MASLD and MASH At the Crossroads of Hepatology Trials and Cardiorenal Metabolic Trials
The challenge is defining the optimal combination of biomarkers, imaging and morbidity/mortality outcomes and ensuring that they are included in future trials while minimizing the burden on patients, trialists and trial sponsors. This paper provides an overview of some of the wide array of CV, liver and kidney measurements that were discussed at the MOSAIC meeting.
KEY FINDINGS: The challenge is defining the optimal combination of biomarkers, imaging and morbidity/mortality outcomes and ensuring that they are included in future trials while minimizing the burden on patients, trialists and trial sponsors. This paper provides an overview of some of the wide array of CV, liver and kidney measurements that were discussed at the MOSAIC meeting.
BACKGROUND: Steatotic liver disease (SLD) is a worldwide public health problem, causing considerable morbidity and mortality. Patients with SLD are at increased risk for major adverse cardiovascular (CV) events, type 2 diabetes mellitus and chronic kidney disease.
DETAILS: Conversely, patients with cardiometabolic conditions have a high prevalence of SLD. In addition to epidemiological evidence linking many of these conditions, there is evidence of shared pathophysiological processes. In December 2022, a unique multi-stakeholder, multi-specialty meeting, called MOSAIC (Metabolic multi Organ Science Accelerating Innovation in Clinical Trials) was convened to foster collaboration across metabolic, hepatology, nephrology and CV disorders. One of the goals of the meeting was to consider approaches to drug development that would speed regulatory approval of treatments for multiple disorders by combining liver and cardiorenal endpoints within a single study. Non-invasive tests, including biomarkers and imaging, are needed in hepatic and cardiorenal trials. They can be used as trial endpoints, to enrich trial populations, to diagnose and risk stratify patients and to assess treatment efficacy and safety. Although they are used in proof of concept and phase 2 trials, they are often not acceptable for regulatory approval of therapies.
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Copyright © John Wiley & Sons, Inc. All rights reserved
Source: Zannad, F., Sanyal, A. J., Butler, J., et al. (2024). MASLD and MASH At the Crossroads of Hepatology Trials and Cardiorenal Metabolic Trials. Journal of Internal Medicine. 2024; 296(1): 24-38. Published: July, 2024. DOI: 10.1111/joim.13793.
Medical Management and Revascularization for Asymptomatic Carotid Stenosis
Among patients with high-grade stenosis without recent symptoms, the addition of stenting led to a lower risk of a composite of perioperative stroke or death or ipsilateral stroke within 4 years than intensive medical management alone. Carotid endarterectomy did not lead to a significant benefit.
KEY FINDINGS: Among patients with high-grade stenosis without recent symptoms, the addition of stenting led to a lower risk of a composite of perioperative stroke or death or ipsilateral stroke within 4 years than intensive medical management alone. Carotid endarterectomy did not lead to a significant benefit.
BACKGROUND: Improvements in medical therapy, carotid-artery stenting, and carotid endarterectomy call into question the preferred management of asymptomatic carotid stenosis. Whether adding revascularization to intensive medical management would provide greater benefit than intensive medical management alone is unclear.
DETAILS: Authors conducted two parallel, observer-blinded clinical trials that enrolled patients with high-grade (>=70%) asymptomatic carotid stenosis across 155 centers in five countries. The stenting trial compared intensive medical management alone (medical-therapy group) with carotid-artery stenting plus intensive medical management (stenting group); the endarterectomy trial compared intensive medical management alone (medical-therapy group) with carotid endarterectomy plus intensive medical management (endarterectomy group). The primary outcome was a composite of any stroke or death, assessed from randomization to 44 days, or ipsilateral ischemic stroke, assessed during the remaining follow-up period up to 4 years. A total of 1245 patients underwent randomization in the stenting trial and 1240 in the endarterectomy trial. In the stenting trial, the 4-year incidence of primary-outcome events was 6.0% (95% confidence interval [CI], 3.8 to 8.3) in the medical-therapy group and 2.8% (95% CI, 1.5 to 4.3) in the stenting group (P=0.02 for the absolute difference). In the endarterectomy trial, the 4-year incidence of primary-outcome events was 5.3% (95% CI, 3.3 to 7.4) in the medical-therapy group and 3.7% (95% CI, 2.1 to 5.5) in the endarterectomy group (P=0.24 for the absolute difference). From day 0 to 44, in the stenting trial, no strokes or deaths occurred in the medical-therapy group and seven strokes and one death occurred in the stenting group; in the endarterectomy trial, three strokes occurred in the medical-therapy group and nine strokes occurred in the endarterectomy group.
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Optical Feedback for Safe Automatic Laser Lithotripsy
The developed optical guidance system provides real-time feedback during laser lithotripsy, improving safety and precision by reducing the risk of accidental tissue damage. The proposed technology is expected to enhance outcomes in minimally invasive urological laser procedures.
Summary
Tissue Sensor Implementation in a Clinical System
[Posted 20/Jan/2026]
AUDIENCE: General Surgery, Nephrology, Internal Medicine
KEY FINDINGS: The developed optical guidance system provides real-time feedback during laser lithotripsy, improving safety and precision by reducing the risk of accidental tissue damage. The proposed technology is expected to enhance outcomes in minimally invasive urological laser procedures.
BACKGROUND: Purpose of this study is to develop an optical feedback system compatible with a commercial surgical laser for automatically distinguishing between urinary stones and soft tissues during laser lithotripsy, thereby enhancing procedural safety.
DETAILS: The system, based on diffuse reflectance spectroscopy (DRS), was implemented in an engineered clinical theranostic platform. In vivo experiments were conducted to collect and analyze DRS spectra of tissues during laser lithotripsy. Illumination was performed via the endoscope, and detection was performed via the treatment fiber. Classification of urinary stones and soft tissues was performed using machine learning methods, i.e., Principal Component Analysis (PCA) and Linear Discriminant Analysis (LDA). The system demonstrated high diagnostic performance, with 93% sensitivity for soft tissue identification and 93% specificity for stone detection evaluated by the LDA method. This real-time differentiation effectively minimized unintended laser exposure to non-target tissues.
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Copyright © Wiley Periodicals LLC. All rights reserved.
Source: Korneva, N., Budylin, G., Tseregorodtseva, P., et al. Optical Feedback for Safe Automatic Laser Lithotripsy: Tissue Sensor Implementation in a Clinical System. Lasers Surg. Med.. 2026; 58(1): 38-48. Published: January, 2026. DOI: 10.1002/lsm.70081.
Hypopigmentation Following Picosecond Laser Treatment for Melasma
While hypopigmentation is rare with PSL treatment, it can occur even with conservative low-fluence settings and adequate intervals between sessions. One possible mechanism is thermal beam- stacking, where slow hand movement during treatment may lead to repeated pulses on the same area. This can result in localised thermal accumulation, potentially causing subcellular disruption of melanosomes without overt melanocyte loss.
Summary
A Case Series
[Posted 13/Jan/2026]
AUDIENCE: General Surgery, Dermmatology, Internal Medicine
KEY FINDINGS: While hypopigmentation is rare with PSL treatment, it can occur even with conservative low-fluence settings and adequate intervals between sessions. One possible mechanism is thermal beam- stacking, where slow hand movement during treatment may lead to repeated pulses on the same area. This can result in localised thermal accumulation, potentially causing subcellular disruption of melanosomes without overt melanocyte loss. These findings suggest the need for clinician vigilance in monitoring for hypopigmentation, as re-pigmentation may not be achievable. Larger, controlled studies are needed to clarify risk factors and guide safer practice.
BACKGROUND: Picosecond lasers (PSL) are increasingly used for treating melasma, with fewer adverse effects reported compared to Q-switched lasers (QSL). However, the incidence of hypopigmentation following PSL treatment remains unexplored in detail. This case series aims to explore outcomes of hypopigmentation following PSL therapy in patients with melasma, and explore potential contributing factors.
DETAILS: A retrospective chart review identified four patients with hypopigmentation following PSL treatment for melasma, including one referral from another clinic. Across the cohort, 796 patients underwent 3096 sessions between 2021 and 2025. Treatments used 755 and/or 1064-nm wavelengths at low fluences, with intervals of 4–12 weeks. Three in-clinic patients (0.38%, 95% CI 0.13%–1.10%) and one referral developed hypopigmentation. Changes occurred across both wavelengths and beam profiles. Histology demonstrated preserved melanocyte density with reduced melanin pigment and melanosome content. None of the cases showed meaningful re-pigmentation at 6-month follow-up. No cases of post-inflammatory hyperpigmentation (PIH) were observed.
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Cardiac Allograft Vasculopathy Inhibition With Alirocumab
Proprotein convertase subtilisin/kexin 9 inhibition with alirocumab in addition to statin therapy early after HT safely lowers low-density lipoprotein cholesterol but did not reduce coronary artery plaque progression after 1 year compared with rosuvastatin alone in patients with a low baseline low-density lipoprotein cholesterol.
KEY FINDINGS: Proprotein convertase subtilisin/kexin 9 inhibition with alirocumab in addition to statin therapy early after HT safely lowers low-density lipoprotein cholesterol but did not reduce coronary artery plaque progression after 1 year compared with rosuvastatin alone in patients with a low baseline low-density lipoprotein cholesterol.
BACKGROUND: Cardiac allograft vasculopathy is an important cause of mortality after heart transplantation (HT). Dyslipidemia is a major contributor to the development of cardiac allograft vasculopathy. The safety and effectiveness of proprotein convertase subtilisin/kexin 9 inhibition to lower cholesterol and to prevent cardiac allograft vasculopathy early after HT are not well established.
DETAILS: In this investigator-initiated, prospective, multicenter, double-blind randomized trial, participants were randomized early after HT to receive either alirocumab or placebo in addition to rosuvastatin. Before randomization and at 1 year, all participants underwent invasive coronary assessment, including angiography, fractional flow reserve, coronary flow reserve, the index of microcirculatory resistance, and intravascular ultrasound with near-infrared spectroscopy. Lipid values were assessed at baseline and at prespecified intervals. The primary end point was the change in coronary artery plaque volume from baseline to 1 year after HT based on serial intravascular ultrasound. A total of 114 HT recipients were included (57 assigned to alirocumab and 57 assigned to placebo). Baseline characteristics were well matched between the 2 groups. The low-density lipoprotein cholesterol levels decreased significantly from baseline to 1 year in the alirocumab arm (72.7±31.7 to 31.5±20.7 mg/dL; P0.001) and did not change with placebo (69.0±22.4 to 69.2±28.1 mg/dL; P=0.92). Plaque volume increased numerically in both groups from baseline to 12 months (alirocumab, 176.3±95.2 to 184.5±105.4 mm³; P=0.23; placebo 173.7±96.7 to 183.1±109.8 mm3; P=0.15). The change in plaque volume (mean difference in differences) did not differ between groups (1.01 [0.89-1.14]; P=0.86). Fractional flow reserve, coronary flow reserve, and the index of microcirculatory resistance did not change significantly with the addition of alirocumab. There were no significant adverse events related to alirocumab.
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Re-envisioning the Lifespan Approach to Cardiovascular Disease Prevention and Treatment in Women
The anticipated life course of women supports a broadening focus on CVD toward that of lifelong care and emphasize key transitional stages for women - early risk factor onset, pregnancy, menopausal transition, and so on. This review is a call to action to re-envision a health system approach for lifespan prevention, detection, and treatment pathways to reduce CVD risk in women.
KEY FINDINGS:
- Mortality: CVD deaths in women exceed combined deaths from breast and lung diseases.
- Gap in Care: Insufficient sex-specific evidence continues to hinder lifesaving care.
- Call to Action: Transition from episodic care to a lifelong cardiovascular health system for women.
BACKGROUND: Despite the common misconception that respiratory or oncological diseases pose the greatest threat to women, Cardiovascular Disease (CVD) accounts for more female deaths than breast cancer, lung cancer, and chronic lung disease combined, with a comparable mortality to that of men. Historically, both the public and the medical community have underestimated CVD risks in women, leading to diagnostic delays and a scarcity of sex-specific evidence to guide clinical interventions. While advances have been made in the diagnosis, treatment and outcomes of CVD in women, there often remains insufficient evidence to guide effective, lifesaving care of women.
DETAILS: This review of sex-specific and traditional CVD risk and risk-enhancing factors in women identifies areas of knowledge gaps to consider for investigation. A focus on the coronary vasculature reveals physiological differences of clinical relevance which can be interrogated. Inspection of and addressing disadvantage and gender bias in both the medical and lay communities should continue to be addressed. As CVD results from traditional risk factors and emerging risk-enhancing factors, a focus on the detection of preclinical cardiovascular disease may be of particular importance for women. Unique risk markers originate early in pre-menopausal women, as this is considered a healthy period of life. Awareness and implementation of the existing knowledge of sex-specific risk factors and sex-specific thresholds to educate women and physicians are needed. The anticipated life course of women supports a broadening focus on CVD toward that of lifelong care and emphasize key transitional stages for women-early risk factor onset, pregnancy, menopausal transition, and so on. This review is a call to action to re-envision a health system approach for lifespan prevention, detection, and treatment pathways to reduce CVD risk in women.
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Specialty: