Change In Grade Research Articles

Improving readability and comprehension levels of otolaryngology patient education materials using ChatGPT

ObjectiveA publicly available large language learning model platform may help determine current readability levels of otolaryngology patient education materials, as well as translate these materials to the recommended 6th-grade and 8th-grade reading levels. Study designCross-sectional analysis. SettingOnline using large language learning model, ChatGPT. MethodsThe Patient Education pages of the American Laryngological Association (ALA) and American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) websites were accessed. Materials were input into ChatGPT (OpenAI, San Francisco, CA; version 3.5) and Microsoft Word (Microsoft, Redmond, WA; version 16.74). Programs calculated Flesch Reading Ease (FRE) scores, with higher scores indicating easier readability, and Flesch-Kincaid (FK) grade levels, estimating U.S. grade level required to understand text. ChatGPT was prompted to “translate to a 5th-grade reading level” and provide new scores. Scores were compared for statistical differences, as well as differences between ChatGPT and Word gradings. ResultsPatient education materials were reviewed and 37 ALA and 72 AAO-HNS topics were translated. Overall FRE scores and FK grades demonstrated significant improvements following translation of materials, as scored by ChatGPT (p < 0.001). Word also scored significant improvements in FRE and FK following translation by ChatGPT for AAO-HNS materials overall (p < 0.001) but not for individual topics or for subspecialty-specific categories. Compared with Word, ChatGPT significantly exaggerated the change in FRE grades and FK scores (p < 0.001). ConclusionOtolaryngology patient education materials were found to be written at higher reading levels than recommended. Artificial intelligence may prove to be a useful resource to simplify content to make it more accessible to patients.

Ten-year changes of periodontitis grading using direct and indirect evidence: a retrospective evaluation.

To evaluate two methods for assessing the changes in periodontitis grading in patients undergoing supportive periodontal therapy (SPT) ten years (T10) after retrospective baseline (BL) grading. The periodontitis grade of 51 SPT-patients was assessed using indirect evidence as the primary criterion for periodontitis progression at BL and T10 (radiographic bone loss/age index, periodontitis phenotype). Grading at T10 was also performed using the direct evidence for periodontitis progression (clinical attachment loss over the previous five years). The use of indirect evidence for periodontal progression at BL and T10 was defined as method 1 (M1) to assess the changes in periodontitis grading. The use of indirect evidence at BL and direct evidence at T10 was defined as method 2 (M2). Changes in periodontitis grading using M1 and M2 were evaluated (Wilcoxon signed-rank test). Agreement between M1 and M2 was assessed (Cohen's kappa). Indirect BL-grading revealed five grade B and 46 grade C patients. The indirect grading at T10 revealed 17 grade B and 34 grade C patients. The direct T10-grading classified all patients as grade C. M1 led to an overall improvement in periodontitis grading after ten years of SPT (p&#61;0.00297), whereas M2 led to a deterioration (p&#61;0.0369). The comparison between M1 and M2 showed that they lead to different results in terms of grading (Cohen's Kappa&#61;0.116208). Periodontitis grading may change during SPT. Using indirect or direct evidence as the primary grading criterion during SPT may lead to different results.

Impact of transcatheter edge to edge repair in functional mitral regurgitation and cardiac resynchronization-therapy nonresponders.

Despite optimal medical therapy and cardiac resynchronization therapy (CRT), significant functional mitral regurgitation (MR) persisted in 30% of the patients and labeled as CRT nonresponders. We sought to study the impact of transcatheter edge-to-edge repair (TEER) in patients with symptomatic grade III and IV functional MR despite CRT. A retrospective analysis was conducted of all patients who had prior CRT for at least 6 months and underwent TEER for significant residual functional MR (grade ≥3) and symptomatic heart failure (HF) at our institution. The primary outcomes were the change in New York Heart Association classification (NYHA), MR grade, echo parameters, and NT-ProBNP from baseline to 1-year post-procedure. A total of 28 patients were identified, mean age of 73 ± 6.7 years and 89% males. Procedure success was achieved in all patients. At 1-year follow-up, patients had lower MR grade (median 2, IQR 1 [1,2] vs. 4, IQR 1 [3,4]; p < 0.001), NYHA class (median 2, IQR 1 [2,3] vs. 3, IQR 1 [3,4]; p < 0.001), and NT-ProBNP (7658 ± 11322 vs. 3760 ± 4431; p = 0.035) compared to before the TEER procedure. The left ventricular end-diastolic volume (255 ± 59vs. 244 ± 66 mm; p = 0.016) and the right ventricular systolic pressure (52 ± 14 mmHg vs. 37 ± 13 mmHg, <0.001) decreased. Patients who remain symptomatic after CRT with severe functional MR had improved functional status and MR grade at 1-year following TEER. There was a signal toward reverse remodeling.

A Dietary Supplement in the Management of Patients with Lumbar Osteochondrosis: A Randomized, Double-Blinded, Placebo-Controlled Study.

Various nutritional supplements are available over the counter, yet few have been investigated in randomized controlled trials. The rationale for using the specific mix of nutritional substances including collagen type II, hyaluronic acid, n-acetyl-glucosamine, bamboo extract, L-lysine, and vitamin C is the assumption that combining naturally occurring ingredients of the intervertebral disc would maintain spine function. This double-blinded, placebo-controlled randomized trial aimed to evaluate the efficacy of a nutraceutical supplement mix in the management of lumbar osteochondrosis. Fifty patients were randomly assigned to either the supplement or placebo group in a 1:1 ratio. Patient-Reported Outcome Measures (PROMs) included the Oswestry Disability Index (ODI), the visual analogue scale for pain (pVAS), short form-12 (SF-12) physical and mental component summary subscale scores (PCS and MCS, respectively), and global physical activity questionnaire (GPAQ). Magnetic resonance imaging (MRI) was used to evaluate degenerative changes of intervertebral discs (IVD) including Pfirrmann grades as well as three-dimensional (3D) volume measurements. Data were collected at baseline and after the 3-month intervention. None of the PROMs were significantly different between the supplement and placebo groups. Disc degeneration according to Pfirrmann classifications remained stable during the 3-month intervention in both groups. Despite no significance regarding the distribution of Pfirrmann grade changes (improvement, no change, worsening; p = 0.259), in the supplement group, one patient achieved a three-grade improvement, and worsening of Pfirrmann grades were only detected in the placebo group (9.1%). Furthermore, in-depth evaluations of MRIs showed significantly higher 3D-measured volume changes (increase) in the supplement (+740.3 ± 796.1 mm3) compared to lower 3D-measured volume changes (decrease) in the placebo group (-417.2 ± 875.0 mm3; p < 0.001). In conclusion, this multi-nutrient supplement might not only stabilize the progression of lumbar osteochondrosis, but it might also potentially even increase IVD volumes as detected on MRIs.

Impact of Laparoscopic Sleeve Gastrectomy on Fatigue in Obese Patients.

Background: Fatigue with obesity negatively affects the motivation to lose weight and causes failure of treatment. So, obesity and fatigue are two related entities that worsen each other in a vicious circle. This study aimed to examine the changes in fatigue levels in obese patients undergoing laparoscopic sleeve gastrectomy (LSG). Methods: Preoperative and postoperative BMI, fat percentage, and obesity degree were determined based on Tanita test results, and the rates of change were calculated. The Fatigue Assessment Scale (FAS) was used to assess the impact of obesity on mental and physical fatigue. Results: Six months after LSG, there was a 29.7% decrease in Body Mass Index (BMI) across all patients (45.0 to 31.4, p < 0.001). Significant reductions in the percentage of body fat, obesity grade, and HgA1C were observed in both women and men and overall (p < 0.001 for all comparisons). Scores on the Fatigue Assessment Scale (FAS) for total, mental, and physical scales decreased significantly for women, men, and all participants (p < 0.001 for all comparisons). There was a weak but significant positive correlation between the percentage change in FAS total and FAS physical scale scores and the change in BMI% (p = 0.015 and 0.004; r = 0.089, 0.106, respectively). Change in obesity grade and FAS physical subscale scores negatively correlated (p = 0.029, r = 0.080). Conclusions: LSG not only leads to significant weight reduction but also improves fatigue levels in patients with obesity.

Parent-Reported Academic Outcomes After a Mild Traumatic Brain Injury in the Pediatric Population.

Millions of children are diagnosed with a traumatic brain injury (TBI) each year, most being mild TBI (mTBI). The effect of mTBIs on academic performance is of significant importance. We investigate mTBI's impact on parent-reported academic outcomes in school-aged pediatric participants. This cross-sectional survey study queried parents (N = 285) regarding letter grade performance and the presence or absence of academic accommodations before and after an mTBI, including complicated mTBI (c-mTBI, or mTBI with radiographic abnormality). We found a parent-reported decline in letter grades following c-mTBI (p < .001), with no significant change following uncomplicated mTBIs. Degree and length of recovery were also associated with grade changes (p < .05). Those with no academic accommodations prior to the injury showed significant decreases in grades after injury regardless of post-injury accommodation status (p < .05). This study underscores the need for an improved framework of support to maximize academic performance of children following mTBI, especially in those with a c-mTBI and still recovering from their injury. Our study identifies children who are at risk for adverse academic outcomes following mTBI. We encourage efforts to better support school nurses in this effort, including improved communication between health care teams and school teams.

Design, analysis and optimisation of a novel adiabatic-isothermal CAES system with coupled stepped phase change energy storage unit

Compressed air energy storage (CAES) technology is one of the important technologies to address the instability of renewable energy sources. To further make full use of the system heat of compression and reduce the problem of energy grade dissipation inside the accumulator, this paper proposes a novel CAES system coupled with a graded phase change thermal energy storage unit (SP-TES) and near isothermal compression of a liquid piston. A combination of adiabatic compression and near-isothermal compression is used to reduce the generation of compression heat, while the graded storage of compression heat through SP-TES reduces the reduction of energy grade. The design of the proposed SP-TES is carried out through the binary eutectic theory, and a one-dimensional transient entransy dissipation model, a thermodynamic model and an economic model are developed to analyze the 4E performance (energy, exergy, entransy, and exergoeconomic) of the proposed SP-TES. Further, the effect patterns of key node parameters on the proposed system are investigated by developing system related models and the system is optimized with multiple objectives from the point of view of economic and thermodynamic performances. The results show that the 4E performance of SP-TES is in between that of high and low temperature single-stage accumulators, and that SP-TES combines the advantages of higher economic performance of single-stage low-temperature accumulators and higher thermal performance of single-stage high-temperature accumulators. The SP-TES with a temperature range of 350 K-451 K is gradually stabilized with the number of charging and discharging, and the efficiency of the system in the stabilization stage is 73.24 %. The SP-TES with a temperature range of 407 K-440 K has the best economic performance with exergoeconomic parameter of 360.05 kJ/USD. The thermal storage performance and power output of the SP-TES decreases with the increase in the number of stages. The multi-objective optimization results show that the new CAES system efficiency is 63.03 % and the design is optimal when the unit energy cost is 0.2217 $/kWh.

Nanofabrication of Losartan Potassium Sustained Release Floating Microspheres using Different Grades of Ethyl Cellulose and its Insight on Release Profiles.

A sustained release system for losartan potassium designed to delay its residence time in the stomach through the preparation of solvent evaporation technique-based floating microspheres. The influence of the different grades of Ethocel™ such as 4 cps, 10 cps, and 22 cps as well as the drug: polymer ratio on various properties of microspheres were tested. Thermal and functional analysis revealed no interaction between the encapsulated drug and polymer. The results indicated that the mean diameter of microspheres increased with a change in grades of ethyl cellulose relating to viscosity. However, the drug incorporation efficiency within ethyl cellulose microspheres decreased with increasing viscosity of ethyl cellulose. The bulk density of the formulations was proportionally dependent on concentration and the viscosity of the polymer, which resulted in a decrease in floating capacity from 90.02% to 73.58%. Moreover, the drug release was indirectly proportional to the viscosity of ethyl cellulose tested. The in vitro release profile exhibited a burst effect with a biphasic release pattern following Fickian diffusion, indicating a diffusioncontrolled release mechanism. The results demonstrated that the viscosity of ethyl cellulose significantly affects the floating capacity and drug release pattern from microspheres.

A randomized, double-blind phase 2b trial to evaluate efficacy of ChAd63-KH for treatment of post kala-azar dermal leishmaniasis

In a recent Phase IIa clinical trial, the candidate leishmaniasis vaccine ChAd63-KH was shown to be safe and immunogenic in Sudanese patients with post kala- azar dermal leishmaniasis. However, its value as a stand-alone therapeutic was unknown. To assess the therapeutic efficacy of ChAd63-KH, we conducted a randomized, double-blind, placebo-controlled Phase IIb trial (Clinicaltrials.gov registration: NCT03969134). Primary outcomes were safety and efficacy (≥90% improvement in clinical disease). Secondary outcomes were change in severity grade and vaccine-induced immune response. 86 participants with uncomplicated post kala azar dermal leishmaniasis of ≥ six months duration were randomised to receive ChAd63-KH (7.5x1010 viral particles once i.m.) or placebo. 75 participants (87%) completed the trial as per protocol. No severe or serious adverse events were observed. At day 90 post vaccination, 6/40 (15%) and 4/35 (11%) participants in the vaccine and placebo groups respectively showed ≥ 90% clinical improvement (RR 1.31 [95% CI, 0.40 to 4.28], p=0.742). There were also no significant differences in PKDL severity grade between study arms. Whole blood transcriptomic analysis identified transcriptional modules associated with interferon responses and monocyte and dendritic cell activation. Thus, a single vaccination with ChAd63-KH showed no therapeutic efficacy in this subset of Sudanese PKDL patients.

Effect of modified facial paralysis rehabilitation nursing on patients with facial paralysis after vestibular schwannoma surgery

Background and objectiveAfter vestibular schwannoma (VS) surgery, some patients exhibit different degrees of peripheral facial paralysis, which can seriously affect their quality of life. The recovery of facial nerve function after surgery typically takes a considerable amount of time; therefore, the recovery of facial nerve function depends mainly on the rehabilitation treatment and nursing after discharge. In the past, we implemented conventional paralysis rehabilitation nursing program for patients with facial paralysis due to VS surgery. However, several patients with facial paralysis have bad compliance and do not achieve ideal facial nerve function recovery. Therefore, this study aimed to investigate whether modified facial paralysis rehabilitation nursing improves the effectiveness of rehabilitation of facial paralysis after VS surgery by analysing the clinical data of patients. MethodsWe screened the patients with facial paralysis after VS surgery from December 2019 to May 2023. The patients were divided into the conventional and modified groups based on the different nursing programs (conventional vs. modified facial paralysis rehabilitation nursing program) to compare the differences in facial nerve function, quality of life of patients, and compliance of rehabilitation between the two groups. ResultsWe analysed 128 patients with facial paralysis after VS surgery who met the inclusion and exclusion criteria; 65 and 63 patients in the conventional and modified group, respectively. The number of patients in the modified group with House–Brackmann grade changes >0 in facial nerve function was significantly higher than that in the conventional group 3 months after surgery (82.5 % vs 63.1 %, p = 0.01). Except for the lacrimal control score, the mean scores of the Chinese version of the FaCE scale were significantly higher in the modified group than those in the conventional group at 1 and 3 months postoperatively. ConclusionsThe modified facial paralysis rehabilitation nursing, i.e., integrated use of facial expressive muscle exercises and facial massage with video-assisted education, substantially improved the facial nerve function, quality of life, and compliance of rehabilitation nursing of patients with facial paralysis after VS surgery.

Insights into the clinical impact of complete blood cell inflammatory markers on body composition variations and fatty liver grading in Iranian adults undergoing bariatric surgery: a retrospective longitudinal study.

In bariatric surgery, inflammatory biomarkers predict outcomes. Limited research on complete blood cell (CBC) markers stresses the need for correlation study. This research explores links between CBC inflammatory markers, body changes, and fatty liver grades in Iranian bariatric patients. This retrospective longitudinal study examined 237 bariatric surgery patients who satisfied the inclusion criteria and were deemed eligible for participation. These criteria encompassed patients who had undergone sleeve or mini-bypass surgery and were aged between 18 and 65 years. The study gathered demographic data, pre and post-surgery changes in CBC inflammatory biomarkers [neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and monocyte-to-lymphocyte ratio (MLR), mean platelet volume (MPV), MPV-to-platelet count ratio (MPV/PC), and red cell distribution width (RDW)] and fatty liver grades. Additionally, it recorded pre and post-surgery changes in body composition, such as weight, muscle mass (MM), fat mass (FM), and fat-free mass (FFM). The pre-surgery RDW marker significantly associated with FM changes, highlighting its predictive nature. While no significant association was found between changes in patients' fatty liver grade and baseline marker values, it's worth noting that individuals with higher MM at 3 months achieved a fatty liver grade of zero. Also, at 6 months, higher FFM and MM were also associated with reaching a fatty liver grade of zero. While the retrospective design of this study limits its findings to existing clinical data, future prospective research should collect additional samples, extend the observation time, and examine the long-term predictive value of these markers.

Effect of Bariatric Surgery on the Sonographic Grade of Metabolic-Associated Fatty Liver Disease at 12-Month Follow-Up.

Metabolic-associated fatty liver disease (MAFLD) is the most prevalent liver disease across the globe. One of the most effective treatments for this disease is weight loss. This study aimed to determine how metabolic and bariatric surgery (MBS) affects MAFLD sonographic grades. In 2021, a pre-post study was conducted on 73 patients who underwent MBS. The study collected demographic information and ultrasound grades of MAFLD before and after MBS. A total of 73 patients underwent MBS, with 58 females and 15 males. The patients had a mean age of 39.8 ± 8.88years and a mean BMI of 42.12 ± 5.98kg/m2. Of these patients, 53 (72.6%) underwent SG, while 20 (27.4%) underwent RYGB. The preoperative BMI for females and males decreased significantly at the 12-month follow-up (P = 0.0001). However, males experienced more prominent weight changes (P = 0.009), but there was no statistically significant difference in fatty liver grade changes after MBS between males and females (P = 0.056), which suggests that the effect of MBS on fatty liver grades is not gender-specific. There was a significant reduction in BMI and fatty liver grade for patients under and over 40years old after surgery (P = 0.0001). However, there was no statistically significant difference in fatty liver grade and BMI changes after MBS between the two age groups. RYGB was found to be more effective than SG in reducing fatty liver grade, BMI, and %TWL (P < 0.05). Bariatric surgery can play a vital role in reducing the weight and severity of metabolic-associated fatty liver disease.

Safety and efficacy of PCSK9 inhibitor (evolocumab) in patients with non-ST segment elevation acute coronary syndrome and non-culprit artery critical lesions: a randomised controlled trial protocol (SPECIAL study)

IntroductionPatients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) and concomitant multivessel coronary artery disease (CAD) are considered patients with extremely high-risk atherosclerotic cardiovascular disease (ASCVD), and current guidelines specify...

Extracorporeal shock wave therapy with imaging examination for early osteonecrosis of the femoral head: a systematic review.

Extracorporeal shockwave therapy (ESWT) is a traditional non-invasive therapy to treat osteonecrosis of the femur head (ONFH). This systematic review aims to investigate whether ESWT can improve the clinical function of ONFH and whether differences in improvement can be observed in radiographic outcomes. Two authors independently searched PubMed, Embase, Cochrane Library, and Web of Science for English articles until October 21, 2023. After screening and reading the literature, the two authors independently used corresponding scales to evaluate the quality of the included articles and extracted data. The key data extracted included the Harris Hip Score (HHS), Visual Analog Scale (VAS), changes in lesion size, the change in the Association Research Circulation Osseous (ARCO) stage, and bone marrow edema stage. Nine articles included 468 males and 248 females. The average age was 43.29 years and the mean follow-up time was 15.19 months. After receiving ESWT, five studies involving 146 hips showed a higher HHS (MD=-33.38; 95%CI, -46.31, -20.45), and the difference was statistically significant (P<0.00001). The average VAS before treatment was above 5, but it dropped to 1.2 after ESWT (MD=4.64; 95%CI, 3.63, 5.64), and the difference was statistically significant (P<0.00001). Three studies found no significant differences in the areas of femoral head necrosis before and after treatment with ESWT(MD=9.66; 95%CI, -0.36, 19.67; P=0.06; I2=84%). Two articles showed that the use of ESWT had no significant effect on the change in the ARCO stage (MD=1.11; 95%CI, 0.76, 1.62; P=0.60; I2=0%). Three studies indicated that using ESWT could improve the bone marrow edema symptom in the early stage of ONFH (MD=4.35; 95%CI, 1.32, 14.37; P=0.02; I2=62%). Based on the current evidence, ESWT shows promise as a therapy to enhance hip function and alleviate pain in the early stage of ONFH. With the advancement of more precise imaging techniques, ESWT can potentially reduce the area affected by ONFH. However, such reduction was not found to be statistically significant at the imaging level. Additionally, ESWT could improve symptoms of bone marrow edema in the early stage. However, no significant change in ARCO grade was observed with ESWT treatment.

The 2021 World Health Organization Central Nervous System Tumor Classification: The Spectrum of Diffuse Gliomas.

The 2021 edition of the World Health Organization (WHO) classification of central nervous system tumors introduces significant revisions across various tumor types. These updates, encompassing changes in diagnostic techniques, genomic integration, terminology, and grading, are crucial for radiologists, who play a critical role in interpreting brain tumor imaging. Such changes impact the diagnosis and management of nearly all central nervous system tumor categories, including the reclassification, addition, and removal of specific tumor entities. Given their pivotal role in patient care, radiologists must remain conversant with these revisions to effectively contribute to multidisciplinary tumor boards and collaborate with peers in neuro-oncology, neurosurgery, radiation oncology, and neuropathology. This knowledge is essential not only for accurate diagnosis and staging, but also for understanding the molecular and genetic underpinnings of tumors, which can influence treatment decisions and prognostication. This review, therefore, focuses on the most pertinent updates concerning the classification of adult diffuse gliomas, highlighting the aspects most relevant to radiological practice. Emphasis is placed on the implications of new genetic information on tumor behavior and imaging findings, providing necessary tools to stay abreast of advancements in the field. This comprehensive overview aims to enhance the radiologist's ability to integrate new WHO classification criteria into everyday practice, ultimately improving patient outcomes through informed and precise imaging assessments.

Comparative evaluation of endoscopic anti-reflux mucosectomy and stretta radiofrequency ablation in the management of gastroesophageal reflux disease: insights from a retrospective multicenter cohort study.

Treatment options for gastroesophageal reflux disease (GERD) that is unresponsive to proton pump inhibitors (PPIs) remain limited. Therefore, we compared the therapeutic effects of anti-reflux mucosectomy (ARMS) and Stretta radiofrequency (SRF) for intractable GERD in over 400 individuals who underwent either procedure. We conducted a retrospective study between 2016 and 2023 to evaluate the effectiveness of SRF and ARMS treatments for refractory GERD. The primary measure of success was the change in the GERD questionnaire (GERDQ) score. The secondary outcomes were various GERD-related indicators, including endoscopic Los Angeles (LA) classification, Hill's type-based flap valve grade (FVG), EndoFLIP™ distensibility index (DI), rate of PPI discontinuation, resolution rate of Barrett's esophagus, and incidence of adverse events. The ARMS group included patients with high GERDQ scores, FVG, LA grade, and Barrett's esophagus. Both groups had similar rates of improvements in GERDQ score (P = 0.884) and PPI withdrawal (P = 0.866); however, the ARMS group had significantly more side effects and improvements in the median change in GERDQ score (P = 0.011), FVG (P < 0.001), LA grade (P < 0.001), EndoFLIP™ DI (P < 0.001), and resolution of Barrett's esophagus (P < 0.001). The ARMS group had a greater GERDQ score improvement than the SRF group but had symptom relief and PPI discontinuation rates similar to those of the SRF group. However, objective measures, including EndoFLIP™ DI and endoscopic evaluations, were better in the ARMS group than in the SRF group.

Optimizing timing for quantification of intracranial aneurysm enhancement: a multi-phase contrast-enhanced vessel wall MRI study.

Aneurysm wall enhancement (AWE) on high-resolution contrast-enhanced vessel wall MRI (VWMRI) is an emerging biomarker for intracranial aneurysms (IAs) stability. Quantification methods of AWE in the literature, however, are variable. We aimed to determine the optimal post-contrast timing to quantify AWE in both saccular and fusiform IAs. Consecutive patients with unruptured IAs were prospectively recruited. VWMRI was acquired on 1 pre-contrast and 4 consecutive post-contrast phases (each phase was 9 min). Signal intensity values of cerebrospinal fluid (CSF) and aneurysm wall on pre- and 4 post-contrast phases were measured to determine the aneurysm wall enhancement index (WEI). AWE was also qualitatively analyzed on post-contrast images using previous grading criteria. The dynamic changes of AWE grade and WEI were analyzed for both saccular and fusiform IAs. Thirty-four patients with 42 IAs (27 saccular IAs and 15 fusiform IAs) were included. The changes in AWE grade occurred in 8 (30%) saccular IAs and 6 (40%) in fusiform IAs during the 4 post-contrast phases. The WEI of fusiform IAs decreased 22.0% over time after contrast enhancement (p = 0.009), while the WEI of saccular IAs kept constant during the 4 post-contrast phases (p > 0.05). When performing quantitative analysis of AWE, acquiring post-contrast VWMRI immediately after contrast injection achieves the strongest AWE for fusiform IAs. While the AWE degree is stable for 36 min after contrast injection for saccular IAs. The standardization of imaging protocols and analysis methods for AWE will be helpful for imaging surveillance and further treatment decisions of patients with unruptured IAs. Imaging protocols and measurements of intracranial aneurysm wall enhancement are reported heterogeneously. Aneurysm wall enhancement for fusiform intracranial aneurysms (IAs) is strongest immediately post-contrast, and stable for 36 min for saccular IAs. Future multi-center studies should investigate aneurysm wall enhancement as an emerging marker of aneurysm growth and rupture.

Two-Year Clinical Outcomes of Staged Transcatheter Mitral Edge-to-Edge Repair After Transcatheter Aortic Valve Replacement

Residual significant mitral regurgitation (MR) can increase the risk of adverse events following transcatheter aortic valve replacement (TAVR). The clinical benefits of staged transcatheter edge-to-edge repair (TEER) post-TAVR remain underexplored. This study aimed to investigate the clinical outcomes of staged TEER for residual significant MR post-TAVR. This observational study included 314 consecutive patients with chronic residual grade 3+ or 4+ MR at 30 days follow-up post-TAVR, with 104 (33.1%) treated with staged TEER (TEER group) and 210 (66.9%) with medical therapy alone (MT group). The primary composite outcomes were all-cause mortality and heart failure (HF) hospitalization at 2 years. Additional analysis, including changes in MR grade and the New York Association (NYHA) functional classification, and subgroup outcome comparisons based on MR etiology were also conducted. In our study, the rate of primary composite outcome was lower in the TEER group than in the MT group (33.7% vs. 48.1%, p = 0.015). Significant improvement in MR grade and NYHA class was observed in the TEER group after 2 years. Subgroup analysis demonstrated that, among patients with degenerative MR, a lower incidence of composite outcome and HF hospitalization was observed in the TEER group (hazard ratio: 0.35; 95% confidence interval: 0.23–0.53, p < 0.001).In conclusion, staged TEER post-TAVR was associated with reduced MR and improved clinical outcomes. The clinical significance of MR post-TAVR should be carefully evaluated, and TEER should be considered for patients with significant residual MR, particularly those with degenerative MR.

Phase 2 study of the lysine-specific demethylase 1 (LSD1) inhibitor bomedemstat in patients with polycythemia vera (PV).

TPS6595 Background: PV is a myeloproliferative neoplasm (MPN) characterized by clonal erythrocytosis that is driven by mutations in JAK2. Currently available treatments reduce thrombotic risk and symptom burden but have little impact on disease course or risk of progression to post-PV myelofibrosis (PPV-MF) or acute myeloid leukemia (AML). There remains a need for novel treatments that can alter the natural history of PV. LSD1 is an enzyme that regulates megakaryocytes and erythrocyte maturation. Bomedemstat is an irreversible inhibitor of LSD1 that has been shown to have manageable safety and clinically relevant activity in other JAK2-mutation–prevalent MPNs (essential thrombocythemia and myelofibrosis). Here, we describe the methods for an open-label phase 2 study (NCT05558696) that has been designed to evaluate the efficacy and safety of bomedemstat in patients with PV who are resistant to or intolerant of standard cytoreductive therapy. Methods: Eligible patients are ≥18 years, have a confirmed diagnosis of PV per World Health Organization 2016 diagnostic criteria, a bone marrow fibrosis score of grade 0 or 1, an ECOG performance status of 0-2, a platelet count of ≥250 × 109/L, an absolute neutrophil count of ≥1.5 × 109/L, and resistance to or intolerance of ≥1 standard cytoreductive therapy. All patients will receive bomedemstat at a starting dose of 40 mg/d by mouth for 36 weeks, with dose titration to a hematocrit target of &lt;45% with no grade ≥1 thrombocytopenia. Treatment with bomedemstat can continue beyond week 36 in patients deriving clinical benefit. Clinic visits will occur every 2 weeks until week 12 and monthly thereafter. Adverse events will be graded per NCI CTCAE version 5.0 criteria and will be monitored for up to 30 days after treatment end. Transfusions or phlebotomy can be administered during treatment as needed. The primary end points are safety and the proportion of patients who achieve a reduction in hematocrit to &lt;45% without phlebotomy by week 36. Secondary end points will be the durability of reduction in hematocrit &lt;45% without phlebotomy; the incidence and durability of reduction in platelet count to ≤450 × 109/L and white blood cell count to &lt;10 × 109/L; the incidence of new thrombotic or major hemorrhagic events; reduction in spleen volume by week 36 in patients with an enlarged spleen at baseline; progression to PPV-MF or myelodysplastic syndrome or transformation to AML; pharmacokinetics; and change in patient-reported symptom burden assessed using the MSAF v4.0 and PGIC. Exploratory end points include change in the concentration of circulating inflammatory cytokines and growth factors, change in mutant allele frequency of JAK2and other mutations, and change in bone marrow fibrosis grade. Approximately 20 patients will be enrolled. Recruitment for this study is currently underway in Australia, the United Kingdom, and the United States. Clinical trial information: NCT05558696 .

Prevalence and Precipitants of Hepatic Encephalopathy in Hospitalized Children With Chronic Liver Disease

ObjectiveHepatic encephalopathy (HE) is a marker of poor prognosis in adults with chronic liver disease (CLD). We prospectively studied the prevalence and precipitants of HE in children with CLD as there is a paucity of literature on the same. MethodsChildren (1-18years) admitted with CLD were examined daily for the presence and grading of HE (West Haven/ Whitington grading). Precipitants were classified as infection, dyselectrolytemia, gastrointestinal bleeding, constipation, and dehydration. Changes in grades of HE and outcome were noted. ResultsOne hundred and sixty children (age 120[84-168] months) were enrolled. HE was present in 50(31.2%) patients with a total of 61 episodes. Maximum grade of HE was grade I (n=16), II (n=23), III (n=11) and IV (n=11). Forty-two cases had single and 8 had recurrent (2-5) episodes. Median duration of HE episodes was 96 (72-192) hours. Precipitants were identified in 55/61(90.2%) episodes with infection (45/61, 73.7%) and dyselectrolytemia (33/61,54%) being most common. Lower albumin and sodium, higher INR and presence of infection were significantly associated with presence of HE. Overall, HE resolved in 33(54%) episodes, while it progressed and persisted in 28(45.9%) episodes. Patients with HE had a poorer outcome (25/50 vs 13/110; p <0.01) with both higher in-hospital (11/50 vs 9/110; p=0.02) and 1month post discharge (14/39 vs 4/101; p<0.01) mortality than those without HE. ConclusionOne third of admitted CLD children have HE, with identifiable precipitants in 90% cases. Children with HE have poorer liver functions, higher rate of infections and worse outcome than those without HE.