Faculty Bibliography

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.

The XIII Banff meeting, held in conjunction the Canadian Society of Transplantation in Vancouver, Canada, reviewed the clinical impact of updates of C4d-negative antibody-mediated rejection (ABMR) from the 2013 meeting, reports from active Banff Working Groups, the relationships of donor-specific antibody tests (anti-HLA and non-HLA) with transplant histopathology, and questions of molecular transplant diagnostics. The use of transcriptome gene sets, their resultant diagnostic classifiers, or common key genes to supplement the diagnosis and classification of rejection requires further consensus agreement and validation in biopsies. Newly introduced concepts include the i-IFTA score, comprising inflammation within areas of fibrosis and atrophy and acceptance of transplant arteriolopathy within the descriptions of chronic active T cell-mediated rejection (TCMR) or chronic ABMR. The pattern of mixed TCMR and ABMR was increasingly recognized. This report also includes improved definitions of TCMR and ABMR in pancreas transplants with specification of vascular lesions and prospects for defining a vascularized composite allograft rejection classification. The goal of the Banff process is ongoing integration of advances in histologic, serologic, and molecular diagnostic techniques to produce a consensus-based reporting system that offers precise composite scores, accurate routine diagnostics, and applicability to next-generation clinical trials.

Antibody-mediated rejection (AMR) is typically treated with plasmapheresis (PP) and intravenous immunoglobulin (standard of care; SOC); however, there is an unmet need for more effective therapy. We report a phase 2b, multicenter double-blind randomized placebo-controlled pilot study to evaluate the use of human plasma-derived C1 esterase inhibitor (C1 INH) as add-on therapy to SOC for AMR. Eighteen patients received 20 000 units of C1 INH or placebo (C1 INH n = 9, placebo n = 9) in divided doses every other day for 2 weeks. No discontinuations, graft losses, deaths, or study drug-related serious adverse events occurred. While the study's primary end point, a difference between groups in day 20 pathology or graft survival, was not achieved, the C1 INH group demonstrated a trend toward sustained improvement in renal function. Six-month biopsies performed in 14 subjects (C1 INH = 7, placebo = 7) showed no transplant glomerulopathy (TG) (PTC+cg≥1b) in the C1 INH group, whereas 3 of 7 placebo subjects had TG. Endogenous C1 INH measured before and after PP demonstrated decreased functional C1 INH serum concentration by 43.3% (p < 0.05) for both cohorts (C1 INH and placebo) associated with PP, although exogenous C1 INH-treated patients achieved supraphysiological levels throughout. This new finding suggests that C1 INH replacement may be useful in the treatment of AMR.

BACKGROUND & AIMS:Treatment of Crohn's disease (CD) may require multiple bowel resections that lead to short bowel syndrome. Intestinal transplantation is an effective treatment for short bowel syndrome, but limited data are available on long-term outcomes in CD. We aimed to characterize the long-term risk of rejection, graft failure, and death among patients with CD after intestinal transplantation, and compare their outcomes with those of patients without CD. METHODS:We performed a retrospective study of adults in the Scientific Registry of Transplant Recipients who received intestinal transplants in the United States from May 1990 through June 2014. Outcomes data were collected at 3 months, 6 months, 1 year, and every year after the procedure. We compared risks of rejection at 1 year after transplantation between patients with and without CD using the chi-square test and logistic regression. Longitudinal risks of graft failure and death were compared between patients with and without CD using the Kaplan-Meier method and Cox proportional hazards. Multivariable analyses adjusted for recipient, donor, and institutional characteristics. RESULTS:Of 1115 cases of intestinal transplantation, 142 were performed for CD and 973 for non-CD indications. One year after the procedure, the transplant was rejected in 36.9% of patients with CD and 33.3% of patients without CD (P = .48). For patients with CD, the actuarial risk of graft failure at 1, 5, and 10 years after intestinal transplantation was 18.6%, 38.7%, and 49.2%; the risk of death was 22.5%, 50.3%, and 59.7%, respectively. The risk of graft failure was greater for patients with CD (adjusted hazard ratio [aHR], 1.48; 95% CI, 1.03-2.13; P = .04), but patients with versus without CD had similar risks of death (aHR, 0.88; 95% CI, 0.64-1.20; P = .41). In subgroup analyses, the risk of graft failure was increased among patients with CD undergoing transplantation between 1990 and 2000 (aHR, 3.49; 95% CI, 1.23-9.92; P = .02), but not after 2000 (aHR, 1.37; 95% CI, 0.92-2.04; P = .12). CONCLUSIONS:In an analysis of patients who received intestinal transplants, the risks of graft rejection or death were similar between patients with versus without CD. Before year 2000, patients with CD had an increased risk of graft failure, but not thereafter. Changes in posttransplant immunosuppression around the same time might be analyzed to learn more about the mechanisms and management strategies to reduce graft failure in CD.