Surgical Management of Valvular Endocarditis

Study Overview
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Brief Summary
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This study aims to achieve the following objectives objective 1 : To review the Investigators' experience of surgical management of infective endocarditis (IE) and analyze the outcomes and associated prognostic factors objective 2 : To provides information on early and late clinical outcomes of patients undergoing surgery for IE objective 3 : To evaluate the impact of perioperative clinical variables and identification of perioperative prognostic factors objective 4 : To determine the indications of surgical intervention and the best time of the surgery

Detailed Description
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The role of surgery in active infective endocarditis (IE) has been expanding since the first report of successful ventricular septal repair and removal of tricuspid vegetation in 1961 and the first successful valve replacement during active IE in 1965 4. The risk of death and complications of infective endocarditis (IE) treated medically has to be balanced against those from surgery in constructing a therapeutic approach . The results of surgery depend upon many factors. The general preoperative condition of the patient, antibiotic treatment, timing of surgery, perioperative management, surgical techniques( including choice of methods for reconstruction), postoperative management, and follow-up are all important determinants of outcome . Despite substantial improvements made in the diagnosis and management of infective endocarditis (IE), infective endocarditis remains a serious condition that is associated with significant morbidity and mortality. Compared with antibiotic treatment alone, surgery for IE has greatly increased survival 1. Surgery for IE is required in 25-30% of cases during the acute phase and in 20-40% during the convalescent phase 2. The most common indications for surgery in IE include intractable heart failure, uncontrolled infection related to peri-valvular extension and resistant organisms, recurrent embolic events and presence of prosthetic material 3. Risk stratification to identify patients at high risk of developing significant morbidity and mortality is important in the management of IE. Some authors have found operation during the acute phase of endocarditis to be associated with a higher risk of persistent or early recurrent prosthetic valve endocarditis (PVE)5. Other studies did not find an increased recurrence rate 6, particularly not after surgery for mitral valve endocarditis 7. In general, the prognosis is better after early surgery undertaken before the cardiac pathology and the general condition of the patient have deteriorated too severely 8

Official Title
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Surgical Management of Valvular Infective Endocarditis = a Single Centre Experience

Conditions
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Valvular Endocarditis

Intervention / Treatment
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* Procedure: Cardiac Valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with native or prosthetic valve infective endocarditis treated with open heart surgery patients without severe neurological injury and CT evidence of hemorrhagic transformation . patients equal to or older than eighteen years old Exclusion Criteria: Cases of infective endocarditis related to non-valvular cardiovascular devices, such as pacemakers and catheters . cases of infective endocarditis managed non-surgically patients with severe neurological evidence and CT evidence of hemorrhagic transformation . patients younger than eighteen years old patients who refuse to enroll in this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiac Valve replacement|Open heart surgery to replace the valvular infective endocarditis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of mortality post-operative | The primary endpoint in this study will be overall cumulative postoperative survival up to one year post-operatively , which will me meassured by the mortalitiy rates . All-cause mortality such as development of sepsis , complications related to stroke , and the development of multisystem organ failure will be discussed . All mortality factors including age of the patient , size of vegetations , type of the involved valve wheather native or prosthetic , Cardiopulmonary bypass time will be well analysed . Statistical analyses were performed using (SPSS) program version 20 (IBM Corporation; Endicott, New York, USA). | up to one year post-operative | 
| The incidince of recurrent endocarditis | The incidince of recurrence of the disease will be on of the primary outcomes in this study . It will be measured by follow up echocardiography , physical signs of the patient , and blood cultures . The following variables will be analyzed for each case: site of infection, active infection at surgery, drug abuse, presence of type 2 diabetes, perivalvular involvement, prosthetic endocarditis, positive blood cultures, previous embolism, and type of prosthetic valve implanted . | up to one year post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expected early and late complications post-operative | Early and late complications post-surgical management Expected early complications include : multi-organ failure secondary to low cardiac output syndrome, fulminant sepsis secondary to residual IE or hospital-acquired pneumonia , acute intracranial hemorrhage, Reoperation for bleeding , Reoperation (valve-related) and Permanent pacemaker . Expected late complications include : reoperation for recurrent or residual IE, for structural valve deterioration of a biological prosthesis , for nonstructural dysfunction and for valve thrombosis of a mechanical valve prosthesis . | up to one year post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endocarditis, Vegetations, Heart valve prosthesis implantation