NCT03857906

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: CMN "20 de Noviembre" · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: —

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

Conditions

• Ischemic Cardiomyopathy
• Heart Failure

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-10-21
• Primary completion: 2018-02-21
• Completion: 2019-01-19
• First posted: 2019-02-28
• Last updated: 2019-03-06

Regulatory

• FDA-regulated device study