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.
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
Study Type
OBSERVATIONAL
Enrollment
129
The IABP (Ultraflex IAB 7.5F, 2.5mm; Arrow International, Reading, PA) was inserted percutaneously through the right femoral artery in the previous 1 - 6 hours before the scheduled surgery. Positioning of the IABP was guided by radioscopy. The balloon size was based on the patient's height (30, 40 or 50 cc). Transesophageal echocardiography was used to confirm correct IABP placement before and after CABG
30-Day All-Cause Mortality
30-Day Mortality
Time frame: 30 days
30-Day Postoperative Myocardial Infarction
Based on the third universal definition on MI criteria
Time frame: 30 days
30-day occurrence rate of PCI
30-day occurrence rate of emergent percutaneous coronary intervention
Time frame: 30 days
Requirement of mechanical ventilation
Requirement of mechanical ventilation for longer than 24 hours
Time frame: 30 days
acute kidney injury
AKIN classification
Time frame: 30 days
Need for renal replacement therapy
Need for RRT (hemodialysis, peritoneal)
Time frame: 30 days
ICU length of stay
ICU and in-hospital length of stay
Time frame: 30 days
Postoperative use of inotropes and vasopressors
Postoperative use of inotropes and vasopressors
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.