Abstract

Introduction: Although event-free survival in patients with infective endocarditis (IE) and large vegetations has been shown to be significantly higher at 6 months in those receiving early surgery vs. conventional treatment, long-term data are lacking. Hypothesis: We tried to compare the long-term outcomes of early surgery with those of a conventional treatment strategy. Methods: The Early Surgery versus Conventional Treatment in Infective Endocarditis (EASE) trial randomly enrolled 76 patients (51 men, 47±16 years) from 2006 through 2011 with left-sided native valve IE accompanied by severe valve disease and a diameter of vegetation > 10 mm. The end points were all-cause death and the composite of death, embolic events and recurrence of IE that occurred within 4 years after enrollment. Results: All patients in the early surgery group (n=37) underwent valve surgery within 48 hours, and 30 (77%) patients in the conventional treatment group (n=39) underwent surgery during the initial hospitalization. During median follow-up of 5.8 years (IQR, 4.8 to 7.1), 4 deaths occurred in the early surgery group and 5 deaths, 10 embolic events and 1 recurrence of IE in the conventional treatment group. There were no significant differences between the early surgery and the conventional treatment group in all-cause mortality (8.1% and 7.7% at 4 years, respectively; HR 1.04; 95% CI, 0.21 to 5.15; P=0.96). At 4 years, the rate of the composite of death from any cause, embolic events or recurrence of IE was 3.7% in the early surgery group as compared with 30.8% in the conventional treatment group (HR, 0.22; 95% CI, 0.06-0.79; P=0.02). The estimated actuarial rate of end points was significantly lower in the early surgery group than in the conventional treatment group (Figure). Conclusions: In the EASE trial, the beneficial effect of early surgery in IE patients with large vegetations persisted during long-term follow-up, and late clinical outcome after surgery was excellent in survivors of IE.

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