RecruitingACTRN12613000293763

Prophylactic intra-aortic balloon counterpulsation in high-risk cardiac surgery: An inception cohort study

The effect of prophylactic intra-aortic balloon counterpulsation in high-risk cardaic surgery patients on mortality and quality of life at 6 months: an inception cohort study

Sponsor

Australia and New Zealand Cardiothoracic Surgery cardiac surgery database program

Enrollment

250 participants

Start Date

Mar 12, 2013

Study Type

Observational

Conditions

High-risk cardiac surgery Ischaemic heart disease

Summary

PINBALL Synopsis Background CABG surgery remains the treatment of choice for many patients with severe ischaemic heart disease, the leading cause of death in Australia and worldwide. Patients undergoing CABG surgery are increasingly older, have greater comorbidities and are at high-risk of serious adverse postoperative outcomes. Prophylactic IABC may reduce postoperative mortality and morbidity in high-risk patients however current evidence is inconclusive and use remains low. Aim To describe the incidence and outcomes of high-risk patients undergoing CABG surgery. Objectives 1. Assess the crude and adjusted odds ratio for the association between prophylactic IABC and six-month postoperative mortality 2. Determine the combination of preoperative characteristics identifying a group of patients in whom prophylactic IABC may be of greatest benefit 3. Describe current perioperative management strategies of high-risk patients undergoing CABG surgery 4. Determine the quality of life at six months of high-risk patients who have undergone CABG surgery 5. Obtain information critical to the design of a RCT of prophylactic IABC in high-risk patients undergoing CABG including the calculation of sample size, determination of recruitment rates and treatment protocols for the intervention and control arms Methods We will conduct a prospective multi-centre inception cohort study of high-risk patients undergoing CABG surgery. All patients booked for CABG surgery with at least two of four high-risk characteristics, (left ventricular fraction less than 30%, redo cardiac surgery, left main coronary artery stenosis greater than 50% and unstable angina), will be included in the study. A telephone follow-up will be conducted at six months post surgery to measure vital status and quality of life. Outcomes Primary outcome: -Six month all-cause mortality Secondary outcomes: - Incidence of high-risk surgery - In-hospital and 30-day mortality - Composite of in-hospital mortality, CVA, AKI, AMI - Duration of MV, ICU and hospital LOS - Adverse events directly attributable to IABC - Six month quality of life

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This is an observational study (not a treatment trial) that is tracking what happens to patients who are considered high-risk when they undergo coronary artery bypass graft (CABG) heart surgery. The researchers want to understand how often these high-risk patients are treated with a device called an intra-aortic balloon pump (IABC) — which helps the heart pump blood — and whether using this device improves their outcomes. This data will help design a proper treatment trial in the future. You may be eligible if: - You are 18 years of age or older - You are scheduled for coronary artery bypass graft surgery - You meet at least 2 of these 4 high-risk conditions: very low heart pumping function (ejection fraction below 30%), repeat cardiac surgery, significant blockage of the left main heart artery (over 50%), or unstable angina You may NOT be eligible if: - You are under 18 years of age - You already have a left ventricular assist device in place before surgery Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

This is an observational study to determine the effect of prophylactic intra-aortic balloon counterpulsation on 6 month mortality and quality of life. We will observe high-risk patients undergoing coronary artery bypass graft surgery and compare patients who receive intra-aortic balloon counterpulsation prior to surgery to those who proceed to surgery without intra-aortic balloon counterpulsation. Intra-aortic balloon counterpulsation is the process of inserting an intraaortic balloon pump, into the aorta, via the femoral artery (much like a coronary angiogram is performed), and having the balloon inflate during diastole (when the heart is relaxed), and deflate rapidly at the beginning of systole (when the heart contracts or pumps). This results in an increase in blood flow to the arteries supplying the heart muscle, and also results in a reduction in the work that heart has to do to pump blood around the body. Intra-aortic balloon counterpulsation is commonly performed to assist cardiac function in patients with poor heart function following acute myocardial infarction or in patients with poor heart function following cardiac surgery. Prophylactic intra-aortic balloon counterpulsation is performed by commencing intra-aortic balloon counterpulsation, prior to cardiac surgery, in patients at high risk of post operative complications, in an attempt to prevent these complications post-operatively.