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.
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.
Disclosure: Copeland JG and Duveau D declare a financial interest with Syncardia Inc. Dr. Copeland JG is co-founder of Syncardia Inc. and part of the Board of Director. Dr. Duveu D has been a consultant and proctor for Syncardia INC. All the other authors declare no conflict of interest for this article and with Syncardia Inc.
Correspondence: Gianluca Torregrossa, MD, Department of Cardiothoracic Surgery, Mount Sinai Hospital, 1190 5th Avenue, Box 1028, New York, NY 10029. Email: email@example.com.