Christian Latrémouille1, Alain Carpentier1, Pascal Leprince2, Jean-Christian Roussel3, Bernard Cholley4, Elodie Boissier5, Eric Epailly6, Antoine Capel7, Piet Jansen7, David M Smadja8. 1. Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Department of Cardiovascular Surgery, AP-HP, European Georges Pompidou Hospital, Paris, France. 2. Department of Cardiovascular Surgery, AP-HP, Pitié-Salpêtrière Hospital, Paris, France. 3. Department of Thoracic and Cardiovascular Surgery, Thorax Institute, University Hospital of Nantes, Nantes, France. 4. Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Department of Anesthesia and Intensive Care, AP-HP, European Georges Pompidou Hospital, Paris, France. 5. Department of Hematology, University Hospital of Nantes, Nantes, France. 6. Department of Cardiovascular Surgery, University Hospital of Strasbourg, Strasbourg, France. 7. Carmat SA, Vélizy-Villacoublay, France. 8. Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Inserm UMR-S1140, Paris, France; Department of Hematology, AP-HP, European Georges Pompidou Hospital, Paris, France. Electronic address: david.smadja@aphp.fr.
Abstract
BACKGROUND: The electro-hydraulically actuated Carmat total artificial heart (C-TAH) is designed to replace the heart in patients with end-stage heart failure, either as bridge to transplant or destination therapy. It provides pulsatile flow and contains bio-prosthetic blood contacting materials. A clinical feasibility study was conducted to evaluate the C-TAH safety and performance. METHODS: Hospitalized patients, at imminent risk of death from irreversible biventricular failure despite optimal medical management, and not eligible for transplant or eligible but on extracorporeal life support, were enrolled. The primary endpoint was 30-days survival. RESULTS: Four patients were implanted with the C-TAH, three as destination therapy (ages 76, 68, 74) and one as bridge to transplant (age 58). They had implant times of 74, 270, 254 and 20 days respectively. All patients were free from hemolysis, clinical neurologic events, clinical evidence of thrombus and device-related infections. Hemodynamic and physical recovery allowed two patients to be discharged home for a cumulative duration of 7 months. The anticoagulation management strategy comprised initial unfractionated heparin, from postoperative day 2, followed by low molecular weight heparin and aspirin. An increased D-dimer level was observed in all patients during months 1 to 4. Temporary suspension of heparin anticoagulation resulted in thrombocytopenia and increased fibrin monomer, reversed by resuming anticoagulation with heparin. Causes of death were device-related (2 cases), respiratory failure and multi-organ failure. CONCLUSIONS: Preliminary clinical results with the C-TAH demonstrated good safety and performance profiles in patients suffering from biventricular failure, which need to be confirmed in a pivotal study.
BACKGROUND: The electro-hydraulically actuated Carmat total artificial heart (C-TAH) is designed to replace the heart in patients with end-stage heart failure, either as bridge to transplant or destination therapy. It provides pulsatile flow and contains bio-prosthetic blood contacting materials. A clinical feasibility study was conducted to evaluate the C-TAH safety and performance. METHODS: Hospitalized patients, at imminent risk of death from irreversible biventricular failure despite optimal medical management, and not eligible for transplant or eligible but on extracorporeal life support, were enrolled. The primary endpoint was 30-days survival. RESULTS: Four patients were implanted with the C-TAH, three as destination therapy (ages 76, 68, 74) and one as bridge to transplant (age 58). They had implant times of 74, 270, 254 and 20 days respectively. All patients were free from hemolysis, clinical neurologic events, clinical evidence of thrombus and device-related infections. Hemodynamic and physical recovery allowed two patients to be discharged home for a cumulative duration of 7 months. The anticoagulation management strategy comprised initial unfractionated heparin, from postoperative day 2, followed by low molecular weight heparin and aspirin. An increased D-dimer level was observed in all patients during months 1 to 4. Temporary suspension of heparin anticoagulation resulted in thrombocytopenia and increased fibrin monomer, reversed by resuming anticoagulation with heparin. Causes of death were device-related (2 cases), respiratory failure and multi-organ failure. CONCLUSIONS: Preliminary clinical results with the C-TAH demonstrated good safety and performance profiles in patients suffering from biventricular failure, which need to be confirmed in a pivotal study.
Authors: Jan F Gummert; Axel Haverich; Jan D Schmitto; Evgenij Potapov; René Schramm; Volkmar Falk Journal: Dtsch Arztebl Int Date: 2019-12-13 Impact factor: 5.594
Authors: Nader Yatim; Jeremy Boussier; David M Smadja; Benjamin Terrier; Richard Chocron; Jérôme Hadjadj; Aurélien Philippe; Nicolas Gendron; Laura Barnabei; Bruno Charbit; Tali-Anne Szwebel; Nicolas Carlier; Frédéric Pène; Célia Azoulay; Lina Khider; Tristan Mirault; Jean-Luc Diehl; Coralie L Guerin; Frédéric Rieux-Laucat; Darragh Duffy; Solen Kernéis Journal: Ann Intensive Care Date: 2021-07-17 Impact factor: 6.925
Authors: David M Smadja; Coralie L Guerin; Richard Chocron; Nader Yatim; Jeremy Boussier; Nicolas Gendron; Lina Khider; Jérôme Hadjadj; Guillaume Goudot; Benjamin Debuc; Philippe Juvin; Caroline Hauw-Berlemont; Jean-Loup Augy; Nicolas Peron; Emmanuel Messas; Benjamin Planquette; Olivier Sanchez; Bruno Charbit; Pascale Gaussem; Darragh Duffy; Benjamin Terrier; Tristan Mirault; Jean-Luc Diehl Journal: Angiogenesis Date: 2020-05-27 Impact factor: 10.658
Authors: Ulysse Richez; Hector De Castilla; Coralie L Guerin; Nicolas Gendron; Giulia Luraghi; Marc Grimme; Wei Wu; Myriam Taverna; Piet Jansen; Christian Latremouille; Francesco Migliavacca; Gabriele Dubini; Antoine Capel; Alain Carpentier; David M Smadja Journal: Heliyon Date: 2019-12-08