成功率为 56.7%，LP 失败率明显更高（p=0.04），导致 10 次因驱动线断开而出现危险（泵停时间为 2-118s，p=0.25）。在初始成功率方面的比较显示了七个关注区域的注视时间差异（p<0.037）。电池更换过程中 DTS 的降低（p<0.001）表明了较高的可学习性。在袋子内更换电池需要更长的时间（中位数 DTS=75.0（IQR=45.0）s，p=0.09），尤其是在老年受试者中（r=0.61，p<0.001）。初始成功率较低的受试者更容易害怕犯错（p=0.048）。
这项基于眼动追踪的人为因素研究提供了对 HM3 外周设备使用体验的深入了解。它突出了非直观和危险的特点，为未来以 LVAD 可穿戴设备为中心的用户设计提供了指导。
