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Journal of Biomechanics

Elsevier BV

Preprints posted in the last 7 days, ranked by how well they match Journal of Biomechanics's content profile, based on 64 papers previously published here. The average preprint has a 0.05% match score for this journal, so anything above that is already an above-average fit.

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Effect of Match-Play Fatigue on Muscle Stiffness and Explosive Force Asymmetries in Soccer Players Post-Anterior Cruciate Ligament Reconstruction

Bari, M. H.; Bhalli, A. Z.; Sattar, H.

2026-07-21 sports medicine 10.64898/2026.07.18.26357476 medRxiv
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ABSTRACT Background: Athletes who return to soccer after anterior cruciate ligament reconstruction (ACLR) remain at elevated risk of secondary injury despite meeting conventional discharge criteria, and neuromuscular deficits in the reconstructed limb are known to be exposed by fatigue. Objective: To determine whether match-play fatigue differentially affects muscle stiffness, countermovement jump (CMJ) force symmetry, and rate of force development (RFD) asymmetry between soccer players with a history of ACLR and uninjured teammates. Methods: A prospective, cross-sectional, matched-control study enrolled 128 competitive soccer players (64 ACLR, 6-22 months post-surgery; 64 uninjured controls) across five recruitment waves (February-June 2026). Bilateral CMJ peak vertical force, jump height, RFD, and myotonometric stiffness of the rectus femoris (RF), vastus medialis (VM), and biceps femoris (BF) were recorded immediately before and after a standardized competitive match. Fatigue was quantified from second-half heart rate (percentage of age-predicted maximum) and end-match rating of perceived exertion (RPE). Within-group pre-to-post changes were evaluated with paired t-tests, between-group differences in the magnitude of change with independent-samples t-tests, and associations between fatigue indices and asymmetry changes with Pearson correlations. Results: Match play reduced CMJ limb symmetry index (LSI) in both groups, but the decline was more than three-fold greater in the ACLR group, 92.6% (SD 5.4%) to 85.1% (SD 7.1%), than in control group, 97.3% (SD 3.9%) to 95.0% (SD 4.2%), group-by-time difference, p < 0.001, (d = 0.64). RFD asymmetry approximately doubled in the ACLR group, 10.6% (SD 4.1%) to 17.6% (SD 6.5%), compared with a smaller rise in control group, 4.6% (SD 2.4%) to 6.3% (SD 3.7%); p < 0.001, d = 0.77). Involved-limb stiffness losses in the ACLR group exceeded those of controls for the RF (-21.2 vs. -9.2 N/m, p < 0.001), VM (-17.7 vs. -6.1 N/m, p < 0.001), and BF (-13.3 vs. -6.6 N/m, p < 0.001), whereas uninvolved-limb stiffness losses did not differ between groups (all p > 0.05). Fatigue markers (heart rate, RPE) were not significantly correlated with the magnitude of individual asymmetry change (|r| [&le;] 0.18, p > 0.15). Conclusions: In competitive soccer players 6-22 months after ACLR, match-play fatigue selectively compromises stiffness and explosive force output of the reconstructed limb, widening inter-limb asymmetries beyond what is seen in uninjured teammates, even though global cardiovascular and perceptual fatigue were comparable between groups. These findings suggest that return-to-sport testing performed only in a rested state may underestimate residual neuromuscular deficits, and support fatigue-inclusive assessment protocols before athletes are cleared for unrestricted competition. Abbreviations: ACL: anterior cruciate ligament, ACLR: anterior cruciate ligament reconstruction, BF: biceps femoris, CMJ: countermovement jump, HRmax: maximum heart rate, LSI: limb symmetry index, RF: rectus femoris, RFD: rate of force development, RPE: rating of perceived exertion, RTS: return to sport, VM: vastus medialis, SD: standard deviation. Keywords: Anterior cruciate ligament reconstruction, muscle fatigue, muscle stiffness, countermovement jump, limb symmetry index, rate of force development, soccer, return to sport.

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Toward precision rehabilitation in adolescent mild traumatic brain injury: leveraging physiologic data from commercially available smartwatches to identify patient subgroups

Kettlety, S. A.; Akrong, E. R.; Suskauer, S. J.; Roemmich, R. T.; Slomine, B. S.; Svingos, A. M.

2026-07-17 pediatrics 10.64898/2026.07.16.26358245 medRxiv
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Autonomic dysfunction is a common sequela of mild traumatic brain injury (mTBI). Physical activity progression is an integral component of mTBI rehabilitation, particularly in addressing autonomic dysfunction. However, clinicians often rely on point-in-time evaluation of orthostatic and exercise intolerance to guide activity recommendations. Commercially available wearable devices (e.g., Fitbits) provide an opportunity to evaluate heart rate response to activity in a real-world setting. Previous work has used physiologic (heart rate) and activity (step count) data to identify subgroups of adults with stroke that may be used to guide activity recommendations. This method may be useful to subgroup youth post-mTBI to identify those who have abnormal physiologic responses to activity. We aimed to identify subgroups using heart rate and step count data in adolescents presenting for specialty care after diagnosed mTBI. Eighty participants aged 13-18 within six months of mTBI diagnosis were recruited to wear a Fitbit Sense 2. Data from seven days and two nights collected within fourteen days of enrollment were included. A group-based steps per minute (SPM) threshold (25th percentile; 10 SPM) and individualized heart rate threshold (20% heart rate reserve (HRR)) were used to classify each minute of active daytime data into one of four quadrants: SPM>10 & HRR>20% (QI), SPM<10 & HRR>20% (QII), SPM<10 & HRR<20% (QIII), and SPM>10 & HRR<20% (QIV). We used percentage of minutes in each quadrant, mean steps per day, percentage of minutes with zero steps, mean SPM in QI, and resting heart rate in a k-means clustering algorithm to identify subgroups. We evaluated subgroup differences by clustering variables using Kruskal-Wallis tests. Sixty-one participants were included. Three subgroups emerged: Sedentary (n=12), Active (n=23), and Atypically Elevated Heart Rate (AEHR; n=26). Subgroups varied significantly on all clustering variables (p<0.01). The Active subgroup took a high number of steps per day, had lower sedentary time, and had the highest activity intensity (mean SPM in QI). The Sedentary subgroup took fewer steps per day compared to the Active subgroup, had high sedentary time, and showed the highest resting heart rate. The AEHR subgroup took fewer steps per day compared to the Active subgroup and had high sedentary time. The AEHR subgroup also spent a higher percentage of time with an atypically high heart rate response to low levels of activity compared to the other subgroups. Our findings suggest that data from wearable devices can identify subgroups of adolescents with mTBI with distinct physiologic/physical activity profiles, which may ultimately be used to inform personalized activity prescriptions. Future work should aim to understand how the identified subgroups relate to longitudinal outcomes.

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Ultrasound Detection of Early Callus Formation in Proximal Humerus Fractures: Protocol for a Pilot and Prospective Cohort Study

Blackman, B.; Fahey, N.; Dolan, S.; O'Reilly, M. K.; Cassidy, J. T.

2026-07-21 orthopedics 10.64898/2026.07.20.26358520 medRxiv
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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.

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Modified Ghost System combining action, observation, and vibration stimulation for recovery after distal radius fracture surgery: A single-arm clinical feasibility study protocol

Kano, A.; Akiyama, Y.; Kamijo, Y.-I.; Hamaguchi, T.

2026-07-18 rehabilitation medicine and physical therapy 10.64898/2026.07.16.26358289 medRxiv
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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.

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Pre-fracture Anemia Is Associated with Nonunion Following Tibia or Femur Fractures: A Retrospective Cohort Study

Merceron, C.; Singh, S.; Whitney, D. G.; Alford, A. I.; Sachdeva, S.; Khoriaty, R.; Hartley, B.; Lang, A.

2026-07-19 orthopedics 10.64898/2026.07.16.26358267 medRxiv
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Fracture nonunion remains a major cause of morbidity, yet patient-specific factors associated with impaired healing remain incompletely characterized. Anemia has been associated with adverse orthopaedic outcomes, but its relationship with fracture nonunion is poorly understood. We examined whether pre-fracture anemia, anemia burden, and clinically relevant anemia subtypes were associated with nonunion following tibial or femoral fractures. Using commercial and Medicare fee-for-service claims from 2016 through 2023, we identified adults aged 19 years or older with a tibial or femoral fracture, continuous enrollment during the preceding year and for at least six months after fracture, and no baseline cancer. Pre-fracture anemia was evaluated as any anemia, the number of distinct anemia diagnoses, and nutritional, hemolytic, aplastic, and other anemia subgroups. Nonunion occurring six to eighteen months after fracture was assessed using incidence rates and multivariable-adjusted hazard models. Among 326,673 adults, 149,704 had pre-fracture anemia and 176,969 did not. The crude incidence of nonunion was 42% higher among individuals with anemia than among those without anemia (incidence rate ratio, 1.42; 95% confidence interval, 1.32 to 1.53) and increased with greater anemia burden. After adjustment for demographic and clinical characteristics, including prior fractures at other anatomical sites, pre-fracture anemia remained associated with nonunion following tibial and femoral fractures, with hazard ratios of 1.83 (95% confidence interval, 1.54 to 2.18) and 1.38 (95% confidence interval, 1.26 to 1.50), respectively. Associations were also observed for nutritional and other anemias, whereas estimates for hemolytic and aplastic anemias were limited by few nonunion events. Within the femur, the association was strongest for distal fractures. These findings demonstrate that pre-fracture anemia is independently associated with nonunion. The increase in risk with greater anemia burden and findings across evaluable subgroups suggest that pre-fracture anemia may help identify patients at increased risk of impaired fracture healing.

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Pathways, Perceptions, and the Luck of the Draw: A Qualitative Study of Adolescent Idiopathic Scoliosis Imaging and Referral Services in England.

Robinson-Smith, L.; Jafari, M.; Kottam, L.; Clark, N.; Rangan, A.; Adamson, J.

2026-07-19 radiology and imaging 10.64898/2026.07.16.26358249 medRxiv
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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.

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Transient Apical Sparing in Hypertensive Heart Disease Explained by Laplace's Law

Hwang, I.-C.; Kim, H. M.; Jang, Y.; Bak, M.; Park, J.; Jeon, J.; Lee, S.-A.; Choi, H.-M.; Yoon, Y. E.; Cho, G.-Y.

2026-07-19 cardiovascular medicine 10.64898/2026.07.16.26358114 medRxiv
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Background: Apical sparing of left ventricular longitudinal strain (LS) is an echocardiographic clue to cardiac amyloidosis but may also occur in hypertensive heart disease (HHD). Objectives: To determine whether apical sparing in HHD is associated with regional left ventricular wall stress estimated according to Laplace's law. Methods: We retrospectively studied 1,559 patients with HHD, 47 with light-chain cardiac amyloidosis (ALCA), and 409 normotensive controls. Artificial intelligence-assisted echocardiography quantified segmental LS, wall thickness, and cavity radius at the basal, midventricular, and apical levels. Wall stress was estimated as mean blood pressure (MBP) x radius/(2 x wall thickness). Apical sparing was defined as a relative regional strain ratio (RRSR)[&ge;]1.0. Results: Apical sparing was present in 14 patients with HHD (0.9%), 13 with ALCA (27.7%), and no controls. Among HHD patients with apical sparing, RRSR decreased from 1.11{+/-}0.13 to 0.72{+/-}0.10 after antihypertensive treatment (P<0.001), accompanied by reduced wall stress and improved basal and midventricular LS, with resolution of apical sparing in all 14 patients. In the overall HHD cohort, changes in MBP and left ventricular mass index were independently associated with changes in RRSR. In an exploratory analysis of HHD patients with apical sparing, a reduction in basal wall stress was associated with a reduction in RRSR ({beta}=0.267 for {bigtriangleup}RRSRx100, 95% CI 0.023-0.511; P=0.036). In ALCA, favorable hematologic response was the only determinant of RRSR reduction. Conclusions: Apical sparing in HHD was uncommon but reversible and may represent a load-sensitive deformation pattern associated with regional wall stress, consistent with Laplace's law.

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Validating Artificial Intelligence Guidance for Ultrasound Acquisition and Remote Interpretation

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.

2026-07-19 radiology and imaging 10.64898/2026.07.16.26356882 medRxiv
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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

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Learned ultrasound segmentation and deformable CT fusion for augmented reality endovascular surgery

Dillon, T. M.; Quevedo Moreno, D.; Rutherford, E. K.; Ayers, B.; Salomon, B.; Kubi, B.; Thomas, J.; Roche, E.

2026-07-17 cardiovascular medicine 10.64898/2026.07.15.26358084 medRxiv
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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.

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An Integrated Anatomic Score for Intraprocedural Risk Stratification in Bicuspid TAVI: Development and External Validation

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.

2026-07-20 cardiovascular medicine 10.64898/2026.07.18.26358381 medRxiv
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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.

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Renal Outcomes of Staged Versus Concomitant Percutaneous Coronary Intervention and Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Chanda, V.; Bittar, V.; Carvalho, P.; Garot, P.

2026-07-21 cardiovascular medicine 10.64898/2026.07.19.26353414 medRxiv
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Background: The optimal timing of percutaneous coronary intervention (PCI) in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear, particularly regarding its impact on renal outcomes. Methods: We conducted systematic review and meta-analysis of studies comparing staged versus concomitant PCI in patients with aortic stenosis and coronary artery disease undergoing TAVR. We searched MEDLINE, Embase, and Cochrane databases comprehensively. Using a random-effects model, we calculated odds ratios (OR) with 95% confidence intervals (CI) to assess the incidence of contrast-induced acute coronary injury (CI-AKI) across different stages. Results: The analysis included 11 studies encompassing 7,119 patients. Overall, staged PCI did not significantly differ from concomitant PCI in reducing CI-AKI (OR 1.02; 95% CI 0.53 to 1.98; p = 0.959; Figure 2A). Subgroup analysis revealed no significant differences in stage 1 (OR 1.99; 95% CI 0.38 to 10.47; p = 0.417; Figure 2B) or stage 2 CI-AKI (OR 1.01; 95% CI 0.39 to 2.64; p = 0.978; Figure 2C). However, a statistically significant difference emerged for stage 3/4 CI-AKI, favoring the staged approach (OR 0.48; 95% CI 0.24 to 0.99; p = 0.046; Figure 2D). Conclusion: While staged PCI does not consistently reduce CI-AKI in patients undergoing TAVR, it may offer potential benefits for more severe kidney injury (stages 3/4). Given the observed heterogeneity, large-scale randomized controlled trials are essential to establish the relationship between procedural timing and renal outcomes.

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Drug-Coated Devices, Wound Healing, and Mortality After Endovascular Therapy for Chronic Limb-Threatening Ischemia

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.

2026-07-17 cardiovascular medicine 10.64898/2026.07.14.26358110 medRxiv
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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.

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One-Year Safety and Effectiveness of the ISAR SUMMIT Polymer-Free Everolimus-Eluting Stent in Real-World Clinical Practice

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.

2026-07-18 cardiovascular medicine 10.64898/2026.07.16.26358282 medRxiv
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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.

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Pediatric Poverty and County-Level Cardiovascular Mortality in the United States: A National Cross-Sectional Analysis

Babapour Digaleh, K.; Bouchekouk, M.; Ronen, B.; Sun, A.; House, W.; Gomibuchi, T.; Alcudia, A.; Moser, G. W.; Mokashi, S.

2026-07-17 cardiovascular medicine 10.64898/2026.07.15.26358197 medRxiv
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Background: Cardiovascular disease remains the leading cause of death in the United States, and marked geographic disparities in cardiovascular mortality persist. However, the community-level socioeconomic indicators most strongly associated with these disparities remain unclear. Community-level measures capture the social and economic conditions that influence cardiovascular health across populations and may help identify communities at greatest risk. We used the Area Health Resources File (AHRF) to identify socioeconomic measures most strongly associated with county-level cardiovascular mortality. Methods: We performed a national cross-sectional ecological analysis using the 2024-2025 Area Health Resources File (AHRF), including counties in the 50 U.S. states and the District of Columbia. The primary outcome was an AHRF-defined cardiovascular mortality composite derived from 2021-2023 National Center for Health Statistics (NCHS) mortality data. Community-level socioeconomic measures included 2023 overall, pediatric, and family childhood poverty and 2019-2023 overall, female, and White unemployment. County-level associations were evaluated using Spearman rank correlation and regional differences using the Kruskal-Wallis test. Sensitivity analyses used a partial mortality composite and Kendall {tau} correlation. Results: Among 1,982 counties, cardiovascular mortality varied significantly across U.S. Census divisions (P<0.001), with the highest population-weighted rate in the East South Central division (348.5 deaths/100,000) and the lowest in the Mountain division (233.9 deaths/100,000). Pediatric poverty demonstrated the strongest association with cardiovascular mortality ({rho}=0.612), followed by family childhood poverty ({rho}=0.603) and overall poverty ({rho}=0.524, all P<0.001). In contrast, unemployment measures were more weakly associated (overall {rho}=0.209, White {rho}=0.176, female {rho}=0.141, all P<0.001). Results were consistent in sensitivity analyses. Conclusions: County-level poverty, particularly pediatric poverty, was more strongly associated with cardiovascular mortality than unemployment across U.S. counties. These findings suggest pediatric poverty may serve as a useful community-level indicator for identifying populations at increased cardiovascular risk and prioritizing future public health interventions.

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Hypertension Phenotypes in a National Database: A Three-Axis State Model Integrating Diagnosis, Treatment Intensity, and Blood Pressure Control (The NDB-K7Ps-Study-8)

nakajima, K.; Sekine, A.

2026-07-19 cardiovascular medicine 10.64898/2026.07.16.26358276 medRxiv
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Hypertension is commonly defined as a binary condition despite substantial heterogeneity in diagnosis, treatment, and blood pressure (BP) control. We propose a three-axis state model integrating diagnosis status, treatment intensity, and BP control to better characterize hypertension phenotypes. The framework generates 27 possible states that can be condensed into seven clinically meaningful groups. We applied the model to 5,129,584 Japanese adults using the National Database of Health Insurance Claims and Specific Health Checkups. Hierarchical cluster analysis, sensitivity analysis excluding patients with cardiovascular diseases other than hypertension, and validation against antihypertensive medication use were performed. Overall, 64% of participants were classified as normotensive, whereas 36% belonged to hypertension-related groups, including 11% with unrecognized hypertension and 7% with diagnosed but untreated hypertension. Agreement with data-driven hierarchical cluster analysis was substantial (weighted {kappa}=0.87). The group distribution remained largely unchanged in the sensitivity analysis, supporting the robustness of the proposed classification. Hypertension diagnosis also showed high validity, with a sensitivity of 96.5%, specificity of 91.8%, and substantial agreement with antihypertensive medication use ({kappa}=0.78). This three-axis framework provides a robust and clinically interpretable approach for characterizing hypertension phenotypes, enabling systematic identification of care gaps and supporting research, clinical decision-making, and population health management.

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Task-sharing echocardiographic screening for rheumatic heart disease with community health workers in First Nations Australian communities: implementation outcomes and realist evaluation from the NEARER SCAN study

Jones, B.; Mitchell, A.; Marangou, J.; Yan, J.; Cannon, J.; Williamson, J. M.; Law, L.; Kaethner, A.; Bailey, M.; Collins, R.; Mayo, L.; Wade, V.; Fitzsimmons, D.; Paterson, A.; Remenyi, B.; Ralph, A. P.; Wheaton, G.; Haynes, E.; Katzenellenbogen, J. M.; Howard, N. J.; Riley, P.; Brown, K.; Gatti, J.; Lockyer, S.; Pears, C.; Stewart, M.; Rossingh, B.; Daniels, C.; Fernandes, A. M.; Hardefeldt, H.; O Brien, J.; Hillis, G. S.; Engelman, D.; Brown, A.; Steer, A. C.; Carapetis, J.; English, M.; Nagraj, S.; Francis, J. R.

2026-07-21 cardiovascular medicine 10.64898/2026.07.18.26358403 medRxiv
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Background: Rheumatic heart disease (RHD) remains a major cause of premature death in low- and middle-income countries and First Nations communities. Early detection and management can prevent progression, but requires echocardiography, which is limited in high-burden settings. Task-sharing echocardiographic screening is an accessible, evidence-based approach but implementation remains unclear. Methods: We conducted a prospective implementation evaluation of a co-designed task-sharing screening programme across five remote First Nations Australian communities between May 2023 and November 2025. Predominantly community health workers (CHWs), alongside nurses and doctors, were trained to scan using handheld devices with off-site cardiologist interpretation. We assessed implementation outcomes and used a realist evaluation to explore how context shaped CHWs ability to complete training and embed screening into routine work. Data included scanning activity, surveys, costing, interviews, focus groups, and field notes. Findings: We trained 32 staff (21 CHWs, 8 nurses, 3 doctors) to scan across five sites. Scanning frequency was lower and more variable than anticipated: 360 scans (including training and post-certification) of 5 - 20 year olds over 14 months, with site-level coverage of 3 - 85%. Fidelity was limited by device unavailability, charging problems, and delays in uploads and reviews. Set-up and training cost A$51,903 per site, plus A$9,858/year in implementation support. Screening was easier for CHWs to embed when the legitimacy of their role as a scanner was communicated, but harder when invisible work outweighed opportunities to scan. Interpretation: Future implementation will require efforts to legitimise CHWs scanning and support invisible work. Event-based screening offers a promising complementary strategy. Scale-up requires policy support. Funding: This research was funded by the Australian Medical Research Futures Fund Cardiovascular Health Mission (GNT2015869), in addition to philanthropic donations from Medtronic Australasia, Edwards Life Sciences and the Rotary Club of Kiama. Hand-held devices (Philips Lumify, USA) were donated by Humpty Dumpty Foundation and East Timor Hearts Fund.

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Depressive Symptoms and Prevalent Cardiovascular Disease: A Cross-Sectional Analysis in Port-au-Prince, Haiti

Pierre, D. M.; Rasul, R.; St. Sauveur, R.; Celestin, K.; Rouzier, V.; Hilaire, E.; Deschamps, M. M.; Pape, J. W.; Yan, L. D.; Ogyu, A.; Bennett, C.; McNairy, M. L.; Sufra, R.; Nash, D.

2026-07-18 cardiovascular medicine 10.64898/2026.07.15.26358073 medRxiv
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Background: Cardiovascular disease (CVD) is the leading cause of mortality in low- and middle-income countries (LMICs). In Haiti, depression remains an underexplored CVD risk factor. We assessed the association between depressive symptoms (DS) and prevalent CVD in urban Haiti and examined sex differences. Methods: We conducted a cross-sectional analysis of enrollment data from the Haiti Cardiovascular Disease Cohort (adults [&ge;]18 years; March 2019--August 2021). DS were measured using the Patient Health Questionnaire-9 (PHQ-9) and categorized as none--mild (<10) versus moderate--severe ([&ge;]10). Prevalent CVD (angina, myocardial infarction, transient ischemic attack or stroke, heart failure) was adjudicated using epidemiologic definitions aligned with international cohorts. We estimated prevalence ratios (PRs) using generalized estimating equation Poisson models with a log link, adjusting for age, sex, education, income, food insecurity, smoking, alcohol use, physical activity, stress, and BMI. Effect modification by sex was assessed on multiplicative and additive scales. Results: Among 2,995 participants (mean age 41.9 years; 58.0% female), 16.2% (95% CI: 14.8-17.5; n=484) had moderate--severe DS. Prevalence was higher in females (22.0%, 95% CI: 19.8-23.6) than males (8.5%, 95% CI: 7.0-10.1). The prevalence of CVD was higher among participants with moderate--severe DS compared with those with none--mild DS, with similar patterns observed in both sexes (males: 21.5% vs 10.6%; females: 23.3% vs 15.3%). Moderate--severe DS were associated with higher CVD prevalence compared with none--mild DS (adjusted PR [aPR]=1.36; 95% CI: 1.08--1.71). In sex-stratified models, aPRs were 1.38 (95% CI: 1.06--1.78) for females and 1.25 (95% CI: 0.75--1.99) for males. Evidence for interaction by sex on the additive scale was limited (RERI=0.07, 95% CI: -0.74 to 0.88). Conclusion: Moderate--severe DS were independently associated with a higher prevalence of CVD in urban Haiti. Associations were consistently stronger among women, although evidence for effect modification by sex was limited. Integrating depression screening and management into CVD prevention efforts may help address the growing burden of both conditions in resource-limited settings. Prospective studies are warranted to better understand the underlying mechanisms and causal pathways.

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Chronic Coronary Syndrome in Mexico: Design and Initial Insights from the RESINCCRO Mexican Registry

Berrios-Barcenas, E. A.; de los Rios-Ibarra, M. O.; Alcocer-Gamba, M. A.; Rodas-Caceres, C. R.; Ruiz-Gastelum, E. D.; Banos-Gonzalez, M. A.; Vizarraga-Thomas, E. M.; Valenzuela-Valenzuela, M. d. J.; Padilla-Padilla, F. G.; Gonzalez-Barrera, L. G.; Rebull-Isusi, J. M.; Lendo-Lopez, A. A.; Bazzoni-Ruiz, A. E.; Roldan-Gomez, F. J.; Gonzalez-Godinez, H.; Hernandez-Herrera, C.; Escalante-Seyffert, M. C.; Nunez-Urquiza, J. P.; Leiva-Pons, J. L.; Cornejo-Avendano, J. R.; Duarte-Montiel, E. D.; Portillo-Romero, A.; Nuriulu-Escobar, P. L.; Navarrete-Gaona, R.; Rodriguez-Reyes, H.; Barrera-Bustillos, M.

2026-07-17 cardiovascular medicine 10.64898/2026.07.15.26358091 medRxiv
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BACKGROUND: Chronic coronary syndromes (CCS) remain under-characterized in Latin America, where clinical profiles may differ from high-income countries. OBJECTIVE: We aim to characterize the clinical presentation, coronary anatomic profile, and pharmacologic treatment patterns of adults living with CCS using data from the Mexican Chronic Coronary Syndrome Registry (RESINCCRO). METHODS: RESINCCRO is an observational, multicenter, cross-sectional registry conducted across ~50 centers in five regions from Mexico. We included adults ([&ge;]18 years) enrolled between September 2024 and March 2025 who met 2019 ESC CCS criteria. Coronary imaging data was collected from medical records into a standardized electronic case report form. RESULTS: We enrolled 3,029 adults (men [72.5%]; mean age 67.2 {+/-} 10.7 years). Cardiometabolic comorbidities were frequent: overweight/obesity (76%), arterial hypertension (69.0%), type 2 diabetes (44.0%), and chronic kidney disease (24.2%). Persistent angina/equivalents occurred in (23.9%), of which most had Canadian Cardiovascular Society class I - II (91.2%). The mean LVEF was of 53.7 {+/-} 12.0. Cardiac rehabilitation participation was (6.2%). Median LDL-C was 70 mg/dL (IQR 51 - 95) and LDL <55 mg/dL was only 26.1%, despite high prescription of lipid-lowering therapies, including statins (93.2%), ezetimibe (24.6%), and PCSK9 inhibitors (2.4%). 60.3% had obstructive epicardial disease. CONCLUSIONS: Mexican adults with CCS exhibit high cardiometabolic burden, frequent symptoms, suboptimal LDL-C goal attainment, low rehabilitation uptake, and a substantial obstructive phenotype. These findings highlight opportunities to intensify secondary prevention, adopt mechanism-directed evaluation and therapy, and expand cardiac rehabilitation to improve CCS care in Mexico.

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Validation of an Assessment Scale for a Low-Tech Laparoscopic Appendectomy Simulation and Its Relevance for Formative Self-Assessment

Tumameu Kouam, T. H.; Renoult, L.; Poitevin, M.; Jourdin, L.; Herve, C.; Meignan, P.; Podevin, G.; Schmitt, F.

2026-07-21 medical education 10.64898/2026.07.20.26358477 medRxiv
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Introduction: Laparoscopic appendectomy is an ideal procedure for acquiring laparoscopic skills through simulation. Nevertheless, technical training is time consuming for surgical trainers to provide constructive feedback, but this could be improved by the development of validated tools that enable appropriate formative self-assessment. For this reason, we developed a structured assessment scale for a laparoscopic appendectomy exercise using a low-fidelity simulator. The objective of this study was to validate the scale for use in formative self-assessment. Methods: During laparoscopic simulation sessions in 2025-2026, participants with varying levels of experience performed a standardized laparoscopic appendectomy (LAP) exercise on a low-fidelity simulator. Performance was assessed through formative self- and external assessment using a specific scale derived from the OSATS (Objective Structured Assessment of Technical Skills) score. Content and construct validity, internal consistency, reproducibility, and reliability in both hetero- and self-assessment were analyzed. Results: Thirty-two participants were included in the validation study of the LAP scale, including 7 medical students, 17 residents in pediatric, visceral, urological, and gynecological surgery, and 8 practicing surgeons. The content of the scale was deemed relevant by 80% of the users. It demonstrated excellent construct validity, with scores increasing according to level of experience: 9.9 +/- 0.7 among students, 12.7 +/- 3.3 among junior residents, 16.6 +/- 3.3 among experienced residents, and 18.8 +/- 0.9 among practicing surgeons (p < 0.0001). Reproducibility and internal consistency were significant, while inter and intrarater reliability were excellent (correlation coefficients r = 0.90 and 0.91; p < 0.0001), as was the correlation between external and self-assessment (r = 0.81; p < 0.0001). Self-assessment was more reliable among experienced learners than among novices. Conclusion: This standardized LAP scale is validated for both external and self-assessment, the latter requiring prior training to be reliable and formative.

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Validity and Test-Retest Reliability of the Hume Pod Bioimpedance Analyzer for Body Composition Assessment

Tinsley, G. M.; Velasquez, C. M.; Florez, C. M.; Way, A. E.; Sullivan, M. H.; Whitson, J. A.; Rudolph, R. A.; Alexander, J. R.; Malladi, A.

2026-07-20 nutrition 10.64898/2026.07.17.26358337 medRxiv
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Consumer-grade bioelectrical impedance analyzers have become widely used for body composition assessment, yet their accuracy varies considerably across devices. The Hume Pod is a popular consumer-grade analyzer marketed as being highly accurate, but independent validation is lacking. The purpose of this study was to evaluate the reliability and validity of the Hume Pod relative to both a four-compartment (4C) model and dual-energy X-ray absorptiometry (DXA). Sixty-seven adults (42 females, 25 males; age 37.2 +/- 13.5 years, body mass index: 24.6 +/- 4.9 kg/m2, body fat percentage [BF%]: 26.4 +/- 10.2%) completed duplicate Hume Pod assessments alongside DXA and 4C evaluations. Reliability was evaluated using the technical error of measurement (TEM) and intraclass correlation coefficients (ICC). Validity was assessed using equivalence testing, Lin's concordance correlation coefficient (CCC), standard error of the estimate (SEE), Bland-Altman analysis, and additional tests. The Hume Pod demonstrated strong reliability, with ICCs >/= 0.993 and TEMs of 0.8% for BF% and 0.6 kg for fat mass (FM) and fat-free mass (FFM). Relative to the 4C model, BF%, FM, and FFM estimates were statistically equivalent (all p<0.05), with strong agreement (CCC=0.95-0.98), low SEE values (3.1%, 2.3 kg, and 2.2 kg, respectively), moderate limits of agreement (+/-6.1%, +/-4.5 kg, and +/-4.5 kg), and no proportional bias. Compared with DXA, generally strong agreement was also observed. These findings indicate that the Hume Pod demonstrates strong reliability and validity compared with laboratory reference methods for body composition estimation, supporting its potential use as a consumer body composition assessment.