EASE TRIAL

Problem Endocarditis (severe)
Format -
Treatment Early surgery (<48hr)
Control Conventional therapy
Population 76 patients in single centre
Inclusion criteria 18 years of age or older
With:
-Left-sided IE
-Native-valve
-High risk of embolism
-Severe MV or AV disease
-Diagnosed
-Vegetations > 10mm

For all patients with suspected infective endocarditis, blood cultures were obtained and transthoracic echocardiography was performed within 24 hours after hospitalization.

Exclusion criteria Moderate-to-severe congestive heart failure
Infective endocarditis complicated by:
Heart block
-Annular or aortic abscess
-Destructive penetrating lesions requiring urgent surgery
-Fungal endocarditis
Infection of Prosthetic valve
Age of more than 80 years
Coexisting major embolic stroke with a risk of hemorrhagic transformation at the time of diagnosis
Serious coexisting conditions (e.g. cancer)
Follow-up Median 749 days
Primary endpoint Composite of in-hospital death or clinical embolic events that occurred within 6 weeks after randomization.

An embolic event was defined as a systemic embolism fulfilling both prespecified criteria: the acute onset of clinical symptoms or signs of embolism and the occurrence of new lesions, as confirmed by follow-up imaging studies. Cutaneous manifestations or metastatic abscesses were not considered to be embolic events. A specific diagnosis of cerebral embolism was confirmed by an experienced neurologist on the basis of additional magnetic resonance imaging of the brain
Secondary endpoint(s) Prespecified secondary end points, at 6 months of follow-up, included
-Death from any cause
-Embolic events
-Recurrence of infective endocarditis
-Repeat hospitalization due to the development of congestive heart failure.
Details Patients assigned to the conventional-treatment group were treated according to the AHA guidelines - i.e. surgery was performed only if complications requiring urgent surgery developed during medical treatment or if symptoms persisted after the completion of antibiotic therapy.

Of the 22 patients with involvement of the mitral valve, 8 patients underwent mitral-valve repair and 14 underwent mitral-valve replacement with a mechanical valve. Of the 15 patients with involvement of the aortic valve or both the mitral and aortic valves, 14 underwent mechanical-valve replacement and 1 underwent valve replacement with a biologic prosthesis. Concomitant coronary-artery bypass grafting at the time of valve surgery was performed in 2 patients (5%).

Of the 39 patients assigned to the conventional-treatment group, 30 (77%) underwent surgery during the initial hospitalization (27 patients) or during follow-up (3).
Brief summary:
PAPER: Early surgery versus conventional treatment for infective endocarditis.
Date 28 Jun 2012
Journal N Engl J Med. 2012 Jun 28;366(26):2466-73.
Information Early (<48hr) surgery vs. conventional therapy in left-sided IE with large vegetations and severe valve disease
-Reduced primary end point of death & embolic events
--Due to reduced embolic events
--No difference in mortality
-No increase in operative mortality or recurrence of IE


N.B. 30 of 39 patients assigned to conventional Rx eventually needed surgery