Abstract 3663: Use of Inhaled Nitric Oxide After Left Ventricular Assist Device Placement: Results of a Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Trial
Background: Although used frequently for right ventricular dysfunction (RVD), the clinical benefit of inhaled nitric oxide (iNO) is still unclear. We therefore conducted a randomized, controlled trial to determine the effect of iNO on incidence of RVD in the setting of left ventricular assist device (LVAD) placement.
Methods: This prospective, randomized, double-blind, multicenter, placebo-controlled trial included 150 patients undergoing LVAD placement with a pulmonary vascular resistance ≥200 dyne/sec/cm−5. Patients received iNO 40 ppm or placebo (an equivalent concentration of nitrogen) until 48 hours after separation from cardiopulmonary bypass, extubation, or upon meeting study-defined RVD (Table 1⇓). Crossover to open-label iNO from placebo was allowed during the 48-hour treatment period if RVD criteria were met. Other secondary efficacy outcomes were measured during the study (Table 2⇓).
Results: A reduction in the incidence of RVD was seen in the iNO group compared with the placebo group (9.6% vs 15.6%; relative risk reduction, 39%); however, this difference did not achieve statistical significance (P=0.33). Time on mechanical ventilation was reduced in the iNO group (median days, 2.0 vs 3.0, P=0.077). There were no differences between groups regarding adverse events.
Conclusions: In this study iNO reduced the incidence of RVD, reduced time on mechanical ventilation, and was safe and well tolerated. Although not statistically significant due to low event rate, these results are clinically meaningful considering the cross-over design. The use of iNO after LVAD placement may improve outcomes and reduce time on mechanical ventilation.