Evaluation of Prophylactic Use of a Preoperative Intra-Aortic Ballon Pump in High-Risk Coronary Artery Bypass Graft Surgery: A Single-Centre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 主要终点
- 30-Day All-Cause Mortality
研究概览
简要总结
Background: The intra-aortic balloon balloon pump (IABP) has been used as a method of percutaneous circulatory assistance high surgical risk patients undergoing coronary artery bypass graft surgery (CABG); Although its applicability has been questioned by clinical trials showing poor impact to reduce the mortality due to cardiogenic shock associated with postoperative acute myocardial infarction (AMI), the real benefit reducing mortality in the postoperative context (PO) has not been determined examined through a prospective study with an adequate design.
Objective: To compare PO complications such as mortality, perioperative infarction and other complications in patients with high surgical risk undergoing CABG in comparison with controls.
详细描述
Methods: Quasi-experimental, prospective, comparative, non-randomized study. The decision to place the BIAC is not part of the study and depends on the multidisciplinary decision of a Heart Team, based on the individualized risk / benefit. The study population consists on high surgical risk patients with atherosclerotic coronary disease undergoing CABG in our centre between 2014-2018. Patients are excluded if any condition is present: cardiogenic shock, with AMI 48 hours prior and / or severe aortic insufficiency. In one group BIAC will be inserted 1-6 hours before surgery (BIAC group) and a second group is control (non-BIAC group). A minimum 30-day postoperative follow-up of will be performed, with primary end points (mortality and AMI type V) and secondary end points (additional PO complications).
Analysis: An evaluation of normality distribution K-S will be performed, the means of quantitative (t-Test) and categorical variables (Fisher or χ² Pearson) will be compared. A multivariate analysis will be performed with linear logistic regression to evaluate the influence of age, sex, peripheral arterial disease (PAD) and EuroSCORE-II on the primary goal. Statistical significance will be considered when p <0.05. Softwares: GraphPad-Prism-5.0 and SPSS-15.0
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients greater than 18 years
- •Scheduled for coronary artery bypass graft (CABG) surgery were eligible
- •Multiple vessel disease with or without left main coronary artery (LMCA) significant stenosis (>50%)
- •Written informed consent provided
排除标准
- •Prior cardiogenic shock,
- •Acute myocardial infarction (AMI) less than 48 hours prior to enrollment
- •Previous IABP use
- •AMI mechanical complications
- •Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation)
- •Tachyarrhythmia
- •Other aortic procedures
- •Other non-CABG surgical procedures
- •Massive pulmonary embolism
- •Older than 90 years of age
- •Any coagulopathy
- •Severe concomitant disease associated with a life expectancy of less than 6 months.
结局指标
主要结局
30-Day All-Cause Mortality
时间窗: 30 days
30-Day Mortality
30-Day Postoperative Myocardial Infarction
时间窗: 30 days
Based on the third universal definition on MI criteria
次要结局
- acute kidney injury(30 days)
- 30-day occurrence rate of PCI(30 days)
- Requirement of mechanical ventilation(30 days)
- ICU length of stay(30 days)
- Need for renal replacement therapy(30 days)
- Postoperative use of inotropes and vasopressors(30 days)
研究者
Héctor Hugo Escutia Cuevas
Clinical Professor
CMN "20 de Noviembre"