Research agency assesses total artificial heart implantation

A March 28, 2003, news release from ECRI indicates that total artificial hearts (TAH) could benefit thousands of people in the United States if they are proven safe and effective. More than 10,000 people experience advanced left and right ventricular heart failure in the United States each year. If medical management fails, they have few options. Heart transplantation is the most effective treatment, but the number of available donor hearts is fewer than the number of patients who need this procedure. Organ shortfall could be relieved by an effective TAH, and TAH could reduce costs and risks associated with lifelong immunosuppressive therapy, which patients who have undergone transplantation must have.

A new ECRI report, Total Artificial Heart (TAH) for Irreversible End-stage Heart Failure, addresses issues related to this emerging technology and focuses on a new device being investigated by the US Food and Drug Administration. This device consists of a thoracic unit and a transcutaneous energy transmission power system that can produce a blood flow of 4 L to 8 L per minute. The device's interior is smooth and seamless to reduce likelihood of clot formation.

Currently, the only way to receive this device is through participation in a clinical trial. Ten people who had a life expectancy of one month or less without a TAH or heart transplantation have participated in this trial. As of March 2003, two TAH recipients remained alive. The survival end point was 60 days, and more than one-half of the recipients surpassed this point, with one surviving longer than one year. Those surpassing the 60-day end point lived longer than expected.

In its report, ECRI outlines patient inclusion criteria for participation in the trial, which include that patients have end-stage heart failure and a life expectancy of fewer than 30 days. The device also must fit correctly inside the thoracic cavity and, because of its large size, will not fit in 80% of women and 50% of men. The report also addresses cost considerations, phase of diffusion, effect on other technologies, cautions and complications, adverse events, and legal and ethical issues. This is emerging technology; therefore, ECRI found no published evidence in peer-reviewed journals relating to use of a TAH as a permanent heart replacement device in humans.

ECRI Assesses Total Artificial Heart Implantation: Technology, Procedure, Risks, and Patient Outcomes (news release, Plymouth Meeting, Po: ECRI, March 28, 2003) http.//www.ecri.org/documents/032803.asp (accessed 1 April 2003).

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