Sally Gustafson

OPTN/SRTR 2015 Annual Data Report: Kidney

The first full year of data after implementation of the new kidney allocation system reveals an increase in deceased donor kidney transplants among black candidates and those with calculated panel‐reactive antibodies 98%–100%, but a decrease among candidates aged 65 years or older. Data from 2015 also demonstrate ongoing positive trends in graft and patient survival for both deceased and living donor kidney transplants, but the challenges of a limited supply of kidneys in the setting of increasing demand remain evident. While the total number of patients on the waiting list decreased for the first time in a decade, this was due to a combination of a decrease in the number of candidates added to the list and an increase in the number of candidates removed from the list due to deteriorating medical condition, as well as an increase in total transplants. Deaths on the waiting list remained flat, but this was likely because of an increasing trend toward removing inactive candidates too sick to undergo transplant.

OPTN/SRTR 2013 Annual Data Report: Kidney: OPTN/SRTR 2013 Annual Data Report

A new kidney allocation system, expected to be implemented in late 2014, will characterize donors on a percent scale (0%‐100%) using the kidney donor profile index (KDPI). The 20% of deceased donor kidneys with the greatest expected posttransplant longevity will be allocated first to the 20% of candidates with the best expected posttransplant survival; kidneys that are not accepted will then be offered to remaining 80% of candidates. Waiting time will start at the time of maintenance dialysis initiation (even if before listing) or at the time of listing with an estimated glomerular filtration rate of 20 mL/min/1.73 m2 or less. Under the current system, the number of candidates on the waiting list continues to increase, as each year more candidates are added than are removed. Median waiting times for adults increased from 3 years in 2003 to more than 4.5 years in 2009. Donation rates have not increased. Short‐term outcomes continue to improve; death‐censored graft survival at 90 days posttransplant was 97% or higher for deceased donor transplants and over 99% for living donor transplants. In 2013, 883 pediatric candidates were added to the waiting list; 65.8% of pediatric candidates on the list in 2013 underwent deceased donor transplant. Five‐year graft survival was highest for living donor recipients aged younger than 11 years (89%) and lowest for deceased donor recipients aged 11 to 17 years (68%).

OPTN/SRTR 2012 Annual Data Report: Pancreas: OPTN & SRTR Annual Data Report 2012

For most end‐stage renal disease patients, successful kidney transplant provides substantially longer survival and better quality of life than dialysis, and preemptive transplant is associated with better outcomes than transplants occurring after dialysis initiation. However, kidney transplant numbers in the us have not changed for a decade. Since 2004, the total number of candidates on the waiting list has increased annually. Median time to transplant for wait‐listed adult patients increased from 2.7 years in 1998 to 4.2 years in 2008. The discard rate of deceased donor kidneys has also increased, and the annual number of living donor transplants has decreased. The number of pediatric transplants peaked at 899 in 2005, and has remained steady at approximately 750 over the past 3 years; 40.9% of pediatric candidates undergo transplant within 1 year of wait‐listing. Graft survival continues to improve for both adult and pediatric recipients. Kidney transplant is one of the most cost‐effective surgical interventions; however, average reimbursement for recipients with primary Medicare coverage from transplant through 1 year posttransplant was comparable to the 1‐year cost of care for a dialysis patient. Rates of rehospitalization are high in the first year posttransplant; annual costs after the first year are lower.

New National Allocation Policy for Deceased Donor Kidneys in the United States and Possible Effect on Patient Outcomes

In 2013, the Organ Procurement and Transplantation Network in the United States approved a new national deceased donor kidney allocation policy that introduces the kidney donor profile index (KDPI), which gives scores of 0%-100% based on 10 donor factors. Kidneys with lower KDPI scores are associated with better post-transplant survival. Important features of the new policy include first allocating kidneys from donors with a KDPI≤20% to candidates in the top 20th percentile of estimated post-transplant survival, adding waiting time from dialysis initiation, conferring priority points for a calculated panel-reactive antibody (CPRA)>19%, broader sharing of kidneys for candidates with a CPRA≥99%, broader sharing of kidneys from donors with a KDPI>85%, eliminating the payback system, and allocating blood type A2 and A2B kidneys to blood type B candidates. We simulated the distribution of kidneys under the new policy compared with the current allocation policy. The simulation showed increases in projected median allograft years of life with the new policy (9.07 years) compared with the current policy (8.82 years). With the new policy, candidates with a CPRA>20%, with blood type B, and aged 18-49 years were more likely to undergo transplant, but transplants declined in candidates aged 50-64 years (4.1% decline) and ≥65 years (2.7% decline). These simulations demonstrate that the new deceased donor kidney allocation policy may improve overall post-transplant survival and access for highly sensitized candidates, with minimal effects on access to transplant by race/ethnicity and declines in kidney allocation for candidates aged ≥50 years.

OPTN/SRTR 2011 Annual Data Report: pancreas.

ABSTRACT  Numbers of pancreas transplants have been decreasing over the past decade, but outcomes continue to improve for all types: simultaneous pancreas‐kidney transplant, pancreas after kidney transplant (PAK), and pancreas transplant alone (PTA). The most notable decrease occurred for PAK transplants, possibly due in part to decreases in numbers of living donor kidney transplants. The number of new candidates on the pancreas transplant waiting list has decreased steadily since 2000; only 1005 active candidates were added in 2011. Transplant rates for all pancreas transplant types reached a low in 2011 of 34.9 transplants per 100 wait‐list years. Deceased donation rates have also been decreasing since 2005, but use of donation after circulatory death has been gradually increasing. The discard rate in 2011 was 27.7%, and higher for pancreata recovered from older donors. Improved outcomes during the early posttransplant period largely reflect improved donor and recipient selection and improved technical strategies. Inconsistent definitions of graft failure across reporting centers creates an ongoing challenge in the interpretation of outcome data for pancreas transplants. Rates of posttransplant re‐hospitalization are high, most occurring in the first 6 months. Rejection rates are highest for PTA recipients, who also experience higher incidence of posttransplant lymphoproliferative disorder.

OPTN/SRTR 2013 Annual Data Report: Pancreas: OPTN/SRTR 2013 Annual Data Report: Pancreas

Pancreas listings and transplants decreased during the past decade, most notably pancreas after kidney transplants. Center‐reported outcomes of pancreas transplant across all groups, short‐term and long‐term, improved during the same period. Changes to the pancreas allocation system creating an efficient, uniform national system will be implemented in late 2014. Pancreas‐alone and simultaneous pancreas‐kidney (SPK) candidates will form a single match‐run list with priority to most SPK candidates ahead of kidney‐alone candidates to decrease waiting times for SPK candidates, given their higher waitlist mortality compared with nondiabetic kidney transplant candidates. The changes are expected to eliminate local variability, providing more consistent pancreas allocation nationwide. Outcomes after pancreas transplant are challenging to interpret due to lack of a uniform definition of graft failure. Consequently, SRTR has not published data on pancreas graft failure for the past 2 years. The Organ Procurement and Transplantation Network Pancreas Transplantation Committee is working on a definition that could provide greater validity for future outcomes analyses. Challenges in pancreas transplantation include high risk of technical failures, rejection (early and late), and surgical complications. Continued outcome improvement and innovation has never been more critical, as alternatives such as islet transplant and artificial pancreas move closer to clinical application.

Sirolimus use and cancer incidence among US kidney transplant recipients.

Sirolimus has anti‐carcinogenic properties and can be included in maintenance immunosuppressive therapy following kidney transplantation. We investigated sirolimus effects on cancer incidence among kidney recipients. The US transplant registry was linked with 15 population‐based cancer registries and national pharmacy claims. Recipients contributed sirolimus‐exposed time when sirolimus claims were filled, and unexposed time when other immunosuppressant claims were filled without sirolimus. Cox regression was used to estimate associations with overall and specific cancer incidence, excluding nonmelanoma skin cancers (not captured in cancer registries). We included 32 604 kidney transplants (5687 sirolimus‐exposed). Overall, cancer incidence was suggestively lower during sirolimus use (hazard ratio [HR] = 0.88, 95% confidence interval [CI] = 0.70–1.11). Prostate cancer incidence was higher during sirolimus use (HR = 1.86, 95% CI = 1.15–3.02). Incidence of other cancers was similar or lower with sirolimus use, with a 26% decrease overall (HR = 0.74, 95% CI = 0.57–0.96, excluding prostate cancer). Results were similar after adjustment for demographic and clinical characteristics. This modest association does not provide strong evidence that sirolimus prevents posttransplant cancer, but it may be advantageous among kidney recipients with high cancer risk. Increased prostate cancer diagnoses may result from sirolimus effects on screen detection.

Allocating Deceased Donor Kidneys to Candidates with High Panel–Reactive Antibodies

BACKGROUND AND OBJECTIVES In December of 2014, the Organ Procurement and Transplant Network implemented a new Kidney Allocation System (KAS) for deceased donor transplant, with increased priority for highly sensitized candidates (calculated panel-reactive antibody [cPRA] >99%). We used a modified version of the new KAS to address issues of access and equity for these candidates. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS In a simulation, 10,988 deceased donor kidneys transplanted into waitlisted recipients in 2010 were instead allocated to candidates with cPRA≥80% (n=18,004). Each candidates unacceptable donor HLA antigens had been entered into the allocation system by the transplant center. In simulated match runs, kidneys were allocated sequentially to adult ABO identical or permissible candidates with cPRA 100%, 99%, 98%, etc. to 80%. Allocations were restricted to donor/recipient pairs with negative virtual crossmatches. RESULTS The simulation indicated that 2111 of 10,988 kidneys (19.2%) would have been allocated to patients with cPRA 100% versus 74 of 10,988 (0.7%) that were actually transplanted. Of cPRA 100% candidates, 74% were predicted to be compatible with an average of six deceased donors; the remaining 26% seemed to be incompatible with every deceased donor organ that entered the system. Of kidneys actually allocated to cPRA 100% candidates in 2010, 66% (49 of 74) were six-antigen HLA matched/zero-antigen mismatched (HLA-A, -B, and -DR) with their recipients versus only 11% (237 of 2111) in the simulation. The simulation predicted that 10,356 of 14,433 (72%) candidates with cPRA 90%-100% could be allocated an organ compared with 7.3% who actually underwent transplant. CONCLUSIONS Data in this simulation are consistent with early results of the new KAS; specifically, nearly 20% of deceased donor kidneys were (virtually) compatible with cPRA 100% candidates. Although most of these candidates were predicted to be compatible with multiple donors, approximately one-quarter are unlikely to receive a single offer.

Effects of maintenance immunosuppression with sirolimus after liver transplant for hepatocellular carcinoma

For recipients of liver transplantations (LTs) for hepatocellular carcinoma (HCC), HCC recurrence after transplantation remains a major concern. Sirolimus (SRL), an immunosuppressant with anticarcinogenic properties, may reduce HCC recurrence and improve survival. In our study, the US Scientific Registry of Transplant Recipients was linked to pharmacy claims. For liver recipients transplanted for HCC, Cox regression was used to estimate associations of early SRL use with recurrence, cancer‐specific mortality, and all‐cause mortality, adjusting for recipient ethnicity, calendar year of transplant, total tumor volume, alpha‐fetoprotein, transplant center size, use of interleukin 2 induction therapy, and allocated and calculated Model for End‐Stage Liver Disease score. We performed stratified analyses among recipients who met Milan criteria, among those without renal failure, among those with deceased liver donors, by age at transplantation, and by tumor size. Among the 3936 included HCC LTs, 234 (6%) were SRL users. In total, there were 242 recurrences and 879 deaths, including 261 cancer‐related deaths. All‐cause mortality was similar in SRL users and nonusers (adjusted hazard ratio [aHR], 1.01; 95% CI, 0.73‐1.39). HCC recurrence and cancer‐specific mortality rates appeared lower in SRL users, but associations were not statistically significant (recurrence aHR, 0.86; 95% CI, 0.45‐1.65; cancer‐specific mortality aHR, 0.80; 95% CI, 0.43‐1.50). Among recipients >55 years old, associations were suggestive of better outcomes for SRL users (all‐cause mortality aHR, 0.62; 95% CI, 0.38‐1.01; recurrence aHR, 0.52; 95% CI, 0.19‐1.44; cancer‐specific mortality aHR, 0.34; 95% CI, 0.11‐1.09), whereas among recipients ≤55 years old, SRL users had worse outcomes (all‐cause mortality aHR, 1.76; 95% CI, 1.12‐2.75; recurrence aHR, 1.49; 95% CI, 0.62‐3.61; cancer‐specific mortality aHR, 1.54; 95% CI, 0.71‐3.32). In conclusion, among HCC liver recipients overall, SRL did not appear beneficial in reducing all‐cause mortality. However, there were suggestions of reductions in recurrence and cancer‐specific mortality, and effects appeared to be modified by age at transplantation. Liver Transplantation 22 627‐634 2016 AASLD.

Cost implications of new national allocation policy for deceased donor kidneys in the United States

Background In December 2014, a new national deceased donor kidney allocation policy was implemented, which allocates kidneys in the top 20% of the kidney donor profile index to candidates in the top 20% of expected survival. We examined the cost implications of this policy change. Methods A Markov model was applied to estimate differences in total lifetime cost of care and quality-adjusted life years (QALY). Results Under the old allocation policy, average lifetime outcomes per listed patient discounted to 2012 US dollars were US