Surgical Management of Valvular Endocarditis

Valvular Endocarditis Clinical Trial

Official title:

Surgical Management of Valvular Infective Endocarditis = a Single Centre Experience

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04572529
• Other study ID #: Valvular endocarditis
• Status: Not yet recruiting
• Start date: March 1, 2021
• Est. completion date: November 2022

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: Ahmed Mohammed Ahmed Mohammed, specialst
• Phone: +201005035399
• Email: ahmedmohammedmakhlof[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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"

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2022
• Est. primary completion date: March 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Valvular Endocarditis

Intervention

Procedure:
• Cardiac Valve replacement
Open heart surgery to replace the valvular infective endocarditis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Chastre J, Trouillet JL. Early infective endocarditis on prosthetic valves. Eur Heart J. 1995 Apr;16 Suppl B:32-8. Review. — View Citation

Daniel WG, Mügge A, Martin RP, Lindert O, Hausmann D, Nonnast-Daniel B, Laas J, Lichtlen PR. Improvement in the diagnosis of abscesses associated with endocarditis by transesophageal echocardiography. N Engl J Med. 1991 Mar 21;324(12):795-800. — View Citation

Jault F, Gandjbakhch I, Rama A, Nectoux M, Bors V, Vaissier E, Nataf P, Pavie A, Cabrol C. Active native valve endocarditis: determinants of operative death and late mortality. Ann Thorac Surg. 1997 Jun;63(6):1737-41. — View Citation

KAY JH, BERNSTEIN S, FEINSTEIN D, BIDDLE M. Surgical cure of Candida albicans endocarditis with open-heart surgery. N Engl J Med. 1961 May 4;264:907-10. — View Citation

Netzer RO, Altwegg SC, Zollinger E, Täuber M, Carrel T, Seiler C. Infective endocarditis: determinants of long term outcome. Heart. 2002 Jul;88(1):61-6. — View Citation

Olaison L, Pettersson G. Current best practices and guidelines indications for surgical intervention in infective endocarditis. Infect Dis Clin North Am. 2002 Jun;16(2):453-75, xi. Review. — View Citation

Verheul HA, van den Brink RB, van Vreeland T, Moulijn AC, Düren DR, Dunning AJ. Effects of changes in management of active infective endocarditis on outcome in a 25-year period. Am J Cardiol. 1993 Sep 15;72(9):682-7. — View Citation

Wolff M, Witchitz S, Chastang C, Régnier B, Vachon F. Prosthetic valve endocarditis in the ICU. Prognostic factors of overall survival in a series of 122 cases and consequences for treatment decision. Chest. 1995 Sep;108(3):688-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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