Early surgery for native valve infective endocarditis

Background The timing and indications for surgical intervention to prevent systemic embolism in infective endocarditis (IE) remain controversial. This trial compares clinical outcomes of early surgery and conventional treatment in patients with IE. Methods Objective: To determine the effect of early surgery (<48 hours) to decrease the rate of death or embolic events as compared with conventional treatment for IE. Design: Prospective randomized trial. Setting: Two academic medical centers in Korea. Subjects: Adult patients with left-sided, native-valve IE and a high risk of embolism. Intervention: Valve repair or replacement with removal of vegetation within 48 hours of random assignment versus no early surgery. Outcomes: Composite primary endpoint of in-hospital death and embolic events occurring within 6 weeks after random assignment. Secondary endpoints, at 6 months, included death from any cause, embolic events, recurrence of IE, and repeat hospitalization due to the development of congestive heart failure. Results Thirty-seven patients were assigned to the early-surgery group (<48 hours), whereas 39 were assigned to conventional therapy. Of the 39 randomly assigned to conventional therapy, 27 patients (77%) underwent surgery during the initial hospitalization and three during follow-up. One patient (3%) in the early-surgery group and nine (23%) in the conventional-treatment group reached the primary endpoint (hazard ratio (HR) 0.10, 95% confidence interval (CI) 0.01 to 0.82; P = 0.03). Th ere was no significant difference in all-cause mortality at 6 months in the early-surgery and conventional-treatment groups (3% and 5%, respectively; HR 0.51, 95% CI 0.05 to 5.66; P = 0.59). The rates of the composite endpoint of death from any cause, embolic events, or recurrence of IE at 6 months were 3% in the early-surgery group and 28% in the conventional-treatment group (HR 0.08, 95% CI 0.01 to 0.65; P = 0.02). Conclusions Early surgery in patients with IE and large vegetations significantly reduced the composite endpoint of death from any cause and embolic events by effectively decreasing the risk of systemic embolism.