X-Rays Detect Fractures in Heart Devices

Researchers experimenting with a new X-ray method have successfully identified life-threatening cracks in heart valves, suggesting new hope for thousands who live with the potentially defective devices implanted within them, Shiley Inc. of Irvine announced Sunday.

Shiley officials were cautious about spreading undue optimism over the success of the procedure, saying that the full extent of the studies will not be completed until late next year.

Surgeons at a Michigan hospital removed Marion F. Genteman’s artificial valve Nov. 1 after the X-ray technique identified a fracture. When researchers examined the 72-year-old retiree’s removed valve, they confirmed the existence of the tiny crack. The efficacy of the technique has also been confirmed in two other patients in similar circumstances, the company said.

The procedure is encouraging news for thousands of patients who have lived for years in uncertainty, not knowing whether their surgically implanted valves are flawed. The Shiley valves have been implanted in about 51,000 people worldwide until 1986. Of those, 300 have died after the valves fractured.

In an effort to identify flaws, doctors conducting a yearlong study at William Beaumont Hospital in Royal Oak, Mich., will scan 300 patients who have been fitted with the Bjork-Shiley convexo-concave valves, Shiley said. The researchers are using the experimental technology to detect tiny cracks. So far, about 60 patients have been scanned.

“We have to be cautious to warn people not to think that this approach has been scientifically validated,” Robert Fauteux, a spokesman for Shiley, said. “We don’t want to miscommunicate about the virtues and certainties of this technique. We believe we will not be able to validate it until the full research is completed.”

The only current method for detecting a faulty valve is exploratory surgery, but that procedure is life-threatening, with a 5% mortality rate. Shiley, along with its parent company, Pfizer Inc. in New York, have maintained that the risks involved in replacement surgery are greater than not having the valves removed.

Still, of 10 studies that the company has sanctioned, the Beaumont Hospital project is furthest along. The same patients at Beaumont also are taking part in an acoustical analysis of their valves, but the data has to be analyzed.

The research is only being done on patients who have the artificial device to replace their mitral valves, the company said. Patients who have artificial mitral valves are considered to be at a higher risk than those who had their aortic valve replaced.

Last August, a federal judge in Cincinnati approved a $215-million settlement offer that Shiley made to recipients of the valves, which were sold between 1979 and 1986. That agreement included $75 million that is to be used for valve-related research, like the method disclosed Sunday.

In addition, valve recipients will receive up to $4,000 in cash and other benefits, including medical or psychological consultations.

Those implanted with the Shiley heart valves have described them as time bombs waiting to go off. Patients have said they dread the day when they no longer hear the soft clicks emitted from the valve, a sign that they may have cracked and are no longer functioning.

Pfizer is funding the settlement by selling off most of Shiley’s assets and with insurance reimbursements.