Evaluation of Prophylactic Use of a Preoperative IABP in High-Risk Coronary Artery Bypass Graft Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluation of Prophylactic Use of a Preoperative Intra-Aortic Ballon Pump in High-Risk Coronary Artery Bypass Graft Surgery: A Single-Centre Study

Conditions
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Ischemic Cardiomyopathy, Heart Failure

Intervention / Treatment
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* Device: Intra-Aortic Ballon Pump insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IABP group<br>Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease Intra-Aortic Ballon Pump insertion 1-6 hours prior to surgery | Device: Intra-Aortic Ballon Pump insertion<br>* 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<br>|
| No-IABP group<br>Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease No IABP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Day All-Cause Mortality | 30-Day Mortality | 30 days | 
| 30-Day Postoperative Myocardial Infarction | Based on the third universal definition on MI criteria | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day occurrence rate of PCI | 30-day occurrence rate of emergent percutaneous coronary intervention | 30 days | 
| Requirement of mechanical ventilation | Requirement of mechanical ventilation for longer than 24 hours | 30 days | 
| acute kidney injury | AKIN classification | 30 days | 
| Need for renal replacement therapy | Need for RRT (hemodialysis, peritoneal) | 30 days | 
| ICU length of stay | ICU and in-hospital length of stay | 30 days | 
| Postoperative use of inotropes and vasopressors | Postoperative use of inotropes and vasopressors | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra-aortic balloon pump, coronary artery bypass graft, preoperative