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Temporary Artificial Heart Wins U.S. Approval


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  • Temporary Artificial Heart Wins U.S. Approval

    Temporary Artificial Heart Wins U.S. Approval

    2 hours, 46 minutes ago Health - Reuters

    By Lisa Richwine

    WASHINGTON (Reuters) - The first artificial heart won U.S. approval Monday for use as a temporary measure to keep alive patients on the verge of death while they wait for live organs to become available for transplants.

    Reuters Photo

    Yahoo! Health
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    The CardioWest Total Artificial Heart, made by privately held SynCardia Systems Inc., replaces the left and right ventricles, the heart's lower pumping chambers. Surgeons sew the device to the upper chambers.

    The implanted heart must be used in hospitals because patients need to be connected to a computerized console to regulate blood flow. The device costs up to $100,000.

    SynCardia's implant will offer an alternative to gravely ill patients with less than 30 days to live.

    The wait for a donated heart can stretch for months. About 4,000 U.S. patients await heart transplants each year, and only about 2,200 donor hearts typically become available.

    Mechanical pumps called left ventricular assist devices can help but often cannot maintain full heart function. Between 30 percent and 40 percent of patients with an assist device die before transplant.

    In a SynCardia study of 81 patients, mostly men, who got the implanted heart, 79 percent stayed alive long enough to get a transplant -- an average of 79 days.

    The newly approved artificial heart should be reserved for only the sickest patients, the Food and Drug Administration (news - web sites) said. Those include people with irreversible failure of both ventricles who have not responded to other treatments and are eligible for transplants. About 100 people per year meet that definition, the FDA (news - web sites) said.

    The temporary device helps revive people who are starting to develop failure of the kidney, liver and other organs, said Dr. Jack Copeland, chief of cardiovascular and thoracic surgery at the University of Arizona Sarver Heart Center.

    Patients can walk and exercise with the implant, Copeland said. The attached console, about the size of a small washing machine, is on wheels, and SynCardia is developing a smaller version.

    Complications include infections, which afflicted 72 percent of patients in SynCardia's study. About 25 percent developed a neurological problem such as a stroke.

    Survival rates after getting a live heart transplant are similar between patients who had the temporary device and others who did not, SynCardia said.

    Scientists have been trying for years to develop an artificial heart.

    Another company, Abiomed Inc., is seeking approval for a fully implanted artificial heart for patients ineligible for a transplant.

    The FDA said it was requiring SynCardia to conduct a follow-up study of patients treated with the device.


    Husband has HCM.
    3 kids - ages 23, 21, & 19. All presently clear of HCM.

  • #2
    Re: Temporary Artificial Heart Wins U.S. Approval

    This is a wonderful advancement for those in need of transplants. Day by day we learn more and have MORE OPTIONS!!

    It is really a wonderful time we are living in!

    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)


    • #3
      Re: Temporary Artificial Heart Wins U.S. Approval

      yes it is Lisa and i never thought i would live long enough to see it, and if my chest don't stop hurting then i may have to go to the hospital tonight, i'm having so such pressurre on my chest right now, i got upset earlier and now i'm paying for it

      Diagnosed 2003
      Myectomy 2-23-2004
      Husband: Ken
      Son: John diagnosed 2004
      Daughter: Janet (free of HCM)

      Grandchildren: Drew 15,Aaron 13,Karen 9,Connor 9


      • #4
        Re: Temporary Artificial Heart Wins U.S. Approval

        Dear Shirley,

        Let us know how it goes tonight. I pray that the pain and pressure will be relieved without having to go to the hospital.