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SynCardia Systems, Inc.

Press Release:

University Hospital of Nantes Presents 18-Year Experience with SynCardia's Total Artificial Heart

French Hospital Achieves 5-Year Post-Transplant Survival of 78% for Patients Bridged to Transplant with Total Artificial Heart

University Hospital of Nantes: Long Term Results After SynCardia Total Artificial Heart Support: Monocentric Experience with 46 Patients University Hospital of Nantes: Long Term Results After SynCardia Total Artificial Heart Support: Monocentric Experience with 46 Patients TUCSON, Ariz. – Nov. 18, 2010 – On Oct. 17, Dr. Jean Christian Roussel from the Thorax Institute at University Hospital of Nantes presented the center's 18-year experience with the SynCardia temporary Total Artificial Heart at the Acute Cardiac Care 2010 medical meeting in Copenhagen, Denmark. The aim of the single center, retrospective study was to assess both the comorbidity and survival of patients awaiting heart transplants while supported by SynCardia's Total Artificial Heart.

The study's authors concluded that the SynCardia Total Artificial Heart "is an excellent bridge-to-transplant device for patients with biventricular failure. Our study demonstrates excellent safety, reliability and efficiency. Exceptional outcome after transplantation underlines its capacity to aid in end-organ recovery."

The study included 46 patients who received the Total Artificial Heart from 1990 to April 2008. Seventy-two percent (33) of these Total Artificial Heart patients were bridged to transplant. At one year post-transplant, 88% of these patients were alive, and at five years, 78%. The overall survival for all patients who received the Total Artificial Heart at five years was >55%.  

Duration of support was 1 to 502 days with a mean of 113± 106 days. Of the 13 patients who died during support, the leading cause of death was multi-organ failure (6). No device malfunctions led to patient death. Adverse events included stroke in 4 patients and infections in 37 patients.

The mean age at time of implantation was 46 (±9.8) and 96% (42) of patients were men. Idiopathic or dilated cardiomyopathy was the pre-implant diagnosis in 43.5% (20) of patients and ischemic cardiomyopathy in 43.5% (20) of patients.

 

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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