Albumin in Cardiac Surgery - ALBICS

Aug 01, 2022
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Prothya Biosolutions (formerly Sanquin Plasma Products); and research fund of Helsinki University Central Hospital.
Date Published:
07/19/2022
Original Posted Date:
08/01/2022
References

Contribution To Literature:

The ALBICS trial showed that treatment with 4% albumin solution for priming and perioperative intravenous volume replacement compared with Ringer acetate did not significantly reduce the risk of adverse events over the following 90 days among patients undergoing on-pump cardiac surgery.

Description:

The goal of the trial was to compare the safety and effectiveness of 4% albumin to Ringer acetate as the priming solution of cardiopulmonary bypass and intraoperative and postoperative volume replacement in patients undergoing on-pump cardiac surgery.

Study Design

Eligible patients undergoing cardiac surgery with cardiopulmonary bypass at Helsinki University Hospital, Helsinki, Finland were randomized in a 1:1 double-blind fashion to either 4% albumin (n = 693) or Ringer acetate (n = 693) solutions. Study solutions were first used for cardiopulmonary bypass priming. Next, during surgery and for the first 24 hours in the intensive care unit (ICU) or until discharged from the ICU, study solutions were given for volume replacement up to 3200 mL.

  • Total number of enrollees: 1,407
  • Number completing the trial: 1,386
  • Duration of follow-up: 90 days
  • Mean patient age: 65 years
  • Percentage female: 22%

Inclusion criteria:

  • Age 18-90 years
  • Primary or repeat open heart surgery procedures (elective surgery or surgery during the index admission) independently or in combination: coronary artery bypass graft surgery; aortic, mitral, or tricuspid valve replacement or repair; aortic root or ascending aorta surgery without hypothermic circulatory arrest; or the maze procedure

Exclusion criteria:

  • Immediate emergency surgery
  • Congenital cardiac surgery
  • Infection anticipated to compromise postprocedural rehabilitation
  • Ongoing heart failure or low output syndrome (predefined significant inotropic support, mechanical ventilation, extracorporeal membrane oxygenation support, intra-aortic balloon pump, mechanical assistance of the left ventricle, left ventricular ejection fraction <20%, or other comparable preoperative conditions)
  • End-stage kidney disease (estimated glomerular filtration rate <20 mL/min)
  • Hemophilia A or B
  • Patient refusal of blood products or derivatives
  • Ticagrelor, prasugrel, clopidogrel, apixaban, or rivaroxaban use within 2 preoperative days or dabigatran use within 3 preoperative day

Other salient features/characteristics:

  • Median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II: 1.7
  • Aortic stenosis surgery: 22%
  • Mean cardiopulmonary bypass time: 110 minutes

Principal Findings:

The primary safety outcome, ≥1 major adverse event at 90 days, for albumin vs. Ringer, was 37.1% vs. 33.8% (p = 0.20).

  • Myocardial injury: 3.9% vs. 8.9% (p < 0.001)
  • Bleeding: 7.5% vs. 4.3% (p = 0.01)
  • Infection: 13.0% vs. 8.9% (p = 0.02)
  • Acute kidney injury: 3.3% vs. 2.6% (p = 0.43)
  • Heart failure: 2.6% vs. 3.3% (p = 0.43)
  • Death: 0.3% vs. 0.6% (p = 0.42)
  • Stroke: 2.7% vs. 2.7% (p > 0.99)

Secondary outcomes for albumin vs. Ringer:

  • Total fluid balance during the intervention period: 4001 vs. 5278 mL (p < 0.001)
  • Red blood cell transfusion: 0 vs. 0 mL (p < 0.001)
  • Days alive without ventilator at 90 days: 89 vs. 89 (p = 0.64)

Interpretation:

The results of this trial indicate that treatment with 4% albumin solution for priming and perioperative intravenous volume replacement compared with Ringer acetate did not significantly reduce the risk of adverse events over the following 90 days among patients undergoing on-pump cardiac surgery. There were some important differences though: patients receiving albumin had less myocardial injury but had a higher risk of bleeding (with a higher need for red blood cell and platelet transfusion), infections, and reoperation. Overall mortality was similar between the two strategies.

References:

Pesonen E, Vlasov H, Suojaranta R, et al. Effect of 4% Albumin Solution vs Ringer Acetate on Major Adverse Events in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Randomized Clinical Trial. JAMA 2022;328:251-8.

Editorial: Podgoreanu MV, Mamoun N. Albumin vs Crystalloid Fluid for Resuscitation in Cardiac Surgery: New Evidence and Arguments in the Timeless Debate. JAMA 2022;328:246-8.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Cardiovascular Care Team, Dyslipidemia, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Lipid Metabolism, Acute Heart Failure, Interventions and Structural Heart Disease

Keywords: Acetates, Acute Kidney Injury, Albumins, Aortic Valve Stenosis, Cardiac Surgical Procedures, Cardiopulmonary Bypass, Coronary Artery Bypass, Coronary Artery Bypass, Off-Pump, Erythrocyte Transfusion, Heart Failure, Intensive Care Units, Maze Procedure, Patient Discharge, Platelet Transfusion, Reoperation, Stroke, Transcatheter Aortic Valve Replacement, Ventilators, Mechanical


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