title: Results with SynCardia total artificial heart beyond 1 year.
abstract: Mechanical circulatory support devices have been increasingly used for long-term support. We reviewed outcomes in all patients supported with a SynCardia total artificial heart (TAH) for more than 1 year to assess its safety in long-term support. As of December 2011, all 47 patients who received the TAH from 10 centers worldwide were included in this retrospective study. Clinical data were collected on survival, infections, thromboembolic and hemorrhagic events, device failures, and antithrombotic therapy. The mean age of patients was 50 ± 1.57 years, the median support time was 554 days (range 365-1373 days). The primary diagnosis was dilated cardiomiopathy in 23 patients, ischemic in 15, and "other" in 9. After a minimum of 1 year of support, 34 patients (72%) were successfully transplanted, 12 patients (24%) died while on device support, and 1 patient (2%) is still supported. Five patients (10%) had a device failure reported. Major complications were as follows: systemic infections in 25 patients (53%), driveline infections in 13 patients (27%), thromboembolic events in 9 patients (19%), and hemorrhagic events in 7 patients (14%). SynCardia TAH has proven to be a reliable and effective device in replacing the entire heart. In patients who reached a minimum of 1 year of support, device failure rate is acceptable and only in two cases was the leading cause of death. Infections and hemorrhagic events were the major causes of death. Patients who remain supported beyond 1 year are still likely to survive to transplantation.
authors.affiliation: From the *Cardiac Surgery, University of Padua, Padova, Italy; †Department of Cardiothoracic Surgery and Department of Anesthesia Mount Sinai Hospital, New York, New York; ‡Herz-und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Bad Oeynhausen, Germany; §Department of Cardiology and Cardiovascular Surgery, Azienda Ospedaliera S. Camillo-Forlanini, Rome, Italy; ¶Department of Thoracic and Cardiovascular Surgery, Institut du Thorax, Nantes, France; ‖Division of Cardiothoracic Surgery, Department of Surgery, Mayo Clinic, Phoenix, Arizona; #Institut de Cardiologie, Service de Chirurgie Thoracique et Cardiovasculaire, Université Pierre et Marie Curie, Paris, France; **Division of Cardiothoracic Surgery, Department of Surgery, Virginia Commonwealth University Health System, Richmond, Virginia; ††Department of Cardiovascular Surgery, University Hospital Medical Center, Freiburg, Germany; ‡‡Deutsches Herzzentrum Berlin, Berlin, Germany; and §§Formerly: Cardiothoracic Unit Department of Surgery, University Medical Center, Tucson, AZ now at University of California San Diego, La Jolla, California.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Torregrossa
authors.forename: Michiel
authors.initials: M
authors.lastname: Morshuis
authors.forename: Robin
authors.initials: R
authors.lastname: Varghese
authors.forename: Leila
authors.initials: L
authors.lastname: Hosseinian
authors.forename: Vladimiro
authors.initials: V
authors.lastname: Vida
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Tarzia
authors.forename: Antonio
authors.initials: A
authors.lastname: Loforte
authors.forename: Daniel
authors.initials: D
authors.lastname: Duveau
authors.forename: Francisco
authors.initials: F
authors.lastname: Arabia
authors.forename: Pascal
authors.initials: P
authors.lastname: Leprince
authors.forename: Vigneshwa
authors.initials: V
authors.lastname: Kasirajan
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.forename: Francesco
authors.initials: F
authors.lastname: Musumeci
authors.forename: Roland
authors.initials: R
authors.lastname: Hetzer
authors.forename: Thoamas
authors.initials: T
authors.lastname: Krabatsch
authors.forename: Jan
authors.initials: J
authors.lastname: Gummert
authors.forename: Jack
authors.initials: J
authors.lastname: Copeland
authors.forename: Gino
authors.initials: G
authors.lastname: Gerosa
mesh_terms: D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects; D015331:Cohort Studies; D018572:Disease-Free Survival; D005260:Female; D006333:Heart Failure / Q000601:surgery; D016027:Heart Transplantation; D006354:Heart, Artificial / Q000009:adverse effects; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011475:Prosthesis Failure; D016459:Prosthesis-Related Infections / Q000209:etiology; D012189:Retrospective Studies; D013923:Thromboembolism / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000925:Anticoagulants