Scientific American AbioCor article
Scientific American AbioCor article
Fri, 28 Jun 2002 19:50:00
New York, NY -Scientific American takes a long look at the AbioCor Total Artificial Heart as it approaches the first anniversary of its implantation into Robert Tools, the first patient to receive the Abiocor (as reported by heartwire at the time). The feature article, appearing in the July issue of the magazine, takes a cautious view of the technology, saying "it is obviously too early to say whether the AbioCor will be a breakthrough or a disappointment." It calls the results from the initial trials "mixed," with 5 of the 7 implanted patients dead as of press time, but the company insisting the severe underlying illness is to blame, not the machine.
A history of the artificial heart is given, starting with the replacement of a dog's heart with a device driven by an air pump by Willem J Kolff and Tetsuzo Akutusu (Cleveland Clinic), extending through the use of early artificial hearts as bridges to transplants to the famous Jarvik-7 experiments and the disastrous effect the publicity had on artificial heart research.
Ethics
A sidebar on the ethics of the trial quotes Arthur Caplan (Director, Center for Bioethics at the University of Pennsylvania School of Medicine), who says the core ethical issue of informed consent hasn't changed since the days of Barney Clark.
"Dying is extremely coercive," Caplan says, "There's very little you can't get a dying person to consent to." Caplan wonders if starting with the very sick is always a good plan for these sorts of trials for a practical reason as well, since it becomes very hard to determine which problems are due to illness and which the machine.
There's very little you can't get a dying person to consent to.
Abiomed's privacy policy (discussed in previous heartwire stories) is also a concern, according to Dr Renee Fox, a social sciences professor at the University of Pennsylvania. Fox grants that Abiomed has done its best to protect the patients from the possibility of media frenzy and does seem to be releasing negative developments in a timely manner, but Fox notes a tendency by the company and the doctors to blame the illness and not the machine.
LVADs and cardiac regeneration
The design of the device itself, as well as the history of the trials so far, is discussed. (all covered in previous heartwire articles). Additional sidebars examine two alternative approaches, the ever-progressing world of VADs, and the possibility of cardiac regeneration.
Arguing that LVADs may render the use of an artificial heart redundant, the article looks at the success of the Heart Mate LVAD in the recent REMATCH trial, and the potential of other LVADs such as the fully implantable LionHeart from Arrow International and the MicroMed DeBakey VAD, as well as the Jarvik 2000.
Dr Robert Jarvik himself is quoted saying that artificial hearts are too risky. "It was not known in 1982 that a heart can improve a lot if you support it in certain very common disease states," Jarvik says, "That's why you should cut out the heart only in the most extreme situations."
Yet another sidebar tackles the potential of stem cells, citing the recently published work of DrPiero Anversa (New York Medical College) on the possibility of cardiac stem cells that may allow the regrowth and repair of damaged heart tissue.
Dr Philippe Menasché (Bichat-Claude Bernard Hospital, Paris), who is working on using stem cells from other parts of the body to help regenerate the heart, dismisses the idea of completely regenerating a heart. "At best, these cells may help enhance other treatments, " he says. He is contradicted by Dr Robert Lanza (Advanced Cell Technology), who predicts a biological artificial heart could be in trials in 15 years.
Quality of life
The core of the debate is quality of life, the article concludes, quoting Dr Claude Lenfant (Director, National Heart, Lung, and Blood Institute), "What quality of life can a total-heart-replacement patient expect? Will there be meaningful clinical benefits to the patient? Is the cost of this therapy acceptable to society?"
The article ends with Robert Tools's wife, Carol, who believes the AbioCor did provide a decent quality of life for her husband. "He had a chance to live quite well," she says, "although unfortunately it was shorter than we would have liked. He never had any regrets about it."
New York, NY -Scientific American takes a long look at the AbioCor Total Artificial Heart as it approaches the first anniversary of its implantation into Robert Tools, the first patient to receive the Abiocor (as reported by heartwire at the time). The feature article, appearing in the July issue of the magazine, takes a cautious view of the technology, saying "it is obviously too early to say whether the AbioCor will be a breakthrough or a disappointment." It calls the results from the initial trials "mixed," with 5 of the 7 implanted patients dead as of press time, but the company insisting the severe underlying illness is to blame, not the machine.
A history of the artificial heart is given, starting with the replacement of a dog's heart with a device driven by an air pump by Willem J Kolff and Tetsuzo Akutusu (Cleveland Clinic), extending through the use of early artificial hearts as bridges to transplants to the famous Jarvik-7 experiments and the disastrous effect the publicity had on artificial heart research.
Ethics
A sidebar on the ethics of the trial quotes Arthur Caplan (Director, Center for Bioethics at the University of Pennsylvania School of Medicine), who says the core ethical issue of informed consent hasn't changed since the days of Barney Clark.
"Dying is extremely coercive," Caplan says, "There's very little you can't get a dying person to consent to." Caplan wonders if starting with the very sick is always a good plan for these sorts of trials for a practical reason as well, since it becomes very hard to determine which problems are due to illness and which the machine.
There's very little you can't get a dying person to consent to.
Abiomed's privacy policy (discussed in previous heartwire stories) is also a concern, according to Dr Renee Fox, a social sciences professor at the University of Pennsylvania. Fox grants that Abiomed has done its best to protect the patients from the possibility of media frenzy and does seem to be releasing negative developments in a timely manner, but Fox notes a tendency by the company and the doctors to blame the illness and not the machine.
LVADs and cardiac regeneration
The design of the device itself, as well as the history of the trials so far, is discussed. (all covered in previous heartwire articles). Additional sidebars examine two alternative approaches, the ever-progressing world of VADs, and the possibility of cardiac regeneration.
Arguing that LVADs may render the use of an artificial heart redundant, the article looks at the success of the Heart Mate LVAD in the recent REMATCH trial, and the potential of other LVADs such as the fully implantable LionHeart from Arrow International and the MicroMed DeBakey VAD, as well as the Jarvik 2000.
Dr Robert Jarvik himself is quoted saying that artificial hearts are too risky. "It was not known in 1982 that a heart can improve a lot if you support it in certain very common disease states," Jarvik says, "That's why you should cut out the heart only in the most extreme situations."
Yet another sidebar tackles the potential of stem cells, citing the recently published work of DrPiero Anversa (New York Medical College) on the possibility of cardiac stem cells that may allow the regrowth and repair of damaged heart tissue.
Dr Philippe Menasché (Bichat-Claude Bernard Hospital, Paris), who is working on using stem cells from other parts of the body to help regenerate the heart, dismisses the idea of completely regenerating a heart. "At best, these cells may help enhance other treatments, " he says. He is contradicted by Dr Robert Lanza (Advanced Cell Technology), who predicts a biological artificial heart could be in trials in 15 years.
Quality of life
The core of the debate is quality of life, the article concludes, quoting Dr Claude Lenfant (Director, National Heart, Lung, and Blood Institute), "What quality of life can a total-heart-replacement patient expect? Will there be meaningful clinical benefits to the patient? Is the cost of this therapy acceptable to society?"
The article ends with Robert Tools's wife, Carol, who believes the AbioCor did provide a decent quality of life for her husband. "He had a chance to live quite well," she says, "although unfortunately it was shorter than we would have liked. He never had any regrets about it."
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