Annals of Biomedical Engineering
○ Springer Science and Business Media LLC
Preprints posted in the last 7 days, ranked by how well they match Annals of Biomedical Engineering's content profile, based on 37 papers previously published here. The average preprint has a 0.04% match score for this journal, so anything above that is already an above-average fit.
Dillon, T. M.; Quevedo Moreno, D.; Rutherford, E. K.; Ayers, B.; Salomon, B.; Kubi, B.; Thomas, J.; Roche, E.
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Minimally invasive endovascular procedures offer reduced surgical trauma, shorter recovery times, and improved outcomes, but rely on 2D fluoroscopic X-ray imaging, which provides limited depth perception and exposes patients and clinicians to ionizing radiation. Here we present an augmented reality (AR) system that fuses intravascular ultrasound (IVUS) and electromagnetic (EM) position tracking with preoperative computed tomography (CT) to produce an anatomically accurate, deformation-corrected navigational reference. A robotic device performs ECG-gated pullback of the IVUS probe, capturing 4D aortic motion across the cardiac cycle. We introduce a deep learning architecture for extracting vascular lumen boundaries and side-branch orifices from artifact-prone IVUS streams, and a semantically driven non-rigid CT-IVUS fusion pipeline robust to false positive landmarks. We evaluate the platform with trained surgeons in benchtop phantom studies and in-vivo ovine models, and demonstrate its application to fenestrated endovascular aneurysm repair (FEVAR). Compared to fluoroscopy alone, AR guidance significantly reduces cannulation time, radiation exposure, and cognitive workload, while improving procedural efficiency and safety. Our IVUS-EM and CT aortic datasets are released open source.
Kano, A.; Akiyama, Y.; Kamijo, Y.-I.; Hamaguchi, T.
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Distal radius fractures (DRFs) can delay return to activities of daily living and social participation because of postoperative pain, temporary joint immobilization, and limited wrist and forearm range of motion. The Ghost System developed at Saitama Prefectural University, Japan, combines visual action observation with tendon vibration stimulation and has shown potential as an adjunct to conventional rehabilitation. This Study Protocol describes a modified Ghost system intended to improve clinical implementation by replacing the head-mounted virtual reality display with iPad-based action observation and by using a wristband-type vibrator. This single-center, single-arm, open-label feasibility trial will enroll 10 adults after palmar locking plate fixation for DRF. The intervention will be delivered twice weekly during outpatient rehabilitation follow-up sessions from the early postoperative period (postoperative days 2-10 after enrollment) through the approved early postoperative rehabilitation period (generally up to postoperative week 8), in parallel with standard rehabilitation practices. Primary feasibility and preliminary clinical outcomes include device fit and acceptability, pain assessed using a 100-mm Visual Analog Scale, and wrist/forearm range of motion. Secondary implementation and safety outcomes include Disabilities of the Arm, Shoulder and Hand (DASH), Patient-Rated Wrist Evaluation (PRWE), Hand20 Questionnaire (HANDS-20), EuroQol 5 Dimensions 5 Levels (EQ-5D-5L), body ownership and hand-illusion questionnaires, setup time, setup errors, adherence, adverse events, and device incidents. We hypothesize that the modified Ghost system will be feasible and acceptable for early postoperative outpatient rehabilitation and will be delivered without serious device-related adverse events. Clinical outcomes will be summarized descriptively to inform a future controlled study rather than to establish efficacy.
Maldonado, T.; Muluk, S.; Rali, P.; Soni, N.; Nathanson, R.; Kuttab, H.; VandeHei, M.; Michels, C.; Swietlik, J.; Speranza, G.; Schaffer, O.; Collaborating Investigators Group, ; Al Noor, F.; Mischkewitz, S.; Kainz, B.; Blaivas, M.; Jacobowitz, G.
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Background: Venous thromboembolism (VTE), including deep vein thrombosis (DVT), remains a major global health burden. Diagnostic pathways rely on ultrasound but are limited by availability and prolonged time-to-imaging. Novel artificial intelligence (AI) guidance systems have been designed to enable non-ultrasound-trained operators to acquire proximal lower extremity compression ultrasounds for remote clinician interpretation. Methods: This multicenter, double-blinded, prospective, nonrandomized study evaluated the performance of an AI guidance system (ThinkSono Guidance, ThinkSono, GmbH). Patients underwent AI-guided ultrasound(s) and standard of care ultrasound(s). Primary and secondary endpoints were image quality, sensitivity and specificity for proximal DVT, and prioritization specificity, a measure of specificity in identifying patients requiring standard of care ultrasound after AI-guided scan. Results: Of 634 recruited subjects, 594 were analyzed, with 67 DVTs across 700 scans. 86.83% of AI-guided scans achieved diagnostic image quality. Triage sensitivity was 92.86%, triage specificity 39.12%, prioritization specificity 97.96%. Standard of care ultrasounds could be avoided in 35.32% of patients. Total median AI-guided scan and review time was 7.57 minutes. Conclusions: Clinician-reviewed AI-guided scans were rapid, sensitive for DVT, and specific for prioritizing patients requiring standard of care ultrasounds. These findings suggest AI-guided ultrasound may be a scalable triage strategy to expand DVT evaluation access, particularly in resource-constrained and after-hours settings
Lee, Y.; Rodway, A. D.; Maytham, G. D.; Ntagiantas, N.; Walton, I.; Pazos-Casal, F.; Allan, C.; Brodmann, M.; Schlager, O.; Harris, J.; Heiss, C.
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Background: The clinical benefit and safety of drug-coated devices in chronic limb-threatening ischemia remain debated, particularly after recent randomized evidence questioning paclitaxel-coated technologies. We evaluated wound healing, limb outcomes, and mortality after infrainguinal endovascular therapy with uncoated, paclitaxel-coated, and sirolimus-coated devices. Methods: Consecutive patients with chronic limb-threatening ischemia undergoing successful infrainguinal endovascular therapy in a prospective single-center service evaluation were analyzed. The primary exposure was use of any drug-coated device during the index procedure. Inverse probability of treatment weighting and multivariable Cox models were used to adjust for baseline differences. Exploratory analyses compared paclitaxel-coated, sirolimus-coated, and uncoated devices. Results: Among 341 patients, 244 (71.6%) received at least one drug-coated device. After weighting, drug-coated device use was associated with more frequent wound healing, whereas major amputation, clinically driven target lesion revascularization, major adverse limb events, and death did not differ significantly between groups. In weighted multivariable models, drug-coated device use remained associated with wound healing (HR, 1.86; 95% CI, 1.14?3.02), but not with mortality or major limb events. Exploratory drug-specific analyses suggested the highest wound-healing rates among patients treated with sirolimus-coated devices, while mortality was comparable between paclitaxel-coated and uncoated devices. Conclusion: In this real-world cohort of patients with chronic limb-threatening ischemia undergoing infrainguinal endovascular therapy, drug-coated device use was not associated with increased adjusted 1-year mortality and was associated with improved wound healing. Exploratory analyses suggested favourable wound-healing outcomes with sirolimus-coated balloons, with a lower observed mortality signal that warrants confirmation in larger comparative studies.
Pasyar, P.; Mei, K.; Im, J. Y.; Roshkovan, L.; Geagan, M.; Noël, P. B.
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ABSTRACT Background: Metallic implants such as orthopedic screws, prostheses, and dental hardware produce beam-hardening, photon-starvation, and streak artifacts that degrade computed tomography (CT) image quality, and the metal artifact reduction (MAR) methods developed to mitigate them require objective, reproducible benchmarking. Purpose: Objective evaluation of MAR algorithms in CT is hindered by the absence of phantoms that simultaneously provide anatomically realistic backgrounds, embedded implants of known geometry, and controllable, ground-truth--referenced artifact intensity. We present a dual-filament, voxel-level three-dimensional (3D) printing method that fulfills these requirements and demonstrate its capabilities on a clinically representative cervical spine case with embedded orthopedic spinal screws. Methods: The proposed method extends the PixelPrint framework, a fused-deposition-modeling (FDM) workflow that converts clinical Digital Imaging and Communications in Medicine (DICOM) data directly into 3D-printer Geometric code (G-code) without intermediate segmentation or surface meshing, to interleaved, voxel-level deposition of two filaments: a calcium-doped polylactic acid (PLA) for soft tissue and bone, and a higher-attenuation metal-doped PLA for metallic implants. For demonstration, anonymized DICOM data of a healthy cervical spine were used to design and fabricate three matched phantoms, each with six embedded spinal screws at C4--C6: a 0% metal-infill ground-truth phantom, a 50% medium-metal-infill phantom, and an 85% high-metal-infill phantom. All phantoms were scanned on a clinical spectral CT system at 120 kVp and 1000 mAs, reconstructed at 0.67 mm slice thickness with virtual monoenergetic imaging (VMI) across 50--190 keV. Method performance was characterized by region of interest (ROI)-based Hounsfield Unit (HU) agreement with the source patient data and by the noise-independent Gumbel-distribution p-index metric. Results: The dual-filament method reproduced patient anatomy, soft-tissue contrast, and screw geometry with high fidelity. ROI HU values agreed with patient data within {+/-}25 HU for soft tissue and trabecular bone; cortical regions were underestimated owing to the current ceiling of the calcium-doped PLA used in this study. The tunable-artifact behavior was quantified as follows: the Gumbel location parameter scaled monotonically from 46.7 HU (no-metal background) to 57.1 HU (50% infill) to 90.5 HU (85% infill) for the VMI 70 keV with standard filter. High-keV VMI reconstructions substantially reduced streak and beam-hardening artifacts while preserving anatomic detail. Conclusions: The proposed dual-filament, voxel-level PixelPrint method enables the fabrication of patient-specific, multi-material CT phantoms with embedded metallic implants and controllable, ground-truth--referenced artifact intensity. Although demonstrated here in a single cervical-spine case, the workflow is anatomy- and implant-agnostic by construction and could in principle be adapted to other musculoskeletal sites (e.g., knee, hip, dental) and implant materials, providing a reproducible methodological foundation for benchmarking MAR algorithms, characterizing spectral CT performance, and validating emerging photon-counting detector systems. Keywords: 3D printing methodology; fused deposition modeling; voxel-level multi-material printing; spectral computed tomography; metal artifact reduction; phantom design; orthopedic implants; dual filament; PixelPrint.
Chandra, P.; Sharma, Y. P.; Kapoor, R.; Singhal, R.; Patel, P.; Jena, A.; Tiwari, D. K.; Mody, R.; Ali, A.; Kapoor, A.; Sharma, P.; Kumar, V.; Sharma, K.; Chopra, V.; Kharche, M. N.; Kataria, V.; Dani, S.; DAVIDSON, D.; Agarwal, R.; Kapardy, P.; Gupta, R.; Ainchwar, R.; Mehta, A.; Khan, A.; Arneja, J.; Kastrati, A.
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Aims Polymer-free drug-eluting stents were developed to enhance vascular biocompatibility and safety while maintaining antirestenotic efficacy. The TRANSEVER registry evaluated 12-month clinical outcomes of the polymer-free everolimus-eluting ISAR SUMMIT stent in a large, real-world population undergoing percutaneous coronary intervention. Methods This prospective, multicentre study enrolled patients with coronary artery disease undergoing PCI with the ISAR SUMMIT stent across 33 centres in India. The primary endpoint was target-lesion failure (TLF) at 12 months, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularisation. Secondary endpoints included the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, stroke, revascularization, and definite/probable stent thrombosis. Results A total of 1,000 patients were enrolled, of whom 996 completed 12-month follow-up. The cohort presented with a high-risk profile, including an acute coronary syndrome (ACS) in 89.8% of the cases and diabetes mellitus in 44.4% of them. Procedural outcomes were excellent in terms of device success and final TIMI 3 flow (achieved in all treated lesions). At 12 months, TLF occurred in 15 patients (1.5%). Definite or probable stent thrombosis was observed in 8 patients (0.8%). POCE was observed in only 21 patients (2.1%). Conclusions In this large, contemporary real-world population with a very high proportion of patients presenting with ACS, the polymer-free everolimus-eluting ISAR SUMMIT stent demonstrated favourable 12-month clinical outcomes, with low rates of target lesion failure and stent thrombosis. These results suggest that this novel device is both safe and effective for routine clinical use.
Rivera, J.; Zhou, Y.; Sak, L.; Pudewa, F.; Lee, J.; Yamamoto, M. T.; Yoo, H.; Lum, M.; Zhang, M.; Patel, A.; Vandenberghe, L. E.; Fenn, S. K.; Wang, Y.; Bailey, B.; Holley, S. M.; Vivas, A. C.; Holly, L. T.; Lu, D. C.
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Objective: Photobiomodulation therapy has emerged as a promising modality to facilitate scar healing and pain management in dermatology and plastic surgery. However, its role in postoperative care following spine surgeries remains understudied. This double-blinded, placebo-controlled study aimed to investigate the effects of photobiomodulation in patients with chronic lower back pain undergoing lumbar decompression, with postoperative wound healing as the primary outcome and pain reduction and functional recovery as secondary outcomes. Methods: Patients were randomized to receive either active photobiomodulation braces (N=13) or placebo braces (N=12). Follow-up assessments were performed at 2, 4, 6, 8, and 12 weeks postoperatively. Outcomes included wound healing (Stony Brook Scar Evaluation Scale), back and leg pain (Visual Analog Scale), quality of life (EuroQol 5D), and functional status (Oswestry Disability Index). Results: Compared to the placebo group, the photobiomodulation treatment group had a 4.12-fold cumulative improvement in final scar scores, with significant between-group differences at postoperative weeks 6, 8, and 12 (p = 0.0062, 0.010, 0.042). Among patients with severe preoperative disability, treatment resulted in a 1.89-fold faster improvement in back pain (p=0.025) and a 1.80-fold faster improvement in ODI scores (p=0.025); and superior treatment effect on wound healing were again observed at weeks 6, 8, and 12. Among patients with poor initial scars, treatment led to a significantly better scar outcome than placebo at week 6 and a 1.94-fold faster EQ5D improvement (p=0.052), with significant gains observed as early as two weeks after surgery. There were no adverse events associated with photobiomodulation treatment. Conclusions: Photobiomodulation significantly promoted postoperative wound healing following lumbar decompression surgery, with therapeutic benefits preserved even in patients with poor baseline scar scores and functional impairment. This indicates that the efficacy of photobiomodulation is not limited by the initial scar condition or disability, supporting its broad clinical applicability. Additionally, patients with severe preoperative disability experienced greater benefits from photobiomodulation than placebo, including faster reduction in back pain and more rapid improvement in functional capacity, highlighting its role in postoperative pain management and rehabilitation. These therapeutic effects are likely mediated by photobiomodulation-induced reduction of inflammation and enhancement of tissue repair. Together, this study suggests that photobiomodulation can be a promising adjunct therapy to facilitate postoperative recovery in patients undergoing spine surgery.
Yao, Y.; Li, Y.; Xiong, T.; Wang, J.; Jiang, W.; Peng, Y.; Wei, J.; He, S.; Zhao, Z.; Wei, X.; Li, X.; Meng, W.; Feng, Y.; Chen, M.
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Background: Bicuspid aortic valve anatomy increases procedural complexity during transcatheter aortic valve implantation, yet outcome-oriented anatomic risk stratification for intraprocedural events remains limited. Aims: We aimed to develop and externally validate an anatomy-driven score to predict a composite intraprocedural endpoint, assessed at exit from the procedure room, in bicuspid transcatheter aortic valve implantation. Methods: Consecutive patients with bicuspid aortic valve undergoing transcatheter aortic valve implantation were analysed in a development cohort (N=793) and a multicentre external validation cohort (N=134). Candidate preprocedural computed tomography and echocardiographic variables were prespecified by expert consensus and refined using penalized regression with bootstrap stability selection within a domain-constrained framework. A five-indicator score (0 to 10 points) was derived from routine imaging metrics spanning the ascending aorta, aortic root, valve complex, annulus-outflow tract unit, and left ventricle, and tested using multivariable logistic regression. Results: The composite intraprocedural endpoint occurred in 101/793 (12.7%) patients in the development cohort, with stepwise increases across risk strata (7.2%, 13.3%, 30.6%; p<0.001). Each 1-point increase was independently associated with higher risk (odds ratio 1.32; 95% confidence interval 1.18-1.47). A similar gradient was observed in external validation (3.1%, 10.8%, 50.0%; p=0.012; odds ratio 1.55 per point), with a C-statistic of 0.725. Higher risk categories were associated with lower early safety and higher 30-day and 1-year mortality. Conclusions: An anatomy-driven score derived from routine preprocedural imaging demonstrates graded discrimination of intraprocedural risk and may inform procedural planning in bicuspid transcatheter aortic valve implantation.
Blackman, B.; Fahey, N.; Dolan, S.; O'Reilly, M. K.; Cassidy, J. T.
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Abstract Introduction: Proximal humerus fractures account for approximately 5-6% of all adult fractures and are primarily managed nonoperatively. Healing is conventionally monitored with radiographs, with radiopaque callus formation indicating healing. Visible radiographic callus appears weeks after biological union begins. Ultrasound provides a dynamic, radiation-free, and cost-effective method that can detect early callus formation before x-ray visibility. Although ultrasound has demonstrated utility for fracture healing in the clavicle and humeral shaft, its role in proximal humerus fractures remains unclear. Methods: This single-centre prospective study will be conducted in two phases. The pilot phase will measure inter-rater reliability for ultrasound detection of early callus formation at 2 and 4 weeks post-injury. Ten patients with proximal humerus fractures treated nonoperatively will undergo standardized anterior and lateral scans. Each patient will generate four saved images (short- and long-axis views), producing forty anonymized images independently reviewed by two raters. The prospective cohort phase will recruit approximately thirty additional patients. Results: Reliability will be quantified using Cohens kappa. A power calculation will be performed after pilot analysis. Results from the prospective cohort phase will help determine the association and predictive value of early ultrasound-detected bridging callus for radiographic and clinical union at three and six months. Patient reported outcome measures will be assessed using the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire. Discussion: This study will develop and validate a standardized ultrasound protocol for assessing early fracture healing in proximal humerus fractures. By establishing both inter-rater reliability and predictive value, the findings may support ultrasound as a reproducible, radiation-free adjunct to conventional imaging and enable earlier identification of union status.
zhang, y.; chen, w.; li, x.; shen, w.
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Objective To develop and validate a risk model for predicting postoperative bleeding in patients with thyroid cancer. Methods A total of 2800 consecutive patients diagnosed with thyroid cancer in the Department of Thyroid and Breast Surgery of the Affiliated Hospital of Xuzhou Medical University between January 2020 and December 2023 were retrospectively analyzed. Patients were categorized into two groups based on postoperative bleeding occurrence: bleeding and non-bleeding groups. Univariate and multivariate logistic regression analyses were utilized to screen independent risk factors. Meanwhile, risk prediction models were developed and nomogram . Subgroup analysis was performed to identify independent risk factors. The predictive effects of the models were assessed using the Hosmer-Lemeshow test and receiver operating characteristic (ROC) curves. Results Of the 2800 recruited patients, 50 had postoperative bleeding, with an incidence rate of 1.7%. Multivariate logistic regression analysis showed that age, hypertension, total thyroidectomy, tumor size [≥]4 cm, and operation time [≥]90 min were the risk factors for postoperative bleeding in thyroid cancer patients (P<0.05). A risk prediction model was established based on the above factors, and the area under the ROC curve was 0.881, with a sensitivity of 94.0%, a specificity of 67.3%, and an accuracy of 74.0%. Decision curve analysis revealed that the model had good predictive ability. Conclusions The constructed risk prediction model has good predictive power and can provide a reference for healthcare professionals to predict the risk of bleeding in patients after thyroid cancer surgery.
Farrow, E.; Balachandran, R.; Embleton, R.; Krogh, K.; Vollebregt, P. F.; Cornish, J.; Christensen, P.
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Aims To develop the Bowel Irrigation Questionnaire (BIQ), a patient-reported experience measure (PREM) designed to assess the user experience of transanal irrigation (TAI). Methods Statements were generated through literature review and qualitative interviews with healthcare professionals (HCPs) and product users. Statements were rated on a 6-point content validity index scale through an international three-round online Delphi survey by 20 expert panel members. Consensus attainment was defined based on percentage agreement, statements which did not meet consensus were discussed at a final international online consensus meeting. The content validity of the PREM was evaluated through cognitive interviews and the Questionnaire on Questionnaires (QQ-10). Reliability was assessed using a test-retest design, where users completed the BIQ on two occasions one week apart. Results 215 statements were generated from 9 multi-disciplinary qualitative interviews and literature review. Statements were refined to reduce repetition and ensure clarity. 73 statements grouped into 11 domains were reviewed through the Delphi survey. Following the Delphi survey and clinical consensus meeting, the preliminary BIQ consisted of 15 items. Six cognitive interviews were conducted, resulting in a finalised BIQ of 16 items. 32 product users completed both the QQ-10 and test-retest study, the results of which demonstrated good content validity and temporal stability respectively. Conclusions The Bowel Irrigation Questionnaire is a novel PREM designed to assess the user experience of TAI in both clinical and research settings. The instrument demonstrates good validity, acceptability and temporal stability, supporting its use as a reliable measure of patient experience.
Mantle, O.; Smith, B. G.; Whiffin, C.; Hobbs, L.; Penmetcha, V.; Menon, A.; Venturini, S.; Bashford, T.; Hutchinson, P. J.
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Background Traumatic brain injury (TBI) affects 69 million individuals globally each year, yet care remains fragmented across complex, multi-specialty pathways and settings. Digital health technologies offer potential to bridge care gaps, particularly in resource-limited settings, yet existing frameworks do not adequately address the complexities of the TBI care pathway or the diverse global contexts in which care occurs. Methods A cross-sectional qualitative study using critical realist-informed thematic analysis was conducted with practising neurosurgeons recruited internationally via National Institute for Health and Care Global Health Research Group on Acquired Brain and Spine Injury (NIHR ABSI) collaborating centres, social media, and society newsletters. Semi-structured interviews were conducted by a single researcher (OM) via Microsoft Teams (March-July 2024), exploring technology availability, healthcare infrastructure, clinical pathways, and contextual challenges, with a systems thinking approach guiding identification of current and potential technology integration points. Fourteen neurosurgeons from twelve countries participated, representing six lower-middle, two upper-middle, and four high-income countries. Results Six inductive themes emerged: Availability, Acceptability, Applicability, Capability, Feasibility, and Possibility- forming a novel conceptual framework visualised as a hexagonal chart for guiding digital health technology design and implementation in TBI care. Marked disparities in technology availability and utilisation were identified across urban/rural settings and income levels. Conclusions This framework offers a practical, context-sensitive tool for researchers, policymakers, and clinicians developing or implementing digital health technologies in TBI care globally. Visualisation in a similar style to a radar-chart enables simultaneous consideration of factors- including digital literacy, infrastructure, and cultural attitudes- whose neglect frequently underlies implementation failures.
Di Giovanni, D. A.; Tanaka, A.; Horikoshi, T.; Tsuboyama, T.; Yokota, H.; Zakarian, R.; Matsumoto, Y.; Vallieres, M.; Reinhold, C.
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Purpose: To compare the cross-site generalization of radiomic features and deep learning embeddings for MRI prediction of substantial lymphovascular space invasion (LVSI) in endometrial cancer. Materials and Methods: This retrospective two-center study included 206 women (mean age, 59.8 years) with endometrial cancer who underwent preoperative 3-T MRI from March 2016 to March 2023. Hospital A (n = 130) was used for development and Hospital B (n = 76) for strict external testing. T2-weighted, reduced field-of-view diffusion-weighted, and apparent diffusion coefficient images were manually segmented. Radiomic features and seed-pooled embeddings from 3D ResNet18, DenseNet121, and U-NEXtractor were modeled with elastic-net logistic regression or XGBoost. Out-of-fold Platt calibration and sensitivity-targeted thresholds were estimated using development data only. AUCs were summarized with 95% bootstrap confidence intervals. Results: External radiomics with elastic-net achieved an AUC of 0.609 (95% CI: 0.464, 0.740) and sensitivity of 0 of 12 (0%). DenseNet121 with elastic-net had the highest external AUC (0.685; 95% CI: 0.538, 0.822) but sensitivity of 3 of 12 (25%). U-NEXtractor with elastic-net detected 10 of 12 positive cases (83.3%) with specificity of 32 of 64 (50.0%) and balanced accuracy of 0.667. XGBoost showed higher apparent development performance but weaker external operating behavior. Conclusion: Under real-world cross-site MRI acquisition shift, DenseNet121 and U-NEXtractor embeddings showed better external generalization than handcrafted radiomic features for substantial LVSI prediction.
Kumbhani, D. J.; batchelor, w.; Cleveland, J. C.; Manandhar, P.; Kosinski, A.; Kapadia, S. R.; Ailawadi, G.; Fontana, G.; Pop, A. M.; Girotra, S.; de Lemos, J. A.; Carroll, J. D.; Brindis, R.; Kaneko, T.; Thourani, V.; Yeh, R. W.; Vora, A. N.; Mack, M. J.; Badhwar, V.; Mehran, R.; Vemulapalli, S.
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Background: Prior analyses have demonstrated an inverse association between transcatheter aortic valve replacement (TAVR) procedural volume and short-term outcomes. However, less is known regarding the relationship between procedural volume and 1-year outcomes in the contemporary TAVR era. Objectives: To evaluate the association between annual hospital and operator TAVR procedural volumes and 1-year clinical outcomes in a contemporary national cohort. Methods: Clinical records from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapies (TVT) Registry for patients undergoing commercial TAVR between January 2020 and December 2022 were linked to Centers for Medicare & Medicaid Services administrative claims. Annualized hospital and operator TAVR volumes were modeled continuously and categorized into tertiles. Primary outcomes included 1-year all-cause mortality, stroke, the composite of mortality or stroke, and all-cause readmissions. Hierarchical risk-adjusted models accounting for patient clustering within sites were used to evaluate associations between procedural volume and outcomes. Results: Among 215,335 patients undergoing TAVR at 788 hospitals by 3,444 operators between 2020 and 2022, median annual hospital and operator volumes were 74 (IQR: 43-115) and 16 (IQR: 10-32), respectively. Volume was then categorized into tertiles (low, medium and high). Compared with high-volume hospitals ([≥]102/year), low-volume hospitals ([≤]52/year) had higher adjusted rates of 1-year all-cause mortality (Odds Ratio (OR): 1.10 [95% CI: 1.05-1.16]), stroke (OR: 1.10 [95% CI: 1.01-1.19]), mortality or stroke (OR: 1.10 [95% CI: 1.05-1.15]), and all-cause readmissions (OR: 1.05 [95% CI: 1.00-1.09]). Compared with high-volume operators ([≥]25/year), low-volume operators ([≤]11/year) had higher adjusted rates of stroke (OR: 1.16 [95% CI: 1.05-1.28]) and mortality or stroke (OR: 1.09 [95% CI: 1.03-1.15]) but not other endpoints. Conclusions: In a large, contemporary national TAVR registry, lower annual hospital ([≤] 52/year) and operator ([≤] 11/year) procedural volumes were independently associated with worse 1-year clinical outcomes. These findings suggest that procedural experience continues to influence outcomes despite maturation of contemporary TAVR practice.
Niazi, U.; Roberts, C. A.; McDonnell, D.; Goss, V. M.; Afolabi, P. R.; Swann, J. R.; Byrne, C. D.; Griffiths, G. O.; Hamady, Z. Z.
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Background: Early detection of pancreatic ductal adenocarcinoma (PDAC) is critical. While faecal elastase-1 (FE-1) is a standard clinical marker for pancreatic function, its diagnostic accuracy for malignancy is limited. We sought to identify plasma metabolites that enhance FE-1 performance in symptomatic "at-risk" patients. Methods: Using the DEPEND cohort (CRUK C45617/A29908), plasma metabolomics was performed on patients with resectable PDAC (n=23) and healthy volunteers (n=24). Predictive modelling included feature selection and cross-validation, with further validation in an independent external cohort. Results: Citrulline was identified as significantly depleted in PDAC patients across discovery and validation cohorts. In isolation, Citrulline achieved an AUC of 0.86 (internal) and 0.88 (external validation). Standalone FE-1 demonstrated an AUC of 0.67. However, combining Citrulline and FE-1 significantly improved diagnostic performance, achieving a combined AUC of 0.96. Stratification revealed distinct metabolomic signatures associated with poorly differentiated tumours, suggesting a link to histological grade. Conclusions: Integrating Citrulline with FE-1 testing substantially improves PDAC detection in symptomatic patients. This non-invasive panel offers high diagnostic potential, though prospective validation is required to establish clinical cut-offs for routine practice.
Jenkins, R. P.; Fu, X.; Waise, S.; Dewan, M.; Griffin, C.; Stuttle, C.; Cruickshank, C.; Dearnaley, D.; Syndikus, I.; Hall, E.; Sahai, E.; Wilkins, A.
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Background: Changes in the extracellular matrix (ECM) are a recognised feature of aggressive prostate cancer, but they are not exploited in clinical decision-making. We aimed to develop automated quantitative ECM parameters to facilitate risk stratification for localised prostate cancer. Methods: 378 quantitative ECM parameters were derived from picrosirius red-stained diagnostic prostate biopsies in a cohort of 422 patients, matched 1:1 for recurrence, recruited to the CHHiP (Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer) trial of radiotherapy fractionation for localised prostate cancer. These ECM parameters comprehensively described fibre architecture, gaps and ECM texture. Machine learning models at the level of both individual image tiles and patients defined how ECM parameters related to tumour versus normal prostate, Gleason grade group and recurrence. Shapley analysis was used to interpret ECM feature importance and develop signatures associated with recurrence. Results: Specific ECM patterns identified tumour versus normal prostate, Gleason pattern 4 versus 3 and recurrence. ECM patterns associated with recurrence were enriched in Gleason 4+3 patients, versus Gleason 3+4 patients. Shapley analysis revealed that biopsies from patients with recurrence had smaller more elongated gaps between fibres, with finer grained ECM texture and lower ECM homogeneity than less recurrent regions. Interpretation: Quantitative automated analysis of ECM architecture can inform probability of prostate cancer recurrence after radiotherapy; Features relating to ECM gap size and texture are of particular relevance.
Iqbal, M. A.; Alsolivany, J.; Ferdowssian, K.; Mertens, R.; Sprünken, E. D.; Wessels, L.; Vajkoczy, P.; Acker, G.; Hecht, N.
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Background: Sex differences in cerebrovascular disease are established determinants of outcome in acute stroke care and vascular interventions, but evidence in cerebrovascular bypass surgery remains limited. This study examined whether biological sex was associated with outcome after superficial temporal artery to middle cerebral artery (STA-MCA) bypass in patients with atherosclerotic cerebrovascular disease (ACVD). Methods: We retrospectively screened adults undergoing extracranial-to-intracranial (EC-IC) bypass (2012?2025) and included ACVD patients treated by STA-MCA bypass with available follow-up. The primary outcome was modified Rankin Scale (mRS) at latest follow-up, analyzed using proportional odds regression. Multivariable models adjusted for age, preoperative mRS, and vascular comorbidities. Cerebrovascular reserve capacity (CVRC) was analyzed in a subgroup. Results: A total of 140 patients (30.7% female) were included. Disease morphology varied by sex, with more multivessel (65.1% vs. 47.4%) and stenotic disease (39.5% vs. 20.6%) in females and more isolated internal carotid artery occlusion in males (43.3% vs. 16.3%). The 30-day risk of symptomatic ischemic stroke was higher in females than in males (9.3% vs. 1.0%). A similar pattern was observed at follow-up (median 13.5 months), with ischemic events predominating in females (16.3% vs. 7.2%) and hemorrhagic events occurring exclusively in males (5.2%). Female sex was independently associated with worse functional outcome (OR 2.59, 95% CI 1.28?5.30, p=0.008). Preoperative mRS was the strongest determinant of outcome (OR 4.30, 95% CI 3.07?6.18, p<0.001). Adjusted analysis detected no significant association between CVRC and outcome (OR 0.80, 95% CI 0.24?2.70, p=0.721). Conclusions: Female sex was independently associated with worse functional outcome after STA-MCA bypass, independent of preoperative functional status, hemodynamic impairment and cardiovascular comorbidities. These findings identify sex as a clinically relevant determinant of outcome in cerebrovascular bypass surgery and should be considered in future risk stratification and trial design.
Robinson-Smith, L.; Jafari, M.; Kottam, L.; Clark, N.; Rangan, A.; Adamson, J.
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Introduction Adolescent idiopathic scoliosis (AIS) requires frequent x-rays for management, exposing young patients to cumulative radiation risks. While radiation-sparing imaging modalities exist, access across the National Health Service (NHS) remains uneven and information given to patients is variable. This qualitative study investigated the systemic, geographic, and interpersonal dynamics of AIS imaging in England. Design This qualitative study employed in-depth semi-structured interviews with healthcare professionals (HCPs) from NHS paediatric spinal centres, patients aged 13 to 25 years old with AIS and parents/carers of young people with AIS. Setting England. Participants A total of 22 HCPs from 13/24 NHS paediatric spinal centres in England, 19 10-25 years with AIS and 11 parents/carers. Results Conventional x-ray remains the main imaging modality. Significant geographic inequality exists. The most commonly available radiation-sparing imaging modality available is the EOS system, which uses slot-scanning technology, is available at 7 centres in England, primarily in London imaging networks. Acquisition of EOS systems is currently driven by local charitable funding rather than a centralised strategy, with high capital and installation costs cited as primary barriers. Inconsistent knowledge of imaging within primary care and a lack of specialist expertise in local secondary care services led to diagnostic redundancy, gatekeeping, and low value inconsistent imaging. These systemic delays frequently closed the window for conservative treatments like bracing. A professional balancing act exists between the duty to inform and the desire to minimise patient anxiety. HCPs often use selective communication regarding radiation risks. Conversely, families demonstrate high relational trust with HCPs and low baseline knowledge of cumulative exposure, often viewing frequent imaging as a reassuring marker of clinical progress. In centres with EOS systems, clinicians felt empowered to lead proactive, transparent risk discussions. In standard X-ray settings, dialogue remains reactive and infrequent, leading to a reliance on implied rather than truly informed consent. Conclusions AIS imaging in England is variable. Geographic location dictates access to low-dose radiation technology and the quality of informed consent. Systemic inefficiencies and fragmented referral pathways contribute to diagnostic redundancy and delayed specialist care. National standardisation of clinical pathways, information provision and a centralised strategy for low-dose technology procurement are essential to eliminate structural inequalities and ensure equitable, transparent care for all patients.
Glavas, D.; Makoudjou, M. A.; Melis, G.; Bernardele, L.; Paolocci, N.; Scarpa, M.; Agrimi, J.; Spolverato, G.
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ABSTRACT Background: Despite its high prevalence and established impact on women's health, the long-term biological effects of Intimate Partner Violence (IPV) remain poorly understood. In particular, its potential role in increasing cancer risk has received limited attention. This review examines whether IPV may be associated with elevated cancer risk in women. Methods: We conducted a systematic review and meta-analysis in accordance with PRISMA and MOOSE guidelines to evaluate whether IPV may be associated with cancer risk. Eligible studies included adult women ([≥]18 years) with documented IPV exposure and cancer or precancerous outcomes. We searched PubMed, Web of Science, Scopus, and Google Scholar for articles published from 2000 to 2025. Study quality was assessed using the Newcastle-Ottawa Scale (NOS). A random-effects meta-analysis was performed on longitudinal studies reporting adjusted risk estimates. Results: Thirteen studies were included in the qualitative synthesis, but only two met criteria for meta-analysis, both reporting on cervical cancer. The pooled odds ratio was 3.00 (95% CI: 2.05 - 4.38; I2 = 0%). A separate pooled prevalence analysis of six retrospective studies showed that 32.2% of women with cancer reported a lifetime history of IPV. Study quality ranged from low to high. Conclusions: This review underscores the limited and heterogeneous nature of the existing evidence on IPV as a potential cancer risk factor. While preliminary findings suggest a possible association, particularly with cervical cancer, the scarcity of high-quality longitudinal studies and the methodological variability in the studies reviewed prevent definitive conclusions regarding causal linkage. Further research, particularly prospective and mechanistic studies, is needed to clarify the relationship between IPV and oncogenesis across different cancer types and to identify underlying biological pathways.
Su, Z.; Li, T.
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The therapeutic landscape for hepatocellular carcinoma (HCC) is evolving rapidly, necessitating scalable approaches to synthesize the expanding scientific literature. We characterized thematic shifts in HCC treatment and prognosis research by conducting a retrospective bibliometric analysis of influential publications from 2023 and 2024. Using the OpenAlex database, we identified the 50 most highly cited papers from each year based on eighteen-month post-publication citation counts. Large language models were deployed to extract, normalize, and classify concepts from unstructured text into canonical topics and parent themes, enabling quantitative year-over-year frequency comparisons. Analysis of these 100 papers revealed a distinct maturation in research focus. Although broad categories like general immunotherapy remained prevalent, their relative frequency declined in favor of specific dual immune checkpoint regimens, notably CTLA-4 inhibition and the durvalumab plus tremelimumab combination. Concurrently, parent themes related to radiomics, imaging, and health systems exhibited significant growth in the 2024 cohort. These findings demonstrate a thematic transition in high-impact HCC research from foundational immuno-oncology toward optimized combination therapies and precision diagnostics. Furthermore, this study highlights the utility of artificial intelligence-driven bibliometrics for objectively tracking dynamic conceptual shifts in oncology. A web interface for exploring the data is available at https://pri.pepkio.com/.