Summary of comeal transplant activity Eye Bank Association of America.

Abstract

Each year, the Eye Bank Association of America (EBAA) reports statistics on the corneal transplant activity in the United States. 1 Eighty member eye banks in the U.S. reported statistics for the year 2000 to the EBAA. Herein, we provide to the readership of Cornea a small selection of material from the annual EBAA statistical report that will profile the corneal donation and transplant activity in North America and will highlight some of the current challenges facing the U.S. eye banking system. Statistics from the past decade indicate that there were fewer corneal transplants performed in the U.S. in 2000 (33,260) than in 1990 (36,037). During this decade, the distribution of corneas for transplant to international sites increased steadily, which more than accounts for the difference. In 1990, 2,726 corneas were exported (7% of the total). Ten years later, the figure exported was reported at 13,689 (29% of the total). Thus, in the year 2000, growing international demand contributed to an increase in the total amount of tissue provided for transplant: 46,949 compared with 38,762, in 1990 (Fig. 1).FIG. 1.: Annual number of corneal transplants; 1990–2000.Seventy-seven eye banks reported recipient diagnoses for the year. The total number of cases with specific recipient diagnoses reported remained approximately the same–31,532 in 2000, compared with 32,394 in 1999. This represents 67% of the corneas distributed by the 80 U.S. eye banks reporting for the year 2000 (Fig. 2)FIG. 2.: Recipient diagnoses 2000.The decrease in the number of corneal transplants performed in the U.S. today, compared with 10 years ago, invites the question of what factors are affecting the demand. Has the need (or clinical indications for) corneal transplantation decreased, or are other factors influencing access to corneal surgery? One possible consideration is the continued transition to newer, less traumatic techniques of phacoemulsification with a resultant decline in the prevalence of pseudophakic corneal edema. In the U.S. today, any patient who is an appropriate candidate for corneal transplantation can be assured of the availability of a cornea suitable for transplant. Tissue is always available for an emergency, and eye banks are providing an adequate number of corneas for elective transplant within the US. Significant attention has been paid by the government to the number of patients on the waiting list to receive organs for transplant. The “waiting list” for corneas is not comparable to waiting lists for organ donation and does not have the same meaning. The corneal transplant waiting list of 1,125 patients represents patients who are candidates waiting for keratoplasty, but whose procedures have been delayed because of elective factors such as a temporary postponement by the surgeon, the patient, or both. Some surgeons defer surgery until their personal criteria for tissue characteristics are met. The majority of these “criteria” relate to donor age. The National Eye Institute, the Castroviejo Cornea Society, and the Eye Bank Association of America have partnered in the sponsorship of the Cornea Donor Study (CDS), a 5-year prospective masked trial designed to determine the safety and efficacy of using older donor tissue for keratoplasty. If the hypothesis of the CDS, that older donor tissue is equally as safe and efficacious as younger tissue, is validated, the potential donor pool will be greatly expanded nationally and internationally, and there will be little rationale for the refusal of tissue on age criteria alone. In a 1-year comparison, donations declined insignificantly, with a 1.5% change reported. For the first time, a greater number of banks reported a decline rather than an increase (42:34). Decreases ranged from minimal to severe, with more than one bank reporting declines of up to 36%, a number that has to be of concern to the communities they serve. Conversely, reported increases were curious, ranging from +0.2% to an astounding + 116.7%. The likely explanation for these fluctuations is the influence of increasing federal regulation. In the future, the effects of greater federal regulation of the transplant community may become an important contributing and even controlling factor in the ability of banks to provide corneal tissue for transplant. For example, the 1998 “COP Rule,” (42 CFR Part 482) promulgated by the Department of Health and Human Services (HHS), identified “conditions of participation” for hospitals that participate in Medicare and/or Medicaid and mandated calls on every death. The same rule established organ procurement organizations (OPOs) as the “gatekeeper” for this system. Eye banks that lacked an area wide network before the implementation of the rule may have benefited from a sharp increase in donor calls, as other banks, with a historically independent and well-established system, suffered a decline in donor calls and donation. The new rule has clearly produced a different relationship between eye banks and sources of tissue donation. In some cases, this has been to the benefit of eye banks; however, it has eliminated the traditionally successful (and inexpensive) route of direct access to hospitals within their area. Many banks pay their area OPO or a third party contractor for every call and, as a consequence, referral costs have increased sharply. This has, in turn, necessitated (or will necessitate), an increase in the overall “processing fee” that is charged to recover costs associated with procurement and distribution of tissue. In an attempt to control costs, a number of banks have developed strict criteria that eliminate older donors and tissues clearly intended for research. Eye banks that function as part of a tissue and/or organ entity reflect the same inconsistency as freestanding eye banks in the current statistical report. A total of 17 of these organizational members reported statistics for the year 2000. Their total eye transplant tissue decreased in one year from 13,048 to 12,554, a 3.8% decline, again, not significant, but not easily explained. Eyes provided for research increased by 5.5%, a surprise in light of reported steep declines by several organizations that place only research tissue. However, the number of eyes provided for training and education declined 29% in one year. Eye banks clearly are deferring donors whose tissue cannot be used for transplantation or research activities at a reimbursement that would meet their costs. This is a trend that may continue, given the continuing emphasis on increasing federal requirements, the need for responsible cost recovery, and balanced budgets. Procurement and distribution are expensive, both in terms of time and personnel resources and cannot always be justified without suitable reimbursement in light of today's economic pressures. The procuring eye bank distributed 23,941 grafts to its self-defined service area. When an eye bank distributes to another U.S. bank outside its procurement area or sends tissue outside of the U.S., the tissue is identified as “exported.” In 2000, 23,009 corneas-a number almost equal to local distribution-were exported. The total number of tissues exported internationally rose by approximately 1000 between 1999 and 2000, to 13,689. This figure is in contrast to the previous year when international exports gained 3,000 tissues, almost 25% (1998:9,718; 1999:12,745). Despite increases over the past decade, there is real potential for the number of corneas made available internationally to decline in future years, unless eye banks can balance the costs of procurement and distribution with the amount received from the importing bank or surgeon. A service integral to the mission of many banks has been the practice of offering corneas gratis or for a processing fee that does not cover the cost of recovery, in need based instances. This has applied to both the U.S. and international communities. Historically, eye banks have made up the difference through community fundraising; however, this avenue, too, has tightened. The economic pressures on American eye banking will continue. Eye banks-all not-for-profit organizations-must adopt business practices to survive in an increasingly regulated and competitive environment. For example, ten eye banks that distributed a total of 7,000 tissues internationally in the year 2000 did not indicate specific distribution sites. This reflects the increased competition among banks and a desire to “protect” market share. As a result, information as to which areas outside the U.S. are regularly receiving tissue from U.S. banks or the amount of tissue being distributed to them is not entirely reliable. The EBAA statistical report for the year 2000 reflects the successes and the challenges faced by American eye banking in its responsibilities to the American public, as well as to the international community. The complete statistical report can be obtained through the office of the Eye Bank Association of America 1015 18th Street, NW, Suite 1010, Washington, DC, 20036. Phone: (202) 775-4999. E-mail: [email protected] The authors thank Dr. James McNeill for his valuable service to the EBAA by providing an analysis of transplant indications in North America.