Surgical Management of Valvular Endocarditis

• Conditions: Valvular Endocarditis

• Registration Number: NCT04572529
• Lead Sponsor: Assiut University

Brief Summary

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

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"

Study Timeline

• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-09-26
• Study First Posted: 2020-10-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-27
• Study Start: 2021-03-01
• Primary Completion: 2022-03
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of mortality post-operative	up to one year 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).
The incidince of recurrent endocarditis	up to one year post-operative	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 .

Secondary Outcome Measures

Name	Time	Method
Expected early and late complications post-operative	up to one year 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 .