Abstract 23235: Implantation Of A Bioprosthetic Total Artificial Heart Induces A Profile Of Acquired Haemocompatibility By Recellularization Of The Blood-contacting Membrane
We report here the results of haemocompatibility in 3 patients from the feasibility study of the first-in-man trail of a novel total artificial heart (C-TAH) containing bioprosthetic blood-contacting membranes in the left and right ventricle. Three male patients (aged 76, 68 and 73 years) at imminent risk of death from biventricular heart failure and ineligible for cardiac transplantation were implanted with the C-TAH and supported for 74, 270 (patients 1 and 2) and 243 days (patient 3). Plasma coagulation, full blood cell count and clinical chemistry parameters were measured. Bioprosthetic membranes of explanted C-TAH were analyzed by histology and scanning as well as transmission electron microscopy. No signs of hemolysis, acquired von Willebrand deficiency, platelet activation or immunogenicity were detected in patients while supported by the C-TAH. DDimer level increase indicated an activation of coagulation in all patients. However, DDimer decreased after 6 months in patients 2 and 3. All patients received unfractionated heparin relayed as soon as possible by a daily injection of low-molecular weight heparin (tinzaparin). Patient 1 and 3 presented bleeding events that resolved by interrupting anticoagulant and antiplatelet treatment. This led to a thrombocytopenia and fibrin monomer increase, both reversible after resuming tinzaparin. Bridging to oral anticoagulation was postponed until 7 months for patient 2, because of dependence to surface anticoagulation induced by LMWH. Histological analysis and electron microscopy of bioprosthetic materials revealed a fibrin network stabilized as a fibrin cap on the 6 membranes. A cell deposition on this cap was noticed, most prominent in the right ventricle. Cells had an endothelial phenotype confirmed by positive labeling for VE-cadherin (CD144) and presence of a tight junction structure observed by electron microscopy. This endocardial reconstruction of bioprosthetic materials was present on more than 30% of the membrane surface in patient number 2. The C-TAH is the first long-term mechanical support device using bioprosthetic membranes that allows an acquired haemocompatibility with recellularization and a neoendocardium formation
Author Disclosures: D.M. Smadja: Consultant/Advisory Board; Modest; Carmat. C. Latremouille: Honoraria; Modest; Carmat. Consultant/Advisory Board; Modest; Carmat. B. Saubamea: None. B. Cholley: None. E. Boissier: None. M. Kindo: None. J. Soulilou: None. D. Duveau: Honoraria; Modest; Carmat. Consultant/Advisory Board; Modest; Carmat. S. Susen: None. M. Epailly: None. N. Gendron: None. E. Van Belle: None. P. Gaussem: None. P. Bruneval: None. A. Capel: Employment; Significant; Carmat. P. Jansen: Employment; Significant; carmat. J. Roussel: None. A. Carpentier: Consultant/Advisory Board; Significant; scientific director of CARMAT. Other; Significant; cofounder and shareholder of CARMAT SA.
- © 2016 by American Heart Association, Inc.