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

NCT03857906 | Completed DMC FDA Device

• 1 other identifier: .2018
• Study Type: observational
• Target: 129
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Cardiomyopathy; Heart Failure

Keywords

intra-aortic balloon pump; coronary artery bypass graft; preoperative

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 30-day occurrence rate of PCI

  30 days

• Requirement of mechanical ventilation

  30 days

• acute kidney injury

  30 days

• Need for renal replacement therapy

  30 days

• ICU length of stay

  30 days

Study Arms (2)

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

No-IABP group

Over 18 years With ischemic heart disease Multivessel disease with/without LMCA involvement High-risk coronary disease No IABP

Interventions

Intra-Aortic Ballon Pump insertion DEVICE

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

IABP group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CMN "20 de Noviembre": lead
• Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado: collaborator

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Juán Antonio Suárez-Cuenca

  CMN "20 de Noviembre"

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 23, 2019
• First Posted: February 28, 2019
• Study Start: October 21, 2014
• Primary Completion: February 21, 2018
• Study Completion: January 19, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03