Life and expectations post-kidney transplant: a qualitative analysis of patient responses.

BACKGROUND: The effect of a kidney transplant on a recipient extends beyond the restoration of kidney function. However, there is limited qualitative analysis of recipient perspectives on life following transplantation, particularly in the United States. To understand the full patient experience, it is necessary to understand recipient views on life adjustments after kidney transplantation, medical management, and quality of life. This could lead to improvements in recipient care and sense of well-being. METHODS: We conducted a paper-based survey from March 23 to October 1, 2015 of 476 kidney transplant recipients at the University of Michigan Health System in Ann Arbor, Michigan. We analyzed their open-ended responses using qualitative research methods. This is a companion analysis to a previous quantitative report on the closed-ended responses to that survey. RESULTS: Common themes relating to changes following transplantation included: improvements in quality of life, a return to normalcy, better health and more energy. Concerns included: duration of graft survival, fears about one day returning to dialysis or needing to undergo another kidney transplant, comorbidities, future quality of life, and the cost and quality of their healthcare. Many recipients were grateful for their transplant, but some were anxious about the burdens transplantation placed on their loved ones. CONCLUSIONS: While most recipients reported meaningful improvements in health and lifestyle after kidney transplantation, a minority of participants experienced declines in energy or health status. Worries about how long the transplant will function, future health, and cost and quality of healthcare are prevalent. Future research could study the effects of providing additional information, programs, and interventions following transplantation that target these concerns. This may better prepare and support kidney recipients and lead to improvements in the patient experience.

Secular Trends in the Cost of Immunosuppressants after Solid Organ Transplantation in the United States.

BACKGROUND AND OBJECTIVES: Immunosuppressive medications are critical for maintenance of graft function in transplant recipients but can represent a substantial financial burden to patients and their insurance carriers. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: To determine whether availability of generic immunosuppressive medications starting in 2009 may have alleviated some of that burden, we used Medicare Part D prescription drug events between 2008 and 2013 to estimate the average annualized per-patient payments made by patients and Medicare in a large national sample of kidney, liver, and heart transplant recipients. Repeated measures linear regression was used to determine changes in payments over the study period. RESULTS: Medicare Part D payments for two commonly used immunosuppressive medications, tacrolimus and mycophenolic acid (including mycophenolate mofetil and mycophenolate sodium), decreased overall by 48%-67% across organs and drugs from 2008 to 2013, reflecting decreasing payments for brand and generic tacrolimus (21%-54%), and generic mycophenolate (72%-74%). Low-income subsidy payments, which are additional payments made under Medicare Part D, also decreased during the study period. Out-of-pocket payments by patients who did not receive the low-income subsidy decreased by more than those who did receive the low-income subsidy (63%-79% versus 24%-44%). CONCLUSIONS: The decline in payments by Medicare Part D and by transplant recipients for tacrolimus and mycophenolate between 2008 and 2013 suggests that the introduction of generic immunosuppressants during this period has resulted in substantial cost savings to Medicare and to patients, largely reflecting the transition from brand to generic products.

Patient selection and volume in the era surrounding implementation of Medicare conditions of participation for transplant programs.

OBJECTIVE: To evaluate evidence of practice changes affecting kidney transplant program volumes, and donor, recipient and candidate selection in the era surrounding the introduction of Centers for Medicare and Medicaid Services (CMS) conditions of participation (CoPs) for organ transplant programs. DATA: Scientific Registry of Transplant Recipients; CMS ESRD and Medicare claims databases. DESIGN: Retrospective analysis of national registry data. METHODS: A Cox proportional hazards model of 1-year graft survival was used to derive risks associated with deceased-donor kidney transplants performed from 2001 to 2010. FINDINGS: Among programs with ongoing noncompliance with the CoPs, kidney transplant volumes declined by 38 percent (n = 766) from 2006 to 2011, including a 55 percent drop in expanded criteria donor transplants. Volume increased by 6 percent (n = 638) among programs remaining in compliance. Aggregate risk of 1-year graft failure increased over time due to increasing recipient age and obesity, and longer ESRD duration. CONCLUSIONS: Although trends in aggregate risk of 1-year kidney graft loss do not indicate that the introduction of the CoPs has systematically reduced opportunities for marginal candidates or that there has been a systematic shift away from utilization of higher risk deceased donor kidneys, total volume and expanded criteria donor utilization decreased overall among programs with ongoing noncompliance.

Insurance type and minority status associated with large disparities in prelisting dialysis among candidates for kidney transplantation.

BACKGROUND AND OBJECTIVES: Disparities in time to placement on the waiting list on the basis of socioeconomic factors decrease access to deceased-donor renal transplantation for some groups of patients with end-stage renal disease. This study was undertaken to determine candidate factors that influence duration of dialysis before placement on the waiting list among candidates for deceased-donor renal transplantation in the United States from January 2001 to December 2004 and the impact of Medicare eligibility rules on access. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Access to the waiting list was measured as the percentage of all wait-listed candidates in the Scientific Registry of Transplant Recipients database who were listed before dialysis and by the duration of dialysis before placement on the waiting list. Multivariate logistic and linear regressions were used to determine variables that were predictive of preemptive listing and the duration of dialysis before listing. RESULTS: The odds for preemptive placement on the waiting list improved during the course of the study period, whereas the median duration of prelisting dialysis did not. The candidate factors that were associated with low rates of preemptive listing and prolonged exposure to prelisting dialysis included Medicare insurance, minority race/ethnicity, and low educational attainment. In patients who were listed after the age of 64 yr, the adverse effect of Medicare insurance on access largely disappeared. CONCLUSIONS: The disparity in dialysis exposure could potentially be diminished by concerted efforts on the part of the nephrology and transplant communities to promote early referral and preemptive placement on the waiting list, by calculating waiting time from the date of initiation of dialysis for patients who are on dialysis at the time of referral, and by relaxing Medicare eligibility requirements.

Impact of the expanded criteria donor allocation system on candidates for and recipients of expanded criteria donor kidneys.

BACKGROUND: A national policy to allocate kidneys from expanded criteria donors (ECD) took effect October 31, 2002. METHODS: To assess its impact, we analyzed data from the Scientific Registry of Transplant Recipients for ECD kidney candidates and recipients between November 1999 and October 2005. RESULTS: The likelihood of being listed for ECD transplant, of receiving any transplant, and of receiving an ECD transplant were assessed using logistic regression models. As of October 31, 2005, 42.6% of candidates were listed with an ECD designation (range by donation service area [DSA], 1.9% to 94.9%). ECD-listed candidates were likely to be older, diabetic, and sensitized. By October 31, 2005, candidates listed for ECD as of November 1, 2002 were 41% more likely to receive any kidney transplant than those not ECD-listed. Among ECD-listed recipients, 30.1% received an ECD transplant and 69.9% a non-ECD transplant. Recipients more likely to receive an ECD transplant were significantly older and in DSAs where a high percentage of ECD transplants were performed and/or a low percentage of candidates were ECD-listed. CONCLUSIONS: A large, regionally variable fraction of candidates are opting to receive ECD offers. Listing with an ECD designation increases the likelihood of transplantation in selected populations. Selective listing of ECD candidates is associated with a higher likelihood of receiving an ECD transplant.

The rationale for the new deceased donor pancreas allocation schema.

BACKGROUND: To ensure the continued success of whole organ pancreas and islet transplantation, deceased donor pancreas allocation policy must continue to evolve. METHODS: To assess the existing system, the Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing Kidney and Pancreas Transplant Committee retrospectively analyzed the disposition and outcomes of deceased donor pancreata in the United States between January 1, 2000 and December 31, 2003. RESULTS: During the time period studied, consent was obtained but the pancreas was not recovered in 48% (11,820) of organ donors. The most common reasons given for nonrecovery were poor quality of the pancreas and difficulty in placement. Of whole organ pancreata that were transplanted, 90% were from donors with a body mass index (BMI) 50 years (P=0.04), and there were trends toward lower graft survival with donor BMI >30 (P=0.06) and increasing cold-ischemia time. CONCLUSIONS: Based on these data, the OPTN adopted a new allocation algorithm in which pancreata from donors >30 kg/m or >50 years of age are, unless accepted for a local whole organ pancreas transplant candidate, preferentially allocated for islet transplantation. These data also suggest that many good quality pancreata are not procured, emphasizing the need for improved communication and cooperation between organ procurement organizations and pancreas and islet transplant programs.

Impact of the expanded criteria donor allocation system on the use of expanded criteria donor kidneys.

BACKGROUND: The U.S. Organ Procurement and Transplantation Network recently implemented a policy allocating expanded criteria donor (ECD) kidneys by waiting time alone. ECD kidneys were defined as having a risk of graft failure > or = 1.7 times that of ideal donors. ECDs include any donor > or = 60 years old and donors 50 to 59 years old with at least two of the following: terminal creatinine >1.5 mg/dL, history of hypertension, or death by cerebrovascular accident. The impact of this policy on use of ECD kidneys is assessed. METHODS: The authors compared use of ECD kidneys recovered in the 18 months immediately before and after policy implementation. Differences were tested using t test and chi2 analyses. RESULTS: There was an 18.3% increase in ECD kidney recoveries and a 15.0% increase in ECD kidney transplants in the first 18 months after policy implementation. ECD kidneys made up 22.1% of all recovered kidneys and 16.8% of all transplants, compared with 18.8% (P<0.001) and 14.5% (P<0.001), respectively, in the prior period. The discard rate was unchanged. The median relative risk (RR) for graft failure for transplanted ECD kidneys was 2.07 versus 1.99 in the prepolicy period (P=not significant); the median RR for procured ECD kidneys was unchanged at 2.16. The percentage of transplanted ECD kidneys with cold ischemia times (CIT) <12 hr increased significantly; the corresponding percentage for CIT > or = 24 hr decreased significantly. CONCLUSIONS: The recent increase in ECD kidney recoveries and transplants appears to be related to implementation of the ECD allocation system.

Development and current status of ECD kidney transplantation.

The worsening shortage of donor kidneys for transplant and the aging of both the donor and candidate populations have contributed to the increasing importance of ECD kidney transplantation. While ECD transplants have an increased risk of graft failure, for most candidates patient survival is still improved over remaining on dialysis. Because of this risk, however, ECD kidneys have a high likelihood of discard; significant geographic variation in discard and transplant rates impedes maximum utilization of these kidneys. The ECD allocation system was implemented to help facilitate expeditious placement of ECD kidneys to pre-consented candidates by a simplified allocation algorithm. Under this system, recovery and transplantation of ECD kidneys have increased at rates not seen with non-ECD kidneys and not predicted by preexisting trends. More disappointing has been the lack of effect on the percentage of discards and DGF, despite significant reductions in CIT. The disadvantage in graft survival for ECD kidneys extends equally across the spectrum of recipient characteristics, such that no one group of candidates has a proportionately smaller increase in risk. However, benefit analyses comparing the risk of accepting an ECD kidney versus waiting for a non-ECD kidney demonstrate a significant ECD benefit for older and diabetic candidates in regions with prolonged waiting times. The potential value of an ECD kidney to an individual candidate hinges upon the ability to receive it substantially earlier than a non-ECD kidney. Thus, future allocation efforts may focus on ensuring that is the case. In allocation driven by net benefit, ECD kidneys may become an alternative for those who might not otherwise receive a kidney transplant.

Longitudinal assessment of mortality risk among candidates for liver transplantation.

Liver allocation policy recently was modified to use the Model for End-Stage Liver Disease (MELD) for patients with chronic liver disease to stratify potential recipients according to risk for waitlist death. In this study, a retrospective cohort of 760 adult patients with chronic liver disease placed on the liver transplant waitlist between January 1995 and March 2001 and followed up for up to 74 months was studied to assess the ability of the MELD to predict mortality among waitlisted candidates and evaluate the prognostic importance of changes in MELD score over time. Serial MELD scores predicted waitlist mortality significantly better than baseline MELD scores or medical urgency status. Each unit of the 40-point MELD score was associated with a 22% increased risk for waitlist death (P <.001), whereas medical urgency status was not a significant independent predictor. For any given MELD score, the magnitude and direction of change in MELD score during the previous 30 days (DeltaMELD) was a significant independent mortality predictor. Patients with MELD score increases greater than 5 points over 30 days had a threefold greater waitlist mortality risk than those for whom MELD scores increased more gradually (P <.0001). We conclude that mortality risk on the liver transplant waitlist is predicted more accurately by serial MELD score determinations than by medical urgency status or single MELD measurements. DeltaMELD score over time reflects progression of liver disease and conveys important additional prognostic information that should be considered in the further evolution of national liver allocation policy.