Blood pressure elevation in erenumab-treated patients with migraine: A retrospective real-world experience.

BACKGROUND: Erenumab is a monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) receptor and is approved for the preventative treatment of migraine in adults. CGRP is involved in the regulation of vasomotor tone under physiologic and pathologic conditions, including hypertension. While there has not been evidence of hypertension in preclinical models or clinical trials, post-marketing data suggest erenumab may be associated with hypertension. This led to a warning in the United States Food and Drug Administration prescribing information for erenumab. OBJECTIVE: To determine the frequency of worsening blood pressure (BP) after initiation of erenumab in patients with migraine and how this is associated with hypertension. METHODS: This is an observational retrospective cohort study evaluating patients at a tertiary headache or neurology department. Systolic and diastolic BPs were compared between the initial visit prior to initiation of erenumab, and follow-up visit while on erenumab. Worsening BP was defined as moving from a lower stage to a higher stage of BP, as defined by the American Heart Association. Serious adverse vascular events were also recorded. RESULTS: A total of 335 patients were included in the final analysis (mean [SD] age of 45.7 [14.40] years, 83.9% [281/335] female). At baseline, 20.9% (70/335) of patients had a prior diagnosis of hypertension. The median (interquartile range) time to follow-up appointment from initial appointment was 20.5 (13.3-35.3) weeks. The mean (SD) BP at baseline was systolic 124.7 (15) mmHg and diastolic 77 (11) mmHg, and at follow-up was systolic 124.0 (15) mmHg and diastolic 77.8 (9) mmHg. Overall, 23.3% (78/335) of all patients had worsening BP, whereas 13/225 (3.9%) patients had improvement in their BP. Patients with atrial fibrillation were more likely to develop worsening BP (odds ratio, 4.9, 95% confidence interval 1.12-21.4; p = 0.035). There was no association between worsening BP and pre-existing hypertension, sex, body mass index, or age. One patient had non-ST elevation myocardial infarction attributed to a hypertensive emergency while on erenumab. CONCLUSION: We found that 23.3% of patients initiated on erenumab may have developed worsening BP, suggesting the need for BP monitoring in patients initiated on erenumab.

Automated Insulin Delivery Technology In The Hospital: Update on Safety and Efficacy Data.

BACKGROUND: Automated insulin delivery systems (AID) are a rapidly growing component in the area of continuous subcutaneous insulin infusion (CSII) therapy. As more patients use these systems in the outpatient setting, it is important to assess safety if their use is allowed to continue in the inpatient setting. METHODS: Analysis was conducted of the records of patients using AID technology upon admission to our hospital between June 2020 and December 2022. Adverse events and glycemic control of AID users were compared to patients using non-AID systems and to patients who had CSII discontinued. RESULTS: There were 185 patients analyzed: 64 on AID, 86 on non-AID, and 35 who had CSII discontinued. The number of patients on AID increased over the course of the observation period, while non-AID users decreased. Pair-wise comparisons indicated that patient-stay mean glucose levels and percentage of hypoglycemic events were similar between all groups, but the percentage of patient hyperglycemic measurements was significantly lower in the AID cohort. No adverse events (diabetic ketoacidosis, pump site complications, equipment malfunction) were reported in any either CSII cohort. CONCLUSION: The type of CSII technology encountered in the hospital is shifting from non-AID towards AID technologies. This analysis supports earlier findings that outpatient AID systems can be successfully transitioned into the inpatient setting. Further study is needed to define if AID systems offer any advantage in glycemic control.

Evaluating the Need for Simultaneous Carpal Tunnel Release With Forearm Fasciotomy.

PURPOSE: The need to include simultaneous carpal tunnel release (sCTR) with forearm fasciotomy for acute compartment syndrome (ACS) or after vascular repair is unclear. We hypothesized that sCTR is more common when: 1) fasciotomies are performed by orthopedic or plastic surgeons, rather than general or vascular surgeons; 2) ACS occurred because of crush, blunt trauma, or fractures rather than vascular/reperfusion injuries; 3) elevated compartment pressures were documented. We also sought to determine the incidence of delayed CTR when not performed simultaneously. METHODS: Retrospective chart review identified patients who underwent forearm fasciotomy for ACS or vascular injury over a period of 10 years. Patient demographics, mechanism of ACS or indication for fasciotomy, surgeon subspecialty, compartment pressure measurements, inclusion of sCTR, complications, reoperations, and timing and method of definitive closure were analyzed. Logistic regression modeling was used to analyze predictors associated with delayed CTR. RESULTS: Fasciotomies were performed in 166 patients by orthopedic (63%), plastic (28%), and general/vascular (9%) surgeons. Orthopedic and plastic surgeons more frequently performed sCTR (67% and 63%, respectively). A total of 107 (65%) patients had sCTR. Fasciotomies for vascular/reperfusion injury were more likely to include sCTR (44%) compared with other mechanisms. If not performed simultaneously, 11 (19%) required delayed CTR at a median of 42 days. ACS secondary to fracture had the highest rate of delayed CTR (35%), and the necessity of late CTR for fractures was not supported by the logistic regression model. Residual hand paresthesias were less frequent in the sCTR group (6.5% vs 20%). Overall complication rates were similar in both groups (63% sCTR vs 70% without sCTR). CONCLUSION: When sCTR is excluded during forearm fasciotomy, 19% of patients required delayed CTR. This rate was higher (35%) when ACS was associated with fractures. Simultaneous CTR with forearm fasciotomy may decrease the incidence of residual hand paresthesias and the need for a delayed CTR. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognosis IV.

Examining patient demographics and major adverse cardiac events following noncardiac surgery: Applying a health equity lens.

BACKGROUND: Major adverse cardiac events (MACE) are a major contributor to postoperative complications. This study employed a health equity lens to examine rates of postoperative MACE by race and ethnicity. METHODS: This single-center, retrospective observational cohort study followed patients with and without pre-existing coronary artery stents from 2008 to 2018 who underwent non-cardiac surgery. MACE was the primary outcome (death, acute MI, repeated coronary revascularization, in-stent thrombosis) and self-reported race and ethnicity was the primary predictor. A propensity score model of a 1:1 cohort of non-Hispanic White (NHW) patients and all other racial and ethnic minority populations (Hispanic and Black) was used to compare the rate of perioperative MACE in this cohort. RESULTS: During the study period, 79,686 cases were included in the analytic sample; 950 patients (1.2 %) had pre-existing coronary artery stents. <1 % of patients experienced MACE within 30 days following non-cardiac surgery (0.8 %). After confounder adjustment and propensity score matching, there were no statistically significant differences in MACE among racial and ethnic minority patients compared to NHW patients (OR = 0.77; 95 % CI: 0.48, 1.25). In our sensitivity analyses, stratifying by sex, there were no differences in MACE by race and ethnicity. CONCLUSIONS: The study found no statistically significant differences in MACE by race and ethnicity among patients who underwent non-cardiac surgery. Access to a high-volume, high-quality hospital such as the one studied may reduce the presence of healthcare disparities and may explain why our findings are not consistent with previous studies.

Sharing Patient Praises With Radiology Staff: Workflow Automation and Impact on Staff.

OBJECTIVE: This study aims to develop and evaluate a semi-automated workflow using natural language processing (NLP) for sharing positive patient feedback with radiology staff, assessing its efficiency and impact on radiology staff morale. METHODS: The HIPAA-compliant, institutional review board-waived implementation study was conducted from April 2022 to June 2023 and introduced a Patient Praises program to distribute positive patient feedback to radiology staff collected from patient surveys. The study transitioned from an initial manual workflow to a hybrid process using an NLP model trained on 1,034 annotated comments and validated on 260 holdout reports. The times to generate Patient Praises e-mails were compared between manual and hybrid workflows. Impact of Patient Praises on radiology staff was measured using a four-question Likert scale survey and an open text feedback box. Kruskal-Wallis test and post hoc Dunn's test were performed to evaluate differences in time for different workflows. RESULTS: From April 2022 to June 2023, the radiology department received 10,643 patient surveys. Of those surveys, 95.6% contained positive comments, with 9.6% (n = 978) shared as Patient Praises to staff. After implementation of the hybrid workflow in March 2023, 45.8% of Patient Praises were sent through the hybrid workflow and 54.2% were sent manually. Time efficiency analysis on 30-case subsets revealed that the hybrid workflow without edits was the most efficient, taking a median of 0.7 min per case. A high proportion of staff found the praises made them feel appreciated (94%) and valued (90%) responding with a 5/5 agreement on 5-point Likert scale responses. CONCLUSION: A hybrid workflow incorporating NLP significantly improves time efficiency for the Patient Praises program while increasing feelings of acknowledgment and value among staff.

Automated target placement for VMAT lattice radiation therapy: enhancing efficiency and consistency.

Objective. An algorithm was developed for automated positioning of lattice points within volumetric modulated arc lattice radiation therapy (VMAT LRT) planning. These points are strategically placed within the gross tumor volume (GTV) to receive high doses, adhering to specific separation rules from adjacent organs at risk (OARs). The study goals included enhancing planning safety, consistency, and efficiency while emulating human performance.Approach. A Monte Carlo-based algorithm was designed to optimize the number and arrangement of lattice points within the GTV while considering placement constraints and objectives. These constraints encompassed minimum spacing between points, distance from OARs, and longitudinal separation along thez-axis. Additionally, the algorithm included an objective to permit, at the user's discretion, solutions with more centrally placed lattice points within the GTV. To validate its effectiveness, the automated approach was compared with manually planned treatments for 24 previous patients. Prior to clinical implementation, a failure mode and effects analysis (FMEA) was conducted to identify potential shortcomings.Main results.The automated program successfully met all placement constraints with an average execution time (over 24 plans) of 0.29 ±0.07 min per lattice point. The average lattice point density (# points per 100 c.c. of GTV) was similar for automated (0.725) compared to manual placement (0.704). The dosimetric differences between the automated and manual plans were minimal, with statistically significant differences in certain metrics like minimum dose (1.9% versus 1.4%), D5% (52.8% versus 49.4%), D95% (7.1% versus 6.2%), and Body-GTV V30% (20.7 c.c. versus 19.7 c.c.).Significance.This study underscores the feasibility of employing a straightforward Monte Carlo-based algorithm to automate the creation of spherical target structures for VMAT LRT planning. The automated method yields similar dose metrics, enhances inter-planner consistency for larger targets, and requires fewer resources and less time compared to manual placement. This approach holds promise for standardizing treatment planning in prospective patient trials and facilitating its adoption across centers seeking to implement VMAT LRT techniques.

Kinetics of SARS-CoV-2 infection biomarkers in a household transmission study.

SARS-CoV-2 is the causative agent of COVID-19. Timely and accurate diagnostic testing is vital to contain the spread of infection, reduce delays in treatment and care, and inform patient management. Optimal specimen type (e.g. nasal swabs or saliva), timing of sampling, viral marker assayed (RNA or antigen), and correlation with viral infectivity and COVID-19 symptoms severity remain incompletely defined. We conducted a field study to evaluate SARS-CoV-2 viral marker kinetics starting from very early times after infection. We measured RNA and antigen levels in nasal swabs and saliva, virus outgrowth in cell culture from nasal swabs, and antibody levels in blood in a cohort of 30 households. Nine household contacts (HHC) became infected with SARS-CoV-2 during the study. Viral RNA was detected in saliva specimens approximately 1-2 days before nasal swabs in six HHC. Detection of RNA was more sensitive than of antigen, but antigen detection was better correlated with culture positivity, a proxy for contagiousness. Anti-nucleocapsid antibodies peaked one to three weeks post-infection. Viral RNA and antigen levels were higher in specimens yielding replication competent virus in cell culture. This study provides important data that can inform how to optimally interpret SARS-CoV-2 diagnostic test results.

Stereotactic Body Proton Therapy Versus Conventionally Fractionated Proton Therapy for Early Prostate Cancer: A Randomized, Controlled, Phase 3 Trial.

PURPOSE: We aimed to determine if ultra-hypofractionated proton therapy delivered via stereotactic body proton therapy (SBPT) is non-inferior to conventionally fractionated proton therapy (CFPT) in patients with early prostate cancer. MATERIALS AND METHODS: This study was a multicenter, randomized, controlled, non-inferiority phase 3 trial that included patients with histologically confirmed low-risk prostate adenocarcinoma defined by Gleason score grouping 1, PSA <10 ng/mL, and clinical stage T1-2a N0 M0 according to AJCC 7th ed. Eligible participants were randomly assigned initially at a 1:1 ratio and later at a 2:1 ratio to SBPT (38 Gy in 5 fractions) or CFPT (79.2 Gy in 44 fractions). The primary endpoint was freedom from failure (FFF) at 2 years from the date of randomization. Non-inferiority for FFF was determined based on one-sided confidence intervals. Toxicities were compared at different time points using Fisher's Exact test. Health-related quality-of-life (HRQoL) was analyzed at different time points using a mixed-effects linear model. This trial is registered with ClinicalTrials.gov, NCT01230866, and is closed to accrual. RESULTS: Between December 10, 2010, and September 29, 2020, 144 patients were enrolled and 135 were randomly assigned (90 to the SBPT group and 45 to the CFPT group). The median follow-up was 5 years (IQR 3.9-5.2). The 2-year FFF was 100% for both groups, with the one-sided 5-year risk difference in FFF between groups reported as 2.63% (90% CI: -1.70%-6.96%), favoring the SBRT arm, thus fulfilling the pre-specified criteria for non-inferiority of SBPT compared to CFPT. Rates of gastrointestinal (GI) and genitourinary (GU) G2 and G3 toxicities did not differ significantly between groups but the the study was not powered to detect significant toxicity differences. Also, HRQoL metrics did not differ significantly between groups over the study median follow up. CONCLUSIONS: SBPT is non-inferior to CFPT regarding FFF, with similar long-term GU and GI toxicity rates and minimal impact in patient reported HRQoL over time.