Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis

Summary

Infective endocarditis (IE) is a deadly disease and the incidence is increasing. An important initial assessment of patients with IE includes whether surgical treatment is indicated; yet, appropriate data to guide this assessment do not exist. The ASTERIx study will assess whether a surgical approach in addition to medical care for treatment of IE is superior to medical care alone. In total, 496 patients will be included in the study over four years. The study is event-driven and will require at least 240 events. The study will assess the primary composite outcome of death, embolization, relapse of IE, new heart failure or reinfection. Study participants who survive to discharge will be followed by routine clinical check-ups at one- and four-weeks post-discharge and at three months. Additionally a 12-month study follow-up is planned. The investigators will also conduct a small substudy to assess the frequency of silent emboli.

Eligibility

Inclusion Criteria:

Definite left-sided infective endocarditis defined by the ESC (European Society of Cardiology) modified Duke Criteria

AND

Valve vegetation =\>10mm AND \<=30mm with 1 or no previous embolic event during current IE case

Exclusion Criteria:

* Unwilling to sign informed consent
* At least one clear class I recommendation for surgery because of heart failure or uncontrolled local infection (abscess, false aneurysm, fistula)
* Unavailable for follow-up (e.g. tourist)

OR

At least one of the following criteria (unsuitable for surgery)

* Intracranial hemorrhage \<1 month
* Life expectancy \<1 year
* Age ≥85 years
* BMI below 15 or above 45
* Possible severe liver cirrhosis (Child-Pugh Class B or worse)
* Clinical frailty score of 5 or above
* EUROSCORE II \> 50%
* Severe pulmonary disease (FEV1 (Forced expiratory volume in 1 second) or DLCO (Diffusing capacity for carbon monoxide) \<30% of expected)
* Left ventricular ejection fraction (\<20%)
* Technically inoperable (e.g. extracorporeal circulation deemed impossible)

Conditions2

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