BACKGROUND: The immediate postoperative period after heart surgery poses a substantial risk of life-threatening complications, notably acute pulmonary and cardiac failure. Use of noninvasive ventilation (NIV) may reduce the incidence of pulmonary or heart failure, or both. 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 of postoperative complications? STUDY DESIGN AND METHODS: We designed a prospective, randomized, monocentric trial comparing preoperative and postoperative NIV in cardiac surgery with standard care. Adult patients classified as being at risk of postoperative cardiac or pulmonary failure were allocated to receive NIV for 5 days before and 5 days after surgery in addition to usual care vs usual care alone. The primary outcome was the composite of predefined and adjudicated cardiorespiratory failure at 1 month after cardiac surgery. RESULTS: Two hundred sixteen patients were included. During the 1-month follow-up period after surgery, the composite outcome occurred in 59 of 107 patients (55.1%) in the NIV group and in 87 of 109 patients (79.8%) in the no NIV group (relative risk, 0.69
95% CI, 0.57-0.84
P <
.001). The benefit persisted at 3 months. No difference between the two groups was found in terms of intubation need and length of hospital stay in cardiac and pulmonary surgery ICUs and in cardiac and pulmonary surgery units. INTERPRETATION: The use of NIV before and after cardiac surgery reduces the rate of cardiopulmonary failure after high-risk cardiac surgery. CLINICAL TRIAL REGISTRY: ClinicalTrials.gov
No.: NCT02302300
URL: www. CLINICALTRIALS: gov.