Publications by authors named "R Sacco"

1,591 Publications

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Predictors of Serious Adverse Events and Non-response in Cirrhotic Patients With Primary Biliary Cholangitis treated with Obeticholic Acid.

Liver Int 2022 Aug 5. Epub 2022 Aug 5.

Liver Unit, San Camillo Hospital, Rome, Italy.

Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with "advanced cirrhosis" because of its narrow therapeutic index. We aimed at better defining the predicting factors of hepatic serious adverse events (SAEs) and non-response in cirrhotic patients undergoing OCA therapy.

Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non-response were reported as risk ratios (RR) with 95% confidence intervals (CIs).

Results: One-hundred PBC cirrhotics were included, 97 Child-Pugh class A and 3 class B. Thirty-one had esophageal varices, 5 had history of ascites. Thirty-three% and 32% of patients achieved a biochemical response at 6 and 12 months, respectively. Male-sex (adjusted-RR 1.75, 95%CI 1.42-2.12), INR (1.37,1.00-1.87), Child-Pugh score (1.79,1.28-2.50), MELD (1.17,1.04-1.30), and bilirubin (1.83,1.11-3.01) were independently associated with non-response to OCA. Twenty-two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted-RR 1.91,95%CI 1.10-3.36), lower albumin levels (0.18,0.06-0.51), Child-Pugh score (2.43,1.50-4.04), history of ascites (3.5,1.85-6.5), and bilirubin (1.30,1.05-1.56), were associated with hepatic SAEs. A total bilirubin≥1.4mg/dL at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA.

Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level≥1.4mg/dL should discourage from its use.
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http://dx.doi.org/10.1111/liv.15386DOI Listing
August 2022

Potential feasibility of Atezolizumab-Bevacizumab therapy in patients with hepatocellular carcinoma treated with tyrosine-kinase inhibitors.

Dig Liver Dis 2022 Jul 27. Epub 2022 Jul 27.

Unit of Semeiotics, Liver and Alcohol-related diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; Unit of Semeiotics, Liver and Alcohol-related diseases, Department of Medical and Surgical Sciences, Alma Mater Studiorum - University of Bologna, Bologna, Italy. Electronic address:

Background: The combination of atezolizumab-bevacizumab has been proven to be superior to sorafenib for the treatment of unresectable hepatocellular carcinoma not amenable to locoregional treatments, becoming the standard of care of systemic therapy.

Aim: This study aimed at assessing real-world feasibility of atezolizumab-bevacizumab in patients treated with tyrosine-kinase inhibitors.

Methods: Among 1447 patients treated with tyrosine-kinase inhibitors from January 2010 to December 2020, we assessed the percentage of those potentially eligible to atezolizumab-bevacizumab (according to IMbrave-150 trial criteria), and the overall survival of eligible and non-eligible patients.

Results: 422 (29%) patients were qualified for atezolizumab-bevacizumab therapy. The main exclusion causes were Child-Pugh class and Performance Status. Adopting the more permissive inclusion criteria of SHARP trial, 535 patients became eligible. The median overall survival of tyrosine-kinase inhibitors patients was 14.9 months, longer in eligible patients than in their counterpart due to better baseline liver function and oncological features.

Conclusion: Real-world data indicate that less than one-third of hepatocellular carcinoma patients treated with tyrosine-kinase inhibitors are potentially eligible to atezolizumab-bevacizumab according to the registration trial criteria. These patients have a longer survival than the non-eligible ones. If the selection criteria of atezolizumab-bevacizumab trial are maintained in clinical practice, tyrosine-kinase inhibitors will remain the most used systemic therapy for hepatocellular carcinoma patients.
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http://dx.doi.org/10.1016/j.dld.2022.07.003DOI Listing
July 2022

Subclinical left ventricular systolic dysfunction and incident stroke in the elderly: long-term findings from Cardiovascular Abnormalities and Brain Lesions.

Eur Heart J Cardiovasc Imaging 2022 Jul 28. Epub 2022 Jul 28.

Department of Medicine, Division of Cardiology, Columbia university Irving Medical Center, 630 W 168th St, New York, NY 10032, USA.

Aims: Heart disease is associated with an increased risk for ischaemic stroke. However, the predictive value of reduced left ventricular ejection fraction (LVEF) for stroke is controversial and only observed in patients with severe reduction. LV global longitudinal strain (LV GLS) can detect subclinical LV systolic impairment when LVEF is normal. We investigated the prognostic role of LV GLS for incident stroke in a predominantly elderly cohort.

Methods And Results: Two-dimensional echocardiography with speckle tracking was performed in the Cardiac Abnormalities and Brain Lesions (CABL) study. Among 708 stroke-free participants (mean age 71.4 ± 9.4 years, 60.9% women), abnormal LV GLS (>-14.7%: 95% of the subgroup without risk factors) was detected in 133 (18.8%). During a mean follow-up of 10.8 ± 3.9 years, 47 participants (6.6%) experienced an ischaemic stroke (26 cardioembolic or cryptogenic, 21 other subtypes). The cumulative incidence of ischaemic stroke was significantly higher in participants with abnormal LV GLS than with normal LV GLS (P < 0.001). In multivariate stepwise logistic regression analysis, abnormal LV GLS was associated with ischaemic stroke independently of cardiovascular risk factors including LVEF, LV mass, left atrial volume, subclinical cerebrovascular disease at baseline, and incident atrial fibrillation [hazard ratio (HR): 2.69, 95% confidence interval (CI): 1.47-4.92; P = 0.001]. Abnormal LV GLS independently predicted cardioembolic or cryptogenic stroke (adjusted HR: 3.57, 95% CI: 1.51-8.43; P = 0.004) but not other subtypes.

Conclusion: LV GLS was a strong independent predictor of ischaemic stroke in a predominantly elderly stroke-free cohort. Our findings provide insights into the brain-heart interaction and may help improve stroke primary prevention strategies.
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http://dx.doi.org/10.1093/ehjci/jeac145DOI Listing
July 2022

In-depth characterization of neuroradiological findings in a large sample of individuals with autism spectrum disorder and controls.

Neuroimage Clin 2022 Jul 16;35:103118. Epub 2022 Jul 16.

University Medical Center Utrecht, Utrecht, the Netherlands.

Background: Autism spectrum disorder (ASD) is a group of neurodevelopmental conditions associated with quantitative differences in cortical and subcortical brain morphometry. Qualitative assessment of brain morphology provides complementary information on the possible underlying neurobiology. Studies of neuroradiological findings in ASD have rendered mixed results, and await robust replication in a sizable and independent sample.

Methods: We systematically and comprehensively assessed neuroradiological findings in a large cohort of participants with ASD and age-matched controls (total N = 620, 348 ASD and 272 controls), including 70 participants with intellectual disability (47 ASD, 23 controls). We developed a comprehensive scoring system, augmented by standardized biometric measures.

Results: There was a higher incidence of neuroradiological findings in individuals with ASD (89.4 %) compared to controls (83.8 %, p = .042). Certain findings were also more common in ASD, in particular opercular abnormalities (OR 1.9, 95 % CI 1.3-3.6) and mega cisterna magna (OR 2.4, 95 % CI 1.4-4.0) reached significance when using FDR, whereas increases in macrocephaly (OR 2.0, 95 % CI 1.2-3.2), cranial deformities (OR 2.4, 95 % CI: 1.0-5.8), calvarian / dural thickening (OR 1.5, 95 % CI 1.0-2.3), ventriculomegaly (OR 3.4, 95 % CI 1.3-9.2), and hypoplasia of the corpus callosum (OR 2.7, 95 % CI 1.1-6.3) did not survive this correction. Furthermore, neuroradiological findings were more likely to occur in isolation in controls, whereas they clustered more frequently in ASD. The incidence of neuroradiological findings was higher in individuals with mild intellectual disability (95.7 %), irrespective of ASD diagnosis.

Conclusion: There was a subtly higher prevalence of neuroradiological findings in ASD, which did not appear to be specific to the condition. Individual findings or clusters of findings may point towards the neurodevelopmental mechanisms involved in individual cases. As such, clinical MRI assessments may be useful to guide further etiopathological (genetic) investigations, and are potentially valuable to fundamental ASD research.
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http://dx.doi.org/10.1016/j.nicl.2022.103118DOI Listing
July 2022

Common carotid artery medialization and fracture dislocation of the cervical spine.

Surg Radiol Anat 2022 Jul 20. Epub 2022 Jul 20.

Department of Orthopaedic Surgery, Spine unit, Rouen University Hospital, 1, rue de Germont, 76031, Rouen Cedex, France.

Purpose: To describe the management of the discovery of a retropharyngeal carotid artery in the context of a cervical dislocation.

Description Of The Case: A 68-year-old female presented acute neck pain and incomplete tetraplegia following a fall on the stairs. Radiographs, contrast-enhanced computed tomography scan and magnetic resonance of the cervical spine revealed a C5-C6 bi-articular dislocation. A detailed preoperative assessment of the images discovered a medialization of the left common carotid artery. An external reduction and a left anterior cervical approach allowed a careful management of the vascular variation and an anterior C5-C6 arthrodesis. At six months, a full neurological recovery was assessed and radiographs demonstrated successful fusion of the cervical arthrodesis.

Discussion/conclusion: Anatomical features such as medialization of the common carotid artery may affect patients with traumatic cervical spine injuries. The severity of the traumatic bone lesions should not overshadow the preoperative analysis of the adjacent anatomical structures encountered during the surgical approach, even in an emergency situation.
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http://dx.doi.org/10.1007/s00276-022-02965-0DOI Listing
July 2022
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