Early Surgery Versus Conventional Treatment in Infective Endocarditis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Comparison of Early Surgery Versus Conventional Treatment Strategy in Patients With High Embolic Risk of Infective Endocarditis

Conditions
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Endocarditis

Intervention / Treatment
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* Procedure: Valve surgery with removal of vegetations


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional<br>Conventional Treatment based on current guidelines | |
| Active Comparator: Surgery<br>Early surgery within 48 hours of randomization | Procedure: Valve surgery with removal of vegetations<br>* Early valve repair or replacement with removal of vegetations within 48 hours of randomization<br>* Other names: early surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With In-hospital Death or Clinical Embolic Events | The composite of in-hospital death and clinical embolic events confirmed by imaging studies: the acute onset of clinical symptoms or signs of embolism and the occurrences of new lesions, as confirmed by follow-up imaging studies. | within 6 weeks from the randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Death |  | up to 6 month after enrollment | 
| Recurrences of Infective Endocarditis |  | up to 6 months after enrollment | 
| All Embolic Events Including Symptomatic and Asymptomatic Embolization Documented by Imaging Studies |  | up to 6 months after enrollment | 
| Readmission Due to Development of Congestive Heart Failure |  | up to 6 months after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endocarditis