Endocarditis Clinical Trial
Official title:
A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis
There have been no prospective clinical studies in infective endocarditis comparing early surgery with the conventional treatment strategy based on current guidelines. The purpose of this prospective randomized trial is to compare clinical outcomes of early surgery versus conventional treatment strategy in patients with high embolic risk of infective endocarditis.
Infective Endocarditis is still associated with high mortality (16-25%) and high incidence
of embolic events (10-49%), and the optimal therapeutic strategy remains unclear. The
benefit of surgery was particularly high in patients with abscess formation, periannular
complications, and moderate to severe heart failure related to acute mitral or aortic
regurgitation. Retrospective studies reported that valve surgery was associated with
improved survival, but the benefit of early surgery has not been adequately studied due to
inherent treatment biases and significant differences in baseline characteristics. Embolic
indications for surgery are more controversial, and surgery is usually performed in cases of
recurrent emboli and persist vegetations despite appropriate antibiotic treatment. The
combined risk of early surgery and valve prosthesis needs to be balanced against the
potential benefit of preventing embolism and improving survival. Risk-benefit balance
changes recently to favor early surgery in patients with high embolic risk of endocarditis
for the following reasons. Identification of patients with high risk of embolism becomes
possible with the use of transesophageal echocardiography. Patients with vegetation length >
10 mm on transesophageal echocardiography have a significantly higher risk of embolization.
With advances in surgical technique, urgent surgery is feasible with low operative
mortality, and the success rate of valve repair has been increased.
To the best of our knowledge, there have been no prospective outcome studies comparing early
surgery with the conventional treatment strategy based on current guidelines. The purpose of
this multi-center, prospective, randomized trial is to compare clinical outcomes of early
surgery versus conventional treatment strategy in patients with high embolic risks of
infective endocarditis.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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