Pharmacovigilance study of the association between peripheral neuropathy and antibody-drug conjugates using the FDA adverse event reporting system.

Antibody-drug conjugates (ADCs) are among the fastest-growing classes of anticancer drugs, making it crucial to evaluate their potential for causing peripheral neuropathy. We analyzed data from the FAERS database (January 1, 2014, to June 30, 2023) using disproportionality and Bayesian methods. We identified 3076 cases of ADC-associated peripheral neuropathy. Our study revealed significant signals for all ADCs (ROR 1.82, 95% CI 1.76-1.89). ADCs with tubulin-binding payloads showed significant peripheral neuropathy signals (ROR 2.31, 95% CI 2.23-2.40), whereas those with DNA-targeting (ROR 0.48, 95% CI 0.39-0.59) and topoisomerase 1 inhibitor (ROR 0.56, 95% CI 0.48-0.66) payloads exhibited non-significant signals. Signals for peripheral sensory neuropathy were 4.83, 2.44, 2.74, and 2.21 (calculated based on IC025) for brentuximab vedotin, trastuzumab emtansine, enfortumab vedotin, and polatuzumab vedotin, while signals for peripheral motor neuropathy were 5.31, 0.34, 2.27, and 0.03, respectively. The median time to onset for all ADCs was 127 days (interquartile range 40-457). Tisotumab vedotin had the highest hospitalization rate at 26.67%, followed by brentuximab vedotin at 25.5%. Trastuzumab emtansine had the highest mortality rate ,with 80 deaths (11.96%) among 669 cases. Based on FAERS database, only ADCs with tubulin-binding payloads exhibited significant peripheral neuropathy signals. Brentuximab vedotin and enfortumab vedotin showed similar profiles for peripheral sensory neuropathy and motor neuropathy. Given the delayed time to onset and potentially poor outcomes, ADC-related peripheral neuropathy warrants significant attention.

Demographics, Histopathology, and Treatment Outcomes of Squamous Cell Carcinoma of the Prostate.

BACKGROUND: Squamous cell carcinoma of the prostate (SCCP) is a neoplasm that comprises fewer than 1% of all primary prostate cancer diagnoses. Given its rarity, there is a paucity of data regarding the treatment of this disease. The limited literature points to the potential of local therapy in conjunction with chemotherapy to improve patient mortality. METHODS: Using the National Cancer Initiative's Surveillance, Epidemiology, and End Results (SEER) database, a retrospective review of patients diagnosed with primary SCCP between 2000 and 2018 was performed. Patient demographics, tumor characteristics, and patient outcomes based on treatment modality were analyzed. Univariate and survival analyses were conducted with p < 0.05 indicating statistical significance. RESULTS: A total of 66 patients were identified. Five-year overall survival (5y OS) was 24%; mean and median survival were 2.2 years (1.8, 2.7) and 1.2 years (0.3, 2.1), respectively. Patients with Grade I or Grade II disease had an increased 5y OS of 55% (27%, 83%). In comparison, 5y OS was 13% (-2%, 29%) for patients with Grade III and Grade IV disease (p = 0.017). Analysis of 5y OS based on disease histology revealed patients with papillary SCC had a 5y OS of 50% [9.2%, 91%], compared to 21% [9%, 34%] for patients with SCC, not otherwise specified and 0% for those with lymphoepithelial carcinoma (p = 0.048). Analysis of 5y OS stratified by treatment modality revealed no statistically significant change with any treatment (surgery, radiotherapy, and chemotherapy). No difference in 5y OS was seen between those treated with radical prostatectomy versus external beam radiation therapy. CONCLUSIONS: The literature on SCCP remains sparse; the rarity of this disease limits analysis. While the investigation undertaken in this paper does not find any change in 5y OS regardless of treatment modality, the variation in 5y OS based on histologic classification of SCCP points to a potential route for the future treatment of this disease.

Survival prediction in peritoneal mesothelioma: a nomogram based on SEER data and a Chinese cohort.

Objective: This study aimed to develop nomogram predicting overall survival (OS) of patients with peritoneal mesothelioma (PeM) using data from Surveillance, Epidemiology, and End Results (SEER) database and a Chinese institution. Methods: 1,177 PeM patients from the SEER database were randomized into training and internal validation cohorts at a 7:3 ratio. An external validation cohort consisting of 109 patients was enrolled from a Chinese institution. Nomogram was constructed based on variables identified through multivariate Cox regression analysis and evaluated by consistency indices (C-index), calibration plots, and receiver operating characteristic (ROC) curves. Patients were stratified into different risk categories, and Kaplan-Meier survival analysis was used to assess OS differences among these groups. Results: The nomogram, incorporating age, gender, histological type, T stage, M stage, and surgical status, demonstrated strong predictive capability with C-index values of 0.669 for the training cohort, 0.668 for the internal validation cohort, and 0.646 for the external validation cohort. The nomogram effectively stratified patients into high-risk and low-risk groups, with the high-risk group exhibiting significantly poorer OS (P < 0.05). Multivariate analysis confirmed gender, age, surgical intervention, and M stage as independent prognostic factors (P < 0.05). Specifically, male gender, older age, and unspecified M stage were linked to worse outcomes, while surgical intervention was associated with improved survival. Conclusion: The nomogram provide a reliable tool for predicting the survival in PeM patients, facilitating more informed treatment decisions. Key independent prognostic factors include gender, age, surgical intervention, and M stage.

Association between hyperglycemia at ICU admission and postoperative acute kidney injury in patients undergoing cardiac surgery: Analysis of the MIMIC-IV database.

Background: This study aimed to explore the correlation between hyperglycemia at intensive care unit (ICU) admission and the incidence of acute kidney injury (AKI) in patients after cardiac surgery. Methods: We conducted a retrospective cohort study, in which clinical data were extracted from the Medical Information Mart for Intensive Care (MIMIC)-IV database. Adults (≥18 years) in the database who were admitted to the cardiovascular intensive care unit after cardiac surgery were enrolled. The primary outcome was the incidence of AKI within 7 days following ICU admission. Secondary outcomes included ICU mortality, hospital mortality, ICU length of stay, and the 28-day and 90-day mortality. Multivariable Cox regression analysis was used to assess the association between ICU-admission hyperglycemia and AKI incidence within 7 days of ICU admission. Different adjustment strategies were used to adjust for potential confounders. Patients were divided into three groups according to their highest blood glucose levels recorded within 24 h of ICU admission: no hyperglycemia (<140 mg/dL), mild hyperglycemia (140-200 mg/dL), and severe hyperglycemia (≥200 mg/dL). Results: Of the 6905 included patients, 2201 (31.9%) were female, and the median (IQR) age was 68.2 (60.1-75.9) years. In all, 1836 (26.6%) patients had severe hyperglycemia. The incidence of AKI within 7 days of ICU admission, ICU mortality, and hospital mortality was significantly higher in patients with severe admission hyperglycemia than those with mild hyperglycemia or no hyperglycemia (80.3% vs. 73.6% and 61.2%, respectively; 2.8% vs. 0.9% and 1.9%, respectively; and 3.4% vs. 1.2% and 2.5%, respectively; all P <0.001). Severe hyperglycemia was a risk factor for 7-day AKI (Model 1: hazard ratio [HR]=1.4809, 95% confidence interval [CI]: 1.3126 to 1.6707; Model 2: HR=1.1639, 95% CI: 1.0176 to 1.3313; Model 3: HR=1.2014, 95% CI: 1.0490 to 1.3760; all P <0.050). Patients with normal glucose levels (glucose levels <140 mg/dL) had a higher 28-day mortality rate than those with severe hyperglycemia (glucose levels ≥200 mg/dL) (4.0% vs. 3.8%, P <0.001). Conclusions: In post-cardiac surgery patients, severe hyperglycemia within 24 h of ICU admission increases the risk of 7-day AKI, ICU mortality, and hospital mortality. Clinicians should be extra cautious regarding AKI among patients with hyperglycemia at ICU admission after cardiac surgery.

Tumor Deposits as an Adverse Prognostic Indicator in Stage III Colon Cancer: A Multicenter Database Study.

Objective: We explored the oncological impact of tumor deposits (TDs) on colon cancer and proposed optimal modifications to the current staging system. Background: In the existing American Joint Committee on Cancer colon cancer staging system, TDs are incorporated into the N category as N1c. When lymph node metastases (LNMs) are present, their number is considered to determine nodal stages, such as N1a/b or N2a/b, regardless of TDs. Methods: 4212 patients with primary colon cancer who underwent surgical resection in the Seoul Colorectal Group (2010-2020) and 93,057 patients from the Surveillance, Epidemiology, and End Results*Stat database (2000-2017) were included in this study. Patients were classified according to the number of metastatic lymph nodes (LNs) (0/1-3/≥4) and the presence of TDs. Results: TDs were significantly associated with left colon cancer, a higher T category, and vascular/perineural invasion. Patients with TDs had higher recurrence rates (23.1 vs 7.5%, P < 0.001). The TD-positive patients had notably worse overall survival (OS) and recurrence-free survival rates. The survival outcomes of TD-positive patients without LNM were inferior to those of TD-negative patients with LN1-3 (5-year OS: 78.9 vs 87.8%, P = 0.04). The survival outcomes of TD-positive patients with LN1-3 were similar to those of TD-negative patients with LN ≥4 (5-year OS: 87.0 vs 77.1%, P = 0.11). Survival outcomes obtained using the Surveillance, Epidemiology, and End Results *Stat database yielded consistent results. Conclusions: TDs were associated with poor prognostic factors and had a significant impact on survival outcomes. The incorporation of tumor deposits into nodal classifications beyond the current N1c criteria may improve the staging system and more accurately reflect the recurrence and survival rates among patients with colon cancer. TD-positive in N1a or N1b could be categorized as N2.

Trend Analysis of Industry-Sponsored Research Funding and Research Productivity in Orthopaedic Surgery Using the Open Payments Database.

Introduction Orthopedic surgery and industry work together in order to provide optimal patient care. The Open Payments Database (OPD), established in 2013, reports industry payments to physicians. This study analyzes the first five years of industry-sponsored research funding (ISRF) to orthopedic surgeons and examines research productivity's effect on ISRF. Methods The OPD was queried from 2014 to 2018 for research payments to orthopedic surgeons in the United States. H-indices and publication volume were queried using the Scopus database. The research payments were sub-categorized to surgeons in teaching hospitals, registered clinical trials, preclinical research, and domestic. Results Between 2014 and 2018, a total of $202.74 million in ISRF was made to 1718 orthopedic surgeons. The proportion of research payments associated with a registered clinical trial significantly increased from 9.62% of payments in 2014 to 42.19% of payments in 2018 (p=0.002). Zimmer Biomet Holdings, Inc. ($20.77 million) contributed the largest value of payments to the greatest number of orthopedic surgeons (n=337). The total value of research payments increased by $3855 for every five-unit increase of a surgeon's H-index (p<0.001) and $762 for every five additional publications (p<0.001). Conclusion Orthopedic surgeons affiliated with a teaching hospital or clinical trial receive more ISRF. There may be a relationship between research productivity and ISRF.

Adverse events related to robotic-assisted knee arthroplasty: a cross-sectional study from the MAUDE database.

BACKGROUND: Robotic-assisted surgical technique has been clinically available for decades, yet real-world adverse events (AEs) and complications associated with primary knee arthroplasty remain unclear. METHODS: In March 2023, we searched the FDA website and extracted AEs related to robotic assisted knee arthroplasty (RAKA) from the MAUDE database over the past 10 years. The "Brand Name" function queried major robotic platforms, including active and semi-active systems. The overall incidence of AEs was estimated based on annual surgical volume from the current American Joint Replacement Registry (AJRR). Two authors independently collected data on event date, event type, device problem, and patient problem. RESULTS: Of 839 eligible reports, device malfunction comprised mechanical failure (343/839, 40.88%) and software failure (261/839, 31.11%). For surgical complications, inappropriate bone resection (115/839, 13.71%) was most frequent, followed by bone/soft tissue damage (83/839, 9.89%). Notably, over-resection exceeding 2 mm (88/839, 10.49%), joint infection (25/839, 2.98%), and aseptic loosening (1/839, 0.12%) were major complications. Only two track pins related AEs were found. Moreover, the distribution of these AEs differed substantially between robot manufacturers. According to the AEs volume and AJRR data, the overall incidences of AEs related to RAKAs were calculated with 0.83% (839/100,892) between November 2010 and March 2023. CONCLUSION: Our analysis shows that while reported AEs might be increasing for RAKAs, the overall rate remains relatively low. Reassuringly, device malfunction was the most commonly AEs observed, with a minor impact on postoperative outcomes. Furthermore, our data provide a benchmark for patients, surgeons, and manufacturers to evaluate RAKA performance, though continued improvement in reducing serious AEs incidence is warranted.

Investigating the coverage of the Arkansas All-Payer Claims Database for examining health disparities related to persistent poverty areas in colorectal cancer patients.

PURPOSE: We aimed to (1) determine the extent of coverage of colorectal cancer patients in Arkansas All-Payer Claims Database (APCD), (2) assess coverage difference between persistent poverty and other areas, and (3) identify patient, tumor, and area factors associated with inclusion in APCD. METHODS: Data were from 2018 to 2020 Arkansas APCD linked with 2019 Arkansas Central Cancer Registry (ACCR). We constructed four cohorts to assess APCD's coverage of CRC patients: (Cohort 1) ≥ 1 day of medical coverage in APCD in 2019; (Cohort 2) APCD coverage in the diagnosis month; continuous APCD coverage in the 30; Year around diagnosis (six months before to five months after diagnosis month) (Cohort 3); or until death within six months (Cohort 4). We compared proportions in the cohorts by area persistent poverty designation. Logistic regressions identified factors associated with inclusion in APCD cohorts. PATIENT SELECTION: CRC patients diagnosed in 2019 from ACCR, excluding in situ disease. RESULTS: Of the 1,510 CRC patients diagnosed in 2019, 83% had ≥ 1 day of medical coverage in 2019 APCD (Cohort1), 81% had coverage in the diagnosis month (Cohort 2), and 63% had continuous coverage in the year around diagnosis (Cohort 3). Additionally, 11% died within six months but had continuous coverage until death (Cohort 4, 74%). No coverage difference was found between persist poverty and other areas. Age and primary payer type at diagnosis were the main predictors of inclusion in APCD. CONCLUSION: Arkansas APCD had high coverage of Arkansas CRC patients. No selection bias by area of persistent poverty designation was present.

Medical, Environmental, and Social Determinants Associated With Periocular Cutaneous Malignancies in the United States Using the All of Us National Database.

OBJECTIVE: To identify common factors associated with periocular cutaneous malignancies using the National Institutes of Health (NIH) All of Us database. METHODOLOGY: In this case-control study, we extracted electronic health records and sociodemographic data for 385 cases of periocular cutaneous malignancies from the All of Us nationwide database. Controls (N = 1540) were matched to the demographic characteristics of the 2020 United States Census. Bivariate analyses and multivariable logistic regression determined variables significantly associated with increased odds of periocular cutaneous malignancies. We analyzed medical, environmental, and social determinants to evaluate which factors were associated with increased odds of periocular cutaneous malignancies. RESULTS: Among the cases, the mean (standard deviation) age was 66.8 (11.2) years at the time of diagnosis. The majority were male (207, 54%) and white (361, 94%). Periocular cutaneous malignancy was significantly more likely among individuals with high sun exposure (odds ratio [OR] 14.79, 95% confidence interval [CI] 3.35-85.73, P = 0.001), those identifying as white race (OR 3.88, 95% CI 1.06-25.33, P = 0.079), and those with higher socioeconomic status, including higher annual income (OR 1.35, 95% CI 1.25-1.46, P < 0.001). CONCLUSIONS: This study demonstrates similar risk factors for periocular cutaneous malignancies, echoing prior research that showed increased associations with lighter-pigmented skin and higher socioeconomic status. It also sheds light on the positive impact of physician surveillance and health utilization factors in the early detection and treatment of these malignancies, aspects less explored in prior analyses.

Prostate cancer treatment recommendation study based on machine learning and SHAP interpreter.

This study utilized data from 140,294 prostate cancer cases from the Surveillance, Epidemiology, and End Results (SEER) database. Here, 10 different machine learning algorithms were applied to develop treatment options for predicting patients with prostate cancer, differentiating between surgical and non-surgical treatments. The performances of the algorithms were measured using the area under the receiver operating characteristic curve (AUC), accuracy, sensitivity, specificity, positive predictive value, negative predictive value. The Shapley Additive Explanations (SHAP) method was employed to investigate the key factors influencing the prediction process. Survival analysis methods were used to compare the survival rates of different treatment options. The CatBoost model yielded the best results (AUC = 0.939, sensitivity = 0.877, accuracy = 0.877). SHAP interpreters revealed that the T stage, cancer stage, age, cores positive percentage, prostate-specific antigen, and Gleason score were the most critical factors in predicting treatment options. The study found that surgery significantly improved survival rates, with patients undergoing surgery experiencing a 20.36% increase in 10-year survival rates compared with those receiving non-surgical treatments. Among surgical options, radical prostatectomy had the highest 10-year survival rate at 89.2%. This study successfully developed a predictive model to guide treatment decisions for prostate cancer. Moreover, the model enhanced the transparency of the decision-making process, providing clinicians with a reference for formulating personalized treatment plans.

Nomograms to predict lung metastasis in malignant primary osseous spinal neoplasms and cancer-specific survival in lung metastasis subgroup.

Purpose: To construct and validate nomograms for predicting lung metastasis probability in patients with malignant primary osseous spinal neoplasms (MPOSN) at initial diagnosis and predicting cancer-specific survival (CSS) in the lung metastasis subgroup. Methods: A total of 1,298 patients with spinal primary osteosarcoma, chondrosarcoma, Ewing sarcoma, and chordoma were retrospectively collected. Least absolute shrinkage and selection operator (LASSO) and multivariate logistic analysis were used to identify the predictors for lung metastasis. LASSO and multivariate Cox analysis were used to identify the prognostic factors for 3- and 5-year CSS in the lung metastasis subgroup. Receiver operating characteristic (ROC) curves, calibration curves, and decision curve analyses (DCA) were used to estimate the accuracy and net benefits of nomograms. Results: Histologic type, grade, lymph node involvement, tumor size, tumor extension, and other site metastasis were identified as predictors for lung metastasis. The area under the curve (AUC) for the training and validating cohorts were 0.825 and 0.827, respectively. Age, histologic type, surgery at primary site, and grade were identified as the prognostic factors for the CSS. The AUC for the 3- and 5-year CSS were 0.790 and 0.740, respectively. Calibration curves revealed good agreements, and the Hosmer and Lemeshow test identified the models to be well fitted. DCA curves demonstrated that nomograms were clinically useful. Conclusion: The nomograms constructed and validated by us could provide clinicians with a rapid and user-friendly tool to predict lung metastasis probability in patients with MPOSN at initial diagnosis and make a personalized CSS evaluation for the lung metastasis subgroup.

Effects of the COVID-19 pandemic on short-term postoperative outcomes of emergency surgery for gastroduodenal perforation: A nationwide study in Japan based on the National Clinical Database.

Aim: To examine the potential negative effects of the COVID-19 pandemic on short-term postoperative outcomes of emergency surgery for gastroduodenal perforation in Japan. Methods: A total of 7973 cases of gastroduodenal perforation from 2019 to 2021 were retrieved from the National Clinical Database (NCD), which includes >95% of surgical cases in Japan. Data were analyzed nationally and in subgroups for subjects in areas with high infection levels (HILs). Postoperative 30-d mortality, surgical mortality, and complications (Clavien-Dindo (CD) grade ≥3) were examined. Months were considered to have significantly high or low mortality or complication rates, if the 95% confidence interval (CI) of the standardized mortality (morbidity) ratio (SMR) does not contain 1. Results: Nationally, data from 2019 vs 2020 and 2021 showed 30-d mortality of 175 (6.7%) vs 398 (7.4%), surgical mortality of 250 (9.5%) vs 537 (10.1%), and complications (CD ≥3) of 558 (21.2%) vs 1163 (21.8%). Among these data, the only significantly high SMR was found for complications in July 2020 (1.36 [95% CI: 1.001-1.80]). In areas with HILs, data from 2019 vs 2020 and 2021 indicated 30-d mortality of 91 (6.3%) vs 215 (7.3%), surgical mortality of 135 (9.4%) vs 294 (10.0%), and complications (CD ≥3) of 304 (21.1%) vs (23.1%). In these data, no month had a significantly high SMR. Conclusion: The COVID-19 pandemic had few negative effects on outcomes after surgery for gastroduodenal perforation. These findings suggest that the emergency system for gastroduodenal perforation in Japan was generally maintained during the pandemic.

Impact of SARS-CoV-2 infection on short-term postoperative outcomes after gastroenterological cancer surgery using data from a nationwide database in Japan.

Background: Due to the coronavirus disease 2019 (COVID-19) pandemic, cancer screening, diagnosis, and treatment have changed. This study aimed to investigate the impact of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection prior to gastroenterological cancer surgeries on postoperative complications using data from a nationwide database in Japan. Methods: Data on patients who underwent surgery for cancer including esophageal, gastric, colon, rectal, liver, and pancreatic cancer between July 1, 2019, and September 300, 2022, from real-world sources in Japan were analyzed. The association between preoperative SARS-CoV-2 infection and short-term postoperative outcomes was evaluated. A similar analysis stratified according to the interval from SARS-CoV-2 infection to surgery (<4 vs. >4 weeks) was conducted. Results: In total, 60 604 patients were analyzed, and 227 (0.4%) patients were diagnosed with SARS-CoV-2 infection preoperatively. The median interval from SARS-CoV-2 infection to surgery was 25 days. Patients diagnosed with SARS-CoV-2 infection preoperatively had a significantly higher incidence of pneumonia (odds ratio: 2.05; 95% confidence interval: 1.05-3.74; p = 0.036) than those not diagnosed with SARS-CoV-2 infection based on the exact logistic regression analysis adjusted for the characteristics of the patients. A similar finding was observed in patients who had SARS-CoV-2 infection <4 weeks before surgery. Conclusions: Patients with a history of SARS-CoV-2 infection had a significantly higher incidence of pneumonia. This finding can be particularly valuable for countries that have implemented strict regulations in response to the COVID-19 pandemic and have lower SARS-CoV-2 infection-related mortality rates.

The World Society for Pediatric and Congenital Heart Surgery: 2024 Update of the World Database for Pediatric and Congenital Heart Surgery.

BACKGROUND: The World Database for Pediatric and Congenital Heart Surgery (WDPCHS), sponsored by the World Society for Pediatric and Congenital Heart Surgery (WSPCHS), provides complex congenital heart surgery outcomes analyses for member programs. This report represents the seven-year descriptive analysis of outcomes from active members of the WDPCHS. METHODS: Individual institutions submit data based on the specific procedure via a password protected platform. The data are collected, stored, and analyzed at Kirklin Solutions Inc., based in Birmingham, Alabama. This report presents a descriptive analysis of these procedures submitted from January 1, 2017, to December 31, 2023. RESULTS: A total of 50,174 procedures were submitted with an overall mortality of 4.6%. The majority of submissions were from Asian countries. The majority of cases submitted from these countries were of STAT mortality category I and II. Repair of a ventricular septal defect (with a mortality of 0.8%) and correction of tetralogy of Fallot (2.0% mortality) were the most common procedures submitted to the database. CONCLUSIONS: The WSPCHS accomplished one of its missions in 2017 when the WDPCHS began accepting data from pediatric and congenital heart surgery programs across the globe. In doing so, it became one of the first organizations to create a platform for the exchange of knowledge and experience, regardless of the socioeconomic status of the particular program or country.

Impact of Atrioventricular Valve Intervention at Each Stage of Single Ventricle Palliation.

Background: Significant atrioventricular valve dysfunction can be associated with mortality or need for transplant in functionally univentricular heart patients undergoing staged palliation. The purposes of this study are to characterize the impact of concomitant atrioventricular valve intervention on outcomes at each stage of single ventricle palliation and to identify risk factors associated with poor outcomes in these patients. Methods: The Society of Thoracic Surgeons Congenital Heart Surgery Database was queried for functionally univentricular heart patients undergoing single ventricle palliation from 2013 through 2022. Separate analyses were performed on cohorts corresponding to each stage of palliation (1: initial palliation; 2: superior cavopulmonary anastomosis; 3: Fontan procedure). Bivariate analysis of demographics, diagnoses, comorbidities, preoperative risk factors, operative characteristics, and outcomes with and without concomitant atrioventricular valve intervention was performed. Multiple logistic regression was used to identify predictors associated with operative mortality or major morbidity. Results: Concomitant atrioventricular valve intervention was associated with an increased risk of operative mortality or major morbidity for each cohort (cohort 1: 62% vs 46%, P < .001; cohort 2: 37% vs 19%, P < .001; cohort 3: 22% vs 14%, P < .001). Black race in cohort 1 (odds ratio [OR] 3.151, 95% CI 1.181-9.649, P = .03) and preterm birth in cohort 2 (OR 1.776, 95% CI 1.049-3.005, P = .032) were notable predictors of worse morbidity or mortality. Conclusions: Concomitant atrioventricular valve intervention is a risk factor for operative mortality or major morbidity at each stage of single ventricle palliation. Several risk factors are associated with these outcomes and may be useful in guiding decision-making.

Decreasing Utilization of Vaginal Hysterectomy in the United States: An Analysis by Candidacy for Vaginal Approach.

INTRODUCTION AND HYPOTHESIS: The objective was to assess trends in hysterectomy routes by patients who are likely and unlikely candidates for a vaginal approach. METHODS: We performed a retrospective cohort study of patients who underwent vaginal, abdominal, or laparoscopic/robotics-assisted laparoscopic hysterectomy between 2017 and 2020 using the National Surgical Quality Improvement Program database. Patients undergoing hysterectomy for a primary diagnosis of benign uterine pathology, dysplasia, abnormal uterine bleeding, or pelvic floor disorders were eligible for inclusion. Patients who were parous, had no history of pelvic or abdominal surgery, and had a uterine weight ≤ 280 g on pathology were considered likely candidates for vaginal hysterectomy based on an algorithm developed to guide the surgical approach. Average annual changes in the proportion of likely vaginal hysterectomy candidates and route of hysterectomy were assessed using logistic regression. RESULTS: Of the 77,829 patients meeting the inclusion criteria, 13,738 (17.6%) were likely vaginal hysterectomy candidates. Among likely vaginal hysterectomy candidates, the rate of vaginal hysterectomy was 34.5%, whereas among unlikely vaginal hysterectomy candidates, it was 14.1%. The overall vaginal hysterectomy rate decreased -1.2%/year (p < 0.01). This decreasing trend was nearly twice as rapid among likely vaginal hysterectomy candidates (-1.9%/year, p < .01) compared with unlikely vaginal hysterectomy candidates (-1.1%/year, P < 0.01); the difference in trends was statistically significant (p < 0.01). CONCLUSIONS: The rate of vaginal hysterectomy performed for eligible indications decreased between 2017 and 2020 in a national surgical registry. This negative trend was more pronounced among patients who were likely candidates for vaginal hysterectomy based on favorable parity, surgical history, and uterine weight.

Assessment of Cardiovascular Events Caused by New-Generation Androgen Receptor Pathway Inhibitors Used for Prostate Cancer: A Real-World Study in Japan.

INTRODUCTION: Androgen receptor pathway inhibitors (ARPIs) that significantly improve the prognosis of patients with prostate cancer include abiraterone acetate (androgen synthesis inhibitor) and enzalutamide (androgen receptor inhibitor). A recent analysis of ARPI and cardiovascular events using the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) has been reported; however, the evidence on cardiovascular events for abiraterone acetate and enzalutamide in real-world clinical practice is insufficient. Using a large Japanese database of medical institutions, the Japanese Medical Data Center (JMDC) medical institution database (JMDC Inc., Tokyo, Japan), this study tested the hypothesis that the risk of cardiovascular events with enzalutamide is lower than that with abiraterone acetate. METHOD: Using the JMDC medical institution database, patients with new use of abiraterone acetate or enzalutamide who had not experienced a major cardiovascular event between October 2014 and February 2022 were included. After adjusting for age, comorbidities, and concomitant medications using propensity score matching, cumulative incidence rates were compared for cardiovascular death and all cardiovascular events as the primary endpoints, and major cardiovascular events, myocardial infarction, heart failure, and stroke as secondary endpoints. RESULT: A total of 3,033 patients in the enzalutamide group and 2,021 in the abiraterone group met the eligibility criteria. After propensity score matching, the cohort included 1,940 patients in the enzalutamide group and 1,940 patients in the abiraterone group. Enzalutamide was associated with significantly lower cumulative rates of cardiovascular death (hazard ratio [HR]: 0.30, 95% confidence interval [CI]: 0.10-0.93), all cardiovascular events (HR: 0.79, 95% CI: 0.64-0.98), major cardiovascular events (HR: 0.79, 95% CI: 0.64-0.97), and myocardial infarction (HR: 0.62, 95% CI: 0.46-0.84) compared to abiraterone. CONCLUSION: In a national sample of males with prostate cancer, those newly treated with enzalutamide had a lower risk of adverse cardiovascular events than those treated with abiraterone acetate.

Impact of Facility Volume on Overall Survival in Patients With Head and Neck Cancer Undergoing Palliative Treatment.

BACKGROUND: Treatment at high-volume facilities (HVF) has been associated with improved prognosis of HNC patients undergoing curative treatment. Whether this systemic factor influences survival outcomes of patients with HNC undergoing palliative treatment is unknown. AIM: To investigate the impact of palliative treatment facility volume on overall survival (OS) in patients with head and neck cancer (HNC). DESIGN: The 2004 to 2018 National Cancer Database was queried retrospectively for patients with HNC undergoing palliative treatment. SETTING/PARTICIPANTS: Patients were stratified based on treatment facility volume percentile. Multivariable binary logistic and Cox proportional hazards regression models were implemented. RESULTS: Of 8682 patients included, 1661 (19.1%) underwent palliative therapy at facilities with volume ≥80th percentile. Among 972 facilities included, 643 (66.2%), 182 (18.7%), 85 (8.8%), 44 (4.5%), and 18 (1.9%) had volume <20th, 20-40th, 40-60th, 60-80th, and ≥80th percentiles, respectively. 5-year OS rates of patients undergoing palliative therapy at facilities with volume <20th, 20-40th, 40-60th, 60-80th, and ≥80th percentile was 11%, 13%, 11%, 14%, and 23%, respectively (P < .001). Facility volume ≥80th percentile was associated with higher 5-year OS on multivariable Cox regression (aHR 0.34, 95% CI 0.16-0.69, P < .001). Surgical treatment (aOR 1.34, 95% CI 1.07-1.68, P = .012) was associated with undergoing treatment at facilities with volume ≥80th percentile. CONCLUSIONS: Undergoing palliative treatment at HVFs is associated with higher OS in HNC. The survival benefit derived from high facility volume should be carefully considered in the context of other patient and facility characteristics in end-of-life management, with specific emphasis on patient-directed goals of care.

Dementia Incidence in Survivors of Multiple Myeloma: A National Case-Control Study Conducted in Korea (The CAREMM-2106 Study).

BACKGROUND: Dementia, a growing global health issue, affects older adults and specific groups like long-term cancer survivors. The link between cancer survival and dementia is debated. Multiple myeloma (MM), a common blood cancer in older adults, is often linked with cognitive issues. This study investigated dementia incidence in long-term MM survivors using Korean national data. METHODS: A retrospective case-control study used data from the Korea National Health Insurance Service (KNHIS), covering about 50 million Koreans. Patients diagnosed with MM between 2009 and 2020 formed the case cohort, while the control cohort included matched individuals without MM using propensity-score matching. Analyzing baseline characteristics, comorbidities, and socioeconomic status, the primary outcome was dementia incidence identified via ICD-10 codes. Statistical methods included Kaplan-Meier plots, cause-specific and Fine-Gray subdistribution hazard models, and a 3-year landmark analysis for immortal time bias. RESULTS: The study included 33,864 patients, with 16,932 in each cohort. The overall cumulative dementia incidence was lower in the MM cohort compared to controls. However, in the first 3 years, MM patients had a higher dementia risk (HR: 1.711, 95% CI, 1.562-1.874) than controls. After 3 years, the risk significantly decreased (HR: 0.625, 95% CI, 0.560-0.696). Age-specific analysis showed a consistent pattern, particularly among MM patients aged 70-79, where dementia risk increased post-3 years. CONCLUSION: This study reveals a lower long-term dementia risk in MM survivors compared to non-MM individuals. Further prospective studies are needed to confirm these findings and explore the underlying mechanisms.

Diseases associated with subsequent peritonsillar abscess: a case-control-study from ENT practices in Germany.

OBJECTIVE: Peritonsillar abscess (PTA) is the most common deep soft tissue infection necessitating surgical intervention in the head and neck region. Potential causes include infections of the palatine tonsils, palatine glands, or branchiogenic rudiments ("acute tonsillitis hypothesis" vs. "Weber's gland hypothesis"). Understanding the currently still unknown predominant cause is crucial for guiding therapeutic strategies, such as abscess tonsillectomy versus incision and drainage alone. This study aims to investigate the pre-diagnoses associated with subsequent PTA using a nationally representative practice database in Germany. METHODS: Data were collected from 195 ENT practices across Germany utilizing the nationally representative practice database IQVIA™ Disease Analyzer. Included were patients aged 18 years and older with a first diagnosis of PTA (index date) between January 2005 and December 2022 and a minimum observation period of 12 months preceding the index date. These patients were matched (1:5) with controls without PTA, based on age, sex, and index year. Frequencies of prior diagnoses coded according to ICD-10 in the 12 months preceding the index date were computed. The association between prior diagnoses and PTA was evaluated using multivariable logistic regression (MLR) and sensitivity analysis (SA). RESULTS: A total of 5,325 cases were compared with 26,725 controls in the multivariable logistic regression (MLR) analysis, and 16,251 cases were compared with 81,255 controls in the sensitivity analysis (SA). Mean age was 45.3 ± 18.3 years (MLR) and 41.9 ± 16.7 years (SA). The proportion of female patients was 51.8% (MLR) and 46.9% (SA), respectively. MLR showed the strongest associations with PTA for the prior diagnoses of "acute tonsillitis" (odds ratio, OR: 6.71; 95% CI: 5.81-7.74), "chronic tonsillitis" (OR: 2.00; 95% CI: 1.58-2.52), and "acute pharyngitis" (OR: 1.74; 95% CI: 1.50-2.03). SA similarly indicated the strongest associations with PTA for the prior diagnoses of "acute tonsillitis" (OR: 5.02; 95% CI: 4.60-5.47), "chronic tonsillitis" (OR: 1.87; 95% CI: 1.64-2.12), and "acute pharyngitis" (OR: 1.27; 95% CI: 1.14-1.41). CONCLUSION: The most prevalent prior diagnosis associated with PTA was acute tonsillitis, followed by chronic tonsillitis and acute pharyngitis. The association with acute pharyngitis suggests possible non-tonsillogenic causes. Other specific causes of PTA, such as inflammation of the palatine gland or branchiogenic remnants, are not captured by the ICD system or the database utilized in this study.