Heart Valve Patient Search

The odds of survival were significantly improved for wearers of a particular artificial heart valve, whose fracture had been implicated in nearly 400 deaths. The improved odds were the result of a public relations program that identified and located wearers of the valve.

During the 10 years before the valve was withdrawn from the market, the manufacturer kept no records of implant recipients. It was estimated that 23,000 valve recipients resided in the United States and Canada.

The search was conducted by Medic Alert Foundation, Turlock, Calif., with a grant from Shiley Inc., Irvine, Calif., manufacturer of the Bjork-Shiley Convexo-Concave (C-C) heart valve. PCI created and conducted the public relations campaign.

A review of the literature showed that the proposed search for heart valve recipients was without precedent; no one ever before had attempted a retrospective search for medical implant patients. Consequently, the heart valve program would be a model for any future efforts to identify and locate patients with other kinds of implants.

The objectives of the communications program would be to identify and locate wearers of the valve to provide them with information and to register them so that future information could be easily communicated. The goal was to potentially save their lives.

A three-part communications program targeted cardiac specialists, hospitals where the valve was implanted, and the general public through the media.

Messages and prototype materials were tested in a series of focus group interviews with C-C heart valve recipients and physicians. When some patients appeared to be excessively alarmed by the information presented at the focus groups, the communications were revised to be more reassuring.

Accommodations had to be made for special sensitivities:

• Communications had to reach heart valve wearers without creating undue alarm. Heart valve fracture, although frequently fatal, is rare.
• Volunteer cooperation was needed of physicians and hospitals, many of whom would be asked for significant commitments of time, personnel and expense.
• The hospital records to be searched were confidential and, in most instances, archived.
• The patient search was under careful scrutiny by the FDA, consumer groups such as the Public Citizen's Health Research Group, as well as members of Congress and staff involved in passage of the Safe Medical Devices Act of 1990.

Components of the physician campaign included information kits distributed by UPS Next Day Air to 19,800 cardiac specialists in the United States and Canada . . . follow-up registered Mailgrams to confirm receipt of the information kits . . . a toll-free in-bound telephone number for physicians to provide identification of implanted patients . . . placement of information about the campaign in the news columns of medical trade media . . . a supplemental paid advertising campaign in nine journals . . . an exhibit booth at major medical meetings.

Components of the hospital campaign included a Western Union Priority Letter to chief executives at 451 hospitals where the valve was implanted . . . telephone follow-up with all hospitals to confirm participation . . . personnel and financial assistance to individual hospitals for their search of patient records . . . meetings with professional associations representing hospital executives and medical record administrators for endorsement of the campaign.

Components of the public campaign included a national media relations program launched with a Washington, D.C., press conference . . . a toll-free telephone number for heart valve wearers and family members to obtain information . . . a patient information kit . . . media coaching for spokespersons for the heart valve program.

The success of the campaign was measured by the numbers of heart valve recipients identified and located:

• 16,737 C-C heart valve recipients identified (73 percent of the estimated 23,000 total valve wearers).
• 51 hospitals pledged to participate in the search patient records (100 percent of the 451 hospitals that implanted the valve).
• 106 million newspaper, television and radio impressions for the toll-free consumer hotline telephone number.
• 19,619 calls to the toll-free hotline telephone number.
• 20,000 physicians pledged participation in the program to identify and locate patients.

Media publicity was the principal way in which the majority of registered implant wearers learned about the patient search. This was confirmed in an audit of the campaign conducted by an independent research firm. The firm's survey of a representative sample of registrants identified the following initial sources of information:

The heart valve patient search won six public relations awards:

• Creativity in Public Relations Award (CIPRA) for best crisis/issues management campaign, Inside PR.
• Gold Quill, International Association of Business Communicators.
• Touchstone Award, American Society for Hospital Marketing and Public Relations.
• Silver Anvil Certificate of Merit, Public Relations Society of America.
• Spectra Award, Chicago Association of Business Communicators
• Silver Trumpet, Publicity Club of Chicago.