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Transplant Statistics: Annual Report : Appendix A
This section explains concepts, provides definitions of data items appearing in the Reference Tables, and documents the analytic methods used. The Reference Tables are divided into 14 subject-area sections. 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. Further information may also be found in Appendix I.
The 2002 Annual Report includes new tables presenting the incidence of transplant for each organ and immunosuppression usage by organ. The methodology for creating each table is described later in this section. For the first time, this Annual Report also presents separate characteristics and posttransplant outcomes for recipients of lungs from deceased and living donors.
Statistics for pancreas transplants are now categorized as either Pancreas Transplant Alone (PTA) or Pancreas After Kidney (PAK). Each is now reported in a separate chapter in the reference tables.
Data from the Social Security Administration are now incorporated into the calculation of posttransplant death rates and graft and patient survival. Information regarding completeness of mortality data can be found in Chapter II of this report.
Two terms used in this report are new and replace older terminology. "Deceased donors" refers to the same donors formerly known as "cadaveric donors." An organ from a deceased donor may continue to be referred to as a "cadaveric organ." "African American" refers to the same group of people called "black" in previous reports, and includes people classified during different periods as either "Black" or "Black or African American."
Most tables are based on OPTN/SRTR data as of August 1, 2002. 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.
Most tables present data by year from 1992 to 2001. 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.
Intestine waiting list data are reported starting in 1993 because that was the year in which the intestine waiting list was established.
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 are presented in the following tables:
These data are obtained from the OPTN Cadaver Donor Registration (CDR) Form. Only deceased donors recovered by United States organ procurement organizations (OPOs) are included in these tables. Data are subject to change on the basis of future data submission or correction.
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 purposes 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, they will be included in each organ-specific donor count. Hearts recovered for heart valves and pancreata recovered for islet cells 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 are presented in the following tables:
These data are based solely on OPTN Living Donor Registration Forms and include living donors from whom organs were transplanted in the United States between 1992-2001. The year of reporting is based on the organ recovery date as reported to the OPTN. Data are subject to change based on future data submission or correction. The numbers of living pancreas, intestine, and heart donors are too small to offer meaningful information, and therefore are not presented in detail.
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.
The deceased donor organ disposition tables show frequency counts and percentages for each disposition category (i.e., local or shared transplant, local or shared non-use, research, foreign exported, 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 non-use 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.
| Disposition | Non-Use | Nonrecovery | |
|---|---|---|---|
| Kidney | Table 3.1 | 3.2 | 3.3 |
| Pancreas | Table 3.4 | 3.5 | 3.6 |
| Liver | Table 3.7 | 3.8 | 3.9 |
| Intestine | Table 3.10 | 3.11 | 3.12 |
| Heart | Table 3.13 | 3.14 | 3.15 |
| Lung | Table 3.16 | 3.17 | 3.18 |
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. Therefore, the number of organs shown here may be greater than the number of deceased donor organs recovered. Hearts recovered for heart valves and pancreata recovered for islet cells are not counted.
The year of reporting is based on the start of organ preservation, as recorded on the CDR Form. Data are subject to change on the basis of future data submission or correction.
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.
The reasons for non-use 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.
Reasons for non-use of recovered organs are shown only from 1994-2001, because these data were not available before 1994.
Table 4.1 shows the number of deceased donors procured by year for each OPO by year. Table 4.2 lists the transplant centers within each OPO's current CMS-designated service area, 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 August 1, 2002. Data are subject to change on the basis of future data submission or correction.
The OPOs listed in Table 4.1 include those that were operational during 1992-2001. 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.
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 purposes of organ transplantation.
The waiting list tables show frequency counts and percentages of certain demographic and medical factors for registrants awaiting transplantation at each year-end. Intestine waiting list data are reported starting in 1993, when that waiting list was established.
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.
These data represent registrants on the waiting list at the end of each year, according to data available August 1, 2002. OPTN members have direct responsibility for submitting, maintaining, and monitoring all waiting list data from the time registrants are listed until they are removed from the list. These waiting list profiles are based on all information available about these registrants, including information received after the date of the snapshot (i.e., December 31 of each year). Registrants 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. Registrants 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 registrants 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, the data in the waiting list characteristic tables are not adjusted for multiple listings of potential transplant recipients. Therefore, the totals reflect the number of registrations rather than number of candidates. Multiple registrations are discussed in Chapters II and IX.
Panel Reactive Antibody (PRA). Peak PRA levels are shown only for the kidney waiting list. These data are not required for registrants 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 liver and heart waiting lists, this item reflects medical urgency status categories used for allocation, as well as inactive waiting list status. 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" 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.
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 a "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.
| Reason for Removal or Current Active Status |
Time to Transplant (Tables 1.5, X.2*) |
Median Waiting Time (Table 1.6) |
|---|---|---|
| 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 |
| August 31, 2002 | Censor | Censor |
In Appendix Table A-1, note the difference between the "censored" registrations and those with "non-Tx" 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 way 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.
The Kaplan-Meier (Kaplan) method is used to fit both types of models, using the statistical procedure PHREG in version 8.2 of SAS (SAS Institute). To exclude inactive time from the Median Waiting Time calculation, discontinuous intervals of risk were implemented (Therneau).
Figures for recent years in these tables may show the symbol "+". This is because there may not been sufficient time for 50% of the registrants to have been transplanted. (See Appendix Table A-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.
All categories of demographic and medical factors with any registrations are listed in the tables, even if there are no transplants in the cohort. The "+" symbol indicates that the statistic was not calculated because of insufficient follow-up time for each percentile of the cohort to be transplanted.
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. (Intestine data are shown from 1993, when this waiting list began.)
Deaths and death rates for each organ-specific waiting list are presented in Table 3 of each organ-specific section.
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 more 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. Data are subject to change on the basis of future data submission or correction.
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.
Tables 1.8, 1.9, and 1.11 present counts of all U.S. 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.
Transplant recipient characteristics data are based primarily on the OPTN 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 1.9 shows a breakdown of such multi-organ transplants.
Table 1.8 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 1.8. 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, each donor is not 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, U.S. residents include both U.S. 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 recipients' 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. Appendix Tables A-3 through A-7 show the detailed diagnoses that are included in each broad category.
Previous Transplant. This is an indicator of whether a patient had a previous transplant of any solid organ. To determine if a recipient has had a previous transplant, the database first is searched for any records of previous transplant for the same recipient. Data collected on the TRR and TCR Forms are then considered. It should be noted that the reliability of items requested on the TRR and TCR Forms pertaining to prior transplants, particularly in earlier years, has been questioned. Because any decision about excluding or including some of these sources might introduce a trend in previous transplant that does not exist or mask an existing one, the SRTR has chosen to report all indications from these forms as previous transplants. Particularly for earlier years, interpretations of previous transplants should be made with caution.
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; using pre-1997 and current definitions, these are Status levels 1, 2, 2A, 2B, 3, and 4 for liver; and 1, 1A, 1B, and 2 for heart, with 1 (or 1A) being the most urgent. Status codes are defined in detail in the Glossary.
Incidence of transplant, defined as the rate of transplantation for the entire population, are presented in Table 5 of each organ-specific section.
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 1992 to 2000 come from the UNITED STATES Census Bureau monthly estimates for July of each year. The 2001 population is determined by UNITED STATES Census population projections using their middle series assumptions for that year.
Table 1.10 presents statistics on immunosuppression usage by organ for 2000 and 2001. The denominator for the distributions is the number of transplants where any immunosuppression details are reported; transplants without immunosuppression forms filed are excluded from this table. 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, or Simulect recorded for induction usage for 2001 transplants is included in this table. We also report on the percent usage of individual drugs used for maintenance at discharge for 2001 transplants, and for current maintenance one year after discharge for 2000 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.
In the organ-specific chapters, four separate subtables 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®)
daclimuzab (Zenapax®)
muromonab-CD3 (OKT3®)
mycophenolate mofetil (CellCept®)
rabbit antithymocyte globulin (Thymoglobulin®)
rapamycin (Rapamune® or sirolimus)
tacrolimus(Prograf® or FK506)
The posttransplant death rate tables and the patient survival tables make use of a multiple-source follow-up date to determine time at risk. Since this year's Annual Report uses both the OPTN and Social Security Death Master File (SSDMF) data to find deaths, we now expect to have nearly complete death ascertainment for anyone receiving a transplant. As detailed in Chapter II, the ascertainment of mortality using both OPTN and SSDMF data 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 (August 1, 2002), allowing an extra two months to ensure completion of forms. (For additional discussion, see Chapters II and IX.) 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.
The death rate tables show deaths per 1,000 patient-years for patients with a functioning graft that is less than one year old at any time during each year. This includes all patients with transplants during the year, as well as patients transplanted in the previous year whose grafts still function at any time during the year examined. Death rates apply only within the first year of transplant. The period at risk begins on January 1 or the transplant date (whichever is later) and ends on the December 31, the date of death, the one-year transplant anniversary, and 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.
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.
Most patients will appear in two separate calendar years, but no single transplant recipient will contribute more than one full year to the entire set of calculations. For example, a patient who is transplanted on July 1, year A and dies on March 31, year B, contributes 0.5 years at risk and 0 deaths to year A, and 0.25 years at risk and 1 death to year B.
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 in a given year by the sum of the years (including partial years) for which patients have reported data and then multiplying by 1,000. The number 1,000 was chosen, rather than the more familiar 100, because of small death rates in some categories.
The OPTN receives notification of a death after transplant when a follow-up form is submitted with a current status indicating death. OPTN death information is supplemented by the SSDMF. 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.
Tables 1.12 and 1.13 present national one-year graft and patient survival for all organs by year of transplant from 1991 to 2000. Table 1.14 presents 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 1.14. 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 are presented in Tables 8 and 9 of each organ-specific section. For kidney and 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.
Please keep in mind that the survival rate data presented here are not risk-adjusted for the many factors that influence transplant outcomes. Therefore, it is incorrect to infer that the variables shown (e.g., donor age, recipient blood type)by themselvescause the outcomes shown.
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 2001, as shown below:
| Three month: | 1999-2000 |
|---|---|
| One year: | 1999-2000 |
| Three year: | 1997-1998 |
| Five year: | 1995-1996 |
| Ten year: | 1990-1991 (Table 1.14 only) |
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 1.14. Heterotopic transplants were excluded for liver and heart transplants.
Patient and transplant procedure characteristics included in all the organ-specific tables are: recipient age, race, ethnicity, gender, blood type, previous transplant, U.S. residency, hospitalized at transplant, life support at transplant, donor age, and center transplant volume. 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).
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 posttransplant 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.
The value N shown in each table represents the number of transplants for which a survival rate could be determined. 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).
The survival rate calculations were performed using the statistical procedure LIFETEST in version 8.2 of SAS (SAS Institute). Using LIFETEST, the survival rates were estimated using the Kaplan-Meier method (Kaplan), and standard errors were estimated using Greenwood's formula (Kalbfleisch).
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. A major change with in this year's Annual Report is that the SSDMF is used to capture deaths that occur after graft failure or loss to follow-up. We believe that we now have reasonably complete death ascertainment after transplant when combining deaths reported to both the OPTN and SSDMF.
Table 10 of each organ-specific section presents information on the number of transplants performed, by state and transplant center, by year.
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 also are computed.
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.
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.
Data on organs from donors with either a history of cancer or cancer seen at the time of procurement are obtained from the CDR Form. Donor data are presented for organs transplanted between 1994-2001, as cancer history information was not collected before 1994.
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.
Andersen PK, Borgun O, Gill RD, Keiding N. Statistical Models Based on Counting Processes. Springer-Verlag, New York, 1993. See pages 334 and 406-407.
Breslow NE, Day NE. Statistical methods in cancer research (Volume II), IARC, Lyon, 1987.
Colett D. Modeling Survival Data in Medical Research. Chapman and Hall, London, 1994. See page 153, equation 5.6, and page 151, equation 5.1.
Cox DR. Regression Models and life tables (with discussion). J R Stat Soc 1972, 34:197-220.
Kalbfleisch J.D, Prentice RL. The Statistical Analysis of Failure Time Data. John Wiley & Sons, Inc., New York, 1980.
Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1972, 53:457-481.
Klein JP, Moeschberger ML. Survival Analysis: Techniques for Censored and Truncated Data. Springer-Verlag, New York, 1997. See pages 109-114.
SAS Institute Inc. SAS/STAT User's Guide, Version 8, Cary, North Carolina: SAS Institute Incorporated, 1999, p 2598-99.
Thernaeu TM, Grambsch PM. Modeling Survival Data: Extending the Cox Model. Springer-Verlag, New York, 2000. See pages 68-77.
Zucker DM. Restricted mean life with covariates: modification and extension of a useful survival analysis method. J. Amer Statist Assoc, 1998, 93:702-709.
| 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 Alport's Syndrome Amyloidosis Membranous Nephropathy Goodpasture'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 |
| Retransplant/Graft Failure | Retransplant/Graft Failure | |
| Other | Other Specify Rheumatoid Arthritis |
Familial Nephropathy |
| Primary Diagnosis Categories | Diagnoses | |
|---|---|---|
| Non-Cholestatic Cirrhosis | Laennec's Cirrhosis (Alcoholic) Laennec'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 Hempatitis (PNC CAH) |
| Cholestatic Liver Disease/Cirrhosis | Primary Biliary Cirrhosis (PBC) Sec Biliary Cirrhosis: Other Specify Sec Biliary Cirrhosis: Caroli's Disease Sec Biliary Cirrhosis: Choledochol Cyst Choles Liver Disease: Other Specify |
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 |
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 |
| 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 |
| 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 (Chrohn's Disease) |
Massive Resection Secondary to Tumor Massive Resection Secondary to Mesenteric Arterial Thrombosis or Embolus Massive Resection Secondary to Mesenteric Venous Thrombosis Short Gut Syndrome: Specify Short Gut Syndrome: Unspecified |
| Functional Bowel Problem | Hirschsprung's Disease Neuronal Intestinal Dysplasia Pseudo-obstruction, Neuropathic Pseudo-obstruction, Myopathic |
Protein-losing Enteropathy Microvillous Inclusion Disease Functional Bowel Problem: Specify Functional Bowel Problem: Unspecified |
| Retransplant/Graft Failure | Retransplant/Graft Failure |
|
| Other | Other Intestinal Disease: Specify |
Other: Specify |
| 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 |
| 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 |
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