Shiley Heart-Valve Recipients Are Focus of Worldwide Search : Health: The Irvine firm has hired non-profit Medic Alert to track down 55,000 patients at risk of death if their implants fail.

Keith Hollingsworth, 79, a retired farmer from central Florida, was disturbed by stories that he read several weeks ago in the Orlando Sentinel about fatal fractures of a heart valve manufactured by Shiley Inc. of Irvine.

The stories troubled Hollingsworth because he had such a device implanted in 1981 after he suffered a massive heart attack. Anxious for more information, he called Shiley, who, in turn, referred him to Medic Alert Foundation International in Turlock.

A nonprofit organization best known for providing bracelets and necklaces to individuals with special medical risks, Medic Alert was recently hired by Shiley to find and inform 55,000 patients with implanted valves about the symptoms and possibility of malfunctions.

The search for Shiley heart-valve recipients is unprecedented in scope. It entails an international hunt for people who may have received the valves up to 14 years ago. No one knows how much the effort will cost, how long it will take or how many lives it might save.

The program is being closely monitored by the U.S. Food and Drug Administration and could serve as a prototype for registries that all manufacturers of medical implant devices soon will be required to establish under legislation recently enacted by Congress.

So far Shiley has committed $2 million to at least a yearlong search for 23,000 heart-valve recipients thought to be living in North America. More will be spent to find another estimated 32,000 valve recipients residing overseas, mostly in Europe.

A Change in Course

The decision of Shiley, a subsidiary of Pfizer Inc., the New York-based pharmaceutical company, to launch the search for valve recipients represents a change in corporate philosophy and a yielding to outside pressures.

The company began selling the Bjork-Shiley Convexo-Concave heart valve in the late 1970s. The device prolonged the lives of patients whose hearts were weakened by disease, congenital deformity or other maladies. But problems began to appear soon after the valve hit the market.

A valve fracture poses the threat of death within minutes or hours. If the struts holding a disc in place break, an uncontrolled surge of blood is released that can cause the heart to pump to exhaustion.

So far, 313 ruptures of the Bjork-Shiley valve have been reported to the FDA, resulting in the deaths of 204 people. Shiley argues that the threat of failure is slim and the risks of replacing the valve--without an actual fracture--are too great to undertake.

Walter Gundaker, acting director of the FDA’s center for devices and radiological health, agreed that the number of valves that fracture is small in percentage terms--0.07% or 7 in 10,000 per year. But two-thirds of those whose valves have fractured have died.

“No other valve has had the fracture rate that this valve has had,” Gundaker said.

Allegations surfaced in congressional hearings last year that Shiley and federal health authorities did not move fast enough to pull the valve off the market after problems were detected in the early 1980s. They were also criticized for not making efforts to inform patients of the potential problems.

Numerous lawsuits have been filed against Shiley and Pfizer by relatives of the deceased, recipients who live in fear that their valves could fail and Public Citizen, a consumer-interest group based in Washington. This month, a class-action lawsuit was filed against Shiley in federal court in Los Angeles seeking “billions of dollars” for valve recipients.

With urging from the FDA, Shiley in 1986 voluntarily stopped manufacturing the controversial valve and recalled all unused valves. But until now, the company had resisted requests that it inform all valve recipients of potential problems.

Since 1980, Shiley periodically has sent letters to heart surgeons and cardiologists to alert them about the valve problems. But Public Citizen complained that the letters were not compelling enough and that physicians were not always willing to notify patients.

Finally, last August, after the FDA told the company that it was considering ordering it to begin notifying patients, Shiley announced that it would voluntarily establish such a program.

Help Offered

Donald Nichols, vice president of business development for Medic Alert, first heard about the controversy surrounding the Shiley valve from the television news program “20-20” in January, 1987. He immediately sent a letter to Shiley offering assistance. There was no response.

Last February, Nichols heard that Shiley had hired Dr. Roger Sachs as medical director. Sachs was put in charge of the sensitive valve issue, and Nichols wrote directly to him. “He (Sachs) immediately said, “Let’s talk,” Nichols recalled.

Sachs liked what he heard and saw at Medic Alert. “Medic Alert seemed an answer to some of our problems,” he said.

As a nonprofit organization, Medic Alert for 35 years has provided bracelets and necklaces that in an emergency will identify people with special medical risks, such as those with diabetes or with allergies to particular drugs.

A low-key operation, Medic Alert was founded in the farming community of Turlock, near Modesto, by Dr. Marion Collins. He wanted to provide a service for people like his own daughter, who was severely allergic to tetanus shots.

The foundation now maintains a computer system that keeps track of 3.5 million people worldwide who wear its identifications. The registry contains current medical information that is provided to physicians who can call its 24-hour, toll-free number.

Medic Alert also took over an international medical device-implant registry in 1988 at the request of a nonprofit medical product research group in Pennsylvania. Currently the registry has 20,000 patients on file with a wide variety of implants ranging from pacemakers to breast prostheses. This registry--although still in its infancy--is considered the most comprehensive and sophisticated service available.

Sachs said Shiley hoped Medic Alert would use its registry experience to locate valve recipients. He said Shiley believed that the foundation would obtain greater cooperation from the medical community than the company because of its nonprofit status, concern for confidentiality of medical records and its reputation as “an honorable group out there for the patients’ good.”

Aided by Computer

To do the job, Medic Alert has developed customized computer software for the valve-registry program. It has set up a separate bank of 20 telephone lines manned by operators who have fielded 10,000 calls from patients, hospitals and physicians since the program was announced Dec. 13.

The purpose of the search is to alert valve recipients to the rare--but very real--possibility that their valve could rupture. But the patients also are told that the risk of replacing a properly functioning valve is greater than gambling that the implanted device will not fail.

Medic Alert explains the risk of fractures to valve recipients who inquire, although the telephone operators have been trained not to discuss the current death rate resulting from the failures, according to Julie Watts, vice president of the heart valve notification program.

So far, most callers, like Hollingsworth in Florida, have learned about the potential danger of the Shiley valve through the media, Watts said. Hollingsworth said his initial concerns were alleviated after he learned about the low odds of fracture.

“I’m not scared a bit. I’m glad to be alive,” he said. “If I hadn’t had the valve, I would be counting grass roots from the bottom side.”

But Hollingsworth also said he now realizes how crucial it would be for him to get promptly to an open-heart surgery center if his valve fails. So he now has a plan. “I would try to get to South Orlando as quick as I could,” he said. “It would probably take me an hour and a half. But that is the closest place that has a hospital that could do me any good.”

And to ease patient concerns, Medic Alert is issuing necklaces or bracelets to individuals with Shiley valves so that medical personnel would be quickly alerted to a problem with the heart device in an emergency.

The foundation is paid $25 for each patient it places in the registry. It will receive $10 per person annually to update records. So far, 1,500 valve recipients have been entered in the registry.

A Difficult Task

The search for patients is not always easy, and Medic Alert is trying to muster help from many quarters.

Shiley supplied information cards to be filled out by hospitals when the heart valves were implanted. But fewer than half of the cards were returned to Shiley. Moreover, cards that were returned give the patients’ names, but not their addresses or phone number.

Medic Alert so far has sent letters or telegrams asking for help to 19,000 cardiologists and heart surgeons and 475 hospitals in North America. About 200 hospitals have already agreed to cooperate and 15 have declined.

Hospitals and physicians who have not responded will hear from Medic Alert by telephone. This month, Medic Alert has been placing full-page advertisements in major medical journals asking for physicians to refer their patients to the registry. As an incentive for hospitals to search their archives for medical records--some implants occurred as early as 1976--Shiley has agreed to reimburse the facilities for their efforts. Still, the records are often outdated, failing to reflect changes of addresses as patients move.

Besides seeking help from hospitals and physicians, Medic Alert officials say they plan to consult with consumer credit operations and perhaps appeal for help from the Social Security Administration.

While some doctors say they are cooperating with Medic Alert as a public service, they may have other reasons.

Dr. Thomas J. Berger, a cardiac surgeon at Montana Deaconess Medical Center in Great Falls, Mont., said he wants to reassure his patients that the risk of a valve failure is “quite small.” But he also wants to protect himself from lawsuits.

Berger, who contends that the potential danger from the valve has been blown out of proportion, said he does not believe the notification is medically necessary. But he contends that it is necessary legally for Shiley and the doctors involved.

“We’re covering our ass and they are covering their ass,” he said. “This whole thing is a massive exercise in ass covering--and you can quote me.”

Sachs, however, denied that legal issues were a major motive for the notification program. “I don’t know if there will be more or less litigation from this,” he said.

Medic Alert is encouraging physicians to answer their patients’ questions about the valve and tell them what symptoms may signal a valve failure, such as shortness of breath and dizziness.

Watts said that doctors who send the names of valve recipients to Medic Alert are mailed packages of information to give to their patients. If the physician does not contact his patient within 35 days, information is sent directly to the valve recipient, she added.

The foundation carefully designed a notification letter for valve recipients designed to avoid frightening them. That was in response to concerns of patients who participated in focus groups and risk management experts, Watts said. The possibility of death from a fracture is not mentioned until the second page of the three-page letter.

Also, the letter is tailored to individual patients, Watts said, spelling out the specific risk associated with their own valves. A particular valve’s risk of fracturing varies, depending on the year in which it was manufactured, she explained.

A Shaky Start

The progress of Medic Alert’s notification program is being monitored by the FDA.

The kickoff of the program did not go smoothly. FDA approved the plan to contact physicians but criticized the packaging of the notices as having “the appearance of slick, promotional material for a new product rather than a notice about an important health issue.”

In response, Medic Alert agreed to put large, red lettering on the envelope of the packages, indicating that “important public health information” is enclosed, and changed the color of the ink on the introduction to Shiley’s letter to physicians from blue to red. Also, the foundation has followed the letters to physicians with telegrams to further catch their attention. Medic Alert attributed the brief tempest to the fact that the packaging it designed was not reviewed by the FDA before mailing.

As a nonprofit foundation, it operates independently--”at arm’s length”--from both Shiley and federal regulators. Medic Alert says it will not make valve recipients’ names available to Shiley, the FDA or attorneys involved in suits over the valve.

But the FDA’s Gundaker said: “Clearly, we are requiring Shiley to track patients and if something goes wrong with the program, we won’t go back to Medic Alert but to Shiley.”

Despite confusion with the start-up of the program, Mark Barnett, the FDA’s assistant director for education and communications, said that agency representatives toured Medic Alert’s operations last week and were favorably impressed.

Kenneth W. Harms, president of Medic Alert, said he hopes that its work for Shiley will be successful enough to convince other implant-device manufacturers to use Medic Alert’s registry service.

Harms said he will lobby the FDA to allow independent registries such as Medic Alert’s to satisfy the Safe Medical Devices Act of 1990 that was signed into law Nov. 28. The federal law will make manufacturers of life-sustaining implants responsible for maintaining patient registries. This will be a major task, since about 1.5 million medical devices are implanted each year in the United States alone.

Gundaker said the law gave the FDA 18 months to adopt regulations that will define exactly how the registries should operate. He said it is “too early to tell if Medic Alert would satisfy all the requirements,” although he added that the Turlock organization “has the right intent and the right ingredients.”

The purpose of the registries, Gundaker said, is to make it easier to contact appropriate patients and doctors when product recalls or other health advisories regarding medical-implant devices are initiated by manufacturers or the FDA.

“Hopefully in the future we will never have to go through a similar situation to Shiley,” he declared.

Potentially Fatal Failure

Distribution of the Convexo-concave 60 Degree Valve was halted in 1986 as a result of fractures in a key component, the outflow strut. When the strut breaks, the tilting disk no longer opens and closes properly to control the flow of blood. Replacement Location for Aortic Valve Rising pressure in the atrium pushes open the mitral valve and the ventricle fills with blood. As the ventricle contracts, increased pressure closes the mitral valve. The arotic valve opens and oxygenated blood flows to the body. Shiley valves have been used to replace both mitral and Aortic valves.

OUTFLOW STRUT Structural problems have occured at the welds joining the outlet strut to the valve’s metal ring.

If you have questions about the Shiley heart valve registry program, call Medic Alert at this toll-free, 24-hour number: 1-800-245-1492.