Early right ventricular failure following HeartMate 3 left ventricular assist device implantation: Risk factors and outcomes.

BACKGROUND

Right ventricular failure (RVF) remains a major determinant of early morbidity and mortality after left ventricular assist device (LVAD) implantation. The long-term consequences of early RVF in contemporary HM3 recipients remain incompletely characterized.

METHODS

We analyzed all HM3 recipients enrolled in the MOMENTUM 3 trials, including the randomized investigational device exemption and the continued access protocol. Patients were stratified by presence or absence of early RVF, according to the 2020 MCS-ARC criteria. Severe RVF was defined as need for right ventricular assist device (RVAD). Primary outcomes were 2-year overall survival and survival free of disabling stroke or device exchange. Cox models were adjusted for age, sex, goal of therapy, and INTERMACS profile.

RESULTS

Among 2200 HM3 patients, 402 (18.3%) developed early RVF, including 141 (6.4%) who required RVAD support. At baseline, patients with early RVF were more likely to have significant tricuspid regurgitation, higher serum creatinine (p<0.001), and higher right atrial pressure to pulmonary capillary wedge pressure ratio. Early RVF was associated with lower 2-year survival (62.0% vs 84.6%; p<0.001) and lower survival free of disabling stroke or device exchange (56.8% vs 80.3%; p<0.001). After multivariable adjustment, early RVF remained a strong independent predictor of mortality (aHR 3.3, 95% CI 2.7-4.1) and the composite endpoint (aHR 2.95, 95% CI 2.4-3.6). Patients requiring RVAD had the worst outcomes, with 2-year survival of 44.7% (HR 5.3, 95% CI 4.1-6.8; p<0.001).

CONCLUSIONS

Early RVF is a powerful predictor of adverse outcomes in HM3 recipients. Development of strategies to prevent, identify, and aggressively manage RVF is essential to fully leverage improvements made in device technology.

TRIAL REGISTRATION: Momentum 3 portfolio, NCT02224755 (Pivotal) and NCT02892955 (CAP).