Outcomes in Smaller Body Size Adults after HeartMate 3 Left Ventricular Assist Device Implantation.

Overview

abstract

BACKGROUND: Outcomes in patients with smaller body size following HeartMate 3 Left Ventricular Assist Device (HM3) implantation are not well characterized. We sought to evaluate outcomes in smaller vs. larger BSA patients in the MOMENTUM 3 pivotal trial and its Continued Access Protocol cohort. METHODS: The analysis cohort included 1015 HM3 patients divided into 2 groups: BSA≤1.70 m² (small patients, n=82) and BSA>1.70 m² (large patients, n=933). The composite primary endpoint was survival at 2-years free of disabling stroke or reoperation to replace or remove a malfunctioning device. Adverse events were compared between groups. RESULTS: Smaller patients were more frequently women (56.1% vs. 17.7%, P<.001), 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/m², P<.001), and lower median serum creatinine (1.1 vs. 1.3 mg/dl, P<.001). The proportion of patients achieving the composite endpoint at 2-years was 77% in both groups (adjusted HR = 1.14 [95% confidence interval: 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. CONCLUSIONS: Outcomes following 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 durable MCS candidates.