Intravenous Immunoglobulins Alone for the Desensitization of Lung Transplant Recipients with Preformed Donor Specific Antibodies and Negative Flow Cytometry Crossmatch.

BACKGROUND: The lack of evidence regarding optimal desensitization strategies for lung transplant candidates with preformed donor specific anti-human leukocyte antigen antibodies (DSAs) has led to varying approaches among centers towards this patient group. Our institution's desensitization protocol for recipients with preformed DSAs and negative flow cytometry crossmatch (FCXM) consists of intravenous immunoglobulin (IVIG) as the sole therapy. The study aimed to determine outcomes using this approach. METHODS: This retrospective study included adults who underwent lung-only transplantation for the first time between January 2015 and March 2022 at a single center. We excluded patients with positive or missing FCXM results. Transplant recipients with any DSA ≥ 1000 MFI on latest testing within three months of transplant were considered DSA-positive, while recipients with DSAs <1000 MFI and those without DSAs were assigned to the low-level/negative group. Graft survival (time to death/retransplantation) and chronic lung allograft dysfunction (CLAD)-free times were compared between groups using Cox proportional hazards models. RESULTS: Thirty-six out of 167 eligible patients (22%) were DSA-positive. At least 50% of preformed DSAs had documented clearance (decrease to <1000 MFI) within the first 6 months of transplant. Multivariable Cox regression analyses did not detect a significantly increased risk of graft failure (aHR 1.04 95%CI 0.55-1.97) or chronic lung allograft dysfunction (aHR 0.71 95%CI 0.34-1.52) in DSA-positive patients compared to patients with low-level/negative DSAs. Incidences of antibody-mediated rejection (p = 1.00) and serious thromboembolic events (p = 0.63) did not differ between study groups. CONCLUSION: We describe a single-center experience of administering IVIG alone to lung transplant recipients with preformed DSAs and negative FCXM. Further studies are required to confirm the efficacy of this strategy against other protocols.

Donor blood cultures and outcomes after lung transplantation: a single-center report.

BACKGROUND: Transplanting lungs from donors with positive blood cultures has not been shown to adversely affect survival. There is limited evidence for potential effects on other outcomes, such as hospital course, graft function, and transmission of infection. METHODS: This retrospective cohort study included adult patients who underwent lung-only transplantation for the first time between March 2010 and December 2022. Outcomes of patients whose donors had positive blood cultures within 72 h of transplant were compared to patients whose donors had negative blood cultures. RESULTS: Twenty-five (10.8%) of 232 donors had positive blood cultures, including a single, unexpected case with candidemia. The most commonly isolated bacteria were Enterobacter cloacae (n = 5), Klebsiella pneumoniae (n = 5), Acinetobacter baumannii (n = 3), Pseudomonas aeruginosa (n = 3), and Staphylococcus aureus (n = 3). Eleven donors had identical bacteria in their respiratory cultures. All patients who were transplanted from donors with positive blood cultures survived beyond 90 days. Positive donor blood cultures were not associated with longer hospital stay, in-hospital complications, acute cellular rejection, or the achievement of 80% predicted forced expiratory volume in the first second. Probable transmission of donor bacteremia occurred in only two cases (both with S. aureus). These two donors had positive respiratory cultures with the same organism. CONCLUSION: The study did not find an increased risk of adverse events when transplanting lungs from donors with positive blood cultures. Allograft cultures may be more predictive of the risk of transmitting infections.

Coronavirus disease 2019 vaccine in pediatric post-kidney transplantation.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections and the resulting disease, coronavirus disease 2019 (COVID-19), have spread to millions of persons worldwide. Many vaccines have been developed; however, their efficacy in pediatric solid organ transplant recipients is yet to be determined. METHODS: This is a prospective observational, non-interventional single-center study on the safety and efficacy of a COVID-19 vaccine (BNT162b2) in pediatric kidney transplant recipients. The primary aim of this study was to evaluate immunogenicity according to SARS-CoV-2-specific neutralizing antibody titer after two vaccine doses. The secondary aims were to investigate the safety of the vaccines, solicited local and systemic adverse reactions, incidence of COVID-19 post-vaccination, and effects on transplant graft function. Baseline investigations were conducted on pediatric renal transplant recipients, and recruited participants were advised to have the Comirnaty® mRNA vaccine according to protocol. RESULTS: A total of 48 patients (male, n = 31, 64.6%; female, n = 17, 35.4%), median age 14 [12-16] years were included, and all received two doses of the vaccine. The vaccine had a favorable safety and side-effect profile. The S-antibody titer of all patients ranged between .4 and 2,500 U/ml and was > 50 U/ml in 89% of the patients. No difference in the measured antibody immune response was noted between infected and uninfected children. No major side effects were reported. CONCLUSION: The vaccine had a favorable safety profile in 12- to 15-year-old kidney transplant recipients, producing a greater measured antibody response than that in older transplant recipients.

Comparison of the safety and immunogenicity of the BNT-162b2 vaccine and the ChAdOx1 vaccine for solid organ transplant recipients: a prospective study.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and its resulting disease, coronavirus disease 2019 (COVID-19), has spread to millions of people worldwide. Preliminary data from organ transplant recipients have shown reduced seroconversion rates after the administration of different SARS-CoV-2 vaccination platforms. However, it is unknown whether different vaccination platforms provide different levels of protection against SARS-CoV-2. To answer this question, we prospectively studied 431 kidney and liver transplant recipients (kidney: n = 230; liver: n = 201) who received either the ChAdOx1 vaccine (n = 148) or the BNT-162b2 vaccine (n = 283) and underwent an assessment of immunoglobulin M/immunoglobulin G spike antibody levels. The primary objective of the study is to directly compare the efficacy of two different vaccine platforms in solid organ transplant recipients by measuring of immunoglobulin G (IgG) antibodies against the RBD of the spike protein (anti-RBD) two weeks after first and second doses. Our secondary endpoints were solicited specific local or systemic adverse events within 7 days after the receipt of each dose of the vaccine. There was no difference in the primary outcome between the two vaccine platforms in patients who received two vaccine doses. Unresponsiveness was mainly linked to diabetes. The rate of response after the first dose among younger older patients was significantly larger; however, after the second dose this difference did not persist (p = 0.079). Side effects were similar to those that were observed during the pivotal trials.

Does Managing Patients With Chronic Rhinosinusitis Improve Their Depression Score? Prospective Study.

BACKGROUND: To assess the risk of depression in patients with chronic rhinosinusitis (CRS) in a tertiary care center and the effect of treatment on depression scores. METHODS: This prospective cohort study was conducted at King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia, between November 2021 and June 2022 and included adult patients (≥14 years) with CRS. The validated Arabic or English Sinonasal Outcome Test (SNOT-22) and Patient Health Questionnaire-9 (PHQ-9) were used before treatment and 3 to 6 months after surgery and maximal medical treatment. PHQ-9 scores were compared at baseline and follow-up visits. The relationship between changes in SNOT-22 and PHQ-9 scores were assessed using Spearman's correlation and simple linear regression. RESULTS: Overall, 38 participants with a mean ± SD age of 32.7 ± 12 years were enrolled. CRS with nasal polyps (55.26%) was the most frequently seen condition, followed by allergic fungal CRS (31.58%) and CRS without nasal polyps (13.16%). Six patients (15.7%) had PHQ-9 scores ≥10, indicating they had major depressive disorder. PHQ-9 and SNOT-22 scores improved significantly after treatment (3.7 ± 5.8 vs 6.5 ± 6.9 pretreatment, P = .001; 20.7 ± 20.5 vs 45.6 ± 28.9 pretreatment, P < .0001, respectively). Mean ± SD change in PHQ-9 and SNOT-22 scores was -2.7 ± 7 and -24.9 ± 29.8, respectively. SNOT-22 and PHQ-9 scores were positively correlated (r = .522, P < .001). PHQ-9 score change was significantly associated with SNOT-22 score change (ß = .178, 95% confidence interval 0.12-0.23, P < .0001). CONCLUSION: CRS affects the quality of life and psychological well-being of patients. Patient-centered care with maximal medical and surgical treatment help overcome its deleterious consequences.

Enhancing research support services in health organizations by implementing a "Research Concierge Desk", a case study.

Health organizations with teaching and research responsibilities face the need to establish a comprehensive system that addresses the processes and challenges associated with research activities; a system that assists local institutes in becoming research-active by identifying gaps and providing actionable recommendations. The involvement of epidemiologists, biostatisticians, and data scientists is paramount in offering technical and scientific support to health researchers. In our organization, research support services, such as technical, statistical, logistical, and scientific assistance, have been provided to researchers for the past 20 years under the name of "Data Clinic Service". This article discusses the establishment of a physical booth called the "Research Concierge Desk" within a medical center to offer on-site, free-of-charge, and direct consultations to researchers, thereby improving accessibility to data clinic services. The underlying concept of the "Research Concierge Desk" is to align the research workflow for busy clinicians, who require vital assistance in the technical aspects of their research. As well, the desk and its digital platform enabled us to assess research process workflow, such as research submission, data clinic requests, research progress tracking, and researcher satisfaction assessment. We present the initiation of the "Research Concierge Desk" as an innovative solution in hospital settings, outline the available resources, benefits, challenges, and propose areas for improvement. The experience gained from implementing the "Research Concierge Desk" model can greatly benefit other health centers in adopting a similar approach to develop enhanced services for clinical researchers.

Donor respiratory multidrug-resistant bacteria and lung transplantation outcomes.

RATIONALE: Respiratory culture screening is mandatory for all potential lung transplant donors. There is limited evidence on the significance of donor multidrug-resistant (MDR) bacteria on transplant outcomes. Establishing the safety of allografts colonized with MDR bacteria has implications for widening an already limited donor pool. OBJECTIVES: We aimed to describe the prevalence of respiratory MDR bacteria among our donor population and to test for associations with posttransplant outcomes. METHODS: This retrospective observational study included all adult patients who underwent lung-only transplantation for the first time at King Faisal Specialist Hospital & Research Centre in Riyadh from January 2015 through May 2022. The study evaluated donor bronchoalveolar lavage and bronchial swab cultures. MAIN RESULTS: Sixty-seven of 181 donors (37%) had respiratory MDR bacteria, most commonly MDR Acinetobacter baumannii (n = 24), methicillin-resistant Staphylococcus aureus (n = 18), MDR Klebsiella pneumoniae (n = 8), MDR Pseudomonas aeruginosa (n = 7), and Stenotrophomonas maltophilia (n = 6). Donor respiratory MDR bacteria were not significantly associated with allograft survival or chronic lung allograft dysfunction (CLAD) in adjusted hazard models. Sensitivity analyses revealed an increased risk for 90-day mortality among recipients of allografts with MDR Klebsiella pneumoniae (n = 6 with strains resistant to a carbapenem and n = 2 resistant to a third-generation cephalosporin only) compared to those receiving culture-negative allografts (25.0% versus 11.1%, p = 0.04). MDR Klebsiella pneumoniae (aHR 3.31, 95%CI 0.95-11.56) and Stenotrophomonas maltophilia (aHR 5.35, 95%CI 1.26-22.77) were associated with an increased risk for CLAD compared to negative cultures. CONCLUSION: Our data suggest the potential safety of using lung allografts with MDR bacteria in the setting of appropriate prophylaxis; however, caution should be exercised in the case of MDR Klebsiella pneumoniae.

Lung transplantation outcomes in underweight recipients: A single center experience.

Background: Current guidelines recommend a body mass index (BMI) of 16 kg/m2 as the minimum threshold for lung transplantation, despite mixed evidence on outcomes in underweight patients. The current study aimed to describe survival outcomes of underweight patients who underwent lung transplantation at a single center. Methods: This retrospective observational study included adult lung transplant recipients who underwent transplantation for the first time between March 2010 and March 2022 at King Faisal Specialist Hospital and Research Center and excluded patients with obesity. We defined an underweight status as a BMI <17 kg/m2. Results: Forty-eight of the 202 lung transplant recipients were underweight at the time of surgery. The underweight patients had similar lengths of hospital (p = 0.53) and intensive care unit (p = 0.81) stays compared to other patients. Thirty-three percent of underweight patients had died within 5-year follow-up, compared to 34% of patients who were not underweight. There was no significant difference in mortality risk between underweight patients and patients with normal BMIs in our multivariable Cox regression model (adjusted HR 1.57, 95%CI: 0.77-3.20, p = 0.21). Exploratory analyses revealed that a pre-transplant BMI <13 kg/m2 was associated with a trend towards increased 5-year mortality (adjusted HR 4.00, 95%CI: 0.87-18.35, p = 0.07). Conclusions: Our findings suggest that patients with BMIs of 13-17 kg/m2 may be candidates for lung transplantation. Large multi-center cohort studies are needed to confirm the lower BMI limit for safely transplanting patients.

Development of a Cardiovascular Disease Risk Prediction Model: A Preliminary Retrospective Cohort Study of a Patient Sample in Saudi Arabia.

Saudi Arabia has an alarmingly high incidence of cardiovascular disease (CVD) and its associated risk factors. To effectively assess CVD risk, it is essential to develop tailored models for diverse regions and ethnicities using local population variables. No CVD risk prediction model has been locally developed. This study aims to develop the first 10-year CVD risk prediction model for Saudi adults aged 18 to 75 years. The electronic health records of Saudi male and female patients aged 18 to 75 years, who were seen in primary care settings between 2002 and 2019, were reviewed retrospectively via the Integrated Clinical Information System (ICIS) database (from January 2002 to February 2019). The Cox regression model was used to identify the risk factors and develop the CVD risk prediction model. Overall, 451 patients were included in this study, with a mean follow-up of 12.05 years. Thirty-five (7.7%) patients developed a CVD event. The following risk factors were included: fasting blood sugar (FBS) and high-density lipoprotein cholesterol (HDL-c), heart failure, antihyperlipidemic therapy, antithrombotic therapy, and antihypertension therapy. The Bayesian information criterion (BIC) score was 314.4. This is the first prediction model developed in Saudi Arabia and the second in any Arab country after the Omani study. We assume that our CVD predication model will have the potential to be used widely after the validation study.

Predictors of disease severity in patients hospitalized with coronavirus disease 2019.

BACKGROUND: Coronavirus disease 2019 (COVID-19), caused by a novel coronavirus, manifests as a respiratory illness primarily and symptoms range from asymptomatic to severe respiratory syndrome and even death. During the pandemic, due to overcrowding of medical facilities, clinical assessment to triage patients for home care or in-hospital treatment was an essential element of management. OBJECTIVES: Study the demographic features, comorbidities and bio-markers that predict severe illness and mortality from COVID-19 infection. DESIGN: Retrospective observational SETTING: Single tertiary care center PATIENTS AND METHODS: The study included all patients admitted with a positive PCR test for COVID-19 during the period from March 2020 to September 2020 (7 months). Data on demographics, clinical data and laboratory parameters was collected from medical records every 3 days during hospital stay or up until transfer to ICU. MAIN OUTCOME MEASURES: Demographic, comorbidities and biochemical features that might predict severe COVID-19 disease. SAMPLE SIZE: 372 RESULTS: Of the 372 patients, 72 (19.4%) had severe disease requiring admission to intensive care unit (ICU); 6 (1.6%) died. Individuals over 62 years were more likely to be admitted to the ICU (P=.0001, while a BMI of 40 and higher increased the odds of severe disease (P=.032). Male gender (P=.042), hypertension (P=.006) and diabetes (P=.001) conferred a statistically significant increased risk of admission to ICU, while coexisting COPD, and ischemic heart disease did not. Laboratory features related to severe COVID-19 infection were: leukocytosis (P=.015), thrombocytopenia (P=.001), high levels of C-reactive protein (P=.0001), lactic dehydrogenase (P=.0001), D-dimer (P=.0001) and ferritin (P=.001). With the multivariate analysis, diabetes, high lac-tate dehydrogenase, C-reactive protein and thrombocytopenia were associated with severity of illness. CONCLUSIONS: Particular demographic and clinical parameters may predict severe illness and need for ICU care. LIMITATIONS: Single referral center, several cases of severe COVID-19 could not be included due to lack of consent and or data. CONFLICT OF INTEREST: None.

The Journey of Clinical Registries Through Various Phases of the Digital Age: A Technical Perspective.

The concept of registry-based medical research goes back to the mid of 18th century where data was collected in actual physical registers and analyzed using manual counts in a very primitive way until computing technologies took over to digitize information, to change the process all the way from data collection to data analysis. This digital age of technology can be hypothetically classified in 3 eras; the Digitization Era, the Integration Era, and finally the Futuristic, Smart Intelligence Era. This study would highlight the changes in the fundamental aspects of a medical registry under each of these digital eras.

Vaccine hesitancy towards childhood immunizations as a predictor of mothers' intention to vaccinate their children against COVID-19 in Saudi Arabia.

BACKGROUND: Despite the success of childhood immunization in reducing vaccine-preventable diseases, vaccine hesitancy is now a global health threat to this achievement. The current COVID-19 pandemic may change the picture of vaccine hesitancy toward childhood immunizations, which could influence the mothers' intention to vaccinate their children against COVID-19. AIM: To measure the prevalence and related factors of vaccine hesitancy towards childhood immunization during the era of COVID-19 along with the prevalence of mothers' intention to vaccinate their children the future COVID-19 and its association with childhood vaccine hesitancy. METHODS: Cross sectional study was conducted among 270 Saudi mothers attending outpatient clinics at King Abdullah University Hospital (KAAUH) in Riyadh by purposive sampling technique. Data were collected from January to February 2021 using SAGE Group standardized questionnaire. RESULTS: Although most mothers strongly agree on the importance of the vaccine (79%), almost one-fourth of mothers were hesitant towards childhood immunization (24.31%). Similar percentage of mothers' intended to vaccinate their children against COVID-19 in the next 6 months was reported (24%). Vaccine hesitancy was found to be a significant predictor of mothers' intention. Mothers' education level was significantly associated with being hesitant towards childhood immunization as well as the intention to accept the future COVID-19 vaccine (p < 0.05). Main reason that was highly significantly associated with being hesitant is the concerns about the side effect (50%). CONCLUSION: The present study reported a considerable percentage of mothers who are hesitant towards childhood immunization which predicts their intension to vaccinate towards COVID19 and is associated with the level of education.