Technical Notes and Analytic Methods

This section explains concepts, provides definitions of data items appearing in the Reference Tables, and documents the analytic methods used throughout this report. The Reference Tables are divided into 14 subject-area sections and a Supplementary Tables section for the legacy tables. This appendix also cross-references those reference tables to which each topic applies.

The OPTN/SRTR data reported here are based on data collected primarily by the OPTN along with other sources, as described in Chapter II of this report.

New in This Year's Report

The 2004 Annual Report includes new tables comparing survival rates over time, waiting list events for urgent-status registrants, and a methodological change in waiting list mortality rate. This section covers changes in the technical and analytic methods. Please refer to the preface for new items in the 2004 Annual Report.

Extra Ascertainment in Mortality on the Waiting List. Deaths and death rates on the waiting list had previously relied exclusively on the OPTN members' reporting of their patients as being removed from the waiting list due to death; this year we have incorporated deaths reported by other OPTN sources (i.e., transplant events and transplant follow-ups), and also included deaths from the Social Security Death Master File (SSDMF) and Centers for Medicare & Medicaid Services (CMS) data sources to provide additional death ascertainment while patients are on the waiting list.

Waiting List Status Changes and Events. New tables presenting status changes and events for patients on the waiting list replace the Time to Transplant tables for liver and heart. For these organs, the ranking of the waiting list is based on severity of illness, allowing readers to compare waiting list outcome in terms of the patient's condition and status change.

Time Periods Covered

Most tables are based on OPTN/SRTR data as of May 3, 2004. This date was chosen to allow the maximum amount of time possible to obtain and validate data while ensuring completion of the report by year-end. All cohorts were chosen to reflect as recent statistics as possible while minimizing the probability of change due to additional data submitted. Data are subject to change on the basis of future data submission or correction.

For a more detailed discussion of the choice of cohorts for different analyses and counts, see Chapter II.

Most tables present data by year from 1994 to 2003. Tables showing posttransplant survival use cohorts of transplants that may be from earlier years in order to allow for reporting of follow-up. Chapter IX includes a discussion of choosing cohorts for different analyses.

Deceased and Living Donor Characteristics

Donor tables show frequency counts and percentages for deceased and living organ donors by year by selected demographic and medical factors (donor age, race, gender, blood type, cause of death, circumstance of death, mechanism of death, and/or donor relation). Table 1.1 presents counts of donors by organ for deceased and living donors. Section 2 presents organ-specific counts and percentages of donors by donor characteristics for deceased and living donors.

Deceased Donor Characteristics

Deceased donor characteristics are presented in the following tables:

Table 2.1	All Donors (Deceased)
Table 2.2	Kidney Donors (Deceased)
Table 2.3	Pancreas Donors (Deceased)
Table 2.4	Liver Donors (Deceased)
Table 2.5	Intestine Donors (Deceased)
Table 2.6	Heart Donors (Deceased)
Table 2.7	Lung Donors (Deceased)

These data are obtained from the OPTN Deceased Donor Registration (DDR) Form. Only deceased donors recovered by United States organ procurement organizations (OPOs) are included in these tables.

For the purposes of this report, a "recovered" deceased donor is one from whom at least one vascularized solid organ (kidney, pancreas, liver, intestine, heart, or lung) was recovered for the purpose of organ transplantation, even if the organ was eventually not used for a transplant. Organ-specific donors (e.g., "kidney donors" or "liver donors") are those from whom at least one organ of that type was recovered. If more than one organ is recovered from a donor, that donor is included in each organ-specific donor count. Hearts recovered for heart valves, pancreata recovered for islet cells and livers recovered for extracorporeal liver or hepatocytes are not counted.

Changes made to the data collection forms in April 1994 affected the way cause of death data were collected. Death information is now reported in three categories: cause of death, circumstance of death, and mechanism of death. Comparisons across time for these variables are shown from the time that the current coding scheme was put in place.

Note that not all recovered organs are actually transplanted. Data tables pertaining to the recovery and disposition of organs are presented in Section 3, Deceased Donor Organ Recovery and Disposition.

Living Donor Characteristics

Living donor characteristics are presented in the following tables:

Table 2.8	All Donors (Living)
Table 2.9	Kidney Donors (Living)
Table 2.10	Liver Segment Donors (Living)
Table 2.11	Lung Lobe Donors
Table 2.11	Lung Lobe Donors (Living)

These data are based on OPTN Living Donor Registration Forms and include living donors from whom organs were transplanted in the United States between 1994 and 2003. The year of reporting is based on the organ recovery date as reported to the OPTN. The numbers of living pancreas, intestine, and heart donors are too small to offer meaningful information, and therefore are not presented in detail.

Some living donations described are the result of complicated operations. Frequent questions are asked about how a living donor heart transplant can be possible. This happens rarely, but can result when a heart-lung transplant is performed. In this case, the recipient's heart has been enlarged from the disease that affected the lungs. The person's own heart may damage the donor lungs if they are transplanted alone, whereas the combined heart-lung bloc is more physiologically matched. The heart of the recipient is useful as a transplant for a large person whose own heart size needs are large. "Domino" liver transplants can occur when a transplant is done for familial amyloidosis. This disease affects the body due to a problem in the liver, but it takes many years for the damage to be done. A person who has a very short life expectancy without a transplant or who is otherwise a high-risk candidate may be willing to accept this otherwise normal donor liver, even though it will cause the disease many years later. Both types of living donor transplants described here are included in these counts.

The number of transplants using living donors may be different from the number of living donors. This is because there is a small number of multi-organ living donors and multiple donors for one transplant. For example, a living donor might donate a kidney and pancreas segment; or two living donors might each donate a lung lobe for one transplant procedure.

Organ Recovery and Disposition FROM DECEASED DONORS

The deceased donor organ disposition tables show frequency counts and percentages for each disposition category (i.e., local or shared transplant, local or shared nonuse, research, foreign exported, used for organ parts, and unknown) for all deceased donor organs recovered by United States OPOs, by organ type and year. In addition, tables are presented showing frequency counts for the reasons for nonuse of recovered organs intended for transplant and nonrecovery of consented organs. Table 1.2 shows the number of organs recovered from all deceased donors. Section 3 shows organ-specific recovery and disposition data.

Tables 3.1, 3.2, 3.3	Kidney Disposition, Nonuse, and Nonrecovery
Tables 3.4, 3.5, 3.6	Pancreas Disposition, Nonuse, and Nonrecovery
Tables 3.7, 3.8, 3.9	Liver Disposition, Nonuse, and Nonrecovery
Tables 3.10, 3.11, 3.12	Intestine Disposition, Nonuse, and Nonrecovery
Tables 3.13, 3.14, 3.15	Heart Disposition, Nonuse, and Nonrecovery
Tables 3.16, 3.17, 3.18	Lung Disposition, Nonuse, and Nonrecovery

Organ Disposition Data

When a donor donates either both kidneys or both lungs, each organ is counted separately. In cases where a liver, intestine, or pancreas is split, both segments can have dispositions and each segment may be counted in these tables.  Hearts recovered for heart valves, pancreata recovered for islet cells, and livers recovered for hepatocytes or extracorporeal liver are not counted. The year of reporting is based on the start of organ preservation as recorded on the DDR Form.

A locally transplanted organ is one that is transplanted within the immediate service area of the OPO that recovered the organ. A shared transplant involves an organ shipped to a transplant hospital outside the immediate service area of the OPO. Determination of local and shared organs is made by examining the relationship between the OPO at which an organ is procured and the center at which it is transplanted, at the time of transplant. Any recovered organ intended for transplant that is neither transplanted nor used in research is referred to as not used.

Nonuse of Recovered Organs and Nonrecovery of Consented Organs

The reasons for nonuse of deceased donor organs intended for transplant and nonrecovery of consented organs are shown for all organs from deceased donors who donated at least one solid organ. (For example, consent is obtained for one donor to donate two kidneys, a liver, and a heart. The kidneys are recovered and used in a transplant. The liver is recovered, but the organ is damaged. The liver, therefore, is listed in the table on organs recovered but not transplanted. The heart, which also is consented for transplantation, is found to have poor function before it is recovered. The heart, therefore, is listed in the table on organs consented but not recovered.) These tables do not include donors whose organs were consented but from whom no organs were ever recovered for transplant. For nonrecovery of consented organs, when both kidneys or both lungs are not recovered, each organ is counted separately.

United States OPOs: Donors Procured and Transplant Centers in Service Area

Table 4.1 shows the number of deceased donors procured by year for each OPO. Table 4.2 lists the transplant centers within each OPO's current CMS-designated Donation Service Area (DSA), by the OPO's home state. Transplant centers in some states are served by OPOs in other states; in such cases, the reader is referred to an alternate home state indicated in the table.

OPO and transplant center data were obtained from the CMS-designated service areas as reported to the OPTN as of May 3, 2004.

The OPOs listed in Table 4.1 include those that were operational during 1994-2003. OPOs operating during only a portion of this period will list "-" donors recovered for years during which they were not functioning. Donor comparisons across years may be difficult, as donors from one or more previously operational organizations have been incorporated into the OPO currently serving their area and because OPO service areas change over time.

Waiting list Patient Characteristics

The waiting list tables show frequency counts and percentages of certain demographic and medical factors for patients awaiting transplantation at each year-end.

Tables 1.3 and 1.4 show the OPTN waiting list at year-end and selected characteristics for all organs. Waiting list tables are presented in Table 1 of each organ-specific section.

Table 5.1 Kidney Waiting List Patient Characteristics

Table 6.1	Pancreas Transplant Alone Waiting List Patient Characteristics
Table 7.1	Pancreas After Kidney Waiting List Patient Characteristics
Table 8.1	Kidney-Pancreas Waiting List Patient Characteristics
Table 9.1	Liver Waiting List Patient Characteristics
Table 10.1	Intestine Waiting List Patient Characteristics
Table 11.1	Heart Waiting List Patient Characteristics
Table 12.1	Lung Waiting List Patient Characteristics
Table 13.1	Heart-Lung Waiting List Patient Characteristics

These data represent patients on the waiting list at the end of each year, according to data available May 3, 2004. OPTN members have direct responsibility for submitting, maintaining, and monitoring all waiting list data from the time patients are listed until they are removed from the list. These waiting list profiles are based on all information available about these patients, including information received after the date of the snapshot (i.e., December 31 of each year). Patients who have died or who received a transplant before they are removed by the center (usually only a matter of a few days) are treated as being removed at death or transplant. Patients on the kidney-pancreas waiting list, regardless of whether they have indicated they will accept one organ without the other, are counted only in the kidney-pancreas waiting list totals.

Some patients are listed at different centers for the same organ type or listed for multiple organ types at the same time (e.g., both a kidney and a liver). With the exception of Table 1.3, which shows both individual registrations and patients, the data in the waiting list characteristic tables are adjusted for multiple listings of potential transplant recipients so that individuals will not be counted more than once. Therefore, the totals reflect the number of candidates rather than number of registrations. When patient characteristics (age, race, etc.) are different between two registrations for the same person, the more recent registration is used. For characteristics that are likely to be different (inactive/active status, waiting time, etc.), we choose by the characteristic that most reflects a patient's activeness on the waiting list (e.g., higher status, longer waiting time).

Panel Reactive Antibody (PRA). Peak PRA levels are shown only for the kidney waiting list. These data are not required for patients waiting for other organ types.

Patient Status. For the kidney, pancreas, kidney-pancreas, intestine, lung, and heart-lung waiting lists, this item reflects the number and percentage of patient registrations listed as either active or temporarily inactive (i.e., temporarily unavailable for transplant) on December 31 of the year examined. For the heart waiting list, this item reflects medical urgency status categories used for allocation, as well as inactive waiting list status. For the liver waiting list, this item reflects medical urgency status categories used for allocation prior to 2002, or the MELD/PELD score along with applicable exceptions that were implemented starting in 2002. In interpreting trends in urgency status, it should be noted that urgency status systems have changed over time. These urgency categories are described in detail in the Glossary.

Time Waiting. This item reflects the total length of time from each registration's entry onto the list until the date of the snapshot, including inactive time. It does not include any time transferred from a prior registration.

TIME TO TRANSPLANT AND MEDIAN WAITING TIME

"Time to Transplant" is shown in Table 1.5, and "Median Waiting Time" is shown in Table 1.6. Time to transplant is also shown in Table 2 of each organ-specific section. For livers and hearts, "Events after Listing" replaces the "Time to Transplant"  tables reported in previous years.

Table 5.2	Kidney Time to Transplant
Table 6.2	Pancreas Alone Time to Transplant
Table 7.2	Pancreas After Kidney Time to Transplant
Table 8.2	Kidney-Pancreas Time to Transplant
Table 9.2	Liver Events after Listing
Table 10.2	Intestine Time to Transplant
Table 11.2	Heart Events after Listing
Table 12.2	Lung Time to Transplant
Table 13.2	Heart-Lung Time to Transplant

The "Time to Transplant" tables report how long it takes for 10%, 25%, and 50% (the median) of the registrants to be transplanted (whether from a deceased or living donor) for each cohort of new waiting list registrations in each calendar year. These tables take the point of view of a new waiting list registrant wishing to know his or her prospects for getting a transplant from any source. Waiting time, shown only in Table 1.6 , measures only actual time actively waiting on the list (excluding periods at inactive status), and considers only transplants from a deceased donor as "success" or event. A third type of table, median waiting time among actual recipients of transplants, is not shown in this Annual Report. Chapter IX describes the difference in perspective between these tables, and the following table documents the difference in treatment.

In Table TN-1 , note the difference between the "censored" registrations and those with "non-Transplant" as a result. The latter, applied to registrants who have died in the "Time to Transplant" models, correctly accounts for the fact that these registrants will never receive a transplant, by extending the time to transplant for these registrants out far beyond any calculated percentiles. Censored registrations, on the other hand, use the assumption that after this removal, had this registrant remained on the waiting list, he or she would have had similar results to other registrants who actually did remain on the list at that time since listing. In order to measure only time actually spent waiting, the median waiting time calculation censors all non-transplant events.

Table TN-1: Primary Differences in Time to Transplant and Median Waiting Time Models

Reason for Removal or Current Active Status	Time to Transplant (Tables 1.5, X.2*)	Median Waiting Time (Table 1.6)
Inactive Time	Included	Excluded
Censor / Event Treatment of Outcomes
Deceased Donor Organ Tx	Transplant	Transplant
Living Donor Tx	Transplant	Censor
Tx at Another Center	Transplant	Transplant
Transfer to Another Center	Censor	Censor
Death or Worsened Condition	Non-Transplant	Censor
Condition Improved	Censor	Censor
May 3, 2004	Censor	Censor

The Kaplan-Meier (1) method is used to fit both types of models, using the statistical procedure PHREG in version 8.2 of SAS (2). To exclude inactive time from the Median Waiting Time calculation, discontinuous intervals of risk were implemented (3).

Figures for recent years in these tables may show the symbol "+". This is because there may not have been sufficient time for 50% of the registrants to have received transplants. (See Table TN-2 for an example in which we are unable to compute the median time to transplant.) For heart-lung and intestine transplants, median time to transplant cannot be determined for most of the one-year registrant cohorts. This can occur if mortality is so high for a given cohort that more than 50% of the registrants may have died before 50% have been transplanted.

Table TN-2: Time to Transplant:

Example of Median Not Computable

	1998	1999	2000
Number of Registrations	20,189	20,989	22,271
10th Percentile of TT	99	110	117
25th Percentile of TT	296	318	354
Median TT	1,106	+	+
Median TT 95% C.I. Lower Bound	1,068	+	+
Median TT 95% C.I. Upper Bound	1,153	+	+

 

For completeness, all categories of demographic and medical factors were listed in the tables, including those with no transplants in the cohort (N=0). The "+" symbol indicates that the statistic was not calculated because of insufficient follow-up time for 50% of the cohort to be transplanted.

Deaths and Death Rates on the Waiting List

The death rate tables show the number of patients ever on the waiting list during the year, the number of patients reported to have died while awaiting transplantation, and the annual death rates per 1,000 patient years at risk. The period at risk begins on January 1 or waiting list registration date (whichever is later) and ends on December 31, the date of death, or the date of waiting list removal (whichever is earliest). Table 1.7 shows the overall death rates for all organs.

Deaths and death rates for each organ-specific waiting list are presented in Table 3 of each organ-specific section.

Table 5.3	Kidney Waiting List
Table 6.3	Pancreas Transplant Alone Waiting List
Table 7.3	Pancreas After Kidney Waiting List
Table 8.3	Kidney-Pancreas Waiting List
Table 9.3	Liver Waiting List
Table 10.3	Intestine Waiting List
Table 11.3	Heart Waiting List
Table 12.3	Lung Waiting List
Table 13.3	Heart-Lung Waiting List

Patient-years describes the actual amount of time each patient spends on the waiting list. For example, Patient A is on the list for six months, Patient B is on the list for three months, and Patient C is on the list for the entire year. Patient A contributes 0.5 patient-years to the calculation, Patient B contributes 0.25 patient-years, and Patient C contributes 1 patient-year to the calculation.

The annual death rate per 1,000 patient years at risk, therefore, is the number of deaths for every 1,000 patient years on the waiting list. The rate is calculated by dividing the number of patients who died in a given year by the sum of the years (including partial years) that patients spent waiting and then multiplying by 1,000. The number 1,000 was chosen, rather than the familiar 100, because of small death rates in some categories.

These tables contain data on all patients who have been removed from or are still active on the OPTN waiting list. The OPTN members have direct responsibility for submitting, maintaining, and monitoring all data from the time their patients are listed until they are removed from the list. In addition, deaths reported from other OPTN sources that associated with the same patients are incorporated into the calculation of the patient's death. We have also included deaths from the Social Security Death Master File (SSDMF) and Centers for Medicare & Medicaid Services (CMS) data sources to provide additional death ascertainment if reported deaths are before patients have been removed from the waiting list.

The OPTN receives notification of a death on the waiting list when a patient is removed from the waiting list with the reason given (via the appropriate code) as death. The year indicated is that in which the death was reported or the patient was removed from the waiting list. Before October 25, 1999, the OPTN did not track date of death, only the date on which the death was reported. Please note that patients who are removed from the waiting list because they are too ill to receive a transplant and who subsequently die are not included in the number of deaths on the waiting list.

Patient age was calculated on December 31 of the indicated year, even if the patient had not yet reached a birthday when removed from the list during the year. In categories that had fewer than 10 patients in the cohort, death rates were not calculated and the symbol  "*" appears.

Transplants and Transplant Recipient Characteristics

Tables 1.7, 1.8, and 1.10 present counts of all single- and multi-organ transplants by organ and donor type and by selected recipient demographic and medical characteristics. Organ-specific recipient characteristics are presented in Table 4 of each organ-specific section.

Table 5.4	Deceased and Living Donor Kidney Recipients
Table 6.4	Pancreas Transplant Alone Recipients
Table 7.4	Pancreas After Kidney Recipients
Table 8.4	Kidney-Pancreas Recipients
Table 9.4	Deceased and Living Donor Liver Recipients
Table 10.4	Intestine Recipients
Table 11.4	Heart Recipients
Table 12.4	Deceased and Living Donor Lung Recipients

Table 13.4 Heart-Lung Recipients

Transplant recipient characteristics data are based primarily on the OPTN Transplant Candidate Registration (TCR) and Transplant Recipient Registration (TRR) Forms. Transplant counts are based on the OPTN donor feedback process, which begins the process of tracking a transplant based on donor organ allocation, or on living donor transplant reports from transplant centers. When a patient is registered on a waiting list or receives a living donor transplant, a TCR Form is completed by a transplant center. The TRR Form is completed by a transplant center after a transplant and is submitted to the OPTN for processing.

While kidney-pancreas and heart-lung transplants are shown as one transplant, other multi-organ transplants of two or more different organ types appear in the organ-specific tables for each organ involved. For example, a kidney-liver transplant would be included in both the kidney data and the liver data. Table 1.8 shows a breakdown of such multi-organ transplants.

Table 1.7 presents a breakdown of transplants for all organs by deceased donor versus living donor. Because living donor pancreas, intestine, and heart (from heart-lung recipients who donate their viable heart) transplants are rare, such transplants are reported only in Table 1.7. Each organ section only includes deceased donor transplants, unless it explicitly states otherwise, as is the case with kidneys, livers, and lungs. Counts reflect the number of transplants, not the number of organs; therefore, not each donor is counted if there are multiple donors, as may be the case with living donor lung lobe transplants.

The organ-specific tables show, for particular characteristics, the number and percentage of transplants by category, for each year, for that type of transplant. Some characteristics may have unknown values. This occurs when transplant centers report values as unknown, or when forms are still outstanding. The percentages in the tables are based on the total reported categories, including the unknown cases. The data are subject to change on the basis of future data submission or correction.

Particular recipient characteristics are discussed below.

Patient Description and Type of Procedure. These data are collected via the TRR Form. Unknown cases are accounted for primarily by data being missing or reported as unknown on TRR Forms, or by TRR Forms being delinquent. In the type of procedure for lung transplants, en bloc and bilateral sequential transplants are included in the double lung category; lung lobe transplants are categorized by the number of lobes received.

Age, Race, Ethnicity, Gender, Blood Type, and Residency. These data are collected via the TCR Form. Unknown cases are accounted for primarily by TCR Forms that are incomplete or not yet received. The Asian group includes Pacific Islanders, which is a separate category on the current TCR Form. In the residency table, US residents include both US citizens and resident aliens. Before April 1, 1994, ethnicity was collected as a choice for race; since then ethnicity has been collected in addition to race.

Primary Diagnosis. The primary diagnosis of the disease causing organ failure for transplant recipients may be obtained from the TRR and/or TCR Forms. Diagnosis categories for each organ type are broad classifications of the recipientsb indications for transplant. There are no primary diagnoses listed for pancreas and kidney-pancreas transplants, as nearly all pancreas recipients have diabetes as their primary diagnosis. Tables TN-6 through TN-10, at the end of these notes, present the detailed diagnoses that are included in each broad category.

Cold Ischemia Time. The cold ischemia time statistics are collected for most organs, except for intestine and thoracic organs only the total ischemia time is reported. The kidney cold ischemic time is used for kidney-pancreas transplants and the heart total ischemia time is used for heart-lung transplants.

Previous Transplant. This is an indicator of whether a patient had a previous transplant of any solid organ. Multiple sources are used to determine if a recipient has had a previous transplant due to the lack of historical transplant records in the database. The calculation is based on "Previous Transplants" fields on the Waitlist Registration, TCR and TRR form and historical transplant records that associated with the same person. It also considers diagnoses on both the TCR and TRR of retransplant or graft failure, and organ primary non-function as risk factors indicated on the TRR form for Liver and Intestine. Due to the questioning of the reliability of items requested on the TCR and TRR forms pertaining to prior transplants, particularly in earlier years, the determination of a previous transplant for recipient is based on the existence of an historical transplant record or any two positive indications of the above mentioned sources.

Previous Transplant of the Same Organ. This indicator of a previous transplant is calculated as above, for transplants of the same organ type. For kidney-pancreas transplants, only a previous simultaneous kidney-pancreas transplant is considered to be a previous transplant of the same organ. For kidney alone and pancreas alone transplants, a previous transplant could be either a previous transplant of that same organ type or a previous simultaneous kidney-pancreas transplant. Similarly, for heart alone and lung alone transplants, a previous transplant could be either a previous transplant of that same organ type or a previous simultaneous heart-lung transplant.

Hospitalized at Transplant and Life Support at Transplant. These variables refer to the patient's condition immediately prior to the transplant procedure. In the tables, "Hospitalized" refers to patients hospitalized but not in an intensive care unit.

PRA (Panel Reactive Antibody). PRA levels, at time of transplant, is shown only for kidney and kidney-pancreas recipients. This item is taken from the Recipient Histocompatibility (RH) Form. Unknown cases are accounted for primarily by RH Forms that are incomplete or not yet received.

Level of HLA Mismatch. This statistic, shown only for kidney and kidney-pancreas transplants, represents the number of HLA antigens found in the donor that are not shared by the recipient. This value is based on the six HLA antigens (two each for the A, B, and DR loci) reported on the Donor Histocompatibility (DH) Form and the RH Form. Unknown cases are accounted for primarily by incomplete DH or RH Forms or by forms not yet received. Mismatched antigens are identified according to the OPTN criteria regarding "split" and "parent" antigens.

Waiting List Status at Transplant. For liver and heart transplants only, the waiting list medical urgency status at transplant is determined by linking each transplant back to the waiting list history file. The waiting list status represents the patient's degree of medical urgency. For heart using pre-1999 and current definitions, these are Status levels 1, 1A, 1B, and 2, with 1 (or 1A) being the most urgent. For liver prior to 2002, these are Status levels 1, 2, 2A, 2B, 3, and 4. Starting in 2002, the MELD/PELD scores replaced the liver status levels in ranking a patient's medical condition, and ranges of MELD/PELD scores, along with exceptions, appear in the tables where status is reported.

Incidence of transplant

Incidence of transplant, defined as the rate of transplantation for the entire population, is presented in Table 5 of each organ-specific section.

Table 5.5	Kidney Transplants
Table 6.5	Pancreas Alone Transplants
Table 7.5	Pancreas After Kidney Transplants
Table 8.5	Kidney-Pancreas Transplants
Table 9.5	Liver Transplants
Table 10.5	Intestine Transplants
Table 11.5	Heart Transplants
Table 12.5	Lung Transplants
Table 13.5	Heart-Lung Transplants

The rates for incidence of transplant presented in these tables are ratios of transplants per 1 million population. Incidence for the entire population and for various cohorts of recipient age, race, ethnicity, and gender are included in these tables. Population figures for 1994 to 2003 come from the US Census Bureau monthly estimates for July of each year.

Immunosuppression use

Table 1.9 presents statistics on immunosuppression usage by organ for 2002 and 2003. The denominator for the distributions is the number of transplants for which any immunosuppression details are reported; transplants without immunosuppression forms filed are excluded from this. The first row shows the percentage of transplants with immunosuppression forms filed, where one or more drugs were used for induction at transplant. The number can be subtracted from 100 to get the corresponding percentage of transplants with no drugs used for induction, as is reported in the organ-specific immunosuppression tables. The "Maintenance At Transplant Discharge" table shows distributions for immunosuppressants among functioning grafts at transplant; while the "Current Maintenance at End of First Year" table shows these distributions for grafts functioning one year after transplant.

The percentage of these transplants that have either ATG, NRATG/NRATS, OKT3 ^®, Thymoglobulin ^®, Zenapax ^®, Simulect ^®, or Campath^® recorded for induction usage for 2003 transplants is included in this table. We also report on the percent usage of individual drugs used for maintenance at discharge for 2003 transplants, and for current maintenance one year after discharge for 2002 transplants. Current maintenance is not reported elsewhere in the Annual Report, as this data was not collected on immunosuppression forms before 1999.

Organ-specific immunosuppression use is presented in Table 6 of each organ-specific section.

Table 5.6	Kidney Transplants
Table 6.6	Pancreas Alone Transplants
Table 7.6	Pancreas After Kidney Transplants
Table 8.6	Kidney-Pancreas Transplants
Table 9.6	Liver Transplants
Table 10.6	Intestine Transplants
Table 11.6	Heart Transplants
Table 12.6	Lung Transplants
Table 13.6	Heart-Lung Transplants

In the organ-specific chapters, four separate sub-tables describe immunosuppression use. One table is devoted to immunosuppression use at transplant for induction. The percentages are calculated by dividing the number of transplants in which a particular drug or drug category was used for induction by the number of transplants with immunosuppression information.

The second table shows the rates of immunosuppressant use prior to transplant discharge for maintenance. The percentages are calculated by dividing the number of transplants in which a particular drug or drug category was used for maintenance by the number of transplants with functioning grafts at discharge and with immunosuppression information recorded for that transplant.

The third table shows the rates of immunosuppressant use for maintenance during the year following transplant discharge. The percentages are calculated by dividing the number of transplants in which a particular drug or drug category was used for maintenance (either current or previous maintenance) at any point in the year after transplant by the number of transplants with follow-up immunosuppression information recorded.

The last table shows the rates of immunosuppressant use for antirejection treatment during the first year following transplantation. The percentages are calculated by dividing the number of transplants in which a particular drug or drug category was used for antirejection treatment at any point in the year after transplant by the number of transplants where antirejection treatment was recorded.

Note: For some immunosuppressants, the original data collection forms listed brand names instead of generic names. The SRTR database follows the terms on the data collection forms, though some of the chapters in this report refer to the drugs by their generic names when there is a one-to-one correlation between the reported brand name and the generic name. The most common examples in this report include the following:

azathioprine (Imuran^®)

basiliximab (Simulect^®)

cyclophosphamide (Cytoxan^®)

daclizumab (Zenapax^®)

muromonab-CD3 (OKT3^®)

mycophenolate mofetil (CellCept^®)

rabbit antithymocyte globulin (Thymoglobulin^®)

rapamycin (Rapamune^® or sirolimus)

tacrolimus (Prograf^® or FK506)

Multiple-Source Follow-up Dates (death rates and patient survival)

The posttransplant death rate tables and the patient survival tables make use of a multiple-source follow-up date to determine time at risk. This Annual Report uses death information from any OPTN member institution, including both the transplanting center and any other center at which the patient may have been relisted or retransplanted, as well as the Social Security Death Master File (SSDMF) and CMS-ESRD data. As detailed in Chapter II of the 2002 Annual Report (4), the ascertainment of mortality using these sources is very good. During time periods when we would expect to learn of a death from both sources, if no death is reported then we assume that the patient is alive.

Using multiple sources for death ascertainment has implications for censoring in mortality analyses. If only follow-up forms returned to the OPTN were being used, censoring would occur when the patient became lost to follow-up, or when the follow-up form was filed. With all sources of death, a patient must be followed after he or she is lost to follow-up, in order to account for time and events that are covered by other sources of mortality data. The multiple-source follow-up or censoring date is calculated as the transplant anniversary (six-month, one-year, two-year, etc.) immediately preceding the current database snapshot date (May 3, 2004), allowing an extra three months to ensure completion of forms. (For additional discussion, see Chapter II.) In some cases, this date falls before reports of deaths are submitted to the OPTN by member centers. In these cases, such events are excluded from the analysis for the following reason: Patients who are alive will only have follow-up status reported when forms are due at six months, one year, two years, etc., after transplant. When a patient dies, however, the center can report that the patient died on an early follow-up form, creating additional reporting on a (biased) sample of dead patients. Simply following patients until the last known OPTN follow-up date will include extra time for patients who die and have the follow-up form turned in early, but will not include this extra time for patients who are alive. To eliminate this bias in reporting deaths, we censor at the date of last expected follow-up.

Deaths and Death Rates For Transplant Recipients

The death rate tables show deaths per 1,000 patient-years for patients transplanted during each year. Death rates apply only within the first year of transplant. Patients are only included when the last expected follow-up is on or after the one-year transplant anniversary. The period at risk begins on the transplant date and ends on the date of death, the one-year transplant anniversary, or the multiple-source follow-up date described above (whichever is earliest). Deaths and death rates for each organ are presented in Table 7 of each organ-specific section.

Table 5.7	Kidney Transplants
Table 6.7	Pancreas Transplant Alone Transplants
Table 7.7	Pancreas After Kidney Transplants
Table 8.7	Kidney-Pancreas Transplants
Table 9.7	Liver Transplants
Table 10.7	Intestine Transplants
Table 11.7	Heart Transplants
Table 12.7	Lung Transplants
Table 13.7	Heart-Lung Transplants

The term "patient-years" describes the actual amount of time for which each patient has reported data after a transplant. For example, Patient A has reported data for six months after her transplant, Patient B only has reported data for three months, and Patient C has reported data indicating that he lived through the entire year. Patient A contributes 0.5 patient-years to the calculation, Patient B contributes 0.25 patient-years, and Patient C contributes 1 patient-year to the calculation.

The annual death rate per 1,000 patient years at risk, therefore, is the number of deaths for every 1,000 patient-years of follow-up after transplant. The rate is calculated by dividing the number of patients who died within one-year after transplant by the sum of the years for which patients have reported data and then multiplying by 1,000. The number 1,000 was chosen, rather than 100, because of small death rates in some categories.

Multiple sources of death, as described above, are used for the death rate tables. Deaths that are reported after the multiple-source follow-up date are not counted. In categories that had fewer than 10 patients in the cohort, death rates were not calculated and the symbol "*" appears.

Graft and Patient Survival

Tables 1.11 and 1.12 present national one-year graft and patient survival, both unadjusted and adjusted, for all organs by year of transplant from 1993 to 2002. Table 1.13 presents unadjusted national graft and patient survival for all organs at three months, one year, three years, five years, and 10 years. Overall survival rates for liver-intestine, kidney-liver, and kidney-heart transplants are shown in Table 1.13. Due to their small number, there are no other specific survival tables for these transplants.

Organ-specific tables of graft and patient survival by recipient characteristics and comparisons of changes over time are presented in Tables 8 through 13 of each organ-specific section. Adjusted survival appears in Tables 8 and 11 of each organ-specific section, while unadjusted survival appears in Tables 9 and 12. Comparisons of changes over time are in Tables 10 and 13 of each organ-specific section. For kidney transplants, separate tables are presented for deceased non-ECD, deceased ECD, and living donor transplants. For liver transplants, separate tables are presented for deceased and living donor transplants. The kidney-pancreas section includes two sets of graft survival tables: one for kidney graft survival and one for pancreas graft survival.

Table 5.8	Kidney Adjusted Graft Survival Rates, Deceased non-ECD
	Kidney Adjusted Graft Survival Rates, Deceased ECD
	Kidney Adjusted Graft Survival Rates, Living Donor
Table 5.9	Kidney Unadjusted Graft Survival Rates, Deceased non-ECD
	Kidney Unadjusted Graft Survival Rates, Deceased ECD
	Kidney Unadjusted Graft Survival Rates, Living Donor
Table 5.10	Kidney Unadjusted Graft Survival by Year of Transplant, Deceased non-ECD
	Kidney Unadjusted Graft Survival by Year of Transplant, Deceased ECD
	Kidney Unadjusted Graft Survival by Year of Transplant, Living Donor
Table 5.11	Kidney Adjusted Patient Survival Rates, Deceased non-ECD
	Kidney Adjusted Patient Survival Rates, Deceased ECD
	Kidney Adjusted Patient Survival Rates, Living Donor
Table 5.12	Kidney Unadjusted Patient Survival Rates, Deceased non-ECD
	Kidney Unadjusted Patient Survival Rates, Deceased ECD
	Kidney Unadjusted Patient Survival Rates, Living Donor
Table 5.13	Kidney Unadjusted Patient Survival by Year of Transplant, Deceased non-ECD
	Kidney Unadjusted Patient Survival by Year of Transplant, Deceased ECD
	Kidney Unadjusted Patient Survival by Year of Transplant, Living Donor
Table 6.8	Pancreas Transplant Alone Adjusted Graft Survival Rates
Table 6.9	Pancreas Transplant Alone Unadjusted Graft Survival Rates
Table 6.10	Pancreas Transplant Alone Unadjusted Graft Survival Rates by Year of Transplant
Table 6.11	Pancreas Transplant Alone Adjusted Patient Survival Rates
Table 6.12	Pancreas Transplant Alone Unadjusted Patient Survival Rates
Table 6.13	Pancreas Transplant Alone Unadjusted Patient Survival Rates by Year of Transplant
Table 7.8	Pancreas After Kidney Adjusted Graft Survival Rates
Table 7.9	Pancreas After Kidney Unadjusted Graft Survival Rates
Table 7.10	Pancreas After Kidney Unadjusted Graft Survival Rates by Year of Transplant
Table 7.11	Pancreas After Kidney Adjusted Patient Survival Rates
Table 7.12	Pancreas After Kidney Unadjusted Patient Survival Rates
Table 7.13	Pancreas After Kidney Unadjusted Patient Survival Rates by Year of Transplant
Table 8.8	Kidney-Pancreas - Kidney Adjusted Graft Survival Rates
	Kidney-Pancreas - Pancreas Adjusted Graft Survival Rates
Table 8.9	Kidney-Pancreas - Kidney Unadjusted Graft Survival Rates
	Kidney-Pancreas - Pancreas Unadjusted Graft Survival Rates
Table 8.10	Kidney-Pancreas - Kidney Unadjusted Graft Survival Rates by Year of Transplant
	Kidney-Pancreas - Pancreas Unadjusted Graft Survival Rates by Year of Transplant
Table 8.11	Kidney-Pancreas Adjusted Patient Survival Rates
Table 8.12	Kidney-Pancreas Unadjusted Patient Survival Rates
Table 8.13	Kidney-Pancreas Unadjusted Patient Survival Rates by Year of Transplant
Table 9.8	Liver Adjusted Graft Survival Rates, Deceased Donor
	Liver Adjusted Graft Survival Rates, Living Donor
Table 9.9	Liver Unadjusted Graft Survival Rates, Deceased Donor
	Liver Unadjusted Graft Survival Rates, Living Donor
Table 9.10	Liver Unadjusted Graft Survival Rates by Year of Transplant, Deceased Donor
	Liver Unadjusted Graft Survival Rates by Year of Transplant, Living Donor
Table 9.11	Liver Adjusted Patient Survival Rates, Deceased Donor
	Liver Adjusted Patient Survival Rates, Living Donor
Table 9.12	Liver Unadjusted Patient Survival Rates, Deceased Donor
	Liver Unadjusted Patient Survival Rates, Living Donor
Table 9.13	Liver Unadjusted Patient Survival Rates by Year of Transplant, Deceased Donor
	Liver Unadjusted Patient Survival Rates by Year of Transplant, Living Donor
Table 10.8	Intestine Adjusted Graft Survival Rates
Table 10.9	Intestine Unadjusted Graft Survival Rates
Table 10.9	Intestine Unadjusted Graft Survival Rates by Year of Transplant
Table 10.11	Intestine Adjusted Patient Survival Rates
Table 10.12	Intestine Unadjusted Patient Survival Rates
Table 10.13	Intestine Unadjusted Patient Survival Rates by Year of Transplant
Table 11.8	Heart Adjusted Graft Survival Rates
Table 11.9	Heart Unadjusted Graft Survival Rates
Table 11.10	Heart Unadjusted Graft Survival Rates by Year of Transplant
Table 11.11	Heart Adjusted Patient Survival Rates
Table 11.12	Heart Unadjusted Patient Survival Rates
Table 11.13	Heart Unadjusted Patient Survival Rates by Year of Transplant
Table 12.8	Lung Adjusted Graft Survival Rates, Deceased Donor
	Lung Adjusted Graft Survival Rates, Living Donor
Table 12.9	Lung Unadjusted Graft Survival Rates, Deceased Donor
	Lung Unadjusted Graft Survival Rates, Living Donor
Table 12.10	Lung Unadjusted Graft Survival Rates by Year of Transplant, Deceased Donor
	Lung Unadjusted Graft Survival Rates by Year of Transplant, Living Donor
Table 12.11	Lung Adjusted Patient Survival Rates, Deceased Donor
	Lung Adjusted Patient Survival Rates, Living Donor
Table 12.12	Lung Unadjusted Patient Survival Rates, Deceased Donor
	Lung Unadjusted Patient Survival Rates, Living Donor
Table 12.13	Lung Unadjusted Patient Survival Rates by Year of Transplant, Deceased Donor
	Lung Unadjusted Patient Survival Rates by Year of Transplant, Living Donor
Table 13.8	Heart-Lung Adjusted Graft Survival Rates
Table 13.9	Heart-Lung Unadjusted Graft Survival Rates
Table 13.10	Heart-Lung Unadjusted Graft Survival Rates by Year of Transplant
Table 13.11	Heart-Lung Adjusted Patient Survival Rates
Table 13.12	Heart-Lung Unadjusted Patient Survival Rates
Table 13.13	Heart-Lung Unadjusted Patient Survival Rates by Year of Transplant

In an effort to reflect the most current survival outcomes and to ensure the availability of sufficient follow-up data, the Annual Report uses different two-year cohorts for the different survival periods. The years for the cohorts are the most recent years for which the particular survival period has elapsed by the end of 2003, as shown below:

Three month	2001-2002
One year	2001-2002
Three year	1999-2000
Five year	1997-1998
Ten year	1992-1993 Table 1.13 only

For the one-, three-, and six-month survival tables by MELD/PELD score Tables 9.9a.1, 9.9b.1, 9.12a.1, and 9.12b.1, the cohort comprises recipients of liver transplants performed between Feb. 27, 2002 and Dec. 31, 2002.

Exclusions

Patient survival statistics for each organ are computed only for the first transplant of that type that a patient received, and exclude subsequent transplants of the same type for that patient. For kidney-liver, kidney-heart, and liver-intestine, patients who have had a previous transplant of either organ are excluded. For kidney-pancreas, patients who have had a previous simultaneous kidney-pancreas transplant only are excluded. Similarly, for heart-lung, patients who have had a previous simultaneous heart-lung transplant only are excluded. Graft survival statistics do not exclude these patients.

In order to present survival rates for the most prevalent types of procedures, the transplant cohorts used for these analyses excluded a number of higher-risk or more unusual procedures. Living donor transplants were excluded for all but the living donor kidney, living donor liver, and living donor lung transplant tables. Multi-organ transplants were excluded from the organ-specific tables, with three exceptions: kidney-pancreas and heart-lung transplants are shown in separate tables, and intestine tables include both intestine only and liver-intestine transplants. Overall short- and long-term survival for kidney-liver, kidney-heart, and liver-intestine transplants are shown in Table 1.13. Heterotopic transplants were excluded for liver and heart transplants.

Descriptions of Additional Factors

Unadjusted survival figures in the organ-specific sections are reported separately for the following patient and transplant procedure characteristics: recipient age, race, ethnicity, gender, blood type, previous transplant, US residency, hospitalized at transplant, life support at transplant, donor age, yearly center transplant volume, and cold ischemia time. For pancreas, the previous transplant characteristic includes tables for previous kidney and previous pancreas. For kidney-pancreas, the previous transplant characteristic includes previous kidney, previous pancreas, and previous simultaneous kidney-pancreas transplant.

For specific organs, additional factors are: PRA at transplant (kidney and kidney-pancreas), level of HLA mismatch (kidney, pancreas, and kidney-pancreas), relation of donor to recipient (living donor kidney, living donor liver), dialysis required during the first week posttransplant (deceased and living donor kidney), procedure type (heart and lung), and waiting list status at time of transplant (liver and heart).

Factors not previously presented in the Technical Notes are described below.

Donor Age. Donor age is obtained from the Donor Registration Form. Delinquent or incomplete forms account for most unknown cases.

Center Volume. Center volume is calculated for each organ, center, and time period as the average number of transplants during the two calendar years included in the cohort of patients reported on for the time period. For each organ, centers are grouped into approximate quintiles by center volume (tertiles for intestine because of the small number of centers performing intestine transplants). Survival is then reported for patients in each group. For kidneys and livers, center volume includes both deceased and living donor transplants. All other living donor transplants are excluded. For all organs, center volume includes multi-organ transplants (including kidney-pancreas and heart-lung) which include the organ of interest. For example, a heart-lung transplant would contribute to the center volume count for hearts, lungs, and heart-lungs. For kidney-pancreas tables, center volume is calculated differently for the patient and graft survival tables. For patient survival, kidney-pancreas center volume includes only kidney-pancreas transplants and multi-organ transplants that include kidney-pancreas. For tables of kidney graft survival from a kidney-pancreas transplant, center volume is calculated as it would be for kidney and so includes kidney and kidney-pancreas transplants, as well as other multi-organ transplants that include a kidney. For tables of pancreas graft survival from a kidney-pancreas transplant, center volume is calculated as it would be for pancreas and so includes pancreas and kidney-pancreas transplants, as well as other multi-organ transplants that include a pancreas.

Dialysis in the First Week. For kidney transplants only, whether patients required dialysis within the first week following transplant is collected from the TRR Form. For these data, the cohorts used are restricted to transplants that did not fail within the first week of transplantation. In other words, the survival rates shown are conditional on the graft's functioning at least one week after transplantation.

Relation of Donor to Recipient. Relation of donor to recipient is shown only for living donor kidney, living donor liver, and living donor lung transplants. The data currently are collected on the Living Donor Registration (LDR) Form. Delinquent or incomplete LDR Forms account for most unknown cases.

Cold Ischemia Time. The cold ischemia time statistics are collected for most organs, except for intestine and thoracic organs only the total ischemia time is reported. The kidney cold ischemic time is used for kidney-pancreas transplants and the heart total ischemia time is used for heart-lung transplants.

Computation of Survival Rate

The value N shown in each table represents the number of transplants on which a survival rate is based. This number may be different for graft and patient survival because patient survival includes only first transplants of that type, whereas graft survival includes all transplants. For graft survival, survival time for each transplant was calculated as the number of days from the date of transplant to the date of graft failure or death (if applicable) or the latest follow-up date reported. For patient survival, survival time for each transplant was calculated as the number of days from the date of transplant to the date of death (if applicable) or the multiple-source follow-up date (described above). Each of these tables provides the standard errors (statistical measures of precision) along with each survival rate. Categories that include relatively few transplants generally exhibit large standard errors. This is an important consideration when comparing survival rates within the tables.

For completeness, all categories of demographic and medical factors were listed in the tables, including those with no transplants in the cohort (N=0).

Patients are followed until death or the multiple-source follow-up date. Deaths that are reported after the multiple-source follow-up date are not counted. Patients are followed only from their first transplant of the organ. We believe that we have reasonably complete death ascertainment using multiple death sources (see above).

Unadjusted Survival Rate

The unadjusted survival rate calculations were performed using the statistical procedure LIFETEST in version 8.2 of SAS (2). Using LIFETEST, the survival rates were estimated using the Kaplan-Meier method (1), and standard errors were estimated using Greenwood's formula (5).

Adjusted Survival Rate

The adjusted survival rate calculations were performed using a Cox proportional hazards regression model for time to graft failure or death (6). This involved using the statistical procedure PHREG in version 8.2 of SAS (2). Possible adjustments include age, gender, race, and diagnosis. The Table TN-3 indicates, by organ type, the adjustments that were applied.

Table TN-3. Adjustments Applied to Survival Tables, by Organ Type

Organ Type	Age	Gender	Race	Diagnosis
Kidney	X	X	X	X
PTA	X	X	X
PAK	X	X	X
KP	X	X	X
Liver	X	X	X	X
Intestine	X
Heart	X	X	X	X
Lung	X	X	X	X*
Heart-Lung	X

In the organ-specific sections, the adjusted survival tables only report rates by age, gender, race, and diagnosis. Here the rates in each table are adjusted for the characteristics other than those of the table itself (e.g., kidney survival by age is adjusted for gender, race, and diagnosis).

The major diagnosis categories used for adjustment are listed in Table TN-4.

Table TN-4. Major Diagnosis Categories Used for Adjustment of Survival Tables

Organ	Major Diagnosis Categories
Kidney	Diabetes, Other
Liver	Non-Cholestatic Cirrhosis, Other
Heart	Cardiomyopathy, Coronary Artery Disease, Other
Lung	Cystic Fibrosis, Primary Pulmonary Hypertension, Idiopathic Pulmonary Fibrosis, Other including Emphysema/COPD

 

For pediatric patients (i.e., under 12 for lung and under 18 for all other organs), the adjustment by diagnosis was not applied.

In the survival tables by year (i.e., Tables 1.11a and 1.12a ), the survival rates are adjusted to the characteristics of the recipients who received a transplant in the last year of the table. In the organ specific tables, the survival rates are adjusted to the characteristics of the recipients in the three-month/one-year cohort.

Interpreting Survival Rates Between Groups

The "P-value" is the approximate probability that a difference in survival between two groups is due to random chance alone, and that there is no real difference between the rates. P-values <0.05 are usually considered statistically significant, meaning that the difference in survival is probably not just due to random chance.

The P-value can be calculated using the survival estimates themselves and their standard errors using the following formula in an Excel spreadsheet, shown in Table TN-5. Let "survival % #1" and "survival % #2" be the survival percentages for any two groups to be compared. The "Std. Err." is the standard error associated with each survival percentage.

Table TN-5. P-Value Calculation for Survival Rates

Spreadsheet Columns
A	B	C	D
Survival % #1	Std. Err. #1	Survival % #2	Std. Err. #2
94.0	0.2	92.3	0.6

This approximation is less accurate for survival percentages close to 0% or 100%.

PREVALENCE OF PEOPLE LIVING WITH A FUNCTIONING TRANSPLANT

Table 1.14 presents an estimated count, by year, of the number of US residents who are living with a functioning transplant. Organ-specific prevalence counts, by recipient characteristic, are presented in Table 14 of each organ-specific section.

Table 5.14	Kidney Transplants
Table 6.14	Pancreas Alone Transplants
Table 7.14	Pancreas After Kidney Transplants
Table 8.14	Kidney-Pancreas Transplants
Table 9.14	Liver Transplants
Table 10.14	Intestine Transplants
Table 11.14	Heart Transplants
Table 12.14	Lung Transplants
Table 13.14	Heart-Lung Transplants

In a manner similar to the graft survival rate tables, the first nine years of the tables count individuals who are alive and are identified as having a functioning graft at year-end. Individuals who are known to be alive but are lost to follow-up or have a graft failure are not counted. In the last year of the table, we count an individual if no negative information (i.e., death, graft failure, or loss to follow-up) is reported by year-end. This allows us to account for cases in which a transplant occurred during the last year or a graft was known to be functioning at the end of the prior year, and scheduled follow-up forms indicating status at year end have yet to be filed.

Transplant Center Activity

Table 15 of each organ-specific section presents information on the number of transplants performed, by state and transplant center, by year.

Table 5.15	Kidney Transplants
Table 6.15	Pancreas Alone Transplants
Table 7.15	Pancreas After Kidney Transplants
Table 8.15	Kidney-Pancreas Transplants
Table 9.15	Liver Transplants
Table 10.15	Intestine Transplants
Table 11.15	Heart Transplants
Table 12.15	Lung Transplants
Table 13.15	Heart-Lung Transplants

Transplant center activity is defined as the number of deceased and living solid organ transplants performed by each transplant center, by type of organ, and by year. Total transplants in each state are also computed. The transplants are recorded at the center where they originally occurred and may not reflect the experience of particular surgeons or teams. Mergers or changes of ownership are not reflected.

Kidney-pancreas and heart-lung transplants are reported in their own tables. Other multi-organ transplants are reported in each organ-specific table. For example, a kidney-liver transplant would be reported in both the kidney transplant activity table and the liver transplant activity table.

Donor and Recipient Tumor Data

The donor and recipient tumor tables show overall frequency counts for donors with a history of cancer, as well as recipient recurrence of pretransplant malignancies, de novo (non-recurrent) posttransplant solid malignancies, and posttransplant lymphoproliferative disorder. Frequency counts and percentages of the type of cancer also are shown for the above-mentioned data for kidney, liver, and heart. The donor and recipient tumor tables are presented in Tables 14.1 to 14.10.

Table 14.1	Organs from Donors with a History of Cancer - All Organs
Table 14.2	Recurrence of Pretransplant Malignancies - All Organs
Table 14.3	De Novo Posttransplant Solid Malignancies - All Organs
Table 14.4	Posttransplant Lymphoproliferative Disorder - All Organs
Table 14.5	Kidney Donors with a History of Cancer
Table 14.6	De Novo Posttransplant Solid Malignancy - Kidney
Table 14.7	Liver Donors with a History of Cancer
Table 14.8	De Novo Posttransplant Solid Malignancy - Liver
Table 14.9	Heart Donors with a History of Cancer
Table 14.10	De Novo Posttransplant Solid Malignancy - Heart

Donor Data

Data on organs from donors with either a history of cancer or cancer seen at the time of procurement are obtained from the DDR Form.

Recipient Data

Recipient tumor data are taken from the TCR, TRR, and follow-up forms. Note that until 1999, posttransplant reporting of tumors was done on a voluntary basis. Therefore, tables are presented to show the distribution of types of tumor among all tumors reported. By no means are these tables intended to provide a measure of the incidence of posttransplant tumor occurrence.

The OPTN began collecting data on posttransplant lymphoproliferative disorder (PTLD) following thoracic organ transplants in 1994 and in 1996 following all other organ transplants. The data in this year's Annual Report include all reports of PTLD since these years.

Although the OPTN has historically collected data on other posttransplant malignancies, until recently these data did not specify whether the tumor was recurrent or de novo, and there were few details regarding the specific cancer site. This year's Annual Report presents data obtained since 1999, when detailed tumor data collection began.

Organ-specific data on the type of cancer are shown for kidney, liver, and heart. Due to the small number of tumors for other transplanted organs, there are no other organ-specific tables presented here.

Table TN-6. Kidney Primary Diagnosis Categories

Primary Diagnosis Categories	Diagnoses
Glomerular Diseases	Anti-GBM Chronic Glomerulonephritis: Unspecified Chronic Glomerulosclerosis: Unspecified Focal Glomerularsclerosis Idio/Post-Inf Crescentic Glomerulonephritis IGA Nephropathy Hemolytic Uremic Syndrome Membranous Glomerulonephritis Mesangio-Capillary 1 Glomerulonephritis	Mesangio-Capillary 2 Glomerulonephritis Systemic Lupus Erythematosus Alportb's Syndrome Amyloidosis Membranous Nephropathy Goodpastureb's Syndrome Henoch-Schoenlein Purpura Sickle-Cell Anemia Wegeners Granulomatosis
Diabetes	Diabetes: Type I Insulin Dep/Juvenile Onset Diabetes: Type II Insulin Dep/Adult Onset	Diabetes: Type I Non-insulin Dep/Juv Onset Diabetes: Type II Non-insulin Dep/Adult Onset
Polycystic Kidneys	Polycystic Kidneys
Hypertensive Nephrosclerosis	Hypertensive Nephrosclerosis
Renovascular and Other Vascular Diseases	Chronic Nephrosclerosis: Unspecified Malignant Hypertension Polyarteritis	Progressive Systemic Sclerosis Renal Artery Thrombosis Scleroderma
Congenital, Rare Familial, and Metabolic Disorders	Congenital Obstructive Uropathy Cystinosis Fabry's Disease Hypoplasia/Dysplasia/Dysgenesis/ Agenesis	Medullary Cystic Disease Nephrophthisis Prune Belly Syndrome
Tubular and Interstitial Diseases	Acquired Obstructive Nephropathy Analgesic Nephropathy Antibiotic-induced Nephritis Cancer Chemotherapy-Induced Nephritis Chronic Pyelonephritis/Reflex Nephropathy Gout Nephritis Nephrolithiasis	Oxalate Nephropathy Radiation Nephritis Acute Tubular Necrosis Cortical Necrosis Cyclosporin Nephrotoxicity Heroin Nephrotoxicity Sarcoidosis Urolithiasis
Neoplasms	Incidental Carcinoma Lymphoma Myeloma	Renal Cell Carcinoma Wilms' Tumor
Other	Other Specify Rheumatoid Arthritis	Familial Nephropathy

 

Table TN-7. Liver Primary Diagnosis Categories

Primary Diagnosis Categories	Diagnoses
Non-Cholestatic Cirrhosis	Laennecb's Cirrhosis (Alcoholic) Laennecb's Cirrhosis and Postnecrotic Cirrhosis Cirrhosis: Postnecrotic - Type C Cirrhosis: Cryptogenic - Idiopathic Cirrhosis: Postnecrotic - Autoimmune, Lupoid Cirrhosis: Postnecrotic - Type B-Hbsag+ Cirrhosis: Postnecrotic - Type Non A Non B Cirrhosis: Postnecrotic - Type B and C	Cirrhosis: Postnecrotic - Other Specify Cirrhosis: Drug/Indust Exposure Other Specify Cirrhosis: Postnecrotic - Type B and D Cirrhosis: Postnecrotic - Type A Cirrhosis: Postnecrotic - Type D Cirrhosis: Postnecrotic - Chronic Active Hepatitis (PNC CAH) Cirrhosis: Fatty Liver - NASH
Cholestatic Liver Disease/Cirrhosis	Primary Biliary Cirrhosis (PBC) Sec Biliary Cirrhosis: Other Specify Sec Biliary Cirrhosis: Carolib's Disease Sec Biliary Cirrhosis: Choledochol Cyst Choles Liver Disease: Other Specify Neonatal Cholestatic Liver Disease	PSC: Other Specify PSC: Ulcerative Colitis PSC: No Bowel Disease PSC: Crohn's Disease (PSC=Primary Sclerosing Cholangitis)
Biliary Atresia	Biliary Atresia: Other Specify Biliary Atresia: Extrahepatic	Biliary Atresia: Alagille's Syndrome Biliary Atresia: Hypoplasia
Acute Hepatic Necrosis	AHN: Etiology Unknown AHN: Type B- Hbsag+ AHN: Drug Other Specify AHN: Non-A Non-B AHN: Type C AHN: Type A Acute Alcoholic Hepatitis	AHN: Other Specify AHN: Type B and C AHN: Type B and D AHN: Type D Hepatatis C: Chronic or Acute Hepatitis B: Chronic or Acute
Metabolic Diseases	Metdis: Alpha-1-Antitrypsin Deficiency A-1-A Metdis: Wilson's Disease Metdis: Hemochromatosis-Hemosiderosis Metdis: Other Specify Metdis: Tyrosinemia Metdis: Primary Oxalosis/Oxaluria, Hyperoxaluria	Metdis: Glyc Stor Dis Type II (GSD-II) Metdis: Glyc Stor Dis Type I (GSD-I) Metdis: Hyperlipidemia-II, Homozygous Hypercholesterolemia Metdis: Maple Syrup Urine Disease
Malignant Neoplasms	PLM: Hepatoma - Hepatocellular Carcinoma PLM: Hepatoma (HCC) and Cirrhosis PLM: Cholangiocarcinoma (CH-CA) PLM: Hepatoblastoma (HBL) PLM: Hemangioendothelioma- Hemangiosarcoma	PLM: Other Specify PLM: Fibrolamellar (FL-HC) Bile Duct Cancer Secondary Hepatic Malignancy Other Specify (PLM=Primary Liver Malignancy)
Other	Other Specifiy Cystic Fibrosis Budd-Chiari Syndome TPN/Hyperalimentation Ind Liver Disease Neonatal Hepatitis Other Specify Congenital Hepatic Fibrosis Familial Cholestasis: Other Specify Benign Tumor: Hepatic Adenoma	Familial Cholestasis: Byler's Disease Trauma Other Specify Graft vs. Host Disease Secondary to Non-Liver Tx Chronic or Acute Benign Tumor: Polycystic Liver Disease Benign Tumor: Other Specify

 

Table TN-8. Intestine Primary Diagnosis Categories

Primary Diagnosis Categories	Diagnoses
Short Gut Syndrome	Intestinal Atresia Necrotizing Enterocolitis Intestinal Volvulus Secondary to Malrotation Intestinal Volvulus Secondary to Adhesions Intestinal Volvulus Sec. to Persistent Omphalomesenteric Duct Gastroschisis Massive Resection Secondary to Inflammatory Bowel Disease (Crohnb)

 

Table TN-9. Heart Primary Diagnosis Categories

Primary Diagnosis Categories	Diagnoses
Cardiomyopathy	Dilated Myopathy: Idiopathic Dilated Myopathy: Myocarditis Dilated Myopathy: Other Specify Dialted Myopathy: Post Partum Dilated Myopathy: Familial Dilated Myopathy: Adriamycin Dilated Myopathy: Viral Dilated Myopathy: Alcoholic	Hypertrophic Cardiomyopathy Restrictive Myopathy: Idiopathic Restrictive Myopathy: Amyloidosis Restrictive Myopathy: Sarcoidosis Restrictive Myopathy: Endocardial Fibrosis Restrictive Myopathy: Other Specify Restrictive Myopathy: Secondary To Radiation/Chemotherapy
Coronary Artery Disease	Coronary Artery Disease	Dilated Myopathy: Ischemic
Congenital Heart Disease	Congenital Heart Disease
Valvular Heart Disease	Valvular Heart Disease
Retransplant/Graft Failure	Heart Re-Tx/GF: Coronary Artery Disease Heart Re-Tx/GF: Other Specify Heart Re-Tx/GF: Non-Specific Heart Re-Tx/GF: Acute Rejection	Heart Re-Tx/GF: Hyperacute Rejection Heart Re-Tx/GF: Primary Failure Heart Re-Tx/GF: Chronic Rejection Heart Re-Tx/GF: Restrictive/Constrictive
Other	Cardiac Disease: Other Specify Heart: Other Specify	Cancer

 

Table TN-10. Lung and Heart-Lung Primary Diagnosis Categories

Primary Diagnosis Categories	Diagnoses
Congenital Disease	Eisenmenger's Syn: Arterial Septal Defect Eisenmenger's Syn: VSD Eisenmenger's Syn: Multiple Congenital Anomalies	Eisenmenger's Syn: PDA Eisenmenger's Syn: Other Specify Congenital: Other Specify
Emphysema/COPD	Emphysema/COPD
Cystic Fibrosis	Cystic Fibrosis
Idiopathic Pulmonary Fibrosis	Idiopathic Pulmonary Fibrosis
Primary Pulmonary Hypertension	Primary Pulmonary Hypertension
Alpha-1-Antitrypsin Deficiency	Alpha-1-Antitrypsin Deficiency
Retransplant/Graft Failure	Lung Re-Tx/GF: Obliterative Bronchiolitis Lung Re-Tx/GF: Other Specify Lung Re-Tx/GF: Non-Specific	Lung Re-Tx/GF: Acute Rejection Lung Re-Tx/GF: Primary Graft Failure Lung Re-Tx/GF: Restrictive
Other	Sarcoidosis Lung Disease: Other Specify Bronchiectasis Pulmonary Fibrosis Other: Specify Cause Lymphangioleiomyomatosis Obliterative Bronchiolitis (Non-Retransplant)	Pulmonary Vascular Disease Occupational Lung Disease: Other Specify Inhalation Burns/Trauma Rheumatoid Disease Lung or Heart-Lung: Other Specify Secondary Pulmonary Hyertension

References

1. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1972, 53:457-481.

2. SAS Institute Inc. SAS/STAT User's Guide Version 8. Cary, North Carolina: SAS Institute Incorporated, 1999, 2598-99.

3. Thernaeu TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. New York: Springer-Verlag, 2000, 68-77.

4. 2002 OPTN/SRTR Annual Report 1992-2001. Chapter II, Data Sources and Structure.

5. Kalbfleisch JD, Prentice RL. The Statistical Analysis of Failure Time Data. New York: John Wiley, 1980.

6. Cox DR. Regression models and life tables (with discussion). J R Stat Soc 1972, 34:197-220.