Destination Therapy with the SynCardia Total Artificial Heart Described in Case Study by EKN Duisburg
Ineligible for a donor heart transplant, the 74-year-old man who could not be supported by an LVAD now lives a normal life with a SynCardia Total Artificial Heart powered by the Freedom® portable driver.
TUCSON, Ariz., June 19, 2014 /PRNewswire/ -- A 74-year-old German patient who is not eligible for a donor heart transplant has lived for more than a year on the SynCardia temporary Total Artificial Heart powered by the Freedom® portable driver, demonstrating the device's use for permanent use, also known as destination therapy.
"A first step beyond traditional boundaries: destination therapy with the SynCardia Total Artificial Heart" was authored by Dr. med Sotirios Spiliopoulos, department of surgical therapy of end-stage heart failure and mechanical circulatory support at the Heart and Vascular Center EKN Duisburg in Germany. Prof. Dr. Reiner Korfer and Prof. Dr. Gero Tenderich were also authors. The article is in the June 2014 issue of the journal Interactive Cardiovascular and Thoracic Surgery.
The patient, admitted for infiltrative cardiomyopathy, experienced kidney failure and heart failure despite therapy to reverse his condition. He was implanted with a SynCardia Heart, which is designed to eliminate the source of end-stage biventricular heart failure. He also fully recovered his renal function.
At the end of the "Case Presentation" section of the paper, the authors wrote, "Compared with baseline, quality of life, measured by the Minnesota living with Heart Failure Questionnaire, improved (45 vs 93). The patient is now able to perform everyday activities (NYHA I–II)."
In the last paragraph of the paper, the authors wrote, "Despite short duration of support, this case demonstrates that therapy with a SynCardia TAH (Total Artificial Heart) has the potential to expand beyond BTT (bridge to transplant) towards DT (destination therapy) for patients ineligible for transplantation. Besides the well-known effect of end-organ recovery…quality of life obviously improves. However, in this early stage, it is crucial to carefully select the appropriate patient."
The SynCardia Total Artificial Heart is the world's first and only Total Artificial Heart approved by the FDA, Health Canada and CE as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.
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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,300 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant Sept. 11, 2011.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by more than 175 patients, accounting for over 100 years of support.
SOURCE SynCardia Systems, Inc.