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Messenger RNA (mRNA) vaccines represent a landmark in vaccinology, especially with their success in COVID-19 vaccines, which have shown great promise for future vaccine development and disease prevention. As a platform technology, synthetic mRNA can be produced with high fidelity using in vitro transcription (IVT). Magnesium plays a vital role in the IVT process, facilitating the phosphodiester bond formation between adjacent nucleotides and ensuring accurate transcription to produce high-quality mRNA. The development of the IVT process has prompted key inquiries about in-process characterization of magnesium ion (Mg++) consumption, relating to the RNA polymerase (RNAP) activation, fed-batch mode production yield, and mRNA quality. Hence, it becomes crucial to monitor the free Mg++ concentration throughout the IVT process. However, no free Mg++ analysis method has been reported for complex IVT reactions. Here we report a robust capillary zone electrophoresis (CZE) method with indirect UV detection. The assay allows accurate quantitation of free Mg++ for the complex IVT reaction where it is essential to preserve IVT samples in their native-like state during analysis to avoid dissociation of bound Mg complexes. By applying this CZE method, the relationships between free Mg++ concentration, the mRNA yield, and dsRNA impurity level were investigated. Such mechanistic understanding facilitates informed decisions regarding the quantity and timing of feeding starting materials to increase the yield. Furthermore, this approach can serve as a platform method for analyzing the free Mg++ in complex sample matrices where preserving the native-like state of Mg++ binding is key for accurate quantitation.
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Electroforesis Capilar , Magnesio , ARN Mensajero , Transcripción Genética , Electroforesis Capilar/métodos , Magnesio/análisis , ARN Mensajero/genética , ARN Mensajero/análisis , SARS-CoV-2/genética , HumanosAsunto(s)
Procedimientos Endovasculares , Radiografía Intervencional , Humanos , Procedimientos Endovasculares/normas , Procedimientos Endovasculares/efectos adversos , Radiografía Intervencional/normas , Niño , Consenso , Resultado del Tratamiento , Lesiones del Sistema Vascular/diagnóstico por imagen , Lesiones del Sistema Vascular/terapia , Lesiones del Sistema Vascular/etiología , Adolescente , Preescolar , Factores de Edad , Lactante , Factores de RiesgoRESUMEN
In the original publication [...].
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Background: Followership is defined as the role individuals play in supporting, contributing to, and realizing the vision and directives set by their leaders. Such a role is indispensable in healthcare, facilitating effective team dynamics and healthcare delivery. Within the nursing field, it encompasses nurses' active engagement and participation in healthcare delivery, ensuring safety, fostering teamwork, and enhancing patient outcomes. Despite its significance, the exploration of followership within the nursing context of Saudi Arabia remains limited. Objective: This study aims to explore how followership is perceived and practiced by nurses in this unique cultural and professional setting, and its implications for healthcare delivery. Methods: We conducted a qualitative inquiry involving seven registered nurses working in hospitals affiliated with the Saudi Arabian Ministry of Health. Semi-structured interviews were conducted, and a thematic analysis was utilized to extract key findings. Results: Our thematic analysis identified four main themes and several sub-themes that encapsulate the participants' perspectives on followership. The themes include: (1) Understanding of followership, where a predominant lack of clarity about the concept was observed, often conflating it with teamwork; (2) Followers' involvement in decision-making, highlighting the limited participation of nurses in decision-making processes due to hierarchical and autocratic leadership structures; (3) Barriers to followership, which encompassed issues such as poor leadership, the undervaluation of the follower role, lack of training and development opportunities, challenges in collaboration, and language barriers; and (4) Facilitators of followership, identified as effective leadership, followership training, communication skills, positive relationships, respect, collaboration, understanding of roles, commitment, and flexibility. These findings elucidate the complex landscape of followership within the nursing profession in Saudi Arabia, revealing both the challenges and pathways to fostering effective followership in healthcare settings. Conclusion and Implications: This study reveals a widespread lack of awareness about followership among nurses in Saudi Arabia, highlighting significant challenges related to hierarchy and the undervaluation of the follower role in nursing practice and education. It underscores the need for educational and training interventions that redefine and elevate the role of followership in clinical settings to enhance collaboration, assertiveness, and decision-making skills. Moreover, the study advocates for the re-evaluation of leadership practices to better acknowledge and value followership, promoting a more flattened hierarchy that encourages active participation in patient care and organizational development. Implementing these changes could improve patient outcomes and increase nurse satisfaction by effectively addressing the identified barriers related to hierarchy and leadership.
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We compared the epidemiology, severity and management of hospitalized respiratory syncytial virus (n = 305) and human metapneumovirus (n = 39) bronchiolitis in a setting with high respiratory virus testing (95% of admissions tested). Respiratory syncytial virus-positive infants were younger and tended to require more hydration support and longer hospital stays compared to human metapneumovirus-positive infants. Respiratory support requirements were similar between groups despite significant age differences.
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Bronquiolitis Viral , Bronquiolitis , Metapneumovirus , Infecciones por Paramyxoviridae , Infecciones por Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , Virus , Lactante , Humanos , Bronquiolitis/diagnóstico , Bronquiolitis/epidemiología , Hospitalización , Infecciones por Virus Sincitial Respiratorio/diagnóstico , Infecciones por Virus Sincitial Respiratorio/epidemiología , Bronquiolitis Viral/diagnóstico , Bronquiolitis Viral/epidemiología , Infecciones por Paramyxoviridae/diagnóstico , Infecciones por Paramyxoviridae/epidemiologíaRESUMEN
STUDY DESIGN: Prospective, randomized, controlled trial. OBJECTIVE: To compare clinical outcomes of anterior cervical discectomy and fusion (ACDF) and cervical disk arthroplasty (CDA) at 20 years. SUMMARY OF BACKGROUND DATA: Concern for adjacent-level disease after ACDF prompted the development of CDA. MATERIALS AND METHODS: Forty-seven patients with single-level cervical radiculopathy were randomized to either BRYAN CDA or ACDF for a Food and Drug Administration Investigational Device Exemption trial. At 20 years, patient-reported outcomes, including visual analog scales (VAS) for neck and arm pain, neck disability index (NDI), and reoperation rates, were analyzed. RESULTS: Follow-up rate was 91.3%. Both groups showed significantly better NDI, VAS arm pain, and VAS neck pain scores at 20 years versus preoperative scores. Comparing CDA versus ACDF, there was no difference at 20 years in mean scores for NDI [11.1 (SD 14.1) vs. 19.9 (SD 17.2), P =0.087], mean VAS arm pain [0.9 (SD 2.4) vs. 2.3 (SD 2.8), P =0.095], or mean VAS neck pain [1.2 (SD 2.5) vs. 2.9 (3.3), P =0.073]. There was a significant difference between CDA versus ACDF groups in the change in VAS neck pain score between 10 and 20 years [respectively, -0.4 (SD 2.5) vs. 1.5 (SD 2.5), P =0.030]. Reoperations were reported in 41.7% of ACDF patients and 10.0% of CDA patients ( P =0.039). CONCLUSIONS: Both CDA and ACDF are effective in treating cervical radiculopathy with sustained improvement in NDI, VAS neck and VAS arm pain at 20 years. CDA demonstrates lower reoperation rates than ACDF. There were no failures of the arthroplasty device requiring reoperation at the index level. The symptomatic nonunion rate of ACDF was 4.2% at 20 years. Despite a higher reoperation rate in the CDA group versus ACDF group, there was no difference in the 20-year NDI, VAS Neck, and VAS arm pain scores.
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Degeneración del Disco Intervertebral , Radiculopatía , Fusión Vertebral , Humanos , Dolor de Cuello/etiología , Dolor de Cuello/cirugía , Resultado del Tratamiento , Radiculopatía/cirugía , Estudios Prospectivos , Vértebras Cervicales/cirugía , Artroplastia , Discectomía , Degeneración del Disco Intervertebral/cirugíaRESUMEN
BACKGROUND: HIV postexposure prophylaxis (PEP) following child sexual assault (CSA) is recommended in select cases. High rates of poor adherence to PEP are reported. We evaluated adherence to the recommended management of children following CSA at the tertiary pediatric facility in Western Australia and compared our approach with international guidelines. METHODS: Medical records were reviewed for all children <16 years old assessed at Perth Children's Hospital between October 1, 2016 and November 30, 2020 following alleged CSA. Data, including exposure type, PEP adherence and follow-up, were collected. A review of contemporary national and international PEP guidelines was undertaken in parallel. RESULTS: There were 511 alleged CSA events over the study period; 62/511 (12%) were appropriately risk-assessed as requiring PEP by the treating clinician. PEP was not prescribed in 8/62 (13%) events, with a reason documented for 6/8 (75%). Overall, less than half of children who were eligible for PEP were adherent to the 28-day regimen (23/54, 43%). Gastrointestinal upset contributed to early cessation in 5/54 (9%). Final 3-month blood-borne virus serology results were available in less than one in 3 children. A review of international clinical practice revealed significant heterogeneity of criteria for the provision of PEP and a paucity of pediatric-specific data. CONCLUSIONS: We identified several areas of our PEP management that required strengthening, with limited direction available in current international guidelines. We have adopted a broader use of fixed drug combinations and implemented a multifaceted follow-up program. It will be essential to review the impact of these changes.
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Infecciones por VIH , Profilaxis Posexposición , Humanos , Profilaxis Posexposición/métodos , Australia Occidental , Niño , Infecciones por VIH/prevención & control , Infecciones por VIH/tratamiento farmacológico , Femenino , Masculino , Preescolar , Adolescente , Abuso Sexual Infantil/prevención & control , Estudios Retrospectivos , Guías de Práctica Clínica como Asunto , Adhesión a Directriz/estadística & datos numéricos , Fármacos Anti-VIH/uso terapéutico , Fármacos Anti-VIH/administración & dosificación , LactanteRESUMEN
PURPOSE: Left renal vein compression syndrome (LRVCS) remains a challenging diagnosis. This study aimed to correlate imaging and hemodynamic findings with clinical outcomes for patients with LRVCS. MATERIALS AND METHODS: A retrospective review of 66 renal venography procedures with or without intravascular ultrasound (IVUS) was performed from 2017 to 2023 at a single institution. Patients with prior LRVCS treatment or other indications were excluded (n = 11). Primary outcome measure was correlation of catheter-based endovascular (CBE) findings with clinical outcomes (n = 55). Secondary outcome measures included correlation of CBE findings and LRV (i.e., beak) angle > 32°, beak sign, aortomesenteric angle (AMA < 41°), and hilar-to-aortomesenteric ratio (HTAMR ≥ 4.9) on cross sectional imaging. Descriptive statistics, chi-square testing, and ROC analyses were used. RESULTS: Of the 55 patients, 52 (94.5%) were females (median age 31, range 14-72) and 56.4% (n = 31) had a diagnosis of LRVCS on CBE evaluation. A renocaval pressure gradient of ≥ 3 mmHg, presence of collaterals, and > 50% area stenosis on IVUS were significantly associated with CBE diagnosis of LRVCS (p < 0.001). Surgical treatment (renal autotransplantation or LRV transposition) was recommended to all patients with CBE diagnosis of LRVCS (n = 31). 81.2% (18/22) of patients who underwent surgery reported symptom resolution or improvement. When the cross sectional imaging measurements were compared with CBE evaluation, AMA was the most sensitive (100%), HTAMR and beak sign were highly specific (93.3%), and beak angle was the most predictive (77.4% sensitivity; 86.7% specificity). CONCLUSION: CBE diagnosis of LRVCS was highly predictive of surgical candidacy and post-surgical symptom resolution. The presence of collaterals, > 50% area stenosis on IVUS, or a renocaval pressure gradient ≥ 3 mmHg had a significant association with a CBE diagnosis of LRVCS.
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BACKGROUND: Solid organ transplantation is a risk predictor for virally-mediated anal squamous intraepithelial lesions and cancer (anal disease). Precancerous squamous intraepithelial lesions can be detected by screening, and treatment may prevent cancer progression. Screening recommendations are not well defined. We aim to define prevalence and describe risk predictors for anal disease in a large population of solid organ transplant recipients. METHODS: Retrospective single-center cohort analysis included solid organ transplant recipients cared for between 2001 and 2022 (Nâ =â 15 362). The cohort of recipients who developed anal disease was compared with those who did not. Greedy propensity score matching was performed for organ-specific recipients, and time-to-event analysis for the development of anal disease was performed in those with genitourinary human papilloma virus (HPV) disease versus those without. RESULTS: Prevalence of anal disease was 0.6% (cancer 0.2%). The average years from transplant to the diagnosis of anal disease was 11.67. Anal disease was more common in women (68.5% versus 31.5%, P â <â 0.001), patients who had other HPV-related genitourinary diseases (40.4% versus 0.6%, P â <â 0.001), who were of younger age at transplant (39.62 versus 46.58, P â <â 0.001), and had increased years from transplant (17.06 versus 12.57, P â <â 0.001). In multivariate analysis, the odds of anal disease increased by 4% each year posttransplant. History of genitourinary HPV disease (odds ratio 69.63) and female sex (odds ratio 1.96) were the most significant risk predictors for anal disease. CONCLUSIONS: The prevalence of anal cancer among solid organ transplant recipients was equal to the general population (0.2%). Due to the low prevalence of overall disease, these data suggest that anal screenings in transplant recipients should be targeted to higher-risk subsets: female recipients farther out from transplant and patients with genitourinary HPV-related diseases.
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Neoplasias del Ano , Trasplante de Órganos , Infecciones por Papillomavirus , Humanos , Femenino , Neoplasias del Ano/virología , Neoplasias del Ano/epidemiología , Masculino , Estudios Retrospectivos , Persona de Mediana Edad , Infecciones por Papillomavirus/epidemiología , Infecciones por Papillomavirus/diagnóstico , Infecciones por Papillomavirus/virología , Trasplante de Órganos/efectos adversos , Factores de Riesgo , Prevalencia , Adulto , Anciano , Lesiones Intraepiteliales Escamosas/virología , Lesiones Intraepiteliales Escamosas/epidemiología , Medición de Riesgo , Receptores de Trasplantes , Factores de Tiempo , Papillomaviridae/aislamiento & purificaciónRESUMEN
The incidence of respiratory syncytial virus (RSV) in adults is inadequately defined and the impact of SARS-CoV-2-related non-pharmaceutical interventions (NPIs) is underexplored. Using laboratory data, we described the detection rate of RSV in adults ≥16 years in Western Australia (WA) between 2017 and 2023. With the exception of 2020, RSV detections rose annually between 2017 and 2023, reaching 50.7 per 100,000 in 2023 (95% confidence interval [CI], 47.9-53.8). RSV testing expanded considerably across the study period, with the testing in 2023 more than five times the 2017 total. The detection rate was highest in adults ≥60 years between 2017 and 2019, particularly those ≥75 years. Following 2020, the detections in all age groups increased, with the highest detection rate in 2023 in those ≥75-years (199.5 per 100,000; 95% CI, 180.5-220). NPIs significantly impacted RSV seasonality; the preceding winter pattern was disrupted, resulting in an absent 2020 winter season and two major summer seasons in 2020/21 and 2021/22. The RSV season began to realign in 2022, reverting to a winter seasonal pattern in 2023 and the largest season in the study period. Ongoing surveillance will be required to understand the stability of these increases and to delineate the impact of new immunisation strategies.
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COVID-19 , Infecciones por Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , Estaciones del Año , Humanos , Infecciones por Virus Sincitial Respiratorio/epidemiología , Infecciones por Virus Sincitial Respiratorio/diagnóstico , Infecciones por Virus Sincitial Respiratorio/virología , Adulto , Australia Occidental/epidemiología , Persona de Mediana Edad , Anciano , Adulto Joven , Adolescente , Virus Sincitial Respiratorio Humano/aislamiento & purificación , Femenino , COVID-19/epidemiología , COVID-19/virología , COVID-19/prevención & control , COVID-19/diagnóstico , Masculino , Incidencia , SARS-CoV-2/inmunología , SARS-CoV-2/aislamiento & purificación , Anciano de 80 o más AñosRESUMEN
Background: Kidney transplant outcomes have dramatically improved since the first successful transplant in 1954. In its early years, kidney transplantation was viewed more skeptically. Today it is considered the treatment of choice among patients with end-stage kidney disease. Methods: Our program performed its first kidney transplant in 1966 and recently performed our 12 000th kidney transplant. Here, we review and describe our experience with these 12 000 transplants. Transplant recipients were analyzed by decade of date of transplant: 1966-1975, 1976-1985, 1986-1995, 1996-2005, 2006-2015, and 2016-2022. Death-censored graft failure and mortality were outcomes of interest. Results: Of 12 000 kidneys, 247 were transplanted from 1966 to 1975, 1147 from 1976 to 1985, 2194 from 1986 to 1995, 3147 from 1996 to 2005, 3046 from 2006 to 2015, and 2219 from 2016 to 2022 compared with 1966-1975, there were statistically significant and progressively lower risks of death-censored graft failure at 1 y, 5 y, and at last follow-up in all subsequent eras. Although mortality at 1 y was lower in all subsequent eras after 1986-1995, there was no difference in mortality at 5 y or the last follow-up between eras. Conclusions: In this large cohort of 12 000 kidneys from a single center, we observed significant improvement in outcomes over time. Kidney transplantation remains a robust and ever-growing and improving field.
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BACKGROUND: Normothermic regional perfusion (NRP) has emerged as a vital technique in organ procurement, particularly in donation after circulatory death (DCD) cases, offering the potential to optimize organ utilization and improve posttransplant outcomes. Recognizing its significance, the American Society of Transplant Surgeons (ASTS) convened a work group to develop standardized recommendations for abdominal NRP in the United States. METHODS: The workgroup, comprising experts in NRP, DCD, and transplantation, formulated recommendations through a collaborative process involving revisions and approvals by relevant committees and the ASTS council. Four key areas were identified for standardization: Preprocedure communication, NRP procedure, Terminology and documentation, and Mentorship/credentialing. RESULTS: The recommendations encompass a range of considerations, including preprocedure communication protocols to facilitate informed decision-making by transplant centers and organ procurement organizations, procedural guidelines for NRP teams, uniform terminology to clarify the NRP process, and standards for mentorship and credentialing of NRP practitioners. Specific recommendations address logistical concerns, procedural nuances, documentation requirements, and the importance of ongoing quality assurance. CONCLUSIONS: The standardized recommendations for abdominal NRP presented in this article aim to ensure consistency, safety, and efficacy in the organ procurement process. By establishing clear protocols and guidelines, the ASTS seeks to enhance organ utilization, honor donor wishes, and uphold public trust in the donation process. Implementation of these recommendations can contribute to the advancement of NRP practices and improve outcomes for transplant recipients.
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Trasplante de Órganos , Perfusión , Humanos , Perfusión/normas , Perfusión/métodos , Trasplante de Órganos/normas , Preservación de Órganos/normas , Preservación de Órganos/métodos , Estados Unidos , Sociedades Médicas/normas , Obtención de Tejidos y Órganos/normas , Abdomen/cirugía , Mentores , Terminología como Asunto , Documentación/normas , Cirujanos/normasRESUMEN
Importance: The indications, safety, and efficacy of chemical venous thromboembolism prophylaxis (cVTE) in pediatric trauma patients remain unclear. A set of high-risk criteria to guide cVTE use was recently recommended; however, these criteria have not been evaluated prospectively. Objective: To examine high-risk criteria and cVTE use in a prospective multi-institutional study of pediatric trauma patients. Design, Setting, and Participants: This cohort study was completed between October 2019 and October 2022 in 8 free-standing pediatric hospitals designated as American College of Surgeons level I pediatric trauma centers. Participants were pediatric trauma patients younger than 18 years who met defined high-risk criteria on admission. It was hypothesized that cVTE would be safe and reduce the incidence of VTE. Exposures: Receipt and timing of chemical VTE prophylaxis. Main Outcomes and Measures: The primary outcome was overall VTE rate stratified by receipt and timing of cVTE. The secondary outcome was safety of cVTE as measured by bleeding or other complications from anticoagulation. Results: Among 460 high-risk pediatric trauma patients, the median (IQR) age was 14.5 years (10.4-16.2 years); 313 patients (68%) were male and 147 female (32%). The median (IQR) Injury Severity Score (ISS) was 23 (16-30), and median (IQR) number of high-risk factors was 3 (2-4). A total of 251 (54.5%) patients received cVTE; 62 (13.5%) received cVTE within 24 hours of admission. Patients who received cVTE after 24 hours had more high-risk factors and higher ISS. The most common reason for delayed cVTE was central nervous system bleed (120 patients; 30.2%). There were 28 VTE events among 25 patients (5.4%). VTE occurred in 1 of 62 patients (1.6%) receiving cVTE within 24 hours, 13 of 189 patients (6.9%) receiving cVTE after 24 hours, and 11 of 209 (5.3%) who had no cVTE (P = .31). Increasing time between admission and cVTE initiation was significantly associated with VTE (odds ratio, 1.01; 95% CI, 1.00-1.01; P = .01). No bleeding complications were observed while patients received cVTE. Conclusions and Relevance: In this prospective study, use of cVTE based on a set of high-risk criteria was safe and did not lead to bleeding complications. Delay to initiation of cVTE was significantly associated with development of VTE. Quality improvement in pediatric VTE prevention may center on timing of prophylaxis and barriers to implementation.
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With improved medical treatments, the prognosis for many malignancies has improved, and more patients are presenting for transplant evaluation with a history of treated cancer. Solid organ transplant (SOT) recipients with a prior malignancy are at higher risk of posttransplant recurrence or de novo malignancy, and they may require a cancer surveillance program that is individualized to their specific needs. There is a dearth of literature on optimal surveillance strategies specific to SOT recipients. A working group of transplant physicians and cancer-specific specialists met to provide expert opinion recommendations on optimal cancer surveillance after transplantation for patients with a history of malignancy. Surveillance strategies provided are mainly based on general population recurrence risk data, immunosuppression effects, and limited transplant-specific data and should be considered expert opinion based on current knowledge. Prospective studies of cancer-specific surveillance models in SOT recipients should be supported to inform posttransplant management of this high-risk population.
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Respiratory syncytial virus (RSV) reinfection in children is poorly understood. We examined the incidence, characteristics, and outcomes of hospital-attended RSV reinfections in children <16 years in Western Australia between 2012 and 2022. Individuals with repeat RSV detections ≥56 days apart were identified using laboratory data. The incidence of reinfection in the first five years of life was estimated using the total birth population from 2012 to 2017. Clinical data on a subset of reinfection episodes were obtained from two metropolitan pediatric centers. A total of 466 children with hospital-attended reinfections were identified. The median interval between RSV detections was 460 days (interquartile range: 324, 812), with a reinfection rate of 95 per 100,000 individuals (95% confidence interval: 82, 109). Reinfection was most common in children who experienced their first RSV detection <6 months of age. Predisposing factors were identified in 56% of children; children with predisposing factors were older at first and second detections, were more likely to be admitted, and had a longer length of stay. This study highlights the significant burden of hospital-attended RSV reinfections in children with and without predisposing factors. Expanded surveillance with in-depth clinical data is required to further characterize the impact of RSV reinfection.
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Infecciones por Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , Niño , Humanos , Lactante , Reinfección , Infecciones por Virus Sincitial Respiratorio/epidemiología , Australia Occidental/epidemiología , HospitalizaciónRESUMEN
Simultaneous liver and kidney (SLK) transplantation is considered the best treatment modality among selected patients with both chronic kidney disease (CKD) and end-stage liver disease (ESLD). Since the first SLK transplant in 1983, the number of SLK transplants has increased worldwide, and particularly in the United States since the implementation of the MELD system in 2002. SLK transplants are considered a relatively low immunological risk procedure evidenced by multiple studies displaying the immunomodulatory properties of the liver on the immune system of SLK recipients. SLK recipients demonstrate lower rates of both cellular and antibody-mediated rejection on the kidney allograft when compared to kidney transplant-alone recipients. Therefore, SLK transplants in the setting of preformed donor-specific HLA antibodies (DSA) are a common practice, at many centers. Acceptance and transplantation of SLKs are based solely on ABO compatibility without much consideration of crossmatch results or DSA levels. However, some studies suggest an increased risk for rejection for SLK recipients transplanted across high levels of pre-formed HLA DSA. Despite this, there is no consensus regarding acceptable levels of pre-formed DSA, the role of pre-transplant desensitization, splenectomy, or immunosuppressive management in this unique population. Also, the impact of post-transplant DSA monitoring on long-term outcomes is not well-studied in SLK recipients. In this article, we review recent and relevant past articles in this field with a focus on the immunological risk factors among SLK recipients, and strategies to mitigate the negative outcomes among them.
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INTRODUCCIÓN Y OBJETIVOS: Los pacientes ancianos con fibrilación auricular están en mayor riesgo de eventos cardioembólicos y hemorragia mayor que los más jóvenes. El cierre de la orejuela izquierda (COI) podría ser una opción atractiva para estos pacientes, pero hay pocos datos sobre los resultados del COI de pacientes de 85 o más años. El objetivo del presente estudio es evaluar la seguridad y la eficacia del COI de pacientes de 85 o más años. MÉTODOS: Se analizó a 1.025 pacientes incluidos en el registro EWOLUTION que se habían sometido al COI, se identificó a 84 de edad ≥ 85 años y se los comparó con el grupo de menos edad. RESULTADOS: Los pacientes de 85 o más años tenían mayores riesgos estimados de accidente cerebrovascular y de hemorragias que los pacientes más jóvenes (edad ≥ 85 frente a <85 años: CHA2DS2-VASc, 5,2+/-1,2 frente a 4,4+/-1,6; p <0,0001; HAS-BLED, 2,7+/-1,1 frente a 2,3+/-1,2; p = 0,003). Las tasas de éxito del procedimiento fueron altas y similares en ambos grupos (el 98,8 frente al 98,5%; p = 0,99). No hubo diferencias en las tasas de eventos adversos relacionados con el dispositivo o el procedimiento a los 7 días (el 2,6 frente al 3,1%; p = 0,80). A pesar del mayor riesgo basal de accidente cerebrovascular, en el seguimiento no hubo diferencias entre los grupos en la tasa de ictus anualizada (0,8 frente a 1,3/100 pacientes-año; p = 0,649). CONCLUSIONES: El COI de los pacientes de edad ≥ 85 años es seguro y eficaz a pesar del alto riesgo de eventos embólicos y hemorrágicos de estos pacientes. El COI puede ser una alternativa razonable a la anticoagulación oral para estos pacientes
INTRODUCTION AND OBJECTIVES: Elderly patients with atrial fibrillation are at greater risk of both cardioembolic events and major bleeding than younger patients. Left atrial appendage occlusion (LAAO) could be an attractive alternative for these patients, but there are limited data on outcomes with LAAO in patients ≥ 85 years old. The aim of the present study was to assess the safety and efficacy of LAAO in patients ≥ 85 years old. METHODS: A total of 1025 patients included in the EWOLUTION registry who underwent LAAO were analyzed and 84 patients ≥ 85 years old were identified and compared with the younger cohort. RESULTS: Patients ≥ 85 years old had higher estimated stroke and hemorrhagic risks than younger patients (CHA2DS2-VASc: 5.2+/-1.2 vs 4.4+/-1.6, P <.0001; HAS-BLED: 2.7+/-1.1 vs 2.3+/-1.2; P=.003; ≥ 85 years vs <85 years). Procedural success was high and similar in both groups (98.8% vs 98.5%; P=.99). There were no differences in 7-day device- or procedure-related adverse event rates (2.6% in ≥ 85 years vs 3.1% in <85 years; P=.80). Despite the higher baseline stroke risk, there was no difference at follow-up between the groups in the annualized stroke rate (0.8/100 patient-years in ≥ 85 years vs 1.3/100 patient-years in <85 years; P=.649). CONCLUSIONS: LAAO in patients ≥ 85 years is safe and effective even though these patients are at high risk for embolic and hemorrhagic events. LAAO may be a reasonable alternative to oral anticoagulation in these patients