title: In vitro haemocompatibility of a novel bioprosthetic total artificial heart.
abstract: OBJECTIVE
  The CARMAT total artificial heart (TAH) is an implantable, electro-hydraulically driven, pulsatile flow device with four bioprosthetic valves. Its blood-pumping surfaces consist of processed bioprosthetic pericardial tissue and expanded polytetrafluorethylene (ePTFE), potentially allowing for the reduction of anti-coagulation. This pre-clinical study assessed the in vitro haemocompatibility of these surfaces.
  
  
  METHODS
  Coupons of pericardial tissue and ePTFE were placed in closed tubular circuits filled with 12.5 ml of fresh human blood exposed to the pulsatile flow at 120 ml/min for 4 h (37°C). Silicone- and heparin-coated polyvinyl chloride (PVC) tubes served as positive and negative controls, respectively. Fresh blood from six donors was used to fill four sets of 12 circuits. Blood samples were taken at baseline and from each circuit after 4 h. Coupons of materials were examined with scanning electron microscopy.
  
  
  RESULTS
  The platelet count was 202 ± 45 10(9) l(-1) at baseline. Four hours after circulation, the platelet counts were 161 ± 30 10(9) l(-1) (compared with baseline, P = 0.0207) for pericardial tissue, 162 ± 35 10(9) l(-1) (P = 0.0305) for ePTFE and 136 ± 42 10(9) l(-1) for positive controls (P = 0.0021). Baseline plasma fibrinogen was 2.9 ± 0.5 mg/dl compared with 3.0 ± 0.5 mg/dl for pericardial tissue and 3.1 ± 0.7 mg/dl for ePTFE, indicating no marked fibrinogen consumption. Thromboxane B2 levels for positive controls were 33.3 ± 8.7 ng/ml compared with 16.2 ± 11.5 ng/ml for pericardial tissue (P = 0.0015) and 15.2 ± 4.7 ng/ml for ePTFE (P < 0.0001). Platelet adhesion was 2.87 ± 1.01 10(9) cm(-2) for positive controls compared with 1.06 ± 0.73 10(9) cm(-2) for pericardial tissue (P < 0.0001) and 0.79 ± 0.75 10(9) cm(-2) for ePTFE (P < 0.0001). Thrombin-antithrombin III complex levels were 3.8 ± 0.5 μg/ml for positive controls compared with 1.9 ± 0.9 for pericardial tissue (P < 0.0001) and 2.1 ± 1.0 for ePTFE (P < 0.0001). With an electro-microscopic examination at ×600, only small depositions of platelets, erythrocytes and fibrin were noticed on the pericardial tissue samples and ePTFE samples. Silicone surfaces showed marked areas of thrombi, and PVC tubings a thin protein layer.
  
  
  CONCLUSIONS
  Haemocompatibility of the TAH blood-contacting surfaces was confirmed by in vitro studies showing a limited consumption of fibrin, limited thromboxane B2 release and platelet adhesion, and minor blood cell depositions on the surfaces. These results will be validated in clinical studies, with the aim of reducing anti-coagulation when using the CARMAT TAH.
authors.affiliation: CARMAT SA, Vélizy-Villacoublay, France. piet.jansen@carmatsas.com
authors.forename: Piet
authors.initials: P
authors.lastname: Jansen
authors.forename: Willem
authors.initials: W
authors.lastname: van Oeveren
authors.forename: Antoine
authors.initials: A
authors.lastname: Capel
authors.forename: Alain
authors.initials: A
authors.lastname: Carpentier
mesh_terms: D001705:Bioprosthesis; D001800:Blood Specimen Collection / Q000379:methods; D020099:Coated Materials, Biocompatible; D006354:Heart, Artificial; D006493:Heparin; D006801:Humans; D008422:Materials Testing / Q000379:methods; D008855:Microscopy, Electron, Scanning; D010496:Pericardium / Q000637:transplantation / Q000648:ultrastructure; D011138:Polytetrafluoroethylene; D011474:Prosthesis Design; D011673:Pulsatile Flow; D012828:Silicones; D013499:Surface Properties
chemical_list: D020099:Coated Materials, Biocompatible; D012828:Silicones; D011138:Polytetrafluoroethylene; D006493:Heparin