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Published on: July 18, 2014
Outcomes in Smaller Body Size Adults After HeartMate 3 Left Ventricular Assist Device Implantation
Ezequiel J Molina1, Jennifer Cowger2, Sangjin Lee3
1Department of Cardiac Surgery, MedStar Heart & Vascular Institute, Georgetown University, Washington, DC.
Insights
Outcomes were similar for smaller and larger patients receiving the HeartMate 3 left ventricular assist device (HM3). Body size should not prevent eligible patients from receiving this mechanical circulatory support.
Area of Science:
- Cardiology
- Medical Devices
- Mechanical Circulatory Support
Background:
- Outcomes in patients with smaller body size after HeartMate 3 (HM3) left ventricular assist device implantation are not well characterized.
- The MOMENTUM 3 trial and its Continued Access Protocol provide data to evaluate this patient subgroup.
Purpose of the Study:
- To evaluate and compare outcomes between smaller (body surface area [BSA] ≤1.70 m²) and larger (BSA >1.70 m²) patients receiving HM3.
- To determine if smaller body size is a contraindication for HM3 implantation.
Main Methods:
- Analysis of 1015 HM3 patients from the MOMENTUM 3 trial and Continued Access Protocol, divided into small (n=82) and large (n=933) BSA groups.
- Comparison of the composite primary endpoint (survival at 2 years free of disabling stroke or reoperation) and adverse events between the two groups.
Main Results:
- Smaller patients were more often women and had lower rates of diabetes and hypertension.
- Two-year survival free of disabling stroke or reoperation was similar between small (77%) and large (77%) patients.
- Higher rates of sepsis and cardiac arrhythmias were observed in larger patients compared to smaller patients.
Conclusions:
- Outcomes after HM3 implantation are comparable between patients with smaller and larger body sizes.
- Smaller body size should not be a reason to deny HM3 implantation to suitable candidates requiring durable mechanical circulatory support.
Background:
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.
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 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.
Results:
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/m2; 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.
Conclusions:
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.
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