U.S. Tightens Artificial Heart Use Rules
Artificial heart implants must comply with new monitoring and reporting restrictions that allow them to continue only with case-by-case approval from the government, the Food and Drug Administration announced Wednesday.
In adopting the recommendations of a government advisory panel, the FDA imposed the restrictions because of a history of strokes and other complications among patients who have received the controversial Jarvik-7 artificial heart.
Detailed Reports Required
The new requirements include the filing of detailed reports every three months on the condition of each patient in whom the device is implanted permanently. At the same time, the FDA banned emergency use of a small version of the Jarvik-7 until its safety can be reviewed.
Three of the six recipients of artificial hearts have died after serious complications and two of the survivors are suffering similar problems, leading critics to question the quality of life for those who receive the hearts permanently.
One of those critics, an attorney and professor of health law at Boston University, urged the FDA’s circulatory system advisory panel last month to place a moratorium on the implants. “An artificial heart cannot save their lives” but can “only change the manner in which they die,” the attorney, George Annas, maintained.
The panel recommended that implants continue to be allowed, but it urged the increased oversight that was imposed Wednesday. Dr. Robert Jarvik, inventor of the heart, had indicated no opposition to the recommendations, calling the panel’s proposals “a very workable way to proceed.”
No Comment by Surgeon
A spokesman for Dr. William C. DeVries of Humana Hospital Audubon in Louisville, who has performed two-thirds of the implants, said that DeVries had no comment on whether the new rules would inhibit his work. The spokesman said that DeVries will “continue to present any information” that the FDA requires.
DeVries was authorized in 1982 to perform seven implants and has performed four. The first recipient, Barney B. Clark, and another of DeVries’ patients, Jack Burcham, have died, Burcham after only 10 days. DeVries’ other patients, William L. Schroeder and Murray P. Haydon, are alive but have suffered serious complications, including debilitating strokes and internal bleeding and clotting.
In Sweden, Leif Stenberg received a Jarvik-7 heart last April and died seven months later. Mary Lund of Kensington, Minn., is reported in stable condition at Abbott Northwestern Hospital in Minneapolis.
FDA spokesman David L. Duarte said that the new guidelines would apply only to the permanent artificial hearts, not to “bridge” implants that are used until a natural replacement can be found for an irreparably damaged heart.
Two Sizes of Hearts
All five Jarvik-7 hearts implanted in men were full-size devices. Symbion Inc. of Salt Lake City, the manufacturer, also makes a smaller version, which was used as an emergency implant last month in Lund.
The full-size hearts still may be used as bridges, Duarte said, but he added that FDA approval must be sought for any additional emergency implants of the smaller heart because the device is still considered experimental.
