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

Completed

• Conditions: Ischemic Cardiomyopathy; Heart Failure
• Interventions: Device: Intra-Aortic Ballon Pump insertion

• Registration Number: NCT03857906
• Lead Sponsor: CMN "20 de Noviembre"

Brief Summary

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

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 Timeline

• Study Start: 2014-10-21
• Primary Completion: 2018-02-21
• Study Completion: 2019-01-19
• Study First Submitted: 2019-02-23
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IABP group	Intra-Aortic Ballon Pump insertion	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

Primary Outcome Measures

Name	Time	Method
30-Day All-Cause Mortality	30 days	30-Day Mortality
30-Day Postoperative Myocardial Infarction	30 days	Based on the third universal definition on MI criteria

Secondary Outcome Measures

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