Department of Cardiac Surgery, MedStar Heart & Vascular Institute, Georgetown University, Washington, DC.
Division of Cardiovascular Medicine, Henry Ford Hospitals, Detroit, Michigan.
Ann Thorac Surg. 2022 Dec;114(6):2262-2269. doi: 10.1016/j.athoracsur.2022.03.071. Epub 2022 Apr 19.
Outcomes in patients with smaller body size after HeartMate 3 left ventricular assist device (HM3) implantation are not well characterized. We sought to evaluate outcomes in smaller vs larger body surface area (BSA) patients in the MOMENTUM 3 pivotal trial and its Continued Access Protocol cohort.
The analysis cohort included 1015 HM3 patients divided into 2 groups: BSA ≤1.70 m (small patients, n = 82) and BSA >1.70 m (large patients, n = 933). The composite primary end point was survival at 2 years free of disabling stroke or reoperation to replace or to remove a malfunctioning device. Adverse events were compared between groups.
Smaller patients were more frequently women (56.1% vs 17.7%; P < .001) and had lower prevalence of diabetes (28.1% vs 43.9%; P = .005) and hypertension (51.2% vs 71.9%; P < .001), larger median indexed LVEDD (normalized by BSA, 40 vs 33 mm/m; P < .001), and lower median serum creatinine concentration (1.1 vs 1.3 mg/dL; P < .001). The proportion of patients achieving the composite end point at 2 years was 77% in both groups (adjusted hazard ratio, 1.14; 95% CI, 0.68-1.91; P = .62). Two-year adverse event rates were also similar between groups except for sepsis (6.1% vs 14.9%; P = .029) and cardiac arrhythmias (24.4% vs 35.3%; P = .005), which were higher in the larger patients.
Outcomes after HM3 implantation were comparable between small and large patients. Smaller body size should not be used to deny HM3 implantation in patients who are otherwise suitable candidates for durable mechanical circulatory support.
在植入 HeartMate 3 左心室辅助装置（HM3）后，体型较小的患者的预后情况尚未得到充分描述。我们旨在评估 MOMENTUM 3 关键试验及其延续准入方案队列中体型较小与较大患者的预后。
分析队列纳入了 1015 例 HM3 患者，分为 2 组：体表面积（BSA）≤1.70 m（小患者组，n=82）和 BSA＞1.70 m（大患者组，n=933）。复合主要终点为无致残性卒中或因装置故障而再次更换或移除装置的 2 年生存率。比较了两组间的不良事件。
小患者组女性更为常见（56.1%比 17.7%；P＜0.001），糖尿病患病率更低（28.1%比 43.9%；P=0.005）和高血压患病率更低（51.2%比 71.9%；P＜0.001），左心室舒张末期内径指数（BSA 归一化，40 比 33 mm/m；P＜0.001）更大，且血清肌酐浓度中位数更低（1.1 比 1.3 mg/dL；P＜0.001）。两组患者在 2 年时达到复合终点的比例均为 77%（调整后危险比，1.14；95%CI，0.68-1.91；P=0.62）。两组间 2 年不良事件发生率也相似，除外感染性休克（6.1%比 14.9%；P=0.029）和心律失常（24.4%比 35.3%；P=0.005），大患者组发生率更高。
HM3 植入后小患者与大患者的预后情况相当。对于其他适合接受耐用性机械循环支持的患者，不应因体型较小而拒绝植入 HM3。
