X-Rays Used to Hunt for Flawed Heart Valves : Technology: Human clinical studies looking for cracks in the implanted devices manufactured by Shiley Inc. of Irvine could ease the anguish of thousands of recipients.

Shiley Inc. said Thursday that researchers have launched human clinical studies using experimental X-ray technology to search for life-threatening cracks in the company’s heart valves.

If proved accurate, the procedure, being tested at a Michigan hospital, could ease the anguish of thousands of heart-valve recipients who have lived for years in uncertainty, not knowing if their surgically implanted valves are flawed.

The Shiley valves have been implanted in about 51,000 people worldwide. Of those, 250 have died because of defects in the devices.

“I could make some important decisions in my life,” said Cypress resident Cornelius Lucey, who has had a Shiley heart valve since 1982. “I just feel like a walking time bomb.”

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 sometimes-faulty devices, Shiley said.

“We feel this is very promising research,” said Dr. William O’Neill, who is heading the study.

The study is not being conducted to identify patients with flawed implanted valves as much as to determine the accuracy of the experimental procedure, O’Neill said.

Until now, he said, patients and physicians “have been in a serious quandary” because there is no way to discover--short of death--whether a patient is carrying a defective valve.

This study, one of 10 under way, is furthest along, according to company officials.

Exploratory surgery to detect flaws can be fatal, leading worried patients to forgo that treatment and hope that their heart valves are good.

For heart-valve recipients who settled a class-action lawsuit against Shiley and its parent, Pfizer Inc. in New York, this week’s announcement is good news, the group’s Irvine attorney said.

“If this is true, I would say that it is a blessing,” said James Capretz, who represents 38 of 75 patients in that suit. Many of them live in Orange County.

He questioned the timing of the announcement, however, coming as it did less than two months after the settlement was approved.

Capretz said that many of the 20,000 patients fitted with potentially faulty valves did not join the class action and therefore may not be able to benefit from the scanning procedure if it proves to be successful.

“This has raised a lot of questions,” Capretz said. “Why wasn’t this (study) revealed as part of a settlement?”

The Bjork-Shiley Convexo-Concave heart valve, which was used in heart surgery from 1979 to 1986, was discontinued when researchers found that cracks occasionally appeared in valves that were manufactured during an 18-month period in 1981.

That revelation led to the lawsuit, which was settled on Aug. 19 by a federal judge in Cincinnati. The settlement provides heart-valve recipients with as much as $4,000 each, sets aside another $300 million for patients who in the future may suffer from fractured valves and designates $75 million for research on detection procedures.

O’Neill, who is heading the William Beaumont Hospital research project, said that neither he nor the company withheld information in order to affect the outcome of the settlement.

“That is just total nonsense,” O’Neill said.

Although he has been planning the study for 18 months, O’Neill said, there is not yet any scientific evidence that the procedure will actually work. If it does, he said, he will publish his findings in a medical journal.

Doctors conducting the human clinical trials have used a special X-ray device on 15 high-risk patients, O’Neill said. The patients are the first of 300 heart-valve recipients in the Midwest and East who were contacted by letter and invited to participate in the study.

Imaging of the heart valves will be analyzed by high-resolution computer equipment at Jet Propulsion Laboratory in Pasadena and the Cleveland Clinic, O’Neill said.

So far, researchers have found no defective heart valves. If the experimental procedure is accurate, O’Neill said, he expects to find between three and nine flawed valves by mid-1993, when the study is to end.