In April 2001, three months prior to the first implant of the AbioCor artificial heart, ABIOMED announced a somewhat unusual "information dissemination policy," developed partly in response to the media frenzy that enveloped the
Jarvik-7. (7) The policy stipulated that, to protect patient privacy and insulate clinical teams, thereby allowing them to focus on patient care, no advance announcement would be given of the time or location where an implant was to be performed.
Four more patients received the
Jarvik-7, and also suffered complications ranging from stroke to mechanical failure of the device.
Simultaneously, the
Jarvik-7 artificial heart made headlines again when the FDA officially withdrew approval of the device's continued experimental use because of deficiencies in its manufacture and quality control and in the monitoring of its clinical use.
Further proof that artificial hearts were here to stay came in 1982 when William DeVries, a surgeon at the University of Utah implanted an air-driven device, the
Jarvik-7, in Barney Clark.
William DeVries of the Human HeartInstitute in Louisville, Ky., placed the plastic-and-metal
Jarvik-7 artificial heart in Schroeder's chest one week later, on Nov.
Among artificial heart recipients, William Schroeder of Jasper, IN, lived the longest, surviving 620 days with a
Jarvik-7 until his death in 1986.
The relationships among members of a health care team that is using the
Jarvik-7 are easily influenced by financial and public relations interests, as the move of implant surgeon William De Vries from the University of Utah to the Humana Hospital Corp.
The newly approved model differs from the
Jarvik-7, which has federal approval for four more implants.
The
Jarvik-7 and other artificial hearts of the 1980s tethered patients to bulky external consoles that dramatically limited their quality of life.
Some medical ethicists question the Arizona team's decision to use the Phoenix heart rather than the
Jarvik-7, the FDA-approved permanent artificial heart developed at the University of Utah that has been implanted in three people since 1982.
Barney Clark, in 1982, was the first person to receive a
Jarvik-7 LVAD.
The 1985 report was issued in the flush of excitement and publicity surrounding the implantation of
Jarvik-7 pneumatic artificial hearts on a permanent basis in four patients--William Schroeder, Murray Haydon, and Jack Burcham in Louisville, KY, and Leif Stenberg in Stockholm--since November 1984.