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Epidemiologic Notes and Reports Update: Creutzfeldt-Jakob Disease in a Second Patient Who Received a Cadaveric Dura Mater Graft

In late May 1988, a 25-year-old man from New Zealand developed a rapidly progressive dementia 31 months after neurosurgery for head injuries sustained from a fall. During surgery, extensive, bilateral dura mater tears were repaired with imported, commercially prepared cadaveric human dura mater grafts. The patient died July 31, 1988, and Creutzfeldt-Jakob disease (CJD) was confirmed by brain necropsy, which demonstrated spongiform encephalopathy. He had no family history of degenerative neurologic disease, nor had he received cadaveric, pituitary-derived human growth hormone. Previous major surgery included an appendectomy at age 10. An ongoing investigation by the New Zealand Department of Health determined that the dural grafts used in this patient were LYODURA, processed by B. Braun Melsungen AG of the Federal Republic of Germany; the lot numbers are unknown. Reported by: TJ Nisbet, PhD, Office for Inquiries, New Zealand Dept of Health; I MacG Donaldson, MD, FRACP, FRCP, Christchurch Hospital, Christchurch, New Zealand; SN Bishara, MCh, FRCS, FRACS, Dunedin Hospital, Dunedin, New Zealand. Food and Drug Administration. Hospital Infections Program and Div of Viral Diseases, Center for Infectious Diseases, CDC. Editoral Note: This is the second patient reported to CDC who developed CJD after receiving a lyophilized, irradiated, human cadaveric dura mater graft, LYODURA. The first patient was a 28-year-old woman from Connecticut who had received her graft, LYODURA (lot 2105), during a surgical resection of a cholesteatoma 19 months before onset of CJD (1,2). The young age of the patient from New Zealand and his recent surgery using the same brand of dura mater graft that was implicated as the source of the CJD agent in the U.S. patient strongly suggest that his dural grafts were the vehicle of transmission of the CJD agent. The surgeries during which LYODURA grafts were used in the two patients were performed within a 6-month period in 1985. Lot 2105 was not distributed to New Zealand. Whether these grafts were produced around the same time is unknown.

This second case of LYODURA-associated CJD supports a published conclusion of the joint CDC/Food and Drug Administration (FDA) investigation of the first patient that "LYODURA may carry a higher risk of transmitting CJD than other dura mater products used in the United States" (2). In June 1987, representatives of B. Braun Melsungen AG reported that their procedures for collection and processing of dura after May 1, 1987, were revised to reduce the risk of CJD transmission.

On April 28, 1987, FDA had issued a safety alert recommending disposal of all LYODURA from packages bearing a four-digit lot number beginning with the digit "2" (code for material packaged in 1982), as well as all unmarked LYODURA (3). Because the lot numbers of the LYODURA used in the New Zealand patient cannot be determined, however, it now may be prudent to avoid using LYODURA produced before the manufacturer's reported changes in procedures were instituted.

The methods of producing and distributing human tissue products, including dura mater grafts, are not routinely subjected to FDA inspection and approval. Health-care providers are urged to use human tissue products that have been handled according to strict guidelines, such as those established by the American Association of Tissue Banks (4,5). In addition, hospitals should maintain records so that infections associated with human tissue products can be linked with specific lot numbers of the specific products.

Previous and current patients who have rapidly progressive dementing illnesses consistent with CJD and who have received a dural graft during an operative procedure should be reported through their appropriate state health department to L. Schonberger, M.D., Division of Viral Diseases, Center for Infectious Diseases, CDC, Building 6, Room 127, Mailstop A32, Atlanta, Georgia 30333; telephone (404) 639-3091.

References

  1. CDC. Rapidly progressive dementia in a patient who received a cadaveric dura mater graft. MMWR 1987;36:49-50,55. 2.CDC. Update: Creutzfeldt-Jakob disease in a patient receiving a cadaveric dura mater graft. MMWR 1987;36:324-5. 3.Food and Drug Administration. FDA safety alert: possibly contaminated dura mater transplant material. Rockville, Maryland: US Department of Health and Human Services, Public Health Service, April 28, 1987. 4.American Association of Tissue Banks. Standards for tissue banking. Arlington, Virginia: American Association of Tissue Banks, 1984. 5.American Association of Tissue Banks. Technical manual for tissue banking: section II--Musculoskeletal Council. Arlington, Virginia: American Association of Tissue Banks, 1987;M-1 to M-25.



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