Autologous Atrial Appendage Derived Cells in the Treatment of Heart Failure

The atrial appendages are a tissue reservoir for cardiomyocyte stem and precursor cells. During coronary artery bypass graft (CABG) surgery part of the right atrial appendage can be excised upon insertion of the right atrial cannula of the heart-lung machine. This study aims to address the surgical feasibility and patient safety of epicardially delivered atrial appendage micrografts during CABG surgery.

Autologous cardiac cells are harvested from right atrial appendage during CABG of six patients. Micrografts consisting atrial appendage-derived cells (AADCs) and their extracellular matrix (ECM) of the atrial appendage are mechanically processed. The cells are placed on a tissue-engineered sheet with fibrin gel and tissue clue and further delivered epicardially on top of a infarction scar. Parameters including echocardiography reflecting cardiac insufficiency are studied pre- and post-operatively as well as at three and six months of the follow-up. Cardiac functional magnetic resonance imaging is performed preoperatively and at six-months follow-up. 20 patients will be recruited to serve as a control group. They are scheduled for elective CABG and are treated according to the normal hospital protocol, without the ECM sheet.

Inclusion criteria

• Informed consent obtained
• Left ventricular ejection fraction (LVEF) between ≤50% and ≥15%
• New York Heart Association (NYHA) Class II-IV heart failure symptoms

Exclusion criteria

• Heart failure due to left ventricular outflow tract obstruction
• History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator
• Stroke or other disabling condition within 3 months before screening
• Severe valve disease or scheduled valve surgery
• Renal dysfunction (GFR <84 ml/min/1.73m)
• Other disease limiting life expectancy
• Contraindications for coronary angiogram or MRI
• Participation in some other clinical trial