Department of Cardiovascular Medicine, University of Louisville, Louisville, Kentucky.
Departments of Cardiovascular Surgery and Cardiovascular Medicine, Northwestern University, Chicago, Illinois.
J Heart Lung Transplant. 2015 Jun;34(6):815-24. doi: 10.1016/j.healun.2014.12.011. Epub 2014 Dec 29.
The Ventricular Assist Device for the Treatment of Advanced Heart Failure (ADVANCE) Bridge to Transplant (BTT) trial was a multicenter, prospective trial of the HeartWare Ventricular Assist Device (HVAD). The performance of the HVAD in various demographic sub-groups was evaluated.
Baseline characteristics, adverse events, and survival were compared for men vs. women and whites vs. non-whites in the combined ADVANCE BTT and continued access protocol trial. Of 332 patients enrolled in these trials, 236 were men and 96 women, with 228 whites and 104 non-whites.
At baseline, women had a smaller body surface area (1.8 ± 0.2 vs. 2.1 ± 0.3 m2, p < 0.0001), less hypertension (50.0% vs. 61.9%, p = 0.05), and less ischemic cardiomyopathy (15.6% vs. 45.3%, p < 0.0001). Differences in Kaplan-Meier survival were not significant at 180 days (men, 91.8%; women, 91.7%) and 1 year (men, 85.3%; women, 85.1%) despite adjustment for baseline differences. Men had a lower incidence of early right heart failure and renal and respiratory dysfunction, and a shorter length of stay. In the analysis by race, non-whites were younger than whites and had less ischemic heart failure, more hypertension, and lower creatinine levels at baseline. Non-whites had lower rates of arrhythmia, bleeding requiring rehospitalization, and device malfunctions than whites. Survival was high in non-whites and whites, at 94.1% vs. 90.4% at 180 days and 89.2% vs. 82.8% at 1 year, respectively, despite adjustment for baseline differences.
Although heart failure etiology differed between men and women and between whites and non-whites, sex and race were not factors that affected survival in patients receiving the HVAD as BTT, which was high in all sub-groups.
治疗晚期心力衰竭的心室辅助装置（ADVANCE）桥接移植（BTT）试验是一项多中心、前瞻性的 HeartWare 心室辅助装置（HVAD）试验。评估了 HVAD 在各种人口统计学亚组中的表现。
在 ADVANCE BTT 和持续准入方案试验中，比较了男性与女性和白种人与非白种人在合并组中的基线特征、不良事件和生存率。在这两项试验中，共纳入 332 例患者，其中 236 例为男性，96 例为女性，228 例为白种人，104 例为非白种人。
基线时，女性的体表面积较小（1.8±0.2m2 比 2.1±0.3m2，p＜0.0001），高血压的发生率较低（50.0%比 61.9%，p=0.05），缺血性心肌病的发生率也较低（15.6%比 45.3%，p＜0.0001）。尽管调整了基线差异，但 180 天（男性 91.8%，女性 91.7%）和 1 年（男性 85.3%，女性 85.1%）的 Kaplan-Meier 生存率差异无统计学意义。男性早期右心衰竭、肾功能和呼吸功能障碍的发生率较低，住院时间较短。在种族分析中，非白种人比白种人年轻，基线时缺血性心力衰竭较少，高血压较多，肌酐水平较低。非白种人心律失常、需要再次住院的出血和器械故障的发生率低于白种人。非白种人和白种人的生存率均较高，分别为 180 天时 94.1%比 90.4%，1 年时 89.2%比 82.8%，尽管调整了基线差异。
尽管男性与女性以及白种人与非白种人之间心力衰竭的病因不同，但在接受 HVAD 作为 BTT 的患者中，性别和种族并不是影响生存率的因素，所有亚组的生存率均较高。
