Early Outcomes of Concomitant Transcatheter Aortic Valve Implantation and Off-pump Coronary Artery Bypass Grafting in Management of Severe Symptomatic Aortic Stenosis and Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications.
- Objective 1: Identify risk factors that are predictive of the need for TAVI and CABG
- Objective3:Assess early 3 months outcomes and postoperative results
Outcome Measure:
- All-cause mortality within 3 months.
Secondary Outcome Measures:
- Stroke
- Myocardial infarction
- Bleeding
- Hospital stay
- Acute kidney injury
- Number of patients with conduction disturbance and pacemaker implantation
- Gradient on implanted valve
- Degree of transvalvular leakage
- 6 weeks follow-up
- 3 months Echo
详细描述
Severe symptomatic aortic stenosis in elderly patients represents a surgical challenge for cardiac surgeons due to heavy calcifications and associated comorbidities. Such conditions usually are associated with dramatic intra and postoperative complications leading to many cases being declined for open surgical replacement. Many treatment modalities were described including trans-catheter valvutomy but with only temporary improvements and high rates of recurrence. Transcatheter Aortic Valve Implantation (TAVI) has offered an alternative solution to such cases in which open surgery is deemed too risky or prohibited.
Coronary artery disease (CAD) is a common comorbidity in patients undergoing TAVI. It has been reported with 40-75% of the patients with increased adverse outcomes.Despite performing TAVI alone in these patient has shown significant improvement, yet CAD has showed increased risk in terms of hemodynamic instability and risk of myocardial infarction during rapid pacing which is an important step during the TAVI procedure.
According to the AHA/ACC guidelines, in patients undergoing Aortic valve replacement/ repair (AVR) who also have significant CAD, the combination of Coronary artery bypass grafting (CABG) and AVR reduces the rates of perioperative Myocardial Infarction, perioperative mortality, late mortality, and morbidity when compared with patients not undergoing simultaneous CABG, even though the combined operation carries a small but real increased risk of mortality (Class II A).
Percutaneous coronary intervention (PCI) has been the commonly used treatment modality for (CAD) which is usually carried out pre TAVI or less commonly simultaneously with TAVI (mainly due to access limitation after valve implantation). In patients with intermediate or high SYNTAX scores, CABG remains the standard therapy. Off-pump coronary artery bypass (OPCAB) procedure has demonstrated excellent results in these patients, due to the avoidance of cardiopulmonary bypass and manipulation of the aorta.
Only a few studies in the literature have reported the combined approach of CABG and TAVI in treatment of coronary artery disease and severe symptomatic aortic stenosis. Here the invesigators decided to study the early three months outcomes of patients undergoing TAVI and surgical revascularization.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe symptomatic aortic stenosis and CAD undergoing TAVI & OPCABG
排除标准
- •Patients with concomitant valvular heart disease.
结局指标
主要结局
All-cause mortality
时间窗: 3 months
次要结局
- Degree of transvalvular leakage(3 months Echo)
- Occurence of Acute kidney injury(I month)
- Occurence of Stroke(I month)
- Occurence of Myocardial infarction(I month)
- Need for reexploration(I month)
- Gradient on implanted valve(3 months Echo)
- Days of Hospital Stay(from day of operation till medically fit for discharge (1 month))
- Number of patients with conduction disturbance and pacemaker implantation(I month)
研究者
Moustafa Mohamed
Assistant Lecturer of Cardiothoracic Surgery/ Principle Investigator
Assiut University