Surgical Management of Valvular Infective Endocarditis = a Single Centre Experience
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Rate of mortality post-operative
研究概览
简要总结
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
详细描述
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".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of mortality post-operative
时间窗: 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
时间窗: 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 .
次要结局
- Expected early and late complications post-operative(up to one year post-operative)
研究者
Ahmed Mohammed Ahmed Mohammed Hassan Makhlof
Principal Investigator
Assiut University