A Comprehensive Analysis of Litigation in Organ Transplantation for Allegations of Insufficient Policy Coverage, Discrimination and Malpractice.

Introduction: Transplantation is a field with unique medical and administrative challenges that involve an equally diverse array of stakeholders. Expectantly, the litigation stemming from this field should be similarly nuanced. There is a paucity of comprehensive reviews characterizing this medicolegal landscape. Design: The Caselaw Access Project Database was used to collect official court briefs of 2053 lawsuits related to kidney, liver, heart, lung, and pancreas transplantation. A thematic analysis was undertaken to characterize grounds for litigation, defendant type, and outcomes. Cases were grouped into policy, discrimination, poor or unsuccessful outcome, or other categories. Results: One hundred sixty-four court cases were included for analysis. Cases involving disputes over policy coverage were the most common across all organ types (N = 55, 33.5%). This was followed by poor outcomes (N = 51, 31.1%), allegations of discrimination against prison systems and employers (N = 37, 22.6%) and other (N = 21, 12.8%). Defendants involved in discrimination trials won with the greatest frequency (N = 29, 90.62%). Defendants implicated in policy suits won 65.3% (N = 32), poor outcomes 62.2% (N = 28), and other 70% (N = 14). Of the 51 cases involving poor outcomes, plaintiffs indicated lack of informed consent in 23 (45.1%). Conclusion: Reconsidering the informed consent process may be a viable means of mitigating future legal action. Most discrimination suits favoring defendants suggested previous concerns of structural injustices in transplantation may not be founded. The prevalence of policy-related cases could be an indication of financial burden on patients. Future work and advocacy will need to substantiate these concerns and address change where legal recourse falls short.

Cerebrovascular Disease Hospitalization Rates in End-Stage Kidney Disease Patients with Kidney Transplant and Peripheral Vascular Disease: Analysis Using the National Inpatient Sample (2005-2019).

Individuals with end-stage kidney disease (ESKD) face higher cerebrovascular risk. Yet, the impact of peripheral vascular disease (PVD) and kidney transplantation (KTx) on hospitalization rates for cerebral infarction and hemorrhage remains underexplored. Analyzing 2,713,194 ESKD hospitalizations (2005-2019) using the National Inpatient Sample, we investigated hospitalization rates for ischemic and hemorrhagic cerebrovascular diseases concerning ESKD, PVD, KTx, or their combinations. Patients hospitalized with cerebral infarction due to thrombosis/embolism/occlusion (CITO) or artery occlusion resulting in cerebral ischemia (AOSI) had higher rates of comorbid ESKD and PVD (4.17% and 7.29%, respectively) versus non-CITO or AOSI hospitalizations (2.34%, p < 0.001; 2.29%, p < 0.001). Conversely, patients hospitalized with nontraumatic intracranial hemorrhage (NIH) had significantly lower rates of ESKD and PVD (1.64%) compared to non-NIH hospitalizations (2.34%, p < 0.001). Furthermore, hospitalizations for CITO or AOSI exhibited higher rates of KTx and PVD (0.17%, 0.09%, respectively) compared to non-CITO or AOSI hospitalizations (0.05%, p = 0.033; 0.05%, p = 0.002). Patients hospitalized with NIH showed similar rates of KTx and PVD (0.04%) versus non-NIH hospitalizations (0.05%, p = 0.34). This nationwide analysis reveals that PVD in ESKD patients is associated with increased hospitalization rates with cerebral ischemic events and reduced NIH events. Among KTx recipients, PVD correlated with increased hospitalizations for ischemic events, without affecting NIH. This highlights management concerns for patients with KTx and PVD.

Concomitant Polyoma BK Virus and West Nile Virus in Renal Allografts.

Surveillance of the renal allograft recipient is essential when monitoring renal function to detect the early onset of rejection and alter therapeutic treatments to treat acute rejection or other causes and improve long-term graft function. If renal function begins to deteriorate, a renal biopsy is often indicated to assess the Banff grade of potential rejection or other causes, especially in the setting of polyoma BK viral load elevation. Although BK infection in the allograft is asymptomatic, reactivation of the virus is known to be associated with the acceleration of pathologic change and a poor outcome in the allograft. BK reactivation in a transplant kidney is not uncommon, and determining inflammation related to the virus versus acute rejection is paramount for appropriate immunosuppressive therapy management. We identified a concomitant polyoma BK virus and West Nile Virus (WNV) infection in two renal transplant patients which, to our knowledge, has not previously been reported. However, other concomitant infections have been reported in renal allografts including BK virus and cytomegalovirus (CMV), CMV and hepatitis C (HCV), and HCV and human immunodeficiency virus (HIV). As WNV has become endemic in many regions of the United States, and since the transmission of the virus via transplanted organs is associated with significant morbidity and mortality, it may be prudent to consider serologic screening for WNV in living donors prior to organ procurement. Regardless, the observation we made and report here should underscore the potential for concomitant viral infections that may be masked when a renal allograft has a significant inflammatory response to BK virus.

A Quality Analysis of Donor Nephrectomy-Related Information on YouTube; Education or Misinformation?

INTRODUCTION: There currently remains an urgent need to increase living kidney donation to help mitigate the high demand for waitlisted kidney failure patients. Potential kidney donors can readily access social media, particularly YouTube, to gain basic knowledge about live donor nephrectomy surgical procedures. YouTube is an open-source platform where anyone can upload videos about any topic without peer review or quality control and is frequently used for disseminating health education. This study aims to assess the quality and accuracy of information regarding live donor nephrectomy on YouTube. METHODS: A YouTube search was performed using the keywords "donor nephrectomy" and "kidney transplant." A total of 57 videos were assessed for eligibility criteria. Two validated tools for evaluating health information, the DISCERN and The Patient Education Materials Assessment Tool for Audiovisual Materials tools, were used to assess YouTube video information quality, understandability, and actionability. RESULTS: A total of 53 of 57 screened videos were included in this study, with 4 videos being excluded for not being primarily in the English language. The mean (SD) DISCERN score was 23.3 (±8.3), and the mean (SD) The Patient Education Materials Assessment Tool for Audiovisual Materials Understandability and Actionability scores of 41.7% (±17.5) and 8.2% (±22.9%), respectively. Although videos were generally relevant in content to donor nephrectomy, videos lacked quality information and actionable items. CONCLUSIONS: Information on living donor nephrectomies is prevalent on YouTube. Our assessment using quality measures of selected videos illustrates substantial misinformation on living donor nephrectomies. YouTube has the potential to be a source of reliable and accurate information on living donor nephrectomies and donations.

Quantifying mortality burden in patients with cancer due to COVID-19 in the US: A national cross-sectional analysis.

INTRODUCTION: There is limited information on the impact of certain social factors on mortality outcomes in patients with cancer and COVID-19 on a national scale. This study aims to characterize excess mortality and analyze a subset of sociodemographic trends in COVID-19 and cancer mortality. METHODS: Patients with cancer listed on their death certificates from 2018 to 2021 and patients with COVID-19 and cancer listed on multiple cause of death certificates from the CDC Wide-Ranging Online Data for Epidemiologic Research database from March 2020 to December 2021 were included. Age-adjusted mortality rates (AAMR) per 1,000,000 population were compared across race/ethnicity groups, sex, and census regions. Crude mortality rates were compared across different age groups and regions based on urbanization status. RESULTS: Average AAMR in patients with COVID-19 and cancer was 41.7 in 2020 and 56.7 in 2021. CONCLUSIONS: Mortality rates in patients with cancer and COVID-19 were significantly higher in certain populations. Targeted interventions are necessary to improve outcomes.

Demographic inequities exist and influence transplant outcomes in liver transplantation for acute alcohol-associated hepatitis.

BACKGROUND: Liver transplantation has inherent disparities but data is scarce in liver transplant (LT) candidates with acute alcohol-associated hepatitis (AAH). We aimed to investigate demographic inequities and its impact on survival outcomes among AAH LT candidates. METHODS: A retrospective analysis using the United Network of Organ Sharing database was conducted between 2000 and 2021. 25 981 LT recipients with alcohol-associated liver cirrhosis and 662 recipients with AAH were included. Waitlisted candidates were also evaluated. RESULTS: In comparison with alcohol-associated liver cirrhosis, AAH LT recipients were more likely Asian or "other" race and younger. Hispanics demonstrated better graft and patient survival (p < 0.05) but were less likely to be waitlisted and transplanted for AAH than for liver cirrhosis. Women with AAH were more likely to be waitlisted and transplanted. Pre-existing diabetes and male sex were associated with higher graft failure (25% and 8% respectively). Increasing recipient age were 2% more likely to experience negative outcomes. Chronicity of liver disease did not impact graft (p = 0.137) or patient survival (p = 0.145). CONCLUSION: Our results revealed demographic factors have a significant impact on transplant listing, organ allocation and survival outcomes. Further investigations are imperative to minimize disparities in LT evaluation and provide equity in healthcare.

The Impact of the COVID-19 Pandemic on Kidney Transplant Candidate Waitlist Status across Demographic and Geographic Groups: A National Analysis of UNOS STAR Data.

The primary goal of this retrospective study is to understand how the COVID-19 pandemic differentially impacted transplant status across race, sex, age, primary insurance, and geographic regions by examining which candidates: (i) remained on the waitlist, (ii) received transplants, or (iii) were removed from the waitlist due to severe sickness or death on a national level. Methods: The trend analysis aggregated by monthly transplant data from 1 December 2019 to 31 May 2021 (18 months) at the transplant center level. Ten variables about every transplant candidate were extracted from UNOS standard transplant analysis and research (STAR) data and analyzed. Characteristics of demographical groups were analyzed bivariately using t-test or Mann-Whitney U test for continuous variables and using Chi-sq/Fishers exact tests for categorical variables. Results: The trend analysis with the study period of 18 months included 31,336 transplants across 327 transplant centers. Patients experienced a longer waiting time when their registration centers in a county where high numbers of COVID-19 deaths were observed (SHR < 0.9999, p < 0.01). White candidates had a more significant transplant rate reduction than minority candidates (-32.19% vs. -20.15%) while minority candidates were found to have a higher waitlist removal rate than White candidates (9.23% vs. 9.45%). Compared to minority patients, White candidates' sub-distribution hazard ratio of the transplant waiting time was reduced by 55% during the pandemic period. Candidates in the Northwest United States had a more significant reduction in the transplant rate and a greater increase in the removal rate during the pandemic period. Conclusions: Based on this study, waitlist status and disposition varied significantly based on patient sociodemographic factors. During the pandemic period, minority patients, those with public insurance, older patients, and those in counties with high numbers of COVID-19 deaths experienced longer wait times. In contrast, older, White, male, Medicare, and high CPRA patients had a statistically significant higher risk of waitlist removal due to severe sickness or death. The results of this study should be considered carefully as we approach a reopening world post-COVID-19, and further studies should be conducted to elucidate the relationship between transplant candidate sociodemographic status and medical outcomes during this era.

Electronic Patient Portal Use After Kidney Transplant: A Single-Center Retrospective Study.

INTRODUCTION: Online patient portals have become a core component of patient-centered care. Limited research exists on such portal use in patients after kidney transplantation. The aim of this study was to examine preoperative, perioperative, and postoperative factors associated with post-transplantation portal use. METHODS: This cross-sectional study included all patients who underwent kidney transplantation from April 2016 to May 2019 at the University of Toledo Medical Center. Exclusion criteria included international travel for transplantation and those without available postoperative lab or follow-up records. Data were collected for 2 y post-transplantation. Univariable and multivariable linear regression was performed to determine associations with portal use. RESULTS: Two hundred and forty-seven kidney transplant recipients were included in the study; 35.6% (n = 88) used the portal versus 64.4% (n = 159) did not. Preoperative factors associated with increased use included income >$40,000 (odds ratio [OR], 2.95; P = 0.006) and cancer history (OR, 2.46; P = 0.007), whereas diabetes history had reduced use (OR, 0.51; P = 0.021). The Black race had the least use. Perioperatively, reduced use was associated with dialysis before transplant (OR, 0.25; P < 0.001) and hospital stay ≥4 d (OR, 0.49; P = 0.009). Postoperatively, associations with increased use included average eGFR >30 (P = 0.04) and hospital readmissions (n = 102), whereas those with ER (n = 138) visits had decreased use. Multivariable analysis revealed increased use with income >$40,000 (OR, 2.51; P = 0.033). CONCLUSIONS: There was no observed difference in clinical outcomes for portal users and nonusers undergoing kidney transplantation, although portal use may decrease the likelihood of ER visits. Socioeconomic status and ethnicity may play a role on who utilizes the patient portals.

Patient-reported disruptions to cancer care during the COVID-19 pandemic: A national cross-sectional study.

BACKGROUND: The aim of this study is to evaluate the extent and associations with patient-reported disruptions to cancer treatment and cancer-related care during the COVID-19 pandemic utilizing nationally representative data. METHODS: This analysis uses data from the 2020 National Health Interview Survey (NHIS), an annual, cross-sectional survey of US adults. Adults (age >18) who reported requiring current cancer treatment or other cancer-related medical care in the second half of 2020 were included. Estimated proportions of patients with self-reported changes, delays, or cancelations to cancer treatment or other cancer care due to the COVID-19 pandemic were calculated using sampling weights and associations with sociodemographic and other health-related variables were analyzed. RESULTS: In total, 574 (sample-weighted estimate of 2,867,326) adults reported requiring cancer treatment and/or other cancer care since the start of the COVID-19 pandemic. An estimated 32.1% reported any change, delay, or cancelation. On sample-weighted univariable analysis, patients who were younger, female, had one or fewer comorbidities, and uninsured were significantly more likely to report disruptions. On sample-weighted, multivariable analysis, patients who were younger and female remained significant predictors. Nearly 90% of patients included in the study reported virtual appointment use. Patients reporting disruptions were also significantly more likely to report feelings of anxiety. CONCLUSIONS: An estimated 1/3 of patients experienced disruptions to cancer care due to the COVID-19 pandemic. Patients experiencing disruptions in care were more likely to be female or younger which may reflect risk stratification strategies in the early stages of the pandemic, and also had higher rates of anxiety. The longitudinal impact of these disruptions on outcomes merits further study.

Trends in female representation in gastroenterology fellowships in the United States.

Background: Women have historically been underrepresented in gastroenterology (GI). Currently they compose only a small percentage of practicing GI physicians in the United States. Despite the rise in women graduating medical school, the percentage of current female GI fellows has remained low in recent years. In this study, we sought to examine the trends of female representation in GI over the past 10 years, to further elucidate the disparity, and to illustrate if any major changes have occurred. The findings were compared to those for other specialties to shed light on the relationship between them. Methods: This retrospective study used data on the gender of residents obtained through the Accreditation Council for Graduate Medical Education Data Resource Books from 2009-2019. Chi-square statistical testing was used to compare representation percentages across groups. Significance was determined at the P<0.05 level, while P<0.01 was also reported. Results: Over a 10-year period from 2009-2019, an average of 33.6% of GI fellowship positions were filled by women, an increase of only 3.3% since 2009. Chi-square analysis of proportions across groups demonstrated a significantly lower percentage of female representation in GI in comparison to other specialties. Conclusions: Despite an increase in the number of women entering and graduating from medical school within the last decade, the number of female gastroenterologists remains a poor reflection of it. GI continues to have a significantly lower female representation than other specialties over the last decade.

Endovascular control during partial nephrectomy in a renal allograft.

Partial nephrectomy of renal allografts is technically challenging. We report a case of robotic-assisted laparoscopic partial nephrectomy performed with selective cannulation and endovascular balloon occlusion of vascular inflow to transplanted kidney. Endovascular control during partial nephrectomy in a renal allograft and review of literature.

False Positive Pregnancy Test Before Kidney Transplant: Case Report and Review of Literature.

Pregnancy tests are routinely done before any surgery under general anesthesia including kidney transplantation. Positive test usually leads to more investigations to detect a possible pregnancy or malignancy and the surgery gets canceled or postponed. Because a kidney transplant from a deceased donor is not elective, it usually gets canceled in this scenario. Some groups have reported on normally elevated human chorionic gonadotrophin (hCG) levels in perimenopausal women and in patients with chronic kidney disease. This is thought to be from the pituitary. We present a highly sensitized prospective kidney transplant recipient with a positive pregnancy test with low levels of serum human chorionic gonadotrophin. She underwent additional preoperative testing after which we proceeded with the kidney transplant. Herein, we discuss the management of patients who have an unexpected positive pregnancy test before transplant.

Conservative Management of Muscle Invasive Bladder Cancer in Kidney-Pancreas Transplant Patient.

Introduction. Solid organ transplant increases the risk for muscle-invasive bladder cancer (MIBC). Although a common tumor, urothelial cell carcinoma (UCC) of the bladder in patients with kidney-pancreas transplants is scarcely reported. Case Presentation. A 65-year-old male with history of type 1 diabetes and a 14-year status post deceased donor pancreas-kidney transplant presented with 3 weeks of gross hematuria. CT scan showed multiple bladder masses. Transurethral resection of bladder tumor (TURBT) showed papillary UCC. 5 months later, the patient reported new-onset gross hematuria. TURBT showed MIBC. The patient elected for bladder-preserving TMT. On cystoscopy there was no gross evidence of carcinoma at 3.5 years of follow up. Discussion. Currently, no specific management guidelines target this population with MIBC. The first-line treatment for MIBC is radical cystectomy (RC) with neoadjuvant chemotherapy. For patients that are medically unfit or unwilling to undergo RC, trimodal therapy (TMT) is an alternative. TMT for bladder cancer consists of complete tumor resection with chemotherapy and radiation. This report demonstrates a unique case of a patient with kidney-pancreas transplant diagnosed with MIBC treated with TMT that has no evidence of gross tumorigenesis at 3.5 years after diagnosis. Our findings suggest that trimodal therapy should be considered for treatment of MIBC in patients with kidney-pancreatic transplants to preserve the donated allografts.

Assessing Vasectomy-Related Information on YouTube: An Analysis of the Quality, Understandability, and Actionability of Information.

This study aims to critically appraise the quality of vasectomy-related health information currently available on YouTube to better address patient information needs moving forward. A YouTube search was performed using the keyword "vasectomy." The first 100 videos were assessed, with irrelevant and duplicate videos excluded. Two independent reviewers evaluated the remaining videos using the DISCERN instrument for evaluating the quality of information and the Patient Education Materials Assessment Tool for Audiovisual materials (PEMAT-A/V) for assessing the understandability and actionability of materials. Source characteristics and markers of bias and misinformation were also collected. Seventy-eight videos were included in the study, with a mean duration of 6.6 minutes and mean of 216,672 views. The median DISCERN score was poor at 28 (IQR 22-33) out of a possible 80 with mean PEMAT-AV Understandability and Actionability scores of 67.6% (±16.7%) and 33.8% (±36.2%), respectively. A medical doctor was present in 61 (78.2%) of the videos, of which 53 (86.9%) were urologists and 38 (62.2%) promoted their personal practice or institution. False statements regarding vasectomy were made in 14 (17.9%) videos. Notably, no significant difference was noted in quality, understandability, or actionability of videos created by those with personal promotion to those without. The quality of information regarding vasectomy on YouTube is poor and reaches a wide audience. Continued appraisal and creation of YouTube videos that contain quality, understandable and actionable information by urologists is necessary to ensure patients are well-informed.

The Sun Is Still Shining: Nature of Industry Payments to Transplant Surgeons From 2014 to 2019.

Background: Established in 2013, the Open Payments Program (OPP) mandated that medical device and pharmaceutical manufacturers submit record of any financial incentive given to physicians to the Centers for Medicare and Medicaid Services, which is in turn made publicly available. This study aims to characterize these payments to transplant surgeons over the first 6 y of OPP data. Methods: The study sample included all physicians who received at least one nonresearch payment as transplant surgeons to the OPP. To capture transplant surgeons who may be listed under their pipeline specialty, the American Society of Transplant Surgeons member directory as of January 2021 was queried. Payments were analyzed temporally, geographically, and by payment type, physician, and industry payer. Results: In total, payments totaling $15 661 536 were made to 1335 transplant surgeons over the study period. The mean payment was $436.90 (SD, $1760), and the median payment was $52.94 (interquartile range, $18.29-$159.80). The top contributing companies were Intuitive Surgical, Inc.; Gilead Sciences, Inc.; and Novartis Pharmaceuticals. Only 5.3% ($827 236) was paid toward faculty or as a speaker for a nonaccredited and noncertified continuing education program and honorarium. Educational payments came in at $1 233 141 (7.9%) over the study period. $13 750 828.60 (87.8%) of the payments were for other categories (consulting fees, food and beverages, etc). Organ transplant and procurement region 7 and 8 transplant surgeons received the highest median payments during the study period. Conclusions: This study is the first to characterize the payments made to transplant surgeons since the passage of the Sunshine Act. Further studies are needed to understand and interpret the relationship between industry and transplant surgeons, as the payments may or may not translate to influence in medical decisions or use of medical devices.

Serum bilirubin as a predictor of graft outcomes after renal transplant.

Bilirubin is a signaling molecule that alters the immune response and metabolism. While bilirubin has been employed as a marker of renal and cardiovascular health, its role in renal transplant recipients is not known. In this study, we sought to determine the impact of bilirubin (total, direct and indirect) on the estimated glomerular filtration rate (eGFR) after renal transplantation. We conducted a retrospective review of pre- and postoperative bilirubin levels in 457 renal transplant recipients at a single center. Pre- and post-rejection bilirubin levels were also assessed in those patients who experienced a rejection episode. No statistically significant differences were found in bilirubin levels during the pre-transplant to post-rejection period among patients who experienced rejection with kidney allograft survival. No statistically significant associations were observed between baseline bilirubin and post-transplant eGFR in the full patient group or within the gender- or race-stratified groups. Baseline bilirubin was not correlated with time to rejection. Our results suggest that bilirubin may not offer renoprotection in renal transplant recipients.

Global Trends in Incidence and Burden of Urolithiasis from 1990 to 2019: An Analysis of Global Burden of Disease Study Data.

BACKGROUND: Urolithiasis is among the most common urologic diagnoses globally, with substantial burden and cost on healthcare systems worldwide. Increasing evidence links urolithiasis with an array of risk factors, including diet and lifestyle trends, noncommunicable diseases such as diabetes and obesity, and global warming. OBJECTIVE: To examine geographic, temporal, and sociodemographic patterns to better understand global disease burden of urolithiasis. DESIGN SETTING AND PARTICIPANTS: We extracted data on age-standardized incidence rate (ASIR), deaths, and disability-adjusted life years (DALYs) attributed to urolithiasis for 21 regions, including 204 countries, for 1990-2019 from the Global Burden of Disease (GBD) study. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data were analyzed at the global, regional, and country levels, as well as stratified by the Socio-Demographic Index. The average annual percentage change (AAPC) was calculated to measure temporal trends across groups. RESULTS AND LIMITATIONS: Globally, total cases, DALYs, and deaths attributed to urolithiasis increased over the study period, while the age-standardized rates of these measures decreased. The age-standardized incidence of urolithiasis decreased from 1696.2 (95% confidence interval [CI] 1358.1-2078.1) cases per 100 000 population in 1990 to 1394.0 (95% CI, 1126.4-1688.2) cases per 100 000 population in 2019, with an AAPC of -0.7 (95% CI [-0.8, -0.6]). Of the GBD regions, Eastern Europe demonstrated a consistently higher ASIR of urolithiasis than all other regions, while the Caribbean had the highest AAPC. This study is limited by the available national and regional data, as described in the original GBD study. CONCLUSIONS: Worldwide, total cases, DALYs, and deaths attributed to urolithiasis have increased since 1990, while age-standardized rates have decreased, with demonstrated regional and sociodemographic variation. Multifaceted strategies to address urolithiasis prevention and treatment are necessary. PATIENT SUMMARY: In this study, we looked at trends in the global burden of stone disease using data from 204 countries from 1990 to 2019. We found that the overall burden has increased, but it varies by age, sociodemographic variables, and geographic region. We conclude that we need adaptable policies that suit the specific needs of the country to address this burden.

Robotic stapler use: Is it safe?-FDA database analysis across multiple surgical specialties.

INTRODUCTION: Robotic-assisted techniques are common across many surgical subspecialties. While robotic stapling offers increased surgeon control, there is limited information on surgical complications related to robotic stapler use. METHODS: We reviewed the FDA's MAUDE database for adverse events related to robotic stapler use. RESULTS: Upon review of the FDA database, the most frequently reported robotic stapler complications were malfunction, failure to form staple line, device fragmentation, and misfire. 31 Clavien-Dindo grade II or higher complications were attributed to stapler use since 2014. CONCLUSIONS: Further research on prevalence of robotic stapler use is needed to quantity the associated complication rate.