Exploring Effects of Race and Differential Item Functioning on PrEP Stigma Experiences: Implications for Latent Stigma Measurement in Racially and Sexually Diverse Populations.

PrEP stigma measurement remains a challenge to the validity of studies and interventions addressing HIV prevention. It may lead to inaccurate assessment of the relationship between PrEP stigma and health outcomes such as PrEP persistence and care retention in groups experiencing HIV-related inequities. The present research explored the psychometric properties of a novel IV pre-exposure prophylaxis (PrEP) stigma scale in a cohort of racially diverse men who have sex with men (MSM). Using item response theory, analyses explored presence of differential item functioning (DIF) among Black and White respondents. Participants completed baseline surveys measuring psychosocial factors, sociodemographic factors, and PrEP stigma items. The primary analysis used a machine learning approach to assess (a) the presence of DIF; and (b) compare latent stigma between Black and White respondents, after correcting for any DIF. The model identified four out of 13 scale items as having a high probability of DIF for Black respondents, which is relatively good given that the original PrEP stigma scale was neither designed nor tested for validation comparing Black and White respondents. The DIF-adjusted latent PrEP stigma measure reveals statistically and substantially significantly higher levels of stigma for Black compared to White respondents (Diff.: 1.05 +/- 0.19). While most items performed well, findings demonstrate the importance of assessing measurement error in populations where stigma is rampant and being studied or intervened upon (and in this case, where multilevel and intersectional stigma may be present).

An 8-year single-centre experience of patients with subclinical rheumatic carditis.

OBJECTIVE: Transthoracic echocardiography is the gold standard method for screening and confirmation of acute rheumatic fever and subclinical rheumatic heart disease. Secondary antibiotic prophylaxis that is regularly employed in subclinical rheumatic heart disease may help to reverse mild rheumatic carditis lesions, delay the progression of the disease, reduce morbidity and mortality, and improve patients' quality of life. MATERIALS AND METHODS: We retrospectively evaluated the outcomes of 180 patients with subclinical rheumatic heart disease who were followed up for a mean of 4.92 ± 2.0 (3.5-6.5) years. RESULTS: Between 1 March 2015 and 31 December 2023, 180 patients diagnosed with subclinical rheumatic heart disease with a mean follow-up of 4.92 ± 2.0 (3.5-6.5) years were included in the study. Of the patients, 50.6% were male, 49.4% were female, mean age at diagnosis was 11.74 ± 3.18 (9.68-13.65) years, and mean follow-up period was 4.92 ± 2.0 (3.5-6.5) years. Further, 87.2 % of the patients had mitral valve regurgitation, 38.3% had aortic valve regurgitation, and 27.2% had both valve (aortic and mitral valve) regurgitation. Moreover, Sydenham chorea was also diagnosed in 7.8% the patients. Of the patients, 90% had mild rheumatic heart disease, 7.8% had moderate rheumatic heart disease, and 2.2% had severe rheumatic heart disease. After the diagnosis of rheumatic heart disease, 76.7% patients received regular and 23.3% irregular secondary benzathine penicillin G prophylaxis. CONCLUSION: We believe that echocardiography demonstrates its efficacy and safety profile in reducing the risk of rheumatic heart disease in patients diagnosed with subclinical rheumatic carditis and complying with regular secondary antibiotic prophylaxis.

No significant difference in skin contamination during anterior cruciate ligament reconstruction with and without preoperative skin cleaning.

PURPOSE: This prospective study aimed to assess whether preoperative antiseptic skin cleansing reduces bacterial contamination and surgical site infections (SSI) following anterior cruciate ligament reconstruction (ACLR). We hypothesized that antiseptic cleaning would lower bacterial load, reducing contamination and early infections. METHODS: One hundred and nineteen patients scheduled for ACLR were included in this prospective, nonrandomized study. Individuals were divided into two groups. Patients in the intervention group applied octenisan® wash lotion daily for three days before surgery and used the wash solution instead of their usual shower gel. Additionally, they swiped their leg with octenisan® soaked gloves on the morning of the operation. The control group followed their usual wash routine with no specific instructions. Fluid samples were taken before surgery from the irrigation bag and at 15-min intervals from the reservoir of the sterile surgical drape during the procedure. Suture material used for the ACL graft and meniscus repair were also collected for testing. The samples were subjected to a 14-day incubation period. Follow-up included outpatient visits at 6 weeks, 12 weeks and 6 months with a final evaluation at 12 months. RESULTS: Contamination rates showed no significant difference between the control and intervention groups. The mean contamination rate in the control group was 6.4% (n = 22) and 6.6% (n = 24) in the intervention group (p = 0.28). At 12-month follow-up, 110 out of 119 participants were included (52 control, 58 intervention). T tests for age (p = 0.19), BMI (p = 0.66), and surgery duration (p = 0.38) showed no significant differences. No early SSI were observed in either group postoperatively. CONCLUSION: Our results indicate that the use of antiseptic wash lotion and gloves does not influence the risk of bacterial contamination during surgery. LEVEL OF EVIDENCE: Level III.

Initial Experience of Long-Term Prophylaxis with Lanadelumab for Hereditary Angioedema in China: A Clinical Observation Study on Six Patients.

INTRODUCTION: Hereditary angioedema (HAE) is a rare genetic disorder caused by deficiency or dysfunction of C1-esterase inhibitor that is characterized by recurrent episodes of bradykinin-mediated edema. Lanadelumab has been the only available first-line therapy for long-term prophylaxis (LTP) of HAE in China since its approval in 2020. The present study aimed to investigate the clinical efficacy and safety of lanadelumab for LTP in Chinese patients. METHODS: A retrospective clinical data were collected for the 6 patients and used to examine the frequency of attack symptoms, disease-related loss of work days, and quality of life before and after LTP with lanadelumab. Health-related quality of life was assessed using the Dermatology Life Quality Index (DLQI) and the Angioedema Quality of Life Questionnaire (AE-QoL). RESULTS: Lanadelumab led to reductions of 97.8% and 98.5% in the attack rate and treated attack rate, respectively. All patients exhibited significant improvements in AE-QoL and DLQI scores (100% reduction rates) during the early treatment period (4 weeks and 2 weeks, respectively) and in missed work days/year (98.9% reduction rate). The efficacy of lanadelumab remained stable during COVID-19 vaccination and infection. No serious/severe treatment-emergent adverse events occurred during lanadelumab treatment. CONCLUSION: This study is the first report that demonstrates the clinical efficacy of lanadelumab and safety of LTP in HAE patients from Chinese mainland. A reasonable dosage plan can ensure a quick and long-lasting protective role of lanadelumab against HAE attacks, during COVID-19 pandemic period.

Rising trend of dentist-prescribed antibiotics in Brazil: 2011-2021.

OBJECTIVES: To describe the trends in antibiotic prescribing by dental practitioners and to investigate the relationship between these trends and some factors of public oral health services in Minas Gerais (MG), Brazil. METHODS: This was a time-series analysis of antibiotics prescribed by dental practitioners between January 2011 and December 2021. The outcome variables were number of defined daily doses (DDD) and DDD/1000 population/year in a sample of cities in MG. Covariates were public oral healthcare factors, such as coverage, estimates of dental procedures, and frequency of dental pain. Linear time-series regression models were used to examine trends and the influence of covariates on antibiotic prescribing. RESULTS: Overall, the number of prescriptions increased by 334.69% between 2011 and 2021, with amoxicillin being the most commonly prescribed drug (78.53%). The number of DDD for all antibiotics increased from 17,147.13 to 77,346.67 and the average DDD/1000 inhabitants/year was 126.66 (SD: 130.28). The linear time-series regression model showed that for each one-year increase, the average log DDD/1000 inhabitants increased by 0.35 (standard error = 0.07, p < 0.001). No covariates were found to be associated with the outcome. CONCLUSIONS: In Minas Gerais, Brazil, a significant upward trend was observed in the number of prescriptions and the number of DDD of antibiotics prescribed by dental practitioners. No influence of factors related to public oral healthcare services on the outcome was observed, thereby emphasizing the need for further research on factors influencing medication use in dental practice.

Impact of Antibiotic Choice at the Time of Sacral Neuromodulation Implantation on Rates of Surgical Site Infection.

PURPOSE: To evaluate the efficacy of specific antibiotic regimens in preventing infection following sacral neuromodulation. MATERIALS AND METHODS: This is a retrospective cohort study utilizing the Premier Healthcare Database. Patients who underwent sacral neuromodulation placement between January 2016 and March 2020. The patients were grouped by those who received dual antibiotic therapy per 2019 AUA guidelines (Gram positive + broad Gram negative coverage), first- or second-generation cephalosporins or any other regimen. Comparison between groups was performed using Kruskal-Wallis and χ2 tests for continuous and categorical variables, respectively. Inverse probability of treatment weighted (IPTW) analysis was used to estimate the average treatment effect of AUA guidelines regimens versus the use the first- or second-generation cephalosporins alone. RESULTS: The sample included 14 179 patients, with 2211 patients receiving prophylaxis that followed the AUA guideline recommendations. There was no significant difference in surgical site infection rates within 3 months (p = 0.28) or within 12 months (p = 0.53) between the groups. On IPTW, the probability of an infection at 3 months was lower with the AUA guideline regimens compared to those who received first- or second-generation cephalosporins alone, but this difference was not statistically significant (OR = 0.73, 95% CI: [0.43, 1.24]). CONCLUSIONS: In the absence of allergies to cephalosporins or penicillin, first- or second-generation cephalosporins alone may be a sufficient preoperative antibiotic regimen for prevention of infection at the time of sacral neuromodulation. TRIAL REGISTRATION: Not applicable due to being a database study.

Pre-exposure Prophylaxis (PrEP) implementation among latino MSM: a qualitative scoping review of implementation determinants and change methods.

INTRODUCTION: The increasing rates of HIV among Latino men who have sex with men (MSM) necessitate innovative and rigorous studies to evaluate prevention and treatment strategies. Pre-exposure prophylaxis (PrEP) is a highly effective tool in preventing HIV acquisition and plays a crucial role in the Ending the HIV Epidemic in the U.S. initiative. However, there is a scarcity of PrEP research specifically focused on Latino MSM, and the factors influencing its implementation remain largely unknown. METHODS: To address this gap, we conducted a comprehensive review exploring the determinants (barriers and facilitators) of PrEP implementation among Latino MSM, as well as the change methods (implementation strategies and adjunctive interventions) that have been evaluated to promote its adoption. Our review encompassed 43 peer-reviewed articles examining determinants and four articles assessing change methods. Determinants were coded using the updated Consolidated Framework for Implementation Research (CFIR 2.0) to understand the multilevel barriers and facilitators associated with implementation. RESULTS: The majority of research has focused on PrEP recipients (i.e., patients), primarily examining their awareness and willingness to use PrEP. Fewer studies have explored the factors influencing clinicians and service delivery systems. Additionally, the evaluation of change methods to enhance clinician adoption and adherence to PrEP and recipient adherence to PrEP has been limited. CONCLUSION: It is evident that there is a need for culturally adapted strategies tailored specifically for Latino MSM, as the current literature remains largely unexplored in this regard. By incorporating principles from implementation science, we can gain a clearer understanding of the knowledge, skills, and roles necessary for effective cultural adaptations. Future research should emphasize factors influencing implementation from a clinician standpoint and focus on innovative change methods to increase PrEP awareness, reach, adoption, and sustained adherence among Latino MSM.

Endocarditis Associated With Coronary Cameral Fistula Presenting With Intracranial Hemorrhage.

Coronary cameral fistulas are rare anomalous connections between coronary circulation and cardiac chambers. Coronary cameral fistulas are often asymptomatic but may cause volume overload on impacted chambers, and also create high velocity turbulent diastolic flow which may predispose patients to endocarditis. This paper presents a unique case of infective endocarditis revealed by intracerebral hemorrhage with a mycotic aneurysm in a patient who was found to have a nonvalvular infective endocarditis located on the mitral anterolateral papillary muscle, at the ventricular site of entrance of a large coronary cameral fistula.

Peritoneal Window With Omental Interposition as a Prophylactic Measure to Prevent Post-Renal Transplant Lymphocele: A Pilot Study.

INTRODUCTION:  Renal transplant is considered to be the most optimum treatment option for chronic kidney disease. One common post-operative complication that can compromise the graft function is lymphocele. Despite the technical advances, the incidence of lymphocele is not negligible. Here, we propose the outcomes of peritoneal window and omental interposition as a prophylactic measure to prevent lymphocele occurrence. METHODS: This was a single-centre prospective study conducted at a tertiary care hospital, between June 2021 and June 2023. The study included patients more than 18 years of age who underwent renal transplants. Both live-related and deceased renal transplant recipients were included. The primary endpoint focused on the incidence of symptomatic post-transplant lymphocele necessitating interventional treatment within six months of follow-up. RESULTS: Out of 50 patients who underwent renal transplants during the study period, only one patient developed lymphocele in the postoperative period. CONCLUSION: Prophylactic peritoneal window with omental interposition serves as a promising technique to prevent post-renal transplant lymphocele formation.

Direct oral anticoagulants (DOACs) for postoperative venous thromboembolism prophylaxis in patients with gynecologic malignancies: A quality mini-review.

Venous thromboembolism (VTE) is a common cause of morbidity and mortality in gynecologic oncology patients with an increased risk in the postoperative period. Historically, international guidelines have recommended 28 days of low molecular weight heparin (LMWH) or unfractionated heparin (UFH) for extended VTE prophylaxis after major abdominal and pelvic surgery for gynecologic malignancies. Direct oral anticoagulants (DOACs) have emerged as an attractive alternative to injectable anticoagulants. This quality mini-review evaluated the literature around the use of DOACs for postoperative VTE prophylaxis after surgery for gynecologic cancer. Overall, the reviewed literature supports the use of DOACs in select patients within this population which may lead to an improved patient experience, higher rates of treatment compliance, and increased cost savings.

Decision Support Tool to Improve Decision-Making for HIV Pre-Exposure Prophylaxis (PrEP): Development Process and Alpha Testing.

BACKGROUND: African, Caribbean, and Black (Black) communities in Canada are disproportionately affected by the HIV epidemic. Pre-exposure prophylaxis (PrEP) is a highly effective option for the prevention of HIV. However, the use of PrEP for HIV prevention among eligible Black clients in Canada remains far below the thresholds necessary to achieve the goal of zero new HIV infections. In a recent study in Toronto, PrEP-eligible Black clients were found to have decisional conflict and unmet decisional needs, which affected the quality of their decision-making process regarding the initiation and adherence to PrEP. There is evidence that decision support tools (DSTs) can improve the quality of a decision, the quality of the decision-making process, the implementation or continuation of the chosen option, and the appropriate use of health services. Despite these benefits, there is currently no DST for PrEP-eligible Black clients being asked to consider PrEP for HIV prevention. OBJECTIVE: Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability. METHODS: We developed and evaluated the PrEP DST for Black patients using the 7-step process outlined in the Ottawa Decision Support Group Guideline for the development and evaluation of DST. To facilitate the implementation of the Ottawa Decision Support Group guideline, we assembled a multidisciplinary team of primary health care providers, researchers, community members with lived experiences, and digital content designers to serve as the steering committee. First, we assessed patients' and primary health care providers' views on decisional support needs, after which we determined the content, design, and distribution plan for the DST. Subsequently, we conducted evidence synthesis, reviews, and appraisal before developing the PrEP DST prototype. The final tool was reviewed by steering committee members for completeness before acceptability and usability testing with potential Black clients and PrEP providers. RESULTS: The web-based DST yielded 27 pages divided into 6 distinct sections. The six sections include (1) an introduction of the DST, (2) clarify your decision, (3) knowledge, (4) a value clarification exercise, (5) support system, and (6) next steps. Both Black clients and PrEP providers reported ease of task performance, general satisfaction, and usefulness of the tool to support decision-making for Black clients. Feedback on usability centered on the need to add a user guide to increase usability. All feedback was incorporated into the final tool. CONCLUSIONS: A PrEP DST for Black clients developed using a systematic process and a multidisciplinary steering committee was acceptable and usable by both Black clients and PrEP providers. Further study (eg, randomized controlled trials) may be needed to evaluate the efficacy of the PrEP DST.

Toxoplasma qPCR kinetics to guide pre-emptive treatment of toxoplasmosis after allogeneic hematopoietic stem cell transplantation.

BACKGROUND: Recent ECIL-guidelines recommend a quantitative PCR (qPCR) guided pre-emptive treatment approach to toxoplasmosis in seropositive recipients of allogeneic hematopoietic cell transplantation (allo-HCT). While qPCR might serve as a sensitive tool for early Toxoplasma detection, its role in treatment follow-up remains unknown. METHODS: We analyzed the qPCR kinetics of allo-HCT recipients experiencing either Toxoplasma infection (TI, n=71) or disease (TD, n=14) in relation to different parameters. We included 85 patients with available qPCR values expressed as quantitative cycle (Cq) from four large hematological centers from 2009 to 2023, and kinetic analysis was performed in a selection of 74 patients screened at least weekly with blood qPCR. Day 0 (D0) was the day of anti-Toxoplasma treatment start or (when untreated) day of diagnosis. RESULTS: Time to qPCR negativity was inversely proportional to the Cq value at D0 (p=0.0063). Not reaching negativity at D10 was associated with a significantly higher mortality at D30 (p=0.023). Patients with a high D0-parasitic load and patients with TD showed slower clearance (p<0.001, p=0.032). Time to negativity was not significantly different for patients started on prophylactic vs curative doses as first-line treatment regimen (p=0.16). CONCLUSIONS: This study underscores the predictive value of qPCR kinetics monitoring in allo-HCT patients with toxoplasmosis. With the aforementioned risk factors, clinicians can identify patients at high-risk for worse outcome. Our results support to consider a therapeutic change or reinforcement if the parasitic load does not decrease after 10 days, supplementing existing clinical guidelines.

Understanding the journey towards rabies vaccination for travellers: Results of a cross-sectional survey with patients and providers in the US, Germany, Sweden, and Switzerland.

BACKGROUND: Although cases of rabies in international travellers are uncommon, they are a fatal risk which can be alleviated through vaccination prior to travel. As international travel recovers post-COVID, it is vital that travellers are made aware of the risk of rabies when travelling to endemic countries and supported to receive the vaccine when eligible. METHODS: Online surveys were conducted in the US, Germany, Sweden and Switzerland between November 2022-January 2023 with both patients and healthcare providers (HCPs). Eligibility criteria for patients included those eligible for rabies pre-exposure prophylaxis (PrEP) due to travel location and activity; HCPs had to be providers of travel vaccinations. In both surveys, questions were asked about discussion of rabies vaccination, decision of whether to administer a rabies vaccine, recommendation to get the rabies vaccine, and final decision to get a vaccine. RESULTS: The final patient sample included n = 1557 patients who were eligible for rabies pre-exposure prophylaxis (US n = 504, Germany n = 353, Sweden n = 350, Switzerland n = 350) and n = 219 HCPs (US n = 75, Germany n = 75, Sweden n = 32, Switzerland n = 37). Although all patients in the sample were eligible for rabies vaccination, only 15 % felt they were at risk of getting rabies, and only 18 % received the rabies vaccine before their trip. HCPs reported discussing PrEP and/or PrEP and PEP with 30 % of patients presenting for travel vaccination advice, on average. CONCLUSIONS: Awareness and perception of rabies risk, and lack of consistent HCP discussion of the need for rabies PrEP may be major barriers to uptake of the vaccine for patients who are eligible to receive it.

Midwives' compliance with post-exposure prophylaxis guidelines in Tshwane District, South Africa.

BACKGROUND:  Human immunodeficiency virus (HIV) remains a major public health concern. Midwifery practitioners as frontline healthcare workers (HCWs) remain susceptible to occupational exposure to infections while performing their routine duties. It is estimated that 90% of occupational exposures occur because of a lack of awareness and training regarding prevention and measures to be taken in case of accidental exposure. OBJECTIVES:  The study aimed to assess the knowledge, attitudes and compliance of midwifery practitioners regarding post-exposure prophylaxis (PEP) guidelines. METHOD:  Concurrent mixed-methods research approach with qualitative nested in quantitative design was followed. A random simple sampling technique was used to collect quantitative data from 71 midwifery practitioners. Simultaneously, a purposive non-probability sampling technique was used for the qualitative approach with two occupational health and safety (OHS) practitioners and 13 midwifery practitioners. Data were collected through questionnaires and semi-structured interviews. Quantitative data were analysed with SPSS version 24 and presented in tables and figures, and thematic analysis was employed for the qualitative strand. RESULTS:  The midwifery practitioners have good knowledge about PEP for HIV. However, the study revealed the underreporting of accidental exposures to blood and body fluids (BBFs) and the underutilisation of available PEP services. CONCLUSION:  Maternity units are high-risk clinical environments. Underreporting of incidents of exposure remains prevalent among midwifery practitioners.Contribution: The findings will inform policy development structures and hospital management regarding knowledge and implementation gaps related to PEP guidelines in the specific hospitals. Strategies to improve compliance with PEP among midwifery practitioners were developed as a derivative from study findings.

EPS T14 from Bacillus licheniformis Prevents Infection of Human Nasal Epithelial Cells by Respiratory Viruses.

Background: Respiratory viral infections are a leading cause of severe diseases and mortality; therefore, novel treatments effective for their prevention are highly requested. Here, we identified a broad-spectrum antiviral activity of a natural exopolysaccharide, EPS T14, purified from a marine thermotolerant strain of Bacillus licheniformis strain T14. Methods: The effects on human normal nasal epithelial cells (HNEpCs) following treatment with EPS T14 was evaluated at different time points and with increasing concentration of compound. To assess the antiviral properties, viability of HNEpCs treated with EPS T14 was analysed following infection with different respiratory viruses. Results: Neither toxicity nor pro-inflammatory properties were observed in vitro on HNEpCs treated with EPS T14 up to high concentrations, thus ensuring its safety. Cell culture-based assays revealed that treatment of HNEpCs with EPS T14 (used at 400ug/mL) results in efficient prevention of cell infection by different respiratory viruses through physically hindering the entry of the viruses via cell surface receptors. Interestingly, in addition to this prophylactic antiviral activity, EPS T14 also shows a long-lasting efficacy by inhibiting viral spread in the cell culture. Finally, combination of EPS T14 with a hypertonic saline solution shows a synergistic antiviral activity. Conclusion: EPS T14 can exert both prophylactic and therapeutic antiviral activity by blocking viral attachment to cellular receptors and could therefore represent a promising antiviral agent for preventing infections by different respiratory viruses.

Perceived risks and benefits of telePrEP interventions: An interview study with rural sexual minority men in Texas.

PURPOSE: Many rural areas lack brick-and-mortar HIV prevention resources despite the increasing rates of HIV. Although online HIV pre-exposure prophylaxis (PrEP) programs can potentially increase uptake among rural sexual minority men (SMM), their attitudes and preferences regarding telehealth-based PrEP (telePrEP) programming are uncertain. This qualitative study examined rural SMM's perceived risks and benefits of participating in a hypothetical telePrEP program. METHODS: Twenty rural SMM living in Texas completed a semi-structured online videoconferencing interview between April 12 and June 14, 2023. Data were analyzed with reflexive thematic analysis. FINDINGS: Four themes were constructed: (1) telePrEP interventions increase accessibility but completely online services might be inadequate; (2) telePrEP and mail-order interventions are convenient but face challenges; (3) telePrEP interventions need to address confidentiality and privacy within the context of the sociopolitical climate; and (4) telePrEP interventions need to address trustworthiness and transparency. CONCLUSIONS: Overall, our results indicate that rural SMM perceive telePrEP interventions that provide at-home and telehealth PrEP, HIV testing, and HIV care services as beneficial. However, overall utility and acceptability depend on perceptions of privacy, confidentiality, trustworthiness, and transparency. Given the HIV prevention and treatment service deserts in which many rural SMM live, telePrEP interventions must purposefully demonstrate how their operations and data will remain safe and secure. Further work should explore contextual or situational factors that influence the willingness and acceptability of rural SMM to participate in online HIV prevention intervention research studies.

Long-term safety and efficacy of garadacimab for preventing hereditary angioedema attacks: Phase 3 open-label extension study.

BACKGROUND: Hereditary angioedema (HAE) is a chronic, unpredictable disease. Long-term prophylactic treatments that offer durable efficacy, safety, and convenience are required to assist patients in achieving complete disease control, per international guidelines. We report an interim analysis of an ongoing phase 3 (VANGUARD) open-label extension (OLE) study evaluating the long-term safety and efficacy of garadacimab for HAE prophylaxis. METHODS: Adults and adolescents aged ≥12 years with HAE previously participating in phase 2 and pivotal phase 3 (VANGUARD) studies were rolled over to an OLE, alongside newly enrolled patients. Patients received garadacimab 200 mg subcutaneously, once monthly for ≥12 months. The primary endpoint was treatment-emergent adverse events (TEAEs) in patients with C1 inhibitor deficiency/dysfunction. RESULTS: At data cut-off (February 13, 2023; N = 161), median (interquartile range) exposure was 13.8 months (11.9-16.3). For the primary endpoint, 133/159 patients experienced ≥1 TEAE (524 events), equivalent to 0.23 events/administration and 2.84 events/patient-year. Garadacimab-related TEAEs (13% of patients, 52 events) were most commonly injection-site reactions (ISRs). No deaths occurred. One patient discontinued treatment due to garadacimab-related moderate ISR. Most TEAEs were mild/moderate; three events were serious (COVID-19, two events; abdominal HAE attack, one event) and not garadacimab related. No abnormal bleeding, thromboembolic, severe hypersensitivity, or anaphylactic events were observed. Mean HAE attack rate decreased by 95% from the run-in period; 60% of patients were attack-free. Almost all patients (93%) rated their response to garadacimab as "good" or "excellent." CONCLUSION: Garadacimab has a favorable safety profile suitable for long-term use and provides durable protection against HAE attacks.

COVID-19 venous thromboembolism prophylaxis guidelines in pediatrics.

INTRODUCTION: SARS-CoV-2 (COVID-19) infection and multisystem inflammatory syndrome in children (MIS-C) are risk factors for venous thromboembolism (VTE). Guidelines for VTE prophylaxis were established at our institution at the beginning of the pandemic. Patients who had any VTE risk factors in addition to COVID-19 met criteria for anticoagulation prophylaxis. Patients who were diagnosed with MIS-C met criteria regardless of additional risk factors. MATERIALS AND METHODS: We conducted a retrospective review of patients admitted with COVID-19 or MIS-C to determine compliance with VTE prophylaxis guidelines and to evaluate the incidence of VTE and bleeding events in our population. RESULTS AND CONCLUSIONS: Among a total of 678 patients admitted with COVID-19 or MIS-C, 519 (76 %) patients met criteria for VTE prophylaxis and 348 (65.6 %) started prophylaxis. Logistic regression analysis identified a personal or family history of thrombosis or thrombophilia, diagnosis of MIS-C, admission to the intensive care unit, and presence of a central venous catheter as significantly associated with starting VTE prophylaxis. There were 18 patients who developed VTE. Minor bleeding events occurred in 19 patients (5 %), patient important bleeding, no intervention occurred in 8 patients (2 %), clinically relevant nonmajor bleeding in 8 patients (2 %), and major bleeding in 10 patients (3 %). The incidence of VTE in our patients with COVID-19 and MIS-C is similar to VTE rates at other institutions. We found that universally recognized VTE risk factors were appropriate to include as risk factors for thrombosis in hospitalized children with COVID-19 and MIS-C.

Practice variation in venous thromboembolism prophylaxis in adolescent trauma patients: A comparative analysis of pediatric, adult, and mixed trauma centers.

INTRODUCTION: Adolescent trauma patients are at increased risk of venous thromboembolism (VTE). It is unclear whether VTE prophylaxis practice patterns differ across trauma center types. METHODS: The ACS-TQP database was queried for patients aged 12-17 admitted to a pediatric, adult, or mixed level I/II trauma center. VTE prophylaxis was compared between center types. Preplanned subgroup analyses were performed to evaluate guideline adherence. RESULTS: Of 101,010 patients included, 35 â€‹% were treated at a pediatric trauma center (PTC), 43 â€‹% at a mixed trauma center (MTC), and 22 â€‹% at an adult trauma center (ATC). VTE prophylaxis was more common at ATCs and MTCs compared to PTCs (51.0 â€‹% vs 24.9 â€‹% vs 5.0 â€‹%,p â€‹< â€‹0.001). This trend persisted in subgroup analyses of patients aged 16-17 (63.8 â€‹% vs 40.5 â€‹% vs 6.4 â€‹%,p â€‹< â€‹0.001) and with injury severity score greater than 25 (83.8 â€‹% vs 74.0 â€‹% vs 35.1 â€‹%,p â€‹< â€‹0.001). CONCLUSION: VTE prophylaxis is administered more frequently to adolescent trauma patients treated at ATCs and MTCs compared to PTCs despite published guidelines. Prospective studies are needed to assess the clinical utility of VTE prophylaxis in the adolescent trauma population.