Group Urges Shiley to Pay Full Cost of Tests for Heart Valve Cracks

A support group for recipients of potentially defective artificial heart valves has called on the manufacturer to bear the full cost of making widely available an experimental technique to identify cracks in the devices.

VALV, based in Pittsburgh, also called on Shiley Inc. of Irvine and its parent, Pfizer Inc. of New York, to establish testing centers where implantees could conveniently get tests using the X-ray technique.

About 51,000 recipients worldwide have been implanted with the Shiley valves, which were made from 1979 to 1986. About 300 recipients have died when the struts that hold the device together pulled apart.

The detection device includes computerized X-ray equipment that can greatly enhance the image of an implanted heart valve and can show microscopic fissures in the metal before they become actual fractures. The procedure is in initial testing stages at a hospital in Michigan, and researchers say they have successfully identified cracks in three out of 70 patients examined.

“This device is something that we have been waiting and praying for a long time,” said Elaine Levenson, a founder of VALV and a heart-valve recipient. “(It) is a very exciting breakthrough which could help us better cope with the fact that we are living with a time bomb in our chests.”

Many recipients could not afford the cost of getting tests using the X-ray technique on their own, she said.

Pfizer said that a decision on whether such testing centers would be set up and if it would pay for their operation is “premature,” given that the X-ray technique faces a long series of federal approvals and has yet to be proved effective.

The company already said it would bear the cost to research and develop the technique under the terms of the settlement of a class-action lawsuit approved by a federal court in August.