Early Surgery Versus Conventional Treatment in Infective Endocarditis (EASE)

Asan Medical Center

Status and phase

Completed

Phase 4

Conditions

Endocarditis

Treatments

Procedure: Valve surgery with removal of vegetations

Study type

Interventional

Funder types

Other

Identifiers

NCT00750373

2006-0257

Details and patient eligibility

About

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.

Full description

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.

Enrollment

76 patients

Sex

All

Ages

15 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed as infective endocarditis based on modified Duke criteria fulfilling both conditions:
- severe mitral or aortic regurgitation
- vegetation length > 10 mm on mitral or aortic valve

Exclusion criteria

Patients with urgent and emergent indication of surgery based on current guidelines; aortic abscess, moderate to severe heart failure due to valvular regurgitation, periannular complications, fungal endocarditis
Prosthetic valve endocarditis
Patient without vegetations on echocardiography
Patients with ischemic or hemorrhagic stroke within 2 weeks before the admission
Patients referred from other hospitals more than 7 days after the appropriate antibiotic treatment of infective endocarditis
Patients who were not candidates for surgery based on age > 80 years and coexisting malignancies
Patients who did not consent to participate