Nevin Manimala

Intern Emerg Med. 2025 Nov 4. doi: 10.1007/s11739-025-04182-0. Online ahead of print.

ABSTRACT

Hemodialysis patients have an increased risk of bleeding related to platelet dysfunction and uremia leading to acquired defects in primary hemostasis. Frequently, these patients have multiple medical comorbidities requiring treatment with antiplatelet agents and anticoagulants, further increasing their bleeding risk. This presents added challenges when they present to the emergency department (ED) with arteriovenous fistula or arteriovenous graft (AVF/AVG) bleeding. This retrospective cohort study aims to characterize patient characteristics, mortality outcomes, hemorrhage outcomes, infectious outcomes, repeat ED visits, non-invasive procedures, and invasive procedures associated with ED encounters for AVF/AVG bleeding. This is a retrospective cohort study evaluating ED encounters for patients on hemodialysis with a chief complaint of a bleeding AVF/AVG. Descriptive statistics as well as logistic regression were used to find correlations between patient and encounter factors and the risk of requiring an advanced procedure to prevent further AVF/AVG bleeding. The primary outcome was the need for a formal intervention to revascularize or perform angioplasty on the patient’s AVF or AVG. This occurred in 173 (50.7%) encounters. A history of any bleeding event was associated with the primary outcome while a higher initial platelet count or the use of antiplatelets were inversely associated with the primary outcome. This multi-center retrospective cohort study evaluated patient and clinical characteristics in encounters involving AVF/AVG bleeding. Correlating factors between ED encounters involving AVF/AVG bleeding and the need for advanced AVF/AVG interventions are described. Further research with a larger, more diverse patient base is needed to confirm these findings before these characteristics can be considered indications for more rapid interventional radiology or vascular surgery follow up in cases of AVF/AVG bleeding.

PMID:41186888 | DOI:10.1007/s11739-025-04182-0

Neth Heart J. 2025 Nov 4. doi: 10.1007/s12471-025-02000-y. Online ahead of print.

ABSTRACT

BACKGROUND: Diagnosing heart failure with preserved ejection fraction (HFpEF) remains challenging. While diagnostic algorithms support clinical evaluation, their performance across sexes is understudied, despite HFpEF being more prevalent in females, which may result in sex-specific underdiagnosis.

PURPOSE: To assess the diagnostic accuracy of three HFpEF algorithms-HFA-PEFF, H₂FPEF, and the ESC HF 2016 criteria-and to evaluate sex-related differences in performance.

METHODS: Two prospective cohorts with unexplained dyspnoea were analysed. The Amsterdam cohort (2014-2020; n = 135) had HFpEF confirmed or excluded via (exercise) right heart catheterization (RHC). The Maastricht cohort (2015-2021; n = 659) had HFpEF confirmed or excluded based on expert consensus with utilisation of HFpEF scores, and RHC when needed. Sex-specific diagnostic performance of three HFpEF algorithms was assessed using ROC curves, AUC, and a panel of metrics with cut-offs determined by the rule-in/rule-out strategies.

RESULTS: HFpEF prevalence was high in both cohorts (84.4% and 82.5%), with a female majority (69.6% and 66.5%). Across all algorithms, males consistently showed lower AUC values than females, although differences were not statistically significant. The highest diagnostic performance within the Amsterdam cohort was observed with H₂FPEF (AUC 0.86 and 0.82 for females and males), while HFA-PEFF performed best within Maastricht cohort (AUC 0.85 and 0.83, respectively). Performance for ruling-in and ruling-out HFpEF was numerically lower in males than females; Amsterdam cohort HFA-PEFF and ESC 2016 specificity were 83% versus 93% and 50% versus 73%, Maastricht cohort H₂FPEF specificity was 81% versus 89%.

CONCLUSIONS: HFpEF diagnostic algorithms may perform better in females than males in referral outpatient settings. Inconsistent performance of diagnostic algorithms between different sexes warrants further optimisation to diagnose HFpEF.

PMID:41186885 | DOI:10.1007/s12471-025-02000-y

Gen Thorac Cardiovasc Surg. 2025 Nov 4. doi: 10.1007/s11748-025-02205-3. Online ahead of print.

ABSTRACT

OBJECTIVE(S): Due to the poor prognosis of dialysis patients, accurately predicting life expectancy after aortic stenosis surgery remains challenging, leading to potential misselection of treatment options. This study aimed to develop a prognostic model specific to dialysis patients to facilitate individualized treatment selection.

METHODS: A total of 171 dialysis patients with aortic stenosis who underwent initial isolated surgical aortic valve replacement at seven cardiovascular centers in Japan between 2011 and 2021 were enrolled. The cohort was randomly divided into the training and validation cohorts in a 2:1 ratio. Risk factors contributing to mortality were identified from preoperative variables, and a prognostic model was developed using the Cox proportional hazards model.

RESULTS: Among the 171 patients, 88 deaths occurred during the total observation period of 488.9 person-years. The cumulative overall survival rates at 1, 3, and 5 years, estimated using the Kaplan-Meier method, were 74.7%, 59.4%, and 38.7%, respectively. An optimal risk model was developed, incorporating six factors: age, serum albumin, peripheral artery disease, sex, insulin-dependent diabetes mellitus, and atrial fibrillation. The model demonstrated strong predictive accuracy, with a 5-year C-statistic of 0.723 (95% confidence interval: 0.658-0.788) and 0.656 (95% confidence interval: 0.543-0.770) in the training and validation cohorts, respectively. Calibration plots confirmed that actual survival up to 5 years was well predicted (intraclass correlation coefficient = 0.918, 95% confidence interval: 0.703-0.981).

CONCLUSIONS: The proposed model is a reliable prognostic tool for dialysis patients who underwent surgical aortic valve replacement.

PMID:41186878 | DOI:10.1007/s11748-025-02205-3

Discov Oncol. 2025 Nov 4;16(1):2027. doi: 10.1007/s12672-025-03853-w.

ABSTRACT

PURPOSE: Several studies have already proven a significant correlation between the microbiota and lung cancer. In this study, we explore the potential relative oral and gut microbiota which influence the risk of lung cancer.

METHODS: We utilized genome-wide association study (GWAS) data from oral microbiota (2984 healthy individuals) and gut microbiota (2002 healthy individuals) and lung cancer with a two-sample Mendelian randomization (MR) analysis method. In this analysis, oral microbiota and gut microbiota were conducted as exposure. Lung cancer data obtained from GWAS including a total of 212,453 individuals. Inverse-variance weighted (IVW) method was used as the primary method.

RESULTS: IVW analysis identified that genus Pauljensenia, Capnocytophaga and Aggregatibacter in oral microbiota are potentially protective against lung cancer. On the contrary, higher abundances of bacteria within the genus Granulicatella, Streptococcus, Saccharimonadaceae TM7x and Neisseria in oral microbiota were associated with increased lung cancer risk. Among gut bacteria, species Enterococcus faecalis were positively associated with an increased risk of lung cancer.

CONCLUSION: The findings of this study suggest a potential causal relationship between distinct oral and gut microbial communities and lung cancer risk, offering valuable insights into microbial candidates that may serve as targets for future diagnostic innovations.

PMID:41186872 | DOI:10.1007/s12672-025-03853-w

Eur Radiol Exp. 2025 Nov 4;9(1):106. doi: 10.1186/s41747-025-00644-4.

ABSTRACT

BACKGROUND: Oversimplified pulmonary nodule phantoms limit the clinical translation of computed tomography (CT) research. Therefore, we manufactured and preliminarily validated patient-realistic part-solid nodule models with heterogeneous radiodensities using a stereolithography apparatus (SLA) benchtop three-dimensional (3D) printing.

MATERIALS AND METHODS: Patient-derived CT images were utilised upon Ethics Committee approval to determine part-solid nodule HU ranges and morphologies. To lower the density of the applied resin (Formlabs Clear V4), we designed variable 3D-beams (340, 510, or 680 µm) into lattice structures with variable gap thicknesses (from 680 to 2,040 µm). These lattice structures were merged with patient-derived nodule segmentations. The 3D-prints were incorporated in a Lungman phantom and evaluated using low-dose CT imaging. A multicentre, single-blinded reader study, involving seventeen radiologists, assessed whether 3D-printed nodules were distinguishable from real part-solid nodules using χ² goodness-of-fit testing.

RESULTS: Through varying combinations of material thicknesses and void sizes, we reproduced multiple target radiodensities of clinical nodules and successfully manufactured pulmonary nodule phantoms consisting of three different ground-glass components around a solidly printed core. There was significant evidence (χ² = 136.13; p = 1.864e-31; 5% confidence level) against readers reliably distinguishing patient nodules from our 3D-printed models. Average accuracy across all radiologists was 53.5%. Moreover, 47.5% of the 3D-printed nodules were incorrectly classified as real nodules.

CONCLUSION: Our SLA 3D-printing workflow produces patient-realistic part-solid pulmonary nodules that are more cost-effective than commercially available counterparts. This methodology could provide customisable ground truth phantom models for CT imaging studies, including software validation, acquisition and reconstruction parameter optimisation and/or image quality evaluation.

RELEVANCE STATEMENT: This study marks the first successful application of SLA 3D-printing to manufacture part-solid pulmonary nodule phantoms, incorporating multiple radiodensities and mimicking patient-realistic morphologies. Our developed methodology offers potential to 3D-printed phantoms with higher degrees of customisation and adaptation to research-specific objectives in CT imaging compared to commercially available standardised phantoms.

KEY POINTS: Part-solid pulmonary nodule phantoms with patient-realistic morphologies and multiple radiodensities were manufactured using benchtop SLA 3D-printing. Clinical relevance of our 3D-printed nodules is demonstrated and statistically substantiated in a multicentre, single-blinded reader study including seventeen reading radiologists. Our methodology renders pulmonary nodule models that overcome limitations of generic, standardised, commercially available phantoms, often lacking complexity and realism. Manufactured nodule phantoms can provide an absolute ground truth for software training and validation, CT protocol optimisation and (image) quality assurance. Our modified 3D-printing method is readily available to other groups and can be customised to specific research applications.

PMID:41186861 | DOI:10.1186/s41747-025-00644-4

Hernia. 2025 Nov 4;30(1):6. doi: 10.1007/s10029-025-03492-8.

ABSTRACT

PURPOSE: The aim of this study was to compare robotic-assisted versus laparoscopic techniques in elective primary minimally invasive inguinal hernia repair, focusing on intraoperative conversion rates, perioperative outcomes, and preoperative risk factors. Given the increasing adoption of robotic surgery, we sought to evaluate whether the proposed technical advantages translate into measurable clinical benefits in a real-world, multicenter population using a nationally representative database.

METHODS: A retrospective cohort study was conducted using the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database (2022-2023). Adult patients undergoing elective minimally invasive inguinal hernia repair were identified using CPT code 49650. Patients were stratified into robotic and laparoscopic cohorts. Primary outcomes included conversion to open surgery and operative time; secondary outcomes included 30-day complications, mortality, hospital length of stay, and readmission. Statistical analyses included univariate and multivariate logistic regression.

RESULTS: Of 34,257 cases analyzed, 54.9% were robotic and 45.1% laparoscopic. Robotic cases had significantly lower conversion to open rates (0.1% vs. 0.4%, p < 0.001) but longer operative times (82.5 vs. 65 min, p < 0.001). Perioperative complications, mortality, and readmission rates were comparable between groups. Multivariate analysis showed robotic surgery as an independent protective factor against conversion (OR 0.36, 95% CI: 0.22-0.57, p < 0.001).

CONCLUSION: Robotic-assisted inguinal hernia repair is associated with a lower conversion rate to open surgery without increased complications, despite longer operative times and a higher comorbidity burden. These findings support the selective use of robotics, particularly in complex cases, while highlighting the need for further cost-effectiveness and long-term outcomes research.

PMID:41186816 | DOI:10.1007/s10029-025-03492-8

Drug Saf. 2025 Nov 4. doi: 10.1007/s40264-025-01633-7. Online ahead of print.

ABSTRACT

BACKGROUND: Medicine shortages are an increasing threat to medicine safety and access. In Australia, a 7-month shortage of Coumadin 5-mg tablets (Dec 2022-Jul 2023) prompted Therapeutic Goods Administration (TGA) intervention via the Serious Scarcity Substitution Instrument (SSSI), allowing pharmacists to substitute 5-mg warfarin tablets with lower-strength tablets. Understanding the impact of this shortage on anticoagulant use and safety is essential for informing future regulatory responses.

AIMS: The aim of this study was to assess the impact of the 2023 warfarin shortage in Australia on dispensing of warfarin and direct oral anticoagulants (DOACs), International Normalised Ratio (INR) testing, and adverse event reporting.

METHODS: Monthly national dispensing data (January 2020-August 2024) were obtained from Pharmaceutical Benefits Scheme (PBS) Date of Supply data. INR pathology data were sourced from Services Australia. The TGA Medicines Shortages Database identified relevant shortage periods. Warfarin-related adverse events were extracted from the TGA Database of Adverse Event Notifications. Interrupted time series assessed changes in dispensing and INR testing trends over time.

RESULTS: Warfarin dispensing declined by 1094 prescriptions per month prior to March 2023 (p < 0.0001). A short-term increase occurred in March 2023 (+ 8625 prescriptions; p = 0.0017) following implementation of the SSSI, although this was not sustained. At the warfarin strength level, dispensing rose for warfarin 1 mg and 2 mg but fell for 5 mg, with subsequent compensatory increases; 3 mg remained stable. DOAC dispensing increased steadily before March 2023 (+ 3771 prescriptions per month; p < 0.0001) but declined thereafter (- 3056 per month; p < 0.0001), most notably for rivaroxaban and dabigatran, while apixaban decreased non-significantly. INR testing briefly increased during the shortage and SSSI. A modest rise in haemorrhage-related adverse events was observed.

CONCLUSION: Warfarin supply was maintained during the 2023 shortage through strength-based substitution under the SSSI, with limited impact on DOAC dispensing.

PMID:41186801 | DOI:10.1007/s40264-025-01633-7

Int J Clin Oncol. 2025 Nov 4. doi: 10.1007/s10147-025-02899-8. Online ahead of print.

ABSTRACT

The number of deaths from colorectal cancer in Japan continues to rise, with over 50,000 deaths recorded in 2018. In the 2024 edition, revisions to all aspects of treatment were undertaken, with corrections and additions made based on knowledge gained since the 2022 version (drug therapy) and the 2019 version (other treatments). The Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2024 for the treatment of colorectal cancer have been prepared to present standard treatment strategies, reduce disparities among institutions, avoid both unnecessary and insufficient treatment, and enhance mutual understanding between healthcare professionals and patients by making these guidelines accessible to the public. These guidelines were developed through consensus by the JSCCR Guideline Committee, following a careful review of evidence retrieved from literature searches and considering the medical insurance system and actual clinical practice in Japan. Therefore, these guidelines serve as a tool for managing colorectal cancer in real-world clinical settings. More specifically, they can be used to support obtaining informed consent from patients and selecting the most appropriate treatment method for each patient. Controversial topics were selected as clinical questions, and recommendations were provided. Each recommendation is accompanied by an evidence classification and a recommendation category, both based on consensus reached by the Guideline Committee members. This article presents the English version of the JSCCR guidelines 2024.

PMID:41186794 | DOI:10.1007/s10147-025-02899-8

J Med Imaging Radiat Oncol. 2025 Nov 4. doi: 10.1111/1754-9485.70040. Online ahead of print.

ABSTRACT

INTRODUCTION: Biliary stent placement is a critical palliative treatment for obstructive jaundice due to malignancies. The site, either supra-ampullary (above the ampulla of Vater) or trans-ampullary (below the ampulla of Vater), may influence complication rates which significantly impact patient outcomes. This study evaluates the infection and obstruction rates associated with these two distinct stent placement strategies.

METHODS: Data from 66 patients who underwent biliary stent placements between 2017 and 2022 at our institution were analysed. Patients were categorised into two groups based on stent placement: supra-ampullary (12 patients) and trans-ampullary (54 patients). We assessed the incidence of infection within 30 and 90 days post-procedure and in these patients evidence of radiological stent obstruction.

RESULTS: In the supra-ampullary group, infection rates were 41.67% within 30 days and 58.33% within 90 days post-procedure. The trans-ampullary group exhibited infection rates of 12.96% within 30 days and 20.37% within 90 days. Higher infection rates were observed in the supra-ampullary group at 30 days, and this difference was statistically significant (p = 0.020). The difference in infection rates at 90 days was also statistically significant (p = 0.008). In cases of infection where stent patency was investigated, radiologically confirmed stent obstructions (either stenosis or occlusion) within 90 days were not statistically significant (p = 0.296).

CONCLUSION: Supra-ampullary stent placements are associated with higher rates of post-procedural infections compared to trans-ampullary placements at both timepoints, highlighting the importance of selecting optimal stent placement strategies to reduce infection rates and improve patient outcomes.

PMID:41186121 | DOI:10.1111/1754-9485.70040

Drug Alcohol Rev. 2025 Nov 4. doi: 10.1111/dar.70062. Online ahead of print.

ABSTRACT

INTRODUCTION: Access to evidence-based treatment for opioid use disorder remains limited, particularly for individuals who have not responded to oral opioid agonist treatment (OAT). A community pharmacy-based model of injectable OAT (iOAT) was piloted in Vancouver, Canada from March 2017 to December 2018. This brief report describes the program structure, participant sociodemographics, reported outcomes, and strengths and areas for improvement of the program.

METHODS: A retrospective review of cross-sectional, interviewer-led questionnaire data from participants who accessed iOAT at the pharmacy site (n = 176) and provided informed consent was conducted. Outcomes include participant-reported changes in symptomatology, function and satisfaction, analysed through descriptive statistics. Open-ended responses were analysed using content analysis to identify strengths and areas for improvement of the program.

RESULTS: Fifty-one participants (29%) completed the questionnaire, and most had multiple previous overdoses and trials of oral OAT. The most commonly reported outcomes were reduction in illicit opioid use (76%), opioid cravings (45%) and illicit substance use (45%). Participants identified key strengths of the program as positive experiences with staff and efficiency of the pharmacy model including flexible dosing time and the ability to pick up other medications at the same time. Suggested improvements focused on medication options (e.g., access to diacetylmorphine, alternate routes of administration), expanded hours and flexibility, additional support services, and increased capacity and space.

DISCUSSION AND CONCLUSIONS: Community pharmacy-based iOAT represents a novel strategy to expand access to evidence-based opioid use disorder treatment among individuals who inject opioids and have not responded to or do not prefer oral OAT.

PMID:41186078 | DOI:10.1111/dar.70062