Dr. Lenfant's announcement of the funding suspension is not well received by four TAH contractors. Senator Orrin Hatch (RUT), ranking Republican on the Senate committee that authorizes the NIH, and Senator Edward Kennedy (D-MA), chairman of that committee, take the lead in pressuring NIH to restore funding to the TAH systems development. Senator Hatch, with the backing of Senator Kennedy, drafts legislation that would require NIH to fulfill existing contracts like those supporting the TAH development before starting any new programs and prohibits the agency from cutting existing programs by more than 10 percent. In support of their action, the senators note that the NHLBI Advisory Council that ratified NHLBI's decision had appealed for more funding to continue the artificial heart program. NIH subsequently restores funding to the TAH contractors.

1989

NHLBI asks the Institute of Medicine (IOM), through its Council on Health Care Technology, to undertake an evaluation of NHLBI's artificial heart program. Given the breadth of the proposed study, the IOM and NHLBI agree that it should be conducted in two phases. The first is to be a five-month planning phase involving a committee to define the scope of study and the specific tasks to be accomplished. The second is the evaluation itself, which will be a more lengthy evaluation by another committee to be appointed by the IOM.

By April, the Jarvik-7 total artificial heart has been used in 92 patients as a potential bridge before transplantation: 63 received new donor hearts and 35 survived.

In May, IOM is awarded a contract to conduct the planning study.

In August, NHLBI releases a request for proposal for a Clinical Evaluation of Implantable Ventricular Assist Systems for Human Subjects with Chronic Refractory Heart Failure, and funds a contract to produce 30 medical-grade totally implantable LVADs for use in patients with end-stage heart disease.

1990

In March, IOM is awarded a contract to conduct the evaluation proposed in the 1989 IOM planning committee's report, The Artificial Heart Program of NHLBI: Plan for Evaluation;in mid-year, the NHLBI funds contracts with St. Louis University and the University of Pittsburgh for a joint clinical trial of 20 Novacor LVADs.

1991

In mid-year, IOM completes its evaluation for NHLBI and issues its report, The Artificial Heart: Prototypes, Policies, and Patients.



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