2012 EYE BANKING STATISTICAL REPORT

Transcription

1 2013. EBAA. All rights reserved 2012 EYE BANKING STATISTICAL REPORT Eye Bank Association of America th Street, N.W. Suite 1010 Washington, DC Phone (202)

2 Table of Contents Introduction / Statistical Report Analysis 3 Referral Trends, Transplant and Conversion Rates - U.S. Eye Banks 12 Referral Trends, Transplant and Conversion Rates International Eye Banks 18 Donor Demographics U.S. Eye Banks 22 Donor Demographics International Eye Banks 27 Eligibility and Suitability for Tissue Intended for Surgery U.S. Eye Banks 30 Eligibility and Suitability for Tissue Intended for Surgery International Eye Banks 43 Reasons Released Tissues Were Not Transplanted U.S. Eye Banks 51 Reasons Released Tissues Were Not Transplanted International Eye Banks 54 Surgical Suitability of Corneal Tissue U.S. Eye Banks 55 Surgical Suitability of Corneal Tissue International Eye Banks 57 Outcomes of Tissue Recovered For Transplant U.S. Eye Banks 58 Outcomes of Tissue Recovered For Transplant International Eye Banks 62 Use of Donated Tissue U.S. Eye Banks 64 Annual Comparison of the Number of Corneal Transplants Supplied by U.S. Banks 65 Use of Donated Tissue International Eye Banks 66 Domestic Surgery Use of Intermediate-Term Preserved Tissue U.S. Eye Banks 67 Annual Comparison of the Domestic Use of U.S. Supplied Intermediate-Term 70 Preserved Tissue Domestic Surgery Use of Intermediate-Term Preserved Tissue International Eye Banks 72 International Use of Intermediate-Term Preserved Tissue U.S. Eye Banks 76 International Use of Intermediate-Term Preserved Tissue International Eye Banks 80 Long-Term Preserved Tissue Preservation and Distribution U.S. Eye Banks 83 Long-Term Preserved Tissue Preservation and Distribution International Eye Banks 87 Tissue Processing for Transplant - U.S. Eye Banks 91 Tissue Processing for Transplant International Eye Banks 95 Forwarded Tissue - U.S. Eye Banks 97 Forwarded Tissue International Eye Banks 99 Indications for Corneal Transplant - U.S. Eye Banks 100 Indications for Corneal Transplant International Eye Banks 107 Eye Banks Submitting Data for the 2012 Statistical Report 113 2

3 Surgical Use and Indications for Corneal Transplant Statistical Report Analysis Overview Enclosed is the Eye Bank Association of America s (EBAA) statistical report for In 2011, the EBAA began a new monthly collection methodology for the Statistical Report using EBAA CONNECT, a realtime, web-based statistical reporting and analytics engine designed specifically for the Eye Bank Association of America by Transplant Connect. In June 2011, the EBAA Statistical Report Subcommittee of the Medical Advisory Board became the EBAA Statistical Committee, under the purview of the EBAA Board. Quarterly reporting of monthly data within 30 days of the close of a quarter became required. Additional information was collected starting in 2011 on tissue lost along the recovery pathway. Additionally, the source entity for tissue became responsible for reporting on the utilization of tissue and recipient surgical diagnoses. Utilization was tracked in more detail, and numbers from each source eye bank had to add up so that tissue utilized and tissue destroyed equaled tissue recovered. The intent of the new formatting and methodology was to make the data collection process more accurate so the data becomes more useable year after year, more timely so that trends can be spotted earlier and easier to collect where data entry can be routinely entered electronically on the same template from each eye bank. The 2012 statistical report of the Eye Bank Association of America (EBAA) includes information on all 80 U.S. member eye banks reporting for the calendar year 2012 (there were 79 eye banks reporting in 2011). For reporting purposes, many eye banks include all of their facilities under one legal entity. For this reason, the 80 reporting eye banks in 2012 represent an essentially complete picture of the eye banking activity of the 84 member banks in the United States, as did the 79 member eye banks reporting data in Stratification of data on indications for transplant (utilization) has undergone continuous evolution and refinement since Prior to 2008, all keratoplasties were counted as penetrating keratoplasty. In 2008, pre-cut and uncut tissue utilization was stratified into penetrating grafts (PK), anterior lamellar keratoplasty (ALK), endothelial keratoplasty (EK), keratolimbal allografts (KLA), and tectonic grafts (TK). Keratoprosthesis (K-Pro) as a specific utilization was added in Because of modifications made since 2008 in the data collection process, exact comparisons of data after 2008 and with data prior to that date may not always be valid. Before 2009, domestic and international data from U.S eye banks were combined. In 2009 and 2010, stratified data was only collected for tissue distributed and used within the U.S. For 2011 and beyond, tissue provided by U.S. eye banks was stratified and separated into domestic and international use. International use of tissue sent from U.S. eye banks was generally not included in statistical analysis before

4 In 2011, international banks utilized a spreadsheet with reduced data collection points to report their data. However, international banks expressed enthusiasm about using the EBAA Connect data system after observing the data analysis capabilities developed by the EBAA. Beginning in 2012, eight international banks began using the EBAA Connect data system. In order to make this transition work, two categories used by American banks had to be adjusted for interpretation. American banks reported surgical uses by domestic placement (in the U.S.) and international placement (outside of the U.S.). International banks were instructed to interpret the data points as surgical use by domestic placement (in the country of origin) and international placement (outside of the country of origin). The 2012 EBAA Statistical Report demonstrates this change by placing American eye bank data analysis and international eye bank data analysis together in sections with commentary on both sources. This allows for better comparison between American and international eye banks. U.S. Eye Bank Tissue Utilization: Domestic eye banks reported 116,990 total tissue recoveries in 2012, an increase of 2.3% from 114,348 recoveries in had a 3.4% increase in recoveries over 2010 and 2010 showed an increase of 3.1% over was the first year that total tissue recoveries exceeded 100,000. Total donors in the United States in 2012 were 59,221, up 2.4% from 57,835 donors in In 2009 and 2010, data includes tissues distributed and used within the U.S. only. In 2011 and later, tissue from U.S. eye banks was stratified separately into domestic and international use. The emphasis of this analysis will be on tissue provided by U.S. eye banks in intermediate term storage solution for domestic use. Most (85%) of long term storage tissue is used for glaucoma shunt procedures was the first year that long-term preserved corneas exceeded sclera as the material of choice for glaucoma shunt procedures. However, a trend of decreasing glaucoma shunt procedures appears to have begun between 2011 and Keratoplasty Procedures: In the U.S., tissue supplied by U.S. eye banks for keratoplasty procedures of all types in 2012 (i.e., total transplants, both pre-cut and not pre-cut) was 68,681, a 1.6% increase from 67,590 in ,546 corneas were exported internationally in 2012 compared to 18,307 in 2011, a 6.8% increase. The number of penetrating keratoplasty grafts performed using U.S. supplied tissue in 2012 was 36,716, a 1.5% increase over 36,144 in However the number of penetrating keratoplasties performed in the U.S. with intermediate-term preserved tissue was 21,422, a 0.9% decrease from 21,620 in Penetrating grafts is one example where data comparisons before and after 2011 are less meaningful due to the modifications in the data collection process over the years. For this reason we have added a table and graph comparing the domestic use of U.S. supplied intermediate-term preserved tissue from 2005 to 2012 (page 70), showing a steady decline in penetrating keratoplasty. 4

5 24,277 corneas (both pre-cut and not pre-cut) were utilized for endothelial keratoplasty (EK) procedures using U.S. supplied tissue in 2012, a 4.2% increase from ,049 corneas were utilized for endothelial keratoplasty in the U.S. in 2012, a 6.9% increase from There had been a steady increase in tissue used for endothelial keratoplasty in the U.S. since 2005: a 12.5% increase in 2011 over 2010, a 5.1% increase in 2010, and a 4.3% increase in A subset of EK procedures, Descemet s Membrane (Stripping) Endothelial Keratoplasty (DMEK) increased 117.4% from 344 in 2011 to 748 in Tissue used for ALK with U.S. supplied tissue in 2012 increased 4.3% to 1855 from 1778 in Tissue used for ALK in the U.S. decreased 5.3% from 932 in 2011 to 883 in There had been a 10.5% decrease in 2011 and a 34.5% increase in Tissue for keratolimbal allografts (KLA) increased 2.1% from 95 in 2011 to 97 in Tissue used for keratoprosthesis (K-Pro) decreased 26.5% from 358 in 2011 to 263 in Tissue Not Used For Transplant: Tissue intended for surgery but not used is a measure of efficiency in the recovery system. The number of corneas intended for transplant but not used numbered 30,185 in 2012, compared to 29,407 in 2011 (2.6% increase). Tissue suitability (slit lamp/specular examination) was the leading cause of tissue judged unsuitable for transplant, responsible for 12,360 corneas discarded in 2012 (40.9% of rejected tissue, compared to 38% in 2011). The second category eliminating donor tissue intended for transplant was positive serology for communicable diseases, removing 9,250 corneas (30.6% of rejected tissue) from distribution (8,299, 28.2% in 2011). The third most common category, medical record or autopsy findings, caused 6,701 corneas (22.2%) to be rejected in 2012, compared to 6,756 (23%) in Of note, the medical/social interview was responsible for 2,158 corneas eliminated, 7.1% compared to 5.8% in The leading serological rule out was hepatitis B core antibody (HBcAb) positive in 4,392 donors (14.6%), compared to 3,538 donors (12%) in 2011 The second leading serological test that caused tissue to be judged unsuitable for transplant was hepatitis C antibody, positive in 1,957 (6.5%) of donors in 2012 and 1,925 (6.5%) in Indications for Transplant (U.S. Eye Banks) The most frequent box checked for indication for penetrating keratoplasty in the Indications for Keratoplasty section in 2012, as in 2011, was unknown, unreported or unspecified. So there is a significant amount of missing data that could affect the statistical breakdown of the indications for keratoplasty. However, the remaining usual categories reported below in the customary fashion are essentially in the same order as last year. The impact of introducing the unknown, unreported or unspecified category has been to reduce the incidence of presumptive reporting of indications by eye banks, increasing the quality of data. 5

6 Indications for Penetrating Keratoplasty Rank Unknown, unreported, or unspecified 9,765 (26.6%) 2 Ectasias/Thinnings (Keratoconus) 6,650 (18.1%) 3 Repeat corneal transplant 4,460 (12.1%) 4 Other causes of corneal dysfunction or distortion (non-endothelial) 3,795 (10.3%) 5 Post-cataract surgery edema TOTAL PK 3,670 (10.0%) Unknown, unreported, or unspecified 8,252 (22.8%) Ectasias/Thinnings (Keratoconus) 7,331 (20.3%) Repeat corneal transplant 4, 271 (11.8%) Other causes of corneal dysfunction or distortion (non-endothelial) 4,115 (11.4%) Post-cataract surgery edema 3,710 (10.3%) Ectasias/Thinnings (Keratoconus) 4,731 (21.2%) Other causes of endothelial dysfunction 4,455 (20.0%) Repeat cornea transplant 4,025 (18.0%) Post-cataract surgery edema 3,104 (13.9%) Other degenerations or dystrophies 1,899 (8.5%) 36,716 36,144 22,312 The second most common indication for PK in 2012 behind unknown was keratoconus in 6,650 cases (18.1%). In the previous two years, keratoconus was also second behind unknown. The third leading cause of PK in 2012 was repeat corneal transplant in 4,460, (12.1%). This category was third in 2011 and in The fourth leading indication for PK in 2012 was the category of other non-endothelial causes of corneal opacification or distortion, a category that includes corneal scars and interstitial keratitis (3, 795, 10.3%). This category was new in 2011, so no previous data is available for comparison. Post-cataract surgery edema was again the fifth leading cause of full thickness transplant in 2012 (3,670, 10.0%) as it had been in 2011 and was the fourth leading cause for PK in Dystrophies and degenerations were sixth in 2012 (1,713, 4.7%) as they had been in 2011 (2,455 or 6.8%) and were the fifth leading indication in The shift in indications for PK has mainly been attributed to the increased popularity of EK, creating a reduction in PK indications related to endothelial dysfunction. 6

7 Indications for Anterior Lamellar Keratoplasty RANK Ectasias/Thinnings (Keratoconus) 805 (43.4%) 2 Unknown, unreported, or unspecified 550 (29.6%) 3 Other causes of corneal dysfunction or distortion (non-endothelial) 150 (8.1%) TOTAL ALK Ectasias/Thinnings (Keratoconus) 740 (41.6%) Unknown, unreported, or unspecified 433 (24.4%) Other degenerations or dystrophies 197 (11.1%) Ectasias/Thinnings (Keratoconus) 419 (40.2%) Other degenerations or dystrophies 263 (25.3%) Other causes of corneal dysfunction or distortion (non-endothelial) 202 (19.4%) 1,855 1,778 1,041 The two leading indications for ALK were unchanged in Keratoconus (KC) was again the leading indication for ALK in 2012 (805, 43.4%) as in 2011, 2010, and 2009 (330, 38.7%). The category Unknown, unreported or unspecified was the second leading indication in 2012 (550 or 29.6%) and 2011 for ALK procedures. Other causes of corneal dysfunction or distortion was third in 2012 (150 or 8.1%) and fourth in Other degenerations and dystrophies was the fourth leading indication for ALK in 2012 (115 or 6.2%) and the third indication for ALK in 2011, where it had been second in Anterior stromal scarring was the third most common indication in 2010 but this category was eliminated in Indications for Endothelial Keratoplasty RANK Endothelial Dystrophies, including Fuchs 11,707 (46.8%) 2 Post-cataract surgery edema 4,770 (19.1%) 3 Unknown, unreported, or unspecified TOTAL EK 3,554 (14.2%) Endothelial Dystrophies, including Fuchs 11,101 (47.7%) Post-cataract surgery edema 4,469 (19.2%) Unknown, unreported, or unspecified 2,886 (12.4%) Endothelial Dystrophies, including Fuchs 9,843 (51.4%) Post-cataract surgery edema 3,783 (19.7%) Other causes of endothelial dysfunction 3,766 (19.7%) 25,025 23,287 19,159 Fuchs dystrophy was the leading indication for endothelial keratoplasty in 2012 (11,707, 46.8%), comprising nearly half of all procedures, similar to 2011, 2010 and 2009 (8,604, 49%). Post-cataract surgery edema was the second leading indication for EK in 2012 (4,770, 19.1%) as it had been in

8 and in Unknown, unreported or unspecified was third in 2012 (3,554, 14.2%) and in This category was introduced in 2011, and comparisons to lists before 2011 will be skewed because this category was not listed. Other causes of endothelial dysfunction was a close fourth (2,905, 11.6%) in 2012 as in 2011 (2,856 or 12.3%), although this category had been third in 2010 (3,766, 19.7%). The fifth leading cause of EK reported by U.S. eye banks in 2012 (2,089, 8.3%) and 2011 (1,974 or 8.5%) was repeat corneal graft. This category was fourth in 2010 because the category unknown was not introduced until the following year. International Eye Banks: The sample size of the surgical indication data from international eye banks was smaller in 2012 than previous years because the Veneto Eye Bank Foundation (Venice, Italy) did not participate in Data accumulated was not large enough to indicate any trends, nor were the trends noted in data collected any different from trends in the U.S. data. For example, in 2012, U.S. eye banks reported information for 36,716 corneas for PK, 1,855 corneas for ALK, and 24,277 corneas for EK. International eye bank data was reported for 1,246 corneas for PK (2460 in 2011), 122 for EK (169 in 2011), and 1,271 for EK (2,293 in 2011). Indications for Keratoplasty Summary: By looking at all three procedures (PK, EK, and ALK) used for a specific diagnosis, one can get an idea of the different indications for which keratoplasty procedures are performed. Utilizing a denominator of 62,848 (the combined number of PK, EK, and ALK procedures from U.S. eye banks in 2012), and stratifying the procedures performed for a specific diagnosis, we can calculate the types of keratoplasty procedures performed for each given diagnosis. Because of the revised format of the statistical report in 2011, comparisons prior to that date are less meaningful; trends noted here for 2012 are compared to # PK % PK # ALK % ALK # EK % EK Diagnosis Rank 2012 Total (U.S.) 36, ,277 Total Unknown, Unreported, or 9,765 70% 550 4% 3,554 26% 13,869 1 Unspecified Endothelial Dystrophies 1,400 11% 11,707 89% 13,107 2 (including Fuchs ) Post-Cataract Surgery 3,670 43% 4,770 57% 8,440 3 Edema Ectasias/Thinnings 6,650 89% % 7,455 4 (Keratoconus) Repeat Corneal Graft 4,460 68% % 2,089 32% 6,549 5 Other Causes of Endothelial 1,131 28% 2,905 72% 4,036 6 Dysfunction Other Causes of Corneal Opacification or Distortion (non-endothelial) 3,795 96% 150 4% 3,

9 # PK % # ALK % # EK % Diagnosis Rank 2011 Total (U.S.) 36,144 1,778 23,287 Total Endothelial Dystrophies 1,392 11% 11,101 89% 12,493 1 (including Fuchs ) Unknown, Unreported, or 8,252 71% 433 4% 2,886 25% 11,571 2 Unspecified Post-Cataract Surgery 3,710 45% 4,469 55% 8,179 3 Edema Ectasias/Thinnings 7,331 91% 740 9% 8,071 4 (Keratoconus) Repeat Corneal Graft 4,271 68% 47 1% 1,975 31% 6,293 5 Other Causes of Corneal 4,115 96% 170 4% 4,285 6 Opacification or Distortion (non-endothelial) Other Causes of Endothelial Dysfunction 1,041 27% 2,856 73% 3,897 7 The leading category for transplant in 2012 was unknown or unspecified, a category previously prone to presumptive reporting, but must be considered when interpreting the known diagnoses. The leading specific diagnosis and second overall category in 2012 was Fuchs Dystrophy in 13,107 patients (21% of all procedures). Fuchs Dystrophy had been first in 2011 (12,493, 20%), and in 2010 (28%). The third leading indication in 2012 was post-cataract surgery edema in 8440 patients (13% of all procedures); this category had also ranked third in Keratoconus was the fourth most common indication for keratoplasty surgery in 2012 (7455, 12% of procedures) as in 2011 (8071, 13%). There were 6580 regrafts across all three procedures, making it the fifth leading indication in 2012, as it was in Combining the three categories of endothelial failure (Fuchs Dystrophy (13,107), post-cataract surgery edema (8440) and other non-specified causes of corneal edema (3945), 25,583 procedures were performed for endothelial cell failure, or 40% of all procedures in Similarly, combining keratoconus (7455) with other non-endothelial causes of dystrophy and ectasia (3945) and postrefractive (80), one can see that 11,480 (18%) procedures were for ectatic disorders of the cornea. These figures explain the continued increase in the number of endothelial keratoplasty procedures performed over the last six years. Observations on U.S. Data for 2012: 1) The number of penetrating grafts performed for corneal disease worldwide using United States tissue in 2012 was 36,716, a 1.6% increase over 36,144 in In the U.S., 21,422 PK grafts were performed in 2012, compared to 21,620 in Previous statistical reports show the number of PKs had declined over six years from a high of 42,063 in 2005 to 22,312 in 2010, demonstrating a continued, though slowing decline of PK surgical use within the U.S. International PK use of U.S. tissue rose in 2012 (15,294) compared with 2011 (14, 524). 9

10 2) The number of endothelial keratoplasty procedures performed in the U.S. in 2012 continues to increase, consistent with the 2012 data showing 40% of all keratoplasty procedures performed for endothelial cell dysfunction. EK was used in 89% of Fuchs Dystrophy in each of the last two years (the remaining 11% were PK), compared to 85% in Penetrating keratoplasty is still indicated in some Fuchs patients with stromal opacification or scarring. EK procedures made up 57% of those for post-cataract surgery edema (55% in 2011). Endothelial keratoplasty remains the surgical treatment of choice for corneal endothelial failure. The low number of DMEK procedures (748) compared to DSEK/DSAEK (22,301) make it difficult to predict trending within the EK category at this time, but the number of DMEK cases reported increased 117% from 344 in 2011 to 748 in ) Anterior lamellar keratoplasty numbers performed in the U.S. in 2012 increased to 1855 from 1778 in 2011 (4.3%), but remain low (11%) compared to penetrating keratoplasty numbers for keratoconus (89%). The percentage of patients with keratoconus who received ALK decreased from 18% in 2010 to 9% in Possible reasons this procedure has not been embraced more are: 1) difficulty with reimbursement, 2) the technical difficulty of the procedures, or 3) the availability of other modalities (PK, Intacs, cross-linking) for treatment of keratoconus. 4) The number of patients who had keratoplasty surgery for keratoconus in 2012 decreased from 8071 in 2011 to 7455 in 2012, (a 7.6% decrease). The increased use of corneal cross-linking (CXL) and Intacs may explain this decrease in patients requiring corneal tissue replacement, although specific numbers for these other modalities are difficult to come by. 5) Corneal tissue used for keratoprosthesis (K-Pro) procedures decreased from 358 in 2011 to 263 in 2012, a 27% drop. The specific category for keratoprosthesis in the statistical report started in 2009, and future trends will be more meaningful as additional data is recorded for this indication. 6) The number of keratolimbal allografts utilizing tissue from U.S. eye banks was essentially unchanged at 97 in 2012 (95 in 2011). This procedure has decreased from a high of 207 in Possible reasons for the decrease in these numbers are 1) declining reimbursement, 2) the technical difficulty of these procedures, or 3) the complexity of post-operative care utilizing systemic immunosuppression, etc. 7) The percentage of tissue intended for transplant but not suitable eliminated due to a positive Hepatitis B Core Antibody (HBcAb) test increased from 12% in 2011 to 14.6% in Tissue eliminated because of the medical-social interview increased from 5.8% in 2011 to 7.1% in It is unclear if the rise in serologic test results as a reason for not releasing tissue recovered for transplant reflects an increasing threat of lifestyle and medical issues affecting the donor pool or if the performance of test kits available is reflected in these numbers. The increase in medicalsocial interview related reasons for not releasing tissue recovered for transplant may be indicative of more active use of donor registry as consent for corneal donation and eye banks weighing risk between recovering without a medical-social interview versus increased death to 10

11 preservation intervals. Slit-lamp and specular evaluation of tissue remains the number one reason that tissue is ruled unsuitable for transplant, and increased from 38% in 2011 to 41% in This suggests that the development of tools or equipment designed to facilitate fieldevaluation of donor tissue, complementary to the in situ excision procedure, may impact tissue recovery in a significantly positive manner. Woodford S. Van Meter, MD Professor of Ophthalmology University of Kentucky 11

12 2012 Eye Banking Statistics Reported by U.S. Banks: Death Referrals and Tissue Recoveries 80 U.S. Eye Banks Reporting Donations Number of Eye Banks Reporting Total Whole Globes and Corneas Donated 116, , , ,289 94,864 Total Number of Donors 59,221 57,835 55,913 53,786 47,776 Death Referrals Total Death Referrals 770, ,405 Death referrals determined eligible 165, ,388 Tissue Recoveries Total Donors 59,221 57,835 Donors recovered not found on donor registry or known to have first person consent 33,016 35,144 Donors recovered found on donor registry or known to have first person consent 26,205 22,691 Eyes or Corneas Recovered with Intent for Surgical Use 103, ,533 Eyes or Corneas Recovered for Other Uses 13,216 12,815 U.S. Eye Banks Recovered Corneas <

13 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Comparison of Eye Bank Cornea Recovery Rates 80 U.S. Eye Banks Reporting In 2012, one eye bank increased the corneas recovered for transplant to over 8,000 corneas. This is a milestone for American eye banking! During the same period, a few bank shifted from medium size (over 1,000, but below 2,000) to smaller size (over 250, but below 500). One eye bank in the 6,001-7,000 size range dropped to the 5,000-6,000 range, while another in the 5,001-6,000 range dropped to the 4,001-5,000 range. The largest change was in the 1,001-2,000 range, which generally followed a trend of contracting in volume of corneas recovered for transplant. 13

14 2012 Eye Banking Statistics Reported by U.S. Banks: Referral Trends, Transplant and Conversion Rates 80 U.S. Eye Banks Reporting Month Transplant Rate Conversion Rate U.S. Eye Banks Death Referrals Transplant Eligible Referrals Transplant Intended Corneas Recovered Jan % 32.2% Feb % 31.9% Mar % 31.2% Apr % 31.6% May % 32.1% Jun % 32.1% Jul % 32.5% Aug % 31.9% Sep % 31.0% Oct % 32.0% Nov % 31.8% Dec % 30.2% Total 66.5% 30.1% Total 66.2% 31.7% Overall Total 66.3% 30.9% Overall Avg. N/A N/A Std. Dev. 1.0% 0.6% *Transplant rate is the number of corneas used for transplant divided by the number recovered for transplant. Conversion rate is the number of transplant donors divided by the number of transplant eligible referrals. 14

15 2012 Eye Banking Statistics Reported by U.S. Banks: Referral Trends, Transplant and Conversion Rates 80 U.S. Eye Banks Reporting 15

16 2012 Eye Banking Statistics Reported by U.S. Banks: Transplant and Conversion Rates 80 U.S. Eye Banks Reporting 16

17 2012 U.S. Eye Banking Statistics: Analysis of Referrals, Transplant & Conversion Rates 80 U.S. and 8 International Eye Banks Reporting In the U.S., the rate of death referrals ranged between roughly 56,000 and 68,000 per month with the exception of December, which spiked to over 80,000 in 2011 and over 71,000 in This showed a small trend of increasing death referral activity at the end of each year, which was consistent with anecdotal evidence. Not surprisingly, the pattern of referrals determined eligible for transplant roughly matched the pattern of referrals received. However, in December 2011, the magnitude of the spike in referrals determined eligible was smaller than the magnitude of the spike of referrals received. In December 2012, the number of referrals determined eligible for transplant did not spike, as did the overall number of referrals. This demonstrated that in periods of reduced surgical demand, eye banks may change medical criteria temporarily to stem the flow of transplant tissue that could expire rather than be used for transplant. The conversion rate trends of the U.S. tissue told another story of how eye banks reduced supply of tissue during periods of reduced surgical activity. The conversion rate, defined as the number of transplant donors recovered from transplant eligible referrals, declined both in December 2011 and December This implied that eye banks may have experienced decreased consent rates (not measured by the EBAA) or may have employed other methods (besides reduced medical criteria) to reduce tissue supply. The U.S. transplant rate remained steady from 2011 through 2012 and though a decrease of 0.3% on average was noted between the two years, no significant trend was noted. During this time period, no significant new eligibility criteria changes by the EBAA or FDA occurred. However, in mid-2011, the Ultrio test for HIV/HBV/HCV NAT, a triplex test, began to replace the HIV/HCV NAT duplex testing. This was incrementally adopted by some organizations from the point of introduction forward and continues to be partially used across the country at the time of this report. This factor may have influenced the transplant rate. In the U.S. in 2012, the ratio of donors recovered using next-of-kin consent vs. donor registry increased slightly in favor of donor registry. This was an expected outcome of eye banks applying donor registry as consent more actively since Donor registry accounted for 44.2% of donors in the U.S., compared with 3.7% at international banks. Referral rate, transplant rate, and conversion rate values are not comparable between U.S. banks and international banks due to the different social influences and developmental stages of eye banking, as well as significantly different sample sizes. One international bank reported referral data for only 2 months. Data from the 10 unreported months were omitted from the analysis and the analysis was corrected appropriately. As in the U.S., peak referral activity occurred in December 2012 and similar to the U.S., transplant eligible referrals declined in November and December However, despite reducing transplant eligibility criteria at the end of the year, the conversion rate spiked in December A final interesting note about the data reported by the international banks was a notable trend of increasing referrals over

18 2012 Eye Banking Statistics Reported by International Banks: Donations and Tissue Recoveries 8 International Eye Banks Reporting Donations Number of Eye Banks Reporting Total Whole Globes and Corneas Donated 6,330 12,851 9,726 Total Number of Donors 3,177 6,433 4,886 Death Referrals Total Death Referrals 28,391 38,616 Death referrals determined eligible 5,695 5,947 Tissue Recoveries Total Donors 3,177 6,433 Eyes or Corneas Recovered with Intent for Surgical Use 5,058 9,021 Eyes or Corneas Recovered for Other Uses 1,272 3,830 18

19 2012 Eye Banking Statistics Reported by International Banks: Referral Trends, Transplant and Conversion Rates 8 International Eye Banks Reporting Month Transplant Rate Conversion Rate International Eye Banks Death Referrals Transplant Eligible Referrals Transplant Intended Corneas Recovered Jan % 43.8% Feb % 41.8% Mar % 39.1% Apr % 38.9% May % 39.7% Jun % 42.9% Jul % 38.2% Aug % 37.8% Sep % 40.0% Oct % 40.7% Nov % 73.2% Dec % 62.6% Total 64.7% 43.3% Avg. N/A N/A Std. Dev. 4.6% 11.1% *Transplant rate is the number of corneas used for transplant divided by the number recovered for transplant. Conversion rate is the number of transplant donors divided by the number of transplant eligible referrals. 19

20 2012 Eye Banking Statistics Reported by International Banks: Referral Trends, Transplant and Conversion Rates 8 International Eye Banks Reporting 20

21 2012 Eye Banking Statistics Reported by International Banks: Transplant and Conversion Rates 8 International Eye Banks Reporting 21

22 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Donors by Age Reported by U.S. Banks 80 U.S. Eye Banks Reporting Age Under One Year % % Age % % Age , % 1, % Age , % 2, % Age , % 3, % Age , % 7, % Age , % 14, % Age , % 18, % Age , % 7, % Over 80 1, % 1, % Total Donors by Age 59,221 57,835 22

23 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Donors by Gender Reported by U.S. Banks 80 U.S. Eye Banks Reporting Donors by Gender Male 36, % 35, % Female 23, % 22, % Total Donors 59,221 57,835 23

24 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Cause of Death Reported by U.S. Banks 80 U.S. Eye Banks Reporting Cause of Death Heart Disease 19, % 19, % Cancer 11, % 10, % Trauma 5, % 6, % Respiratory Disease 5, % 5, % Cerebral Vascular Accident 6, % 5, % Other Diseases 10, % 10, % Total Donors by Cause of Death 59,221 57,835 24

25 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Cause of Death Reported by U.S. Banks 80 U.S. Eye Banks Reporting COD - Heart COD - Cancer U.S. Eye Banks COD - CVA COD - Resp COD - Trauma COD - Other Month Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total Total Overall Total Overall Avg Std. Dev

26 2012 Analysis of Donor Demographics 80 U.S. and 8 International Eye Banks Reporting Compared to previous years, the patterns of demographics observed in 2012 showed predictable patterns. Male donors outnumber female donors, comprising 61% of the donor volume, as in Heart disease remains as the leading cause of death for the American ocular donor with 34% of donors dying of cardiac or vascular problems. This is the same as in With respect to age, the shape of the bell curve in 2012 matches that of These demographic values demonstrate no major change in eye banking practice or cultural behaviors over the last two years. Data from international banks is available only for The international banks demonstrate a slightly greater tendency for female donors, with males comprising 59% of the donor volume. The cause of death profile reported by international banks is dramatically different from the U.S. banks. Internationally, ocular donors are nearly twice as likely to die from cancer, half as likely to die of trauma, and 1/3 less likely to die of heart or vascular disease. These values may reflect both the nature of public health and the relationships with referral sources (e.g. hospital vs. hospice vs. medical examiner offices). As in the U.S., international banks report that the most likely age range to be an ocular donor is 61-70, however, the next most significant age group is for international banks, compared to for U.S. banks. This difference is attributable to U.S. banks' selectivity of donors based on age in an attempt to optimize donor tissue quality. 26

27 2012 Eye Banking Statistics Reported by International Banks: Donor Profiles: Age 8 International Eye Banks Reporting Age Under One Year 0 0.0% 6 0.1% Age % % Age % % Age % % Age % % Age % % Age % 1, % Age , % 2, % Age % 1, % Over % % Total Donors by Age 3,177 6,433 27

28 2012 Eye Banking Statistics Reported by International Banks: Donor Profiles: Gender and Cause of Death 8 International Eye Banks Reporting Donors by Gender Male 1, % 3, % Female 1, % 2, % Total Donors 3,177 6,433 International Eye Banks Month COD - Heart COD - Cancer COD - CVA COD - Resp COD - Trauma COD - Other Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total Avg Std. Dev

29 2012 Eye Banking Statistics Reported by International Banks: Donor Profiles: Cause of Death 8 International Eye Banks Reporting Cause of Death Heart Disease % 1, % Cancer 1, % 1, % Trauma % % Respiratory Disease % % Cerebral Vascular Accident % % Other Diseases % 1, % Total Donors by Cause of Death 3,177 6,433 29

30 2012 Eye Banking Statistics Reported by U.S. Banks: Reasons Tissue Intended for Surgery Was Not Released 80 U.S. Eye Banks Reporting There are several reasons why tissue intended for surgery may not ultimately be used for surgery. These include positive serology results, defects noted at the time of evaluation (scars, infiltrates, low cell counts, etc.) and/or medical or social history information, all of which occur subsequent to initial screening and procurement. Contraindications for Transplant Positive or Reactive Test for Communicable Disease Agent or Disease 9, % 8, % Anti-HIV-1/ % % HIV-1 Nucleic Acid Test Positive % % Anti-HCV 1, % 1, % Hepatitis C Nucleic Acid Test Positive % % Hepatitis B Surface Antigen (HBsAg) Positive % % Hepatitis B Core (HBcAb) Positive 4, % 3, % Syphilis Positive % % HTLV Antibody (HTLV I/II Ab) % % Other Positive Serology % % Other Communicable Disease Testing Issue % % Medical Record or Autopsy Findings 6, % 6, % Dementia % % Sepsis 3, % 3, % Sepsis - (determined by positive blood cultures) % % Sepsis - (determined by other indicators) 2, % 2, % Plasma Dilution % % Unknown Cause of Death % % Medical Record or Autopsy Findings: Other 1, % 2, % Medical/Social Interview 2, % 1, % Travel Questions % % Dementia / Neurological Issues % % Medical/Social Interview: Other 1, % 1, % Body Exam % % Total eyes/corneas intended for transplant but not released for transplant 30,185 29,407 1 Some tissues had multiple contraindications. 30

31 2012 Eye Banking Statistics Reported by U.S. Banks: Reasons Tissue Intended for Surgery Was Not Released 80 U.S. Eye Banks Reporting Contraindications for Transplant (continued) Tissue Suitability (e.g. slit lamp/spec eval) 12, % 11, % Epithelium % % Stroma 5, % 4, % Prior reactive surgery % % Scar 1, % % Infiltrate 2, % 2, % Foreign Body % % Other 1, % 1, % Descemet s membrane % % Endothelium 6, % 5, % Quality Issue % % Storage % % Labeling % % Processing % % Supply or Reagent % % Environmental Control % % Other Reason prior to Tissue Release 2, % % Total eyes/corneas intended for transplant but not released for transplant 30,185 29, Tissue Not Released Serologic Test Testing Issue Med. Rec./Autopsy Med/Soc History Body Exam Tissue Suitability Quality Issue Other Reason 31

32 2012 Eye Banking Statistics Reported by U.S. Banks: Reasons Tissue Intended for Surgery Was Not Released 80 U.S. Eye Banks Reporting 32

33 Analysis of the Reasons Tissue Intended for Surgery Was Not Suitable for Transplant 80 U.S. Eye Banks Reporting Month Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Eye Bank Data Subset: Not Released for Transplant (Overview) All Medical Medical Reasons Record / / Social Not Serology Testing Autopsy History Body Tissue Released Tests Issue Finding Finding Exam Suitability Quality Issue Other Reason Jan % 8.7% 0.4% 6.4% 2.2% 0.1% 12.0% 0.3% 1.6% Feb % 8.6% 0.3% 6.2% 2.1% 0.2% 13.0% 0.4% 2.9% Mar % 8.9% 0.3% 6.8% 2.0% 0.3% 11.9% 0.4% 2.6% Apr % 9.1% 0.2% 5.8% 2.2% 0.2% 12.0% 0.3% 2.2% May % 8.7% 0.3% 7.0% 1.6% 0.4% 11.2% 0.3% 1.8% Jun % 8.6% 0.2% 6.9% 1.7% 0.3% 11.0% 0.3% 1.9% Jul % 9.0% 0.4% 6.1% 2.5% 0.5% 11.5% 0.4% 2.3% Aug % 10.1% 0.4% 7.0% 2.3% 0.4% 11.7% 0.4% 3.1% Sep % 8.1% 0.2% 6.6% 1.8% 0.2% 12.6% 0.5% 2.3% Oct % 9.6% 0.4% 6.7% 1.6% 0.2% 11.4% 0.3% 1.9% Nov % 8.8% 0.1% 6.1% 2.4% 0.2% 13.1% 0.5% 1.9% Dec % 8.7% 0.4% 5.7% 2.5% 0.2% 11.6% 0.2% 2.3% 2011 Avg. 29.0% 8.2% 0.2% 6.7% 1.7% 0.2% 11.0% 0.5% 0.5% 2012 Avg. 29.1% 8.9% 0.3% 6.5% 2.1% 0.3% 11.9% 0.4% 2.2% Overall Avg. 29.0% 8.5% 0.3% 6.6% 1.9% 0.2% 11.5% 0.4% 1.4% Std. Dev. 0.9% 0.5% 0.1% 0.5% 0.3% 0.1% 0.7% 0.1% 0.5% When reviewing information on tissue not released for transplant to identify trends, percentages must be observed, since raw numbers vary too much with recovery rates. Percentages are calculated by dividing the number of corneas not released for any given reason by the number of corneas recovered for transplant use. In the U.S., between 2011 and 2012, the categories that increased appreciably were serologic testing (up 0.7%), tissue suitability (up 0.9%), and "other reasons" (up 1.7%). Testing issues (up 0.1%), body exam (up 0.1%), and medical/social history findings (up 0.4%) increased by a lesser magnitude. The only categories of reasons for not releasing tissue that decreased were medical record and autopsy findings (down 0.2%) and quality issues (down 0.1%). The most striking change in this data (in the U.S.) was due to "other reasons." The values for "other reasons" spiked to a new plateau in January 2012 and continue at the new level from that point forward. This suggests that at a bank or two of large size there was a change in the staff that collect data, resulting in a different interpretation and reporting, or that there was an unreported specific influence on the release of donor tissue at several banks. Without further investigation with those who reported significant increases in this value, the reason for this change at the time of this report is unexplainable. 33

34 Analysis of the Reasons Tissue Intended for Surgery Was Not Suitable for Transplant 80 U.S. Eye Banks Reporting Comparing U.S. and international banks, a few notable differences are apparent. The U.S. does not release tissue for transplant due to serologic testing in 2012 at a rate of 8.9%, while international banks report the same occurrence at 5.9%. Other comparisons include medical record or autopsy findings (6.5% in the U.S., 5.1% internationally), medical/social history findings (2.1% in the U.S., 3.7% internationally), tissue suitability (11.9% in the U.S., 10.0% internationally), quality reasons (0.4% in the U.S., 0.8% internationally), and "other reasons" (2.2% in the U.S., 5.1% internationally) Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Eye Bank Data Subset: Serologic Testing All Month Serology Tests HIV Ab HIV NAT HBsAg HBcAb HCV Ab HCV NAT Syphilis HTLV Ab Other Test Jan % 0.2% 0.1% 1.0% 4.0% 1.9% 0.6% 0.3% 0.2% 0.4% Feb % 0.2% 0.2% 0.7% 3.8% 2.0% 0.7% 0.3% 0.2% 0.5% Mar % 0.1% 0.1% 0.7% 4.1% 2.1% 0.5% 0.4% 0.4% 0.6% Apr % 0.2% 0.1% 0.9% 4.2% 1.8% 0.7% 0.2% 0.3% 0.6% May % 0.1% 0.1% 0.8% 4.2% 1.8% 0.7% 0.5% 0.2% 0.4% Jun % 0.1% 0.1% 0.8% 4.3% 1.8% 0.5% 0.2% 0.3% 0.5% Jul % 0.1% 0.1% 1.0% 4.7% 1.7% 0.6% 0.3% 0.2% 0.3% Aug % 0.3% 0.0% 0.7% 4.8% 2.0% 0.7% 0.5% 0.2% 0.9% Sep % 0.1% 0.0% 1.0% 3.9% 1.6% 0.4% 0.3% 0.2% 0.5% Oct % 0.2% 0.1% 0.8% 4.6% 2.0% 0.8% 0.3% 0.2% 0.6% Nov % 0.1% 0.1% 0.8% 4.0% 2.2% 0.8% 0.3% 0.1% 0.4% Dec % 0.2% 0.1% 0.8% 4.0% 1.8% 0.6% 0.3% 0.2% 0.6% 2011 Avg. 8.2% 0.2% 0.2% 0.7% 3.5% 1.9% 0.7% 0.3% 0.3% 0.3% 2012 Avg. 8.9% 0.2% 0.1% 0.8% 4.2% 1.9% 0.6% 0.3% 0.2% 0.5% Overall Avg. 8.5% 0.2% 0.2% 0.8% 3.9% 1.9% 0.7% 0.3% 0.3% 0.4% Std. Dev. 0.5% 0.1% 0.0% 0.1% 0.3% 0.2% 0.1% 0.1% 0.1% 0.1% *Percentages read from this table should be read as "of the tissue recovered with transplant intent" In the U.S., positive serologic testing for hepatitis B increased from 2011 to This trend was not observed with data reported by international banks. HBV NAT testing as a reason for not releasing tissue for transplant was not measured in 2011 or HIV, Hepatitis C, and syphilis tests, as reasons for not releasing tissue for transplant, either remained flat (HIV Ab, HCV Ab, and syphilis), as trends, or decreased slightly (HIV NAT and HCV NAT). 34

35 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 80 U.S. Eye Banks Reporting 35

36 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 80 U.S. Eye Banks Reporting Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Eye Bank Data Subset: Medical Record and Autopsy Month All Medical Record Dementia / Neuro Sepsis (Cultures) Sepsis (Other) Plasma Dilution Unknown Cause of Death Other Jan % 0.3% 1.1% 2.5% 0.2% 0.2% 2.0% Feb % 0.4% 0.9% 2.3% 0.2% 0.3% 2.1% Mar % 0.6% 0.8% 2.7% 0.4% 0.6% 1.7% Apr % 0.4% 0.9% 2.2% 0.3% 0.3% 1.7% May % 0.6% 0.7% 2.7% 0.4% 0.5% 2.2% Jun % 0.6% 0.8% 2.9% 0.3% 0.5% 1.9% Jul % 0.5% 0.9% 2.2% 0.3% 0.5% 1.7% Aug % 0.6% 0.9% 2.6% 0.3% 0.4% 2.2% Sep % 0.7% 0.8% 2.2% 0.2% 0.5% 2.2% Oct % 0.5% 1.0% 2.5% 0.7% 0.3% 1.7% Nov % 0.5% 0.7% 2.1% 0.4% 0.3% 2.0% Dec % 0.5% 0.7% 2.1% 0.2% 0.4% 1.6% 2011 Avg. 6.7% 0.5% 0.9% 2.3% 0.4% 0.5% 2.0% 2012 Avg. 6.5% 0.5% 0.8% 2.4% 0.3% 0.4% 1.9% Overall Avg. 6.6% 0.5% 0.9% 2.4% 0.4% 0.4% 2.0% Std. Dev. 0.5% 0.1% 0.1% 0.3% 0.1% 0.1% 0.2% *Percentages read from this table should be read as "of the tissue recovered with transplant intent" 2012 Tissue Not Released - Medical Record & Autopsy Dementia / Neuro Sepsis (Other) Unknown Cause of Death Sepsis (Cultures) Plasma Dilution Other 36

37 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 80 U.S. Eye Banks Reporting Medical record or autopsy findings as a reason for not releasing tissue for transplant decreased slightly in the U.S., but were more significant than as reported by international banks. As access to electronic medical records to donor coordinators during the process of screening referrals becomes more available and common in the U.S., there is potential that this value may decrease further. Through networking with other eye bank professionals, there is also potential that the value of "unknown cause of death" may be decreased through sharing methods on working with pathologists, coroners, and medical examiners reluctant to state a cause of death within the timeframe necessary for corneal surgical use. The sepsis category is divided into two subparts; sepsis determined by positive cultures and sepsis determined by other values. This may empower eye banks to reduce these values by making appropriate improvements to their systems or by electronic medical records access combined with donor coordinator education Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Eye Bank Data Subset: Medical & Social History All Medical / Month Social History Travel Dementia / Neuro Other Jan % 0.3% 0.2% 1.8% Feb % 0.2% 0.2% 1.7% Mar % 0.2% 0.2% 1.6% Apr % 0.4% 0.1% 1.6% May % 0.2% 0.1% 1.3% Jun % 0.1% 0.1% 1.5% Jul % 0.4% 0.2% 1.9% Aug % 0.2% 0.3% 1.9% Sep % 0.3% 0.2% 1.3% Oct % 0.2% 0.2% 1.2% Nov % 0.3% 0.0% 2.0% Dec % 0.3% 0.2% 2.0% 2011 Avg. 1.7% 0.3% 0.1% 1.3% 2012 Avg. 2.1% 0.3% 0.2% 1.6% Overall Avg. 1.9% 0.3% 0.2% 1.5% Std. Dev. 0.3% 0.1% 0.1% 0.3% 37

38 2012 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 80 U.S. Eye Banks Reporting 2012 Tissue Not Released - Medical & Social History Travel Dementia / Neuro Other Tissue not released due to medical/social history findings was limited by the fact that when a donor risk assessment interview was performed prior to recovery and reveals information that determines a donor ineligible for transplant use of tissue, the tissue was most often not recovered for transplant. Reducing instances of recovering prior to having the completed interview may reduce the occurrence of these reported values. However, with an increase in the use of donor registry as consent for donation, there is potential that this value may increase as surprises are found after recovery. The data reported by U.S. and international banks differed greatly. In the U.S., despite recovery using donor registry, there was a less than 50% relative occurrence of this reason compared to international banks. International banks reported travel exclusionary reasons at a rate more than twice that reported by the U.S., while dementia and neurological reasons were a sliver of the international reasons, compared with four times the rate in the U.S. "Other" reasons found in the donor risk assessment interview were 2.7% internationally, compared with 1.6% in the U.S. during the same period. This suggested varied interview questions and methods, as there was no standard interview tool available during this period. Other factors influencing the difference in the U.S. and international bank data were social, cultural, economic, and demographic. 38