Schlöglhofer Thomas, Grausenburger Anna-Sophie, Widhalm Gregor, Haberl Lisa, Suda Wolfgang, Schwingenschlögl Harald, Riebandt Julia, Laufer Günther, Wiedemann Dominik, Moscato Francesco, Zimpfer Daniel, Schima Heinrich
Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria; Ludwig Boltzmann Institute for Cardiovascular Research, Vienna, Austria; Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.
Department of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
J Heart Lung Transplant. 2023 Apr;42(4):466-477. doi: 10.1016/j.healun.2022.12.015. Epub 2022 Dec 27.
Despite design improvements in left ventricular assist devices (LVADs) over the past decade, limitations of external, wearable VAD components affect patient quality of life and safety. The aim of this study was to describe both user experience and human factor issues of 2 contemporary LVADs.
This single-center, cross-sectional study included LVAD outpatients who were at least 3 months after implantation. Before developing the 16-item survey, a systematic literature review and 2-round Delphi method involving 9 VAD clinicians were used to select items in 6 domains: power supply, emergency situations, wearability, mobility, and freedom to travel, user modifications, lifestyle, and home adaptations.
Fifty-eight patients (61.6 ± 11.6 years, 13.8% female, HeartMate 3 (HM3)/HVAD: n = 39/19) completed the one-time survey after median of 853 days on device: 10.3% reported problems changing power supply, 12.7% unintentional driveline disconnection (HM3: 5.6% vs HVAD: 26.3%, p = 0.041). Against the recommendation 74.1% sleep with battery-support (HM3: 88.9% vs HVAD: 44.4%, p = 0.001). About 65.3% criticized the carry bag weight/size (HM3: 71.4% vs HVAD: 50.0%, p = 0.035), thus 24.1% wear an own carrying-system, 42.1% modified their wearables, 38.9% their clothing, and 65.3% their home to cope with life on LVAD support. Mobility is reduced due to limited wearability: 18.9% went abroad (only 3.7% by plane) and 40.0% use less public transport than before implantation (the older the less: r = -0.37, p = 0.013).
HVAD and HM3 wearables still show a variety of human factors issues and potential for improved user experience. User-centered design and incorporation of patient feedback may increase user satisfaction, and patient safety.
尽管在过去十年中左心室辅助装置（LVAD）的设计有所改进，但外部可穿戴VAD组件的局限性仍会影响患者的生活质量和安全性。本研究的目的是描述两种当代LVAD的用户体验和人为因素问题。
这项单中心横断面研究纳入了植入LVAD至少3个月后的门诊患者。在制定16项调查问卷之前，通过系统的文献综述和两轮德尔菲法（涉及9名VAD临床医生），从6个领域中选择调查项目：电源、紧急情况、可穿戴性、移动性、出行自由度、用户改装、生活方式和家庭适应性。
58名患者（61.6±11.6岁，13.8%为女性，HeartMate 3（HM3）/HVAD：n = 39/19）在使用装置中位数853天后完成了一次性调查：10.3%的患者报告在更换电源时出现问题，12.7%的患者出现无意的驱动线断开（HM3：5.6% vs HVAD：26.3%，p = 0.041）。74.1%的患者违反建议在电池支持下睡眠（HM3：88.9% vs HVAD：44.4%，p = 0.001）。约65.3%的患者批评携带包的重量/尺寸（HM3：71.4% vs HVAD：50.0%，p = 0.035），因此24.1%的患者使用自己的携带系统，42.1%的患者改装了可穿戴设备，38.9%的患者改装了衣服，65.3%的患者改装了家居以适应LVAD支持下的生活。由于可穿戴性有限，移动性降低：18.9%的患者出国（仅3.7%乘飞机），40.0%的患者使用公共交通工具的频率比植入前低（年龄越大，使用频率越低：r = -0.37，p = 0.013）。
HVAD和HM3可穿戴设备仍然存在各种人为因素问题，并且有改善用户体验的潜力。以用户为中心的设计和纳入患者反馈可能会提高用户满意度和患者安全性。
