Background:Heart failure disproportionately affects Black patients. Whether differences among race influence outcomes in advanced heart failure with use of a fully magnetically levitated continuous-flow left ventricular assist device remains uncertain.Methods:We included 515 IDE (Investigational Device Exemption) clinical trial patients and 500 Continued Access Protocol patients implanted with the HeartMate 3 left ventricular assist device in the MOMENTUM 3 study (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3). Outcomes were compared between Black and White left ventricular assist device recipients for the primary end point of survival free of disabling stroke or reoperation to replace or remove a malfunctioning device at 2 years, overall survival, adverse events, 6-minute walk distance, and quality of life scores.Results:Of 1015 HeartMate 3 patients, 675 were self-identified as White and 285 as Black individuals. The Black patient cohort was younger, more obese and with a history of hypertension, and more nonischemic cause of heart failure, relative to the White patient group. Black and White patients did not experience a difference in the primary end point (81.1% versus 77.9%; hazard ratio, 1.08 [95% CI, 0.76–1.54], P=0.6568). Black patients were at higher risk of adverse events (calculated as events per 100 patient-years), including bleeding (75.4 versus 63.5; P<0.0001), stroke (9.5 versus 7.2; P=0.0183), and hypertension (10.1 versus 3.2; P<0.0001). The 6-minute walk distance was not different at baseline and 6 months between the groups, however, the absolute change from baseline was greater for White patients (median: +183.0 [interquartile range, 42.0–335.3] versus +163.8 [interquartile range, 42.3–315.0] meters, P=0.01). The absolute quality of life measurement (EuroQoL group, 5-dimension, 5-level instrument visual analog scale) at baseline and 6 months was better in the Black patient group, but relative improvement from baseline to 6 months was greater in White patients (median: +20.0 [interquartile range, 5.0–40.0] versus +25.0 [interquartile range, 10.0–45.0]; P=0.0298).Conclusions:Although the survival free of disabling stroke or reoperation to replace/remove a malfunctioning device at 2 years with the HM 3 left ventricular assist device did not differ by race, Black HeartMate 3 patients experienced a higher morbidity burden and smaller gains in functional capacity and quality of life when compared with White patients. These findings require efforts designed to better understand and overcome these gaps through systematic identification and tackling of putative factors.Registration:URL: https://www.clinicaltrials.gov; Unique identifiers: NCT02224755 and NCT02892955.

中文翻译：

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种族对全磁悬浮左心室辅助装置植入后临床结果的影响：来自 MOMENTUM 3 试验的分析

背景：心力衰竭不成比例地影响黑人患者。种族之间的差异是否会影响使用全磁悬浮连续流动左心室辅助装置治疗晚期心力衰竭的结果仍然不确定。方法：我们包括 515 名 IDE（调查装置豁免）临床试验患者和 500 名植入了在 MOMENTUM 3 研究（使用 HeartMate 3 进行机械循环支持治疗的 MagLev 技术多中心研究）中的 HeartMate 3 左心室辅助装置。比较黑人和白人左心室辅助装置接受者的主要终点是无致残性卒中或再次手术以更换或移除故障装置的 2 年、总生存率、不良事件、6 分钟步行距离和生活质量评分。结果：在 1015 名 HeartMate 3 患者中，675 名自我认定为白人，285 名自我认定为黑人。与白人患者组相比，黑人患者组更年轻、更肥胖、有高血压病史和更多的非缺血性心力衰竭原因。黑人和白人患者的主要终点没有差异（81.1% 对 77.9%；风险比，1.08 [95% CI，0.76–1.54]，1% 对 77.9%；风险比，1.08 [95% CI，0.76–1.54]，1% 对 77.9%；风险比，1.08 [95% CI，0.76–1.54]，P = 0.6568）。黑人患者发生不良事件的风险较高（按每 100 患者年发生的事件计算），包括出血（75.4 对 63.5；P <0.0001）、中风（9.5 对 7.2；P = 0.0183）和高血压（10.1 对 3.2；P <0.0001）。6 分钟步行距离在基线和 6 个月之间没有差异，但是，白人患者相对于基线的绝对变化更大（中位数：+183.0 [四分位距，42.0-335.3] vs +163.8 [四分位距， 42.3–315.0] 米，P=0.01）。在基线和 6 个月时，黑人患者组的绝对生活质量测量（EuroQoL 组，5 维，5 级仪器视觉模拟量表）更好，但白人患者从基线到 6 个月的相对改善更大（中位数） ：+20.0 [四分位距，5.0–40.0] 与 +25.0 [四分位距，10.0–45.0]；P=0.0298). 结论：尽管使用 HM 3 左心室辅助装置在 2 年内无致残性卒中或再次手术以更换/移除故障装置的存活率没有因种族而异，但 Black HeartMate 3 患者经历了更高的发病率负担和更小与白人患者相比，功能能力和生活质量有所提高。这些发现需要努力通过系统地识别和处理假定因素来更好地理解和克服这些差距。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT02224755 和 NCT02892955。