6/28/23, 11:01 PM HEARTMATE II Pathway Feedback Search Clinical Topics Home Studies HEARTMATE II HEARTMATE II Disease Heart failure 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 N = 200 84.2% male 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 89.0 % 89 66.8 % 54 https://web.pathway.md/studies/recx1Bq38rDHR1Tlv 1/2 6/28/23, 11:01 PM HEARTMATE II Pathway 44.5 % Significant decrease 22.3 % NNT = 3 0.0 % Continuous flow LVAD Pulsatile-flow LVAD 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. Open reference URL https://web.pathway.md/studies/recx1Bq38rDHR1Tlv 2/2