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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Ischemic Cardiomyopathy
• Intervention / Treatment: Device: Intra-Aortic Ballon Pump insertion

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 Type: Observational
• Enrollment (Actual): 129

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for cardiac surgery were assessed for the inclusion/exclusion criteria, provided signed informed consent, and were allocated to one of two treatments: IABP insertion before skin incision (IABP group) or no IABP insertion (control group). In all cases, the decision of the IABP insertion was generated in a previous Heart Team session, this team was integrated by a Clinical Cardiologist, Cardiac Interventionist, Cardiothoracic Surgeon and Anesthesiologist, in base on the personal risk/benefit of each patient. There was no blinding for patients or physicians in aware of the Heart Team decisions. Outcome assessors were unaware of the assigned treatment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IABP group; 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; 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
No-IABP group; Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease No IABP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CMN "20 de Noviembre"
• Collaborators: Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
• Investigators: Principal Investigator: Juán Antonio Suárez-Cuenca, CMN "20 de Noviembre"

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2014
• Primary Completion (Actual): February 21, 2018
• Study Completion (Actual): January 19, 2019

Study Registration Dates

• First Submitted: February 23, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 6, 2019
• Last Update Submitted That Met QC Criteria: March 5, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: coronary artery bypass graft; preoperative; intra-aortic balloon pump
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Cardiomyopathies
• Other Study ID Numbers: .2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes