title: First clinical use of a bioprosthetic total artificial heart: report of two cases.
abstract: BACKGROUND
  The development of artificial hearts in patients with end-stage heart disease have been confronted with the major issues of thromboembolism or haemorrhage. Since valvular bioprostheses are associated with a low incidence of these complications, we decided to use bioprosthetic materials in the construction of a novel artificial heart (C-TAH). We report here the device characteristics and its first clinical applications in two patients with end-stage dilated cardiomyopathy. The aim of the study was to evaluate safety and feasibility of the CARMAT TAH for patients at imminent risk of death from biventricular heart failure and not eligible for transplant.
  
  
  METHODS
  The C-TAH is an implantable electro-hydraulically actuated pulsatile biventricular pump. All components, batteries excepted, are embodied in a single device positioned in the pericardial sac after excision of the native ventricles. We selected patients admitted to hospital who were at imminent risk of death, having irreversible biventricular failure, and not eligible for heart transplantation, from three cardiac surgery centres in France.
  
  
  RESULTS
  The C-TAH was implanted in two male patients. Patient 1, aged 76 years, had the C-TAH implantation on Dec 18, 2013; patient 2, aged 68 years, had the implantation on Aug 5, 2014. The cardiopulmonary bypass times for C-TAH implantation were 170 min for patient 1 and 157 min for patient 2. Both patients were extubated within the first 12 postoperative hours and had a rapid recovery of their respiratory and circulatory functions as well as a normal mental status. Patient 1 presented with a tamponade on day 23 requiring re-intervention. Postoperative bleeding disorders prompted anticoagulant discontinuation. The C-TAH functioned well with a cardiac output of 4·8-5·8 L/min. On day 74, the patient died due to a device failure. Autopsy did not detect any relevant thrombus formation within the bioprosthesis nor the different organs, despite a 50-day anticoagulant-free period. Patient 2 experienced a transient period of renal failure and a pericardial effusion requiring drainage, but otherwise uneventful postoperative course. He was discharged from the hospital on day 150 after surgery with a wearable system without technical assistance. After 4 months at home, the patient suffered low cardiac output. A change of C-TAH was attempted but the patient died of multiorgan failure.
  
  
  CONCLUSIONS
  This preliminary experience could represent an important contribution to the development of total artificial hearts using bioprosthetic materials.
  
  
  BACKGROUND
  CARMAT SA.
authors.affiliation: Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France. Electronic address: alain.carpentier@egp.aphp.fr.
authors.forename: Alain
authors.initials: A
authors.lastname: Carpentier
authors.affiliation: Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: Christian
authors.initials: C
authors.lastname: Latrémouille
authors.affiliation: Department of Anaesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Cholley
authors.affiliation: Department of Haematology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: David M
authors.initials: DM
authors.lastname: Smadja
authors.affiliation: Institut du Thorax, Hôpital Guillaume et René Laënnec, Université de Nantes, France.
authors.forename: Jean-Christian
authors.initials: JC
authors.lastname: Roussel
authors.affiliation: Institut du Thorax, Hôpital Guillaume et René Laënnec, Université de Nantes, France.
authors.forename: Elodie
authors.initials: E
authors.lastname: Boissier
authors.affiliation: Institut du Thorax, Hôpital Guillaume et René Laënnec, Université de Nantes, France.
authors.forename: Jean-Noël
authors.initials: JN
authors.lastname: Trochu
authors.affiliation: Institut du Thorax, Hôpital Guillaume et René Laënnec, Université de Nantes, France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Gueffet
authors.affiliation: Institut du Thorax, Hôpital Guillaume et René Laënnec, Université de Nantes, France.
authors.forename: Michèle
authors.initials: M
authors.lastname: Treillot
authors.affiliation: Institut du Thorax, Hôpital Guillaume et René Laënnec, Université de Nantes, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Bizouarn
authors.affiliation: Department of Anaesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Méléard
authors.affiliation: Department of Anaesthesiology and Intensive Care, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: Marie-Fazia
authors.initials: MF
authors.lastname: Boughenou
authors.affiliation: Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Ponzio
authors.affiliation: CARMAT SA, Vélizy-Villacoublay, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Grimmé
authors.affiliation: CARMAT SA, Vélizy-Villacoublay, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Capel
authors.affiliation: CARMAT SA, Vélizy-Villacoublay, France.
authors.forename: Piet
authors.initials: P
authors.lastname: Jansen
authors.affiliation: Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: Albert
authors.initials: A
authors.lastname: Hagège
authors.affiliation: Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Desnos
authors.affiliation: Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Université Paris Descartes-Sorbonne Paris Cité, Paris, France.
authors.forename: Jean-Noël
authors.initials: JN
authors.lastname: Fabiani
authors.affiliation: Institut du Thorax, Hôpital Guillaume et René Laënnec, Université de Nantes, France.
authors.forename: Daniel
authors.initials: D
authors.lastname: Duveau
mesh_terms: D000368:Aged; D001705:Bioprosthesis; D002311:Cardiomyopathy, Dilated / Q000601:surgery*; D017809:Fatal Outcome; D005240:Feasibility Studies; D016027:Heart Transplantation / Q000295:instrumentation* / Q000379:methods; D006354:Heart, Artificial; D006801:Humans; D008297:Male; D016896:Treatment Outcome