Retrospective Chart Review Study Research Articles

Ceftaroline fosamil treatment patterns and outcomes in adults with community-acquired pneumonia: a real-world multinational, retrospective study.

This multicentre, observational, retrospective chart review study assessed ceftaroline fosamil treatment patterns and outcomes in adults hospitalized with community-acquired pneumonia (CAP) in usual care settings. Anonymized patient data were extracted from hospital records of adults with CAP who received ≥4 consecutive IV ceftaroline fosamil doses at sites in Brazil, Colombia, France, Greece, Italy, Russia and Spain. The dataset included 185 patients (58.9% male; mean age 62.2 years), of whom 128 (69.2%) had severe CAP defined by CURB-65, PSI/PORT score or physician judgement. Streptococcus pneumoniae (n = 44; 23.8%) and Staphylococcus aureus [MSSA (n = 15) and MRSA (n = 14)] were the most frequently identified pathogens. Clinical response occurred in 151 (81.6%) patients overall, and in 104 (81.3%) severe CAP patients. Response within ≤4 and >4 days occurred in 79 (42.7%) and 62 (33.5%) patients (unknown, n = 10), respectively. Twenty (10.8%) patients required readmission within 30 days. Thirty-day all-cause mortality rates were 9.7% (n = 18) overall and 10.2% (n = 13) in severe CAP. In sensitivity analysis using ICU admission as a more objective marker of severe CAP (n = 75), clinical response and 30 day mortality occurred in 57 (76.0%) and 10 (13.3%) patients, respectively. Overall, clinical response to ceftaroline fosamil was associated with >60% shorter length of ICU stay (3.6 versus 9.2 days), and >30% lower hospital costs ($8449 versus $12 559) versus non-responders. Ceftaroline fosamil was effective in treating adults with CAP, including severe CAP, in Europe and Latin America. Clinical response to ceftaroline fosamil was associated with reductions in healthcare resource use compared with non-responders.

Healthcare resource utilization following ustekinumab initiation among bio-naïve Canadian patients with moderately-to-severely active Crohn's disease

Healthcare resource utilization following ustekinumab initiation among bio-naïve Canadian patients with moderately-to-severely active Crohn's disease

Diagnostic Accuracy of MMP-8 and IL-6-Based Point-of-Care Testing to Detect Peritoneal Dialysis-Related Peritonitis: A Single-Center Experience.

Peritoneal dialysis-related peritonitis (PDRP) is the most common complication of peritoneal dialysis (PD), which can lead to poor outcomes if not diagnosed and treated early. We aimed to investigate the diagnostic accuracy of MMP-8 and IL-6-based point-of-care tests (POCTs) in diagnosing PDRP in PD patients. This retrospective chart review study was conducted at a comprehensive kidney center in Qatar. It involved all adult PD patients who underwent PDRP from July 2018 to October 2019 and for whom MMP-8 and IL-6-based POCTs were used to diagnose presumptive peritonitis. Measures of diagnostic accuracy were computed. Peritoneal fluid effluent analysis was the reference standard. We included 120 patients (68 [56.7%] females, ages 55.6 ± 15.6 years, treatment duration 39.5 ± 30.4 months [range: 5-142 months]). In this population, MMP-8 and IL-6-based POCTs yielded 100% in all dimensions of diagnostic accuracy (sensitivity, specificity, positive and negative predictive values). MMP-8 and IL-6-based POCTs might be helpful in the early detection of PDRP. This monocentric observation requires further confirmation in a prospective multicentric setting.

Rates of Acute Brain Injury Among Severely Hypertensive Patients Seen in the Emergency Department.

Identifying patients with acute brain injury among patients who present to the Emergency Department (ED) with severe hypertension can be challenging. We explored rates of brain injury in a cohort of ED patients with severe hypertension in whom acute target-organ damage was or was not initially suspected. We conducted a retrospective chart-review study at two different hospitals within the same urban health system. Consecutive adult patients seen from 10/1/2020 to 5/1/2022 with a systolic blood pressure ≥180mmHg or diastolic blood pressure ≥120mmHg were included. A total of 972 patients met our eligibility criteria. The average age was 59years (SD: 16.5), 454 (46.7%) were women, and 582 (59.9%) were non-White. A total of 186/972 (19.1%) patients were initially thought to have acute target-organ damage in the ED with 97/186 (52.2%) diagnosed with stroke or TIA. The remaining 786/972 (80.9%) patients were not initially diagnosed with target-organ damage (hypertensive urgency [HU]). Of the 786 patients with HU, a head CT was obtained in 216/786 (27.7%) and brain MRI in 74/786 (9.4%). Of the HU patients with a brain MRI, 23/74 (31.1%) had acute abnormalities; most abnormalities on brain MRI (17/23 [73.9%]) were not seen on preceding head CT. In a multicenter study of ED patients, nearly 1 in 5 patients though to have HU who eventually underwent brain MRI had unexpected acute neurological findings, though brain MR was obtained in only 9%.

STIMA: Submucosal Temporary Inferior Maxillary Antrostomy: A Modification of Conventional Antrostomy, A Retrospective Review.

Introduction: Maxillary sinus pathology is commonly approached through endoscopic middle meatal antrostomy (MMA). However, MMA does not provide full exposure to certain aspects of the maxillary sinus, such as alveolar, zygomatic, and prelacrimal recesses. In these hidden maxillary sinus niches, a combination approach with MMA is required for better exposure and access. In this article, we present a modification of inferior maxillary antrostomy (IMA) to allow for a temporary intraoperative window with no significant postoperative consequences. Objectives: (1) To describe our modification of IMA. (2) To report the outcome of maxillary sinus disease, postoperative complications, and flap condition. Methods: This is a retrospective chart review study. It was performed on 20 patients where submucosal temporary inferior maxillary antrostomy (STIMA) was indicated in the period from January 1, 2020, and July 1, 2023. All patients were assessed for their demographics, diagnosis, indication for STIMA, maxillary disease outcome, presence of postoperative complications, and flap condition. Result: Total of 18 patients fulfilled our inclusion/exclusion criteria; of them, 13 were males while the remaining were females. Mean age of patients was 33 years; most common diagnosis was chronic sinusitis. Status of maxillary sinus mucosa was healthy in all except 4 patients having polypoidal mucosa while flap condition was intact in all patients except 2 patients with pinpoint defects. Postoperative complications assessment demonstrated no neural, orbital, lacrimal, or dental complications in all patients. Conclusion: This retrospective chart review showed promising technique to address challenging maxillary lesions in difficult-to-access locations where combined approaches are necessary.

Efficacy of recombinant erythropoietin for the late treatment of anemia of prematurity in a level IV neonatal intensive care unit: a retrospective single-center cohort study.

To describe the population to which we administered recombinant erythropoietin and to determine the effectiveness of this treatment as quantified by the change in hematocrit. This retrospective chart review study included infants who received erythropoietin for the treatment of anemia of prematurity. There were 132 infants representing 162 unique treatment courses included in the study. The average duration of therapy was 9 days (±7) and 6 doses (±2). The average change in hematocrit (Hct) was 6.2% (SD 3.9%, p < 0.001). Rise in Hct was associated with a higher number of rEPO doses (p < 0.001) and higher postmenstrual age (p < 0.001). In our small cohort we did not find an association between the number of rEPO doses and retinopathy of prematurity (ROP) requiring treatment. Erythropoietin is safe and effective at treating anemia of prematurity as evidenced by a clinically and statistically significant increase in Hct from baseline.

Evaluation of the effect of voxelotor and darbepoetin alfa on hemoglobin levels in patients with sickle cell disease

ABSTRACT Background To date, there is limited evidence on patients utilizing both voxelotor and darbepoetin alfa and its impact on hemoglobin levels. The objective is to evaluate the effect of voxelotor and darbepoetin alfa on hemoglobin levels in patients with SCD. Research design and methods This was a retrospective chart review study that assessed the primary independent variable as the utilization of either voxelotor alone, darbepoetin alfa alone, or the concurrent administration of voxelotor and darbepoetin alfa. Descriptive statistics were utilized to obtain the mean standard deviation for numerical variables and proportions for categorical variables. Results A total of 23 participants were included in this study. When comparing baseline to 2 months and 3 months, participants on voxelotor alone experienced a 3% decrease and a 6.6% increase in hemoglobin, darbepoetin alfa alone group a 4.3% decrease and a 0.6% increase in hemoglobin and voxelotor and darbepoetin group a 4.4% decrease and a 0.5% decrease in hemoglobin levels. Fifty percent of the participants in the voxelotor group and 6 (66.7%) participants in the voxelotor plus darbepoetin alfa group experienced adverse drug events. Conclusions Voxelotor resulted in a clinically significant difference in the percent change of hemoglobin from baseline to 3 months.

Prediction of the small aperture intraocular lens on visual acuity in patients with keratoconus.

To investigate the impact of corneal higher-order aberrations (HOAs) on predicted corrected distance visual acuity (CDVA) in patients with keratoconus at varying simulated pupil apertures. Ophthalmology Clinics, Medical University of South Carolina, Charleston, South Carolina. Retrospective chart review study. 56 eyes with keratoconus were examined using Scheimpflug tomography during routine examinations before medical intervention. The severity of keratoconus was graded using the Amsler-Krumeich classification. Zernike analysis was used to obtain corneal aberrations using simulated pupil diameters of 6 mm, 4 mm, and 2 mm. These data were extrapolated to obtain the total root mean square HOAs for a 1.6 mm simulated pupil to evaluate the potential effect of a small aperture intraocular lens (IOL). Correlation analysis was used to study the impact and relative contributions of HOAs on CDVA. Convolution of HOAs from OPD-Scan III provided a clinical method to predict CDVA with different simulated pupil sizes in corneas with irregular astigmatism. There were statistically significant positive correlations between photopic CDVA and the magnitude of total and individual (coma, spherical aberration, and trefoil) HOAs in this cohort of keratoconus participants. A keratoconus case with the small aperture IOL confirms the improvement in vision due to the pinhole effect. The small aperture IOL is expected to markedly reduce aberrations in patients with keratoconus up to Amsler-Krumeich class 4 severity to levels consistent with the levels seen in healthy patients. Convolution of corneal HOAs with the Early Treatment Diabetic Retinopathy Study chart provides a useful simulation of the impact of pinhole optics in aberrated eyes.

Comparative analysis of tabelecleucel and current treatment in patients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease following hematopoietic cell transplant or solid organ transplant

Aims With recent European Union marketing authorization, tabelecleucel is the first off-the-shelf, allogeneic Epstein-Barr virus (EBV)-specific T-cell immunotherapy approved for the treatment of relapsed/refractory EBV-positive post-transplant lymphoproliferative disease (EBV+ PTLD). In the absence of a control arm, real-world evidence can provide a comparative benchmark for single-arm studies in ultra-rare populations. This study assessed the treatment effect of tabelecleucel in the single-arm phase 3 ALLELE study (NCT03394365) versus a treatment group from a multinational, multicenter retrospective chart review study (RS002) of patients with EBV+ PTLD. Methods In ALLELE, patients had disease relapsed/refractory to rituximab ± chemotherapy and received tabelecleucel 2x106 cells/kg on days 1, 8, and 15 in 35-day cycles. Patients in RS002 had disease relapsed/refractory to rituximab ± chemotherapy and received next line of systemic therapy between January 2000 and December 2018. Propensity score-based standardized mortality/morbidity ratio weighting was used to achieve balance between treatment and comparator arms. Kaplan-Meier estimators and Cox regression models were used to compare overall survival (OS) in the re-weighted sample. Results 30 patients (n = 14 hematopoietic cell transplant [HCT], n = 16 solid organ transplant [SOT]) from ALLELE (data cutoff: November 2021) and 84 patients (n = 36 HCT, n = 48 SOT) from RS002 (data lock: January 2021) were included. Median time from diagnosis to first tabelecleucel dose (ALLELE) or start date of next line of systemic therapy (RS002) was 3.6 months. Tabelecleucel was associated with a substantial OS benefit compared with current treatment, with an unadjusted HR of 0.47 (95% confidence interval [CI] 0.25–0.88) and adjusted HR of 0.37 (95% CI 0.20–0.71) when using the start date of the next line of therapy as the index date. Sensitivity analyses yielded consistent results. Conclusions In this study of real-world data, tabelecleucel was associated with an OS benefit among patients with R/R EBV+ PTLD for whom there is high unmet need.

SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia.

Insulin degludec/liraglutide (IDegLira) is a fixed-ratio combination of insulin degludec (a basal insulin) and liraglutide (a glucagon-like peptide-1 receptor agonist [GLP-1RA]). This study aimed to investigate clinical outcomes in people with type 2 diabetes mellitus (T2DM) after initiating IDegLira treatment in a real-world setting in Colombia. SPIRIT is a non-interventional, single-arm, retrospective chart review study to assess clinical outcomes in people with T2DM. Participating patients were switched from a treatment regimen of basal insulin (with or without oral antidiabetics [OADs]) and started on treatment with IDegLira a minimum of 26 ± 6weeks before the data collection start date. Data were collected from the medical records of 175 patients in ten clinical centers across Colombia. Compared with baseline, there was a significant reduction in glycated hemoglobin (HbA1c) (1.3%; 95% confidence interval [CI] -1.6 to -1.0; p < 0.0001) after 26 ± 6weeks of follow-up. The mean HbA1c at baseline and at the end of the study was 9.1% and 7.8%, respectively. In addition, IDegLira significantly reduced absolute body weight by 1kg (95% CI -1.5 to -0.5; p < 0.0001), from a mean of 76.1kg at baseline to 75.1kg after follow-up. The mean IDegLira dose at the end of the study was 21.3 U, and no severe hypoglycemic events were observed during the follow-up period. In real-world practice, initiating IDegLira in patients with T2DM previously treated with basal insulin (± OAD) was associated with improved glycemic control, reduced body weight and reduced risk of hypoglycemia. ClinicalTrials.gov identifier: NCT05324462.

Anticytokine Therapy and Corticosteroids for Cytokine Release Syndrome and for Neurotoxicity Following T-Cell Engager or CAR T-Cell Therapy

What Is the Issue? Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are the most common toxicities secondary to T-cell engager or chimeric antigen receptor (CAR) T-cell therapy. The US FDA and Health Canada approved tocilizumab, an anti-interleukin-6 receptor antagonist, for the management of severe or life-threatening cases of CRS. Corticosteroids also play an important role in CRS management and are the mainstay of ICANS management. Decision-makers are interested in understanding the use of anticytokine drugs (i.e., tocilizumab, anakinra, siltuximab) and/or corticosteroids in the management of CRS and ICANS following T-cell engager or CAR T-cell therapy. What Did We Do? We identified and summarized the literature comparing the clinical effectiveness and safety of anticytokine therapy and/or corticosteroids with alternative care or treatment as usual for treating and preventing of CRS and ICANS. We also searched for evidence-based recommendations for the use of anticytokine therapy and/or corticosteroids to treat and prevent CRS and ICANS. A research information specialist conducted a literature search of peer-reviewed and grey literature sources published between January 1, 2019 and February 26, 2024 for CRS; and between January 1, 2019 and March 4, 2024 for ICANS. One reviewer screened citations for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings. What Did We Find? This report presents evidence-based findings on 3 retrospective chart review studies, 2 prospective cohort studies, and 4 consensus guidelines. Limited and low-quality clinical evidence from studies with a high risk of bias suggested that early use of tocilizumab or corticosteroids, or prophylactic use of tocilizumab or anakinra may reduce the risk of a high-grade CRS without a negative impact on neurotoxicity or immunotherapy treatment outcomes. The included guidelines recommend the use of tocilizumab for treatment of higher-grade CRS, or for treatment of grade 1 CRS if symptoms persist for 3 days or more. Corticosteroids could be added in conjunction if there is no improvement or persistent symptoms after tocilizumab therapy. For the management of ICANS in the absence of concurrent CRS, supportive care is the preferred treatment option for grade 1 ICANS, while corticosteroids are recommended for the management of grade 2 to 4 ICANS. In the presence of concurrent CRS, guidelines recommend tocilizumab therapy as per management of CRS, and corticosteroids should be continued until improvement to grade 1. We did not identify any clinical evidence regarding the clinical efficacy and safety of anticytokine therapy and/or corticosteroids for treatment of CRS and ICANS compared with alternative treatment or treatment as usual. We also did not identify any guidelines for the use of prophylactic anticytokine therapy, corticosteroids, or both for the prevention of CRS and ICANS. What Does This Mean? Despite limited and low-quality evidence, the findings suggest some potential benefits of prophylactic or early use of anticytokine therapy and corticosteroids for the management of immunotherapy-related toxicities. Guidelines offer guidance on the management of CRS, ICANS and other less common toxicities related to immunotherapy based on the available low-quality evidence. When using the clinical evidence and recommendations summarized in this report to inform decisions, decision-makers should consider that the evidence is limited and of low quality. To improve the certainty of findings, there is a need for more robust prospective clinical trials with larger sample sizes, and lower risk of bias.

Abstract PO2-04-04: Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: an updated overall survival analysis using data from a multicenter retrospective study (ROSET-BM)

Abstract Background: ROSET-BM (UMIN000044995) was a multicenter, retrospective chart review study of patients (pts) who received trastuzumab deruxtecan (T-DXd) treatment for HER2-positive (HER2+) metastatic breast cancer (MBC) with brain metastases (BM) and/or leptomeningeal carcinomatosis (LMC). Primary results (data cutoff, October 31, 2021) were presented at SABCS2022 (median progression-free survival [PFS], 16.1 months; 1-year overall survival [OS] rate, 74.9%; and median follow-up duration, 11.2 months). To confirm the long-term effectiveness of T-DXd in HER2+ MBC pts with BM and/or LMC, we conducted an updated analysis using additional 1-year follow-up data. Methods: Pts who started T-DXd treatment between May 25, 2020, and April 30, 2021, were registered for ROSET-BM. For this updated OS analysis, the extended observation period ended on October 31, 2022. OS, PFS, and time to treatment failure (TTF) were evaluated. Median survival times and 95% CIs were calculated using the Kaplan–Meier method. In addition, prespecified and exploratory subgroup analyses were performed based on patient background characteristics. Univariate and multivariate Cox proportional hazards regression models were used to evaluate baseline prognostic factors for OS. Results: 104 pts from 62 institutions were included in this updated OS analysis. Median duration of follow-up was 20.4 months. Median number of prior lines of therapy was 4 (range, 1–15). Median time from first diagnosis of MBC to first administration of T-DXd was 37.5 months. Median time from first diagnosis of BM to first administration of T-DXd was 18.9 months. The prevalence of active BM, stable BM, LMC, and unclassified (image not evaluated) was 64.4% (n=67), 11.5% (n=12), 18.3% (n=19), and 5.8% (n=6), respectively. Median OS was not reached (NR) among all pts (1-year OS rate, 74.8%; 2-year OS rate, 56.0%). Subgroup analyses showed that median OS in pts with active BM was 27.0 months (95% CI, 16.4 to NR) and that median OS was NR in pts with stable BM or LMC (2-year OS rate for pts with stable BM, 71.6%; 2-year OS rate for pts with LMC, 61.6%). The results of univariate and multivariate analyses for OS showed no relevant baseline prognostic factors. Among all pts, median PFS was 14.6 months (95% CI, 10.6–20.8). Subgroup analyses showed that in pts with active BM, stable BM, and LMC, median PFS was 13.2 months (95% CI, 10.0–20.3), NR (95% CI, 5.3 to NR), and 17.5 months (95% CI, 8.3–22.1), respectively. Among all pts, median TTF was 9.3 months (95% CI, 6.3–11.8). The most common event and adverse event leading to discontinuation of T-DXd was progressive disease (37 pts, 35.6%) and interstitial lung disease (ILD; 24 pts, 23.1%), respectively. Median time to onset of an ILD event was 5.3 months (range, 0.7–20.0). ILD was grade 1 in 14 pts (13.5%), grade 2 in 3 pts (2.9%), grade 3 in 5 pts (4.8%), grade 4 in 2 pts (1.9%), and grade 5 in 0 pts. The Table summarizes the primary and updated results of ROSET-BM. Conclusion: The updated OS results of this retrospective chart review show that T-DXd has promising effectiveness in HER2+ MBC pts with long-term and heavily pretreated BM and LMC. This study was funded by Daiichi Sankyo Co., Ltd. Primary and updated results from the ROSET-BM study The updated results show that T-DXd has promising effectiveness in HER2+ MBC pts with long-term and heavily pretreated BM and LMC. Citation Format: Takashi Yamanaka, Naoki Niikura, Takahiro Nakayama, Mitsugu Yamamoto, Kazuo Matsuura, Kenichi Inoue, Sachiko Takahara, Hironori Nomura, Shosuke Kita, Miki Yamaguchi, Tomoyuki Aruga, Nobuhiro Shibata, Akihiko Shimomura, Yuri Ozaki, Shuji Sakai, Daisuke Takiguchi, Takehiko Takata, Armin Bastanfard, Kazuhito Shiosakai, Junji Tsurutani. Trastuzumab deruxtecan for the treatment of patients with HER2-positive breast cancer with brain and/or leptomeningeal metastases: an updated overall survival analysis using data from a multicenter retrospective study (ROSET-BM) [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-04-04.

Trends in Female Sterilization Since Dobbs v. Jackson at an Academic Institution [ID 2683460

INTRODUCTION: The Dobbs v. Jackson United States Supreme Court decision, issued June 24, 2022, fundamentally altered options for addressing unintended pregnancy. This curtailing of access to abortion care may be an inflection point in how individuals capable of becoming pregnant select contraceptive options. We hypothesize that in the immediate wake of the Dobbs v. Jackson decision, those undergoing surgical sterilization will be younger in age and more likely to be nulliparous. METHODS: This was a retrospective chart review study. IRB approval was obtained for the study. Using CPT codes, we utilized Epic to identify all patients undergoing surgical sterilizations at an academic, tertiary care hospital during the 12 months preceding the Dobbs decision (June 24, 2021 to June 24, 2022) and the 12 months immediately after the Dobbs decision (June 25, 2022 to June 25, 2023). Charts were reviewed for age, insurance status, highest level of education, gravidity, parity, and type of sterilization procedure, as well as time between request for and completion of surgical sterilization. RESULTS: In the 12 months after the Dobbs v. Jackson decision, individuals undergoing female surgical sterilization via salpingectomy or tubal occlusion had a lower mean age and lower mean parity compared to those undergoing sterilization in the 12 months preceding Dobbs. CONCLUSION: This study demonstrates that, since the Dobbs v. Jackson decision, individuals seeking female surgical sterilization are younger and less likely to be multiparous. This implies that as access to abortion care in the United States becomes more tenuous, those who seek female surgical sterilization procedures as contraception are younger and lower parity individuals.

Variables Leading to Usage of Alteplase Versus Heparin Lock in Patients With Tunneled Catheters in Hemodialysis Care Project Centers, Saudi Arabia.

A hemodialysis tunneledcatheter is one option for vascular access used with hemodialysis patients; however, catheter complications such as thrombosis are still inevitable. To prevent thrombosis formation, a catheter-locking solution is instilled between dialysis sessions. Heparin is used as a default locking solution in our Hemodialysis Care Project centers, while arecombinant tissue plasminogen activator (rt-PA) such as alteplase is used to treat suspected catheter thrombosis. This study aimed to identify the clinical factors, catheter brands, and hemodialysis variables that influence the choice of use for alteplase versus heparin, for those patients with tunneled catheters, and reduce overprescribing of high-alert medication alteplase. A retrospective medical chart review study was conducted involving 230 patients with tunneled catheters; the first group of 133 patients used alteplase regularly three times a week, while the second group of 97 patients completed at least one year using the same catheter access with heparin lock only. Multivariate logistic regression and logistic regression analysis showed a significant association (p < 0.05) between different variables. Results suggest that overweight and hyperlipidemia patients are more likely to use alteplase. Patients using brand-name catheters such as Hemostar/Vas-cath (BD, Franklin Lakes, NJ) are less likely to use heparin than those using Medcompcatheters (Medcomp, Yuma, AZ). In addition, patients having a history of angioplasty would be less likely to have heparin than no angioplasty. Moreover, if the patient's fluid removal were equal to or less than 2 kg, they would be more likely to use heparin and vice versa. The study postulates that identified variables affect whether alteplase or heparin is used in hemodialysis tunneled catheters, and may be useful to increase awareness, improve practices, or judiciously control the use of alteplase within Saudi Arabia and globally.

Genetic Microcephaly in a Saudi Population: Unique Spectrum of Affected Genes Including a Novel One.

Background: Genetic microcephaly is linked to an increased risk of developmental disabilities, epilepsy, and motor impairment. The aim of this study is to describe the spectrum of identifiable genetic etiologies, clinical characteristics, and radiologic features of genetic microcephaly in patients referred to a tertiary center in Saudi Arabia. Method: This is a retrospective chart review study of all patients with identifiable genetic microcephaly presenting to a tertiary center in Saudi Arabia. The patients' demographics, clinical, laboratory, radiologic, and molecular findings were collected. Results: Of the total 128 cases referred, 52 cases (40%) had identifiable genetic causes. Monogenic disorders were found in 48 cases (92%), whereas chromosomal disorders were found in only 4 cases (8%). Developmental disability was observed in 40 cases (84%), whereas only 8 cases (16%) had borderline IQ or mild developmental delay. Epilepsy was seen in 29 cases (56%), and motor impairment was seen in 26 cases (50%). Brain magnetic resonance imaging (MRI) revealed abnormalities in 26 (50%) of the cohort. Hereditary neurometabolic disorders were seen in 7 (15%) of the 48 cases with monogenic disorders. The most common gene defect was ASPM, which is responsible for primary microcephaly type 5 and was seen in 10 cases (19%). A novel PLK1 gene pathogenic mutation was seen in 3 cases (6%). Conclusion: Single gene defect is common in this Saudi population, with the ASPM gene being the most common. Hereditary neurometabolic disorders are a common cause of genetic microcephaly. Furthermore, we propose the PKL1 gene mutation as a possible novel cause of genetic microcephaly.

Timing of Mifepristone Relative to Misoprostol Critical for Reducing Blood Loss and Need for Surgical Procedure for Induction of Labor in the Second Trimester [ID 2683544

INTRODUCTION: Mifepristone is used in combination with misoprostol to facilitate inpatient induction of labor in the second trimester; however, the optimal interval of time between administration of these drugs is not known. Current practice guidelines recommend an interval of 24–48 hours. METHODS: In a single-institution retrospective chart review study, we examined whether mifepristone administration practices at that institution improved loss induction duration or adverse outcomes. This study was determined to be exempt from IRB approval. RESULTS: Among 267 loss inductions from 2018 to 2022, 54% received mifepristone. When misoprostol-alone inductions are compared to those that also received mifepristone, results demonstrate no difference in time to delivery (15.1 versus 15.9 hours; P=.62) or adverse outcomes, including blood loss greater than 1 L (8.2% versus 13.1%; P=.24) and need for operating room (OR) procedure (15.6% versus 16.6%; P=.86). Importantly, the average interval in this study between administration of mifepristone and misoprostol was 1.3 hours (median, 0.1 hours). Further analysis of those patients who received mifepristone demonstrated improved outcomes only if mifepristone was given at least 3 hours prior to misoprostol, including blood loss greater than 1 L (17.4% versus 0%; P=.0037) and need for OR procedure (21.4% versus 2.7%; P=.0088). There remained no difference in time to delivery (16.0 versus 15.8 hours; P=.94). CONCLUSION: These data demonstrate the importance of the timing of mifepristone and misoprostol administration for loss induction and strongly suggest that at least a 3-hour interval is required to improve adverse outcomes. Further prospective study is warranted to broaden the scope of these findings.

Metal implant allergy: A retrospective cohort analysis at a university allergy practice.

Background: Concern of metal sensitization in pre- and postsurgical evaluation is growing, with the recent guidelines remaining the criterion standard for consideration of patch testing. Information remains scarce on surgical screening in the groups of patients who reported a history of metal sensitivity versus those with no reported history. Objective: The objective of this study was to assess the utility of patch testing in surgical candidates based on reported metal allergy history. The secondary objective was to evaluate the utility and outcomes in postsurgical patch testing. Methods: Nine hundred and thirty-one patient charts of patients with the diagnosis of "contact dermatitis" who underwent an evaluation at a single allergy clinic site between January 2013 and December 2022 were identified and reviewed as part of a retrospective chart review study. Patients were included in subgroups based on the time of patch testing and history of reported metal allergy. Results: In all, 67 patients underwent patch testing, 10 (14.9%) of whom were surgical candidates without a history of metal sensitivity, 31 (46.2%) of whom were surgical candidates with a history of metal sensitivity, and 26 (38.8%) of whom were postsurgical patients. Twenty-nine (43.3%) of patients had positive patch testing results, with only one (10%) in the presurgical group, 17 (54.8%) in the presurgical with a history of metal sensitivity, and 11 (42.3%) in the postsurgical group. Zero patients in our cohort without metal sensitivity who were undergoing the Nuss procedure had positive reactions on patch testing, whereas two of four (50%) with reported metal sensitivity who were undergoing the Nuss procedure had positive relevant metal reactions. Conclusion: Ambiguity in the utility of patch testing for surgical decision making remains, despite common utilization. Recent guidelines along with coordination of care among the surgeon, allergist, and patient remains the criterion standard of care.

Association between the Thickness or Area of the Temporal Muscle and Skeletal Muscle Mass in Bioimpedance Analysis

Introduction: Sarcopenia associated with stroke can significantly impact patient prognosis; however, the current standard diagnostic methods for sarcopenia are rarely used in stroke patients. Therefore, the aim of the current study was to investigate whether the temporal muscle thickness (TMT) or area (TMA) could serve as a surrogate marker for measuring skeletal muscle mass. Methods: This retrospective chart review study was conducted on 244 participants from March 2018 to February 2020. The TMT and TMA were measured at the supraorbital roof level using brain CT or T1-weighted MR imaging obtained from participants. The skeletal muscle mass and skeletal muscle index (SMI) and whole-body phase angle (WBPA) at 50 kHz were collected. Pearson correlation analysis was used to assess the relationship between the TMT or TMA and the results of the bioimpedance analysis. Results: The mean TMT showed significant positive correlations with skeletal muscle mass (male, r = 0.520; female, r = 0.706), SMI (male, r = 0.426; female, r = 0.582), and WBPA (male, r = 0.295; female, r = 0.232). The mean TMA showed significant positive correlations with skeletal muscle mass (male, r = 0.490; female, r = 0.657), SMI (male, r = 0.289; female, r = 0.473), and WBPA (male, r = 0.232; female, r = 0.243). Conclusion: We observed moderate to strong positive correlations between body composition analysis measured by BIA and TMT or TMA, suggesting that TMT or TMA could serve as a reliable surrogate marker for identifying low skeletal muscle mass in cerebrovascular disease.

Safety and oncological outcome of early intraoperative intravesicle mitomycin C vs. deferred instillation in patients receiving robot-assisted radical nephroureterectomy.

Radical nephroureterectomy with concurrent bladder cuff excision (RNUBCE) is the gold standard surgical approach for high-risk primary upper tract urothelial carcinoma (UTUC). Given the notably high incidence of bladder tumor recurrence following this procedure, this study aimed to evaluate the effect and safety of intraoperative mitomycin-C (MMC) instillation vs. deferred instillation on overall oncological outcomes following robot-assisted RNUBCE. This is a retrospective chart review study. Patients with non-invasive (N0, not T3/T4) UTUC who underwent robotic RNUBCE combined an intraoperative MMC instillation or a deferred MMC instillation after surgery at a medical center in Taiwan between November 2013 and June 2020 were eligible for inclusion. Patients with prior bladder UC, carcinomas of other origins, received neoadjuvant chemotherapy, and had undergone kidney transplantation were excluded. All surgeries were executed by a single surgical team under the guidance of the same surgeon. The primary outcomes was the risk of bladder tumor recurrence between patients received intraoperative (IO) vs. deferred MMC instillation postoperatively (PO) during one-year follow-up. The secondary outcome was postoperative adverse events assessed by the Clavien-Dindo classification. Univariate and multivariable Cox regression analyses were performed to determine the associations between study variables and the outcomes. A total of 54 patients were included in the analysis. 12 (22.2%) patients experienced a bladder tumor recurrence during follow-up (IO: 7.7%, PO: 35.7%, p < 0.021). After adjustment in the multivariable, intraoperative MMC instillation was significantly associated with lower risk of bladder recurrence [adjusted hazard ratio (aHR) = 0.15, 95% CI: 0.03-0.81, p = 0.028]. No MMC-related Clavien-Dindo Grade III-IV adverse events were found in either group. IIntraoperative MMC instillation is safe and associated with a lower bladder tumor recurrence risk in patients undergoing robotic RNUBCE for UTUC than deferred instillation. Future large, prospective studies are still warranted to confirm the findings.

Real-world prevalence of microsatellite instability testing and related status in women with advanced endometrial cancer in Europe

PurposeTo assess the real-world prevalence of microsatellite instability (MSI)/mismatch repair (MMR) testing and related tumor status in recurrent/advanced endometrial cancer patients in Europe.MethodsData were from two multi-center, retrospective patient chart review studies conducted in the United Kingdom, Germany, Italy, France and Spain: The Endometrial Cancer Health Outcomes-Europe-First-Line (ECHO-EU-1L) study and the ECHO-EU-Second-Line (ECHO-EU-2L) study. ECHO-EU-1L included recurrent/advanced endometrial cancer patients who received first-line systemic therapy between 1/JUN/2016 and 31/MAR/2020 after recurrent/advanced diagnosis. ECHO-EU-2L included patients with recurrent/advanced endometrial cancer who progressed between 1/JUN/2016 and 30/JUN/2019 following prior first-line systemic therapy. Data collected included patient demographics, MSI/MMR tumor testing and results, and clinical/treatment characteristics.ResultsECHO-EU-1L included 242 first-line patients and ECHO-EU-2L included 475 s-line patients. For all patients, median age at recurrent/advanced diagnosis was 69 years, roughly half had endometrioid carcinoma histology and over 75% had Stage IIIB-IV disease at initial diagnosis. The prevalence of MSI/MMR testing in the first-line and second-line cohorts was similar (36.4 and 34.9%, respectively). Among those tested, a majority had non-MSI-high/MMR proficient tumors (80.7 and 74.7% among first- and second-line patients, respectively). About 15% had MSI-high/MMR deficient tumors in both cohorts, and a few patients had discordant results (3.4 and 10.8% among first- and second-line patients, respectively).ConclusionPrior to the approvals of biomarker-directed therapies for recurrent/advanced endometrial cancer patients in Europe, there were low MSI/MMR testing rates for these patients of just over one-third. Given the availability of biomarker-directed therapies, increased MSI/MMR testing may help inform treatment decisions for recurrent/advanced endometrial cancer patients in Europe.