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In the United States, potential transplant candidates with insulin-dependent diabetes mellitus are inconsistently offered pancreas transplantation (PTx), contributing to a dramatic decline in pancreas allograft utilization over the past 2 decades. The American Society of Transplantation organized a workshop to identify barriers inhibiting PTx and to develop strategies for a national comeback. The 2-day workshop focused on 4 main topics: (1) referral/candidate selection, (2) organ recovery/utilization, (3) program performance/patient outcomes, and (4) enhanced education/research. Topics were explored through expert presentations, patient testimonials, breakout sessions, and strategic planning, including the identification of tasks for immediate focus. Additionally, a modified-Delphi survey was conducted among workshop members to develop and rate the importance of barriers, and the impact and feasibility of workgroup-identified improvement strategies. The panelists identified 16 barriers to progress and 44 strategies for consideration. The steps for a national comeback in PTx involve greater emphasis on efficient referral and candidate selection, better donor pancreas utilization practices, eliminating financial barriers to procurement and transplant, improving collaboration between transplant and diabetes societies and professionals, and increasing focus on PTx training, education, and research. Partnership between national societies, patient advocacy groups, and professionals will be essential to realizing this critical agenda., Competing Interests: Declaration of competing interest The authors of this manuscript have conflicts of interest to disclose as described by the American Journal of Transplantation. Krista L. Lentine is supported by the Mid-America Transplant/Jane A. Beckman Endowed Chair in Transplantation and National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant R01DK120518. Krista L. Lentine and David A. Axelrod are senior staff of the SRTR. Unrelated to this work: Krista L. Lentine receives consulting fees from CareDx and speaker honoraria from Sanofi; David A. Axelrod receives consulting fees from CareDx. Workshop participant Joseph Scalea is co-founder and CMO of MediGO., (Copyright © 2024 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Simultaneous liver-kidney transplant (SLK) allocation policy in the United States was revised in August 2017, reducing access for liver transplant candidates with sustained acute kidney injury (sAKI) and potentially adversely impacting vulnerable populations whose true renal function is overestimated by commonly used estimation equations., Methods: We examined national transplant registry data containing information for all liver transplant recipients from June 2013 to December 2021 to assess the impact of this policy change using instrumental variable estimation based on date of listing., Results: Posttransplant survival was compared for propensity-matched patients with sAKI who were only eligible for liver transplant alone (LTA_post; n = 638) after the policy change but would have been SLK-eligible before August 2017, with similar patients who were previously able to receive an SLK (SLK; n = 319). Overall posttransplant patient survival was similar at 3 y (81% versus 80%; P = 0.9). However, receiving an SLK versus LTA increased survival among African Americans (87% versus 61% at 3 y; P = 0.029). A trend toward survival benefit from SLK versus LTA, especially later in the follow-up period, was observed in recipients ≥ age 60 (3-y survival: 84% versus 76%; P = 0.2) and women (86% versus 80%; P = 0.2)., Conclusions: The 2017 United Network for Organ Sharing SLK Allocation Policy was associated with reduced survival of African Americans with end-stage liver disease and sAKI and, potentially, older patients and women. Our study suggested the use of race-neutral estimation of renal function would ameliorate racial disparities in the SLK arena; however, further studies are needed to reduce disparity in posttransplant outcomes among patients with liver and kidney failure., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Importance: Representative surgical case sampling, rather than universal review, is used by US Department of Veterans Affairs (VA) and private-sector national surgical quality improvement (QI) programs to assess program performance and to inform local QI and performance improvement efforts. However, it is unclear whether case sampling is robust for identifying hospitals with safety or quality concerns., Objective: To evaluate whether the sampling strategy used by several national surgical QI programs provides hospitals with data that are representative of their overall quality and safety, as measured by 30-day mortality., Design, Setting, and Participants: This comparative effectiveness study was a national, hospital-level analysis of data from adult patients (aged ≥18 years) who underwent noncardiac surgery at a VA hospital between January 1, 2016, and September 30, 2020. Data were obtained from the VA Surgical Quality Improvement Program (representative sample) and the VA Corporate Data Warehouse surgical domain (100% of surgical cases). Data analysis was performed from July 1 to December 21, 2022., Main Outcomes and Measures: The primary outcome was postoperative 30-day mortality. Quarterly, risk-adjusted, 30-day mortality observed-to-expected (O-E) ratios were calculated separately for each hospital using the sample and universal review cohorts. Outlier hospitals (ie, those with higher-than-expected mortality) were identified using an O-E ratio significantly greater than 1.0., Results: In this study of data from 113 US Department of Veterans Affairs hospitals, the sample cohort comprised 502 953 surgical cases and the universal review cohort comprised 1 703 140. The majority of patients in both the representative sample and the universal sample were men (90.2% vs 91.1%) and were White (74.7% vs 74.5%). Overall, 30-day mortality was 0.8% and 0.6% for the sample and universal review cohorts, respectively (P < .001). Over 2145 quarters of data, hospitals were identified as an outlier in 11.7% of quarters with sampling and in 13.2% with universal review. Average hospital quarterly 30-day mortality rates were 0.4%, 0.8%, and 0.9% for outlier hospitals identified using the sample only, universal review only, and concurrent identification in both data sources, respectively. For nonsampled cases, average hospital quarterly 30-day mortality rates were 1.0% at outlier hospitals and 0.5% at nonoutliers. Among outlier hospital quarters in the sample, 47.4% were concurrently identified with universal review. For those identified with universal review, 42.1% were concurrently identified using the sample., Conclusions and Relevance: In this national, hospital-level study, sampling strategies employed by national surgical QI programs identified less than half of hospitals with higher-than-expected perioperative mortality. These findings suggest that sampling may not adequately represent overall surgical program performance or provide stakeholders with the data necessary to inform QI efforts.

In the United States, living donor liver transplantation (LDLT) is limited to transplant centers with specific experience. However, the impact of recipient characteristics on procedure selection (LDLT vs. deceased donor liver transplant [DDLT]) within these centers has not been described. Transplant registry data for centers that performed ≥1 LDLT in 2002-2019 were analyzed using hierarchal regression modeling to quantify the impact of patient and center factors on the adjusted odds ratio (aOR) of LDLT (vs DDLT). Among 73,681 adult recipients, only 4% underwent LDLT, varying from <1% to >60% of total liver transplants. After risk adjustment, the likelihood of receiving an LDLT rose by 73% in recent years (aOR 1.73 for 2014-2019 vs. 2002-2007) but remained lower for older adults, men, racial and ethnic minorities, and obese patients. LDLT was less commonly used in patients with hepatocellular carcinoma or alcoholic cirrhosis, and more frequently in those with hepatitis C and with lower severity of illness (Model for End-Stage Liver Disease (MELD) score < 15). Patients with public insurance, lower educational achievement, and residence in the Northwest and Southeast had decreased access. While some differences in access to LDLT reflect clinical factors, further exploration into disparities in LDLT utilization based on center practice and socioeconomic determinants of health is needed., (© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Biliary complications (BCs) continue to impact patient and graft survival after liver transplant (LT), despite improvements in organ preservation, surgical technique, and posttransplant care. Real-world evidence provides a national estimate of the incidence of BC after LT, implications for patient and graft outcomes, and attributable cost not available in transplant registry data., Methods: An administrative health claims-based BC identification algorithm was validated using electronic health records (N = 128) and then applied to nationally linked Medicare and transplant registry claims., Results: The real-world evidence algorithm identified 97% of BCs in the electronic health record review. Nationally, the incidence of BCs within 1 y of LT appears to have improved from 22.2% in 2002 to 20.8% in 2018. Factors associated with BCs include donor type (living versus deceased), recipient age, diagnosis, prior transplant, donor age, and donor cause of death. BCs increased the risk-adjusted hazard ratio (aHR) for posttransplant death (aHR, 1.43; P  < 0.0001) and graft loss (aHR, 1.48; P  < 0.0001). Nationally, BCs requiring intervention increased risk-adjusted first-year Medicare spending by $39 710 ( P  < 0.0001)., Conclusions: BCs remain an important cause of morbidity and expense after LT and would benefit from a systematic quality-improvement program., Competing Interests: The authors declare no funding or conflict of interests., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The Scientific Registry of Transplant Recipients (SRTR) Living Donor Collective (LDC), the first effort to create a lifetime registry for living donor candidates in the United States, requires transplant programs to register donor candidates while the SRTR conducts follow-up., Methods: To better understand facilitators and barriers to program participation, we conducted a brief electronic survey of U.S. transplant program staff from October 26, 2021 to December 17, 2021., Results: We received 132 responses, with at least one response from 87 living donor programs (46 kidney programs, 33 kidney and liver programs, and eight liver programs alone). We found 86% of program representatives strongly agreed or agreed that funding adequate to cover the cost of data collection would facilitate LDC participation, 92% agreed or strongly agreed with importance of electronic data submission options, and 74% reported that elimination of requirements to submit duplicative pre-operative information to the Organ Procurement and Transplantation Network (OPTN) would be helpful. Other potentially enabling factors include reduction in duration of OPTN postdonation follow-up requirements, ease-of-use, protection from data use for regulation, adequate data security, and equity in data access., Conclusion: This survey identifies potential targets to strengthen participation in the effort to create a national living donor registry in the United States. Collaboration and investment to overcome barriers to LDC participation among transplant programs are vital to generate long-term data on living donation for donor candidates, donors, and patients in need of transplant., (© 2023 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Coronary heart disease is an important source of mortality and morbidity among kidney transplantation and liver transplantation candidates and recipients and is driven by traditional and nontraditional risk factors related to end-stage organ disease. In this scientific statement, we review evidence from the past decade related to coronary heart disease screening and management for kidney and liver transplantation candidates. Coronary heart disease screening in asymptomatic kidney and liver transplantation candidates has not been demonstrated to improve outcomes but is common in practice. Risk stratification algorithms based on the presence or absence of clinical risk factors and physical performance have been proposed, but a high proportion of candidates still meet criteria for screening tests. We suggest new approaches to pretransplantation evaluation grounded on the presence or absence of known coronary heart disease and cardiac symptoms and emphasize multidisciplinary engagement, including involvement of a dedicated cardiologist. Noninvasive functional screening methods such as stress echocardiography and myocardial perfusion scintigraphy have limited accuracy, and newer noninvasive modalities, especially cardiac computed tomography-based tests, are promising alternatives. Emerging evidence such as results of the 2020 International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Chronic Kidney Disease trial emphasizes the vital importance of guideline-directed medical therapy in managing diagnosed coronary heart disease and further questions the value of revascularization among asymptomatic kidney transplantation candidates. Optimizing strategies to disseminate and implement best practices for medical management in the broader end-stage organ disease population should be prioritized to improve cardiovascular outcomes in these populations.

An electronic survey canvassing current policies of transplant centers regarding a COVID-19 vaccine mandate for transplant candidates and living donors was distributed to clinicians at US solid organ transplant centers performing transplants from October 14, 2021-November 15, 2021. Responses were received from staff at 141 unique transplant centers. These respondents represented 56.4% of US transplant centers, and responding centers performed 78.5% of kidney transplants and 82.4% of liver transplants in the year prior to survey administration. Only 35.7% of centers reported implementing a vaccine mandate, while 60.7% reported that vaccination was not required. A minority (42%) of responding centers with a vaccine mandate for transplant candidates also mandated vaccination for living organ donors. Centers with a vaccine mandate most frequently cited clinical evidence supporting the efficacy of pre-transplant vaccination (82%) and stewardship obligations to ensure organs were transplanted into the lowest risk patients (64%). Centers without a vaccine mandate cited a variety of reasons including administrative, equity, and legal considerations for their decision. Transplant centers in the United States exhibit significant heterogeneity in COVID-19 vaccination mandate policies for transplant candidates. While all centers encourage vaccination, most centers have not mandated COVID-19 vaccination for candidates and living donors, citing administrative opposition, legal prohibitions, and concern about equity in access to transplants., (© 2022 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: The development of cytomegalovirus (CMV) infection after kidney transplant remains a significant cause of posttransplant morbidity, graft loss, and mortality. Despite appropriate antiviral therapy, recipients without previous CMV exposure can currently be allocated a kidney from a donor with previous CMV infection (D+R-) that carries the greatest risk of posttransplant CMV infection and associated complications. Preferential placement of CMV D- organs in negative recipients (R-) has been shown to reduce the risk of viral infection and associated complications., Methods: To assess the long-term survival and economic benefits of allocation policy reforms, a decision-analytic model was constructed to compare receipt of CMV D- with CMV D+ organ in CMV R- recipients using data from transplant registry, Medicare claims, and pharmaceutical costs., Results: For CMV R- patients, receipt of a CMV D- organ was associated with greater average survival (14.3 versus 12.6 y), superior quality-adjusted life years (12.6 versus 9.8), and lower costs ($529 512 versus $542 963). One-way sensitivity analysis demonstrated a survival advantage for patients waiting as long as 30 mo for a CMV D- kidney., Conclusions: Altering national allocation policy to preferentially offer CMV D- organs to CMV R- recipients could improve survival and lower costs after transplant if appropriately implemented., Competing Interests: The authors declare no funding or conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: The incidence, risks, and outcomes associated with pulmonary hypertension (P-HTN) in the kidney transplant (KTx) population are not well described., Methods: We linked US transplant registry data with Medicare claims (2006-2016) to investigate P-HTN diagnoses among Medicare-insured KTx recipients (N = 35 512) using billing claims. Cox regression was applied to identify independent correlates and outcomes of P-HTN (adjusted hazard ratio [aHR] 95%LCLaHR95%UCL) and to examine P-HTN diagnoses as time-dependent mortality predictors., Results: Overall, 8.2% of recipients had a diagnostic code for P-HTN within 2 y preceding transplant. By 3 y posttransplant, P-HTN was diagnosed in 10.310.6%11.0 of the study cohort. After adjustment, posttransplant P-HTN was more likely in KTx recipients who were older (age ≥60 versus 18-30 y a HR, 1.912.403.01) or female (aHR, 1.151.241.34), who had pretransplant P-HTN (aHR, 4.384.795.24), coronary artery disease (aHR, 1.051.151.27), valvular heart disease (aHR, 1.221.321.43), peripheral vascular disease (aHR, 1.051.181.33), chronic pulmonary disease (aHR, 1.201.311.43), obstructive sleep apnea (aHR, 1.151.281.43), longer dialysis duration, pretransplant hemodialysis (aHR, 1.171.371.59), or who underwent transplant in the more recent era (2012-2016 versus 2006-2011: aHR, 1.291.391.51). Posttransplant P-HTN was associated with >2.5-fold increased risk of mortality (aHR, 2.572.843.14) and all-cause graft failure (aHR, 2.422.642.88) within 3 y posttransplant. Outcome associations of newly diagnosed posttransplant P-HTN were similar., Conclusions: Posttransplant P-HTN is diagnosed in 1 in 10 KTx recipients and is associated with an increased risk of death and graft failure. Future research is needed to refine diagnostic, classification, and management strategies to improve outcomes in KTx recipients who develop P-HTN., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: National surgical quality improvement (QI) programs use periodic, risk-adjusted evaluation to identify hospitals with higher than expected perioperative mortality. Rapid, accurate identification of poorly performing hospitals is critical for avoiding potentially preventable mortality and represents an opportunity to enhance QI efforts., Methods: Hospital-level analysis using Veterans Affairs (VA) Surgical Quality Improvement Program data (2011-2016) to compare identification of hospitals with excess, risk-adjusted 30-day mortality using observed-to-expected (O-E) ratios (ie, current gold standard) and cumulative sum (CUSUM) with V-mask. Various V-mask slopes and radii were evaluated-slope of 2.5 and radius of 1.0 was used as the base case., Results: Hospitals identified by CUSUM and quarterly O-E were identified midway into a quarter [median 47 days; interquartile range (IQR): 24-61 days before quarter end] translating to a median of 129 (IQR: 60-187) surgical cases and 368 (IQR: 145-681) postoperative inpatient days occurring after a CUSUM signal, but before the quarter end. At hospitals identified by CUSUM but not O-E, a median of 2 deaths within a median of 5 days triggered a signal. In some cases, these clusters extended beyond CUSUM identification date with as many as 8 deaths undetected using O-E. Sensitivity and negative predictive values for CUSUM relative to O-E were 71.9% (95% confidence interval: 66.2%-77.1%) and 95.5% (94.4%-96.4%), respectively., Conclusions: CUSUM evaluation identifies hospitals with clusters of mortality in excess of expected more rapidly than periodic analysis. CUSUM represents an analytic tool national QI programs could utilize to provide participating hospitals with data that could facilitate more proactive implementation of local interventions to help reduce potentially avoidable perioperative mortality., Competing Interests: D.A.A serves as a consultant for CareDx and Sanofi. The remaining authors declare no conflict of interest., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Transplant centers were challenged by the Executive Order on Advancing Kidney health to increase access to kidney transplant (KTx) by accepting higher risk patients and organs. However, Medicare reimbursement for KTx does not include adjustment for major complicating comorbidities (MCCs) like other transplants. The prevalence of MCCs was assessed for KTx performed from 10/15 to 10/19 at a single academic center, using Medicare ICD10 MCC criteria exclusive of end-stage kidney disease. KTx hospital resource utilization and estimated margin, assuming Medicare reimbursement, were determined for cases with and without MCC. Among 260 KTx recipients, 49 (19%) had an MCC. Patients with MCCs had longer wait times (1121 days vs 703 days, P < .001); however, there were no differences in age, gender, race, or diagnosis. Donor characteristics associated with an MCC included greater cold ischemic time (1042 vs 670 minutes, P < .001) and fewer living donor KTx (9% vs 32%, P < .001). KTx cost, exclusive of organ acquisition, was 31% higher (MCC: $38 293 vs No MCC: $29 132) and estimated margin was markedly lower (-$7750 vs -$1001, P = .001). In conclusion, KTx with qualifying MCCs resulted in significant financial losses and modification of KTx payment methodology to align with other organ transplants is needed., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Changes to the United States kidney allocation system targeted at reducing organ discard have failed to improve organ utilization. High Kidney Donor Profile Index kidneys continue to be discarded at high rates as a result of the regulatory and financial barriers to widespread utilization of these organs. However, there are potential changes to clinical practice that could improve organ utilization. Expediting the time from initial offer to final organ acceptance would reduce cold ischemic time and should improve utilization. Implementation of procurement biopsy standards to avoid biopsy of low risk organs may prevent organ discards due to inaccurate data or excessive cold ischemia time. Further, standardization of procurement biopsy pathological interpretation coupled with electronic accessibility would enable early acceptance of difficult to transplant organs. These changes to allocation practice patterns are vital given proposals to expand the geographic sharing of deceased donor kidneys. Implementation of new allocation policies must be evaluated to ensure they result in higher transplant rates and acceptable post-transplant outcomes., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Despite the passage of a decade since the tragic loss of an organ recovery team from the University of Michigan, there are currently no national standards governing air and ground transportation of organ recovery personnel. Consequently, the American Society of Transplant Surgeons, the Association of Organ Procurement Organizations, and the United Network for Organ Sharing jointly convened a transportation summit to review and update recommendations for national transportation standards. Expanded air transport quality assurance protocols, including a requirement for two engine turbine-powered aircraft piloted by two qualified pilots certified through onsite inspections was recommended. Ground transportation providers must ensure adequate safety restraints are available, ambulance avoided if possible, and the use of lights and sirens minimized. Finally, adequate insurance coverage for all team members, including trainees should be provided and should not rely on carrier liability insurance policies. The summit participants have committed the support of their organizations to promote and enact these regulations nationally., (© 2020 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Understanding the economic implications of induction and maintenance immunosuppression (ISx) is important in developing personalized kidney transplant (KTx) care. Using data from a novel integrated data set including financial records from the University Health System Consortium, Medicare, and pharmacy claims (2007-2014), we estimated the differences in the impact of induction and maintenance ISx regimens on transplant hospitalization costs and Medicare payments from KTx to 3 years. Use of thymoglobulin (TMG) significantly increased transplant hospitalization costs ($12 006; P = .02), compared with alemtuzumab and basiliximab. TMG resulted in lower Medicare payments in posttransplant years 1 (-$2058; P = .05) and 2 (-$1784; P = .048). Patients on steroid-sparing ISx incurred relatively lower total Medicare spending (-$10 880; P = .01) compared with patients on triple therapy (tacrolimus, antimetabolite, and steroids). MPA/AZA-sparing, mammalian target of rapamycin inhibitors-based, and cyclosporine-based maintenance ISx regimens were associated with significantly higher payments. Alternative ISx regimens were associated with different KTx hospitalization costs and longer-term payments. Future studies of clinical efficacy should also consider cost impacts to define the economic effectiveness of alternative ISx regimens., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Cannabis is categorized as an illicit drug in most US states, but legalization for medical indications is increasing. Policies and guidance on cannabis use in transplant patients remain controversial., Methods: We examined a database linking national kidney transplant records (n = 52 689) with Medicare claims to identify diagnoses of cannabis dependence or abuse (CDOA) and associations [adjusted hazard ratio (aHR) with 95% upper and lower confidence limits (CLs)] with graft, patient, and other clinical outcomes., Results: CDOA was diagnosed in only 0.5% (n = 254) and 0.3% (n = 163) of kidney transplant recipients in the years before and after transplant, respectively. Patients with pretransplant CDOA were more likely to be 19 to 30 years of age and of black race, and less likely to be obese, college-educated, and employed. After multivariate and propensity adjustment, CDOA in the year before transplant was not associated with death or graft failure in the year after transplant, but was associated with posttransplant psychosocial problems such as alcohol abuse, other drug abuse, noncompliance, schizophrenia, and depression. Furthermore, CDOA in the first year posttransplant was associated with an approximately 2-fold increased risk of death-censored graft failure (aHR, 2.29; 95% CL, 1.59-3.32), all-cause graft loss (aHR, 2.09; 95% CL, 1.50-2.91), and death (aHR, 1.79; 95% CL, 1.06-3.04) in the subsequent 2 years. Posttransplant CDOA was also associated with cardiovascular, pulmonary, and psychosocial problems, and with events such as accidents and fractures., Conclusions: Although associations likely, in part, reflect associated conditions or behaviors, clinical diagnosis of CDOA in the year after transplant appears to have prognostic implications for allograft and patient outcomes. Recipients with posttransplant CDOA warrant focused monitoring and support.

Evolving literature suggests that the epidemic of prescription opioid use affects the transplant population. We examined a novel database wherein national U.S. transplant registry records were linked to a large pharmaceutical claims warehouse (2007-2015) to characterize prescription opioid use before and after kidney transplant, and associations (adjusted hazard ratio, 95% LCL aHR 95% UCL ) with death and graft loss. Among 75 430 eligible patients, 43.1% filled opioids in the year before transplant. Use was more common among recipients who were women, white, unemployed, publicly insured, and with longer pretransplant dialysis. Of those with the highest level of pretransplant opioid use, 60% continued high-level use posttransplant. Pretransplant opioid use had graded associations with one-year posttransplant outcomes; the highest-level use predicted 46% increased risk of death (aHR 1.28 1.46 1.66 ) and 28% increased risk of all-cause graft failure (aHR 1.17 1.28 1.41 ). Effects of high-level opioid use in the first year after transplant were stronger, predicting twice the risk of death (aHR 1.93 2.24 2.60 ) and 68% higher all-cause graft failure risk (aHR 1.50 1.68 1.89 ) over the subsequent year; increased risk persisted over five years. While associations may, in part, reflect underlying conditions or behaviors, opioid use history is relevant in assessing and providing care to transplant candidates and recipients., (© 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Multidisciplinary hepatocellular carcinoma (HCC) treatment is associated with optimal outcomes. There are few data analyzing the impact of treating hospitals' therapeutic offerings on survival. We performed a retrospective cohort study of patients aged 18-70 years with HCC in the National Cancer Database (2004-2012). Hospitals were categorized based on the level of treatment offered (Type I-nonsurgical; Type II-ablation; Type III-resection; Type IV-transplant). Associations between overall risk of death and hospital type were evaluated with multivariable Cox shared frailty modeling. Among 50,381 patients, 65% received care in Type IV hospitals, 26% in Type III, 3% in Type II, and 6% in Type I. Overall 5-year survival across modalities was highest at Type IV hospitals (untreated: Type IV-13.1% versus Type I-5.7%, Type II-7.0%, Type III-7.4% [log-rank, P < 0.001]; chemotherapy and/or radiation: Type IV-18.1% versus Type I-3.6%, Type II-4.6%, Type III-7.7% [log-rank, P < 0.001]; ablation: Type IV-33.3% versus Type II-13.6%, Type III-23.6% [log-rank, P < 0.001]; resection: Type IV-48.4% versus Type III-39.1% [log-rank, P < 0.001]). Risk of death demonstrated a dose-response relationship with the hospital type-Type I (ref); Type II (hazard ratio [HR] 0.81, 95% confidence interval [0.73-0.90]); Type III (HR 0.67 [0.62-0.72]); Type IV hospitals (HR 0.43 [0.39-0.47]). Conclusion: Although care at hospitals offering the full complement of HCC treatments is associated with decreased risk of death, one third of patients are not treated at these hospitals. These data can inform the value of health policy initiatives regarding regionalization of HCC care., (© 2018 by the American Association for the Study of Liver Diseases.)

Transplant immunosuppressants are often used off-label because of insufficient randomized prospective trial data to achieve organ-specific US Food and Drug Administration (FDA) approval. Transplant recipients who rely on Medicare Part D for immunosuppressant drug coverage are vulnerable to coverage denial for off-label prescriptions, unless use is supported by Centers for Medicare & Medicaid Services (CMS)-approved compendia. An integrated dataset including national transplant registry data and 3 years of dispensed pharmacy records was used to identify the prevalence of immunosuppression use that is both off-label and not supported by CMS-approved compendia. Numbers of potentially vulnerable transplant recipients were identified. Off-label and off-compendia immunosuppression regimens are frequently prescribed (3-year mean: lung 66.5%, intestine 34.2%, pancreas 33.4%, heart 21.8%, liver 16.5%, kidney 0%). The annual retail cost of these at-risk medications exceeds $30 million. This population-based study of transplant immunosuppressants vulnerable to claim denials under Medicare Part D coverage demonstrates a substantial gap between clinical practice, current FDA approval processes, and policy mandates for pharmaceutical coverage. This coverage barrier reduces access to life-saving medications for patients without alternative resources and may increase the risk of graft loss and death from medication nonadherence., (© 2018 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Medicare costs vary for solid organ transplant recipients by outcome: survival with graft function, survival with graft failure, and death. Average per-person per-year reimbursement was $75 thousand for kidney recipients who survived the first year posttransplant with a functioning graft, $171 thousand for those who required a return to dialysis or retransplant, and $350 thousand for those who died with function. For pancreas recipients: $105 thousand for those who survived the first year with a functioning graft, $120 thousand for those who survived pancreas failure, and $443 thousand for those who died with function. For liver recipients: $154 thousand for those who survived with a functioning graft, $388 thousand for those who required retransplant, and $740 thousand who died with function. For intestine recipients: $301 thousand for those who survived with a functioning graft and $1 million for those who died with function. For heart recipients: $272 thousand for those who survived with a functioning graft and $1.2 million for those who died with function. For lung recipients: $196 thousand for those who survived with a functioning graft, $642 thousand for those who required retransplant, and $761 thousand for those who died with function., (.)

The liver transplant allocation system has evolved to a ranking system of “sickest-first” system based on objective criteria. Yet, organs continue to be distributed first within OPOs and regions that are largely based on historical practice patterns related to kidney transplantation and were never designed to minimize waitlist death or equalize opportunity for liver transplant. The current proposal is a move to enhance survival though the application of modern mathematical techniques to optimize liver distribution. Like MELDbased allocation, it will never be perfect and should be continually evaluated and revised. However, the disparity in access, which favors those residing in or able to travel to privileged areas, to the detriment of the patients dying on the list in underserved areas, is simply not defensible in 2015.

Although biliary complications (BCs) have a significant impact on the outcome of liver transplantation (LT), variation in BC rates among transplant centers has not been previously analyzed. BC rate, LT outcome and spending were assessed using linked Scientific Registry of Transplant Recipients and Medicare claims (n = 16,286 LTs). Transplant centers were assigned to BC quartiles based upon risk-adjusted observed to expected (O:E) ratio of BC separately for donation after brain death (DBD) and donation after cardiac death (DCD) donors. The median incidence of BC was 300% greater in the highest versus lowest DBD quartiles (19.0% vs. 5.9%) and varied 250% between DCD quartiles (20.3%-8.4%). Donor and recipient characteristics suggest that high BC centers actually used lower donor risk index organs, fewer split livers and fewer imports (p < 0.001 for all). Transplant at a center in the highest O:E quartile was associated with increased posttransplant mortality (adjusted hazard ratio [aHR] 2.53, p = 0.007) in DCD transplant and increased graft loss (aHR 1.21, p = 0.02) in DBD transplant. Medicare spending was $22,895 (p < 0.0001) higher at centers in highest versus lowest BC quartile. In summary, BC rates vary widely among transplant centers and higher rates are a marker for an increased risk of death, graft failure and health-care spending., (© Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.)

While the costs to Medicare of solid organ transplant are varied and considerable, the total Medicare expenditure of $4.4 billion for solid organ transplant recipients was less than 1 remains one of the most cost-effective surgical interventions in medicine. Heart transplant, the most expensive of the major transplants, is likely cost-effective; SRTR has released an Excel-based tool for investigators to use in exploring this question further. It is likely that most solid organ transplants are cost-effective, given the results presented here and the relatively high cost of heart transplant. However, this must be verified with further study., (© Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: Despite improvement in surgical technique and medical management of liver transplant recipients, biliary complications remain a frequent cause of posttransplant morbidity and graft loss. Biliary complications require potentially expensive interventions including radiologic procedures and surgical revisions., Methods: A national data set linking transplant registry and Medicare claims data for 12,803 liver transplant recipients was developed to capture information on complications, treatments, and associated direct medical costs up to 3 years after transplantation., Results: Biliary complications were more common in recipients of donation after cardiac death compared to donation after brain death allografts (23% vs. 19% P<0.001). Among donation after brain death recipients, biliary complications were associated with $54,699 (95% confidence interval [CI], $49,102 to $60,295) of incremental spending in the first year after transplantation and $7,327 in years 2 and 3 (95% CI, $4,419-$10,236). Biliary complications in donation after cardiac death recipients independently increased spending by $94,093 (95% CI, $64,643-$124,542) in the first year and $12,012 (95% CI, $-1,991 to $26,016) in years 2 and 3., Conclusion: This national study of biliary complications demonstrates the significant economic impact of this common perioperative complication and suggests a potential target for quality of care improvements.

Background: The provision of effective surgical care for end-stage renal disease (ESRD) requires efficient evaluation and transplantation. Prior assessments of transplant access have focused primarily on waitlisted patients rather than the overall populations served by "accountable" providers of transplant services., Methods: Novel transplant referral regions (TRRs) were defined using United Network for Organ Sharing registry data for 301,092 kidney transplant listings to assign zip codes to "accountable" transplant programs. Subsequently, risk-adjusted observed to expected (O:E) rates of listing and transplant procedures were calculated for each TRR. Finally, the impact of variation in TRR listing and transplant rates on mortality was assessed for ESRD patients <60 years old diagnosed between 2000 and 2008., Results: In total, 113 TRRs were defined, 51% of which included >1 transplant center. The likelihood of being evaluated and listed for transplant varied significantly between TRRs (risk-adjusted O:E, 0.58-1.95). Variation was greater for the overall transplant rate (0.62-2.19), living donor transplantation (0.36-3.08), and donation after cardiac death transplant (0-15.4) than for standard criteria donors (0.64-2.86). Mortality was decreased for ESRD patients living in TRRs in the highest tertile of listings (hazard ratio, 0.89; P < .0001) and transplantation (0.90; P < .0001)., Conclusion: Residence in a TRR with care delivery systems that increase access to transplant services is associated with significant, risk-adjusted decreases in ESRD-related mortality. Transplant centers should continue to focus on improving access to care within the communities they serve., (Copyright © 2014 Mosby, Inc. All rights reserved.)

Despite improved overall liver transplant outcomes, biliary complications remain a significant cause of morbidity. A national data set linking transplant registry and Medicare claims data for 17,012 liver transplant recipients was used to identify all recipients with a posttransplant biliary diagnosis code within the first 6 months after transplantation. Patients were further categorized as follows: a diagnosis without a procedure, a diagnosis and an associated radiological or endoscopic procedure, or a diagnosis treated with surgery. Overall, 15.0% had a biliary diagnosis, 11.2% required a procedure, and 2.2% had a surgical revision. Factors independently associated with biliary complications included donation after cardiac death (DCD), donor age, recipient age, split grafts, and long cold ischemia times. Graft loss was significantly more common for patients with biliary diagnoses [adjusted hazard ratio (aHR) = 1.89, confidence interval (CI) = 1.63-2.19], interventions (aHR = 2.08, CI = 1.77-2.44), and surgical procedures (aHR = 1.80, CI = 1.31-2.49). Mortality after transplantation was also markedly increased for patients with biliary diagnoses (aHR = 2.18, CI = 1.97-2.40), procedures (aHR = 2.21, CI = 1.99-2.46), and surgeries (aHR = 1.77, CI = 1.41-2.23). In stratified analyses, the impact of early biliary complications was greater for DCD liver recipients, but they remained highly significant for recipients of allografts from brain-dead donors as well. Reducing biliary complications should improve posttransplant survival and reduce graft loss., (© 2014 American Association for the Study of Liver Diseases.)

Previous economic analyses of liver transplantation have focused on the cost of the transplant and subsequent care. Accurate characterization of the pretransplant costs, indexed to severity of illness, is needed to assess the economic burden of liver disease. A novel data set linking Medicare claims with transplant registry data for 15,710 liver transplant recipients was used to determine average monthly waitlist spending (N = 249,434 waitlist months) using multivariable linear regression models to adjust for recipient characteristics including Model for End-Stage Liver Disease (MELD) score. Characteristics associated with higher spending included older age, female gender, hepatocellular carcinoma, diabetes, hypertension and increasing MELD score (p < 0.05 for all). Spending increased exponentially with severity of illness: expected monthly spending at a MELD score of 30 was 10 times higher than at MELD of 20 ($22,685 vs. $2030). Monthly spending within MELD strata also varied geographically. For candidates with a MELD score of 35, spending varied from $19,548 (region 10) to $36,099 (region 7). Regional variation in waitlist costs may reflect the impact of longer waiting times on greater pretransplant hospitalization rates among high MELD score patients. Reducing the number of high MELD waitlist patients through improved medical management and novel organ allocation systems could decrease total spending for end-stage liver care., (© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

The Scientific Registry of Transplant Recipients is charged with providing program-specific reports for organ transplant programs in the United States. Monitoring graft survival for pancreas transplant programs has been problematic as there are three different pancreas transplant procedures that may have different outcomes, and analyzing them separately reduces events and statistical power. We combined two consecutive 2.5-year cohorts of transplant recipients to develop Cox proportional hazards models predicting outcomes, and tested these models in the second 2.5-year cohort. We used separate models for 1- and 3-year graft and patient survival for each transplant type: simultaneous pancreas-kidney (SPK), pancreas after kidney (PAK) and pancreas transplant alone (PTA). We first built a predictive model for each pancreas transplant type, and then pooled the transplant types within centers to compare total observed events with total predicted events. Models for 1-year pancreas graft and patient survival yielded C statistics of 0.65 (95% confidence interval, 0.63-0.68) and 0.66 (0.61-0.72), respectively, comparable to C statistics for 1-year patient and graft survival for other organ transplants. Model calibration (Hosmer-Lemeshow method) was also acceptable. We conclude that pooling the results of SPK, PAK and PTA can produce potentially useful models for reporting program-specific pancreas transplant outcomes., (No claim to original US government works© Copyright 2013 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Background: Disparity in access to liver transplantation (LT) in the United States persists despite directives from the federal government to reduce geographic variation. We assessed the impact of socioeconomic status (SES) and traveling to alternative donation service areas (DSAs) on patient survival., Methods: A prospective cohort study integrating transplant registry and U.S. Census data was analyzed using multivariate linear Cox proportional hazards models. A separate matched-pairs analysis was used to assess the benefit of traveling on patient survival and transplantation rate., Results: High SES is associated with increased access to LT (adjusted hazard ratio [aHR], 1.05; 95% confidence interval [95% CI], 1.01-1.08) and reduced mortality after waitlisting (aHR [95% CI], 0.88 [0.85-0.93]). Increased access is mediated, in part, through inter-DSA travel. Travel was associated with high SES, white race, blood group O, private insurance, and residence in regions 1, 5, and 11. Transplant candidates in the highest SES quartile were approximately 70% more likely to travel (aHR [95% CI], 1.67 [1.43-1.97]) than those in the lowest SES quartile. Compared with matched control patients, travelers were 74% more likely to be transplanted (aHR [95% CI], 1.74 [1.56-1.94]) and 20% less likely to die after listing (aHR [95% CI], 0.79 [0.69-0.92])., Conclusion: High SES and inter-DSA travel are strongly associated with increased LT access and reduced mortality. Travelers are more likely to be sociodemographically advantaged and privately insured and to live in regions with reduced access to deceased-donor organs.

Background: The economic ramifications of acute rejection (AR) are not well characterized in a contemporary population of kidney transplant recipients., Methods: Data for Medicare-insured transplant recipients in 2000 to 2007 (n=45,250) were drawn from the United States Renal Data System. AR events were ascertained from the Organ Procurement and Transplantation Network reports covering months 0 to 12 (yr1), 13 to 24 (yr2), and 25 to 36 (yr3) after transplantation. AR was subclassified as antibody (Ab)-treated AR or other management (non-Ab-treated AR). The marginal cost impact of AR events during and before a period of interest was quantified by multivariate linear regression including covariates for recipient, donor, and transplant factors., Results: Among recipients of standard criteria donor allografts, both Ab-treated AR events (yr1, $22,407; yr 2, $18,803; yr3, $13,909) and non-Ab-treated AR events (yr1, $14,122; yr2, $7852; yr3, $8234) were associated with significant increases in the cost of care. Patterns were similar among recipients of living donor and expanded criteria donor transplants. After weighting by population frequency, AR accounted for 2.3% to 3.8% of total costs incurred during 1 year of posttransplantation care. Subanalysis of recipients with yr1 estimated glomerular filtration rate (eGFR) information demonstrated markedly stronger cost variation across eGFR levels. For example, among those with non-Ab-treated AR, adjusted total yr2 costs were $22,747 with eGFR of 60 mL/min/1.73 m or higher but $43,881 with eGFR of 30 mL/min/1.73 m or lower., Conclusions: AR is a significant contributor to individual posttransplantation costs. However, because of its low frequency, AR accounts for a small proportion of posttransplantation costs in the population. Healthcare costs in patients with AR are markedly higher among those with reduced compared with preserved allograft function.

Accurate assessment of the impact of donor quality on liver transplant (LT) costs has been limited by the lack of a large, multicenter study of detailed clinical and economic data. A novel, retrospective database linking information from the University HealthSystem Consortium and the Organ Procurement and Transplantation Network registry was analyzed using multivariate regression to determine the relationship between donor quality (assessed through the Donor Risk Index [DRI]), recipient illness severity, and total inpatient costs (transplant and all readmissions) for 1 year following LT. Cost data were available for 9059 LT recipients. Increasing MELD score, higher DRI, simultaneous liver-kidney transplant, female sex, and prior liver transplant were associated with increasing cost of LT (P < 0.05). MELD and DRI interact to synergistically increase the cost of LT (P < 0.05). Donors in the highest DRI quartile added close to $12,000 to the cost of transplantation and nearly $22,000 to posttransplant costs in comparison to the lowest risk donors. Among the individual components of the DRI, donation after cardiac death (increased costs by $20,769 versus brain dead donors) had the greatest impact on transplant costs. Overall, 1-year costs were increased in older donors, minority donors, nationally shared organs, and those with cold ischemic times of 7-13 hours (P < 0.05 for all). In conclusion, donor quality, as measured by the DRI, is an independent predictor of LT costs in the perioperative and postoperative periods. Centers in highly competitive regions that perform transplantation on higher MELD patients with high DRI livers may be particularly affected by the synergistic impact of these factors., (Copyright © 2011 American Association for the Study of Liver Diseases.)

Optimizing the possibilities for kidney-paired donation (KPD) requires the participation of donor-recipient pairs from wide geographic regions. Initially it was envisaged that donors would travel to the recipient center; however, to minimize barriers to participation and simplify logistics, recent trends have involved transporting the kidneys rather than the donors. The goal of this study was to review outcomes of this practice. KPD programs throughout the United States were directly queried about all transplants involving live donor kidney transport. Early graft function was assessed by urine output in the first 8 h, postoperative serum creatinine trend, and incidence of delayed graft function. Between April 27, 2007 and April 29, 2010, 56 live donor kidneys were transported among 30 transplant centers. Median CIT was 7.2 h (IQR 5.5-9.7, range 2.5-14.5). Early urine output was robust (>100 cc/h) in all but four patients. Creatinine nadir was <2.0 mg/dL in all (including the four with lower urine output) but one patient, occurring at a median of 3 days (IQR 2-5, range 1-49). No patients experienced delayed graft function as defined by the need for dialysis in the first week. Current evidence suggests that live donor kidney transport is safe and feasible., (©2011 The Authors Journal compilation©2011 The American Society of Transplantation and the American Society of Transplant Surgeons.)

The Patient Protection and Affordable Care Act passed in 2010 will result in dramatic expansion of publically funded health insurance coverage for low-income individuals. It is estimated that of the 32 million newly insured, 16 million will obtain coverage through expansion of the Medicaid Program, and the remaining 16 million will purchase coverage through their employer or newly legislated insurance exchanges. While the Act contains numerous provisions to improve access to private insurance as discussed in Part I of this analysis, public sector coverage will significantly be affected. The cost of health care reform will be borne disproportionately by Medicare, which faces nearly $500 billion in cuts to be identified by a new independent board. Transplant centers should be concerned about the impact of the reform on the financial aspects of transplantation. In addition, this legislation also utilizes the Medicare Program to drive reform of the health care delivery system, by encouraging the development of integrated Accountable Care Organizations, experimentation with new 'models' of healthcare delivery, and expanded support for Comparative Effectiveness Research. Transplant providers, including transplant centers and physicians/surgeons need to lead this movement, drawing on our experience providing comprehensive multidisciplinary care under global budgets with publically reported outcomes.

The Health Care Reform (HCR) legislation passed by Congress in 2010 will have significant impact on transplant centers, patients and health care professionals. The Act seeks to expand coverage, limit the growth in health care costs and reform the delivery and insurance systems. In Part I of this two part series, we provide an overview and perspective of changes in private health insurance resulting from HCR. Under the plan, all Americans will be required to purchase coverage through their employer or via an improved individual/small group market. This legislation limits abusive practices such as limitations on preexisting conditions, lifetime and annual coverage limitations and dropping of beneficiaries if they become sick. The legislation will also limit high-cost plans and regulate premium increases. Private sector reforms are likely to benefit our patients by increasing the number of patients with access to transplant services, since the use of 'preexisting' conditions will be eliminated. However without a concomitant increase in the organ supply, longer waiting times and greater use of marginal organs are likely to increase the cost of transplant. Furthermore, transplant providers will receive reduced reimbursement as a result of market consolidation and the growing power of large transplant networks.

The waiting list for kidney transplantation continued to grow between 1999 and 2008, from 41 177 to 76 089 candidates. However, active candidates represented the minority of this increase (36 951-50 624, a 37% change), while inactive candidates increased over 500% (4226-25 465). There were 5966 living donor (LD) and 10 551 deceased donor (DD) kidney transplants performed in 2008. The total number of pancreas transplants peaked at 1484 in 2004 and has declined to 1273. Although the number of LD transplants increased by 26% from 1999 to 2008, the total number peaked in 2004 at 6647 before declining 10% by 2008. The rate of LD transplantation continues to vary significantly as a function of demographic and geographic factors, including waiting time for DD transplant. Posttransplant survival remains excellent, and there appears to be greater use of induction agents and reduced use of corticosteroids in LD recipients. Significant changes occurred in the pediatric population, with a dramatic reduction in the use of LD organs after passage of the Share 35 rule. Many strategies have been adopted to reverse the decline in LD transplant rates for all age groups, including expansion of kidney paired donation, adoption of laparoscopic donor nephrectomy and use of incompatible LD.

Context: Disparities in access to organ transplantation exist for racial minorities, women, and patients with lower socioeconomic status or inadequate insurance. Rural residents represent another group that may have impaired access to transplant services., Objective: To assess the association of rural residence with waiting list registration for heart, liver, and kidney transplant and rates of transplantation among wait-listed candidates., Design, Setting, and Patients: Five-year US cohort of 174,630 patients who were wait-listed and who underwent heart, liver, or kidney transplantation between 1999 and 2004., Main Outcome Measures: Rates of new waiting list registrations and transplants per million population for residents of 3 residential classifications (rural/small town population, <10,000; micropolitan, 10,000-50,000; and metropolitan >50,000 or suburb of major city)., Results: Compared with urban residents, waiting list registration rates for rural/small town residents were significantly lower for heart (covariate-adjusted rate ratio [RR] = 0.91; 95% confidence interval [CI], 0.86-0.96; P<.002), liver (RR = 0.86; 95% CI, 0.83-0.89; P<.001), and kidney transplants (RR = 0.92; 95% CI, 0.90-0.95; P<.001). Compared with residents in urban areas, rural/small town residents had lower relative transplant rates for heart (RR = 0.88; 95% CI, 0.81-0.94; P = .004), liver (RR = 0.80; 95% CI, 0.77-0.84; P<.001), and kidney transplantation (covariate-adjusted RR = 0.90; 95% CI, 0.88-0.93; P<.001). These disparities were consistent across national organ allocation regions. Significantly longer waiting times among rural patients wait-listed for heart transplantation were observed but not for liver and kidney transplantation. There were no significant differences in posttransplantation outcomes between groups., Conclusions: Patients living in rural areas had a lower rate of wait-lisiting and transplant of solid organs, but did not experience significantly different outcomes following transplant. Differences in rates of wait-listing and transplant may be due to variations in the burden of disease between different patient groups or barriers to evaluation and waiting list entry for rural residents with organ failure.

The disparity between the organ supply and the demand for liver transplantation (LT) has resulted in the growing utilization of 'marginal donor' organs. While economic outcomes for subsets of 'marginal' organs have been described for renal transplantation, similar analyses have not been performed for LT. Using UNOS data for 17 710 LTs performed between 2002 and 2005, we assessed the relationship between recipient model for end-stage liver disease (MELD) score, organ quality as defined by donor risk index (DRI, Feng et al. 2005) and hospital length of stay (LOS). Single-center cost-accounting data for 338 liver transplants were then analyzed with a multivariate linear regression model to determine the estimated cost associated with a day of LOS. Overall, 8.4% of donor organs were classified as high risk (DRI > 2-2.5) and 1.9% as very high risk (DRI > 2.5). In the lowest MELD group (0-10), the LOS difference between 'ideal' donors (DRI < 1.0) and very high risk (DRI > 2.5) was 10.6 days which was associated with an estimated incremental cost of $47 986. For patients with MELD >35, the average LOS increased from 23.2 to 41.8 days when very high DRI donors were used, resulting in an estimated increase in cost of nearly $84 000. We conclude that the use of marginal liver grafts results in increased hospital costs independent of recipient risk factors.

Objective: To determine whether high-volume hospitals (HVHs) have lower in-hospital death rates after abdominal aortic aneurysm (AAA) repair compared with low-volume hospitals (LVHs)., Summary Background Data: Select statewide studies have shown that HVHs have superior outcomes compared with LVHs for AAA repair, but they may not be representative of the true volume-outcome relationship for the entire United States., Methods: Patients undergoing repair of intact or ruptured AAAs in the Nationwide Inpatient Sample (NIS) for 1996 and 1997 were included (n = 13,887) for study. The NIS represents a 20% stratified random sample representative of all U.S. hospitals. Unadjusted and case mix-adjusted analyses were performed., Results: The overall death rate was 3.8% for intact AAA repair and 47% for ruptured AAA repair. For repair of intact AAAs, HVHs had a lower death rate than LVHs. The death rate after repair of ruptured AAA was also slightly lower at HVHs. In a multivariate analysis adjusting for case mix, having surgery at an LVH was associated with a 56% increased risk of in-hospital death. Other independent risk factors for in-hospital death included female gender, age older than 65 years, aneurysm rupture, urgent or emergent admission, and comorbid disease., Conclusions: This study from a representative national database documents that HVHs have a significantly lower death rate than LVHs for repair of both intact and ruptured AAA. These data support the regionalization of patients to HVHs for AAA repair.

Changes in the structure of the health care system have placed unprecedented stress on the surgeon-patient relationship. The essential trust placed in the surgeon by her patients has been weakened by changes in the structure and financing of the health care system. This article considers the historical and ethical foundation of the surgeon-patient relationship and proposes that the primary moral obligation of surgeons is to strengthen and earn patient trust. By improving communication skills, enhancing ethical education, serving as consistent advocates for patients, and conducting patient-focused outcome research, the surgical community can meet its moral obligation by increasing trust in the surgeon-patient relationship.