BACKGROUND: The immediate postoperative period following heart surgery poses a substantial risk of life-threatening complications notably acute pulmonary and cardiac failure. Non-invasive ventilation (NIV) use may reduce the incidence of pulmonary and/or heart failure. RESEARCH QUESTION: Is the use of NIV before and after cardiac surgery associated with a lower rate of acute pulmonary and heart failure in patients at risk for post-operative complications? STUDY DESIGN AND METHODS: We designed a prospective, randomized, monocentric trial comparing pre- and post-operative NIV in cardiac surgery to standard care. Adult patients classified at risk of post-operative cardiac or pulmonary failure were allocated to receive NIV for five days before and five days after surgery in addition to usual care versus usual care alone. The primary outcome was the composite of predefined and adjudicated cardio-respiratory failure at one month after cardiac surgery. RESULTS: Two hundred and sixteen patients were included. During the one-month follow-up period after surgery, the composite outcome occurred in 59/107 (55.1%) patients in the NIV group and in 87/109 (79.8%) patients in the No-NIV group (RR 0.69 95%CI [0.57-0.84]
p<
0.001). The benefit was persistent at three months. There was no difference between the two groups in terms of intubation need and length of hospital stay in cardiac and pulmonary surgery intensive care unit and in cardiac and pulmonary surgery unit. INTERPRETATION: The use of NIV before and after cardiac surgery reduces the rate of cardiopulmonary failure after high-risk cardiac surgery.