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

Heart Failure Clinical Trial

— IABP-HR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03857906
• Other study ID #: .2018
• Status: Completed
• Start date: October 21, 2014
• Est. completion date: January 19, 2019

Study information

• Verified date: March 2019
• Source: CMN "20 de Noviembre"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: January 19, 2019
• Est. primary completion date: February 21, 2018
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Ischemic Cardiomyopathy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
CMN "20 de Noviembre"	Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-Day All-Cause Mortality	30-Day Mortality	30 days
Primary	30-Day Postoperative Myocardial Infarction	Based on the third universal definition on MI criteria	30 days
Secondary	30-day occurrence rate of PCI	30-day occurrence rate of emergent percutaneous coronary intervention	30 days
Secondary	Requirement of mechanical ventilation	Requirement of mechanical ventilation for longer than 24 hours	30 days
Secondary	acute kidney injury	AKIN classification	30 days
Secondary	Need for renal replacement therapy	Need for RRT (hemodialysis, peritoneal)	30 days
Secondary	ICU length of stay	ICU and in-hospital length of stay	30 days
Secondary	Postoperative use of inotropes and vasopressors	Postoperative use of inotropes and vasopressors	30 days