Impact of Atrioventricular Valve Intervention at Each Stage of Single Ventricle Palliation.

Background: Significant atrioventricular valve dysfunction can be associated with mortality or need for transplant in functionally univentricular heart patients undergoing staged palliation. The purposes of this study are to characterize the impact of concomitant atrioventricular valve intervention on outcomes at each stage of single ventricle palliation and to identify risk factors associated with poor outcomes in these patients. Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database was queried for functionally univentricular heart patients undergoing single ventricle palliation from 2013 through 2022. Separate analyses were performed on cohorts corresponding to each stage of palliation (1: initial palliation; 2: superior cavopulmonary anastomosis; 3: Fontan procedure). Bivariate analysis of demographics, diagnoses, comorbidities, preoperative risk factors, operative characteristics, and outcomes with and without concomitant atrioventricular valve intervention was performed. Multiple logistic regression was used to identify predictors associated with operative mortality or major morbidity. Results: Concomitant atrioventricular valve intervention was associated with an increased risk of operative mortality or major morbidity for each cohort (cohort 1: 62% vs 46%, P < .001; cohort 2: 37% vs 19%, P < .001; cohort 3: 22% vs 14%, P < .001). Black race in cohort 1 (odds ratio [OR] 3.151, 95% CI 1.181-9.649, P = .03) and preterm birth in cohort 2 (OR 1.776, 95% CI 1.049-3.005, P = .032) were notable predictors of worse morbidity or mortality. Conclusions: Concomitant atrioventricular valve intervention is a risk factor for operative mortality or major morbidity at each stage of single ventricle palliation. Several risk factors are associated with these outcomes and may be useful in guiding decision-making.

Knowledge, Attitudes, and Beliefs Toward Organ Donation Registration Among Asian Americans: Development and Pilot-testing of Educational Intervention Video.

Background: Organ donation registration rates in the United States are lowest among Asian Americans. This study aimed to investigate the reasons for low organ donation registration rates among Asian Americans and develop educational material to help improve organ donation rates and awareness. Methods: We conducted a 2-phase study. In phase 1, a cross-sectional observational survey was distributed in-person on an iPad to members of the Asian community in Queens, New York, to investigate their knowledge, attitudes, and beliefs toward organ donation. Based on the results, an educational video was developed, and the efficacy of the video was assessed with an independent cohort of participants in phase 2 using a pre-/post-video comprehension assessment survey. Results: Among 514 Chinese or Korean Americans who participated in the phase 1 survey, 97 participants (19%) reported being registered organ donors. Registered donors were more likely to have previously discussed their organ donation wishes with their family (adjusted odds ratio [aOR], 4.77; 95% confidence interval [CI], 2.56-8.85; P < 0.01), knowledge of the different registration methods (aOR, 2.57; 95% CI, 1.24-5.31; P < 0.01), or know a registered organ donor (aOR, 2.62; 95% CI, 1.39-4.95; P < 0.01). For the educational video efficacy assessment given pre-/post-video, the majority (90%) of the respondents reported learning something new from the video. After watching the video, there was a significant improvement in the mean knowledge score regarding organ donation (63% versus 92%; P < 0.01) and an increase in intention to have discussion regarding organ donation with family. Conclusions: We found varies factors associated with low organ donation registration rates among Asian Americans and demonstrated the potential of our educational video to impart organ donation knowledge to viewers and instigate the intention to have family discussions regarding organ donation. Further research is needed to assess the impact of videos in motivating actual organ donation registration.

Highly Sensitized Kidney Transplant Outcomes After the 2014 Kidney Allocation System Change.

Introduction: Kidney Allocation System (KAS) was implemented by United Network for Organ Sharing in 2014 to reduce allocation disparities. Research Questions: Outcomes of highly sensitized patients (calculated panel reactive antibody (cPRA) ≥ 97%) before and after KAS were compared to low-risk recipients (cPRA <10%) in the post-KAS era were examined. The impact on racial disparities was determined. Design: This was a retrospective study of national registry data. Two cohorts of adult candidates waitlisted for deceased donor transplantation during 3-year periods before and after KAS were identified. Results: Highly sensitized patients (N = 1238 and 4687) received a deceased donor kidney transplant between January 1, 2011 and December 31, 2013 and between January 1, 2015 and December, 31, 2017. Racial disparity for highly sensitized patients improved, yet remained significant (P < 0.001), with Black patients comprising 40% and 41% of the highly sensitized candidates and 28% and 34% of the recipients pre- and post-KAS. While posttransplant death-censored graft failure for highly sensitized recipients was similar overall, post-KAS was associated with improved graft survival in the first year after transplant (HR 0.56, 95% CI 0.40-0.78). When compared to contemporaneous lowrisk recipients, both death-censored and all-cause graft failure were similar for highly sensitized recipients and was associated with increased risk for death-censored graft failure beyond the first year (HR 1.39, 95% CI 1.11-1.73). Conclusion: The allocation system led to an increase in transplantation in highly sensitized candidates without compromising outcomes. Although KAS has led to more balanced transplant rates between highly sensitized Black and White patients, racial inequalities persist.

Donor-derived membranous nephropathy in the allograft kidney: A rare but probably underestimated complication.

Transmitted donor-derived glomerular diseases in the allograft kidney are rare, especially when encountered in an allograft from a living donor. To date, only individual reports of donor-derived membranous nephropathy (MN) have been described. In this report, we present a case of MN discovered in a postreperfusion biopsy of a living-donor allograft. A follow-up biopsy 3 weeks later demonstrated persistent deposits. Thirteen months posttransplant, the recipient showed mildly worsening proteinuria but stable kidney function. To further our understanding of this exceedingly rare complication, we share our experience with 7 additional in-house cases together with 6 cases described in the literature to date. A minority of the donors were living. Most donors did not exhibit significant proteinuria illustrating how predonation screening could potentially miss donor-derived MN. Reactivity for phospholipase A2 receptor and thrombospondin type 1 domain containing 7A were negative in all stained cases. On follow-up, recipients variably exhibited slow resolution of the immune deposits, variable degrees of proteinuria (mainly subnephrotic), and no significant impairment of kidney function. Donor-derived MN is rare, phospholipase A2 receptor-negative, and can still be encountered in living donors despite rigorous screening. This report provides a brief examination of the pathology, clinical, and laboratory features of such patients involved.

Long-term outcomes following the Ross procedure in neonates and infants: A multi-institutional analysis.

OBJECTIVES: For neonates and infants with aortic valve pathology, the Ross procedure historically has been associated with high rates of morbidity and mortality. Data regarding long-term durability are lacking. METHODS: The international, multi-institutional Ross Collaborative included 6 tertiary care centers. Infants who underwent a Ross operation between 1996 and 2016 (allowing a minimum 5 years of follow-up) were retrospectively identified. Serial echocardiograms were examined to study evolution in neoaortic size and function. RESULTS: Primary diagnoses for the 133 patients (n = 30 neonates) included isolated aortic stenosis (14%, n = 19), Shone complex (14%, n = 19), and aortic stenosis plus other (excluding Shone complex; n = 95, 71%), including arch obstruction (n = 55), left ventricular hypoplasia (n = 9), and mitral disease (moderate or greater stenosis or regurgitation, n = 31). At the time of the Ross procedure, median age was 96 days (interquartile range, 36-186), and median weight was 4.4 kg (3.6-6.5). In-hospital mortality occurred in 13 of 133 patients (10%) (4/30 [13%] neonates). Postdischarge mortality occurred in 10 of 120 patients (8%) at a median of 298 days post-Ross. Post-Ross neoaortic dilatation occurred, peaking at 4 to 5 SDs above normal at 2 to 3 years before returning to near-baseline z-score at a median follow-up of 11.5 [6.4-17.4] years. Autograft/left ventricular outflow tract reintervention was required in 5 of 120 patients (4%) at a median of 10.3 [4.1-12.8] years. Freedom from moderate or greater neoaortic regurgitation was 86% at 15 years. CONCLUSIONS: Neonates and infants experience excellent postdischarge survival and long-term freedom from autograft reintervention and aortic regurgitation after the Ross. Neoaortic dilatation normalizes in this population in the long-term. Increased consideration should be given to Ross in neonates and infants with aortic valve disease.

Incomplete reporting of clinically significant acute rejection episodes in the national kidney transplant registry.

Administrative claims data could provide a unique opportunity to identify acute rejection (AR) events using specific antirejection medications and to validate rejected data reported to the Organ Procurement and Transplantation Network. This retrospective cohort study examined differences in registry-reported events and those identified using claims data among adult kidney transplant recipients from 2012 to 2017 using Standard Analysis Files from the US Renal Data System. Rejection rates, survival estimates, and center-level differences were assessed using each approach. Among 45 880 first-time kidney transplant recipients, we identified 3841 AR events within 12 months of transplant reported by centers in the registry; claims data yielded 2945 events. Of all events occurring within 12 months of transplant, 48.5% were reported using registry only, 32.9% were identified using claims only, and 18.6% were identified using both approaches. A 3-year death-censored graft survival probability was 90.0%, 88.4%, and 81.2% (P < .001) for ARs identified using registry only, claims data only, and both approaches, respectively. The large discordance between registry-reported and claims-based events suggests incomplete and potentially inaccurate reporting of events in the Organ Procurement Transplant Network registry. These findings have important implications for analyses that use AR data and underscore the need for improved capture of clinically meaningful events.

Association of Implantation Biopsy Findings in Living Donor Kidneys With Donor and Recipient Outcomes.

RATIONALE & OBJECTIVE: Some living donor kidneys are found to have biopsy evidence of chronic scarring and/or glomerular disease at implantation, but it is unclear if these biopsy findings help predict donor kidney recovery or allograft outcomes. Our objective was to identify the prevalence of chronic histological changes and glomerular disease in donor kidneys, and their association with donor and recipient outcomes. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Single center, living donor kidney transplants from January 2010 to July 2022. EXPOSURE: Chronic histological changes, glomerular disease in donor kidney implantation biopsies. OUTCOME: For donors, single-kidney estimated glomerular filtration rate (eGFR) increase, percent total eGFR loss, ≥40% eGFR decline from predonation baseline, and eGFR<60mL/min/1.73m2 at 6 months after donation; for recipients, death-censored allograft survival. ANALYTICAL APPROACH: Biopsies were classified as having possible glomerular disease by pathologist diagnosis or chronic changes based on the percentage of glomerulosclerosis, interstitial fibrosis/tubular atrophy, and vascular disease. We used logistic regression to identify factors associated with the presence of chronic changes, linear regression to identify the association between chronic changes and single-kidney estimated glomerular filtration rate (eGFR) recovery, and time-to-event analyses to identify the relationship between abnormal biopsy findings and allograft outcomes. RESULTS: Among 1,104 living donor kidneys, 155 (14%) had advanced chronic changes on implantation biopsy, and 12 (1%) had findings suggestive of possible donor glomerular disease. Adjusted logistic regression showed that age (odds ratio [OR], 2.44 per 10 years [95% CI, 1.98-3.01), Hispanic ethnicity (OR, 1.87 [95% CI, 1.15-3.05), and hypertension (OR, 1.92 [95% CI, 1.01-3.64), were associated with higher odds of chronic changes on implantation biopsy. Adjusted linear regression showed no association of advanced chronic changes with single-kidney eGFR increase or relative risk of eGFR<60mL/min/1.73m2. There were no differences in time-to-death-censored allograft failure in unadjusted or adjusted Cox proportional hazards models when comparing kidneys with chronic changes to kidneys without histological abnormalities. LIMITATIONS: Retrospective, absence of measured GFR. CONCLUSIONS: Approximately 1 in 7 living donor kidneys had chronic changes on implantation biopsy, primarily in the form of moderate vascular disease, and 1% had possible donor glomerular disease. Abnormal implantation biopsy findings were not significantly associated with 6-month donor eGFR outcomes or allograft survival. PLAIN-LANGUAGE SUMMARY: Kidney biopsies are the gold standard test to identify the presence or absence of kidney disease. However, kidneys donated by healthy living donors-who are extensively screened for any evidence of kidney disease before donation-occasionally show findings that might be considered "abnormal," including the presence of scarring in the kidney or findings suggestive of a primary kidney disease. We studied the frequency of abnormal kidney biopsy findings among living donors at our center. We found that about 14% of kidneys had chronic abnormalities and 1% had findings suggesting possible glomerular kidney disease, but the presence of abnormal biopsy findings was not associated with worse outcomes for the donors or their recipients.

Extracorporeal blood purification with Oxiris® filter in critically ill patients with COVID-19 requiring continuous renal replacement therapy.

INTRODUCTION: Severe COVID-19 is associated with a dysregulated immune response that usually leads to cytokine release syndrome. This study aimed to compare the use of extracorporeal blood purification therapy (Oxiris®) versus standard continuous renal replacement therapy (CRRT) in critically-ill patients with severe COVID-19. METHODS: This was a national, multicenter, retrospective study of patients with COVID-19 admitted to the intensive care unit (ICU) between March and October 2020 who required CRRT. Patients were categorized into two groups: Oxiris® CRRT and standard CRRT. The primary outcome was the number of patients alive and ventilator-free at 30-days post-CRRT treatment. Key secondary endpoints included change in inflammatory markers, Sequential Organ Failure Assessment (SOFA) scores, and PaO2/FiO2 ratio at 24- and 72-h post Oxiris® initiation. RESULTS: Thirty-five patients received Oxiris® CRRT and 23 patients received standard CRRT. The primary outcome was 31.4% in the Oxiris® group versus 4.3% in the standard CRRT group (adjusted odds ratio 5.97, 95% confidence interval [CI], 0.64-55.6; p = 0.117). In the Oxiris® group, interleukin-6 (IL-6) concentrations significantly decreased at 24 and 72-h (p = 0.033) and PaO2/FiO2 ratio significantly increased at 24 and 72 h after Oxiris® initiation (p = 0.001). There was no significant change in SOFA scores at 24- and 72-h after Oxiris® initiation. CONCLUSION: The number of patients alive and ventilator-free at 30-days was higher in the Oxiris® group than that in the standard CRRT group; however, the difference did not reach statistical significance after adjusting for the baseline severity of illness. There was a significant reduction in IL-6 and significant improvement in PaO2/FiO2 ratio after Oxiris® CRRT initiation.

Recommendations for Centers Performing Pediatric Heart Surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Recommendations for centers performing pediatric heart surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Disparities in Kidney Transplant Waitlisting Among Young Patients Without Medical Comorbidities.

Importance: Disparities in kidney transplant referral and waitlisting contribute to disparities in kidney disease outcomes. Whether these differences are rooted in population differences in comorbidity burden is unclear. Objective: To examine whether disparities in kidney transplant waitlisting were present among a young, relatively healthy cohort of patients unlikely to have medical contraindications to kidney transplant. Design, Setting, and Participants: This retrospective cohort study used the US Renal Data System Registry to identify patients with end-stage kidney disease who initiated dialysis between January 1, 2005, and December 31, 2019. Patients who were older than 40 years, received a preemptive transplant, were preemptively waitlisted, or had documented medical comorbidities other than hypertension or smoking were excluded, yielding an analytic cohort of 52 902 patients. Data were analyzed between March 1, 2022, and February 1, 2023. Main Outcome(s) and Measure(s): Kidney transplant waitlisting after dialysis initiation. Results: Of 52 902 patients (mean [SD] age, 31 [5] years; 31 132 [59%] male; 3547 [7%] Asian/Pacific Islander, 20 782 [39%] Black/African American, and 28 006 [53%] White) included in the analysis, 15 840 (30%) were waitlisted for a kidney transplant within 1 year of dialysis initiation, 11 122 (21%) were waitlisted between 1 and 5 years after dialysis initiation, and 25 940 (49%) were not waitlisted by 5 years. Patients waitlisted within 1 year of dialysis initiation were more likely to be male, to be White, to be employed full time, and to have had predialysis nephrology care. There were large state-level differences in the proportion of patients waitlisted within 1 year (median, 33%; range, 15%-58%). In competing risk regression, female sex (adjusted subhazard ratio [SHR], 0.92; 95% CI, 0.90-0.94), Hispanic ethnicity (SHR, 0.77; 95% CI, 0.75-0.80), and Black race (SHR, 0.66; 95% CI, 0.64-0.68) were all associated with lower waitlisting after dialysis initiation. Unemployment (SHR, 0.47; 95% CI, 0.45-0.48) and part-time employment (SHR, 0.74; 95% CI, 0.70-0.77) were associated with lower waitlisting compared with full-time employment, and more than 1 year of predialysis nephrology care, compared with none, was associated with greater waitlisting (SHR, 1.51; 95% CI, 1.46-1.56). Conclusions and Relevance: This retrospective cohort study found that fewer than one-third of patients without major medical comorbidities were waitlisted for a kidney transplant within 1 year of dialysis initiation, with sociodemographic disparities in waitlisting even in this cohort of young, relatively healthy patients unlikely to have a medical contraindication to transplantation. Transplant policy changes are needed to increase transparency and address structural barriers to waitlist access.

Outcomes After Hybrid Palliation for Infants With Critical Left Heart Obstruction.

BACKGROUND: Hybrid palliation (bilateral pulmonary artery banding with or without ductal stenting) is an initial management strategy for infants with critical left heart obstruction and serves as palliation until subsequent operations are pursued. OBJECTIVES: This study sought to determine patient characteristics and factors associated with subsequent outcomes for infants who underwent hybrid palliation. METHODS: From 2005 to 2019, 214 of 1,236 prospectively enrolled infants within the Congenital Heart Surgeons' Society's critical left heart obstruction cohort underwent hybrid palliation across 24 institutions. Multivariable hazard modeling with competing risk methodology was performed to determine risk and factors associated with outcomes of biventricular repair, Fontan procedure, transplantation, or death. RESULTS: Preoperative comorbidities (eg, prematurity, low birth weight, genetic syndrome) were identified in 70% of infants (150 of 214). Median follow-up was 7 years, ranging up to 17 years. Overall 12-year survival was 55%. At 5 years after hybrid palliation, 9% had biventricular repair, 36% had Fontan procedure, 12% had transplantation, 35% died without surgical endpoints, and 8% were alive without an endpoint. Factors associated with transplantation were absence of ductal stent, older age, absent interatrial communication, smaller aortic root size, larger tricuspid valve area z-score, and larger left ventricular volume. Factors associated with death were low birth weight, concomitant genetic syndrome, cardiopulmonary bypass use during hybrid palliation, moderate to severe tricuspid valve regurgitation, and smaller ascending aortic size. CONCLUSIONS: Mortality remains high after hybrid palliation for infants with critical left heart obstruction. Nonetheless, hybrid palliation may facilitate biventricular repair for some infants and for others may serve as stabilization for intended functional univentricular palliation or primary transplantation.

Recommendations for Centers Performing Pediatric Heart Surgery in the United States.

Care and outcomes for the more than 40,000 patients undergoing pediatric and congenital heart surgery in the United States annually are known to vary widely. While consensus recommendations have been published across numerous fields as one mechanism to promote a high level of care delivery across centers, it has been more than two decades since the last pediatric heart surgery recommendations were published in the United States. More recent guidance is lacking, and collaborative efforts involving the many disciplines engaged in caring for these children have not been undertaken to date. The present initiative brings together professional societies spanning numerous care domains and congenital cardiac surgeons, pediatric cardiologists, nursing, and other healthcare professionals from diverse programs around the country to develop consensus recommendations for United States centers. The focus of this initial work is on pediatric heart surgery, and it is recommended that future efforts focus in detail on the adult congenital population. We describe the background, rationale, and methodology related to this collaborative effort, and recommendations put forth for Essential Care Centers (essential services necessary for any program), and Comprehensive Care Centers (services to optimize comprehensive and high-complexity care), encompassing structure, process, and outcome metrics across 14 domains.

Discrepant Outcomes between National Kidney Transplant Data Registries in the United States.

SIGNIFICANCE STATEMENT: Effects of reduced access to external data by transplant registries to improve accuracy and completeness of the collected data are compounded by different data management processes at three US organizations that maintain kidney transplant-related datasets. This analysis suggests that the datasets have large differences in reported outcomes that vary across different subsets of patients. These differences, along with recent disclosure of previously missing outcomes data, raise important questions about completeness of the outcome measures. Differences in recorded deaths seem to be increasing in recent years, reflecting the adverse effects of restricted access to external data sources. Although these registries are invaluable sources for the transplant community, discrepancies and incomplete reporting risk undermining their value for future analyses, particularly when used for developing national transplant policy or regulatory measures. BACKGROUND: Central to a transplant registry's quality are accuracy and completeness of the clinical information being captured, especially for important outcomes, such as graft failure or death. Effects of more limited access to external sources of death data for transplant registries are compounded by different data management processes at the United Network for Organ Sharing (UNOS), the Scientific Registry of Transplant Recipients (SRTR), and the United States Renal Data System (USRDS). METHODS: This cross-sectional registry study examined differences in reported deaths among kidney transplant candidates and recipients of kidneys from deceased and living donors in 2000 through 2019 in three transplant datasets on the basis of data current as of 2020. We assessed annual death rates and survival estimates to visualize trends in reported deaths between sources. RESULTS: The UNOS dataset included 77,605 deaths among 315,346 recipients and 61,249 deaths among 275,000 nonpreemptively waitlisted candidates who were never transplanted. The SRTR dataset included 87,149 deaths among 315,152 recipients and 60,042 deaths among 259,584 waitlisted candidates. The USRDS dataset included 89,515 deaths among 311,955 candidates and 63,577 deaths among 238,167 waitlisted candidates. Annual death rates among the prevalent transplant population show accumulating differences across datasets-2.31%, 4.00%, and 4.03% by 2019 from UNOS, SRTR, and USRDS, respectively. Long-term survival outcomes were similar among nonpreemptively waitlisted candidates but showed more than 10% discordance between USRDS and UNOS among transplanted patients. CONCLUSIONS: Large differences in reported patient outcomes across datasets seem to be increasing, raising questions about their completeness. Understanding the differences between these datasets is essential for accurate, reliable interpretation of analyses that use these data for policy development, regulatory oversight, and research. PODCAST: This article contains a podcast at https://dts.podtrac.com/redirect.mp3/www.asn-online.org/media/podcast/JASN/2023_10_24_JASN0000000000000194.mp3.