Small continuous flow left ventricular assist devices (LVAD) are providing new options for women in advanced heart failure who due to body size limitations were historically excluded from use of large first generation pulsatile devices. We report the experience of women one year after implantation with the new, HeartMate II continuous flow LVAD for bridge to transplantation. Patients (n=279), 24% female (F), 76% male (M) in NYHA Class IV heart failure, LV ejection fraction 16±7% (F), 16±6% (M), mostly inotrope dependent and about half on intraaortic balloon pump support (50% F, 43% M), who had been enrolled in the HM II clinical trial for at least 1 year as a bridge to cardiac transplantation at 33 centers were analyzed. Outcomes and causes of death in the first year of support between F and M recipients were determined. The percentage of patients who had undergone transplantation, recovery of the heart with device removal, or continued on HM II support after one year were the same (80%) between M and F. However, the percentage of patients who had received a heart transplant was significantly less for F (38%) than M (53%) (p<0.05). Median duration of support for F was 226 days (range 8–1004) vs. 143 days (range 0–1057) for M. Mortality on device support was 20% for F and 18% M. There were no statistically significant differences in leading causes of death: sepsis (1.5% F vs 4.2% M), ischemic stroke (3.1% F vs 1.9% M), hemorrhagic stroke (3.1% F vs 1.4% M), and right heart failure (3.1% F vs 1.9% M). Of 82 patients continuing on support at 1 year, 26 (32%) were F with median BSA of 1.65 vs 2.14 m
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for M. Kaplan Meier survival at one year was similar for females (74%) and males (76%). The smaller, more durable HM II rotary LVAD may be especially advantageous to women with advanced HF as a bridge to cardiac transplantation, because of significantly smaller BSA and need for extended duration of mechanical support due to longer wait times for suitable organ donors.
Outcomes at one-year
A Novel Extracorporeal Continuous-Flow Ventricular Assist System for Patients With Advanced Heart Failure ― Initial Clinical Experience ―
