Cryopreserved Aortic Homograft Versus Conventional Prosthetic Valves for Infective Endocarditis Involving the Aortic Valve : a Propensity Score Matched Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 760
- 试验地点
- 2
- 主要终点
- Treatment failure
研究概览
简要总结
: Evidence suggested that autologous or allogeneic tissue is more suitable to synthetic material in an infected field. Given the unwillingness of some surgeons to use artificial foreign materials, such as conventional mechanical or stent xenograft valve prostheses, cryopreserved aortic homografts (CAH) have been recommended revealing favorable outcomes in aortic valve endocarditis (AVE) surgery (1-5). This aspect is even more evident in cases involving prosthetic valve endocarditis (PVE) and other complex and aggressive lesions involving the aortic root and intervalvular fibrosa with abscess formation. However, most of these reports are fixed on single-arm observational studies without comparing CAH with conventional prostheses.
The key question of this study is to establish the difference in treatment failure (death, recurrent aortic valve regurgitation and reoperation), all-cause and cause-specific (cardiac vs noncardiac) mortality, hospitalizations for heart failure during follow-up (structural/non structural valve deterioration, thromboembolism and recurrent endocarditis) in patients who received the CAH vs conventional mechanical or stent xenograft valve prostheses for aortic valve replacement (AVR) secondary to infective endocarditis (IE)
详细描述
The target population enrolled in the study includes patients with aortic-valve endocarditis at risk of embolization, heart failure and uncontrolled infection undergoing AVR with the use of CAH or conventional mechanical or stent xenograft valve prostheses. Individuals were adequately treated per applicable standards, including for the treatment of infection, LV dysfunction and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.
Three groups of patients are included in the study. Patients who were managed with CAH, patients who received AVR with conventional stented xenograft and recipients of AVR undergoing surgery with the use of mechanical prostheses.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duke Criteria
- •Uncontrolled Infection Local abscess Large vegetation False aneurysm, Fistula, Dehiscence of PV
- •Embolism Large vegetation >10mm, persistent infection
- •Heart Failure Involvement of aortic root, intervalvular fibrosa, pulmonary edema, cardiogenic shock
排除标准
- •Pediatric
- •Any echocardiographic evidence of absence of IE
结局指标
主要结局
Treatment failure
时间窗: 10 years
The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation
Treatment failure
时间窗: 10 years]
The primary end point of the study is the degree of treatment failure as assessed by death, recurrent aortic valve regurgitation and reoperation
次要结局
- Overall Mortality(10 years)
- Cardiac Death(10 years)
- Hospitalizations for Heart Failure (HF)(10 years)
- Echocardiographic Parameter Changes (recurrence)(10 years)
- Echocardiographic Parameter Changes (LVEDD)(10 years)
- Echocardiographic Parameter Changes (Aortic Root diameter)(10 years)
- Echocardiographic Parameter Changes (LVEF)(10 years)
- Non Cardiac Death(10 years)
- Major Adverse Cardiac or Cerebrovascular Events (MACCE)(10 years)