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The ohio solid organ transplantation consortium: A 15-year experience
The Ohio Solid Organ Transplantation Consortium: A 15-Year Experience James A. Schulak,AudreyBohnengel,Douglas W..Hanto,J. MichaelHenderson, Mitchell L. Hemy, ThomasE. Walsh, and Frederick C. Ryckman The Ohio Solid Organ Transplantation Consortium (OSOTC) was established by the Ohio Department of Health in 1984 for the purpose of providing a means for regulating the practice of nonrenal organ transplantation in the State of Ohio. The OSOTC comprises all transplant centers in Ohio that provide these services including The Cleveland Clinic Foundation, the University of Cincinnati Hospitals/ Children's Hospital Medical Center, the Medical College of Ohio Hospitals, The Ohio State University Hospitals/Children's Hospital, and the University Hospitals of Cleveland. The mission of the OSOTC is to ensure equitable access to quality organ transplantation services in Ohio for those in need of a heart, lung, liver, pancreas, or small bowel transplant; to manage transplantation costs; and, in general, to support organ transplantation and organ donation in the state. These goals are achieved, in part, by mandatory pretransplant patient candidate reviews, adherence to strict patient listing criteria, submission of yearly transplant volume and outcomes data, and yearly program outcomes reviews. Since its inception, the OSOTC has performed almost 5000 transplant candidate reviews and more than 2300 patients in Ohio have received a nonrenal transplant. In this article, we describe these activities and review the data accumulated to date. In addition, the impact that the OSOTC has had on organ transplantation in Ohio will be discussed. It is the opinion of all of the member institutions and their respective transplant staffs that participation in the OSOTC has been beneficial to their patients and has fostered a collegial interaction among the transplant professionals in Ohio. Copyright © 1999 by W.B. Saunders Company Key words: Ohio Solid Organ Transplantation Consortium, nonrenal, transplantation.
rgan transplantation has become a widely practiced and very successful clinical venture since its inception more than 40 years ago. Although always beset by complex issues, transplantation now finds itself in one quagmire after another, with such issues as the scarcity of donors, organ allocation, patient selection, disparities in center outcomes, and inadequate reimbursement. As if with prescience, in 1984 the state of Ohio established the Ohio Solid Organ Transplantation Consortium (OSOTC) to provide a structure by which these many complex issues could be addressed. More specifically, the OSOTC was created to provide oversight to nonrenal transplantation, and as such, is not at all involved in any aspects of kidney transplantation. During the past 15 years, the OSOTC has developed a rigorous
O
From the OhioSolid Organ TransplantationConsortium, Worthington, OH. Address reprint requests to James A. Schulak, MD, Department of Surgery, UniversityHostn'ialsof Cleveland, 11100 Euclid Ave, Cleveland, 0H44106. Copyright© 1999 by W.B. SaundersCompany 0955-470X/99/1303-0003510.00/0
method of performing prospective patient review before transplant candidates are listed with the United Network for Organ Sharing (UNOS) for transplantation; developed criteria for center and professional standards for heart, lung, liver, pancreas, and small-bowel transplantation; performed yearly audits of its member center outcomes to ensure that they comply with OSOTC survival and volume performance guidelines; and maintained a comprehensive database regarding all these issues, in addition to compiling and extensively analyzing the cost data generated by its member institutions. The OSOTC experience has been used by UNOS in its development of Regional Review Boards for liver transplant recipients and has also been used as a template for the development of similar consortia in other states. Moreover, requests by various organizations in the health care arena for procedural information, patient selection criteria, and other types of data are frequently made to the OSOTC. Consequently, it is our hope that a comprehensive review of the OSOTC experience might be helpful to the many individuals in the field of transplantation who
Transplantation Reviews, Vo113, No 3 (Ju~,), 1999:pp 135-147
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ongoing balance between organs imported into Ohio and those shared with other states.
Patient Selection Committee This committee and its six organ-specific subcommittees are perhaps the most important of all the OSOTC committees, and as such, its activities will be considered in greater detail later in this review. Briefly, the Patient Selection Committee is composed of representatives from each member hospital, a representative from the ODH, a member of the clergy, an ethicist, and an attorney. This committee is charged with establishing policy that is consistent with the principles of both the Consortium and UNOS as they pertain to patient selection. This committee also reviews the amendments to the patient selection process that are proposed by the organ-specific patient selection committees and reports to the Board regarding its recommendations. There are specific patient selection subcommittees for heart, lung, liver, pancreas, and small-bowel transplantation, as well as a pediatric liver subcommittee. Each of these is composed of one transplant surgeon or physician from each of the member programs, along with the clergy, a representative of the ODH, and an attorney. The primary duties of these organ-specific subcommittees are to establish patient selection criteria for their organ and to prospectively review candidates for transplantation.
Program Review Committee This committee, composed of a representative from each of the member hospitals and a representative from the ODH, is responsible for conducting the annual Program Review and reporting its findings to the Board. In this process, each member program is audited for compliance with both the OSOTC personnel and transplant volume and outcomes criteria. Programs that are not found to be in compliance with any of these criteria are then designated as either inactive or under review. Inactive programs must stop performing transplantations until they can show they have acquired the appropriate personnel to once again come into compliance with OSOTC rules. Programs that are under review are required to submit interim reports describing their progress in bringing their volume and survival rates up to Consortium standards. Members are required to notify the OSOTC when there are changes in key personnel that may affect their compliance with the regulations so that reviews can be conducted outside of the usual yearly schedule, when appropriate. This past year, all
programs in the OSOTC met both personnel and performance criteria. However, in previous years, both the inactive and under review statuses have been voluntarily accepted by programs that were deemed by the Program Review Committee to be deficient in either key personnel or in outcomes, respectively.
Research and Publications Committee This committee is responsible for reviewing any manuscript or abstract submitted for publication or presentation at a non-OSOTC forum by any of its members. The purpose of these reviews is to ensure that all documents meet OSOTC standards for scientific inquiry and correctly represent OSOTC data. In all cases, OSOTC data must be presented in aggregate form because it is Consortium policy that individual center data be kept strictly confidential. To date, the OSOTC liver transplantation data have been presented to the Central Surgical Society, the OSOTC heart transplantation data have been presented to the American Society of Transplant Physicians, and a general overview of the OSOTC has been presented to the American Society of Transplant Surgeons.
Patient S e l e c t i o n Perhaps one of the most important activities performed by the OSOTC is the prospective review of all patients in Ohio who are candidates for extrarenal transplantation in Ohio. The impetus for prospective review was severalfold. First, the OSOTC members wanted to ensure there was equitable access to transplantation in Ohio. This could only be achieved if all centers were operating under the same rules and therefore performing transplantation on the same types of patients. Consequently, it was decided that all programs would use the same eligibility criteria and submit all transplant candidates to prospective review, using the specific listing and exclusion criteria originally developed by the organspecific patient selection committees. These criteria are modified periodically by these same committees to be in accord with current clinical practice. For example, cholangiocarcinoma was originally an approved indication for liver transplantation provided that the patient was enrolled onto an adjuvant chemotherapy protocol. However, after completing a limited series of these transplants, the OSOTC data analysis consistently showed poor outcomes for this group of patients. Consequently, the liver sub-
Ohio Solid Organ Transplantation Consortium
subcommittee recommended to the Board that this diagnosis be changed to an absolute contraindication for liver transplantation. The second reason for subjecting all Ohio patients to prospective review was to facilitate the willingness of the insurance industry in Ohio to provide coverage for extrarenal transplantation. This has become a very important aspect of patient selection in Ohio because many insurance companies now require OSOTC review before granting coverage for specific transplants. Moreover, the Ohio Medicaid program in Ohio has agreed to provide coverage for all extrarenal transplantations to all qualified citizens if they meet Consortium standards, as determined by committee review.
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vote. Emergency reviews on weekends and holidays for patients in need of urgent listing, such as patients with fulminant fiver failure, can be accomplished in one of two ways. The listing center may perform a direct phone survey of individual subcommittee members, during which they present the case and solicit a vote. When four approvals are obtained, the center may list the patient with UNOS and then submit the standard review form for retrospective formal committee review. Alternatively, the center may list the patient with UNOS and retrospectively submit the candidate form on the next business day. In this latter scenario, the center is subject to censorship and Board action if the candidate is ultimately disapproved but undergoes transplantation.
Selection Process It is OSOTC policy that all extrarenal transplant candidates in Ohio must first be approved by the Patient Selection Committee before they can be listed with UNOS for organ allocation. All reviews are conducted on a prospective basis, using a standard candidate summary form. In addition to a brief narrative medical history, which includes the patient's diagnosis and indication for transplantation and recent laboratory and imaging data, a social commentary that specifically addresses the issues of family and social support, financial and insurance status, chemical dependency, history of compliance with medical regimens, and a commitment to proceed with transplantation is required. The forms are sent to the OSOTC office by fax and are then forwarded to each of the subcommittee members, also by fax. The committee members have a choice of voting for approval, requesting additional information before making a decision, requesting a conference call, or voting for disapproval. A majority vote of four approvals is sufficient to permit the patient to be listed with UNOS for transplantation. Controversial patients, as well as those turned down by the committee, may be revie~4ed further by the committee at a conference call requested by physicians at the listing center, during which they may act as their patient's advocate. Others on the committee may represent the interests of the patients on the waiting list who are also competing for the limited supply of organs. After this discussion, a second vote is taken and the results stand. The review process for noncontroversial patients usually is completed within 24 hours and is facilitated by phone calls from the OSOTC staff to committee members, urging them to complete their review and
Patient Selection Activity Since its inception, the OSOTC patient selection committees have reviewed more than 5,000 candidates for extrarenal transplantation in the state of Ohio. Through June 1998, these included 1,995 liver, 1,974 heart, 1,074 pancreas, 310 lung, 17 heart-lung, and 5 liver-pancreas candidates for transplantation. As shown in Figure 1, the number of patients submitted for review each year has increased steadily over the years, whereas the number of patients actually receiving a transplant has begun to level out because of the shortage of organs available for transplantation. The outcomes of the review processes are listed in Table 2. Clearly, the vast majority of patients presented for scrutiny by the patient selection committees have been found to be appropriate transplant candidates and have been granted approval on first review. For patients reviewed between 1994 and 1997, 96% of the candidates for liver transplantation were approved after their initial review. Of the remaining candidates, 19 patients were subsequently approved after being discussed at a conference call in which the listing center was successful in convincing the committee that the transplant was appropriate. Seven patients were either disapproved or had their candidacy withdrawn by their transplant center when disapproval appeared to be imminent. During this same period, 782 of 784 candidates for heart transplantation were approved after their initial review. Both disapproved patients were subsequently given approval after further scrutiny during the conference call discussion. Between 1994 and 1997, all candidates for pancreas and lung transplantation were approved after their initial review.
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A Heart Number of PaUents 240 220 200 180 160 140 120 100 80 60 40 20 I t ! ~ I I I I I i I t t 0 84-85 85-86 86-87 87-88 88-89 89-90 90-91 91-92 92-93 93-94 94-95 95-96 96-97 97-98
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Organ Allocation Although not included in the original mission of the OSOTC, organ allocation also has come under the review process of this organization. Through the establishment of a UNOS-approved statewide sharing agreement in 1989, later revised in 1995, it was determined that the four OPOs in Ohio could share organs with each other before they were offered to the other transplant programs in UNOS Region 10. The rationale for this was that the other two states in UNOS Region 10, Michigan and Indiana, had single statewide OPOs and walt fists and therefore, organs in those two states would always be offered to citizens of those states before being offered to the other states in Region 10. Without the provision to match organs donated in Ohio with patients on the Ohio waiting list first, patients listed at the Ohio transplant centers were put at a disadvantage. To rectify this situation, the OSOTC acted as a facilitator to
Figure 1. Number of patients in Ohio undergoing an initial OSOTC prospective review (solid lines) and undergoing transplantation (hatched lines) between 1984and 1998. (A) Heart, (B) liver.
accomplish the development of an organ sharing protocol to be used by the four Ohio OPOs. With the 1989 agreement, each OPO was to offer extrarenal organs to their local transplant centers first, to the remaining centers in Ohio second, and then to UNOS Region 10. Under this protocol, organs were to be used locally regardless of whether there were sicker patients elsewhere in Ohio. This protocol appeared to be reasonable for heart, pancreas, and lung transplantation. With heart transplantation, the majority of patients were typically status 1, and with pancreas transplantation, there are no patients in urgent need of a transplant. Moreover, at that time, there was only one lung transplant program in the state. Over the years, it became increasingly clear, however, that it was not an appropriate scheme for allocating life-saving organs such as livers and hearts. In 1995, again under the auspices of the OSOTC,
Ohio Solid Organ Transplantation Consortium
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Panc~as
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the five fiver transplant centers in Ohio and the four OPOs developed a new fiver allocation sharing agreement that accommodated the needs of those most urgently in need of a liver transplant in Ohio. Subsequently, a similar model was also applied to allocation of the thoracic organs as well. There are two unique features of this agreement that warrant further discussion. First, the sharing protocol placed primacy on local use of the organ above statewide seniority when patients of equal medical urgency were present on more than one of the Ohio OPO wait lists. For example, a liver procured in Cleveland would be allocated to a status 1 patient in a CleveTable 2. Outcomes of ReviewProcess by OSOTC Patient Selection Committees Organ
PatientsReviewed
PatientsApproved
Liver Heart Pancreas Lung
1,995 1,974 1,074 310
1,875 1,907 1,073 278
~ -
#Transplanted
land transplant center, regardless of seniority, before being allocated to a status 1 patient on one of the other Ohio wait lists. Moreover, a Cleveland status 2 or 3 patient could not undergo transplantation using a locally procured fiver if there was a patient with a more urgent medical status elsewhere in the state. All transplant centers and OPOs agreed to this protocol to minimize both cold ischemia times and transportation costs when patients of equivalent urgency could undergo transplantation without the logistic inconvenience of sharing. This "zigzag" protocol has recently been modified to accommodate Ohio's participation in UNOS Region 10 liver sharing for UNOS status 1 patients in need of liver transplantation. The second important, and at the time, unique feature of the Ohio liver allocation protocol was its requirement for further characterization of patients designated to be UNOS status 2. At that time, the only criterion for UNOS status 2 eligibility was that patients were in the hospital for 5 consecutive days
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Schulaket al
because of their liver disease. The OSOTC liver committee was of the opinion that this criterion was not strict enough to ensure that all patients designated status 2 were truly in equal need of a liver transplant and potentially could encourage inappropriate and extended hospital admissions. Consequently, the committee made obtaining a status 2 designation in Ohio more stringent by adding the need to meet specific medical criteria. In addition to the requirement for 5 days in hospital, patients in Ohio had to satisfy two of the following six criteria before they could be listed as a UNOS status 2 liver transplant candidate: (1) bilirubin level greater than 7.0 mg/dL, (2) albumin level less than 2.5 mg/dL, (3) documented active variceal hemorrhage, (4) grade II encephalopathy, (5) hepatorenal syndrome reflected by a creatinine value greater than 2.0 mg/dL (or three times baseline in pediatric patients), (6) coagulopathy defined by a prothrombin time greater than 18 seconds or international normalized ratio (INR) greater than 1.5. Use of these expanded criteria for designation as status 2 gave all the transplant centers the comfort of knowing they were performing transplantation patients of equal urgency and made it easier for them to accept the allocation of livers procured by their local OPO to patients elsewhere in Ohio. Once again, the OSOTC has led the way in that UNOS now uses similar criteria for liver patients to be listed as status 2B.
Table 3. Age at Time of Transplantation for OSOTC Patients .
Organ
MeanAge (y)
Age Range
Liver (n = 1,260) Heart (n = 1,172) Pancreas (n = 723) Lung (n = 139)
40 49 38 45
20 d-71 y 9 d-73 y 20 y-57 y 11 y-62y
for heart and liver transplantation are also shown in Figure 2A and B, which clearly shows that the bulk of these transplantations are being performed in individuals aged older than 40 years. However, there is the expected bimodal distribution for liver transplants owing to the need for liver replacement for many children with biliary atresia. The age ranges for lung and pancreas transplant patients are some-
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Demographic and Transplantation Outcomes Data Through the patient selection process and the requirement for yearly program review, the OSOTC has been able to accumulate a large amount of data regarding who undergoes transplantation in Ohio and their ultimate outcomes. Outside of UNOS, the OSOTC has perhaps one of the largest databases of this kind in the country. The remainder of this review will be devoted to the presentation of both demographic and outcomes data regarding the Ohio experience with extrarenal transplantation.
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Demographic Data Age. The mean age and age ranges for patients undergoing heart, liver, pancreas, and lung transplantation in Ohio between 1984 and 1998 are listed in Table 3. As might be expected, the ranges are very wide for both heart and liver recipients, reflecting that these types of transplants may be performed in infants shortly after birth. The age distribution data
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Figure 2. Age distribution of patients in Ohio undergoing either (A) liver or (B) heart transplantation between 1984 and 1998.
Ohio Solid Organ Transplantation Consortium
what smaller, particularly for the latter (Table 3). The vast majority of pancreas transplant recipients were adults who had developed end-stage renal failure caused by diabetes and who were recipients of either combined pancreas-kidney transplants or an isolated pancreas transplant after having previously undergone a successful kidney transplant for diabetic nephropathy. Sex. The sex distribution for patients listed for and receiving a heart, liver, pancreas, or lung transplant in this series are listed in Table 4. Several interesting relationships have been observed. The majority of patients listed for and receiving a heart transplant have been men, but the chance of actually receiving a heart transplant in Ohio appears to be better if one is a woman (66% of the women listed underwent transplantation compared with only 60% of the men; P = .01). Conversely, a greater percentage of patients listed for lung transplantation were women, but men were more likely to be matched with an organ (58% v 43%;P = .01), possibly because of the requirement for size matching in the context of more men than women donors. Although there was a slight trend toward more men listed for both liver and pancreas transplantation, the percentage of patients receiving either organ in transplantation was essentially identical. Race. The racial distribution of patients undergoing liver, heart, and pancreas transplantation in Ohio is listed in Table 5. For these organs, there was a large predominance of white patients both listed and undergoing transplantation. The racial distribution for liver and heart transplantation is compatible with the distribution ofthe races in the Ohio population in general. We currently do not have an explanation for the apparent deficiency of blacks undergoing pancreas transplantation but believe that this discrepTable 4. Sex of OSOTC Transplant Recipients Organ Transplanted Liver Listed Transplanted Heart Listed Transplanted Pancreas Listed Transplanted Lung Listed Transplanted
Men
Women
1,012 (54%) 686 (54%)
863 (46%) 574 (46%)
1,505 (79%) 906 (77%)
402 (21%) 266 (23%)
604 (59%) 425 (59%)
426 (42%) 298 (41%)
123 (44%) 72 (52%)
155 (56%) 67 (48%)
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Table 5. Racial Distribution of OSOTC Liver, Heart, and Pancreas Transplant Recipients Organ Transplanted Liver Listed Transplanted Heart Listed Transplanted Pancreas Listed Transplanted
Black (%)
White (%)
Other (%)
Il 10
85 86
4 4
12 12
83 87
5 1
7 5
92 95
1 0
ancy may, in part, be explained by racial differences in the incidence of type I diabetes and the fact that H I A matching has some impact on the allocation of pancreata for transplantation, thereby favoring white recipients. Insurance coverage. A rarely reported demographic characteristic is the insurance status of patients at the time of transplantation. In Ohio, the OSOTC has collected these data as well. As listed in Table 6, the majority of patients, particularly those who received a heart, liver, or lung transplant, had their procedure paid for by private insurance. More specifically, approximately two thirds of these patients had private insurance that reimbursed the physicians and hospitals for transplantation. Pancreas transplantation did not fare as well in that only 56% of the patients had private insurance coverage for their transplantation compared with 44% who had some type of governmental coverage. The OSOTC defines governmental insurance as coverage provided by Medicare, Medicaid, Bureau of Children with Medical Handicaps, Champus, or the Veterans Administration. Outcomes Data Waiting time. Although the OSOTC database has complete data for this outcomes parameter, for the Table 6. Insurance Status of OSOTC Transplant Recipients Organ Private Government No Transplanted Insurance(%) Insurance*(%) Insurance(%) Liver Heart Pancreas Lung
66 70 56 67
33 27 43 30
1 3 1 3
*Includes Medicare, Medicaid, Champus/Veterans Affairs, Bureau ofChildrenwithMedicalHandicaps.
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Schulak et al
sake of brevity, only a snapshot of three different eras is listed in Table 7. The time on the waiting list has steadily increased for patients undergoing either liver or pancreas transplantation in Ohio, whereas the waiting time for heart patients has remained relatively stable. Although an explanation for the stability in waiting time for heart patients is not dear, in fiver transplantation, there was a clear shift toward earlier listing and later transplantation of more urgent patients. For pancreas transplantation, however, the trend toward longer waits simply may have been caused by the growing size of the list in the context of static donor availability. During the time of this analysis, the total number of lung transplantations performed in Ohio was too small to permit valid comparisons with the other organs. Somewhat surprisingly, these trends toward longer waits for transplantation did not translate into greater waiting list mortality. Before 1991, the mortality rate while waiting for heart and fiver transplant candidate was 24% and 17%, respectively, whereas since 1991, these death rates were 16% and 13% for these two groups, respectively. Length of stay and readraissions. The median length of stay (LOS) data, calculated from day of transplantation to day of discharge, are shown in Figure 3. Early in the OSOTC experience, most patients undergoing extrarenal transplantation were in the hospital for 3 to 6 weeks, with considerable variability in LOS between the types of transplants. More recently, however, most patients, regardless of the type of transplant they received, are in the hospital for approximately 2 weeks after transplantation. Interestingly, there was little variability in heart patients according to their UNOS status, with a median LOS for both status 1 and status 2 patients of approximately 15 days (P = .56). For liver patients, however, the LOS clearly was dependent on the severity of liver failure at the time of transplantation, with median LOS values of 18, 22, 28, and 31 days for UNOS status 3, 2B, 2A, and 1 patients, respectively (P = .0001). The rate of readmission to the hospital in the first 2 years after transplantation also was Table 7. Median Waiting Times in Days for OSOTC Transplant Recipients Year
Liver
Hea~
Pancreas
Lung
1985-1986 1992-1993 1997-1998
28 72 207
17 55 83
102 125 327
NA 66 219
Abbre~ation:NA,notappfica~e.
tracked for heart, liver, and pancreas transplant recipients. These data are listed in Table 8. Pancreas recipients were most likely to require a return to the hospital after transplantation, and the heart recipients were least likely to do so. In all cases, the average number of admissions to hospital in the second posttransplant year was less than those observed compared with the first year. Pat/ent and graft surv/va/. Patient and graft survival data for liver, heart, kidney-pancreas, and pancreas-only transplants, performed throughout the life of the OSOTC, are shown in Figure 4. Survival data for lung transplantation are not presented because they were derived from a single-center experience, and the OSOTC confidentiality policy prohibits publication of single-center data. As might be expected, because pancreas graft failure usually is not lethal, the patient survival for both kidney-pancreas and pancreas-only transplants exceeds that of graft survival, whereas patient and graft survival for both heart and liver transplantation were approximately equivalent. A more accurate picture of OSOTC patient survival for both heart and liver transplantation can be obtained by looking at the data between 1990 and 1998, because this allows for all centers to have experienced their learning curves. For heart transplantation, the 1- and 5-year patient survival rates were 87% and 75%, respectively, and those for liver transplant recipients were 82% and 7 I% for the same time periods, respectively. Moreover, during this same period, the l-year patient survival rates for each year have steadily improved. In 1990, the 1-year patient survival rates for heart and liver transplant recipients were 81% and 79%, respectively, whereas the corresponding survival rates in 1998 were 90% and 86%. A comparison of patient survival rates between both sexes for all organ transplant groups did not show an advantage for either sex because the survival curves were essentially identical (data not shown). A similar comparison of patient survival rates between white and black patients showed a small but statistically significant survival advantage for white heart and liver recipients, but not pancreas recipients (data not shown). The most common cause of death for heart transplant recipients was rejection (33%), whereas for fiver recipients, it was infection (30%). Finally, the retransplantation rate for fiver patients was approximately 11%,whereas for heart patients, it was only 1%. Rehab//atat/on. An important measure of organ transplantation success is whether patients are able to return to a normal lifestyle after their operation.
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Ohio Solid Organ Transplantation Consortium
Median Lengthof Slay Numberof Days 70 60 ............................................................................
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Figure 3. Median length of stay in days for patients in Ohio undergoing heart, liver, and pancreas transplantation between 1984and 1998.
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The OSOTC has collected this type of outcome information for most Ohio heart and liver transplant recipients since its inception, and these data are listed in Table 9. There were no appreciable differences between heart and liver patients regarding their posttransplantation rehabilitation outcomes. However, because a greater number of adult heart patients (81%) were either medically disabled or unemployed before transplantation compared with adult liver patients (51%), their rehabilitation potential could be construed as better than that of the liver patients. This difference, however, may be caused somewhat by an averaging effect of clumping all OSOTC data together for analysis. For example, before 1996, the majority of liver transplantations performed in Ohio were in UNOS status 3 patients, whereas the majority of heart patients were UNOS status 1 at the time of their transplantation. More recently, however, the number of Ohio liver transplantations performed in sicker individuals (UNOS status 2B or greater) has exceeded 60%. Consequently, it is not clear whether the difference in rehabilitation trends between heart and fiver transplant patients as described will prevail in the future.
Discussion It is the currently held opinion by all member institutions and their transplant personnel that participation in the OSOTC has been and continues to Table 8. Average Number of Readmissions to the Hospital After Transplantation for OSOTC Patients Organ Transplanted
Year I
Year 2
Liver Heart Pancreas
2.1 1.4 2.9
0.8 0.8 1.0
~ -
Liver
---
Pancm8
be a very positive and rewarding experience. Early on, however, there was skepticism by most members regarding the value of membership in the OSOTC. Many individuals believed the requirement by the Ohio Department of Health for all transplant centers to belong to the OSOTC, as a requirement for approval to perform extrarenal transplantation, was another example of undesired governmental intrusion into the practice of medicine. That attitude has clearly waned over the years, primarily because of the many benefits to both the transplant centers and their patients that have been realized as a consequence of membership in the Consortium. Consequently, with the enthusiastic participation of all Ohio extrarenal transplant centers, the OSOTC has become, perhaps, one of the most influential nongovernmental agencies in the health care arena in this state. For example, the OSOTC opinion has been solicited by the ODH on many issues, such as insurance coverage for transplantation, development of appropriate quality indicators of transplant outcomes, and the center and professional criteria for performing transplantation in general now that Ohio no longer has a certificate of need law. Without question, in Ohio, the OSOTC is considered the authority on most issues pertaining to extrarenal transplantation. In addition to facilitating the interactions between transplant centers and the state government, participation in the OSOTC has greatly improved communication and cooperation between the transplant centers in this state. Important issues are discussed in a collegial atmosphere that benefits each participant by exposing them to sometimes divergent but constructive points of view, whereas affording the opportunity to develop consensus solutions to problems before adversarial attitudes emerge. For ex-
146
Schulak et al
Pa~ent Survival
A 100 -~F:."- . . . . .
~__~
:
......
2 P
.............................
50
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60
72
84
96
Months HT
..........
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.......
W
Graft Survival
B 100~
9o! eoi 7oi 6oi > P
50 40 30~
1 LI - - - - 1 1 L. . . . . t----L__ - "i
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Months HT
.......... KP
.......
L¥
ample, the O S O T C policy requiring prospective patient review before listing for transplantation has leveled the playing field with regard to patient selection for all centers. Although it may appear that the O S O T C patient selection process has been perfunctory with the high initial approval rates, it is our impression that this actually reflects a strict adherence to the consortium listing criteria for each type of transplant. Member centers know what type of patient is likely to obtain a favorable review and are not inclined to test the system. Prospective patient review not only has ensured equal access to extrarenal
72
84
96
Figure 4. (A) Patient and (B) graft survival curves for patients undergoing heart (HT), liver (LV), and pancreas transplantation in Ohio between 1984 and 1998. The pancreas data are presented for both patients receiving an isolated pancreas graft (P) or a pancreas as part of a combined pancreas-kidney transplant
(KP).
transplantation in Ohio, but also has fostered a sense of trust between the transplant centers. It is this trust that permitted the development of the somewhat unique and very successful zig-zag statewide sharing agreement for liver allocation between the four organ procurement organizations in the state and the O S O T C transplant centers. It is our belief that some variant of this zig-zag sharing protocol should be considered by UNOS in its quest to develop larger organ sharing regions on a national level. Participation in the O S O T C also furthers the tradition of medical excellence in each of the m e m -
Ohio Solid Organ Transplantation Consortium
147
Table 9. Rehabilitation Outcomes for OSOTC Liver and Heart Transplant Recipients
Heart
Medically disabled (%) Employed* (%) Unemployedt (%)
Liver
6 Months Before Transplant
1 YearAfter Transplant
6 Months Before Transplant
1 YearAfter Transplant
72 17 11
30 44 26
42 37 2l
30 42 28
*Includesthosewithjobs outsidethe home,homemakers,and students. "Hndudesthosenot disabledand not working,retired individuals,andjuveniles. ber hospitals by affording them the opportunity to meet with experts from across the state to discuss various issues of relevance to transplantation. This is achieved both on an as needed ad hoc basis and at the biennial OSOTC professional meeting. At the latter, which is a day-long symposium, issues pertaining to transplantation in general are presented and discussed in the morning session and sessions specific to either thoracic organ or abdominal organ transplantation are available to the participants in the afternoon. Through these various activities, state-of-theart surgical techniques and protocols for patient management have been shared with all OSOTC members. As transplantation embarks on the next millennium, there will continue to be many important issues facing our discipline. Some of these include the disparity between the growing number of people who could benefit from transplantation and the inad-
equate number of organs available, the consequent problems of appropriate patient selection and fair organ allocation, the increasing need for meaningful transplant outcomes analysis, the increasing cost of providing transplantation care, and xenotransplantation. Whereas the elimination of small- and mediumsized transplant programs and the subsequent development of large regional centers may facilitate the management of some of these issues by eliminating competition and achieving the economy of scale both in efficacy and cost, this potential solution remains very controversial for many reasons.~ Alternatively, the establishment of regional transplant consortia, like the OSOTC, also may achieve many of the same end points. In conclusion, we believe that the OSOTC has provided both the transplant professionals and patients in Ohio with an effective mechanism for addressing the important issues facing transplantation.
rgan transplantation has become a widely practiced and very successful clinical venture since its inception more than 40 years ago. Although always beset by complex issues, transplantation now finds itself in one quagmire after another, with such issues as the scarcity of donors, organ allocation, patient selection, disparities in center outcomes, and inadequate reimbursement. As if with prescience, in 1984 the state of Ohio established the Ohio Solid Organ Transplantation Consortium (OSOTC) to provide a structure by which these many complex issues could be addressed. More specifically, the OSOTC was created to provide oversight to nonrenal transplantation, and as such, is not at all involved in any aspects of kidney transplantation. During the past 15 years, the OSOTC has developed a rigorous
O
From the OhioSolid Organ TransplantationConsortium, Worthington, OH. Address reprint requests to James A. Schulak, MD, Department of Surgery, UniversityHostn'ialsof Cleveland, 11100 Euclid Ave, Cleveland, 0H44106. Copyright© 1999 by W.B. SaundersCompany 0955-470X/99/1303-0003510.00/0
method of performing prospective patient review before transplant candidates are listed with the United Network for Organ Sharing (UNOS) for transplantation; developed criteria for center and professional standards for heart, lung, liver, pancreas, and small-bowel transplantation; performed yearly audits of its member center outcomes to ensure that they comply with OSOTC survival and volume performance guidelines; and maintained a comprehensive database regarding all these issues, in addition to compiling and extensively analyzing the cost data generated by its member institutions. The OSOTC experience has been used by UNOS in its development of Regional Review Boards for liver transplant recipients and has also been used as a template for the development of similar consortia in other states. Moreover, requests by various organizations in the health care arena for procedural information, patient selection criteria, and other types of data are frequently made to the OSOTC. Consequently, it is our hope that a comprehensive review of the OSOTC experience might be helpful to the many individuals in the field of transplantation who
Transplantation Reviews, Vo113, No 3 (Ju~,), 1999:pp 135-147
135
138
Schulak et al
ongoing balance between organs imported into Ohio and those shared with other states.
Patient Selection Committee This committee and its six organ-specific subcommittees are perhaps the most important of all the OSOTC committees, and as such, its activities will be considered in greater detail later in this review. Briefly, the Patient Selection Committee is composed of representatives from each member hospital, a representative from the ODH, a member of the clergy, an ethicist, and an attorney. This committee is charged with establishing policy that is consistent with the principles of both the Consortium and UNOS as they pertain to patient selection. This committee also reviews the amendments to the patient selection process that are proposed by the organ-specific patient selection committees and reports to the Board regarding its recommendations. There are specific patient selection subcommittees for heart, lung, liver, pancreas, and small-bowel transplantation, as well as a pediatric liver subcommittee. Each of these is composed of one transplant surgeon or physician from each of the member programs, along with the clergy, a representative of the ODH, and an attorney. The primary duties of these organ-specific subcommittees are to establish patient selection criteria for their organ and to prospectively review candidates for transplantation.
Program Review Committee This committee, composed of a representative from each of the member hospitals and a representative from the ODH, is responsible for conducting the annual Program Review and reporting its findings to the Board. In this process, each member program is audited for compliance with both the OSOTC personnel and transplant volume and outcomes criteria. Programs that are not found to be in compliance with any of these criteria are then designated as either inactive or under review. Inactive programs must stop performing transplantations until they can show they have acquired the appropriate personnel to once again come into compliance with OSOTC rules. Programs that are under review are required to submit interim reports describing their progress in bringing their volume and survival rates up to Consortium standards. Members are required to notify the OSOTC when there are changes in key personnel that may affect their compliance with the regulations so that reviews can be conducted outside of the usual yearly schedule, when appropriate. This past year, all
programs in the OSOTC met both personnel and performance criteria. However, in previous years, both the inactive and under review statuses have been voluntarily accepted by programs that were deemed by the Program Review Committee to be deficient in either key personnel or in outcomes, respectively.
Research and Publications Committee This committee is responsible for reviewing any manuscript or abstract submitted for publication or presentation at a non-OSOTC forum by any of its members. The purpose of these reviews is to ensure that all documents meet OSOTC standards for scientific inquiry and correctly represent OSOTC data. In all cases, OSOTC data must be presented in aggregate form because it is Consortium policy that individual center data be kept strictly confidential. To date, the OSOTC liver transplantation data have been presented to the Central Surgical Society, the OSOTC heart transplantation data have been presented to the American Society of Transplant Physicians, and a general overview of the OSOTC has been presented to the American Society of Transplant Surgeons.
Patient S e l e c t i o n Perhaps one of the most important activities performed by the OSOTC is the prospective review of all patients in Ohio who are candidates for extrarenal transplantation in Ohio. The impetus for prospective review was severalfold. First, the OSOTC members wanted to ensure there was equitable access to transplantation in Ohio. This could only be achieved if all centers were operating under the same rules and therefore performing transplantation on the same types of patients. Consequently, it was decided that all programs would use the same eligibility criteria and submit all transplant candidates to prospective review, using the specific listing and exclusion criteria originally developed by the organspecific patient selection committees. These criteria are modified periodically by these same committees to be in accord with current clinical practice. For example, cholangiocarcinoma was originally an approved indication for liver transplantation provided that the patient was enrolled onto an adjuvant chemotherapy protocol. However, after completing a limited series of these transplants, the OSOTC data analysis consistently showed poor outcomes for this group of patients. Consequently, the liver sub-
Ohio Solid Organ Transplantation Consortium
subcommittee recommended to the Board that this diagnosis be changed to an absolute contraindication for liver transplantation. The second reason for subjecting all Ohio patients to prospective review was to facilitate the willingness of the insurance industry in Ohio to provide coverage for extrarenal transplantation. This has become a very important aspect of patient selection in Ohio because many insurance companies now require OSOTC review before granting coverage for specific transplants. Moreover, the Ohio Medicaid program in Ohio has agreed to provide coverage for all extrarenal transplantations to all qualified citizens if they meet Consortium standards, as determined by committee review.
139
vote. Emergency reviews on weekends and holidays for patients in need of urgent listing, such as patients with fulminant fiver failure, can be accomplished in one of two ways. The listing center may perform a direct phone survey of individual subcommittee members, during which they present the case and solicit a vote. When four approvals are obtained, the center may list the patient with UNOS and then submit the standard review form for retrospective formal committee review. Alternatively, the center may list the patient with UNOS and retrospectively submit the candidate form on the next business day. In this latter scenario, the center is subject to censorship and Board action if the candidate is ultimately disapproved but undergoes transplantation.
Selection Process It is OSOTC policy that all extrarenal transplant candidates in Ohio must first be approved by the Patient Selection Committee before they can be listed with UNOS for organ allocation. All reviews are conducted on a prospective basis, using a standard candidate summary form. In addition to a brief narrative medical history, which includes the patient's diagnosis and indication for transplantation and recent laboratory and imaging data, a social commentary that specifically addresses the issues of family and social support, financial and insurance status, chemical dependency, history of compliance with medical regimens, and a commitment to proceed with transplantation is required. The forms are sent to the OSOTC office by fax and are then forwarded to each of the subcommittee members, also by fax. The committee members have a choice of voting for approval, requesting additional information before making a decision, requesting a conference call, or voting for disapproval. A majority vote of four approvals is sufficient to permit the patient to be listed with UNOS for transplantation. Controversial patients, as well as those turned down by the committee, may be revie~4ed further by the committee at a conference call requested by physicians at the listing center, during which they may act as their patient's advocate. Others on the committee may represent the interests of the patients on the waiting list who are also competing for the limited supply of organs. After this discussion, a second vote is taken and the results stand. The review process for noncontroversial patients usually is completed within 24 hours and is facilitated by phone calls from the OSOTC staff to committee members, urging them to complete their review and
Patient Selection Activity Since its inception, the OSOTC patient selection committees have reviewed more than 5,000 candidates for extrarenal transplantation in the state of Ohio. Through June 1998, these included 1,995 liver, 1,974 heart, 1,074 pancreas, 310 lung, 17 heart-lung, and 5 liver-pancreas candidates for transplantation. As shown in Figure 1, the number of patients submitted for review each year has increased steadily over the years, whereas the number of patients actually receiving a transplant has begun to level out because of the shortage of organs available for transplantation. The outcomes of the review processes are listed in Table 2. Clearly, the vast majority of patients presented for scrutiny by the patient selection committees have been found to be appropriate transplant candidates and have been granted approval on first review. For patients reviewed between 1994 and 1997, 96% of the candidates for liver transplantation were approved after their initial review. Of the remaining candidates, 19 patients were subsequently approved after being discussed at a conference call in which the listing center was successful in convincing the committee that the transplant was appropriate. Seven patients were either disapproved or had their candidacy withdrawn by their transplant center when disapproval appeared to be imminent. During this same period, 782 of 784 candidates for heart transplantation were approved after their initial review. Both disapproved patients were subsequently given approval after further scrutiny during the conference call discussion. Between 1994 and 1997, all candidates for pancreas and lung transplantation were approved after their initial review.
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Schulak et al
A Heart Number of PaUents 240 220 200 180 160 140 120 100 80 60 40 20 I t ! ~ I I I I I i I t t 0 84-85 85-86 86-87 87-88 88-89 89-90 90-91 91-92 92-93 93-94 94-95 95-96 96-97 97-98
iiiii i ! i!
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Years # Patients Reviewed
~
-
#Transplants
B Liver
Number of Patients 360
320
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# Transplants
Organ Allocation Although not included in the original mission of the OSOTC, organ allocation also has come under the review process of this organization. Through the establishment of a UNOS-approved statewide sharing agreement in 1989, later revised in 1995, it was determined that the four OPOs in Ohio could share organs with each other before they were offered to the other transplant programs in UNOS Region 10. The rationale for this was that the other two states in UNOS Region 10, Michigan and Indiana, had single statewide OPOs and walt fists and therefore, organs in those two states would always be offered to citizens of those states before being offered to the other states in Region 10. Without the provision to match organs donated in Ohio with patients on the Ohio waiting list first, patients listed at the Ohio transplant centers were put at a disadvantage. To rectify this situation, the OSOTC acted as a facilitator to
Figure 1. Number of patients in Ohio undergoing an initial OSOTC prospective review (solid lines) and undergoing transplantation (hatched lines) between 1984and 1998. (A) Heart, (B) liver.
accomplish the development of an organ sharing protocol to be used by the four Ohio OPOs. With the 1989 agreement, each OPO was to offer extrarenal organs to their local transplant centers first, to the remaining centers in Ohio second, and then to UNOS Region 10. Under this protocol, organs were to be used locally regardless of whether there were sicker patients elsewhere in Ohio. This protocol appeared to be reasonable for heart, pancreas, and lung transplantation. With heart transplantation, the majority of patients were typically status 1, and with pancreas transplantation, there are no patients in urgent need of a transplant. Moreover, at that time, there was only one lung transplant program in the state. Over the years, it became increasingly clear, however, that it was not an appropriate scheme for allocating life-saving organs such as livers and hearts. In 1995, again under the auspices of the OSOTC,
Ohio Solid Organ Transplantation Consortium
C
141
Panc~as
Numberof Patients 200 180 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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120 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 80 . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Number of Paf~ents
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Figure 1. (Continued). (C) Pancreas, (D) lung.
#PaUenbReviewed
the five fiver transplant centers in Ohio and the four OPOs developed a new fiver allocation sharing agreement that accommodated the needs of those most urgently in need of a liver transplant in Ohio. Subsequently, a similar model was also applied to allocation of the thoracic organs as well. There are two unique features of this agreement that warrant further discussion. First, the sharing protocol placed primacy on local use of the organ above statewide seniority when patients of equal medical urgency were present on more than one of the Ohio OPO wait lists. For example, a liver procured in Cleveland would be allocated to a status 1 patient in a CleveTable 2. Outcomes of ReviewProcess by OSOTC Patient Selection Committees Organ
PatientsReviewed
PatientsApproved
Liver Heart Pancreas Lung
1,995 1,974 1,074 310
1,875 1,907 1,073 278
~ -
#Transplanted
land transplant center, regardless of seniority, before being allocated to a status 1 patient on one of the other Ohio wait lists. Moreover, a Cleveland status 2 or 3 patient could not undergo transplantation using a locally procured fiver if there was a patient with a more urgent medical status elsewhere in the state. All transplant centers and OPOs agreed to this protocol to minimize both cold ischemia times and transportation costs when patients of equivalent urgency could undergo transplantation without the logistic inconvenience of sharing. This "zigzag" protocol has recently been modified to accommodate Ohio's participation in UNOS Region 10 liver sharing for UNOS status 1 patients in need of liver transplantation. The second important, and at the time, unique feature of the Ohio liver allocation protocol was its requirement for further characterization of patients designated to be UNOS status 2. At that time, the only criterion for UNOS status 2 eligibility was that patients were in the hospital for 5 consecutive days
142
Schulaket al
because of their liver disease. The OSOTC liver committee was of the opinion that this criterion was not strict enough to ensure that all patients designated status 2 were truly in equal need of a liver transplant and potentially could encourage inappropriate and extended hospital admissions. Consequently, the committee made obtaining a status 2 designation in Ohio more stringent by adding the need to meet specific medical criteria. In addition to the requirement for 5 days in hospital, patients in Ohio had to satisfy two of the following six criteria before they could be listed as a UNOS status 2 liver transplant candidate: (1) bilirubin level greater than 7.0 mg/dL, (2) albumin level less than 2.5 mg/dL, (3) documented active variceal hemorrhage, (4) grade II encephalopathy, (5) hepatorenal syndrome reflected by a creatinine value greater than 2.0 mg/dL (or three times baseline in pediatric patients), (6) coagulopathy defined by a prothrombin time greater than 18 seconds or international normalized ratio (INR) greater than 1.5. Use of these expanded criteria for designation as status 2 gave all the transplant centers the comfort of knowing they were performing transplantation patients of equal urgency and made it easier for them to accept the allocation of livers procured by their local OPO to patients elsewhere in Ohio. Once again, the OSOTC has led the way in that UNOS now uses similar criteria for liver patients to be listed as status 2B.
Table 3. Age at Time of Transplantation for OSOTC Patients .
Organ
MeanAge (y)
Age Range
Liver (n = 1,260) Heart (n = 1,172) Pancreas (n = 723) Lung (n = 139)
40 49 38 45
20 d-71 y 9 d-73 y 20 y-57 y 11 y-62y
for heart and liver transplantation are also shown in Figure 2A and B, which clearly shows that the bulk of these transplantations are being performed in individuals aged older than 40 years. However, there is the expected bimodal distribution for liver transplants owing to the need for liver replacement for many children with biliary atresia. The age ranges for lung and pancreas transplant patients are some-
A Numbm"of I.~KIL T , l n S ~ I I I ~
J
300-
i
250 200 172 150
100
Demographic and Transplantation Outcomes Data Through the patient selection process and the requirement for yearly program review, the OSOTC has been able to accumulate a large amount of data regarding who undergoes transplantation in Ohio and their ultimate outcomes. Outside of UNOS, the OSOTC has perhaps one of the largest databases of this kind in the country. The remainder of this review will be devoted to the presentation of both demographic and outcomes data regarding the Ohio experience with extrarenal transplantation.
50
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10to19 20to29 30to39 40to49 50to50
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210
Demographic Data Age. The mean age and age ranges for patients undergoing heart, liver, pancreas, and lung transplantation in Ohio between 1984 and 1998 are listed in Table 3. As might be expected, the ranges are very wide for both heart and liver recipients, reflecting that these types of transplants may be performed in infants shortly after birth. The age distribution data
60+
AGE
tlg
O-
0tO0
101019
201029
30 tO3O
401040
501059
60+
AGE
Figure 2. Age distribution of patients in Ohio undergoing either (A) liver or (B) heart transplantation between 1984 and 1998.
Ohio Solid Organ Transplantation Consortium
what smaller, particularly for the latter (Table 3). The vast majority of pancreas transplant recipients were adults who had developed end-stage renal failure caused by diabetes and who were recipients of either combined pancreas-kidney transplants or an isolated pancreas transplant after having previously undergone a successful kidney transplant for diabetic nephropathy. Sex. The sex distribution for patients listed for and receiving a heart, liver, pancreas, or lung transplant in this series are listed in Table 4. Several interesting relationships have been observed. The majority of patients listed for and receiving a heart transplant have been men, but the chance of actually receiving a heart transplant in Ohio appears to be better if one is a woman (66% of the women listed underwent transplantation compared with only 60% of the men; P = .01). Conversely, a greater percentage of patients listed for lung transplantation were women, but men were more likely to be matched with an organ (58% v 43%;P = .01), possibly because of the requirement for size matching in the context of more men than women donors. Although there was a slight trend toward more men listed for both liver and pancreas transplantation, the percentage of patients receiving either organ in transplantation was essentially identical. Race. The racial distribution of patients undergoing liver, heart, and pancreas transplantation in Ohio is listed in Table 5. For these organs, there was a large predominance of white patients both listed and undergoing transplantation. The racial distribution for liver and heart transplantation is compatible with the distribution ofthe races in the Ohio population in general. We currently do not have an explanation for the apparent deficiency of blacks undergoing pancreas transplantation but believe that this discrepTable 4. Sex of OSOTC Transplant Recipients Organ Transplanted Liver Listed Transplanted Heart Listed Transplanted Pancreas Listed Transplanted Lung Listed Transplanted
Men
Women
1,012 (54%) 686 (54%)
863 (46%) 574 (46%)
1,505 (79%) 906 (77%)
402 (21%) 266 (23%)
604 (59%) 425 (59%)
426 (42%) 298 (41%)
123 (44%) 72 (52%)
155 (56%) 67 (48%)
143
Table 5. Racial Distribution of OSOTC Liver, Heart, and Pancreas Transplant Recipients Organ Transplanted Liver Listed Transplanted Heart Listed Transplanted Pancreas Listed Transplanted
Black (%)
White (%)
Other (%)
Il 10
85 86
4 4
12 12
83 87
5 1
7 5
92 95
1 0
ancy may, in part, be explained by racial differences in the incidence of type I diabetes and the fact that H I A matching has some impact on the allocation of pancreata for transplantation, thereby favoring white recipients. Insurance coverage. A rarely reported demographic characteristic is the insurance status of patients at the time of transplantation. In Ohio, the OSOTC has collected these data as well. As listed in Table 6, the majority of patients, particularly those who received a heart, liver, or lung transplant, had their procedure paid for by private insurance. More specifically, approximately two thirds of these patients had private insurance that reimbursed the physicians and hospitals for transplantation. Pancreas transplantation did not fare as well in that only 56% of the patients had private insurance coverage for their transplantation compared with 44% who had some type of governmental coverage. The OSOTC defines governmental insurance as coverage provided by Medicare, Medicaid, Bureau of Children with Medical Handicaps, Champus, or the Veterans Administration. Outcomes Data Waiting time. Although the OSOTC database has complete data for this outcomes parameter, for the Table 6. Insurance Status of OSOTC Transplant Recipients Organ Private Government No Transplanted Insurance(%) Insurance*(%) Insurance(%) Liver Heart Pancreas Lung
66 70 56 67
33 27 43 30
1 3 1 3
*Includes Medicare, Medicaid, Champus/Veterans Affairs, Bureau ofChildrenwithMedicalHandicaps.
144
Schulak et al
sake of brevity, only a snapshot of three different eras is listed in Table 7. The time on the waiting list has steadily increased for patients undergoing either liver or pancreas transplantation in Ohio, whereas the waiting time for heart patients has remained relatively stable. Although an explanation for the stability in waiting time for heart patients is not dear, in fiver transplantation, there was a clear shift toward earlier listing and later transplantation of more urgent patients. For pancreas transplantation, however, the trend toward longer waits simply may have been caused by the growing size of the list in the context of static donor availability. During the time of this analysis, the total number of lung transplantations performed in Ohio was too small to permit valid comparisons with the other organs. Somewhat surprisingly, these trends toward longer waits for transplantation did not translate into greater waiting list mortality. Before 1991, the mortality rate while waiting for heart and fiver transplant candidate was 24% and 17%, respectively, whereas since 1991, these death rates were 16% and 13% for these two groups, respectively. Length of stay and readraissions. The median length of stay (LOS) data, calculated from day of transplantation to day of discharge, are shown in Figure 3. Early in the OSOTC experience, most patients undergoing extrarenal transplantation were in the hospital for 3 to 6 weeks, with considerable variability in LOS between the types of transplants. More recently, however, most patients, regardless of the type of transplant they received, are in the hospital for approximately 2 weeks after transplantation. Interestingly, there was little variability in heart patients according to their UNOS status, with a median LOS for both status 1 and status 2 patients of approximately 15 days (P = .56). For liver patients, however, the LOS clearly was dependent on the severity of liver failure at the time of transplantation, with median LOS values of 18, 22, 28, and 31 days for UNOS status 3, 2B, 2A, and 1 patients, respectively (P = .0001). The rate of readmission to the hospital in the first 2 years after transplantation also was Table 7. Median Waiting Times in Days for OSOTC Transplant Recipients Year
Liver
Hea~
Pancreas
Lung
1985-1986 1992-1993 1997-1998
28 72 207
17 55 83
102 125 327
NA 66 219
Abbre~ation:NA,notappfica~e.
tracked for heart, liver, and pancreas transplant recipients. These data are listed in Table 8. Pancreas recipients were most likely to require a return to the hospital after transplantation, and the heart recipients were least likely to do so. In all cases, the average number of admissions to hospital in the second posttransplant year was less than those observed compared with the first year. Pat/ent and graft surv/va/. Patient and graft survival data for liver, heart, kidney-pancreas, and pancreas-only transplants, performed throughout the life of the OSOTC, are shown in Figure 4. Survival data for lung transplantation are not presented because they were derived from a single-center experience, and the OSOTC confidentiality policy prohibits publication of single-center data. As might be expected, because pancreas graft failure usually is not lethal, the patient survival for both kidney-pancreas and pancreas-only transplants exceeds that of graft survival, whereas patient and graft survival for both heart and liver transplantation were approximately equivalent. A more accurate picture of OSOTC patient survival for both heart and liver transplantation can be obtained by looking at the data between 1990 and 1998, because this allows for all centers to have experienced their learning curves. For heart transplantation, the 1- and 5-year patient survival rates were 87% and 75%, respectively, and those for liver transplant recipients were 82% and 7 I% for the same time periods, respectively. Moreover, during this same period, the l-year patient survival rates for each year have steadily improved. In 1990, the 1-year patient survival rates for heart and liver transplant recipients were 81% and 79%, respectively, whereas the corresponding survival rates in 1998 were 90% and 86%. A comparison of patient survival rates between both sexes for all organ transplant groups did not show an advantage for either sex because the survival curves were essentially identical (data not shown). A similar comparison of patient survival rates between white and black patients showed a small but statistically significant survival advantage for white heart and liver recipients, but not pancreas recipients (data not shown). The most common cause of death for heart transplant recipients was rejection (33%), whereas for fiver recipients, it was infection (30%). Finally, the retransplantation rate for fiver patients was approximately 11%,whereas for heart patients, it was only 1%. Rehab//atat/on. An important measure of organ transplantation success is whether patients are able to return to a normal lifestyle after their operation.
145
Ohio Solid Organ Transplantation Consortium
Median Lengthof Slay Numberof Days 70 60 ............................................................................
50 ~ . . . . . . . . . . . . . .
30 F
~x_
~ . _
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Figure 3. Median length of stay in days for patients in Ohio undergoing heart, liver, and pancreas transplantation between 1984and 1998.
100 .....
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.............
I .... 95-96
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Years Head
The OSOTC has collected this type of outcome information for most Ohio heart and liver transplant recipients since its inception, and these data are listed in Table 9. There were no appreciable differences between heart and liver patients regarding their posttransplantation rehabilitation outcomes. However, because a greater number of adult heart patients (81%) were either medically disabled or unemployed before transplantation compared with adult liver patients (51%), their rehabilitation potential could be construed as better than that of the liver patients. This difference, however, may be caused somewhat by an averaging effect of clumping all OSOTC data together for analysis. For example, before 1996, the majority of liver transplantations performed in Ohio were in UNOS status 3 patients, whereas the majority of heart patients were UNOS status 1 at the time of their transplantation. More recently, however, the number of Ohio liver transplantations performed in sicker individuals (UNOS status 2B or greater) has exceeded 60%. Consequently, it is not clear whether the difference in rehabilitation trends between heart and fiver transplant patients as described will prevail in the future.
Discussion It is the currently held opinion by all member institutions and their transplant personnel that participation in the OSOTC has been and continues to Table 8. Average Number of Readmissions to the Hospital After Transplantation for OSOTC Patients Organ Transplanted
Year I
Year 2
Liver Heart Pancreas
2.1 1.4 2.9
0.8 0.8 1.0
~ -
Liver
---
Pancm8
be a very positive and rewarding experience. Early on, however, there was skepticism by most members regarding the value of membership in the OSOTC. Many individuals believed the requirement by the Ohio Department of Health for all transplant centers to belong to the OSOTC, as a requirement for approval to perform extrarenal transplantation, was another example of undesired governmental intrusion into the practice of medicine. That attitude has clearly waned over the years, primarily because of the many benefits to both the transplant centers and their patients that have been realized as a consequence of membership in the Consortium. Consequently, with the enthusiastic participation of all Ohio extrarenal transplant centers, the OSOTC has become, perhaps, one of the most influential nongovernmental agencies in the health care arena in this state. For example, the OSOTC opinion has been solicited by the ODH on many issues, such as insurance coverage for transplantation, development of appropriate quality indicators of transplant outcomes, and the center and professional criteria for performing transplantation in general now that Ohio no longer has a certificate of need law. Without question, in Ohio, the OSOTC is considered the authority on most issues pertaining to extrarenal transplantation. In addition to facilitating the interactions between transplant centers and the state government, participation in the OSOTC has greatly improved communication and cooperation between the transplant centers in this state. Important issues are discussed in a collegial atmosphere that benefits each participant by exposing them to sometimes divergent but constructive points of view, whereas affording the opportunity to develop consensus solutions to problems before adversarial attitudes emerge. For ex-
146
Schulak et al
Pa~ent Survival
A 100 -~F:."- . . . . .
~__~
:
......
2 P
.............................
50
"I U)
3O ~
2oi 10 0 ' ' ' ' ' I ' ' ' ' ' I ' ' ; ' ' I ' ' ' ' ' I ' ' ' ' ' I ' ' ' ' ' I ' ' ' ' ' I ' ' ' ' ' I
12
24
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48
60
72
84
96
Months HT
..........
KP
.......
W
Graft Survival
B 100~
9o! eoi 7oi 6oi > P
50 40 30~
1 LI - - - - 1 1 L. . . . . t----L__ - "i
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12
24
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Months HT
.......... KP
.......
L¥
ample, the O S O T C policy requiring prospective patient review before listing for transplantation has leveled the playing field with regard to patient selection for all centers. Although it may appear that the O S O T C patient selection process has been perfunctory with the high initial approval rates, it is our impression that this actually reflects a strict adherence to the consortium listing criteria for each type of transplant. Member centers know what type of patient is likely to obtain a favorable review and are not inclined to test the system. Prospective patient review not only has ensured equal access to extrarenal
72
84
96
Figure 4. (A) Patient and (B) graft survival curves for patients undergoing heart (HT), liver (LV), and pancreas transplantation in Ohio between 1984 and 1998. The pancreas data are presented for both patients receiving an isolated pancreas graft (P) or a pancreas as part of a combined pancreas-kidney transplant
(KP).
transplantation in Ohio, but also has fostered a sense of trust between the transplant centers. It is this trust that permitted the development of the somewhat unique and very successful zig-zag statewide sharing agreement for liver allocation between the four organ procurement organizations in the state and the O S O T C transplant centers. It is our belief that some variant of this zig-zag sharing protocol should be considered by UNOS in its quest to develop larger organ sharing regions on a national level. Participation in the O S O T C also furthers the tradition of medical excellence in each of the m e m -
Ohio Solid Organ Transplantation Consortium
147
Table 9. Rehabilitation Outcomes for OSOTC Liver and Heart Transplant Recipients
Heart
Medically disabled (%) Employed* (%) Unemployedt (%)
Liver
6 Months Before Transplant
1 YearAfter Transplant
6 Months Before Transplant
1 YearAfter Transplant
72 17 11
30 44 26
42 37 2l
30 42 28
*Includesthosewithjobs outsidethe home,homemakers,and students. "Hndudesthosenot disabledand not working,retired individuals,andjuveniles. ber hospitals by affording them the opportunity to meet with experts from across the state to discuss various issues of relevance to transplantation. This is achieved both on an as needed ad hoc basis and at the biennial OSOTC professional meeting. At the latter, which is a day-long symposium, issues pertaining to transplantation in general are presented and discussed in the morning session and sessions specific to either thoracic organ or abdominal organ transplantation are available to the participants in the afternoon. Through these various activities, state-of-theart surgical techniques and protocols for patient management have been shared with all OSOTC members. As transplantation embarks on the next millennium, there will continue to be many important issues facing our discipline. Some of these include the disparity between the growing number of people who could benefit from transplantation and the inad-
equate number of organs available, the consequent problems of appropriate patient selection and fair organ allocation, the increasing need for meaningful transplant outcomes analysis, the increasing cost of providing transplantation care, and xenotransplantation. Whereas the elimination of small- and mediumsized transplant programs and the subsequent development of large regional centers may facilitate the management of some of these issues by eliminating competition and achieving the economy of scale both in efficacy and cost, this potential solution remains very controversial for many reasons.~ Alternatively, the establishment of regional transplant consortia, like the OSOTC, also may achieve many of the same end points. In conclusion, we believe that the OSOTC has provided both the transplant professionals and patients in Ohio with an effective mechanism for addressing the important issues facing transplantation.