Clinical Characteristics Of Recipients Research Articles

Characteristics and Outcomes for Recipients of NVX-CoV2373: A Real-World Retrospective Study in Germany.

Real-world evidence supports SARS-CoV-2 vaccination strategies during the COVID-19 pandemic. This real-world retrospective study utilized the German Disease Analyzer database to characterize recipients of NVX-CoV2373 and explore vaccination outcomes. Recipients (≥12 years) of NVX-CoV2373 as a primary series or booster in Germany were vaccinated between March and December 2022. Outcomes included demographics and clinical characteristics of recipients, tolerability/reactogenicity-related events within 7 and 14 days post-vaccination, and protection from COVID-19. Overall, there were 597 recipients (mean age ~60 years) of NVX-CoV2373; 81% were vaccinated by a general practitioner, and 68% had a Standing Committee on Vaccination (STIKO) high-risk factor. The most common baseline comorbidities were chronic neurological (36%) and chronic intestinal (21%) diseases. Among recipients with metabolic disease (~11%), 65% had diabetes. Tolerability/reactogenicity-related symptoms were recorded in ~1% of recipients. There were no sick-leave notes associated with NVX-CoV2373. After 10 months (median, 7 months) of follow-up, 95% (95% CI, 93-95) of recipients were estimated to be protected from COVID-19. Outcomes were similar across the primary series, booster, and STIKO populations. Tolerability and COVID-19 protection support the use of NVX-CoV2373 as a primary/booster vaccination for all authorized populations, including high-risk.

Temporal Trends and Evolving Outcomes After Simultaneous Liver-Kidney Transplantation: Results from the US SLKT Consortium.

We aimed to understand the contemporary changes in the characteristics and the determinants of outcomes among simultaneous liver-kidney transplantation (SLKT) recipients at 6 liver transplantation centers in the United States. We retrospectively enrolled SLKT recipients between 2002 and 2017 in the US Multicenter SLKT Consortium. We analyzed time-related trends in recipient characteristics and outcomes with linear regression and nonparametric methods. Clustered Cox regression determined the factors associated with 1-year and overall survival. We enrolled 572 patients. We found significant changes in the clinical characteristics of SLKT recipients: as compared with 2002, recipients in 2017 were older (59 versus 52years; P<0.001) and more likely to have chronic kidney disease (71% versus 33%; P<0.001). There was a marked improvement in 1-year survival during the study period: 89% in 2002 versus 96% in 2017 (P<0.001). We found that the drivers of 1-year mortality were SLKT year, hemodialysis at listing, donor distance, and delayed kidney allograft function. The drivers of overall mortality were an indication of acute kidney dysfunction, body mass index, hypertension, creatinine at SLKT, ventilation at SLKT, and donor quality. In this contemporary cohort of SLKT recipients, we highlight changes in the clinical characteristics of recipients. Further, we identify the determinants of 1-year and overall survival to highlight the variables that require the greatest attention to optimize outcomes.

Cognitive Function in Liver Transplant Recipients Who Survived More Than 6 Months.

Current research in the areas of liver transplant and cognitive function has primarily examined cognitive changes from pre- to 1-year posttransplant, resulting in an insufficient understanding of cognitive trajectory beyond early periods of transplant and its impact on self-management. This study aimed (1) to describe global and domain-specific cognitive function in liver transplant recipients who survived more than 6 months after transplant and (2) to describe patient and clinical characteristics of recipients with impaired global and/or domain-specific cognitive function. Further, this study explored the potential relationships between cognitive function and self-management by examining differences in cognitive function by levels of self-management. This secondary data analysis included 107 adult liver transplant recipients, who had a functioning transplant for at least 6 months. Data of cognitive function, demographic and clinical characteristics, and self-management were extracted for this study. T tests, Mann-Whitney tests, and Kruskal-Wallis tests were used to examine differences in cognitive function by variables. More than half of the recipients had global cognitive impairment. Significant differences were found in global and domain-specific cognitive function. Older, male, married, or deceased donor recipients had lower cognitive test scores than younger, female, single, or living donor recipients. There were no significant differences in global and domain-specific cognitive function by time since transplant and levels of self-management. Future longitudinal studies should examine the long-term trajectory of cognitive function posttransplant. Other factors such as caregivers' participation in self-management should be accounted for in future studies when examining the relationship between cognitive function and self-management.

RSV and non-RSV illness hospitalization in RSV immunoprophylaxis recipients: A systematic literature review.

Respiratory syncytial virus (RSV) immunoprophylaxis (IP) has been shown to reduce RSV hospitalization rates in high-risk infants; however, it is unclear whether RSV IP is associated with increased risk of non-RSV disease, particularly non-RSV hospitalizations. We conducted a systematic literature review to understand the occurrences of non-RSV disease and/or non-RSV hospitalizations in published studies of RSV IP. Cochrane, Embase, and PubMed databases were searched and reviewed to summarize data regarding the incidence of RSV and non-RSV respiratory disease among RSV IP recipients and controls in randomized and non-randomized studies. Independent investigators screened and selected studies for inclusion. Risk-of-bias assessment was conducted to assess strength/validity of the data using the Jadad scoring system and Downs and Black quality assessment tool, where appropriate. Twenty studies were included for review (5 randomized controlled trials [RCTs]; 15 non-randomized studies). RCTs of RSV IP demonstrated reductions in RSV hospitalizations and all-cause hospitalizations, with no increase in hospitalizations for non-RSV disease. Non-randomized studies also demonstrated reduced RSV hospitalizations in RSV IP recipients but had mixed results in assessments of hospitalizations for non-RSV disease. When RSV IP recipients and controls were more similar in disease severity risk, results of non-randomized studies aligned more closely with RCTs. Observations of increased non-RSV hospitalization rates among RSV IP recipients in some non-randomized studies could be primarily explained by differences in the clinical characteristics between RSV IP recipients and controls.

The data and characteristics of the human milk banks in mainland China

BackgroundHuman milk banks (HMB) have been established for over 100 years in North America and Europe. This study aimed to describe and summarize the operation and characteristics of the HMBs in mainland China since the first nonprofit HMB operated in 2013.MethodsOperation of HMB in mainland China is based on the standards and guidelines of the Human Milk Banking Association of North America and some countries in Europe and was modified to meet the needs and circumstances in China such as donation only in the local HMB by medical staff. We reviewed the descriptive data of these 14 HMBs and the clinical characteristics of recipients, the eligible milk donors and the donor milk retrospectively.ResultsIn mainland China, from March 2013 to December 2016, 14 nonprofit HMBs were developed and operational in public hospitals except one and located in the south, east, north and northwest of mainland China. In total, 2680 eligible donors donated 4608.2 L of breast milk. The mean age of these donors was 29.4 years with 60.6% receiving college education and 90.6% term delivery. A total of 4678 recipients including preterm infants (n = 2990, 63.9%), feeding intolerance (n = 711, 15.2%), maternal illness (n = 345, 7.4%), serious infection (n = 314, 6.7%), necrotising enterocolitis (n = 244, 5.2%), post-surgery (n = 38, 0.8%) and others (n = 36, 0.8%). The rate of discarded raw milk was only 4.4% because of hepatitis B and C or cytomegalovirus positivity.ConclusionsHMB has been developing rapidly in mainland China. Donor human milk was used not only for preterm infants but also for other ill children. But the sustainability of milk banking needs proper management and more financial support by relative health authorities and the government.

New Factors Predicting Delayed Graft Function: a Multi-Center Cohort Study of Kidney Donation After Brain Death Followed by Circulatory Death

Background/Aims: Delayed graft function (DGF) is a common complication following kidney transplantation adversely affecting graft outcomes. Donation after brain death followed by circulatory death (DBCD), a novel donation pattern, is expected to correlate with high incidence of DGF. However, little information is available about factors associated with DGF in DBCD. Methods: A total of 383 kidney transplants from DBCD donation in three institutions were enrolled. Associations of DGF with the clinical characteristics of recipients and donors were quantified. Results: In this retrospective multi-center study, the incidence of DGF was 19.3%. Lower incidence of DGF was found in recipients for whom antithymocyte globulin was used for induction (p < 0.05), which was an independent protective factor against DGF (odds ratio [OR] = 0.48; 95% CI 0.27-0.86). Two novel explicative variables were recognized as independent risk factors, including use of vasoactive drugs (OR = 3.15; 95% CI 1.39-7.14) and cardiopulmonary resuscitation (OR = 2.51; 95% CI 1.05-6.00), which contributed significantly to increased risk of DGF (p < 0.05). Prolonged warm ischemia time (> 18 min; OR = 2.42; 95% CI 1.36-4.32), was also predictive of DGF in DBCD. A prediction model was developed and achieved an area under the curve of 0.89 in predicting DGF when combined with reported parameters. Conclusion: The novel factors, confirmed for the first time in our study, will help to improve risk prediction of DGF and to determine optimal interventions to prevent DGF in clinical practice.

Registro Español de Trasplante Cardiaco (Adultos). XXV Informe Oficial de la Sección de Insuficiencia Cardiaca y Trasplante Cardiaco de la Sociedad Española de Cardiología (1984–2013)

This article describes the characteristics and outcomes of heart transplantations in patients aged 16 years or more in Spain from May 1984, when the technique was first used in the country. It contains a descriptive analysis of the characteristics of recipients, donors and surgical procedures and of the outcomes of all heart transplantations performed up to December 31, 2013. In 2013, 219 procedures were carried out in patients aged 16 years or more at the time of transplantation. These patients form part of the historical series of 6632 procedures carried out in this age group. In recent years, there has been progressive worsening of the clinical characteristics of recipients (i.e. 32% were aged over 60 years, 23% had severe renal failure, 19% were insulin- dependent diabetics, 27% had undergone cardiac surgery and 15% were on mechanical ventilation), donors (i.e. 45% were aged over 45 years and 25% had a recipient-donor weight mismatch >20%), and surgical procedures (i.e. 28% involved an ischemia time >4 hours and 37% were urgent). The survival rate at 1, 5, 10, and 15 years was 77%, 65%, 53%, and 37%, respectively. These figures have remained stable since 1995. Over the last few years there has been a slow decline in the number of heart transplantations performed in Spain. However, despite a clear deterioration in the clinical characteristics of recipients, donors and surgical procedures, mortality has remained comparable with that observed in neighboring countries.

Registro Español de Trasplante Cardiaco. XXIV Informe Oficial de la Sección de Insuficiencia Cardiaca y Trasplante Cardiaco de la Sociedad Española de Cardiología (1984-2012)

Introduction and objectivesThe present article reports the characteristics and results of heart transplantation in Spain since this therapeutic modality was first used in May 1984. MethodsWe summarize the main features of recipients, donors, and surgical procedures, as well as the results of all heart transplantations performed in Spain until December 31, 2012. ResultsA total of 247 heart transplantations were performed in 2012. The whole series consisted of 6775 procedures. Recent years have seen a progressive worsening in the clinical characteristics of recipients (34% aged over 60 years, 22% with severe kidney failure, 17% with insulin-dependent diabetes, 29% with previous heart surgery, 16% under mechanical ventilation) and donors (38% aged over 45 years, 26% with recipient: donor weight mismatch>20%), and in surgical conditions (29% of procedures at >4h ischemia and 36% as emergency transplantations). The probability of survival at 1, 5, 10, and 15 years of follow-up was 78%, 67%, 53%, and 38%, respectively. These results have remained stable since 1995. ConclusionsIn recent years, the number of heart transplantations/year in Spain has remained stable at around 250. Despite the worsening of recipient and donor clinical characteristics and of time-to-surgery, the results in terms of mortality have remained stable and compare favorably with those of other countries.Full English text available from:www.revespcardiol.org/en

Spanish Heart Transplantation Registry. 24th Official Report of the Spanish Society of Cardiology Working Group on Heart Failure and Heart Transplantation (1984-2012)

Introduction and objectivesThe present article reports the characteristics and results of heart transplantation in Spain since this therapeutic modality was first used in May 1984. MethodsWe summarize the main features of recipients, donors, and surgical procedures, as well as the results of all heart transplantations performed in Spain until December 31, 2012. ResultsA total of 247 heart transplantations were performed in 2012. The whole series consisted of 6775 procedures. Recent years have seen a progressive worsening in the clinical characteristics of recipients (34% aged over 60 years, 22% with severe kidney failure, 17% with insulin-dependent diabetes, 29% with previous heart surgery, 16% under mechanical ventilation) and donors (38% aged over 45 years, 26% with recipient: donor weight mismatch>20%), and in surgical conditions (29% of procedures at >4 h ischemia and 36% as emergency transplantations). The probability of survival at 1, 5, 10, and 15 years of follow-up was 78%, 67%, 53%, and 38%, respectively. These results have remained stable since 1995. ConclusionsIn recent years, the number of heart transplantations/year in Spain has remained stable at around 250. Despite the worsening of recipient and donor clinical characteristics and of time-to-surgery, the results in terms of mortality have remained stable and compare favorably with those of other countries.

Emergency cardiac re-transplantation: is it justified? Data from the National Heart Transplant registry

Background: For many years, high-emergency cardiac re-transplantation (HE-CR) has been considered as the choice therapeutic option for patients with irreversible primary graft failure during the early postoperative period of a previous heart transplantation (HT). HE-CR is also occasionally considered for HT patients in a critical clinical condition due to late graft failure secondary to chronic rejection. Aims: To describe the early postoperative and long-term outcomes of patients undergoing HE-CR and to compare them with those of patients undergoing a first heart transplantation under a high-emergency status (FHT-HE). Methods: Multicenter registry including 711 patients aged >18 who underwent high-emergency HT between January 1, 2000 and December 31, 2009 in fifteen out of the sixteen hospitals provided with an adult HT program. All patients suffered from severe cardiac failure depending on intravenous inotropes or mechanical circulatory support, or complicated with refractory arrythmic storm. Data were collected from the National Heart Transplant Registry database and clinical records. Early postoperative outcomes and long-term survival of HE-CR and FHT-HE patients were compared. Data on patients' vital status were available as for October 31, 2010. Kaplan-Meier post-transplant long-term survival curves were estimated, and then compared by means of the log-rank test. Results: 31 (4.5%) patients underwent HE-CR and 680 patients underwent FHT-HE. Mean age was 50 years, and 20% were women. No significant differences regarding basal clinical characteristics of recipients or donors were observed between the two groups, with the exception that HE-CR patients showed a higher mean serum creatinin (1.7±0.7 versus 1.3±0.7 mg/dl, p=0.01). The proportion of patients supported on a short-term VAD was 26% in the HE-CR group and 15% in the HE-FHT group (p=0.09). During the early postoperative period, the HE-CR group presented significantly higher rates of major surgical bleeding (48% versus 24%, p=0.02), primary graft failure (52% versus 24%, p<0.001), and in-hospital death (45% versus 26%, p=0.02) than the FHT-HE group. Post-transplant long-term survival of the HE-CR group was significantly reduced in comparison with the FHT-HE group (p=0.031). Long-term survival of patients who survived the early postoperative period was not significantly different between both groups. Conclusion: HE-CR is associated with a high risk of adverse postoperative outcomes and mortality. In the current era of increasing donor scarcity, the indication of this procedure should be restricted.

Depressive Disorder in Renal Transplantation: An Analysis of Medicare Claims

Little is known about depression after kidney transplantation. Retrospective observational study. US Renal Data System data; first kidney-only recipients who underwent transplantation in 1995 to 2003 with Medicare as primary payer (n = 47,899). Demographic and clinical characteristics of recipients (age, sex, race, ethnicity, primary cause of kidney disease, pretransplantation time on dialysis therapy, body mass index, initial immunosuppressive medications, and use of induction antibodies) and donors (age, sex, race, and living or deceased), transplantation year, and number of HLA mismatches. Depression incidence identified in Medicare claims and associations with clinical outcomes during the first 3 years posttransplantation. Depression was identified in 3,360 transplant recipients in the 3 years posttransplantation. Cumulative incidences were 5.05%, 7.29%, and 9.10% at 1, 2, and 3 years posttransplantation. In Cox proportional hazards analysis, white race, female sex, diabetes as primary cause of kidney disease, more than 3 years on dialysis therapy before transplantation, marked obesity (body mass index >or= 35 kg/m(2)), rapamycin use, antilymphocyte globulin or antithymocyte globulin for antibody induction therapy, donor age of 65 years or older, more recent transplantation, and presence of 6 HLA mismatches were associated with more depression, as identified in claims. Controlling for other known risk factors, time-dependent Cox proportional hazards analysis showed that depression was associated with increased graft failure (hazard ratio, 2.10; 95% confidence interval, 1.94 to 2.27; P < 0.001), return to dialysis therapy (hazard ratio, 1.97; 95% confidence interval, 1.76 to 2.19; P < 0.001), and death with a functioning graft (hazard ratio, 2.24; 95% confidence interval, 2.00 to 2.50; P < 0.001). Depression identified through Medicare claims, limiting case ascertainment; limited number of recipient- or donor-related factors explored for potential associations; and limited depression treatment and pretransplantation depression information. Depression is associated with several identifiable factors and a 2-fold greater risk of graft failure and death with a functioning graft.

Rehabilitation in Nursing Homes: A Cross-National Comparison of Recipients

to examine the prevalence of therapy use in nursing homes in selected countries and to describe the characteristics of nursing home residents who receive therapy. DESIGN and the design of the study is cross-sectional, using Minimum Data Set (MDS) assessments of nursing home residents. The sample includes all nursing home residents in six US states (n = 273491), in Copenhagen, Denmark (n = 3451), Reyjkavik, Iceland (n = 1254), and selected locations in Italy (n = 1089) and Japan (n = 1255). we determined who had received physical or occupational therapy treatments in the last 7 days. Demographic and clinical characteristics of recipients were compared relative to other nursing home residents within each country. in the five countries, the prevalence of receiving therapy was 31% (Iceland), 30% Japan), 23% (Denmark), 14% (Italy) and 11% (USA). Substantial proportions of the recipients were over the age of 85, were clinically stable and had been in the nursing home for longer than 90 days. Across all countries, residents with poorer activities of daily living (ADL) scores but good cognitive scores were more likely to receive therapy than other residents. Rehabilitation nursing, an adjunct to therapy, was concentrated on residents with poor ADL scores. substantial numbers of long-stay residents receive therapy in nursing homes, including those over the age of 85 years and those with cognitive impairment. Hence, future rehabilitation outcome studies can involve these previously understudied patient populations.

Outpatient Antiarrhythmic Drug Use From 1970 Through 1986

Antiarrhythmic drugs have been marketed in the United States for more than three decades. However, little is known about the prevalence of use of these drugs. Using data from the National Prescription Audit, we examined trends in outpatient use of oral antiarrhythmic agent types 1 and 3 from 1970 through 1986. Using the National Disease and Therapeutic Index, we assessed prescribing physician specialty and general demographic and clinical characteristics of recipients. We adjusted the numbers of prescriptions dispensed for broad changes in the US population demographics over the 17-year period. From 1970 through 1986 the number of antiarrhythmic agent prescriptions dispensed increased by 200%, from 3.8 million to 11.5 million. This increase is greater than that expected due to changes in size of the US population, estimated changes in prevalence of heart disease, or estimated changes in the proportion of patients with heart disease who have arrhythmias. The weight of evidence suggests that more persons were receiving antiarrhythmic agents in 1986 than in 1970. Physicians probably recognized and/or treated arrhythmias more frequently in 1986 than in 1970.