Mitigating Post-operative Right Ventricular Dysfunction After Left Ventricular Assist Device: The RV Protection Study.

Background: Despite improvements in hemocompatibility-related adverse events (HRAEs) with the HeartMate 3 left ventricular assist device (LVAD), hemodynamic-related events (HDREs), such as right ventricular failure (RVF) and aortic insufficiency, still result in considerable morbidity and mortality. We investigated a comprehensive, upfront RV protection strategy combining hemodynamic, ventilatory and pharmaceutical optimization to mitigate the risk of RVF.

Methods/results: Participants were prospectively randomized in a 1:1 fashion to either the RV-protection strategy or usual care for post-operative LVAD management. The RV-protection strategy targeted RV afterload (inhaled NO ≥ 48 hrs, PCWP < 18), RV preload (CVP 8-14), RV perfusion (MAP 70-90, Hgb > 8), RV contractility (IV inotropes), rate/rhythm control (HR >100, normal sinus), ventilatory management (SpO2 >95, PaCO² < 50, plateau pressure < 30, PEEP ≤ 5), and RV geometry (echo-guided septal position). The primary outcome was survival free from any HDREs or HRAEs at 24 weeks. Secondary outcomes included severe RVF, according to INTERMACS and ARC definitions. Twenty participants were randomized: 10 to the RV-protection strategy and 10 to usual care. The median age was 60 years (IQR 54-69), 50% were Black, and 50% had ischemia. At 24 weeks, the RV-protection strategy showed significantly greater survival rates free from HDREs or HRAEs compared to usual care (80% vs 40%; P = 0.04). Event-free survival for HRAEs resulted in similar findings. No HDREs occurred with the RV protection strategy vs 3 (30%) with usual care (P = 0.067). Similarly, severe RVF according to INTERMACS or ARC did not occur in the RV protection strategy vs 3 (30%) in the usual-care cohort (P = 0.20).

Conclusions: Participants receiving a novel, comprehensive, upfront RV protection strategy post-LVAD implantation had significantly greater survival rates free from HDREs or HRAEs at 24 weeks.