2013 EYE BANKING STATISTICAL REPORT

Transcription

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

2 Table of Contents Statistical Report Analysis: Surgical Use and Indications for Corneal Transplant, Statistics from United States Eye Banks Referral Trends, Transplant and Conversion Rates 8 Donor Demographics 15 Eligibility and Suitability for Tissue Intended for Surgery 19 Reasons Released Tissues Were Not Transplanted 33 Outcomes of Tissue Recovered For Transplant 36 Use of Donated Tissue 40 Annual Comparison of the Number of Corneal Transplants Supplied by U.S. Banks 41 Domestic Surgery Use of Intermediate-Term Preserved Tissue 42 Annual Comparison of the Domestic Use of U.S. Supplied Intermediate-Term 45 Preserved Tissue International Use of Intermediate-Term Preserved Tissue 47 Long-Term Preserved Tissue Preservation and Distribution 51 Tissue Processing for Transplant 55 Forwarded Tissue 59 Indications for Corneal Transplant 61 Statistics from International Eye Banks Referral Trends, Transplant and Conversion Rates 70 Donor Demographics 75 Eligibility and Suitability for Tissue Intended for Surgery 78 Reasons Released Tissues Were Not Transplanted 86 Outcomes of Tissue Recovered For Transplant 87 Use of Donated Tissue 89 Domestic Surgery Use of Intermediate-Term Preserved Tissue 90 International Use of Intermediate-Term Preserved Tissue 94 Long-Term Preserved Tissue Preservation and Distribution 97 Tissue Processing for Transplant 101 Forwarded Tissue 104 Indications for Corneal Transplant 105 Eye Banks Submitting Data for the 2012 Statistical Report 112 2

3 Surgical Use and Indications for Corneal Transplant Statistical Report Analysis 2013 Introduction: The 2013 Eye Banking Statistical Report from the Eye Bank Association of America (EBAA) includes information on all 76 U.S. and 10 international member eye banks reporting data for the calendar year 2013, and represents an essentially complete picture of eye banking activity of the eye banks in the United States. For details on the history and methodology of the reporting process and information on EBAA Connect, please refer to the Overview from the 2012 EBAA Statistical Report Analysis. Utilization of Tissue: Domestic eye banks for 2013 reported an increase in total number of donors (62,274, 5.2%) and total globes/corneas donated (123,079, 5.2%) compared to Utilization of tissue supplied by U.S. eye banks for both domestic and international use is shown in Table 1: Use of Donated Tissues. Total grafts (72,736) were up 5.9% in While penetrating keratoplasty numbers were flat (36,998, up 0.8%), more tissue was used for endothelial keratoplasty (EK) (27,298, up 12.4%) and for lamellar keratoplasty (ALK) (2,009, up 8.3%) in 2013 than in There was no significant change in the number of corneas used for KLA or keratoprosthesis. Table 1: Use of U.S. Donated Tissues Distribution Corneal Grafts Total 72,736 68,681 67,590 59,271 59,784 Penetrating Keratoplasty 36,998 36,716 36,144 21,970 23,269 Anterior Lamellar Keratoplasty 2,009 1,855 1,778 1, Endothelial Keratoplasty 27,298 24,277 23,287 19,159 18,221 Keratolimbal Allograft Keratoprosthesis (K-Pro) Glaucoma Shunt Patch or other nonkeratoplasty use Other keratoplasty (experimental surgery) Unknown or Unspecified 1,068 1,554 2, Sclera 3,693 3,497 5,507 6,746 7,634 Long-Term Preserved Corneas 4,840 5,095 4,409 3,518 2,053 Keratoplasty Glaucoma Shunt Patching 4,040 4,435 3, Other Surgical Uses Research 17,384 19,320 19,230 17,260 14,547 Training 7,451 6,850 6,940 5,726 7,113 3

4 Domestically, the number of PKs performed continued to decrease in 2013 (20,954, -2.2%). See Table 2 and Figure 1: Domestic Surgery Use of U.S. Supplied Intermediate Term Preserved Tissues below. At the same time, the number of corneas used for endothelial keratoplasty (24,987, 8.4%) and ALK (951, 7.7%) increased in Endothelial keratoplasty is now the most common keratoplasty procedure performed in the United States. Table 2: Domestic Use of Intermediate-Term Preserved Tissues Annual Comparison Domestic Surgery Use Penetrating Keratoplasty 20,954 21,422 21,620 21,970 23,269 32,524 34,806 37,776 42,063 Endothelial Keratoplasty 24,987 23,049 21,555 19,159 18,221 17,468 14,159 6,027 1,398 Anterior Lamellar Keratoplasty , , Keratolimbal Allograft Figure 1: Domestic Surgery Use of U.S. Supplied Intermediate Term Preserved Tissues The frequency of PK, EK and ALK use is shown in Figure 2: Domestic PK vs. EK vs. DALK. The number of DMEK procedures has more than doubled (1,522, up 103.5%), and figures 3 ( Domestic DSEK trend) and 4 ( Domestic DMEK Trend) suggest increased interest in DMEK as an endothelial keratoplasty procedure. 4

5 Figure 2: Domestic PK vs. EK vs. ALK Surgery Trends Figure 3: Domestic DSEK Trend Figure 4: Domestic DMEK Trend Domestic DMEK Trend - U.S. Eye Banks Jan-11 Apr-11 Jul-11 Oct-11 Jan-12 Apr-12 Jul-12 Oct-12 Jan-13 Apr-13 Jul-13 Oct-13 Indications for Transplant: Since 2011, the most frequent indication for transplant noted has been unknown ; the indications for transplant of all 66,305 corneas accounted for in the system are shown in Table 3: Indications for Corneal Transplant Reported by US Banks, on page 61 of the report. Table 4 below shows the data in table 3 condensed into four basic categories that now dictate the procedure performed: 1) endothelial cell failure, 2) stromal or full thickness (non-endothelial) disease, 3) regrafts and 4) unknown. Within these categories, Fuchs dystrophy was the most common indication for keratoplasty in 2013 (14,153, 21.3%). Post cataract surgery edema was second (8,244, 12.4%) and keratoconus (6,894, 10.4%) was third. Repeat transplants were fourth (6,585, 9.9%). 5

6 Table 4: Indications for Transplant Endothelial Cell Failure Surgical Diagnosis PK ALK EK TOTAL A Post-cataract surgery 3, % , % 8,244 edema C Fuch's Dystrophy 1, % , % 14,153 M Other causes of 1, % , % 4,112 endothelial dysfunction Subtotal 5, % 0 0% 20, % 26, % of PK 75.7% of EK 40.0% of total Stromal or Full Thickness (non-endothelial) Disease Surgical Diagnosis PK ALK EK TOTAL B Keratoconus 6, % % ,894 E Other Degenerations 1, % % ,911 of Dystrophies F Post-refractive % % Surgery G Microbial Changes % % H Mechanical or 1, % % ,197 Chemical Trauma I Congenital Opacities % % J Pterygium % % K Non-infectious 1, % % ,137 ulcerative keratitis or perforations L Other causes of 3, % % ,301 corneal dysfunction or distortion Subtotal 14, % 1, % 0 0% 16, % of PK 56.6% of ALK 24.3% of total D Regraft Surgical Diagnosis PK ALK EK TOTAL Repeat Corneal 4, % % 2, % 6,585 Transplant 11.5% of PK 1.9% of ALK 8.4% of EK 9.9% of Total Unknown / Unspecified Surgical Diagnosis PK ALK EK TOTAL Z. Unknown, unreported, 11, % % 4, % 17,085 or unspecified 32.2% of PK 41.4% of ALK 15.9% of EK 25.8% of Total PK ALK EK TOTAL Total for Each Procedure 36, % 2, % 27, % 66,305 6

7 Forty per cent of all keratoplasty procedures were performed for endothelial failure (Fuchs, post cataract surgery edema and other caused of edema). Of this 40%, there were 20,662 EKs (77.9%) and 5,847 PKs (22.1%). 24.3% of keratoplasty procedures were performed for stromal or full thickness disease; 92.9% were PKs and 7.1% were ALK. For keratoconus, there were 6,215 (90.2%) PKs and 679 (9.8%) DALKs performed. There were 6,585 (9.9%) regrafts performed: regraft rates were 1.9% for ALK, 8.4% for EK and 11.5% for PK. Of concern is the 25.8% unknown diagnosis submitted for all keratoplasty procedures, which could skew the data in any direction and limit the significance of conclusions drawn. The unknowns are mostly internationally distributed tissue and should have the profile of internationally used tissue. Conclusions: 1) Endothelial keratoplasty was the most common U.S. keratoplasty procedure in ) 40% of all keratoplasty procedures were for endothelial disease in ) EK increased 9.2% in 2013 while PK numbers were essentially unchanged. a) DMEK increased 103.5%, from 748 in 2012 to 1,522 in 2013 b) DSEK increased 5.2%, from 22,301 in 2012 to 23,465 in ) The number of penetrating keratoplasty procedures with tissue in intermediate-term storage medium was essentially unchanged in ) There was no significant change in KLA or keratoprosthesis numbers in ) The number of keratoplasty procedures reported as Unknown continues to be a significant surgeon induced source of error in the statistical reporting process and may be improved by implementing a recipient registry. Woodford S. Van Meter, MD Professor of Ophthalmology University of Kentucky Medical Director Lions Eye Bank of Lexington 7

8 2013 Eye Banking Statistics Reported by U.S. Banks: Death Referrals and Tissue Recoveries 76 U.S. Eye Banks Reporting Donations Number of Eye Banks Reporting Total Whole Globes and Corneas Donated 123, , , , ,289 Total Number of Donors 62,274 59,221 57,835 55,913 53,786 Death Referrals Total Death Referrals 738, ,479 Death referrals determined eligible 168, ,688 Tissue Recoveries Total Donors 62,274 59,221 Donors recovered not found on donor registry or known to have first person consent 32,628 33,016 Donors recovered found on donor registry or known to have first person consent 29,646 26,205 Eyes or Corneas Recovered with Intent for Surgical Use 110, ,774 Eyes or Corneas Recovered for Other Uses 12,714 13,216 Using the number of corneas recovered for transplant use as a measure of eye bank size, a trend of eye bank growth is evident. While the number of corneas recovered for transplant use grew by nearly 7,000 between 2012 and 2013, it is evident that the two largest eye banks were responsible for nearly half of this growth. 79 U.S. banks reported data in 2011, 80 eye banks reported data in 2012, and 76 eye banks reported data in The change in 2013 did not reflect that there were fewer eye banks, rather that a series of associated eye banks began reporting as one entity. The remaining half of the growth was distributed over the mid-tier eye banks. The average number of corneas recovered for transplant per eye bank rose by 44 between 2011 and 2012, but rose by 155 between 2012 and In the second year of reporting data using the same system as U.S. domestic eye banks, 10 international EBAA member eye banks reported data in 2013, compared to 8 in The average number of corneas recovered per eye bank decreased by 169 between 2012 and 2013, indicative of induction of smaller eye banks into the EBAA. 8

9 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Comparison of Eye Bank Cornea Recovery Rates 76 U.S. Eye Banks Reporting Recovered Corneas < , ,001-2, ,001-3, ,001-4, ,001-5, ,001-6, ,001-7, ,001-8, ,001-9, ,001-10, >10, Avg. Corneas Recovered for Transplant

10 2013 Eye Banking Statistics Reported by U.S. Banks: Referral Trends, Transplant and Conversion Rates 76 U.S. Eye Banks Reporting U.S. Eye Banks Month Transplant Rate Conversion Rate Death Referrals Transplant Eligible Referrals Transplant Intended Corneas Recovered Jan % 31.7% Feb % 30.4% Mar % 30.7% Apr % 32.5% May % 32.1% Jun % 33.9% Jul % 34.1% Aug % 34.8% Sep % 34.5% Oct % 35.2% Nov % 35.8% Dec % 31.5% Total 66.5% 30.1% Total 66.2% 31.7% Total 65.9% 33.0% Avg. N/A N/A Std. Dev. 1.0% 1.8% *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. 10

11 2013 Eye Banking Statistics Reported by U.S. Banks: Referral Trends, Transplant and Conversion Rates 76 U.S. Eye Banks Reporting 11

12 2013 Eye Banking Statistics Reported by U.S. Banks: Referral Trends, Transplant and Conversion Rates 76 U.S. Eye Banks Reporting 12

13 2013 Eye Banking Statistics Reported by U.S. Banks: Transplant and Conversion Rates 76 U.S. Eye Banks Reporting 13

14 2013 U.S. Eye Banking Statistics: Analysis of Referrals, Transplant & Conversion Rates 76 U.S. 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 2011 (80,590), December 2012 (71,399), and January 2013 (74,396). This showed a small trend of spiking death referral activity annually during cold months (perhaps related to winter season pathogens like influenza). Not surprisingly, the pattern of referrals determined eligible for transplant roughly matched the pattern of referrals received. However, in December 2011 and December 2013, the magnitude of the spike in referrals determined eligible was smaller than the magnitude of the spike of referrals received. 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. Throughout 2013, the conversion rate of eligible death referrals into donors continually increased until the holiday season (December). The conversion rate trends repeatedly demonstrate 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 In December 2012, the surgical demand in the U.S. did not decline as dramatically as in December 2011 and December The U.S. transplant rate decreased slightly in During this time period, no significant new eligibility criteria changes by the EBAA or FDA occurred. Eye banks recovered more tissue intended for transplant in 2013 and did so from an increased rate of upper age ranges. In mid-2011, the Ultrio test for HIV/HBV/HCV NAT, a triplex test, began to replace the HIV/HCV NAT duplex testing, introducing HBV NAT into the testing regime (at least partially). In 2013, West Nile Virus NAT testing began to appear on some eye donors shared with tissue banks. There was an increased rate of positive serological tests, dementia found by medical record, stromal infiltrates, and processing damage in A trend of donors with known donor registry documentation continued to increase, while those with no known donor registration decreased. As eye banks increase use of donor registration as consent to recover tissue, this established a trend in which donor registration may exceed next-of-kin consent by This was an expected outcome of eye banks applying donor registry as consent more actively since Donor registry accounted for 47.6% of donors in the U.S. (up from 44.2% in 2012), compared with 3.5% at international banks. Referral rate, transplant rate, and conversion rate values are not comparable between U.S. banks and international banks due to the vastly different social influences and developmental stages of eye banking, as well as significantly different sample sizes. One international bank reported referral data for only 3 months. The two new international eye banks only submitted partial data for the year, since they became EBAA members mid-year. Useful analysis of referral activity was significantly hindered by this limited reporting. Conversion rate by the reporting international eye banks found a new plateau in 2013 around 64%, while transplant rate vacillated around 65%, a value comparable to U.S. eye banks. 14

15 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Donors by Age Reported by U.S. Banks 76 U.S. Eye Banks Reporting Age <1 Age 1-10 U.S. Eye Banks - Age Profile Age Age Age Age Age Age Age Month Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total Total Total Monthly Avg Std. Dev Age >80 15

16 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Donors by Age Reported by U.S. Banks 76 U.S. Eye Banks Reporting Age Under One Year % % Age % % Age , % 1, % Age , % 2, % Age , % 3, % Age , % 7, % Age , % 14, % Age , % 19, % Age , % 7, % Over 80 2, % 1, % Total Donors by Age 62,274 59,221 16

17 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Donors by Gender Reported by U.S. Banks 76 U.S. Eye Banks Reporting U.S. Eye Banks - Sex Profile Month Male Female Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total Total Total Monthly Avg Std. Dev Donor Sex Profile - U.S. Eye Banks 39% Male 61% Female 17

18 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Cause of Death Reported by U.S. Banks 76 U.S. Eye Banks Reporting U.S. Eye Banks - Cause of Death Profile Month Heart Cancer CVA Respiratory Trauma Other Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Total Total Total Monthly Avg Std. Dev

19 2013 Eye Banking Statistics Reported by U.S. Banks: Reasons Tissue Intended for Surgery Was Not Released 76 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, % 9, % Anti-HIV-1/ % % HIV-1 Nucleic Acid Test Positive % % Anti-HCV 2, % 1, % Hepatitis C Nucleic Acid Test Positive % % Hepatitis B Surface Antigen (HBsAg) Positive % % Hepatitis B Core (HBcAb) Positive 4, % 4, % Syphilis Positive % % HTLV Antibody (HTLV I/II Ab) % % Other Positive Serology % % Other Communicable Disease Testing Issue % % Medical Record or Autopsy Findings 7, % 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, % 1, % Medical/Social Interview 2, % 2, % Travel Questions % % Dementia / Neurological Issues % % Medical/Social Interview: Other 1, % 1, % Body Exam % % Total eyes/corneas intended for transplant but not released for transplant 32,456 30,185 1 Some tissues had multiple contraindications. 19

20 2013 Eye Banking Statistics Reported by U.S. Banks: Reasons Tissue Intended for Surgery Was Not Released 76 U.S. Eye Banks Reporting Contraindications for Transplant (continued) Tissue Suitability (e.g. slit lamp/spec eval) 12, % 12, % Epithelium % % Stroma 5, % 5, % Prior reactive surgery % % Scar 1, % 1, % Infiltrate 2, % 2, % Foreign Body % % Other 1, % 1, % Descemet s membrane % % Endothelium 5, % 6, % Quality Issue % % Storage % % Labeling % % Processing % % Supply or Reagent % % Environmental Control % % Other Reason prior to Tissue Release 2, % 2, % Total eyes/corneas intended for transplant but not released for transplant 32,456 30,185 20

21 2013 Eye Banking Statistics Reported by U.S. Banks: Reasons Tissue Intended for Surgery Was Not Released 76 U.S. Eye Banks Reporting 21

22 Analysis of the Reasons Tissue Intended for Surgery Was Not Suitable for Transplant 76 U.S. Eye Banks Reporting Month All Reasons Not Released U.S. Eye Banks: Not Released for Transplant (Overview) Serology Tests Testing Issue Medical Record/ Autopsy Finding Medical / Social History Finding Body Exam Tissue Suitability Quality Issue Other Reason Jan % 8.4% 0.3% 7.0% 2.1% 0.2% 12.1% 0.4% 2.3% Feb % 9.3% 0.4% 6.0% 2.1% 0.2% 12.1% 0.6% 1.6% Mar % 8.7% 0.6% 7.0% 1.7% 0.1% 12.2% 0.6% 1.9% Apr % 8.7% 0.3% 6.3% 2.0% 0.2% 11.3% 0.3% 2.5% May % 9.0% 0.4% 6.4% 1.9% 0.1% 9.6% 0.3% 2.7% Jun % 9.1% 0.3% 6.0% 2.1% 0.1% 10.2% 0.3% 2.3% Jul % 8.9% 0.2% 7.2% 1.7% 0.3% 11.4% 0.4% 1.6% Aug % 8.3% 0.2% 6.2% 1.8% 0.1% 10.8% 0.3% 1.7% Sep % 9.1% 0.3% 6.3% 2.0% 0.2% 11.5% 0.3% 1.8% Oct % 8.6% 0.6% 6.2% 2.1% 0.1% 10.7% 0.4% 2.1% Nov % 8.2% 0.3% 6.5% 2.1% 0.3% 11.4% 0.3% 2.3% Dec % 8.8% 0.2% 6.4% 2.2% 0.2% 11.4% 0.3% 2.2% 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% 2013 Avg. 29.4% 8.7% 0.3% 6.5% 2.0% 0.2% 11.2% 0.4% 2.1% Std. Dev. 0.9% 0.3% 0.1% 0.4% 0.2% 0.1% 0.8% 0.1% 0.4% *Percentages read from this table should be read as "of the tissue recovered with transplant intent" When reviewing information on tissue not released for transplant, percentages must be used to identify trends, 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., tissue not released due to serologic testing decreased 0.2% (about 400 additional seropositive donors with about 6,600 more donors recovered for transplant). Between 2012 and 2013, the only category that increased appreciably was serologic testing. Tissue suitability decreased significantly (0.7%), but did not fall to the same level as in Other categories remained similar in magnitude to the rates in The most striking change in this data (in the U.S.) between 2011 and 2012 was due to "other reasons." The values for "other reasons" spiked to a new plateau in January 2012 and continued at the new level from that point forward. A change in the staff that collected 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 appeared to have occurred. Whatever the inexplicable cause, the trend remained the same throughout

23 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 2013 at a rate of 8.7%, while international banks report the same occurrence at 6.0%. Interestingly, the U.S. and international eye banks experienced the same rate of increase in positive serologic testing as a percentage of tissue recovered for transplant use. Other comparisons include medical record or autopsy findings (6.5% in the U.S., 4.0% internationally), medical/social history findings (2.0% in the U.S., 3.6% internationally), tissue suitability (11.2% in the U.S., 10.2% internationally), quality reasons (0.4% in the U.S., 1.1% internationally), and "other reasons" (2.1% in the U.S., 6.6% internationally). Notably, as U.S. eye banks increase the rate of donor recovery using donor designation, the rate of finding tissue ineligible due to medical/social interview findings has not increased. 23

24 Analysis of the Reasons Tissue Intended for Surgery Was Not Suitable for Transplant 76 U.S. Eye Banks Reporting Month Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Eye Bank Data Subset: Serologic Testing All Serology Tests HIV Ab HIV NAT HBsAg HBcAb HCV Ab HCV NAT Syphilis HTLV Ab Other Test Jan % 0.2% 0.1% 0.7% 4.1% 2.0% 0.6% 0.4% 0.2% 0.2% Feb % 0.1% 0.1% 0.6% 4.4% 2.1% 1.0% 0.4% 0.2% 0.4% Mar % 0.2% 0.1% 0.7% 4.0% 1.8% 0.9% 0.4% 0.3% 0.3% Apr % 0.1% 0.0% 0.5% 4.5% 2.0% 0.7% 0.3% 0.2% 0.5% May % 0.1% 0.0% 0.8% 4.1% 2.2% 0.7% 0.3% 0.3% 0.5% Jun % 0.1% 0.1% 1.0% 4.4% 1.7% 0.7% 0.4% 0.2% 0.5% Jul % 0.1% 0.2% 0.8% 4.3% 1.8% 0.7% 0.4% 0.2% 0.4% Aug % 0.3% 0.1% 0.7% 3.6% 1.8% 0.7% 0.4% 0.2% 0.6% Sep % 0.1% 0.0% 0.6% 4.7% 1.9% 0.7% 0.3% 0.2% 0.6% Oct % 0.2% 0.1% 0.7% 4.5% 1.6% 0.5% 0.3% 0.2% 0.6% Nov % 0.1% 0.1% 0.9% 3.7% 1.7% 0.5% 0.4% 0.2% 0.7% Dec % 0.2% 0.1% 0.7% 4.3% 1.6% 0.6% 0.3% 0.2% 0.8% 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% 2013 Avg. 8.7% 0.2% 0.1% 0.7% 4.2% 1.8% 0.7% 0.4% 0.2% 0.5% Std. Dev. 0.3% 0.1% 0.0% 0.1% 0.3% 0.2% 0.1% 0.1% 0.0% 0.2% *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 decreased slightly between 2012 (5.0%) and 2013 (4.8%). The rate is still higher than in 2011 (4.2%). Internationally, the rate of hepatitis B positive donors increased between 2012 (3.2%) and 2013 (3.7%). HBV NAT testing as a reason for not releasing tissue for transplant was not measured in 2011 through 2013, but will be an independent measure in Trends for Hepatitis C, syphilis, and HIV tests, remained flat (within 0.1% change) in the U.S. International banks reported a drop in HCV positive donors between 2012 (1.7%) and 2013 (1.1%). U.S. banks reported an increasing trend in "other tests" as a reason for not releasing tissue for transplant. This is a result of increased use of HBV NAT and WNV NAT testing. 24

25 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 76 U.S. Eye Banks Reporting 25

26 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 76 U.S. Eye Banks Reporting Month Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Eye Bank Data Subset: Medical Record and Autopsy All Medical Record Dementia / Neuro Sepsis (Cultures) Sepsis (Other) Plasma Dilution Unknown Cause of Death Other Jan % 0.7% 1.0% 2.8% 0.4% 0.5% 1.7% Feb % 0.6% 0.8% 2.2% 0.5% 0.4% 1.6% Mar % 0.5% 0.8% 2.8% 0.6% 0.5% 1.9% Apr % 0.5% 0.9% 2.4% 0.4% 0.5% 1.6% May % 0.4% 0.7% 2.3% 0.5% 0.5% 2.0% Jun % 0.5% 0.8% 2.2% 0.4% 0.6% 1.5% Jul % 0.7% 1.1% 2.8% 0.4% 0.4% 1.8% Aug % 0.7% 0.9% 2.4% 0.3% 0.5% 1.4% Sep % 0.6% 0.9% 2.3% 0.4% 0.5% 1.6% Oct % 0.7% 0.8% 2.1% 0.4% 0.5% 1.8% Nov % 0.7% 0.9% 2.3% 0.3% 0.2% 2.2% Dec % 0.7% 0.9% 2.0% 0.4% 0.3% 2.1% 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% 2013 Avg. 6.5% 0.6% 0.9% 2.4% 0.4% 0.4% 1.8% Std. Dev. 0.4% 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" 26

27 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 76 U.S. Eye Banks Reporting Trends for medical record or autopsy findings as a reason for not releasing tissue for transplant between 2012 and 2013 remained the same in the U.S., but decreased significantly as reported by international banks (5.1% and 4.0%, respectively). Through networking with other eye bank professionals, there is potential that the value of "unknown cause of death" may be decreased. Further, more effective use of electronic medical record access prior to recovery may aid in decreasing all of these incidences. Use of a more recently developed clinical test for bacterial sepsis, procalcitonin, has been increasing in U.S. hospitals. This may be a laboratory value of interest for eye banks to review during screening of potential donors, to aid in the reduction of recovering donor tissue later determined ineligible due to sepsis. Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Eye Bank Data Subset: Medical & Social History Month All Medical / Social History Travel Dementia / Neuro Other Jan % 0.2% 0.2% 1.7% Feb % 0.3% 0.3% 1.4% Mar % 0.3% 0.3% 1.2% Apr % 0.3% 0.2% 1.5% May % 0.3% 0.2% 1.4% Jun % 0.3% 0.2% 1.6% Jul % 0.3% 0.2% 1.2% Aug % 0.2% 0.1% 1.5% Sep % 0.3% 0.1% 1.7% Oct % 0.4% 0.2% 1.6% Nov % 0.3% 0.1% 1.7% Dec % 0.3% 0.2% 1.7% 2011 Avg. 1.7% 0.3% 0.1% 1.3% 2012 Avg. 2.1% 0.3% 0.2% 1.6% 2013 Avg. 2.0% 0.3% 0.2% 1.5% Std. Dev. 0.2% 0.1% 0.1% 0.2% *Percentages read from this table should be read as "of the tissue recovered with transplant intent" 27

28 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 76 U.S. Eye Banks Reporting 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, the tissue was most often not recovered for transplant. Reducing instances of recovering prior to having the completed interview reduced the occurrence of these reported values, since only recovered tissue is reported. Increased use of donor registry as consent for donation has not demonstrated an increase in donor tissue found ineligible 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 significantly lower occurrence of this reason compared to international banks (2.0% in the U.S., 3.6% at international locations). International banks reported travel exclusionary reasons at a rate twice that reported by the U.S., while dementia and neurological reasons were reported by U.S. banks as half that of the international reasons. "Other" reasons found in the donor risk assessment interview were 2.5% at international banks, compared with 1.5% in the U.S. in This suggested varied interview questions and methods, as there was no standard interview tool available during this period. Adoption of the Donor Risk Assessment Interview tool, developed in collaboration between AOPO, AATB, and the EBAA has endured slow adoption in the U.S. Other factors influencing the difference in the U.S. and international eye bank data were social, cultural, economic, and demographic. 28

29 Month 2013 U.S. Eye Banking Statistics Reported by U.S. Banks: Reasons Tissues Were Not Released 76 U.S. Eye Banks Reporting Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Tissue Suitability Data Subset All Tissue Suitability Reasons Epithelium Prior Refractive Surgery Scar Infiltrate Foreign Body Other Stromal Finding Descemet's Membrane Endothelium Jan % 0.6% 0.4% 1.4% 2.6% 0.1% 0.9% 0.4% 5.7% Feb % 0.2% 0.3% 1.3% 2.3% 0.2% 1.2% 0.2% 6.4% Mar % 0.3% 0.3% 1.3% 2.5% 0.2% 1.1% 0.3% 6.3% Apr % 0.2% 0.4% 0.9% 2.7% 0.1% 1.1% 0.5% 5.4% May % 0.2% 0.4% 1.1% 2.3% 0.2% 0.8% 0.1% 4.5% Jun % 0.1% 0.4% 1.1% 2.7% 0.2% 0.9% 0.3% 4.6% Jul % 0.2% 0.4% 1.1% 2.6% 0.2% 0.9% 0.4% 5.5% Aug % 0.2% 0.3% 1.0% 2.6% 0.2% 1.1% 0.3% 5.1% Sep % 0.3% 0.4% 1.3% 2.6% 0.2% 1.1% 0.3% 5.3% Oct % 0.3% 0.6% 1.3% 2.2% 0.1% 0.9% 0.4% 5.0% Nov % 0.2% 0.3% 1.3% 2.5% 0.1% 1.1% 0.2% 5.6% Dec % 0.1% 0.2% 1.5% 2.9% 0.2% 0.8% 0.2% 5.4% 2011 Avg. 11.0% 0.4% 0.3% 1.0% 2.2% 0.2% 1.0% 0.4% 5.5% 2012 Avg. 11.9% 0.3% 0.3% 1.0% 2.4% 0.2% 1.4% 0.4% 6.0% 2013 Avg. 11.2% 0.3% 0.4% 1.2% 2.5% 0.2% 1.0% 0.3% 5.4% Std. Dev. 0.8% 0.1% 0.1% 0.2% 0.2% 0.0% 0.2% 0.1% 0.6% 29

30 2013 Eye Banking Statistics: Analysis of Tissue Suitability Reasons for Non Release 76 U.S. and 10 International Eye Banks Reporting In the U.S., between 2011 and 2012, there was a significant increase in tissue not released for transplant due to tissue suitability. In 2013, while tissue recovery increased, the rate of tissue not released for transplant due to tissue suitability decreased to near 2011 rates. Endothelium, the most significant portion of this category, decreased (6.0% in 2012 compared with 5.4% in 2013) and a decrease in "other stromal findings" (1.4% in 2012 compared with 1.0% in 2013, were responsible for the largest portions of the overall categorical decrease. Notably, international banks found tissues to have lower quality endothelia and stroma at roughly the same magnitude as American banks (5.1% and 0.7%, respectively). Notable differences between data reported by U.S. banks and international banks were prior refractive surgery and epithelium. American banks reported prior refractive surgery as a reason for not releasing tissue for transplant at a rate of 0.4%, while international banks reported this reason at a rate of 0.2% in Both the U.S. banks and the international banks noted a modest increase of 0.1%. While the difference was not great, it may have represented a difference in the rate at which the general population in the U.S. had a history of prior refractive surgery compared with the rate in the international banks' locales. Epithelium was reported at 1.0% by international banks and 0.3% by U.S. banks. At the time of this report, there was no reasonable explanation for this value, though possible explanations may be related to values not measured by the EBAA (e.g. death to preservation interval or death to cooling interval). 30

31 2013 Eye Banking Statistics Reported by U.S. Banks: Quality Issues 76 U.S. Eye Banks Reporting Month Reasons Tissue Recovered for Transplant Not Used for Transplant U.S. Eye Bank Data Subset: Quality Issues and Other Reasons All Quality and Other Issues Storage Issue Labeling Issue Processing Issue (before release) Supply or Reagent Issue Environmental Control Issue Body Exam Other Serologic Testing Issue Jan % 0.1% 0.0% 0.3% 0.0% 0.0% 0.2% 0.3% 2.3% Feb % 0.2% 0.0% 0.3% 0.1% 0.0% 0.2% 0.4% 1.6% Mar % 0.1% 0.0% 0.3% 0.1% 0.1% 0.1% 0.6% 1.9% Apr % 0.1% 0.0% 0.2% 0.1% 0.0% 0.2% 0.3% 2.5% May % 0.1% 0.0% 0.1% 0.0% 0.0% 0.1% 0.4% 2.7% Jun % 0.0% 0.0% 0.1% 0.1% 0.0% 0.1% 0.3% 2.3% Jul % 0.1% 0.0% 0.2% 0.0% 0.1% 0.3% 0.2% 1.6% Aug % 0.1% 0.0% 0.2% 0.0% 0.0% 0.1% 0.2% 1.7% Sep % 0.1% 0.1% 0.2% 0.0% 0.0% 0.2% 0.3% 1.8% Oct % 0.1% 0.0% 0.2% 0.0% 0.0% 0.1% 0.6% 2.1% Nov % 0.0% 0.0% 0.2% 0.0% 0.0% 0.3% 0.3% 2.3% Dec % 0.1% 0.0% 0.1% 0.1% 0.0% 0.2% 0.2% 2.2% Other Issue 2011 Avg. 1.4% 0.2% 0.0% 0.1% 0.1% 0.0% 0.2% 0.2% 0.5% 2012 Avg. 3.1% 0.1% 0.0% 0.2% 0.0% 0.0% 0.3% 0.3% 2.2% 2013 Avg. 3.0% 0.1% 0.0% 0.2% 0.0% 0.0% 0.2% 0.3% 2.1% Std. Dev. 0.4% 0.0% 0.0% 0.1% 0.0% 0.0% 0.1% 0.1% 0.4% *Percentages read from this table should be read as "of the tissue recovered with transplant intent" 31

32 2013 Eye Banking Statistics Reported by U.S. Banks: Quality Issues 76 U.S. Eye Banks Reporting Regarding the overall rate of not releasing tissue that was recovered for transplant use, quality reasons were not a large portion of the reasons (0.3% in the U.S., 1.2% internationally). This was a testament to the quality assurance and quality control processes employed both in the U.S. and internationally. A great example of this was the rate of not releasing tissue for transplant due to labeling, which was 0.0% (though did account for 44 in the U.S. in 2011, 14 in the U.S. in 2012, 14 in the U.S. in 2013, 0 internationally in 2012, and 5 internationally in 2013). This was remarkable. However, quality reasons, by nature, are often avoidable and may continue to be an area of improvement for eye banks in the U.S. and abroad. By comparison, international banks experienced serologic testing issues twice as frequently as U.S. banks in 2012, but in 2013, while the U.S. banks reported no change in the rate of occurrence of these events, international eye banks reported a drop from 0.6% in 2012 to 0.1% in Storage was a more significant reason for not releasing tissue at international banks than at U.S. banks, by percentage, but represented fewer instances (127 in the U.S. in 2011, 116 in the U.S. in 2012, 101 in the U.S. in 2013, 10 internationally in 2012, and 22 internationally in 2013). As a general comparison, the quality systems of the U.S. and international banks accredited by the EBAA were comparable and worthy of pride. "Other issue" jumped significantly at international eye banks, mostly because of events in December The value of this reason for not releasing tissue rose to 6.6% (360 corneas) in 2013, compared to 5.1% (260 corneas) in In the U.S. this reason dropped to 2.1% in 2013 from 2.2% in 2012, after an initial change in magnitude between 2011 and The interpretation of how to categorize events as "other" appeared to have settled by those performing data collection both in the U.S. and at international banks. 32

33 2013 Eye Banking Statistics Reported by U.S. Banks: Reasons Tissue Intended for Surgery Was Not Suitable for Transplant 76 U.S. Eye Banks Reporting Reasons Released Tissues Were Not Transplanted Transportation Issue % % Surgeon Issue % % Recipient Issue % % Returned and Unable to Place Again % % Donor Information Not Available at the Time of Tissue Release % % Expired or Unable to Place Tissue 3, % 3, % Tissue Damaged During Processing % % Other Reason After Release of Tissue % % Total eyes/corneas released for transplant but not used for transplant 5,182 4,908 33

34 2013 Eye Banking Statistics Reported by U.S. Banks: Reasons Released Tissues Were Not Transplanted 76 U.S. Eye Banks Reporting Month Tissues Released Not Transplanted Transport Issue Surgeon Issue U.S. Eye Banks Recipient Issue Returned Tissue Unable to Place Again Donor Info Received after Release Expired Tissue / Unable to Place Processing Damage after Release Other Reason after Release Jan % 0.1% 0.2% 0.1% 0.3% 0.0% 3.8% 0.6% 0.7% Feb % 0.1% 0.2% 0.1% 0.2% 0.0% 2.7% 0.4% 0.5% Mar % 0.1% 0.1% 0.0% 0.1% 0.0% 2.7% 0.4% 0.6% Apr % 0.1% 0.2% 0.0% 0.2% 0.0% 2.8% 0.5% 0.5% May % 0.2% 0.2% 0.0% 0.2% 0.0% 3.3% 0.4% 0.4% Jun % 0.1% 0.1% 0.0% 0.2% 0.0% 3.1% 0.4% 0.9% Jul % 0.2% 0.2% 0.0% 0.4% 0.0% 2.8% 0.4% 0.5% Aug % 0.1% 0.2% 0.0% 0.4% 0.0% 4.0% 0.5% 0.8% Sep % 0.1% 0.1% 0.0% 0.2% 0.1% 2.9% 0.4% 1.0% Oct % 0.0% 0.1% 0.0% 0.2% 0.1% 2.3% 0.5% 1.1% Nov % 0.1% 0.1% 0.0% 0.3% 0.3% 3.0% 0.5% 0.4% Dec % 0.1% 0.1% 0.0% 0.2% 0.1% 3.8% 0.5% 0.5% 2011 Avg. 4.5% 0.1% 0.2% 0.1% 0.3% 0.0% 3.1% 0.3% 0.4% 2012 Avg. 4.7% 0.1% 0.1% 0.0% 0.3% 0.0% 3.7% 0.4% 0.3% 2013 Avg. 4.7% 0.1% 0.1% 0.0% 0.2% 0.0% 3.1% 0.5% 0.6% Std. Dev. 0.6% 0.0% 0.0% 0.0% 0.1% 0.1% 0.5% 0.1% 0.2% *Percentages read from this table should be read as "of the tissue recovered with transplant intent" 34

35 2013 Eye Banking Statistics Analysis of Reasons Released Tissues Were Not Transplanted 76 U.S. and 10 International Eye Banks Reporting Between 2011 and 2012, U.S. eye banks expressed a modest increase in reasons tissues were released but not transplanted (0.2%), but this increasing trend did not continue in 2013, despite an increase in recovered tissue. A notable drop in expired tissue unable to be placed was reported by U.S. and international banks (3.0% in the U.S. 2012, 3.7% in the U.S. in 2013, 4.9% internationally in 2012, and 3.6% internationally in 2013). International banks reported 6.0% of tissue released that did not get transplanted compared to 4.7% in the U.S. in The most significant reason for both U.S. and international banks not transplanting released tissue was expired tissue/unable to place. In 2013, the U.S. reported 24,168 processing events with a total of 726 corneas not transplanted due to processing damage (before and after release), for a rate of 3.0% processing damage (up from 2.1% in 2012). During this same period, international banks reported 451 processing events with a total of 55 corneas not transplanted due to processing damage (before and after release), for a rate of 12.2% processing damage (up from 6.1% in 2012). Interestingly, international banks reported an increase in processing damage, combined with a decrease in processing events, while U.S. banks continue an upward trend in processing events. 3,322 corneas reported by U.S. banks and 198 corneas reported by international banks were not transplanted due to expiration. Additionally, 267 corneas reported by U.S. banks and 53 corneas reported by international banks were returned and unable to place again. Disproportionate to the overall pool of corneas recovered for transplant, the corneas that suffer expiration were of lower tissue quality (though still of transplant suitability). Returned tissue, however, due to the time period to retrieve, test, evaluate, distribute, return, and reevaluate tissue were often of "normal" or high quality, but were not used for transplant due to aging of the tissue (not to be confused with expiration). A large percentage of these corneas could have transplanted with improved pipelines to locations in the world needing tissue of all tissue qualities and may represent an opportunity for either the eye banks or a third party to better aid in seeing tissue to these locations. While access to electronic medical records prior to recovery of tissue or prior to tissue release is on the rise, there is a risk of increasing incidence of released corneas not being transplanted due to information about the donor received after release. This scenario impacted 54 corneas in the U.S. in 2013, up from 12 in The cause is due to late entry of consultations and progress notes in the medical record at the hospital, a relatively commonplace practice that may pose a threat to donor safety. 35

36 2013 Eye Banking Statistics Reported by U.S. Banks: Outcomes of Tissue Recovered for Transplant 76 U.S. Eye Banks Reporting Donations % Change Eye Banks Reported *0.0% Total Whole Globes and Corneas Donated 123, , % Total Number of Donors 62,274 59, % Distribution % Change Intermediate-Term Preserved Corneas 68,526 66, % Sclera 3,693 3, % Long-Term Preserved Corneas 4,840 5,095 (-5.0%) Research 17,384 19,320 (-10.0%) Training 7,451 6, % * 5 Eye Banks now reporting as one corporate entity Outcomes of Tissue Recovered for Transplant - U.S. Eye Banks Month Corneas Recovered for Transplant Corneas Segmented Corneal Segments Produced Not Released Released but Not Transplanted Whole Corneas and Segments Transplanted Preserved Long-Term Jan % % % % Feb % % % % Mar % % % % Apr % % % % May % % % % Jun % % % % Jul % % % % Aug % % % % Sep % % % % Oct % % % % Nov % % % % Dec % % % % 2011 Total % % % % 2012 Total % % % % 2013 Total % % % % 2013 Avg N/A 432 N/A 5704 N/A 358 N/A Std. Dev % % % % *Percentages read from this table should be read as "of the tissue recovered with transplant intent" 36

37 2013 Eye Banking Statistics Reported by U.S. Banks: Outcomes of Tissue Recovered for Transplant 76 U.S. Eye Banks Reporting 37

38 2013 Eye Banking Statistics Reported by U.S. Banks: Outcomes of Tissue Recovered for Transplant 76 U.S. Eye Banks Reporting 38

39 2013 Eye Banking Statistics: Analysis of Outcomes of Tissue Recovered for Transplant 76 U.S. and 10 International Eye Banks Reporting In eye banks that preserve tissue in intermediate-term preservation media at the time of recovery or shortly afterward, tissue recovered with intent for transplant will meet one of four potential outcomes within two weeks. Either tissue will not be released for transplant, be released for transplant but not transplanted, be transplanted, or be preserved in long-term preservation media. As an extreme historical example, in the U.S., a spike in transplanted tissue and tissue not released for transplant in December 2011 was consistent with a spike in tissue recovered for transplant due to a significant rise in referral activity. Total referrals were 27.6% above average, transplanted corneas were 11.8% above average, and tissue not released for transplant was 10.5% above average. Referral activity did not spike as dramatically since. In 2013, a less obvious pattern emerged with minor spikes in long-term preservation of tissue in April due to ASCRS, June due to decreased demand consistent with end of school and onset of summer, and December due to the holidays. In January, the increased recovery of corneas for transplant was complemented with a spike in tissue released, but not transplanted with expired tissue as a spike. In December, tissue released but not transplanted and a decreased rate of recovery were also associated with the holidays. Internationally, similar patterns emerged, with a reduction in transplanted tissue in December. As transplant rate is relatively steady, the trends of data reported by the U.S. banks shows that the surgical use of tissue was predictably and relatively steady as well. Surgical use of tissue was influenced mainly by holidays and ophthalmological society meetings. Due to the smaller sample size, activity at the international banks was more difficult to analyze and showed a greater correlation to transplant rate. At the international banks, it was notable that the decreased demand during December 2012 resulted in a 229% increase in preservation of tissue long-term. This did not repeat in 2013; however the tissue not released for transplant was at its highest level in December at the international banks. 39

40 2013 Eye Banking Statistics Reported by U.S. Banks: Use of Donated Tissues 76 U.S. Eye Banks Reporting Distribution Corneal Grafts Total 72,736 68,681 67,590 59,271 59,784 Penetrating Keratoplasty 36,998 36,716 36,144 21,970 23,269 Anterior Lamellar Keratoplasty 2,009 1,855 1,778 1, Endothelial Keratoplasty 27,298 24,277 23,287 19,159 18,221 Keratolimbal Allograft Keratoprosthesis (K-Pro) Glaucoma Shunt Patch or other nonkeratoplasty use Other keratoplasty (experimental surgery) Unknown or Unspecified ,554 2, Sclera 3,693 3,497 5,507 6,746 7,634 Long-Term Preserved Corneas 4,840 5,095 4,409 3,518 2,053 Keratoplasty Glaucoma Shunt Patching 4,040 4,435 3, Other Surgical Uses Research 17,384 19,320 19,230 17,260 14,547 Training 7,451 6,850 6,940 5,726 7,113 The highlighted numbers reflect tissues distributed and used within the U.S. only. Data for tissue distributed internationally in these years were not collected by surgery type. Data from previous years included U.S. and international distribution of tissues. In 2010, Corneal Grafts Total did not include long-term preserved corneal tissue. In 2011 and beyond, long-term preserved corneal tissue is included in the total. 40