Clinical trial NCT04572529: Surgical Management of Valvular Endocarditis
Official title: Surgical Management of Valvular Infective Endocarditis = a Single Centre Experience
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Valvular Endocarditis
Keywords: Endocarditis
Vegetations
Heart valve prosthesis implantation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet the inclusion criteria will be managed in Asyut university hospitals . The information gathered from the eligible patients will be entered into a data sheet containing the variables of interest that will be analysed later at the end of the study. This study will not alter the patients' treatment and follow up at our centre, by any means. In-hospital mortality was defined as all-cause mortality during the hospital stay for the surgical treatment of IE.Variable of interest includes : age , gender , left ventricular ejection fraction , Diabetes mellitus , Renal failure (creatinine clearance\<60 ml/min), Atrial fibrillation, Previous cardiac surgery , Coronary artery disease and Preoperative stroke

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"

Eligibility criteria: 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

Primary outcomes:
measure: Rate of mortality post-operative
timeFrame: up to one year post-operative
measure: The incidince of recurrent endocarditis
timeFrame: up to one year post-operative
Secondary outcomes:
measure: Expected early and late complications post-operative
timeFrame: up to one year post-operative
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ali Mohammed Abd-Elwahab, professor
role: STUDY_DIRECTOR
References:
citation: Netzer RO, Altwegg SC, Zollinger E, Tauber M, Carrel T, Seiler C. Infective endocarditis: determinants of long term outcome. Heart. 2002 Jul;88(1):61-6. doi: 10.1136/heart.88.1.61.
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. doi: 10.1016/s0891-5520(01)00006-x.
citation: Daniel WG, Mugge 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. doi: 10.1056/NEJM199103213241203.
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. doi: 10.1056/NEJM196105042641804. No abstract available.
citation: Chastre J, Trouillet JL. Early infective endocarditis on prosthetic valves. Eur Heart J. 1995 Apr;16 Suppl B:32-8. doi: 10.1093/eurheartj/16.suppl_b.32.
citation: Verheul HA, van den Brink RB, van Vreeland T, Moulijn AC, Duren 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. doi: 10.1016/0002-9149(93)90885-g.
citation: Wolff M, Witchitz S, Chastang C, Regnier 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. doi: 10.1378/chest.108.3.688.
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. doi: 10.1016/s0003-4975(97)00117-3.