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Artificial Heart Plan Raises Questions


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  • Artificial Heart Plan Raises Questions


    Artificial Heart Plan Raises Questions

    The Associated Press
    Tuesday, April 29, 2003; 11:24 PM

    BOSTON - Officials at Abiomed Inc. said Tuesday they were considering implanting their artificial heart into patients who have suffered major heart attacks and whose relatives would have to give consent.

    Company officials have discussed the proposal with ethics experts and believe it could be done "without compromising patients' rights or patient integrity," said Edward E. Berger, the company's vice president for strategic planning and policy.

    But other experts raised questions.

    "It's such an extraordinary experiment that informed consent is absolutely essential," said George Annas, a professor of health law and bioethics at Boston University. "I really see no way you could justify this without the individual's consent."

    Abiomed has gained worldwide attention for its trial of the Abiocor, a self-contained, implantable replacement heart. The Abiocor has been implanted in 10 people since July 2001. Nine have died. The 10th is in stable condition at the Texas Heart Institute in Houston, more than two months after the operation.

    So far, the clinical trial has used patients with end-stage heart failure who have a 70 percent chance of dying within a month and no hope of other treatment.

    The company's proposal concerns people who have suffered massive heart attacks, who still have little chance of surviving, but who are otherwise healthier because they haven't been debilitated by a long-term progressive condition.

    These patients are frequently heavily sedated or being kept alive by life support.

    Berger said the company hopes it will suffice to have a previously authorized health care proxy - usually a relative - consent to the implant.

    Proxies allow a relative to make a decision about treatment for a patient unable to express his or her wishes. But it's not clear if laws on medical proxies would allow a relative to put a patient in a medical experiment.

    "I guess the question is: Is society comfortable with the notion that somebody can give their body to science while they're still alive, but are no longer conscious and aren't able to give their consent?" asked Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia.

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

  • #2
    Re: Artificial Heart Plan Raises Questions

    This is a tough one! I suggest living wills for all and advance directives so that our loved ones are not stuck with making these choices for us.

    Very interesting advances here - also - those with advanced heart failure have weaknesses in other systems making it hard for them to recover from any procedure - so attempting this in those who were "'health" yesterday and had an MI today may provide some meaningful data for the future??

    Thank God for research.

    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)