Efficacy of Intraoperative Hemodynamic Optimization Using FloTrac/EV1000 Platform for Early Goal-directed Therapy to Improve Postoperative Outcomes in Patients Undergoing Coronary Artery Bypass Graft with Cardiopulmonary Bypass: A Randomized Controlled Trial

Background: Early goal-directed therapy (EGDT) using the FloTrac system reportedly decreased mortality, morbidity, and length of stay (LOS) in intensive care unit (ICU) and hospital among high-risk patients undergoing non-cardiac surgery. The objective of this study was to evaluate the efficacy of the FloTrac/EV1000 platform for improving postoperative outcomes in cardiac surgery. Methods: Eighty-six adults undergoing coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) were randomized to the EV1000 or Control group. The Control group was managed with standard care to achieve the following goals: mean arterial pressure 65-90 mmHg; central venous pressure 8-12 mmHg; urine output ≥ 0.5 mL/kg/h; oxygen saturation > 95%; and hematocrit 26-30%. The EV1000 group was managed to reach similar goals using information from the FloTrac/EV1000 monitor. The targets were: stroke volume variation (SVV) < 13%; cardiac index (CI) 2.2-4.0 L/min/m2; stroke volume index (SVI) 33‑65 mL/beat/m2; and systemic vascular resistance index (SVRI) 1600‑2500 dynes/s/cm5/m2. Results: The LOS in ICU of the EV1000 group was significantly shorter (mean difference -29.5 h; 95%CI -17.2 to -41.8, p < 0.001). The mechanical ventilation time was also shorter in the EV1000 group (mean difference -11.3 h; 95%CI -2.7 to -19.9, p = 0.011). The hospital LOS was shorter in the EV1000 group (mean difference -1.1 d; 95%CI -0.1 to -2.1, p =0.038). The EV1000 group received a higher number of inotropic or vasoactive drugs than the Control group in pre-bypass period, but less in post-bypass, postoperative period before transfer to the ICU, and in the ICU. The EV1000 group had less atrial fibrillation with rapid ventricular response, acute respiratory distress syndrome, and acute renal injury.Conclusions: Compared with standard care, intraoperative hemodynamic optimization using the FloTrac/EV1000 platform for the EGDT protocol in patients undergoing CABG with CPB resulted in shorter ventilator time, shorter ICU and hospital LOS, and fewer postoperative complications. The EV1000 group required more fluid and inotropic or vasoactive drugs in the pre-bypass period to optimize SVV, CI, and SVRI and to maintain the target MAP resulting in better myocardium oxygen supply reflected in fewer drugs required during post-bypass, before transfer to, and in, the ICU.Trial registrationThe study was registered with ClinicalTrials.gov (NCT04292951) on 03/03/2020.