Researchers Try X-Ray Test to Find Heart-Valve Cracks : Medicine: The non-surgical method may give hope to those of patients with potentially defective Shiley valves.
Shiley Inc. said Thursday that researchers have launched human clinical studies to search for life-threatening cracks in potentially defective heart valves that the company sold until 1986.
If it works, the procedure, being tested at a Michigan hospital, could ease the suffering 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 after their defective valves fractured.
Cypress resident Cornelius Lucey, who has had a Shiley heart valve since 1982, is hopeful that the procedure will give him peace of mind. “I could make some important decisions in my life,” he said. “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 Bjork-Shiley Convexo-Concave valves, Shiley said. The researchers will be using experimental X-ray technology to detect tiny cracks.
“We feel this is very promising research,” said Dr. William O’Neill, a Michigan cardiologist who is heading the study.
The study is not being conducted to identify patients with flawed 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 surgery--whether a patient is carrying a defective valve.
Of 10 company studies now underway, company officials said, the Beaumont Hospital project is furthest along.
The only current method for detecting a faulty valve is exploratory surgery, but that procedure can be life-threatening and many patients have not considered that a viable option.
For heart-valve recipients who settled a class-action lawsuit against Shiley and its parent, New York-based Pfizer Inc., 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 about half of 75 patients in that suit.
He questioned the timing of the announcement, however, coming as it did less than two months after the settlement was approved.
Capretz said many patients fitted with Bjork-Shiley 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 valve, which Shiley marketed 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 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, the findings would be published 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.
