Impact of FloTrac/EV1000-guided intraoperative hemodynamic optimization on postoperative outcomes in cardiac valve surgery: a randomized controlled trial
摘要
Cardiac valve surgery is associated with significant postoperative morbidity and mortality. This study evaluated the impact of intraoperative hemodynamic optimization using FloTrac/EV1000 on postoperative outcomes in patients undergoing cardiac valve surgery. In this single-center, prospective, randomized controlled trial, 82 patients undergoing elective cardiac valve surgery were randomly allocated to either FloTrac/EV1000 management (EV1000 group, n = 42) or conventional management (Control group, n = 40). The primary outcome was ICU length of stay. Secondary outcomes included mechanical ventilation duration, hospital length of stay, vasoactive drug requirements, fluid balance, and postoperative complications. The EV1000 group had significantly shorter ICU (30.2%) and hospital (13.6%) stay (p = 0.007 and 0.047, respectively) compared to the Control group. The EV1000 group required more vasoactive drugs during pre-bypass (p = 0.018) but fewer before ICU transfer (p = 0.003) and during their ICU stay (p < 0.05). The incidence of postoperative ventricular fibrillation (0 vs. 15.0%, p = 0.011), bradycardia (11.9 vs. 35.0%, p = 0.016), atrial fibrillation with rapid ventricular response (14.3 vs. 25.0%, p = 0.032), acute respiratory distress syndrome (0 vs. 5.0%, p = 0.045), and acute kidney injury (0 vs. 5.0%, p = 0.045) was lower in the EV1000 group. Goal-directed hemodynamic management using FloTrac/EV1000 monitoring in cardiac valve surgery was associated with shorter ICU and hospital length of stay, reduced postoperative vasoactive drug requirements, and fewer postoperative complications compared with conventional management. Whether this benefit derives from the monitoring technology, the structured hemodynamic algorithm, or their combination warrants confirmation in future multicenter trials.
Trial registration: NCT04292951 (The full date of first registration on https://ClinicalTrials.gov: March 1, 2020).