131 * CHRONIC ANIMAL EXPERIENCE WITH THE CARMAT BIOPROSTHETIC ARTIFICIAL HEART

Abstract

S 28 EACTS Left ventricular assist device 2 Monday, 13 October 2014 131 CHRONIC ANIMAL EXPERIENCE WITH THE CARMAT BIOPROSTHETIC ARTIFICIAL HEART C. Latremouille, D. Duveau, B. Cholley, L. Zilberstein, P. Bruneval, J. Perles, P. Jansen, A. Carpentier Cardiovascular Surgery, European Hospital Georges Pompidou, Paris, France; Cardiovascular and Thoracic Surgery, Hopital G. et R. Laennec, Nantes, France; Anesthesie-Reanimation, European Hospital Georges Pompidou, Paris, France; Anaesthesiology & Critical Care, Ecole Nationale Veterinaire d’Alfort, Maisons-Alfort, France; Pathology, European Hospital Georges Pompidou, Paris, France; Medical, CARMAT SA, Velizy, France Objectives: The CARMAT total artificial heart (TAH) contains bioprosthetic blood-contacting surfaces and is designed for orthotopic cardiac replacement. In preparation for clinical studies, we evaluated the TAH performance and its effects on end-organ function in an animal model. Methods: Twelve female Charolais calves, 2–8 months of age and weighing 102– 122 kg were implanted with the TAH through a mid-sternotomy to ensure an adequate anatomic fit. The intended support duration was 4–10 days. Haematologic values, creatinine, bilirubin and lactate levels were measured and mean arterial and central venous pressure, central venous oxygen saturation and TAH parameters were monitored. Results: All calves were placed in a cage immediately postoperatively and extubated on postoperative day 1. Average support duration was 3 days, with 4/12 calves supported for 4, 4, 8 and 10 days. The initial procedures were used to refine surgical techniques and postoperative care. Pump output ranged from 7.3 to 10 l/min. Haemodynamic parameters and blood analysis stayed within acceptable ranges (Table). No device failures occurred. The calves were euthanised because of respiratory insufficiency/infections in most cases. Kidney and brain histology showed no evidence of thrombo-embolic depositions. Device explant analysis showed no thrombus formation inside the blood cavities. Parameter Pre-op Post-op Day1 Day2 Day3 Day4 Haemoglobin (g/100 ml) 10.7 ± 1.8 10.4 ± 1.7 9.7 ± 2.3 8.8 ± 1.7 8.8 ± 0.7 8.4 ± 0.5 Platelets (10/μl) 253 ± 95 122 ± 92 124 ± 88 94 ± 24 66 ± 19 86 ± 20 Free Hgb (mg/dl) 11.1 ± 6 34.4 ± 31.6 31.6 ± 26.5 8.1 ± 4.4 5.5 ± 1.9 10.4 ± 3.4 Creatinine (mmol/l) 134 ± 23 230 ± 32 362 ± 96 317 ± 189 289 ± 184 255 ± 181 Total bilirubin (mmol/l) 5.5 ± 2.6 4.9 ± 3.3 4.9 ± 1.9 5.3 ± 1.7 7.5 ± 4.2 N/A SVO2 (%) 73 ± 8 81 ± 9 70 ± 17 69 ± 8 78 ± 3 73 ± 12 Lactate (mmol/l) 0.6 ± 0.3 5.4 ± 3.1 8.3 ± 7.6 1.9 ± 1.4 2.1 ± 1.9 2 ± 1.1 MAP (mmHg) 92 ± 20 96 ± 20 80 ± 19 92 ± 11 99 ± 9 N/A CVP (mmHg) 12 ± 6 13 ± 4 8 ± 6 11 ± 10 N/A N/A Pump flow (l/min) 7.3 ± 2.4 6.7 ± 2.3 7.2 ± 1 9 ± 0.5 9.4 ± 1.2 9.4 ± 1.3 MAP: mean arterial pressure; CVP: central venous pressure. Conclusion: The CARMAT bioprosthetic TAH implanted in calves up to 10 days provided adequate blood flow to organs and tissues. Haemocompatibility of the TAH was confirmed by low levels of haemolysis and no evidence of thromboembolic depositions in major organs and device cavities. Interactive CardioVascular and Thoracic Surgery Sunday A bsracts 01 –06