Faculty Bibliography

The impact of interferon (IFN)-free direct-acting antiviral (DAA) hepatitis C virus (HCV) treatments on utilization and outcomes associated with HCV-positive deceased donor liver transplantation (DDLT) is largely unknown. Using the Scientific Registry of Transplant Recipients, we identified 25 566 HCV-positive DDLT recipients from 2005 to 2015 and compared practices according to the introduction of DAA therapies using modified Poisson regression. The proportion of HCV-positive recipients who received HCV-positive livers increased from 6.9% in 2010 to 16.9% in 2015. HCV-positive recipients were 61% more likely to receive an HCV-positive liver after 2010 (early DAA/IFN era) (aRR:_1.45 1.61_1.79 , p < 0.001) and almost three times more likely to receive one after 2013 (IFN-free DAA era) (aRR:_2.58 2.85_3.16 , p < 0.001). Compared to HCV-negative livers, HCV-positive livers were 3 times more likely to be discarded from 2005 to 2010 (aRR:_2.69 2.99_3.34 , p < 0.001), 2.2 times more likely after 2010 (aRR:_1.80 2.16_2.58 , p < 0.001) and 1.7 times more likely after 2013 (aRR:_1.37 1.68_2.04 , p < 0.001). Donor HCV status was not associated with increased risk of all-cause graft loss (p = 0.1), and this did not change over time (p = 0.8). Use of HCV-positive livers has increased dramatically, coinciding with the advent of DAAs. However, the discard rate remains nearly double that of HCV-negative livers. Further optimization of HCV-positive liver utilization is necessary to improve access for all candidates.

In the setting of an overall decline in living organ donation and new questions about long-term safety, a better understanding of outcomes after living donation has become imperative. Adequate information on outcomes important to donors may take many years to ascertain and may be evident only by comparing large numbers of donors with suitable controls. Previous studies have been unable to fully answer critical questions, primarily due to lack of appropriate controls, inadequate sample size, and/or follow-up duration that is too short to allow detection of important risks attributable to donation. The Organ Procurement and Transplantation Network does not follow donors long term and has no prospective control group with which to compare postdonation outcomes. There is a need to establish a national living donor registry and to prospectively follow donors over their lifetimes. In addition, there is a need to better understand the reasons many potential donors who volunteer to donate do not donate and whether the reasons are justified. Therefore, the US Health Resources and Services Administration asked the Scientific Registry of Transplant Recipients to establish a national registry to address these important questions. Here, we discuss the efforts, challenges, and opportunities inherent in establishing the Living Donor Collective.

Under Share 35, deceased donor (DD) livers are offered regionally to candidates with Model for End-Stage Liver Disease (MELD) scores ≥35 before being offered locally to candidates with MELD scores <35. Using Scientific Registry of Transplant Recipients data from June 2013 to June 2015, we identified 1768 DD livers exported to regional candidates with MELD scores ≥35 who were transplanted at a median MELD score of 39 (interquartile range [IQR] 37-40) with 30-day posttransplant survival of 96%. In total, 1764 (99.8%) exports had an ABO-compatible candidate in the recovering organ procurement organization (OPO), representing 1219 unique reprioritized candidates who would have had priority over the regional candidate under pre-Share 35 allocation. Reprioritized candidates had a median waitlist MELD score of 31 (IQR 27-34) when the liver was exported. Overall, 291 (24%) reprioritized candidates had a comparable MELD score (within 3 points of the regional recipient), and 209 (72%) were eventually transplanted in 11 days (IQR 3-38 days) using a local (50%), regional (50%) or national (<1%) liver; 60 (21%) died, 13 (4.5%) remained on the waitlist and nine (3.1%) were removed for other reasons. Of those eventually transplanted, MELD score did not increase in 57%; it increased by 1-3 points in 37% and by ≥4 points in 5.7% after the export. In three cases, OPOs exchanged regional exports within a 24-h window. The majority of comparable reprioritized candidates were not disadvantaged; however, 21% died after an export.

BACKGROUND:The Physician Payment Sunshine Act was implemented to provide transparency to financial transactions between industry and physicians. Under this law, the Open Payments Program (OPP) was created to publicly disclose all transactions and inform patients of potential conflicts of interest. Collaboration between industry and cardiothoracic surgeon-scientists is essential in developing new approaches to treating patients with cardiac disease. The objective of this study is to characterize industry payments to cardiothoracic surgeons as reported by the OPP. METHODS:We used the first wave of Physician Payment Sunshine Act data (August 2013 to December 2013) to assess industry payments made to cardiothoracic surgeons. RESULTS:Cardiothoracic surgeons (n = 2,495) received a total of $4,417,545 during a 5-month period. Cardiothoracic surgeons comprised 0.5% of all persons in the OPP and received 0.9% of total disclosed industry funding. Among cardiothoracic surgeons receiving funding, 34% received payments less than $100, 43% received payments of $100 to $999, 19% received payments of $1,000 to $9,999, 4% received payments of $10,000 to $99,999, and 0.2% received payments of more than $100,000. The median was $181 (interquartile range [IQR]: $60 to $843) and the mean ± SD was $1,771 ± $7,664. The largest payment to an individual surgeon was $159,444. The three largest median payments made to cardiothoracic surgeons by expense category were royalty fees $8,398 (IQR: $536 to $12,316), speaker fees $3,600 (IQR: $1,500 to $8,000), and honoraria $3,344 (IQR: $1,563 to $7,350). CONCLUSIONS:Among cardiothoracic surgeons who are listed as recipients of nonresearch industry payments, 50% of cardiothoracic surgeons received less than $181. Awareness of the OPP data is critical for cardiothoracic surgeons, as it provides a means to prevent potential public misconceptions about industry payments within the specialty that may affect patient trust.

OBJECTIVE:To determine the survival benefit of kidney transplantation in human immunodeficiency virus (HIV)-infected patients with end-stage renal disease (ESRD). SUMMARY BACKGROUND DATA:Although kidney transplantation (KT) has emerged as a viable option for select HIV-infected patients, concerns have been raised that risks of KT in HIV-infected patients are higher than those in their HIV-negative counterparts. Despite these increased risks, KT may provide survival benefit for the HIV-infected patient with ESRD, yet this important clinical question remains unanswered. METHODS:Data from the Scientific Registry of Transplant Recipients were linked to IMS pharmacy fills (January 1, 2001 to October 1, 2012) to identify and study 1431 HIV-infected KT candidates from the first point of active status on the waiting list. Time-dependent Cox regression was used to establish a counterfactual framework for estimating survival benefit of KT. RESULTS:Adjusted relative risk (aRR) of mortality at 5 years was 79% lower after KT compared with dialysis (aRR 0.21; 95% CI 0.10-0.42; P <0.001), and statistically significant survival benefit was achieved by 194 days of KT. Among patients coinfected with hepatitis C, aRR of mortality at 5 years was 91% lower after KT compared with dialysis (aRR 0.09; 95% CI 0.02-0.46; P < 0.004); however, statistically significant survival benefit was not achieved until 392 days after KT. CONCLUSIONS:Evidence suggests that for HIV-infected ESRD patients, KT is associated with a significant survival benefit compared with remaining on dialysis.

BACKGROUND:After kidney transplantation, early readmission is independently associated with graft loss and mortality. The mechanism of this association is poorly understood. Understanding the timeline of risk, that is, during the readmission hospitalization versus periods postreadmission, will provide additional insights. METHODS:We used national registry data to study 56 076 adult Medicare-primary first-time kidney transplant recipients from December 1999 to October 2011. Piecewise Cox proportional hazard models were used to estimate the association between graft loss, mortality, and readmission for 2 periods: readmission hospitalization and postreadmission. RESULTS:During the readmission hospitalization, graft loss was substantially higher (deceased donor kidney transplant [DDKT] without delayed graft function [DGF] hazard ratio: 24.634.447.9, P < 0.001; with DGF: 10.815.221.4, P < 0.001; live donor kidney transplant [LDKT]: 18.136.774.2, P < 0.001) and mortality was substantially higher (DDKT without DGF: 14.120.830.7, P < 0.001; with DGF: 9.0312.818.0, P < 0.001; LDKT: 9.0018.241.3, P < 0.001). Immediately after readmission discharge, graft loss (DDKT without DGF: 2.082.402.77, P < 0.001; with DGF: 1.832.142.51, P < 0.001; LDKT: 2.002.503.13, P < 0.001), and mortality (DDKT without DGF: 2.162.432.73, P < 0.001; with DGF: 1.832.162.88, P < 0.001; LDKT: 1.902.342.88, P < 0.001) remained elevated, but much less so. After readmission, the hazard of graft loss remained, but decreased 19% per year for DDKT recipients (time varying coefficient 0.780.810.85, P < 0.001) and 14% per year for LDKT recipients (0.790.860.93, P < 0.001). The hazard of mortality remained, but decreased 14% per year for DDKT recipients (0.830.860.89, P < 0.001) and 9% per year for LDKT recipients (0.850.910.98, P < 0.001). CONCLUSIONS:In conclusion, readmission is most strongly associated with graft loss and mortality during the readmission hospitalization, but also portends a lasting, albeit attenuated, risk postreadmission.

Determining candidacy for live kidney donation among obese individuals remains challenging. Among healthy non-donors, body mass index (BMI) above 30 is associated with a 16% increase in risk of end-stage renal disease (ESRD). However, the impact on the ESRD risk attributable to donation and living with only one kidney remains unknown. Here we studied the risk of ESRD associated with obesity at the time of donation among 119 769 live kidney donors in the United States. Maximum follow-up was 20 years. Obese (BMI above 30) live kidney donors were more likely male, African American, and had higher blood pressure. Estimated risk of ESRD 20 years after donation was 93.9 per 10 000 for obese; significantly greater than the 39.7 per 10 000 for non-obese live kidney donors. Adjusted for age, sex, ethnicity, blood pressure, baseline estimated glomerular filtration rate, and relationship to recipient, obese live kidney donors had a significant 86% increased risk of ESRD compared to their non-obese counterparts (adjusted hazard ratio 1.86; 95% confidence interval 1.05-3.30). For each unit increase in BMI above 27 kg/m² there was an associated significant 7% increase in ESRD risk (1.07, 1.02-1.12). The impact of obesity on ESRD risk was similar for male and female donors, African American and Caucasian donors, and across the baseline estimated glomerular filtration rate spectrum. These findings may help to inform selection criteria and discussions with persons considering living kidney donation.

BACKGROUND:The Physician Payments Sunshine Act (PSSA) is a government initiative that requires all biomedical companies to publicly disclose payments to physicians through the Open Payments Program (OPP). The goal of this study was to use the OPP database and evaluate all nonresearch-related financial transactions between plastic surgeons and biomedical companies. METHODS:Using the first wave of OPP data published on September 30, 2014, we studied the national distribution of industry payments made to plastic surgeons during a 5-month period. We explored whether a plastic surgeon's scientific productivity (as determined by their h-index), practice setting (private versus academic), geographic location, and subspecialty were associated with payment amount. RESULTS:Plastic surgeons (N = 4195) received a total of US $5,278,613. The median (IQR) payment to a plastic surgeon was US $115 (US $35-298); mean, US $158. The largest payment to an individual was US $341,384. The largest payment category was non-CEP speaker fees (US $1,709,930) followed by consulting fees (US $1,403,770). Plastic surgeons in private practice received higher payments per surgeon compared with surgeons in academic practice (median [IQR], US $165 [US $81-$441] vs median [IQR], US $112 [US $33-$291], rank-sum P < 0.001). Among academic plastic surgeons, a higher h-index was associated with 77% greater chance of receiving at least US $1000 in total payments (RR/10 unit h-index increase = 1.47 1.772.11, P < 0.001). This association was not seen among plastic surgeons in private practice (RR = 0.89 1.091.32, P < 0.4). CONCLUSIONS:Plastic surgeons in private practice receive higher payments from industry. Among academic plastic surgeons, higher payments were associated with higher h-indices.