HEARTMATE II
Trial question
What is the role of continuous-flow LV assist device in patients with advanced HF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
15.8% female
84.2% male
N = 200
200 patients (31 female, 169 male).
Inclusion criteria: patients with advanced HF who were ineligible for transplantation.
Key exclusion criteria: irreversible, severe renal, pulmonary, or hepatic dysfunction or active infection.
Interventions
N=134 continuous flow LVAD (continuous-flow HeartMate II).
N=66 pulsatile-flow LVAD (pulsatile-flow HeartMate XVE).
Primary outcome
Death, disabling stroke, or reoperation to repair or replace device at 2 years
54%
89%
89.0 %
66.8 %
44.5 %
22.3 %
0.0 %
Continuous flow
LVAD
Pulsatile-flow
LVAD
Significant
decrease ▼
NNT = 2
Significant decrease in death, disabling stroke, or reoperation to repair or replace the device at 2 years (54% vs. 89%; HR 0.38, 95% CI 0.27 to 0.54).
Secondary outcomes
Significant decrease in the rate of death 2 years (42% vs. 76%; RR 0.54, 95% CI 0.34 to 0.86).
Safety outcomes
No significant differences in stroke (17% vs. 14%, p=0.21).
Significant differences in sepsis (36% vs. 44%, p < 0.001), pump replacement (9% vs. 34%, p < 0.001), respiratory failure (38% vs. 41%, p < 0.001), renal failure (16% vs. 24%, p < 0.001), cardiac arrhythmia (56% vs. 59%, p = 0.006).
Conclusion
In patients with advanced HF who were ineligible for transplantation, continuous flow LVAD was superior to pulsatile-flow LVAD with respect to death, disabling stroke, or reoperation to repair or replace the device at 2 years.
Reference
Slaughter MS, Rogers JG, Milano CA et al. Advanced heart failure treated with continuous-flow left ventricular assist device. N Engl J Med. 2009 Dec 3;361(23):2241-51.
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