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1. AAV gene therapy for hereditary spastic paraplegia type 50: a phase 1 trial in a single patient.

Author: Dowling, James, Pirovolakis, Terry, Devakandan, Keshini, Stosic, Ana, Pidsadny, Mia, Nigro, Elisa, Sahin, Mustafa, Ebrahimi-Fakhari, Darius, Messahel, Souad, Varadarajan, Ganapathy, Greenberg, Barry, Chen, Xin, Minassian, Berge, Cohn, Ronald, Bonnemann, Carsten, and Gray, Steven
Subjects: Humans, Dependovirus, Spastic Paraplegia, Hereditary, Genetic Therapy, Child, Preschool, Male, Genetic Vectors, Treatment Outcome
Abstract: There are more than 10,000 individual rare diseases and most are without therapy. Personalized genetic therapy represents one promising approach for their treatment. We present a road map for individualized treatment of an ultra-rare disease by establishing a gene replacement therapy developed for a single patient with hereditary spastic paraplegia type 50 (SPG50). Through a multicenter collaboration, an adeno-associated virus-based gene therapy product carrying the AP4M1 gene was created and successfully administered intrathecally to a 4-year-old patient within 3 years of diagnosis as part of a single-patient phase 1 trial. Primary endpoints were safety and tolerability, and secondary endpoints evaluated efficacy. At 12 months after dosing, the therapy was well tolerated. No serious adverse events were observed, with minor events, including transient neutropenia and Clostridioides difficile gastroenteritis, experienced but resolved. Preliminary efficacy measures suggest a stabilization of the disease course. Longer follow-up is needed to confirm the safety and provide additional insights on the efficacy of the therapy. Overall, this report supports the safety of gene therapy for SPG50 and provides insights into precision therapy development for rare diseases. Clinical trial registration: NCT06069687 .
Published: 2024

2. Temporal dynamics of the multi-omic response to endurance exercise training

Author: Bae, Dam, Dasari, Surendra, Dennis, Courtney, Evans, Charles R, Gaul, David A, Ilkayeva, Olga, Ivanova, Anna A, Kachman, Maureen T, Keshishian, Hasmik, Lanza, Ian R, Lira, Ana C, Muehlbauer, Michael J, Nair, Venugopalan D, Piehowski, Paul D, Rooney, Jessica L, Smith, Kevin S, Stowe, Cynthia L, Zhao, Bingqing, Clark, Natalie M, Jimenez-Morales, David, Lindholm, Malene E, Many, Gina M, Sanford, James A, Smith, Gregory R, Vetr, Nikolai G, Zhang, Tiantian, Almagro Armenteros, Jose J, Avila-Pacheco, Julian, Bararpour, Nasim, Ge, Yongchao, Hou, Zhenxin, Marwaha, Shruti, Presby, David M, Natarajan Raja, Archana, Savage, Evan M, Steep, Alec, Sun, Yifei, Wu, Si, Zhen, Jimmy, Bodine, Sue C, Esser, Karyn A, Goodyear, Laurie J, Schenk, Simon, Montgomery, Stephen B, Fernández, Facundo M, Sealfon, Stuart C, Snyder, Michael P, Adkins, Joshua N, Ashley, Euan, Burant, Charles F, Carr, Steven A, Clish, Clary B, Cutter, Gary, Gerszten, Robert E, Kraus, William E, Li, Jun Z, Miller, Michael E, Nair, K Sreekumaran, Newgard, Christopher, Ortlund, Eric A, Qian, Wei-Jun, Tracy, Russell, Walsh, Martin J, Wheeler, Matthew T, Dalton, Karen P, Hastie, Trevor, Hershman, Steven G, Samdarshi, Mihir, Teng, Christopher, Tibshirani, Rob, Cornell, Elaine, Gagne, Nicole, May, Sandy, Bouverat, Brian, Leeuwenburgh, Christiaan, Lu, Ching-ju, Pahor, Marco, Hsu, Fang-Chi, Rushing, Scott, Walkup, Michael P, Nicklas, Barbara, Rejeski, W Jack, Williams, John P, Xia, Ashley, Albertson, Brent G, Barton, Elisabeth R, Booth, Frank W, Caputo, Tiziana, Cicha, Michael, De Sousa, Luis Gustavo Oliveira, Farrar, Roger, Hevener, Andrea L, Hirshman, Michael F, Jackson, Bailey E, Ke, Benjamin G, Kramer, Kyle S, Lessard, Sarah J, Makarewicz, Nathan S, Marshall, Andrea G, and Nigro, Pasquale
Subjects: Health Sciences, Sports Science and Exercise, Prevention, Human Genome, Cardiovascular, Behavioral and Social Science, Genetics, Physical Activity, 2.1 Biological and endogenous factors, 1.1 Normal biological development and functioning, Generic health relevance, Inflammatory and immune system, Good Health and Well Being, Animals, Female, Humans, Male, Rats, Acetylation, Blood, Cardiovascular Diseases, Databases, Factual, Endurance Training, Epigenome, Inflammatory Bowel Diseases, Internet, Lipidomics, Metabolome, Mitochondria, Multiomics, Non-alcoholic Fatty Liver Disease, Organ Specificity, Phosphorylation, Physical Conditioning, Animal, Physical Endurance, Proteome, Proteomics, Time Factors, Transcriptome, Ubiquitination, Wounds and Injuries, MoTrPAC Study Group, Lead Analysts, MoTrPAC Study Group, General Science & Technology
Abstract: Regular exercise promotes whole-body health and prevents disease, but the underlying molecular mechanisms are incompletely understood1-3. Here, the Molecular Transducers of Physical Activity Consortium4 profiled the temporal transcriptome, proteome, metabolome, lipidome, phosphoproteome, acetylproteome, ubiquitylproteome, epigenome and immunome in whole blood, plasma and 18 solid tissues in male and female Rattus norvegicus over eight weeks of endurance exercise training. The resulting data compendium encompasses 9,466 assays across 19 tissues, 25 molecular platforms and 4 training time points. Thousands of shared and tissue-specific molecular alterations were identified, with sex differences found in multiple tissues. Temporal multi-omic and multi-tissue analyses revealed expansive biological insights into the adaptive responses to endurance training, including widespread regulation of immune, metabolic, stress response and mitochondrial pathways. Many changes were relevant to human health, including non-alcoholic fatty liver disease, inflammatory bowel disease, cardiovascular health and tissue injury and recovery. The data and analyses presented in this study will serve as valuable resources for understanding and exploring the multi-tissue molecular effects of endurance training and are provided in a public repository ( https://motrpac-data.org/ ).
Published: 2024

3. Sexual dimorphism and the multi-omic response to exercise training in rat subcutaneous white adipose tissue

Author: Many, Gina M, Sanford, James A, Sagendorf, Tyler J, Hou, Zhenxin, Nigro, Pasquale, Whytock, Katie L, Amar, David, Caputo, Tiziana, Gay, Nicole R, Gaul, David A, Hirshman, Michael F, Jimenez-Morales, David, Lindholm, Malene E, Muehlbauer, Michael J, Vamvini, Maria, Bergman, Bryan C, Fernández, Facundo M, Goodyear, Laurie J, Hevener, Andrea L, Ortlund, Eric A, Sparks, Lauren M, Xia, Ashley, Adkins, Joshua N, Bodine, Sue C, Newgard, Christopher B, and Schenk, Simon
Subjects: Medical Biochemistry and Metabolomics, Medical Physiology, Biomedical and Clinical Sciences, Nutrition and Dietetics, Physical Activity, Women's Health, Prevention, Behavioral and Social Science, Animals, Male, Female, Physical Conditioning, Animal, Rats, Sex Characteristics, Adipose Tissue, White, Subcutaneous Fat, Adipogenesis, Rats, Sprague-Dawley, Multiomics, MoTrPAC Study Group, Medical biochemistry and metabolomics, Medical physiology, Nutrition and dietetics
Abstract: Subcutaneous white adipose tissue (scWAT) is a dynamic storage and secretory organ that regulates systemic homeostasis, yet the impact of endurance exercise training (ExT) and sex on its molecular landscape is not fully established. Utilizing an integrative multi-omics approach, and leveraging data generated by the Molecular Transducers of Physical Activity Consortium (MoTrPAC), we show profound sexual dimorphism in the scWAT of sedentary rats and in the dynamic response of this tissue to ExT. Specifically, the scWAT of sedentary females displays -omic signatures related to insulin signaling and adipogenesis, whereas the scWAT of sedentary males is enriched in terms related to aerobic metabolism. These sex-specific -omic signatures are preserved or amplified with ExT. Integration of multi-omic analyses with phenotypic measures identifies molecular hubs predicted to drive sexually distinct responses to training. Overall, this study underscores the powerful impact of sex on adipose tissue biology and provides a rich resource to investigate the scWAT response to ExT.
Published: 2024

4. Clinicopathologic Features of Pediatric Oligodendrogliomas

Author: Rodriguez, Fausto J, Tihan, Tarik, Lin, Doris, McDonald, William, Nigro, Janice, Feuerstein, Burt, Jackson, Sadhana, Cohen, Kenneth, and Burger, Peter C
Subjects: Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Rare Diseases, Clinical Research, Brain Disorders, Pediatric, Brain Cancer, Adolescent, Brain Neoplasms, Child, Child, Preschool, Chromosome Deletion, Chromosomes, Human, Pair 1, Female, Humans, Immunohistochemistry, In Situ Hybridization, Fluorescence, Infant, Kaplan-Meier Estimate, Male, Oligodendroglioma, Polymerase Chain Reaction, Young Adult, oligodendroglioma, pediatric glioma, 1p19q, IDH1, brain tumor, Pathology, Clinical sciences
Abstract: Oligodendrogliomas are an important adult form of diffuse gliomas with a distinctive clinical and genetic profile. Histologically similar tumors occurring rarely in children are incompletely characterized. We studied 50 patients with oligodendrogliomas (median age at diagnosis 8 y, range 7 mo to 20 y). Tumors resembling dysembryoplastic neuroepithelial tumors or pilocytic astrocytomas or those having a "mixed" histology were excluded. Tumors at first diagnosis were low grade (n=38) or anaplastic (n=12). Histologic features included uniform round cells with perinuclear halos (100%), secondary structures (predominantly perineuronal satellitosis) (90%), calcifications (46%), and microcysts (44%). Sequential surgical specimens were obtained in 8 low-grade oligodendroglioma patients, with only 1 progressing to anaplasia. Studies for 1p19q performed in 40 cases demonstrated intact 1p19q loci in 29 (73%), 1p19q codeletion in 10 (25%), and 1p deletion with intact 19q in 1 (2%). Except for 2 young patients (3 and 11 y of age), patients with 1p19q codeletion were older than 16 years at diagnosis. Mutant IDH1 (R132H) protein immunohistochemistry was positive in 4 (of 22) (18%) cases, 3 of which also had 1p19q codeletion, whereas 1p19q status was not available on the fourth case. There was a nonsignificant trend for worse overall survival in grade III tumors, but no significant association with age, extent of resection, or 1p19q status. In summary, oligodendrogliomas with classic histology occur in the pediatric population but lack 1p19q codeletion and IDH1 (R132H) mutations in most instances. They are predominantly low grade, recur/clinically progress in a subset, but demonstrate a relatively low frequency of histologic progression.
Published: 2014

5. Bone Targeting Agents in Patients with Prostate Cancer: General Toxicities and Osteonecrosis of the Jaw

Author: Veronica Mollica, Giacomo Nuvola, Elisa Tassinari, Maria Concetta Nigro, Andrea Marchetti, Matteo Rosellini, Alessandro Rizzo, Costantino Errani, Francesco Massari, Mollica V., Nuvola G., Tassinari E., Nigro M.C., Marchetti A., Rosellini M., Rizzo A., Errani C., and Massari F.
Subjects: Male, Prostate cancer, Bone Density Conservation Agents, Osteonecrosis of the jaw, Bone targeting agent, Osteonecrosis, Prostatic Neoplasms, Bone Neoplasms, HSPC, Bone metastasi, Humans, CRPC, Denosumab, Zoledronic acid
Abstract: Introduction: Bone metastases are the most frequent site of secondary localization of prostate cancer (PCa) and are present in about 90% of cases of advanced disease. Consequently, an adequate management of bone involvement is of pivotal importance in the therapeutic approach and skeletal-related events (SREs) need to be closely monitored and promptly assessed and treated. Bone targeting agents (BTAs), consisting in bisphosphonates and denosumab, are an essential part of the treatment of metastatic prostate cancer that accompanies systemic treatments throughout the most part of the history of the disease. Activity and safety of bone targeting agents: These treatments are correlated to better outcomes in terms of reduction of SREs and, in metastatic castration resistant setting, of increased overall survival (OS), but several important adverse events have to be managed and prevented. Of these, osteonecrosis of the jaw (ONJ) is extremely invalidating and should be managed with a special attention. Discussion: The role of BTAs in prostate cancer is pivotal throughout many stages of the disease, but several toxicities should be quickly recognized and treated. We aim at recollecting evidence on clinical benefit of BTAs, common and specific toxicities, and explore the pathophysiology and clinical aspects of osteonecrosis of the jaw. We present a review of the literature to report the role of the different types of bone targeting agents in the management of prostate cancer with bone metastases with a particular focus on common toxicities and ONJ to recollect current evidences on the activity of these compounds and the correct management of their adverse events.
Published: 2022

6. Arrhythmic CArdiac DEath in MYotonic dystrophy type 1 patients (ACADEMY 1) study: the predictive role of programmed ventricular stimulation

Author: Vincenzo Russo, Andrea Antonio Papa, Anna Rago, Carmine Ciardiello, Anna Maria Martino, Alessandra Stazi, Paolo Golino, Leonardo Calò, Gerardo Nigro, Russo, Vincenzo, Papa, Andrea Antonio, Rago, Anna, Ciardiello, Carmine, Martino, Anna Maria, Stazi, Alessandra, Golino, Paolo, Calò, Leonardo, and Nigro, Gerardo
Subjects: Adult, Male, Primary prevention, Myotonic dystrophy, Defibrillators, Implantable, Sudden cardiac death, Prospective Studie, Death, Sudden, Cardiac, Physiology (medical), Tachycardia, Ventricular, Humans, Programmed ventricular stimulation, Prospective Studies, Cardiology and Cardiovascular Medicine, Arrhythmia, Human
Abstract: Aims Myotonic dystrophy type 1 (DM1) predisposes to the development of life-threatening arrhythmias and sudden cardiac death. Our study aimed to evaluate the prognostic value of programmed ventricular stimulation (PVS) in DM1 patients with conduction system disease. Methods and results Arrhythmic CArdiac DEath in MYotonic dystrophy type 1 patients (ACADEMY 1) is a double-arm non-randomized interventional prospective study. Myotonic dystrophy type 1 patients with permanent cardiac pacing indication were eligible for the inclusion. The study population underwent to pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation according to the inducibility of ventricular tachyarrhythmias at PVS. Primary endpoint of the study was a composite of appropriate ICD therapy and cardiac arrhythmic death. The secondary study endpoint was all-cause mortality. Seventy-two adult-onset DM1 patients (51 ± 12 years; 39 male) were enrolled in the study. A ventricular tachyarrhythmia was induced in 25 patients (34.7%) at PVS (PVS+) who underwent dual chambers ICD implantation. The remaining 47 patients (65.3%) without inducible ventricular tachyarrhythmia (PVS−) were treated with dual-chamber PM. During an average observation period of 44.7 ± 10.2 months, nine patients (12.5%) met the primary endpoint, four in the ICD group (16%) and five (10.6%) in the PM group. Thirteen patients died (18.5%), 2 in the ICD group (8%) and 11 in PM group (23.4%). The Kaplan–Meier analysis did not show a significantly different risk of both primary and secondary endpoint event rates between the two groups. Conclusions The inducibility of ventricular tachyarrhythmias has shown a limited value in the arrhythmic risk stratification among DM1 patients.
Published: 2021

7. A MT-TL1 variant identified by whole exome sequencing in an individual with intellectual disability, epilepsy, and spastic tetraparesis

Author: de Boer, Elke, Ockeloen, Charlotte W., Matalonga, Leslie, Horvath, Rita, Cohen, Enzo, Cuesta, Isabel, Danis, Daniel, Denommé-Pichon, Anne-Sophie, Duffourd, Yannis, Gilissen, Christian, Johari, Mridul, Laurie, Steven, Li, Shuang, Nelson, Isabelle, Peters, Sophia, Paramonov, Ida, Prasanth, Sivakumar, Robinson, Peter, Sablauskas, Karolis, Savarese, Marco, Steyaert, Wouter, Töpf, Ana, van der Velde, Joeri K., Vitobello, Antonio, Rodenburg, Richard J., Coenen, Marieke J. H., Janssen, Mirian, Henssen, Dylan, Banka, Siddharth, Benetti, Elisa, Casari, Giorgio, Ciolfi, Andrea, Clayton-Smith, Jill, Dallapiccola, Bruno, Ellwanger, Kornelia, Faivre, Laurence, Graessner, Holm, Haack, Tobias B., Hammarsjö, Anna, Havlovicova, Marketa, Hoischen, Alexander, Hugon, Anne, Jackson, Adam, Kleefstra, Tjitske, Lindstrand, Anna, López-Martín, Estrella, Macek, Milan, Morleo, Manuela, Nigro, Vicenzo, Nordgren, Ann, Pettersson, Maria, Pinelli, Michele, Pizzi, Simone, Posada, Manuel, Radio, Francesca Clementina, Renieri, Alessandra, Rooryck, Caroline, Ryba, Lukas, Schwarz, Martin, Tartaglia, Marco, Thauvin, Christel, Torella, Annalaura, Verloes, Alain, Vissers, Lisenka, Votypka, Pavel, Vyshka, Klea, Zurek, Birte, Trimouille, Aurélien, Vissers, Lisenka E. L. M., Laboratoire Maladies Rares: Génétique et Métabolisme (Bordeaux) (U1211 INSERM/MRGM), Université de Bordeaux (UB)-Groupe hospitalier Pellegrin-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de génétique [Robert Debré], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), European Research Council, Evelyn Trust, Newton Fund, European Project: 825619,AI4EU, Dutch Research Council (Holanda), Medical Research Council (Reino Unido), Lily Foundation, Unión Europea. Comisión Europea. H2020, Ockeloen, Charlotte W [0000-0003-0329-1520], Horvath, Rita [0000-0002-9841-170X], Rodenburg, Richard J [0000-0001-5227-3527], Gilissen, Christian [0000-0003-1693-9699], Steyaert, Wouter [0000-0001-8393-0788], Trimouille, Aurélien [0000-0002-3457-5684], Verloes, Alain [0000-0003-4819-0264], Vissers, Lisenka ELM [0000-0001-6470-5497], Apollo - University of Cambridge Repository, de Boer, E., Ockeloen, C. W., Matalonga, L., Horvath, R., Rodenburg, R. J., Coenen, M. J. H., Janssen, M., Henssen, D., Gilissen, C., Steyaert, W., Paramonov, I., Trimouille, A., Kleefstra, T., Verloes, A., Vissers, L. E. L. M., Nigro, V., Torella, A., and Banfi, S.
Subjects: Male, Proband, Mitochondrial DNA, RNA, Transfer, Leu, Brief Communication, Quadriplegia, Whole Exome Sequencing, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18], Young Adult, 03 medical and health sciences, Epilepsy, 0302 clinical medicine, Intellectual Disability, Exome Sequencing, Genetics research, Intellectual disability, Genetics, medicine, Humans, Genetics (clinical), Exome sequencing, 0303 health sciences, Neurodevelopmental disorders Donders Center for Medical Neuroscience [Radboudumc 7], business.industry, Neurodevelopmental disorders, 030305 genetics & heredity, Correction, Metabolic Disorders Radboud Institute for Molecular Life Sciences [Radboudumc 6], Translational research, medicine.disease, Heteroplasmy, 3. Good health, MT-TL1, Mutation, Inflammatory diseases Radboud Institute for Health Sciences [Radboudumc 5], Spastic tetraparesis, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Neurological disorders, 030217 neurology & neurosurgery
Abstract: Correction: A MT-TL1 variant identified by whole exome sequencing in an individual with intellectual disability, epilepsy, and spastic tetraparesis. Eur J Hum Genet. 2021 Sep;29(9):1470-1471. doi: 10.1038/s41431-021-00937-3. The genetic etiology of intellectual disability remains elusive in almost half of all affected individuals. Within the Solve-RD consortium, systematic re-analysis of whole exome sequencing (WES) data from unresolved cases with (syndromic) intellectual disability (n = 1,472 probands) was performed. This re-analysis included variant calling of mitochondrial DNA (mtDNA) variants, although mtDNA is not specifically targeted in WES. We identified a functionally relevant mtDNA variant in MT-TL1 (NC_012920.1:m.3291T > C; NC_012920.1:n.62T > C), at a heteroplasmy level of 22% in whole blood, in a 23-year-old male with severe intellectual disability, epilepsy, episodic headaches with emesis, spastic tetraparesis, brain abnormalities, and feeding difficulties. Targeted validation in blood and urine supported pathogenicity, with heteroplasmy levels of 23% and 58% in index, and 4% and 17% in mother, respectively. Interestingly, not all phenotypic features observed in the index have been previously linked to this MT-TL1 variant, suggesting either broadening of the m.3291T > C-associated phenotype, or presence of a co-occurring disorder. Hence, our case highlights the importance of underappreciated mtDNA variants identifiable from WES data, especially for cases with atypical mitochondrial phenotypes and their relatives in the maternal line. This work was financially supported by Aspasia grants of the Dutch Research Council (015.014.036 to TK and 015.014.066 to LELMV), the European Research Council (ERC to RH), the Well come Investigator Award (109915/Z/15/Z to RH), the Medical Research Council UK (MR/N025431/1 to RH), the Newton Fund (MR/N027302/1 to RH), the Lily Foundation (RH), and the Evelyn Trust (RH). The Solve-RD project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 779257. Sí
Published: 2021

8. Is 40 Joules Enough to Successfully Defibrillate With Subcutaneous Implantable Cardioverter-Defibrillators?

Author: Maurizio Eugenio Landolina, Antonio Pangallo, Antonio D'Onofrio, Grigorios Katsouras, Mauro Biffi, Stefano Viani, Gerardo Nigro, Sergio Valsecchi, Mariolina Lovecchio, Matteo Ziacchi, Carlo Lavalle, Michele Manzo, Vincenzo Bonfantino, 'S-Icd Rhythm Detect' Investigators, Paolo Pieragnoli, Igor Diemberger, Maria Grazia Bongiorni, Valter Bianchi, Giovanni Battista Perego, Pietro Palmisano, Luca Ottaviano, Biffi M., Bongiorni M.G., D'Onofrio A., Manzo M., Pieragnoli P., Palmisano P., Ottaviano L., Perego G.B., Pangallo A., Lavalle C., Bonfantino V., Nigro G., Landolina M.E., Katsouras G., Diemberger I., Viani S., Bianchi V., Lovecchio M., Valsecchi S., and Ziacchi M.
Subjects: implantable defibrillator, Male, medicine.medical_specialty, Test failure, Defibrillation, medicine.medical_treatment, 030204 cardiovascular system & hematology, Implantable defibrillator, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, defibrillation test, Humans, Medicine, 030212 general & internal medicine, conversion, Lead (electronics), Male gender, High rate, business.industry, Arrhythmias, Cardiac, subcutaneou, medicine.disease, Defibrillators, Implantable, Shock (circulatory), Ventricular Fibrillation, Ventricular fibrillation, Cardiology, medicine.symptom, business, Human
Abstract: Objectives: This study evaluated the efficacy of conversion test performed at 40 J (defibrillation margin ≥40 J), and factors potentially associated with test failure were identified. Background: Current subcutaneous implantable cardioverter-defibrillator (S-ICD) devices deliver a maximum of 80 J. Functional defibrillation testing is recommended at S-ICD implantation, and it is usually conducted by delivering a shock energy of 65 J to ensure a safety defibrillation margin ≥15 J. Although high rates of successful conversion were reported at 65 J, limited data exist on the defibrillation margin extent. Methods: Ventricular fibrillation was induced and conversion test was performed by delivering a 40-J shock in 308 patients. Success was defined as termination of ventricular fibrillation by the first shock delivered in standard polarity. The S-ICD system positioning was evaluated with the PRAETORIAN score using bidirectional chest X-rays. Results: The generator was positioned in an intermuscular pocket in 301 patients (98%) and the lead was implanted by means of a 2-incision technique. The PRAETORIAN score was 50 (OR: 2.93; 95% CI: 1.26 to 6.83; p = 0.013) were independently associated with conversion failure. Conclusions: The authors showed a high rate of defibrillation success with 40-J shocks in S-ICD systems implanted by means of modern surgical techniques. The variables associated with shock failure were male gender, higher body mass index, and suboptimal device position according to the PRAETORIAN score.
Published: 2021

9. Cellular adhesion regulates p53 protein levels in primary human keratinocytes.

Author: Nigro, JM, Aldape, KD, Hess, SM, and Tlsty, TD
Subjects: Stem Cell Research, Stem Cell Research - Nonembryonic - Human, Genetics, Human Genome, Underpinning research, 2.1 Biological and endogenous factors, 1.1 Normal biological development and functioning, Aetiology, Cell Adhesion, Cell Cycle, Cell Nucleus, Cells, Cultured, Cyclin-Dependent Kinase Inhibitor p21, Cyclins, DNA Damage, Fibroblasts, Humans, Keratinocytes, Male, Nuclear Proteins, Proto-Oncogene Proteins, Proto-Oncogene Proteins c-mdm2, RNA, Messenger, Transcriptional Activation, Tumor Suppressor Protein p53, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract: To gain insight into p53 tissue-specific regulatory pathways and biological activities, we investigated mechanisms that may account for the elevated levels of p53 protein in human foreskin keratinocytes, relative to levels in dermal fibroblasts in vitro. Here, we report that the loss of cell anchorage resulted in an approximately 5-fold decrease in p53 levels in keratinocytes, which was reversible upon reattachment of cells to a substratum. In contrast, fibroblasts did not exhibit such adhesion-dependent regulation of p53 protein. Furthermore, p53 function was attenuated in keratinocytes relative to fibroblasts. These results link p53 to cell adhesion pathways and may provide a molecular basis for epigenetic differences in the maintenance of genomic stability among normal cell types.
Published: 1997

10. Use of bronchoscopic steam thermal ablation (BTVA) in a clinically compromised patient

Author: Roberto Marchese, Chiara Lo Nigro, and Federica Scaduto
Subjects: Aged, 80 and over, Male, Pulmonary and Respiratory Medicine, Emphysema, RD1-811, General Medicine, Pulmonary Disease, Chronic Obstructive, Steam, Pulmonary Emphysema, Anesthesiology, Lung volume reduction, Bronchoscopy, BTVA, Humans, COPD, Surgery, RD78.3-87.3, Pneumonectomy, Cardiology and Cardiovascular Medicine
Abstract: BackgroundBronchoscopic lung volume reduction (BLVR) techniques improve lung function and increase exercise tolerance in patients with chronic obstructive pulmonary disease (COPD) and BLVR treatment is included in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines for these patients. BTVA (Intervapor Uptake Medical, Tustin, CA, USA) represents a recent therapy of this group that allows to treat sublobar areas and for this reason is used clinically compromised patients, like in this case report.Case presentationIn this paper we describe a case report of an 85-year-old male with severe respiratory failure and a diagnosis of emphysema presented with dyspnea and clinical worsening, despite the best medical therapy practiced. For comorbidity and pathology’s features he was excluded from surgical treatment options, like lung volume reduction surgical (LVRS) and from positioning of endobronchial valves (EBV) for the presence of collateral ventilation and he was addressed to BTVA. The procedure was successful for this patient.ConclusionsThis case supports recent suggestions that BTVA can be a good alternative treatment for patients properly selected.
Published: 2022

11. Kidney failure prediction models

Author: Ramspek, Chava L, Evans, Marie, Wanner, Christoph, Drechsler, Christiane, Chesnaye, Nicholas C, Szymczak, Maciej, Krajewska, Magdalena, Torino, Claudia, Porto, Gaetana, Hayward, Samantha, Caskey, Fergus, Dekker, Friedo W, Jager, Kitty J, van Diepen, Merel, EQUAL Study Investigators: Adamasco Cupisti, Adelia Sagliocca, Alberto Ferraro, Aleksandra Musiała, Alessandra Mele, Alessandro Naticchia, Alex Còsaro, Alistair Woodman, Andrea Ranghino, Andrea Stucchi, Andreas Jonsson, Andreas Schneider, Angelo Pignataro, Anita Schrander, Anke Torp, Anna McKeever, Anna Szymczak, Anna-Lena Blom, Antonella De Blasio, Antonello Pani, Aris Tsalouichos, Asad Ullah, Barbara McLaren, Bastiaan van Dam, Beate Iwig, Bellasi Antonio, Biagio Raffaele Di Iorio, Björn Rogland, Boris Perras, Butti Alessandra, Camille Harron, Carin Wallquist, Carl Siegert, Carla Barrett, Carlo Gaillard, Carlo Garofalo, Cataldo Abaterusso, Charles Beerenhout, Charlotte O'Toole, Chiara Somma, Christian Marx, Christina Summersgill, Christof Blaser, Claudia D'alessandro, Claudia Emde, Claudia Zullo, Claudio Pozzi, Colin Geddes, Cornelis Verburgh, Daniela Bergamo, Daniele Ciurlino, Daria Motta, Deborah Glowski, Deborah McGlynn, Denes Vargas, Detlef Krieter, Domenico Russo, Dunja Fuchs, Dympna Sands, Ellen Hoogeveen, Ellen Irmler, Emöke Dimény, Enrico Favaro, Eva Platen, Ewelina Olczyk, Ewout Hoorn, Federica Vigotti, Ferruccio Ansali, Ferruccio Conte, Francesca Cianciotta, Francesca Giacchino, Francesco Cappellaio, Francesco Pizzarelli, Fredrik Sundelin, Fredrik Uhlin, Gaetano Greco, Geena Roy, Gaetana Porto, Giada Bigatti, Giancarlo Marinangeli, Gianfranca Cabiddu, Gillian Hirst, Giordano Fumagalli, Giorgia Caloro, Giorgina Piccoli, Giovanbattista Capasso, Giovanni Gambaro, Giuliana Tognarelli, Giuseppe Bonforte, Giuseppe Conte, Giuseppe Toscano, Goffredo Del Rosso, Gunilla Welander, Hanna Augustyniak-Bartosik, Hans Boots, Hans Schmidt-Gürtler, Hayley King, Helen McNally, Hendrik Schlee, Henk Boom, Holger Naujoks, Houda Masri-Senghor, Hugh Murtagh, Hugh Rayner, Ilona Miśkowiec-Wiśniewska, Ines Schlee, Irene Capizzi, Isabel Bascaran Hernandez, Ivano Baragetti, Jacek Manitius, Jane Turner, Jan-Willem Eijgenraam, Jeroen Kooman, Joachim Beige, Joanna Pondel, Joanne Wilcox, Jocelyn Berdeprado, Jochen Röthele, Jonathan Wong, Joris Rotmans, Joyce Banda, Justyna Mazur, Kai Hahn, Kamila Jędrzejak, Katarzyna Nowańska, Katja Blouin, Katrin Neumeier, Kirsteen Jones, Kirsten Anding-Rost, Knut-Christian Gröntoft, Lamberto Oldrizzi, Lesley Haydock, Liffert Vogt, Lily Wilkinson, Loreto Gesualdo, Lothar Schramm, Luigi Biancone, Łukasz Nowak, Maarten Raasveld, Magdalena Durlik, Manuela Magnano, Marc Vervloet, Marco Ricardi, Margaret Carmody, Maria Di Bari, Maria Laudato, Maria Luisa Sirico, Maria Stendahl, Maria Svensson, Maria Weetman, Marjolijn van Buren, Martin Joinson, Martina Ferraresi, Mary Dutton, Merel van Diepen, Michael Matthews, Michele Provenzano, Monika Hopf, Moreno Malaguti, Nadja Wuttke, Neal Morgan, Nicola Palmieri, Nikolaus Frischmuth, Nina Bleakley, Paola Murrone, Paul Cockwell, Paul Leurs, Paul Roderick, Pauline Voskamp, Pavlos Kashioulis, Pawlos Ichtiaris, Peter Blankestijn, Petra Kirste, Petra Schulz, Phil Mason, Philip Kalra, Pietro Cirillo, Pietro Dattolo, Pina Acampora, Rincy Sajith, Rita Nigro, Roberto Boero, Roberto Scarpioni, Rosa Sicoli, Rosella Malandra, Sabine Aign, Sabine Cäsar, Sadie van Esch, Sally Chapman, Sandra Biribauer, Santee Navjee, Sarah Crosbie, Sharon Brown, Sheila Tickle, Sherin Manan, Silke Röser, Silvana Savoldi, Silvio Bertoli, Silvio Borrelli, Siska Boorsma, Stefan Heidenreich, Stefan Melander, Stefania Maxia, Stefano Maffei, Stefano Mangano, Stephanie Palm, Stijn Konings, Suresh Mathavakkannan, Susanne Schwedler, Sylke Delrieux, Sylvia Renker, Sylvia Schättel, Szyszkowska Dorota, Teresa Cicchetti, Teresa Nieszporek, Theresa Stephan, Thomas Schmiedeke, Thomas Weinreich, Til Leimbach, Tiziana Rappa, Tora Almquist, Torsten Stövesand, Udo Bahner, Ulrika Jensen, Valentina Palazzo, Walter De Simone, Wolfgang Seeger, Ying Kuan, Zbigniew Heleniak, Zeynep Aydin, Internal Medicine, Chava L, Ramspek, Marie, Evan, Christoph, Wanner, Christiane, Drechsler, Nicholas C, Chesnaye, Maciej, Szymczak, Magdalena, Krajewska, Claudia, Torino, Gaetana, Porto, Samantha, Hayward, Fergus, Caskey, Friedo W, Dekker, Kitty J, Jager, Merel, van Diepen, Study Investigators: Adamasco Cupisti, Equal, Sagliocca, Adelia, Ferraro, Alberto, Musiała, Aleksandra, Mele, Alessandra, Naticchia, Alessandro, Còsaro, Alex, Woodman, Alistair, Ranghino, Andrea, Stucchi, Andrea, Jonsson, Andrea, Schneider, Andrea, Pignataro, Angelo, Schrander, Anita, Torp, Anke, Mckeever, Anna, Szymczak, Anna, Blom, Anna-Lena, De Blasio, Antonella, Pani, Antonello, Tsalouichos, Ari, Ullah, Asad, Mclaren, Barbara, van Dam, Bastiaan, Iwig, Beate, Antonio, Bellasi, Raffaele Di Iorio, Biagio, Rogland, Björn, Perras, Bori, Alessandra, Butti, Harron, Camille, Wallquist, Carin, Siegert, Carl, Barrett, Carla, Gaillard, Carlo, Garofalo, Carlo, Abaterusso, Cataldo, Beerenhout, Charle, O'Toole, Charlotte, Somma, Chiara, Marx, Christian, Summersgill, Christina, Blaser, Christof, D'Alessandro, Claudia, Emde, Claudia, Zullo, Claudia, Pozzi, Claudio, Geddes, Colin, Verburgh, Corneli, Bergamo, Daniela, Ciurlino, Daniele, Motta, Daria, Glowski, Deborah, Mcglynn, Deborah, Vargas, Dene, Krieter, Detlef, Russo, Domenico, Fuchs, Dunja, Sands, Dympna, Hoogeveen, Ellen, Irmler, Ellen, Dimény, Emöke, Favaro, Enrico, Platen, Eva, Olczyk, Ewelina, Hoorn, Ewout, Vigotti, Federica, Ansali, Ferruccio, Conte, Ferruccio, Cianciotta, Francesca, Giacchino, Francesca, Cappellaio, Francesco, Pizzarelli, Francesco, Sundelin, Fredrik, Uhlin, Fredrik, Greco, Gaetano, Roy, Geena, Porto, Gaetana, Bigatti, Giada, Marinangeli, Giancarlo, Cabiddu, Gianfranca, Hirst, Gillian, Fumagalli, Giordano, Caloro, Giorgia, Piccoli, Giorgina, Capasso, Giovanbattista, Gambaro, Giovanni, Tognarelli, Giuliana, Bonforte, Giuseppe, Conte, Giuseppe, Toscano, Giuseppe, Del Rosso, Goffredo, Welander, Gunilla, Augustyniak-Bartosik, Hanna, Boots, Han, Schmidt-Gürtler, Han, King, Hayley, Mcnally, Helen, Schlee, Hendrik, Boom, Henk, Naujoks, Holger, Masri-Senghor, Houda, Murtagh, Hugh, Rayner, Hugh, Miśkowiec-Wiśniewska, Ilona, Schlee, Ine, Capizzi, Irene, Bascaran Hernandez, Isabel, Baragetti, Ivano, Manitius, Jacek, Turner, Jane, Eijgenraam, Jan-Willem, Kooman, Jeroen, Beige, Joachim, Pondel, Joanna, Wilcox, Joanne, Berdeprado, Jocelyn, Röthele, Jochen, Wong, Jonathan, Rotmans, Jori, Banda, Joyce, Mazur, Justyna, Hahn, Kai, Jędrzejak, Kamila, Nowańska, Katarzyna, Blouin, Katja, Neumeier, Katrin, Jones, Kirsteen, Anding-Rost, Kirsten, Gröntoft, Knut-Christian, Oldrizzi, Lamberto, Haydock, Lesley, Vogt, Liffert, Wilkinson, Lily, Gesualdo, Loreto, Schramm, Lothar, Biancone, Luigi, Nowak, Łukasz, Raasveld, Maarten, Durlik, Magdalena, Magnano, Manuela, Vervloet, Marc, Ricardi, Marco, Carmody, Margaret, Di Bari, Maria, Laudato, Maria, Luisa Sirico, Maria, Stendahl, Maria, Svensson, Maria, Weetman, Maria, van Buren, Marjolijn, Joinson, Martin, Ferraresi, Martina, Dutton, Mary, van Diepen, Merel, Matthews, Michael, Provenzano, Michele, Hopf, Monika, Malaguti, Moreno, Wuttke, Nadja, Morgan, Neal, Palmieri, Nicola, Frischmuth, Nikolau, Bleakley, Nina, Murrone, Paola, Cockwell, Paul, Leurs, Paul, Roderick, Paul, Voskamp, Pauline, Kashioulis, Pavlo, Ichtiaris, Pawlo, Blankestijn, Peter, Kirste, Petra, Schulz, Petra, Mason, Phil, Kalra, Philip, Cirillo, Pietro, Dattolo, Pietro, Acampora, Pina, Sajith, Rincy, Nigro, Rita, Boero, Roberto, Scarpioni, Roberto, Sicoli, Rosa, Malandra, Rosella, Aign, Sabine, Cäsar, Sabine, van Esch, Sadie, Chapman, Sally, Biribauer, Sandra, Navjee, Santee, Crosbie, Sarah, Brown, Sharon, Tickle, Sheila, Manan, Sherin, Röser, Silke, Savoldi, Silvana, Bertoli, Silvio, Borrelli, Silvio, Boorsma, Siska, Heidenreich, Stefan, Melander, Stefan, Maxia, Stefania, Maffei, Stefano, Mangano, Stefano, Palm, Stephanie, Konings, Stijn, Mathavakkannan, Suresh, Schwedler, Susanne, Delrieux, Sylke, Renker, Sylvia, Schättel, Sylvia, Dorota, Szyszkowska, Cicchetti, Teresa, Nieszporek, Teresa, Stephan, Theresa, Schmiedeke, Thoma, Weinreich, Thoma, Leimbach, Til, Rappa, Tiziana, Almquist, Tora, Stövesand, Torsten, Bahner, Udo, Jensen, Ulrika, Palazzo, Valentina, De Simone, Walter, Seeger, Wolfgang, Kuan, Ying, Heleniak, Zbigniew, Aydin, Zeynep, Medical Informatics, ACS - Pulmonary hypertension & thrombosis, APH - Aging & Later Life, APH - Health Behaviors & Chronic Diseases, APH - Methodology, APH - Quality of Care, and APH - Global Health
Subjects: Male, progression of chronic renal failure, medicine.medical_specialty, Time Factors, epidemiology and outcome, 030232 urology & nephrology, Risk Assessment, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Older patients, external validation, Predictive Value of Tests, medicine, Humans, Failure risk, Clinical Epidemiology, In patient, comprehensive external validation, 030212 general & internal medicine, Statistic, Aged, Aged, 80 and over, Kidney, Models, Statistical, business.industry, External validation, General Medicine, prediction, kidney failure, Europe, prediction model, medicine.anatomical_structure, chronic kidney disease, epidemiology and outcomes, prognosis, Nephrology, Emergency medicine, Disease Progression, Kidney Failure, Chronic, Female, business, prognostic, Predictive modelling, prognosi, Cohort study
Abstract: Background Various prediction models have been developed to predict the risk of kidney failure in patients with CKD. However, guideline-recommended models have yet to be compared head to head, their validation in patients with advanced CKD is lacking, and most do not account for competing risks. Methods To externally validate 11 existing models of kidney failure, taking the competing risk of death into account, we included patients with advanced CKD from two large cohorts: the European Quality Study (EQUAL), an ongoing European prospective, multicenter cohort study of older patients with advanced CKD, and the Swedish Renal Registry (SRR), an ongoing registry of nephrology-referred patients with CKD in Sweden. The outcome of the models was kidney failure (defined as RRT-treated ESKD). We assessed model performance with discrimination and calibration. Results The study included 1580 patients from EQUAL and 13,489 patients from SRR. The average c statistic over the 11 validated models was 0.74 in EQUAL and 0.80 in SRR, compared with 0.89 in previous validations. Most models with longer prediction horizons overestimated the risk of kidney failure considerably. The 5-year Kidney Failure Risk Equation (KFRE) overpredicted risk by 10%-\18%. The four- and eight-variable 2-year KFRE and the 4-year Grams model showed excellent calibration and good discrimination in both cohorts. Conclusions Some existing models can accurately predict kidney failure in patients with advanced CKD. KFRE performed well for a shorter time frame (2 years), despite not accounting for competing events. Models predicting over a longer time frame (5 years) overestimated risk because of the competing risk of death. The Grams model, which accounts for the latter, is suitable for longer-term predictions (4 years).
Published: 2021

12. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case-control matched analysis from a large multicenter study

Author: Maria Vittoria Pensieri, Ettore D'Argento, Giovanni Mansueto, Lorenza Landi, Mario Occhipinti, Diego Cortinovis, Robin Cornelissen, Diego Signorelli, Lorenzo Antonuzzo, Gabriele Minuti, Valerio Maria Napoli, Corrado Ficorella, Francesco Grossi, Raffaele Giusti, Cinzia Baldesarri, Vincenzo Di Noia, Giampiero Porzio, Alfredo Addeo, Luigi Della Gravara, Vincenzo Sforza, Serena Ricciardi, Paola Bordi, Francesca Rastelli, Alessandro Inno, Giuseppe Luigi Banna, Giovanni Rossi, Michele De Tursi, Matteo Santoni, Rita Chiari, Alessandro De Toma, Olga Nigro, Andrea De Giglio, Clelia Donisi, Luca Cantini, Fabrizio Citarella, Alessio Cortellini, Michele Montrone, Alain Gelibter, Gianmarco Leone, Alessandro Follador, Annamaria Catino, Federica Zoratto, Marco Filetti, Pietro Di Marino, Giulio Metro, Alex Friedlaender, Alessandro Leonetti, Rossana Berardi, Maria Rita Migliorino, Marco Russano, Katia Cannita, Pulmonary Medicine, Cortellini A., De Giglio A., Cannita K., Cortinovis D.L., Cornelissen R., Baldessari C., Giusti R., D'Argento E., Grossi F., Santoni M., Catino A., Berardi R., Sforza V., Rossi G., Antonuzzo L., Di Noia V., Signorelli D., Gelibter A., Occhipinti M.A., Follador A., Rastelli F., Chiari R., Gravara L.D., Inno A., De Tursi M., Di Marino P., Mansueto G., Zoratto F., Filetti M., Montrone M., Citarella F., Pensieri M.V., Russano M., Cantini L., Nigro O., Leonetti A., Bordi P., Minuti G., Landi L., De Toma A., Donisi C., Ricciardi S., Migliorino M.R., Napoli V.M., Leone G., Metro G., Banna G.L., Friedlaender A., Addeo A., Ficorella C., and Porzio G.
Subjects: Male, non‐small cell lung cancer, 0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, First line, Respiratory System, Pembrolizumab, immunotherapy, non-small cell lung cancer, pembrolizumab, smoking, tobacco, lcsh:RC254-282, 03 medical and health sciences, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, Chemotherapy, Science & Technology, business.industry, Hazard ratio, Original Articles, General Medicine, Immunotherapy, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Former Smoker, Survival Analysis, Lung Neoplasm, 030104 developmental biology, Case-Control Studies, 030220 oncology & carcinogenesis, Cohort, Female, Original Article, Smoking status, Case-Control Studie, business, Life Sciences & Biomedicine, Human
Abstract: Background Improved outcome in tobacco smoking patients with non‐small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first‐line immunotherapy in patients with high PD‐L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first‐line pembrolizumab and platinum‐based chemotherapy. Results A total of 962 NSCLC patients with PD‐L1 expression ≥50% who received first‐line pembrolizumab and 462 NSCLC patients who received first‐line platinum‐based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression‐free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking status and treatment modality was concordantly statistically significant with respect to ORR (p = 0.0074), PFS (p = 0.0001) and OS (p = 0.0020), confirming the significantly different impact of smoking status across the two cohorts. Conclusions Among metastatic NSCLC patients with PD‐L1 expression ≥50% receiving first‐line pembrolizumab, current/former smokers experienced improved PFS and OS. On the contrary, worse outcomes were reported among current/former smokers receiving first‐line chemotherapy., Improved outcome in tobacco smoking NSCLC patients following treatment with immune checkpoint inhibitors (ICIs) has previously been reported. Little is known regarding this association during first‐line immunotherapy in patients with high PD‐L1 expression. Clinical outcomes according to the smoking status of two large multicenter cohorts were compared in this study. Smokers with high PD‐L1 expression ≥ 50% experienced improved progression‐free survival (PFS) and overall survival (OS) with first‐line pembrolizumab. The opposite trend was found in NSCLC patients treated with first‐line platinum‐based chemotherapy.
Published: 2021

13. Current androgen receptor antagonists under investigation for resistant prostate cancer

Author: Maria Concetta Nigro, Veronica Mollica, Andrea Marchetti, Michael Cheng, Matteo Rosellini, Rodolfo Montironi, Liang Cheng, and Francesco Massari
Subjects: Male, Prostatic Neoplasms, Castration-Resistant, Oncology, Receptors, Androgen, Nitriles, Androgen Receptor Antagonists, Humans, Androgen Antagonists, Pharmacology (medical)
Abstract: The gold standard of medical therapy for advanced prostate cancer is based on the use of androgen-receptor inhibitors and taxane-based chemotherapy. Several new agents, such as enzalutamide, apalutamide, darolutamide and abiraterone, are now approved and currently used in clinical practice.We present a review of the literature on the current state of the art on the use of androgen receptors inhibitors for the treatment of castration-resistant prostate cancer. We also provide an update on recent significant progress and ongoing clinical trials, and discuss the underlying cancer biology of castration resistance.The advent of second-generation androgen receptor inhibitors has radically changed the therapeutic landscape of advanced prostate cancer. Novel strategies targeting the androgenic signaling pathway are being evaluated in order to overcome resistance mechanisms, to optimize the sequence of drugs currently available and to develop new combinational approaches to improve survival outcomes of advanced prostate cancer patients. New clinical trials, predictive biomarkers research, and real-world experience may further improve clinical outcomes and guide clinicians in the decision-making process.
Published: 2021

14. Prevalence and clinical predictors of inappropriate direct oral anticoagulant dosage in octagenarians with atrial fibrillation

Author: Paolo Golino, Valentina Parisi, Giovanni Nigro, Antonello D'Andrea, E Attena, Francesco Santelli, Roberta Bottino, Vincenzo Russo, Carmine Mazzone, Andreina Carbone, Carbone, A., Santelli, F., Bottino, R., Attena, E., Mazzone, C., Parisi, V., D'Andrea, A., Golino, P., Nigro, G., Russo, V., Carbone, Andreina, Santelli, F, Bottino, Roberta, Attena, Emilio, Mazzone, Carmine, Parisi, Valentina, D’Andrea, Antonello, Golino, Paolo, Nigro, Gerardo, Russo, Vincenzo, and Santelli, Francesco
Subjects: Male, medicine.medical_specialty, Administration, Oral, Hemorrhage, Coronary Artery Disease, Elderly, Risk Factors, Internal medicine, Stroke prevention, Prevalence, medicine, Humans, Pharmacology (medical), Pharmacology, Aged, 80 and over, business.industry, Risk Factor, Direct oral anticoagulant, Inappropriate dosage, Eldery, Anticoagulant, Anticoagulants, Atrial fibrillation, General Medicine, medicine.disease, Stroke, Oral anticoagulant, Cardiology and Cardiovascular Medicine, business, Human
Abstract: Purpose Older age is associated with inappropriate dose prescription of direct oral anticoagulants. The aim of our study was to describe the prevalence and the clinical predictors of inappropriate DOACs dosage among octogenarians in real-world setting. Methods Data for this study were sourced from the multicenter prospectively maintained Atrial Fibrillation (AF) Research Database (NCT03760874). Of the AF patients aged ≥ 80 who received DOACs treatment, 253 patients were selected. Participants were categorized as appropriate dosage, overdosage, or underdosage. Underdosage and overdosage were, respectively, defined as administration of a lower or higher DOAC dose than recommended in the EHRA consensus. Results A total of 178 patients (71%) received appropriate DOACs dose and 75 patients (29%) inappropriate DOACs dose; among them, 19 patients (25.6%) were overdosed and 56 (74.4%) were underdosed. Subgroup analysis demonstrated that underdosage was independently associated with male gender [OR = 3.15 (95% IC; 1.45–6.83); p Conclusion In our analysis, nearly one-third of octogenarians with AF received an inappropriate dose of DOAC. Several clinical factors were associated with DOACs’ overdosage (diabetes mellitus type II, previous bleeding) or underdosage (male gender, coronary artery disease, and higher body mass index). Octogenarians with inappropriate DOACs underdosage showed less survival.
Published: 2021

15. Novel unconventional variants expand the allelic spectrum of <scp> OPHN1 </scp> gene

Author: Antonella Casella, Enza Maria Valente, Vincenzo Nigro, V. Brankovic, Caterina Caputi, Vincenzo Leuzzi, Sara Nuovo, Nuovo, S., Brankovic, V., Caputi, C., Casella, A., Nigro, V., Leuzzi, V., and Valente, E. M.
Subjects: Male, 0301 basic medicine, Adolescent, Developmental Disabilitie, Genes, Recessive, RhoGAP domain, 030105 genetics & heredity, Biology, Nervous System Malformation, 03 medical and health sciences, Neurodevelopmental disorder, Cerebellum, Intellectual Disability, Neurodevelopmental Disorder, Intellectual disability, Cytoskeletal Protein, Genetics, medicine, Missense mutation, Genetic Predisposition to Disease, Allele, Child, Cerebellar hypoplasia, allelic spectrum, Genetics (clinical), Loss function, proline-rich domain, Nuclear Protein, GTPase-Activating Protein, BAR domain, oligophrenin, OPHN1, High-Throughput Nucleotide Sequencing, Infant, Genetic Diseases, X-Linked, medicine.disease, Pedigree, 3. Good health, 030104 developmental biology, Child, Preschool, Female, Human, Ventriculomegaly
Abstract: Mutations in the OPHN1 gene cause a rare X-linked recessive neurodevelopmental disorder characterized by intellectual disability, variably associated with cerebellar hypoplasia and distinctive facial appearance. In most of cases so far reported, the identified genomic variants involve the region encoding the central RhoGAP domain of the oligophrenin-1 protein, and are predicted to result in a complete loss of function. By using a NGS-based diagnostic approach, we identified three male and a female patients from two unrelated families carrying novel non-disruptive OPHN1 variants (the in-frame c.116_127 deletion and the missense c.2129C>T change, respectively), affecting either the BAR domain or the C-terminus proline-rich domain of the protein. Clinical and neuroimaging findings in the patients recapitulated the main features of OPHN1-related syndrome, including developmental delay, intellectual disability, behavioral disorder, dysmorphic features, seizures, cerebellar hypoplasia, and ventriculomegaly. Yet, we observed a wide variability even among affected siblings, confirming the lack of clear genotype–phenotype correlation. Our results expand the allelic spectrum of OPHN1 and illustrate the challenges for clinical interpretation of non-disruptive variants affecting X-linked genes.
Published: 2021

16. Ferric carboxymaltose for iron deficiency at discharge after acute heart failure

Author: Stefano Savonitto, D Soon, V Tseluyko, J Heymeriks, L Petrescu, Fabio T. M. Costa, P Garcia Pacho, G Chapidze, Michael Motro, M Diez, A Prado, Piotr Ponikowski, Sanjib Kumar Sharma, DL Serban, A. Salvioni, S del Prado, Giuseppe Boriani, Stephan von Haehling, HG Cestari, PR Nierop, LC Iosipescu, Hans Kragten, Má Hominal, Bridget-Anne Kirwan, Andre Keren, D Horvat, J Thierer, D Sim, Rabih R. Azar, Peter van der Meer, G Stanciulescu, F Cosmi, Sy Loh, Jarosław Drożdż, David Sim, K Paposhvili, M Berli, Alain Cohen-Solal, Stefan D. Anker, Arnaout, ML Parody, GO Zapata, T Ben-Gal, J Schaap, Bas L.J.H. Kietselaer, O Raed, G Kiwan, Marco Metra, Shaul Atar, Udo Michael Göhring, Edoardo Gronda, A Ružić, C Beltrano, Dpw Beelen, Davor Milicic, R Ray, JM Weinstein, FI Ga Bosa Ojeda, Y-K Wong, Dalton Bertolim Précoma, Javed Butler, JR Gonzalez Juanatey, V Chumburidze, Gerasimos Filippatos, V Witzling, Y Malynovsky, I Kraiz, A Samodol, J Trevelyan, L Nigro Maia, M Stanislavchuk, Gilmar Reis, I Khintibidze, D Zdrenghea, Beata Wożakowska-Kapłon, BD Molina, C Abdallah, Ham van Kesteren, Tim Friede, Marcin Gruchała, Majdi Halabi, Ewa A. Jankowska, P Van Bergen, Constantin Militaru, O Koval, DA Darabantiu, A Kormann, J Szachniewicz, Maria Dorobantu, M van de Wetering, R Nijmeijer, H Hamdan, Stefano Ghio, Henry J. Dargie, G Azize, Nicolas Danchin, S Chaaban, S Gerward, P Pimentel Filho, M Uguccioni, K Abdelbaki, N Vita, J.F.K. Saraiva, D Almeida, Michael Shochat, M Ohlsson, R Van de Wal, V Zolotaikina, W Kinany, A Tycińska, A Hershson, T Shaburishvili, Vincent Fabien, FR dos Santos, Alfredo Bardají, Rgej Groutars, M Flugelman, J Bono, M Udovicic, M Artuković, K Šutalo, J Drozdz, TJ Yeo, F Ferre Pacora, Z Lominadze, M Emans, S Pettit, HA Luquez, P Terrosu, Marcus Ohlsson, M Gąsior, S Tušek, Enrico Passamonti, Nyy Al-Windy, P Midi, DA Pascual Figal, P van der Meer, V Zvi, Wilco Tanis, Felipe Martinez, RR Borelli, Diana A. Gorog, O Parhomenko, Klaus H Jensen, M Meijs, J Nessler, M Piepoli, DM Toader, Jose C. Nicolau, A Glenny, José Luis Zamorano, L Tilling, T McDonagh, K Pesek, H Fernandez, Davor Miličić, Domingo A. Pascual-Figal, Theresa McDonagh, G Khabeishvili, Josep Comin-Colet, Israel Gotsman, S Rassi, M Dorobantu, E Straburzyńska-Migaj, L Fattore, L Rudenko, D Crisu, S.S. Kabbani, M Gomez Bueno, Basil S. Lewis, S Goland, Y Arbel, M Bronisz, I Vakaliuk, A Fucili, A Mortara, R Zukermann, N Emukhvari, B Hassouna, K Mizia-Stec, F Turrini, R Szelemej, A Rodica Dan, L Lobo Marquez, Hadi Skouri, A Kabir, Frank Ruschitzka, R García Durán, R Gil, Michael Shechter, P Westendorp, Piergiuseppe Agostoni, A Fernandez, Oscar Pereira Dutra, P Ameri, Wolfram Doehner, JG Smith, Irakli Khintibidze, Luciano Moreira Baracioli, J Šikić, Stuart Pocock, Olivier C. Manintveld, MC Tomescu, M Di Biase, Luiz Carlos Bodanese, E Mirek-Bryniarska, Alexander Parkhomenko, Cardiovascular Centre (CVC), Restoring Organ Function by Means of Regenerative Medicine (REGENERATE), Cardiology, leboeuf, Christophe, Wrocław Medical University, London School of Hygiene and Tropical Medicine (LSHTM), Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], King's College Hospital (KCH), Universitatea din Bucuresti (UB), University of Lódź, Vifor Pharma Ltd [Glattbrugg, Switzerland], National and Kapodistrian University of Athens (NKUA), Hadassah Hebrew University Medical Center [Jerusalem], Tbilisi State University, Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], Prague University of Economics and Business, Università degli Studi di Brescia = University of Brescia (UniBs), University of Zagreb, Universidade de São Paulo = University of São Paulo (USP), Skane University Hospital [Malmo], Lund University [Lund], National Scientific Center 'M.D. Strazhesko Institute of Cardiology' [Kyiv, Ukraine] (NSC/MDSIC), Universidad de Murcia, University hospital of Zurich [Zurich], National Heart Centre Singapore (NHCS), Saint Joseph Medical Center [Beirut], University Medical Center Groningen [Groningen] (UMCG), Clinical Cardiovascular Research Institute [Haifa, Israel] (2CRI), Bellvitge University Hospital [Barcelona, Spain], University Medical Center Göttingen (UMG), Biomarqueurs CArdioNeuroVASCulaires (BioCANVAS), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Européen Georges Pompidou [APHP] (HEGP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO), Charité Campus Virchow-Klinikum (CVK), University of Glasgow, Tel Aviv University (TAU), University of Southern Mississippi (USM), Socar Research S.A. [Nyon, Switzerland] (SR), and AFFIRM-AHF investigators: G Azize, A Fernandez, G O Zapata, P Garcia Pacho, A Glenny, F Ferre Pacora, M L Parody, J Bono, C Beltrano, A Hershson, N Vita, H A Luquez, H G Cestari, H Fernandez, A Prado, M Berli, R García Durán, J Thierer, M Diez, L Lobo Marquez, R R Borelli, M Á Hominal, M Metra, P Ameri, P Agostoni, A Salvioni, L Fattore, E Gronda, S Ghio, F Turrini, M Uguccioni, M Di Biase, M Piepoli, S Savonitto, A Mortara, P Terrosu, A Fucili, G Boriani, P Midi, E Passamonti, F Cosmi, P van der Meer, P Van Bergen, M van de Wetering, Nyy Al-Windy, W Tanis, M Meijs, Rgej Groutars, Hks The, B Kietselaer, Ham van Kesteren, Dpw Beelen, J Heymeriks, R Van de Wal, J Schaap, M Emans, P Westendorp, P R Nierop, R Nijmeijer, O C Manintveld, M Dorobantu, D A Darabantiu, D Zdrenghea, D M Toader, L Petrescu, C Militaru, D Crisu, M C Tomescu, G Stanciulescu, A Rodica Dan, L C Iosipescu, D L Serban, J Drozdz, J Szachniewicz, M Bronisz, A Tycińska, B Wozakowska-Kaplon, E Mirek-Bryniarska, M Gruchała, J Nessler, E Straburzyńska-Migaj, K Mizia-Stec, R Szelemej, R Gil, M Gąsior, I Gotsman, M Halabi, M Shochat, M Shechter, V Witzling, R Zukermann, Y Arbel, M Flugelman, T Ben-Gal, V Zvi, W Kinany, J M Weinstein, S Atar, S Goland, D Milicic, D Horvat, S Tušek, M Udovicic, K Šutalo, A Samodol, K Pesek, M Artuković, A Ružić, J Šikić, T McDonagh, J Trevelyan, Y-K Wong, D Gorog, R Ray, S Pettit, S Sharma, A Kabir, H Hamdan, L Tilling, L Baracioli, L Nigro Maia, O Dutra, G Reis, P Pimentel Filho, J F Saraiva, A Kormann, F R Dos Santos, L Bodanese, D Almeida, D Precoma, S Rassi, F Costa, S Kabbani, K Abdelbaki, C Abdallah, M S Arnaout, R Azar, S Chaaban, O Raed, G Kiwan, B Hassouna, A Bardaji, J Zamorano, S Del Prado, J R Gonzalez Juanatey, F I Ga Bosa Ojeda, M Gomez Bueno, B D Molina, D A Pascual Figal, D Sim, T J Yeo, S Y Loh, D Soon, M Ohlsson, J G Smith, S Gerward, I Khintibidze, Z Lominadze, G Chapidze, N Emukhvari, G Khabeishvili, V Chumburidze, K Paposhvili, T Shaburishvili, G Khabeishvili, O Parhomenko, I Kraiz, O Koval, V Zolotaikina, Y Malynovsky, I Vakaliuk, L Rudenko, V Tseluyko, M Stanislavchuk.
Subjects: Male, medicine.medical_specialty, Anemia, 030204 cardiovascular system & hematology, Rate ratio, Placebo, Ferric Compounds, Ventricular Function, Left, law.invention, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, Double-Blind Method, Randomized controlled trial, law, Internal medicine, medicine, Humans, 030212 general & internal medicine, Maltose, Adverse effect, TOLVAPTAN, Aged, Aged, 80 and over, Heart Failure, RISK, Ejection fraction, Anemia, Iron-Deficiency, business.industry, MORTALITY, Hazard ratio, DEATH, General Medicine, Middle Aged, medicine.disease, Patient Discharge, [SDV.MHEP.CSC] Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, 3. Good health, Hospitalization, Treatment Outcome, Heart failure, Administration, Intravenous, Female, HOSPITALIZATIONS, business
Abstract: Background: Intravenous ferric carboxymaltose has been shown to improve symptoms and quality of life in patients with chronic heart failure and iron deficiency. We aimed to evaluate the effect of ferric carboxymaltose, compared with placebo, on outcomes in patients who were stabilised after an episode of acute heart failure. Methods: AFFIRM-AHF was a multicentre, double-blind, randomised trial done at 121 sites in Europe, South America, and Singapore. Eligible patients were aged 18 years or older, were hospitalised for acute heart failure with concomitant iron deficiency (defined as ferritin
Published: 2020

17. Biallelic variants in CENPF causing a phenotype distinct from Stromme syndrome

Author: Gerarda Cappuccio, Simona Brillante, Roberta Tammaro, Michele Pinelli, Margherita Lucia De Bernardi, Maria Grazia Gensini, Emilia K. Bijlsma, Tamara T. Koopmann, Mariette J. V. Hoffer, Kimberly McDonald, Laura G. Hendon, Sofia Douzgou, Charulata Deshpande, Stefano D'Arrigo, Annalaura Torella, Vincenzo Nigro, Brunella Franco, Nicola Brunetti‐Pierri, Cappuccio, Gerarda, Brillante, Simona, Tammaro, Roberta, Pinelli, Michele, De Bernardi, Margherita Lucia, Gensini, Maria Grazia, Bijlsma, Emilia K, Koopmann, Tamara T, Hoffer, Mariette J V, Mcdonald, Kimberly, Hendon, Laura G, Douzgou, Sofia, Deshpande, Charulata, D'Arrigo, Stefano, Torella, Annalaura, Nigro, Vincenzo, Franco, Brunella, and Brunetti-Pierri, Nicola
Subjects: Male, duodenal atresia, Stromme syndrome, Chromosomal Proteins, Non-Histone, Microfilament Proteins, Intestinal Atresia, CENPF, cilia, Eye Abnormalitie, Phenotype, Strømme syndrome, Intellectual Disability, Mutation, Microcephaly, Genetics, Humans, Female, anterior chamber defect, Eye Abnormalities, Genetics (clinical), Human
Abstract: Biallelic loss-of-function (LoF) variants in CENPF gene are responsible for Stromme syndrome, a condition presenting with intestinal atresia, anterior ocular chamber anomalies, and microcephaly. Through an international collaboration, four individuals (three males and one female) carrying CENPF biallelic variants, including two missense variants in homozygous state and four LoF variants, were identified by exome sequencing. All individuals had variable degree of developmental delay/intellectual disability and microcephaly (ranging from -2.9 SDS to -5.6 SDS) and a recognizable pattern of dysmorphic facial features including inverted-V shaped interrupted eyebrows, epicanthal fold, depressed nasal bridge, and pointed chin. Although one of the cases had duodenal atresia, all four individuals did not have the combination of internal organ malformations of Stromme syndrome (intestinal atresia and anterior eye segment abnormalities). Immunofluorescence analysis on skin fibroblasts on one of the four cases with the antibody for ARL13B that decorates primary cilia revealed shorter primary cilia that are consistent with a ciliary defect. This case-series of individuals with biallelic CENPF variants suggests the spectrum of clinical manifestations of the disorder that may be related to CENPF variants is broad and can include phenotypes lacking the cardinal features of Stromme syndrome.
Published: 2022

18. Management of older patients with unexplained, recurrent, traumatic syncope and bifascicular block: Implantable loop recorder versus empiric pacemaker implantation-Results of a propensity-matched analysis

Author: Pietro Palmisano, Federico Guerra, Vittorio Aspromonte, Gabriele Dell’Era, Pier Luigi Pellegrino, Mattia Laffi, Carlo Uran, Silvana De Bonis, Michele Accogli, Antonio Dello Russo, Giuseppe Patti, Francesco Santoro, Antonella Torriglia, Gerardo Nigro, Antonio Bisignani, Giovanni Coluccia, Giulia Stronati, Vincenzo Russo, Ernesto Ammendola, Palmisano, Pietro, Guerra, Federico, Aspromonte, Vittorio, Dell'Era, Gabriele, Pellegrino, Pier Luigi, Laffi, Mattia, Uran, Carlo, De Bonis, Silvana, Accogli, Michele, Dello Russo, Antonio, Patti, Giuseppe, Santoro, Francesco, Torriglia, Antonella, Nigro, Gerardo, Bisignani, Antonio, Coluccia, Giovanni, Stronati, Giulia, Russo, Vincenzo, and Ammendola, Ernesto
Subjects: Aged, 80 and over, Male, Pacemaker, Artificial, Unexplained syncope, Bundle-Branch Block, Empiric pacemaker implantation, Bradyarrhythmia, Syncope, Bifascicular block, Pacemaker, Traumatic syncope, Implantable loop recorder, Insertable cardiac monitor, Physiology (medical), Bradycardia, Electrocardiography, Ambulatory, Humans, Female, Prospective Studies, Cardiology and Cardiovascular Medicine, Aged
Abstract: In patients with unexplained syncope and bifascicular block (BFB), syncope may be caused by intermittent atrioventricular (AV) block. When a correlation between syncope and bradyarrhythmia is not documented in these patients, 2 alternative management strategies can be adopted: (1) empiric pacemaker (PM) implantation or (2) long-term continuous electrocardiographic monitoring by implantable loop recorder (ILR).The purpose of this study was to compare the risk of syncope recurrence associated with empiric PM implantation or ILR monitoring.A prospective, multicenter, observational study enrolled consecutive patients with unexplained, recurrent, traumatic syncope and BFB who underwent ILR monitoring or empiric PM implantation. The risk and causes of syncope recurrence were assessed and compared between the 2 groups. Individual 1:1 propensity matching of baseline characteristics was performed.A total of 309 consecutive patients (age 77.2 ± 12.2 years; 60.8% male) were enrolled. Propensity matching yielded 89 matched pairs. After median follow-up of 33 months, empiric PM implantation was associated with a significantly lower risk of syncope recurrence than ILR monitoring (19.1 vs 46.1%; P.001). A total of 35 patients (39.3%) who underwent ILR monitoring developed bradyarrhythmias (68.6% paroxysmal AV block) requiring PM implantation during follow-up. Excluding bradyarrhythmic syncope, the most frequent causes of syncope recurrence in both study groups were reflex syncope and orthostatic hypotension.In patients with unexplained, recurrent, traumatic syncope and BFB, empiric PM implantation significantly reduced the risk of syncope recurrence in comparison with ILR monitoring. A high rate of patients who underwent ILR monitoring developed bradyarrhythmias requiring PM implantation.
Published: 2022

19. Dapagliflozin in patients with cardiometabolic risk factors hospitalised with COVID-19 (DARE-19): a randomised, double-blind, placebo-controlled, phase 3 trial

Author: Jan Oscarsson, Emily E Akin, Ali Javaheri, Diogo D.F. Moia, Russell Esterline, Fengming Tang, Gary G. Koch, Audes D. M. Feitosa, Robert Gordon, Samvel B. Gasparyan, Joan Buenconsejo, Cristiano P Jaeger, Weimar Kunz Sebba Barroso, Philip Ambery, Omar Mukhtar, Paulo Leães, Anna Maria Langkilde, Subodh Verma, Conrado R. Hoffmann Filho, Ronaldo V P Soares, Kensey Gosch, Lilia Nigro Maia, Michael Pursley, Otavio Berwanger, Michael E. Nassif, Sheryl L. Windsor, Mikhail Kosiborod, José Roberto Lazcano Soto, Felipe Martinez, Vijay K. Chopra, Remo H.M. Furtado, Matthew Aboudara, Fabio Serra Silveira, Alberto Fonseca, and Vishnu Garla
Subjects: Male, medicine.medical_specialty, Multiple Organ Failure, Endocrinology, Diabetes and Metabolism, Population, Placebo, law.invention, chemistry.chemical_compound, Endocrinology, Double-Blind Method, Glucosides, Randomized controlled trial, law, Internal medicine, Correspondence, Internal Medicine, medicine, Humans, Benzhydryl Compounds, Dapagliflozin, education, Adverse effect, Sodium-Glucose Transporter 2 Inhibitors, Aged, education.field_of_study, SARS-CoV-2, business.industry, Hazard ratio, Organ dysfunction, COVID-19, Cardiometabolic Risk Factors, Articles, Middle Aged, medicine.disease, Treatment Outcome, chemistry, Female, medicine.symptom, business, Kidney disease
Abstract: Summary Background COVID-19 can lead to multiorgan failure. Dapagliflozin, a SGLT2 inhibitor, has significant protective benefits for the heart and kidney. We aimed to see whether this agent might provide organ protection in patients with COVID-19 by affecting processes dysregulated during acute illness. Methods DARE-19 was a randomised, double-blind, placebo-controlled trial of patients hospitalised with COVID-19 and with at least one cardiometabolic risk factor (ie, hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and chronic kidney disease). Patients critically ill at screening were excluded. Patients were randomly assigned 1:1 to dapagliflozin (10 mg daily orally) or matched placebo for 30 days. Dual primary outcomes were assessed in the intention-to-treat population: the outcome of prevention (time to new or worsened organ dysfunction or death), and the hierarchial composite outcome of recovery (change in clinical status by day 30). Safety outcomes, in patients who received at least one study medication dose, included serious adverse events, adverse events leading to discontinuation, and adverse events of interest. This study is registered with ClinicalTrials.gov , NCT04350593 . Findings Between April 22, 2020 and Jan 1, 2021, 1250 patients were randomly assigned with 625 in each group. The primary composite outcome of prevention showed organ dysfunction or death occurred in 70 patients (11·2%) in the dapagliflozin group, and 86 (13·8%) in the placebo group (hazard ratio [HR] 0·80, 95% CI 0·58–1·10; p=0·17). For the primary outcome of recovery, 547 patients (87·5%) in the dapagliflozin group and 532 (85·1%) in the placebo group showed clinical status improvement, although this was not statistically significant (win ratio 1·09, 95% CI 0·97–1·22; p=0·14). There were 41 deaths (6·6%) in the dapagliflozin group, and 54 (8·6%) in the placebo group (HR 0·77, 95% CI 0·52–1·16). Serious adverse events were reported in 65 (10·6%) of 613 patients treated with dapagliflozin and in 82 (13·3%) of 616 patients given the placebo. Interpretation In patients with cardiometabolic risk factors who were hospitalised with COVID-19, treatment with dapagliflozin did not result in a statistically significant risk reduction in organ dysfunction or death, or improvement in clinical recovery, but was well tolerated. Funding AstraZeneca.
Published: 2021

20. Immunoglobulins G modulate endothelial function and affect insulin sensitivity in humans

Author: Raffaele Napoli, Antonio Ruvolo, Fabio Magliulo, Cecilia Nigro, Claudia Miele, Giuseppe Spadaro, Antonio Pecoraro, Antonio Cittadini, Giovanni Esposito, Paola Triggianese, Simona Grassi, Gabriele G. Schiattarella, Amato de Paulis, Nella Prevete, Napoli, R., Ruvolo, A., Triggianese, P., Prevete, N., Schiattarella, G. G., Nigro, C., Miele, C., Magliulo, F., Grassi, S., Pecoraro, A., Cittadini, A., Esposito, G., de Paulis, A., and Spadaro, G.
Subjects: Blood Glucose, Male, Time Factors, Brachial Artery, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, Medicine (miscellaneous), chemistry.chemical_compound, Insulin, Medicine, Infusions, Intravenou, Brachial artery, Endothelial dysfunction, Infusions, Intravenous, Cells, Cultured, Nutrition and Dietetics, biology, Flow mediated dilation, Immunoglobulins, Intravenous, Vasodilation, Treatment Outcome, Atherosclerosi, Female, Antibody, Case-Control Studie, Cardiology and Cardiovascular Medicine, Human, medicine.medical_specialty, Time Factor, Adolescent, Nitric Oxide, Nitric oxide, Young Adult, Insulin resistance, Internal medicine, Diabetes mellitus, medicine.artery, Immunoglobulin, Humans, business.industry, Common variable immunodeficiency, Endothelial function, Biomarker, medicine.disease, Common Variable Immunodeficiency, Endocrinology, chemistry, Immunoglobulins, Intravenou, Case-Control Studies, Immunoglobulin G, biology.protein, Endothelium, Vascular, Insulin Resistance, business, Biomarkers
Abstract: Background and aims: Data from animals suggest that immunoglobulins G (IgG) play a mechanistic role in atherosclerosis and diabetes through endothelial dysfunction and insulin resistance. Patients with common variable immunodeficiency (CVID), who have low circulating levels of IgG and are treated with intravenous polyclonal IgG (IVIgG), may provide an ideal model to clarify whether circulating IgG modulate endothelial function and affect insulin sensitivity in humans. Methods and results: We studied 24 patients with CVID and 17 matched healthy controls (HC). Endothelial function was evaluated as flow mediated dilation (FMD) of the brachial artery at baseline and 1, 7, 14, and 21 days after IVIgG infusion in the CVID patients. We measured also plasma glucose, insulin, and calculated the HOMA-IR index. We also investigated the role of human IgG on the production of Nitric Oxide (NO) in vitro in Human Coronary Artery Endothelial Cells (HCAEC). Compared to HC, FMD of CVID patients was significantly impaired at baseline (9.4 ± 0.9 and 7.6 ± 0.6% respectively, p < 0.05) but rose above normal levels 1 and 7 days after IVIgG infusion to return at baseline at 14 and 21 days. Serum insulin concentration and HOMA-IR index dropped by 50% in CVID patients after IVIgG (p < 0.002 vs. baseline). In vitro IgG stimulated NO production in HCAEC. Conclusions: Reduced IgG levels are associated with endothelial dysfunction and IVIgG stimulates endothelial function directly while improving insulin sensitivity. The current findings may suggest an anti-atherogenic role of human IgG.
Published: 2020

21. Direct Current Cardioversion in Atrial Fibrillation Patients on Edoxaban Therapy Versus Vitamin K Antagonists: a Real-world Propensity Score–Matched Study

Author: Anna Rago, Emilio Attena, Andrea Antonio Papa, Vincenzo Russo, Valentina Parisi, Paolo Golino, Gerardo Nigro, Rago, A., Papa, A. A., Attena, E., Parisi, V., Golino, P., Nigro, G., and Russo, V.
Subjects: Male, Vitamin K, Pyridines, medicine.medical_treatment, Pyridine, Embolism, 030204 cardiovascular system & hematology, Cardioversion, Uninterrupted vitamin K antagonists, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, Transesophageal echocardiogram, Medicine, Pharmacology (medical), Cumulative incidence, 030212 general & internal medicine, Direct electrical current cardioversion, Stroke, Aged, 80 and over, Atrial fibrillation, General Medicine, Vitamin K antagonist, Middle Aged, Ischemic Attack, Transient, Cohort, Original Article, Female, Uninterrupted vitamin K antagonist, Cardiology and Cardiovascular Medicine, Human, medicine.medical_specialty, medicine.drug_class, Electric Countershock, Hemorrhage, Medication Adherence, 03 medical and health sciences, Internal medicine, Humans, Propensity Score, Aged, Pharmacology, business.industry, medicine.disease, Discontinuation, Thiazoles, chemistry, Thiazole, business, Factor Xa Inhibitor, Factor Xa Inhibitors
Abstract: Purpose The purpose of the present study was to compare the long-term effectiveness and safety of newly initiated anticoagulation with edoxaban (EDO) versus uninterrupted vitamin K antagonist (VKA) therapy in patients with atrial fibrillation (AF) scheduled for transesophageal echocardiogram (TEE)-guided direct electrical current cardioversion (DCC). Methods A propensity score-matched cohort observational study was performed comparing the safety and effectiveness of edoxaban versus well-controlled VKA therapy among a cohort of consecutive non-valvular AF patients scheduled for DCC. The primary safety outcome was major bleeding. The primary efficacy outcome was the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). Findings A total of 130 AF patients receiving edoxaban 60-mg (EDO) treatment were compared with the same number of VKA recipients. The cumulative incidence of major bleedings was 1.54% in the EDO group and 3.08% in the VKA group (P = 0.4). The cumulative incidence of thromboembolic events was 1.54% in the EDO group and 2.31% in the VKA group (P = 0.9). A non-significant trend in improved adherence was observed between the EDO and VKA groups with a total anticoagulant therapy discontinuation rate of 4.62% (6/130) vs 6.15% (8/130), respectively (P = 0.06). Implications Our study provides the evidence of a safe and effective use of edoxaban in this clinical setting, justified by no significant difference in major bleedings and thromboembolic events between edoxaban and well-controlled VKA treatments.
Published: 2020

22. BROX haploinsufficiency in familial nonmedullary thyroid cancer

Author: Domenico Salvatore, Daniela Esposito, Furio Pacini, Silvia Cantara, P. Sabatino, Annalaura Torella, F. Del Vecchio Blanco, Vincenzo Nigro, Giacomo Accardo, Maria Grazia Castagna, Daniela Pasquali, Filomena Barbato, Pasquali, D., Torella, A., Accardo, G., Esposito, D., Del Vecchio Blanco, F., Salvatore, D., Sabatino, P., Pacini, F., Barbato, F., Castagna, M. G., Cantara, S., and Nigro, V.
Subjects: Adult, Male, 0301 basic medicine, EGFR, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Haploinsufficiency, Biology, Thyroid cancer, Papillary thyroid cancer, Frameshift mutation, 03 medical and health sciences, symbols.namesake, 0302 clinical medicine, Endocrinology, medicine, Humans, Genetic Predisposition to Disease, Genetic Testing, Thyroid Neoplasms, Gene, Germ-Line Mutation, Genetic testing, Thyroid, Genetics, HABP2, Endosomal Sorting Complexes Required for Transport, medicine.diagnostic_test, FNMTC, Middle Aged, Prognosis, medicine.disease, Penetrance, 030104 developmental biology, BROX, Thyroid Cancer, Papillary, NGS, Mendelian inheritance, symbols, Female
Abstract: Background: The familial nonmedullary thyroid cancer (FNMTC) is suspected to be a Mendelian condition in up to 3–8% of thyroid cancers. The susceptibility chromosomal loci and genes of 95% of FNMTC cases remain to be characterized. The inheritance of FNMTC appears to be autosomal dominant with incomplete penetrance and variable expressivity. The finding of the causative gene of FNMTC and the identification of patients at risk that need genetic testing were our aim. Methods: We analyzed by whole-exome sequencing patients and non-affected relatives of five families with at least two family members affected by papillary thyroid cancer, selecting for new or extremely rare variants with predicted pathogenic value. Results: A family showed, in all three affected members, a new loss-of-function variant (frameshift deletion) in BROX gene at 1q41 that was absent from all internal and external databases. In a second family with three affected relatives, we found an additional new BROX variant. The smaller families presented no variants in BROX or in the other causative genes studied. Conclusions: BROX could be a new causative gene for FNMTC. Variants in BROX may result in the haploinsufficiency of a key gene involved in the morphogenesis of MVBs, in the endosomal sorting of cargo proteins, and in EGFR. Functional studies are needed to support this result. The thorough genomic analysis by NGS in all families with three or more affected members should become a routine approach to obtain a comprehensive genetic view and find confirmative second cases.
Published: 2020

23. Cardioinhibitory syncope with asystole during nitroglycerin potentiated head up tilt test: prevalence and clinical predictors

Author: Vincenzo Russo, Erika Parente, Anna Rago, Angelo Comune, Nunzia Laezza, Andrea Antonio Papa, Celeste Chamberland, Thao Huynh, Paolo Golino, Michele Brignole, Gerardo Nigro, Russo, Vincenzo, Parente, Erika, Rago, Anna, Comune, Angelo, Laezza, Nunzia, Papa, Andrea Antonio, Chamberland, Celeste, Huynh, Thao, Golino, Paolo, Brignole, Michele, and Nigro, Gerardo
Subjects: Male, Endocrine and Autonomic Systems, Asystole, Gender, Reflex neurally mediated, Syncope, Heart Arrest, Nitroglycerin, Age, Retrospective Studie, Tilt-Table Test, Prevalence, Syncope, Vasovagal, Diuretic, Humans, Female, Neurology (clinical), Diuretics, Predictor, Human, Retrospective Studies
Abstract: Aims The aim of our study was to evaluate the prevalence and clinical predictors of cardioinhibitory (CI) responses with asystole at the nitroglycerin (NTG)-potentiated head-up tilt test (HUTT) in patients with a history of syncope admitted to a tertiary referral syncope unit. Methods We retrospectively evaluated all consecutive patients who underwent NTG-potentiated HUTT for suspected reflex syncope at our institution from March 1 2017 to May 1 2020. The prevalence of HUTT-induced CI syncope was assessed. Univariate and multivariate analyses were performed to test the association of asystolic response to HUTT with a set of clinical covariates. Results We enrolled 1285 patients (45 ± 19.1 years; 49.6% male); 368 (28.6%) showed HUTT-induced CI response with asystole. A multivariate analysis revealed that the following factors were independently associated with HUTT-induced CI syncope: male sex (OR 1.48; ConInt 1.14–1.92; P = 0.003), smoking (OR 2.22; ConInt 1.56–3.115; P P P = 0.002), and the use of diuretics (OR 9.94; ConInt 3.83–25.76; P Conclusions The cardioinhibitory syncope with asystole induced by NTG-potentiated HUTT is more frequent than previously reported. The male gender, smoking habit, history of traumatic syncope, and use of diuretics were independent predictors of HUTT-induced CI responses. Conversely, the history of situational syncope seems to reduce this probability.
Published: 2022

24. Postnatal microcephaly and retinal involvement expand the phenotype of RPL10-related disorder

Author: Gerarda Cappuccio, Margherita Lucia De Bernardi, Alessia Morlando, Cristina Peduto, Iris Scala, Michele Pinelli, Emanuele Bellacchio, Flavio Gioele Gallo, Adriano Magli, Carmen Plaitano, Mercedes Serrano, Leticia Pías, Jaume Català, Mercè Bolasell, Annalaura Torella, Vincenzo Nigro, Ginevra Zanni, Nicola Brunetti‐Pierri, Cappuccio, Gerarda, De Bernardi, Margherita Lucia, Morlando, Alessia, Peduto, Cristina, Scala, Iri, Pinelli, Michele, Bellacchio, Emanuele, Gallo, Flavio Gioele, Magli, Adriano, Plaitano, Carmen, Serrano, Mercede, Pías, Leticia, Català, Jaume, Bolasell, Mercè, Torella, Annalaura, Nigro, Vincenzo, Zanni, Ginevra, and Brunetti-Pierri, Nicola
Subjects: Male, Phenotype, RPL10, Autism Spectrum Disorder, intellectual disability, Genetics, Humans, microcephaly, retinal dystrophy, Nervous System Malformations, Genetics (clinical), ocular
Abstract: Hemizygous missense variants in the RPL10 gene encoding a ribosomal unit are responsible for an X-linked syndrome presenting with intellectual disability (ID), autism spectrum disorder, epilepsy, dysmorphic features, and multiple congenital anomalies. Among 15 individuals with RPL10-related disorder reported so far, only one patient had retinitis pigmentosa and microcephaly was observed in approximately half of the cases. By exome sequencing, three Italian and one Spanish male children, from three independent families, were found to carry the same hemizygous novel missense variant p.(Arg32Leu) in RPL10, inherited by their unaffected mother in all cases. The variant, not reported in gnomAD, is located in the 28S rRNA binding region, affecting an evolutionary conserved residue and predicted to disrupt the salt-bridge between Arg32 and Asp28. In addition to features consistent with RPL10-related disorder, all four boys had retinal degeneration and postnatal microcephaly. Pathogenic variants in genes responsible for inherited retinal degenerations were ruled out in all the probands. A novel missense RPL10 variant was detected in four probands with a recurrent phenotype including ID, dysmorphic features, progressive postnatal microcephaly, and retinal anomalies. The presented individuals suggest that retinopathy and postnatal microcephaly are clinical clues of RPL10-related disorder, and at least the retinal defect might be more specific for the p.(Arg32Leu) RPL10 variant, suggesting a specific genotype/phenotype correlation.
Published: 2022

25. Randomized post-induction and delayed intensification therapy in high-risk pediatric acute lymphoblastic leukemia: long-term results of the international AIEOP-BFM ALL 2000 trial

Author: Luca Lo Nigro, Christin Linderkamp, Peter Bader, Michaela Kuhlen, Georg Mann, Maria Grazia Valsecchi, Renate Panzer-Grümayer, Franco Locatelli, Peter Lang, Carmelo Rizzari, M Suttorp, Felix Niggli, Elena Barisone, Andishe Attarbaschi, Gianni Cazzaniga, Rosanna Parasole, C. Flotho, Christina Peters, Giuseppe Basso, Valentino Conter, Anja Möricke, Antonella Colombini, Martin Zimmermann, Gunnar Cario, Martin Schrappe, Maria Caterina Putti, Andrea Biondi, Melchior Lauten, University of Zurich, Attarbaschi, Andishe, Attarbaschi, A, Mann, G, Zimmermann, M, Bader, P, Barisone, E, Basso, G, Biondi, A, Cario, G, Cazzaniga, G, Colombini, A, Flotho, C, Kuhlen, M, Lang, P, Lauten, M, Linderkamp, C, Locatelli, F, Lo Nigro, L, Moricke, A, Niggli, F, Panzer-Grumayer, R, Parasole, R, Peters, C, Caterina Putti, M, Rizzari, C, Suttorp, M, Valsecchi, M, Conter, V, and Schrappe, M
Subjects: Male, Cancer Research, Pediatrics, medicine.medical_specialty, Adolescent, 2720 Hematology, Treatment outcome, MEDLINE, 610 Medicine & health, acute lymphoblastic leukemia, Time, law.invention, Randomized controlled trial, Pediatric Acute Lymphoblastic Leukemia, law, Antineoplastic Combined Chemotherapy Protocols, Asparaginase, Humans, Medicine, 1306 Cancer Research, Child, Cyclophosphamide, Mercaptopurine, business.industry, Daunorubicin, Cytarabine, Infant, Hematology, Long term results, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Methotrexate, Treatment Outcome, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Oncology, Multicenter study, Vincristine, 10036 Medical Clinic, Child, Preschool, randomized controlled trial, Prednisone, Female, 2730 Oncology, ALL, business, Intensification therapy
Published: 2019

26. Predictive ability of a drug-based score in patients with advanced non–small-cell lung cancer receiving first-line immunotherapy

Author: Giampiero Porzio, Luigi Della Gravara, Carlo Genova, Danilo Rocco, Luca Cantini, Sebastiano Buti, Sergio Bracarda, Marco Filetti, Alessandro Tuzi, R. Bisonni, Giulio Metro, Claudia Bareggi, Francesco Grossi, Francesca Mazzoni, Alfredo Addeo, David J. Pinato, Emilio Bria, Giovanni Mansueto, Vincenzo Adamo, Joachim G.J.V. Aerts, Raffaele Giusti, Diego Signorelli, Alessio Cortellini, Miriam Grazia Ferrara, Giorgia Guaitoli, Lorenza Landi, Corrado Ficorella, Gabriele Minuti, Fabiana Perrone, Fabrizio Citarella, Melissa Bersanelli, Giuseppe Luigi Banna, Emanuela Olmetto, Marina Chiara Garassino, Marco Siringo, Alain Gelibter, Michele De Tursi, Marco Russano, Giulia Mazzaschi, Gian Paolo Spinelli, Vincenzo Sforza, Luca Carmisciano, Rita Chiari, Katia Cannita, Fabrizio Tabbò, Diego Cortinovis, Alessandro De Toma, Serena Ricciardi, Stefania Gori, Olga Nigro, Mariangela Torniai, Rossana Berardi, Marcello Tiseo, Maria Rita Migliorino, Fausto Barbieri, Alessandro Follador, Alessandro Russo, Massimo Di Maio, Pietro Di Marino, Alex Friedlaender, Federica Zoratto, and Pulmonary Medicine
Subjects: Male, 0301 basic medicine, Oncology, Cancer Research, Lung Neoplasms, medicine.medical_treatment, Pembrolizumab, Predictive score, 0302 clinical medicine, Adrenal Cortex Hormones, Risk Factors, Carcinoma, Non-Small-Cell Lung, Monoclonal, Drug Interactions, Concomitant medications, First-line, Immunotherapy, Non–small-cell lung cancer, Non-Small-Cell Lung, Aged, Anti-Bacterial Agents, Antibodies, Monoclonal, Humanized, Clinical Decision-Making, Female, Humans, Immune Checkpoint Inhibitors, Italy, Patient Selection, Polypharmacy, Predictive Value of Tests, Progression-Free Survival, Proton Pump Inhibitors, Reproducibility of Results, Retrospective Studies, Risk Assessment, Decision Support Techniques, Humanized, 030220 oncology & carcinogenesis, Cohort, Cohort study, medicine.medical_specialty, Antibodies, 03 medical and health sciences, SDG 3 - Good Health and Well-being, Internal medicine, medicine, Progression-free survival, Lung cancer, Chemotherapy, business.industry, Carcinoma, Case-control study, medicine.disease, 030104 developmental biology, Concomitant, business
Abstract: Background: We previously demonstrated the cumulative poor prognostic role of concomitant medications on the clinical outcome of patients with advanced cancer treated with immune checkpoint inhibitors, creating and validating a drug-based prognostic score to be calculated before immunotherapy initiation in patients with advanced solid tumours. This ‘drug score’ was calculated assigning score 1 for each between proton-pump inhibitor and antibiotic administration until a month before cancer therapy initiation and score 2 in case of corticosteroid intake. The good risk group included patients with score 0, intermediate risk with score 1–2 and poor risk with score 3–4. Methods: Aiming at validating the prognostic and putative predictive ability depending on the anticancer therapy, we performed the present comparative analysis in two cohorts of advanced non–small-cell lung cancer (NSCLC), respectively, receiving first-line pembrolizumab or chemotherapy through a random case-control matching and through a pooled multivariable analysis including the interaction between the computed score and the therapeutic modality (pembrolizumab vs chemotherapy). Results: Nine hundred fifty and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. After the case-control random matching, 589 patients from the pembrolizumab cohort and 589 from the chemotherapy cohort were paired, with no statistically significant differences between the characteristics of the matched subjects. Among the pembrolizumab-treated group, good, intermediate and poor risk evaluable patients achieved an objective response rate (ORR) of 50.0%, 37.7% and 23.4%, respectively, (p < 0.0001), whereas among the chemotherapy-treated group, patients achieved an ORR of 37.0%, 40.0% and 32.4%, respectively (p = 0.4346). The median progression-free survival (PFS) of good, intermediate and poor risk groups was 13.9 months, 6.3 months and 2.8 months, respectively, within the pembrolizumab cohort (p < 0.0001), and 6.2 months, 6.2 months and 4.3 months, respectively, within the chemotherapy cohort (p = 0.0280). Among the pembrolizumab-treated patients, the median overall survival (OS) for good, intermediate and poor risk patients was 31.4 months, 14.5 months and 5.8 months, respectively, (p < 0.0001), whereas among the chemotherapy-treated patients, it was 18.3 months, 16.8 months and 10.6 months, respectively (p = 0.0003). A similar trend was reported considering the two entire populations. At the pooled analysis, the interaction term between the score and the therapeutic modality was statistically significant with respect to ORR (p = 0.0052), PFS (p = 0.0003) and OS (p < 0.0001), confirming the significantly different effect of the score within the two cohorts. Conclusion: Our ‘drug score’ showed a predictive ability with respect to ORR in the immunotherapy cohort only, suggesting it might be a useful tool for identifying patients unlikely to benefit from first-line single-agent pembrolizumab. In addition, the prognostic stratification in terms of PFS and OS was significantly more pronounced among the pembrolizumab-treated patients.
Published: 2021

27. Dietary influence on adiponectin in patients with type 2 diabetes

Author: Ersilia Nigro, Angela A. Rivellese, Aurora Daniele, Lutgarda Bozzetto, Giovanni Annuzzi, Rita Polito, Giuseppe Della Pepa, Giuseppina Costabile, Marilena Vitale, Anna Prinster, Claudia Vetrani, Bozzetto, Lutgarda, Polito, Rita, Nigro, Ersilia, Prinster, Anna, Della Pepa, Giuseppe, Costabile, Giuseppina, Vetrani, Claudia, Vitale, Marilena, Daniele, Aurora, Rivellese, Angela Albarosa, Annuzzi, Giovanni, Bozzetto, L., Polito, R., Nigro, E., Prinster, A., Della Pepa, G., Costabile, G., Vetrani, C., Vitale, M., Daniele, A., Rivellese, A. A., and Annuzzi, G.
Subjects: Adult, Dietary Fiber, Male, medicine.medical_specialty, medicine.medical_treatment, Clinical Biochemistry, Plasma adiponectin, Type 2 diabetes, 030204 cardiovascular system & hematology, Carbohydrate metabolism, Biochemistry, Fatty Acids, Monounsaturated, 03 medical and health sciences, 0302 clinical medicine, monounsaturated fatty acid, Internal medicine, Liver fat, Dietary Carbohydrates, Humans, Insulin, Medicine, In patient, 030212 general & internal medicine, Aged, Adiponectin, adiponectin, business.industry, dietary fibre, Fasting, General Medicine, Middle Aged, liver fat, Postprandial Period, medicine.disease, Diet, Endocrinology, Postprandial, Diabetes Mellitus, Type 2, Liver, Glycemic Index, glycaemic index, Female, type 2 diabetes, business
Abstract: Background Here, we evaluate the effects of a diet rich in low-glycaemic index carbohydrates and fibre (CHO/Fibre diet) or monounsaturated fatty acids (MUFA diet), on fasting and postprandial adiponectin concentrations and their relationship with the beneficial effects of the experimental diets on postprandial glucose metabolism and liver fat in type 2 diabetes (T2D).Methods Fasting and postprandial adiponectin plasma concentrations were measured before and after dietary interventions in the participants to a randomized controlled trial (NCT01025856), wherein 37 men and 8 women with T2D, aged 35-70 years, followed a CHO/Fibre diet or a MUFA diet for an 8-week period. Hepatic fat content by H-1 NMR and fasting and postprandial plasma glucose and insulin measurements were also available.Results Fasting adiponectin plasma levels did not change after both diets. Postprandial adiponectin significantly increased after the CHO/fibre diet (9.9 +/- 1.6 mu g/mL vs. 10.8 +/- 2.3 mu g/mL; P = .033) but not after the MUFA diet (10.6 +/- 1.8 mu g/mL vs. 10.6 +/- 1.6 mu g/mL; P = .935) with a significant difference between changes (P = .035). In the combined CHO/Fibre and MUFA groups, fasting and postprandial adiponectin significantly and inversely correlated with postprandial insulin iAUC at baseline and after intervention, and with liver fat content after intervention.Conclusions A diet rich in CHO/Fibre increased postprandial plasma adiponectin significantly more than a MUFA diet in patients with T2D. Independently of diet, adiponectin levels associated with postprandial insulin concentrations. The dietary interventions modulated the relationship between adiponectin and liver fat.
Published: 2021

28. Outcome of relapsed/refractory acute promyelocytic leukaemia in children, adolescents and young adult patients — a 25-year Italian experience

Author: Concetta Micalizzi, Luca Lo Nigro, Alfonso Piciocchi, Giuseppe Menna, Nicola Santoro, C. Putti, Anna Maria Testi, Saverio Ladogana, Robin Foà, Riccardo Masetti, Marco Zecca, Paolo Pierani, Ottavio Ziino, Valentina Arena, Daniela Onofrillo, Franco Locatelli, Carmelo Rizzari, Maria Vittoria Micheletti, Fabio Timeus, Daniela Diverio, Sara Mohamed, Testi, A, Mohamed, S, Diverio, D, Piciocchi, A, Menna, G, Rizzari, C, Timeus, F, Micalizzi, C, Lo Nigro, L, Santoro, N, Masetti, R, Micheletti, M, Ziino, O, Onofrillo, D, Ladogana, S, Putti, C, Pierani, P, Arena, V, Zecca, M, Foa, R, Locatelli, F, Testi A.M., Mohamed S., Diverio D., Piciocchi A., Menna G., Rizzari C., Timeus F., Micalizzi C., Lo Nigro L., Santoro N., Masetti R., Micheletti M.V., Ziino O., Onofrillo D., Ladogana S., Putti C., Pierani P., Arena V., Zecca M., Foa R., and Locatelli F.
Subjects: Male, Pediatrics, medicine.medical_specialty, Adolescent, acute promyelocytic leukaemia, Salvage treatment, salvage treatment, Antineoplastic Agents, Tretinoin, Young Adult, Antineoplastic Agents, Immunological, Arsenic Trioxide, Leukemia, Promyelocytic, Acute, immune system diseases, medicine, Humans, Anthracyclines, Young adult, Child, neoplasms, Retrospective Studies, Salvage Therapy, business.industry, Remission Induction, Hematopoietic Stem Cell Transplantation, Hematology, Prognosis, Combined Modality Therapy, Gemtuzumab, Progression-Free Survival, Treatment Outcome, Italy, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, adolescent children, Case-Control Studies, Child, Preschool, Relapsed refractory, relapsed/refractory disease, Early adolescents, Female, Acute promyelocytic leukaemia, Neoplasm Recurrence, Local, business
Abstract: Acute promyelocytic leukaemia (APL) is a rare subtype ofchildhood acute myeloid leukaemia (AML), accounting for5–12% of all AML cases. Treatment with all-trans-retinoicacid (ATRA) and anthracyclines yields complete remission(CR) rates >90% and 10-year event-free survival (EFS) ratesaround 80%.1–3The recent front-line arsenic trioxide(ATO)-based regimens have further improved the APL out-come by reducing toxicity and preventing relapse.4–6Relapsed APL patients are a rare and heterogeneous group,whose prognosis depends on front-line treatment and timeelapsing between diagnosis and recurrence. Currently, ATOis the treatment of choice for relapsed APL. Due to the rarityof relapsed childhood APL, 17–27% in ATRA- andchemotherapy-1,3,7–9and 4% in ATO-containing regimens,10it will be difﬁcult, in the future, to design future prospectivecomparative trials for these patients. In an attempt to designtherapeutic guidelines, recommendations on management ofrelapsed/refractory paediatric APL have been publishedrecently
Published: 2021

29. BAG3-related myofibrillar myopathy: a further observation with cardiomyopathy at onset in pediatric age

Author: Scarpini G., Valentino M. L., Giannotta M., Ragni L., Torella A., Columbaro M., Nigro V., Pini A., Scarpini, Gaia, Valentino, Maria Lucia, Giannotta, Melania, Ragni, Luca, Torella, Annalaura, Columbaro, Marta, Nigro, Vincenzo, Pini, Antonella, Scarpini G., Valentino M.L., Giannotta M., Ragni L., Torella A., Columbaro M., Nigro V., and Pini A.
Subjects: Male, Apoptosis Regulatory Protein, Adolescent, BAG3, Case Report, pediatric neuromuscular disorder, myofibrillar myopathy, Mutation, Child, cardiomyopathy, Adaptor Proteins, Signal Transducing, Human, Cardiomyopathie, Myopathies, Structural, Congenital
Abstract: Myofibrillar myopathies are a heterogeneous group of neuromuscular disorders characterized by degeneration of Z-disk, causing the disintegration of myofibrils. They may be caused by mutations in different genes, among these, the BAG3 gene (Bcl-2 associed-athanogene-3) encodes a multidomain protein that plays an important role in many cellular processes. We report the case of a 16-year-old male who at 4 years of age presented with a hypertrophic obstructive cardiomyopathy, then developed axonal sensory motor polyneuropathy, muscle weakness, rigid spine, severe kyphoscoliosis and respiratory failure. Muscle biopsy showed the typical hallmark of myofibrillar myopathy with abnormal cytoplasmic expression of multiple proteins. Ade novo heterozygous common mutation in the BAG3 gene with a c.626C > T (p.Pro209Leu) was discovered on NGS genetic analysis. Mutations in the BAG3 gene are causes of a severe and progressive condition and natural history data are important to be collected. An early diagnosis is critical for prognostic implications in cardiomyopathy and respiratory failure treatment.
Published: 2021

30. Causes of syncopal recurrences in patients treated with permanent pacing for bradyarrhythmic syncope: Findings from the SYNCOPACED registry

Author: Gabriele Dell'Era, Natale Daniele Brunetti, Enrico Boggio, Pier Luigi Pellegrino, Antonio Dello Russo, Germano Gaggioli, Alessandro Guido, Mauro Biffi, Gerardo Nigro, Ernesto Ammendola, Giuseppe Patti, Mattia Laffi, Matteo Ziacchi, Federico Guerra, Pietro Palmisano, Vittorio Aspromonte, Lorenzo Pimpini, Cardiac Pacing, Michele Accogli, and Francesco Santoro
Subjects: Male, medicine.medical_specialty, 030204 cardiovascular system & hematology, Syncope, Bifascicular block, 03 medical and health sciences, Orthostatic vital signs, 0302 clinical medicine, Heart Rate, Recurrence, Physiology (medical), Internal medicine, medicine, Humans, In patient, Prospective Studies, Registries, 030212 general & internal medicine, Vasovagal syncope, Collapse (medical), Aged, biology, business.industry, Incidence, Cardiac Pacing, Artificial, Syncope (genus), Atrial fibrillation, medicine.disease, biology.organism_classification, Italy, Chronic Disease, Cardiology, Female, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Atrioventricular block, Follow-Up Studies
Abstract: Background Few studies have examined the causes of syncope/collapse recurrences in patients with a previously implanted pacemaker for bradyarrhythmic syncope. Objective The purpose of this study was to assess the causes of syncope/collapse recurrences after pacemaker implantation for bradyarrhythmic syncope in a large patient population. Methods The SYNCOpal recurrences in patients treated with permanent PACing for bradyarrhythmic syncope (SYNCOPACED) registry was a prospective multicenter observational registry enrolling 1364 consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope. During follow-up, the time to the first syncope/collapse recurrence was recorded. Patients with syncope/collapse recurrences underwent a predefined diagnostic workup aimed at establishing the mechanism of syncope/collapse. Results During a median follow-up of 50 months, 213 patients (15.6%) reported at least 1 syncope/collapse recurrence. The risk of syncope/collapse recurrence was highest in patients who underwent implantation for cardioinhibitory vasovagal syncope (26.4%), followed by unexplained syncope and chronic bifascicular block (21.5%), cardioinhibitory carotid sinus syndrome (17.2%), atrial fibrillation needing pacing (15.5%), atrioventricular block (13.6%), and sinus node disease (12.5%) (P = .017). The most frequent cause of syncope/collapse recurrence was reflex syncope (27.7%), followed by orthostatic hypotension (26.3%), pacemaker or lead malfunction (5.6%), structural cardiac disease (5.2%), and atrial and ventricular tachyarrhythmias (4.7% and 3.8%, respectively). In 26.8% of cases, the mechanism of syncope/collapse remained unexplained. Conclusion In patients receiving a pacemaker for bradyarrhythmic syncope, reflex syncope and orthostatic hypotension are the most frequent mechanisms of syncope/collapse recurrence after implantation. Pacing system malfunction, structural cardiac diseases, and tachyarrhythmias are rare mechanisms. The mechanism remains unexplained in >25% of patients.
Published: 2021

31. Robotic Versus Laparoscopic Adrenalectomy: Pluriannual Experience in a High-Volume Center Evaluating Indications and Results

Author: Micaela Piccoli, C Nigro, Giovanni Colli, Francesca Pecchini, Francesco Serra, Bruno Madeo, Barbara Mullineris, Davide Gozzo, Vincenzo Rochira, and Lucia Zirilli
Subjects: Adult, Male, robotic adrenalectomy, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Operative Time, Adrenal Gland Neoplasms, Blood Loss, Surgical, macromolecular substances, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Robotic Surgical Procedures, Full Reports, robotic surgery, medicine, Humans, Robotic surgery, Intraoperative Complications, Aged, Retrospective Studies, Aged, 80 and over, Laparoscopic adrenalectomy, business.industry, Adrenalectomy, adrenalectomy, Robotics, Length of Stay, Middle Aged, Conversion to Open Surgery, Surgery, adrenal gland surgery, laparoscopic adrenalectomy, 030220 oncology & carcinogenesis, Female, Laparoscopy, 030211 gastroenterology & hepatology, business
Abstract: Background: Robotic adrenalectomy offers several clinical benefits if compared with laparoscopic adrenalectomy; however, its superiority is still under debate. The aim of this study was the investigation of differences between the two techniques, and a comparison when approaching right or left side adrenal lesions was further conducted. Materials and Methods: All patients undergoing laparoscopic and robotic unilateral adrenalectomy at our institution from January 2006 to December 2019 were collected and retrospectively analyzed. Statistical analysis was conducted; differences between the two cohorts were reported. Results: A total of 160 cases were included (84 patients in laparoscopic adrenalectomy-group [LA-g] 76 cases in robotic adrenalectomy-group [RA-g]). The groups were homogeneous for demographic data. No intraoperative complications were reported; mean amount of intraoperative blood loss was comparable. No cases of conversion to open surgery were required. RA-g presented a longer operative time than LA-g for right adrenalectomy (P = .05), no differences were noted for left side (P = .187). Overall morbidity was 21% for LA-g and 10.5% for RA-g (P = .087), with an inferior rate of surgical complications for RA-g (P = .024), and for robotic left adrenalectomy than robotic right procedure (P = .03). Length of hospital stay was shorter for RA-g (P = .005). Conclusions: Robotic adrenalectomy presents similar outcomes as laparoscopic approach with some benefits for selected cases. Left adrenal lesions seem to receive greater advantages from robotic technique. Large randomized controlled trials are required to determine the role of robotic adrenal surgery and if the indication can be standardized based on the laterality of adrenal procedure.
Published: 2021

32. Staged Repair of Van Praagh Truncus Type A3

Author: John J. Nigro, Srujan Ganta, Howaida El-Said, Rohit P. Rao, Kirsten Dummer, Nicole Duster, John H. Artrip, and Ian Golding
Subjects: Adult, Male, Aortic arch, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, medicine.medical_treatment, Aorta, Thoracic, Pulmonary Artery, 030204 cardiovascular system & hematology, Truncus arteriosus, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, medicine.artery, Angioplasty, Internal medicine, medicine, Humans, cardiovascular diseases, 030212 general & internal medicine, Cardiac Surgical Procedures, Arterial trunk, Lung, medicine.diagnostic_test, business.industry, Infant, Newborn, Drug-Eluting Stents, General Medicine, Truncus Arteriosus, Persistent, medicine.anatomical_structure, Truncus, Pediatrics, Perinatology and Child Health, Angiography, Pulmonary artery, cardiovascular system, Cardiology, Female, Surgery, Tomography, X-Ray Computed, Cardiology and Cardiovascular Medicine, business
Abstract: Van Praagh (VP) A3 variant of truncus arteriosus (or common arterial trunk) is defined by only one pulmonary artery (usually the right) originating from the common trunk, while the other lung is supplied either by collaterals or a pulmonary artery arising from the aortic arch. This report describes a staged approach to manage a VP-A3 variant truncus arteriosus with ductal origin of the left pulmonary artery (LPA), a hypoplastic right pulmonary artery, and cyanosis. Initially, the ductal portion of the proximal LPA was stented with a Resolute Onyx drug-eluting stent. The pulmonary arteries grew and at four months of age had an acceptable McGoon ratio and Nakata index. The patient then underwent repair which included unifocalization of the branch pulmonary arteries, closure of the ventricular septal defect, and placement of a right ventricle-to-pulmonary artery homograft conduit.
Published: 2021

33. Retrieval of a leadless transcatheter pacemaker from the right pulmonary artery: A case report

Author: Paolo Golino, Gerardo Nigro, Anna Correra, Diego Colonna, Michele D'Alto, Berardo Sarubbi, Maurizio Cappelli, Emanuele Romeo, Romeo, Emanuele, D'Alto, Michele, Cappelli, Maurizio, Nigro, Gerardo, Correra, Anna, Co, Diego, Sarubbi, Berardo, and Golino, Paolo
Subjects: Male, Pacemaker, Artificial, medicine.medical_specialty, medicine.medical_treatment, embolization, Pulmonary Artery, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine.artery, Side branch, Atrial Fibrillation, medicine, Humans, 030212 general & internal medicine, Embolization, Device Removal, Sinus (anatomy), Aged, 80 and over, Sick Sinus Syndrome, dislocation, Ischemic cardiomyopathy, business.industry, Angiography, General Medicine, Right pulmonary artery, medicine.anatomical_structure, Ventricle, Pulmonary artery, extraction, Cardiology, Cardiology and Cardiovascular Medicine, business, Micra transcatheter pacing system, leadless pacemaker
Abstract: This case report describes a procedure of retrieval of a leadless transcatheter pacemaker from the right pulmonary artery 3 days after device implantation. An 80-year-old man affected by ischemic cardiomyopathy and sinus node dysfunction was implanted with a leadless transcatheter pacemaker in the low septum of the right ventricle. Three days after the procedure, the leadless pacemaker migrated into a side branch of the right pulmonary artery. The device was successfully removed using two snares hooked to a tine via the proximal retrieval feature. This article is protected by copyright. All rights reserved.
Published: 2021

34. Cardiac pacing procedures during coronavirus disease 2019 lockdown in Southern Italy: insights from Campania Region

Author: Angelo Carbone, Antonio Ruocco, Antonello D'Andrea, Mario Volpicelli, Raffaele Chianese, Gianluca Manzo, Gerardo Nigro, Antonio D'Onofrio, Ernesto Ammendola, Valentino Ducceschi, Felice Nappi, Giovanni Russo, Gregorio Covino, Anna Rago, Antonio Rapacciuolo, Pia Clara Pafundi, Gianna Maria Montella, Carlo Uran, Marcello de Divitiis, Giuseppe Del Giorno, Emilio Attena, Francesca Esposito, Vincenzo Russo, Russo, Vincenzo, Pafundi, Pia Clara, Rapacciuolo, Antonio, de Divitiis, Marcello, Volpicelli, Mario, Ruocco, Antonio, Rago, Anna, Uran, Carlo, Nappi, Felice, Attena, Emilio, Chianese, Raffaele, Esposito, Francesca, Del Giorno, Giuseppe, D'Andrea, Antonello, Ducceschi, Valentino, Russo, Giovanni, Ammendola, Ernesto, Carbone, Angelo, Covino, Gregorio, Manzo, Gianluca, Montella, Gianna Maria, Nigro, Gerardo, and D'Onofrio, Antonio
Subjects: Male, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Cardiac pacing, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, 030212 general & internal medicine, Aged, Retrospective Studies, Infection Control, SARS-CoV-2, business.industry, Attendance rate, Significant difference, Cardiac Pacing, Artificial, COVID-19, Arrhythmias, Cardiac, Retrospective cohort study, Admission rate, General Medicine, Emergency department, Organizational Innovation, CARDIAC PACING PROCEDURES, Outcome and Process Assessment, Health Care, Italy, Emergency medicine, Female, Cardiology Service, Hospital, Cardiology and Cardiovascular Medicine, business
Abstract: BACKGROUND: Aim of our study was to assess the association between COVID-19 lockdown and cardiac pacing (CP) procedures rates in Campania Region, the third-most-populous region of Italy with about 5.8 million residents. METHODS: Data about type of CP procedures and unit admissions were obtained from 14 CP centers throughout Campania region from March 10th and May 4Th 2020 and compared with the same time frame in 2019. RESULTS: A remarkable reduction in both temporary (reduction rate: -62.5%), definitive pace maker (reduction rate: -30.2%), ICD (reduction rate: -48.3%) and CRT (reduction rate: -48.4%) implantation and in CRT replacement (reduction rate: -88.8%) procedures has been shown between the two observation periods among 951 hospitalized patients. Planned hospitalizations showed a reduction rate of 69.3%. Conversely, urgent intra-hospital admissions (increase rate +430%; Pâ
Published: 2021

35. Nonlinear net ankle quasi-stiffness reduces error and changes with speed but not load carried

Author: Elisa S. Arch, Luke Nigro, Corey Koller, Joseph J. Glutting, and Jill S. Higginson
Subjects: Male, Polynomial regression, Mean squared error, Rehabilitation, Biophysics, Linear model, 030229 sport sciences, Biomechanical Phenomena, Moment (mathematics), 03 medical and health sciences, Nonlinear system, 0302 clinical medicine, Quadratic equation, Gait (human), Control theory, Linear regression, Humans, Female, Orthopedics and Sports Medicine, Ankle, Gait, 030217 neurology & neurosurgery, Mathematics
Abstract: Background Natural ankle quasi-stiffness (NAS) is a key metric used to personalize orthotic and prosthetic ankle-foot devices. NAS has traditionally been defined as the average slope (i.e. linear regression) of the net ankle moment vs. ankle angle curve during stance. However, NAS appears to have nonlinear characteristics. Characterizing nonlinear NAS across a wide range of tasks will enable us to incorporate these attributes into future orthotic and prosthetic ankle-foot device designs. Research question Does nonlinear NAS change across multiple intensities of walking, running, and load carriage tasks? Methods This observational study examined 22 young, healthy individuals as they walked, ran, and walked while carrying a load at three intensities (speed or load). Linear, quadratic, and cubic regressions were done on the net ankle moment vs. ankle angle curve over three phases of stance: impact, loading, and push-off. RMSE between regressions and measured data were computed to determine regression accuracy, and multilevel linear models (MLMs) were used to determine significant differences between coefficients across intensities. Results Quadratic and cubic regressions of NAS had significantly lower RMSE than linear NAS for all phases of stance. Because of diminishing reductions in RMSE between quadratic and cubic regressions, only quadratic regression coefficients were further analyzed. Most first (linear) and second (nonlinear) order coefficients of quadratic regressions exhibited clear trends with respect to changes in walking or running speed, but not to increases in load. Significance This was the first study to our knowledge to thoroughly characterize nonlinear NAS across multiple gait tasks and intensities. This study provides an advanced understanding of the characteristics of nonlinear NAS for the design of future prosthetic and orthotic ankle-foot devices.
Published: 2021

36. Synchronous Partial Nephrectomy and Renal Artery Aneurysm Repair in Bilateral Renal Cancers: Case Report and Literature Review

Author: Yamume Thsomba, Domenico Nigro, Nazario Foschi, Pierfrancesco Bassi, Luca Di Gianfrancesco, Mauro Ragonese, Pierluigi Russo, Giovanni Tinelli, and Simona Sica
Subjects: Male, medicine.medical_specialty, Urology, medicine.medical_treatment, Renal function, urologic and male genital diseases, Nephrectomy, Renal artery aneurysm, Renal Artery, Aneurysm, medicine.artery, medicine, Partial nephrectomy, Humans, Renal artery, Aged, Settore MED/06 - ONCOLOGIA MEDICA, Settore MED/24 - UROLOGIA, business.industry, Cancer, Renal cancers, medicine.disease, Settore MED/22 - CHIRURGIA VASCOLARE, Kidney Neoplasms, Surgery, Renal cancer, Radiological weapon, business
Abstract: The treatment of renal cancer has changed in the last decades with an increase in application of conservative surgery such as partial nephrectomy (PN) in order to achieve an optimal oncological outcome with the maximum preservation of renal function. The indication for PN is mandatory in case of bilateral tumors or in case of impaired renal function. Renal artery (RA) aneurysm (RAA) is a rare occurrence, and its treatment could be radiological or surgical according to the anatomy of the aneurysm and the clinical characteristics of the patients. Here, we report a case of simultaneous ipsilateral occurrence of renal cancer and RAA in a patient with bilateral renal masses, treated with 1 surgical procedure with good functional and oncological outcomes. This rare occurrence must be known by surgeons treating renal cancers, and it is possible to perform the 2 procedures in 1 surgical step.
Published: 2021

37. Diagnostic Accuracy of Magnetic Resonance Imaging Measures of Brain Atrophy Across the Spectrum of Progressive Supranuclear Palsy and Corticobasal Degeneration

Author: Ignacio Illán-Gala, Salvatore Nigro, Lawren VandeVrede, Neus Falgàs, Hilary W. Heuer, Cèlia Painous, Yaroslau Compta, Maria J. Martí, Victor Montal, Javier Pagonabarraga, Jaime Kulisevsky, Alberto Lleó, Juan Fortea, Giancarlo Logroscino, Andrea Quattrone, Aldo Quattrone, David C. Perry, Maria Luisa Gorno-Tempini, Howard J. Rosen, Lea T. Grinberg, Salvatore Spina, Renaud La Joie, Gil D. Rabinovici, Bruce L. Miller, Julio C. Rojas, William W. Seeley, and Adam L. Boxer
Subjects: Male, Corticobasal Degeneration, Cerebellum, Humans, Female, Neurodegenerative Diseases, General Medicine, Prospective Studies, Supranuclear Palsy, Progressive, Atrophy, Magnetic Resonance Imaging, eye diseases
Abstract: Importance: The accurate diagnosis of progressive supranuclear palsy (PSP) and corticobasal degeneration (CBD) is hampered by imperfect clinical-pathological correlations. Objective: To assess and compare the diagnostic value of the magnetic resonance parkinsonism index (MRPI) and other magnetic resonance imaging-based measures of cerebral atrophy to differentiate between PSP, CBD, and other neurodegenerative diseases. Design, setting, and participants: This prospective diagnostic study included participants with 4-repeat tauopathies (4RT), PSP, CBD, other neurodegenerative diseases and available MRI who appeared in the University of California, San Francisco, Memory and Aging Center database. Data were collected from October 27, 1994, to September 29, 2019. Data were analyzed from March 1 to September 14, 2021. Main outcomes and measures: The main outcome of this study was the neuropathological diagnosis of PSP or CBD. The clinical diagnosis at the time of the MRI acquisition was noted. The imaging measures included the MRPI, cortical thickness, subcortical volumes, including the midbrain, pons, and superior cerebellar peduncle volumes. Multinomial logistic regression models (MLRM) combining different cortical and subcortical regions were defined to discriminate between PSP, CBD, and other pathologies. The areas under the receiver operating characteristic curves (AUROC) and cutoffs were calculated to differentiate between PSP, CBD, and other diseases. Results: Of the 326 included participants, 176 (54%) were male, and the mean (SD) age at MRI was 64.1 (8.0) years. The MRPI showed good diagnostic accuracy for the differentiation between PSP and all other pathologies (accuracy, 87%; AUROC, 0.90; 95% CI, 0.86-0.95) and between 4RT and other pathologies (accuracy, 80%; AUROC, 0.82; 95% CI, 0.76-0.87), but did not allow the discrimination of participants with CBD. Its diagnostic accuracy was lower in the subgroup of patients without the canonical PSP-Richardson syndrome (PSP-RS) or probable corticobasal syndrome (CBS) at MRI. MLRM combining cortical and subcortical measurements showed the highest accuracy for the differentiation between PSP and other pathologies (accuracy, 95%; AUROC, 0.98; 95% CI, 0.97-0.99), CBD and other pathologies (accuracy, 83%; AUROC, 0.86; 95% CI, 0.81-0.91), 4RT and other pathologies (accuracy, 89%; AUROC, 0.94; 95% CI, 0.92-0.97), and PSP and CBD (accuracy, 91%; AUROC, 0.95; 95% CI, 0.91-0.99), even in participants without PSP-RS or CBS at MRI. Conclusions and relevance: In this study, the combination of widely available cortical and subcortical measures of atrophy on MRI discriminated between PSP, CBD, and other pathologies and could be used to support the diagnosis of 4RT in clinical practice.
Published: 2022

38. Exome reanalysis and proteomic profiling identified TRIP4 as a novel cause of cerebellar hypoplasia and spinal muscular atrophy (PCH1)

Author: Töpf, Ana, Pyle, Angela, Griffin, Helen, Matalonga, Leslie, Schon, Katherine, Sickmann, Albert, Schara–Schmidt, Ulrike, Hentschel, Andreas, Chinnery, Patrick F., Kölbel, Heike, Roos, Andreas, Horvath, Rita, Cohen, Enzo, Cuesta, Isabel, Danis, Daniel, Denommé-Pichon, Anne-Sophie, Duffourd, Yannis, Gilissen, Christian, Johari, Mridul, Laurie, Steven, Li, Shuang, Nelson, Isabelle, Paramonov, Ida, Peters, Sophia, Prasanth, Sivakumar, Robinson, Peter, Sablauskas, Karolis, Savarese, Marco, Steyaert, Wouter, Van Der Velde, Joeri K., Vitobello, Antonio, Baets, Jonathan, Beijer, Danique, Bonne, Gisèle, Cossins, Judith, Evangelista, Teresinha, Ferlini, Alessandra, Hackman, Peter, Hanna, Michael G., Houlden, Henry, Lau, Jarred, Lochmüller, Hanns, Macken, William L., Musacchia, Francesco, Nascimento, Andres, Natera-De Benito, Daniel, Nigro, Vincenzo, Piluso, Giulio, Pini, Veronica, Pitceathly, Robert D. S., Polavarapu, Kiran, Cruz, Pedro M. Rodriguez, Sarkozy, Anna, Selvatici, Rita, Thompson, Rachel, Torella, Annalaura, Udd, Bjarne, Van De Vondel, Liedewei, Vandrovcova, Jana, Zaharieva, Irina, Schon, Katherine [0000-0001-8054-8954], Horvath, Rita [0000-0002-9841-170X], Apollo - University of Cambridge Repository, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Barcelona Institute of Science and Technology (BIST), University of Cambridge [UK] (CAM), Leibniz-Institut für Analytische Wissenschaften - ISAS - e.V., University of Aberdeen, Ruhr-Universität Bochum [Bochum], University Children's Hospital of Essen [Essen, Germany], Enzo Cohen, Isabel Cuesta, Daniel Danis, Anne-Sophie Denommé-Pichon, Yannis Duffourd, Christian Gilissen, Mridul Johari, Steven Laurie, Shuang Li, Isabelle Nelson, Ida Paramonov, Sophia Peters, Sivakumar Prasanth, Peter Robinson, Karolis Sablauskas, Marco Savarese, Wouter Steyaert, Joeri K van der Velde, Antonio Vitobello, Jonathan Baets, Danique Beijer, Gisèle Bonne, Judith Cossins, Teresinha Evangelista, Alessandra Ferlini, Peter Hackman, Michael G Hanna, Henry Houlden, Jarred Lau, Hanns Lochmüller, William L Macken, Francesco Musacchia, Andres Nascimento, Daniel Natera-de Benito, Vincenzo Nigro, Giulio Piluso, Veronica Pini, Robert D S Pitceathly, Kiran Polavarapu, Pedro M Rodriguez Cruz, Anna Sarkozy, Rita Selvatici, Rachel Thompson, Annalaura Torella, Bjarne Udd, Liedewei Van de Vondel, Jana Vandrovcova, Irina Zaharieva, Töpf, Ana, Pyle, Angela, Griffin, Helen, Matalonga, Leslie, Schon, Katherine, Sickmann, Albert, Schara-Schmidt, Ulrike, Hentschel, Andrea, Chinnery, Patrick F, Kölbel, Heike, Roos, Andrea, Horvath, Rita, Nigro, Vincenzo, Torella, Annalaura, and Piluso, Giulio
Subjects: 0301 basic medicine, Male, Proteome, 45/41, Developmental Disabilities, Medizin, 45/22, Biology, Bioinformatics, Nervous System Malformations, Brief Communication, 82/80, Muscular Atrophy, Spinal, 03 medical and health sciences, 0302 clinical medicine, Cerebellum, 38/23, Genetics research, Genetics, medicine, [SDV.MHEP.AHA]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Exome, Genetic Testing, Gene, Cerebellar hypoplasia, Genetics (clinical), Exome sequencing, Proteomic Profile, Proteomic Profiling, 82/58, 631/208/514/2254, brief-communication, 692/308/2056, Infant, Metabolic Disorders Radboud Institute for Molecular Life Sciences [Radboudumc 6], Spinal muscular atrophy, medicine.disease, 3. Good health, 030104 developmental biology, Congenital muscular dystrophy, Next-generation sequencing, 030217 neurology & neurosurgery, Transcription Factors
Abstract: TRIP4 is one of the subunits of the transcriptional coregulator ASC-1, a ribonucleoprotein complex that participates in transcriptional coactivation and RNA processing events. Recessive variants in the TRIP4 gene have been associated with spinal muscular atrophy with bone fractures as well as a severe form of congenital muscular dystrophy. Here we present the diagnostic journey of a patient with cerebellar hypoplasia and spinal muscular atrophy (PCH1) and congenital bone fractures. Initial exome sequencing analysis revealed no candidate variants. Reanalysis of the exome data by inclusion in the Solve-RD project resulted in the identification of a homozygous stop-gain variant in the TRIP4 gene, previously reported as disease-causing. This highlights the importance of analysis reiteration and improved and updated bioinformatic pipelines. Proteomic profile of the patient's fibroblasts showed altered RNA-processing and impaired exosome activity supporting the pathogenicity of the detected variant. In addition, we identified a novel genetic form of PCH1, further strengthening the link of this characteristic phenotype with altered RNA metabolism. The Solve-RD project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 779257. Several authors of this study are members of the European Reference Network for Neuromuscular disease, Project ID No 739543. This study was supported by the AFM (grant 21644 to AR), the framework of the NME-GPS project by the European Regional Development Fund (AR/US/AS), the support by the Ministerium für Kultur und Wissenschaft des Landes Nordrhein-Westfalen, the Regierende Bürgermeister von Berlin-inkl. Wissenschaft und Forschung, and the Bundesministerium für Bildung und Forschung (AH and AS), the European Research Council (RH), the Wellcome Investigator Award (109915/Z/15/Z to RH), the Medical Research Council UK (MR/N025431/1 to RH), the Newton Fund (MR/N027302/1 to RH), the Lily Foundation (RH) and the Evelyn Trust (RH). This research was supported by an MRC strategic award to establish an International Centre for Genomic Medicine in Neuromuscular Diseases (ICGNMD) MR/S005021/1 and the NIHR Cambridge Biomedical Research Centre (BRC-1215-20014). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care
Published: 2020

39. Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol

Author: Gregory G. Schwartz, Michael Szarek, Vera A. Bittner, Rafael Diaz, Shaun G. Goodman, J. Wouter Jukema, Ulf Landmesser, Patricio López-Jaramillo, Garen Manvelian, Robert Pordy, Michel Scemama, Peter R. Sinnaeve, Harvey D. White, Ph Gabriel Steg, P.h. Gabriel Steg, Deepak L. Bhatt, Robert A. Harrington, Andreas M. Zeiher, Pierluigi Tricoci, Matthew T. Roe, Kenneth W. Mahaffey, Jay M. Edelberg, Corinne Hanotin, Guillaume Lecorps, Angèle Moryusef, William J. Sasiela, Jean-François Tamby, Philip E. Aylward, Heinz Drexel, Peter Sinnaeve, Mirza Dilic, Renato D. Lopes, Nina N. Gotcheva, Juan-Carlos Prieto, Huo Yong, Ivan Pećin, Zeljko Reiner, Petr Ostadal, Steen Hvitfeldt Poulsen, Margus Viigimaa, Markku S. Nieminen, Nicolas Danchin, Vakhtang Chumburidze, Nikolaus Marx, Evangelos Liberopoulos, Pablo Carlos Montenegro Valdovinos, Hung-Fat Tse, Robert Gabor Kiss, Denis Xavier, Doron Zahger, Marco Valgimigli, Takeshi Kimura, Hyo Soo Kim, Sang-Hyun Kim, Andrejs Erglis, Aleksandras Laucevicius, Sasko Kedev, Khalid Yusoff, Gabriel Arturo Ramos López, Marco Alings, Sigrun Halvorsen, Roger M. Correa Flores, Rody G. Sy, Andrzej Budaj, Joao Morais, Maria Dorobantu, Yuri Karpov, Arsen D. Ristic, Terrance Chua, Jan Murin, Zlatko Fras, Anthony J. Dalby, José Tuñón, H. Asita de Silva, Emil Hagström, Christian Müller, Chern-En Chiang, Piyamitr Sritara, Sema Guneri, Alexander Parkhomenko, Kausik K. Ray, Patrick M. Moriarty, Robert Vogel, Bernard Chaitman, Sheryl F. Kelsey, Anders G. Olsson, Jean-Lucien Rouleau, Maarten L. Simoons, Karen Alexander, Chiara Meloni, Robert Rosenson, Eric J.G. Sijbrands, John H. Alexander, Luciana Armaganijan, Akshay Bagai, Maria Cecilia Bahit, J. Matthew Brennan, Shaun Clifton, Adam D. DeVore, Shalonda Deloatch, Sheila Dickey, Keith Dombrowski, Grégory Ducrocq, Zubin Eapen, Patricia Endsley, Arleen Eppinger, Robert W. Harrison, Connie Ng Hess, Mark A. Hlatky, Joseph Dedrick Jordan, Joshua W. Knowles, Bradley J. Kolls, David F. Kong, Sergio Leonardi, Linda Lillis, David J. Maron, Jill Marcus, Robin Mathews, Rajendra H. Mehta, Robert J. Mentz, Humberto Graner Moreira, Chetan B. Patel, Sabrina Bernardez Pereira, Lynn Perkins, Thomas J. Povsic, Etienne Puymirat, William Schuyler Jones, Bimal R. Shah, Matthew W. Sherwood, Kenya Stringfellow, Darin Sujjavanich, Mustafa Toma, Charlene Trotter, Sean F.P. van Diepen, Matthew D. Wilson, Andrew Tze-Kay Yan, Lilia B. Schiavi, Marcelo Garrido, Andrés F. Alvarisqueta, Sonia A. Sassone, Anselmo P. Bordonava, Alberto E. Alves De Lima, Jorge M. Schmidberg, Ernesto A. Duronto, Orlando C. Caruso, Leonardo P. Novaretto, Miguel Angel Hominal, Oscar R. Montaña, Alberto Caccavo, Oscar A. Gomez Vilamajo, Alberto J. Lorenzatti, Luis R. Cartasegna, Gustavo A. Paterlini, Ignacio J. Mackinnon, Guillermo D. Caime, Marcos Amuchastegui, Oscar Salomone, Oscar R. Codutti, Horacio O. Jure, Julio O.E. Bono, Adrian D. Hrabar, Julio A. Vallejos, Rodolfo A. Ahuad Guerrero, Federico Novoa, Cristian A. Patocchi, Cesar J. Zaidman, Maria E. Giuliano, Ricardo D. Dran, Marisa L. Vico, Gabriela S. Carnero, Pablo N. Guzman, Juan C. Medrano Allende, Daniela F. Garcia Brasca, Miguel H. Bustamante Labarta, Sebastian Nani, Eduardo D.S. Blumberg, Hugo R. Colombo, Alberto Liberman, Victorino Fuentealba, Hector L. Luciardi, Gabriel D. Waisman, Mario A. Berli, Ruben O. Garcia Duran, Horacio G. Cestari, Hugo A. Luquez, Jorge A. Giordano, Silvia S. Saavedra, Gerardo Zapata, Osvaldo Costamagna, Susana Llois, Jonathon H. Waites, Nicholas Collins, Allan Soward, Chris L.S. Hii, James Shaw, Margaret A. Arstall, John Horowitz, Daniel Ninio, James F. Rogers, David Colquhoun, Romulo E. Oqueli Flores, Philip Roberts-Thomson, Owen Raffel, Sam J. Lehman, Constantine Aroney, Steven G.M. Coverdale, Paul J. Garrahy, Gregory Starmer, Mark Sader, Patrick A. Carroll, Ronald Dick, Robert Zweiker, Uta Hoppe, Kurt Huber, Rudolf Berger, Georg Delle-Karth, Bernhard Frey, Dirk Faes, Kurt Hermans, Bruno Pirenne, Attilio Leone, Etienne Hoffer, Mathias C.M. Vrolix, Luc De Wolf, Bart Wollaert, Marc Castadot, Karl Dujardin, Christophe Beauloye, Geert Vervoort, Harry Striekwold, Carl Convens, John Roosen, Emanuele Barbato, Marc Claeys, Frank Cools, Ibrahim Terzic, Fahir Barakovic, Zlatko Midzic, Belma Pojskic, Emir Fazlibegovic, Azra Durak-Nalbantic, Mehmed Kulić, Dusko Vulic, Adis Muslibegovic, Boris Goronja, Gilmar Reis, Luciano Sousa, Jose C. Nicolau, Flavio E. Giorgeto, Ricardo P. Silva, Lilia Nigro Maia, Rafael Rech, Paulo R.F. Rossi, Maria José A.G. Cerqueira, Norberto Duda, Renato Kalil, Adrian Kormann, José Antonio M. Abrantes, Pedro Pimentel Filho, Ana Priscila Soggia, Mayler O.N. de Santos, Fernando Neuenschwander, Luiz C. Bodanese, Yorghos L. Michalaros, Freddy G. Eliaschewitz, Maria H. Vidotti, Paulo E. Leaes, Roberto V. Botelho, Sergio Kaiser, Euler Roberto F. Fernandes Manenti, Dalton B. Precoma, Jose C. Moura Jorge, Pedro Silva, Jose A. Silveira, Wladmir Saporito, Jose A. Marin Neto, Gilson S. Feitosa, Luiz Eduardo F. Ritt, Juliana A. de Souza, Fernando Costa, Weimar K.S.B. Souza, Helder J.L. Reis, Leandro Machado, José Carlos Aidar Ayoub, Georgi V. Todorov, Fedya P. Nikolov, Elena S. Velcheva, Maria L. Tzekova, Haralambi O. Benov, Stanislav L. Petranov, Haralin S. Tumbev, Nina S. Shehova-Yankova, Dimitar T. Markov, Dimitar H. Raev, Mihail N. Mollov, Kostadin N. Kichukov, Katya A. Ilieva-Pandeva, Raya Ivanova, Maryana Gospodinov, Valentina M. Mincheva, Petar V. Lazov, Bojidar I. Dimov, Manohara Senaratne, James Stone, Jan Kornder, Stephen Pearce, Danielle Dion, Daniel Savard, Yves Pesant, Amritanshu Pandey, Simon Robinson, Gilbert Gosselin, Saul Vizel, Gordon Hoag, Ronald Bourgeois, Anne Morisset, Eric Sabbah, Bruce Sussex, Simon Kouz, Paul MacDonald, Ariel Diaz, Nicolas Michaud, David Fell, Raymond Leung, Tycho Vuurmans, Christopher Lai, Frank Nigro, Richard Davies, Gustavo Nogareda, Ram Vijayaraghavan, John Ducas, Serge Lepage, Shamir Mehta, James Cha, Robert Dupuis, Peter Fong, Sohrab Lutchmedial, Josep Rodes-Cabau, Hussein Fadlallah, David Cleveland, Thao Huynh, Iqbal Bata, Adnan Hameed, Cristian Pincetti, Sergio Potthoff, Juan C. Prieto, Monica Acevedo, Arnoldo Aguirre, Margarita Vejar, Mario Yañez, Guillermo Araneda, Mauricio Fernandez, Luis Perez, Paola Varleta, Fernando Florenzano, Laura Huidobro, Carlos A. Raffo, Claudia Olivares, Leonardo Nahuelpan, Humberto Montecinos, Jiyan Chen, Yugang Dong, Weijian Huang, Jianzhong Wang, Shi'An Huang, Zhuhua Yao, Xiang Li, Lan Cui, Wenhua Lin, Yuemin Sun, Jingfeng Wang, Jianping Li, Xuelian Zhang, Hong Zhu, Dandan Chen, Lan Huang, Shaohong Dong, Guohai Su, Biao Xu, Xi Su, Xiaoshu Cheng, Jinxiu Lin, Wenxia Zong, Huanming Li, Yi Feng, Dingli Xu, Xinchun Yang, Yuannan Ke, Xuefeng Lin, Zheng Zhang, Zeqi Zheng, Zhurong Luo, Yundai Chen, Chunhua Ding, Yi Zhong, Yang Zheng, Xiaodong Li, Daoquan Peng, Shuiping Zhao, Ying Li, Xuebo Liu, Meng Wei, Shaowen Liu, Yihua Yu, Baiming Qu, Weihong Jiang, Yujie Zhou, Xingsheng Zhao, Zuyi Yuan, Ying Guo, Xiping Xu, Xubo Shi, Junbo Ge, Guosheng Fu, Feng Bai, Weiyi Fang, Xiling Shou, Xiangjun Yang, Jian'An Wang, Meixiang Xiang, Yingxian Sun, Qinghua Lu, Ruiyan Zhang, Jianhua Zhu, Yizhou Xu, Zhongcai Fan, Tianchang Li, Chun Wu, Nicolas Jaramillo, Gregorio Sanchez Vallejo, Diana C. Luna Botia, Rodrigo Botero Lopez, Dora I. Molina De Salazar, Alberto J. Cadena Bonfanti, Carlos Cotes Aroca, Juan Diego Higuera, Marco Blanquicett, Sandra I. Barrera Silva, Henry J. Garcia Lozada, Julian A. Coronel Arroyo, Jose L. Accini Mendoza, Ricardo L. Fernandez Ruiz, Alvaro M. Quintero Ossa, Fernando G. Manzur Jatin, Aristides Sotomayor Herazo, Jeffrey Castellanos Parada, Rafael Suarez Arambula, Miguel A. Urina Triana, Angela M. Fernandez Trujillo, Maja Strozzi, Siniša Car, Melita Jerić, Davor Miličić, Martina Lovrić Benčić, Hrvoje Pintarić, Đeiti Prvulović, Jozica Šikić, Viktor Peršić, Dean Mileta, Kresimir Štambuk, Zdravko Babić, Vjekoslav Tomulic, Josip Lukenda, Stanka Mejic-Krstulovic, Boris Starcevic, Jindrich Spinar, David Horak, Zdenek Velicka, Josef Stasek, David Alan, Vilma Machova, Ales Linhart, Vojtech Novotny, Vladimir Kaucak, Richard Rokyta, Robert Naplava, Zdenek Coufal, Vera Adamkova, Ivo Podpera, Jiri Zizka, Zuzana Motovska, Ivana Marusincova, Premysl Svab, Petr Heinc, Jiri Kuchar, Petr Povolny, Jiri Matuska, Steen H. Poulsen, Bent Raungaard, Peter Clemmensen, Lia E. Bang, Ole May, Morten Bøttcher, Jens D. Hove, Lars Frost, Gunnar Gislason, John Larsen, Peter Betton Johansen, Flemming Hald, Peter Johansen, Jørgen Jeppesen, Tonny Nielsen, Kjeld S. Kristensen, Piotr Maria Walichiewicz, Jens D. Lomholdt, Ib C. Klausen, Peter Kaiser Nielsen, Flemming Davidsen, Lars Videbaek, Mai Soots, Veiko Vahula, Anu Hedman, Üllar Soopõld, Kaja Märtsin, Tiina Jurgenson, Arved Kristjan, Heikki Huikuri, Juhani Airaksinen Pierre Coste, Emile Ferrari, Olivier Morel, Gilles Montalescot, Jacques Machecourt, Gilles Barone-Rochette, Jacques Mansourati, Yves Cottin, Florence Leclercq, Abdelkader Belhassane, Nicolas Delarche, Franck Boccara, Franck Paganelli, Jérôme Clerc, Francois Schiele, Victor Aboyans, Vincent Probst, Jacques Berland, Thierry Lefèvre, Bernard Citron, Irakli Khintibidze, Tamaz Shaburishvili, Zurab Pagava, Ramaz Ghlonti, Zaza Lominadze, George Khabeishvili, Rayyan Hemetsberger, Kemala Edward, Ursula Rauch-Kröhnert, Matthias Stratmann, Karl-Friedrich Appel, Ekkehard Schmidt, Heyder Omran, Christoph Stellbrink, Thomas Dorsel, Emmanouil Lianopoulos, Hans Friedrich Vöhringer, Roger Marx, Andreas Zirlik, Detlev Schellenberg, Thomas Heitzer, Ulrich Laufs, Christian Werner, Stephan Gielen, Sebastian Nuding, Bernhard Winkelmann, Steffen Behrens, Karsten Sydow, Mahir Karakas, Gregor Simonis, Thomas Muenzel, Nikos Werner, Stefan Leggewie, Dirk Böcker, Rüdiger Braun-Dullaeus, Nicole Toursarkissian, Michael Jeserich, Matthias Weißbrodt, Tim Schaeufele, Joachim Weil, Heinz Völler, Johannes Waltenberger, Mohammed Natour, Susanne Schmitt, Dirk Müller-Wieland, Stephan Steiner, Lothar Heidenreich, Elmar Offers, Uwe Gremmler, Holger Killat, Werner Rieker, Sotiris Patsilinakos, Athanasios Kartalis, Athanassios Manolis, Dimitrios Sionis, Geargios Chachalis, Ioannis Skoumas, Vasilios Athyros, Panagiotis Vardas, Frangkiskos Parthenakis, John Lekakis, Apostolos Hatzitolios, Sergio R. Fausto Ovando, Juan L. Arango Benecke, Edgar R. Rodriguez De Leon, Bryan P.Y. Yan, David C.W. Siu, Tibor Turi, Bela Merkely, Imre Ungi, Geza Lupkovics, Lajos Nagy, András Katona, István Édes, Gábor Müller, Iván Horvath, Tibor Kapin, Zsolt Szigeti, József Faluközy, Mukund Kumbla, Manjinder Sandhu, Sharath Annam, Naveen Reddy Proddutur, Reddy Regella, Rajendra K. Premchand, Ajaykumar Mahajan, Sudhir Pawar, Atul D. Abhyanakar, Prafulla Kerkar, Ravishankar A. Govinda, Abraham Oomman, Dhurjati Sinha, Sachin N. Patil, Dhiman Kahali, Jitendra Sawhney, Abhijeet B. Joshi, Sanjeev Chaudhary, Pankaj Harkut, Santanu Guha, Sanjay Porwal, Srimannarayana Jujjuru, Ramesh B. Pothineni, Minguel R. Monteiro, Aziz Khan, Shamanna S. Iyengar, Jasprakash Singh Grewal, Manoj Chopda, Mahesh C. Fulwani, Aparna Patange, Patil Sachin, Vijay K. Chopra, Naresh K. Goyal, Rituparna Shinde, Gajendra V. Manakshe, Nitin Patki, Sumeet Sethi, Vengatesh Munusamy, Sunil Karnaand Sunil Thanvi, Srilakshmi Adhyapak, Chandrakant Patil, Ulhas Pandurangi, Rishabh Mathur, Jugal Gupta, Suhas Kalashetti, Ajit Bhagwat, Bagirath Raghuraman, Shiv Kumar Yerra, Prasant Bhansali, Rohidas Borse, Patil Rahul, Srihari Das, Vinay Kumar, Jabir Abdullakutty, Shireesh Saathe, Priya Palimkar, Jabir Abdullkutty, Shireesh Sathe, Shaul Atar, Michael Shechter, Morris Mosseri, Yaron Arbel, Chorin Ehud, Havakuk Ofer, Chaim Lotan, Uri Rosenschein, Amos Katz, Yaakov Henkin, Adi Francis, Marc Klutstein, Eugenia Nikolsky, Robert Zukermann, Yoav Turgeman, Majdi Halabi, Alon Marmor, Ran Kornowski, Michael Jonas, Offer Amir, Yonathan Hasin, Yoseph Rozenman, Shmuel Fuchs, Vered Zvi, Osamah Hussein, Dov Gavish, Zvi Vered, Yoseph Caraco, Mazen Elias, Naveh Tov, Efrat Wolfovitz, Michael Lishner, Nizar Elias, Giancarlo Piovaccari, Annamaria De Pellegrin, Raffaella Garbelotto, Gabriele Guardigli, Valgimigli Marco, Giovanni Licciardello, Carla Auguadro, Filippo Scalise, Claudio Cuccia, Alessandro Salvioni, Giuseppe Musumeci, Michelle Senni, Paolo Calabrò, Salvatore Novo, Pompilio Faggiano, Marco Metra, Nicoletta B. De Cesare, Sergio Berti, Claudio Cavallini, Enrico Puccioni, Marcello Galvani, Maurizio Tespili, Piermarco Piatti, Michela Palvarini, Giuseppe De Luca, Roberto Violini, Alessandro De Leo, Zoran Olivari, Pasquale Perrone Filardi, Maurizio Ferratini, Vittorio Racca, Kazuoki Dai, Yuji Shimatani, Haruo Kamiya, Kenji Ando, Yoshihiro Takeda, Yoshihiro Morino, Yoshiki Hata, Kazuo Kimura, Koichi Kishi, Ichiro Michishita, Hiroki Uehara, Toshinori Higashikata, Atsushi Hirayama, Keiji Hirooka, Yasuji Doi, Satoru Sakagami, Shuichi Taguchi, Akihiro Koike, Hiroyuki Fujinaga, Shinji Koba, Ken Kozuma, Tomohiro Kawasaki, Yujiro Ono, Masatoshi Shimizu, Yousuke Katsuda, Atsuyuki Wada, Toshiro Shinke, Junya Ako, Kenshi Fujii, Toshiyuki Takahashi, Tomohiro Sakamoto, Koichi Nakao, Yutaka Furukawa, Hiroshi Sugino, Ritsu Tamura, Toshiaki Mano, Masaaki Uematsu, Noriaki Utsu, Kashima Ito, Takuya Haraguchi, Katsuhiko Sato, Yasunori Ueda, Akira Nishibe, Kazuteru Fujimoto, Motomaru Masutani, Jung Han Yoon, Hack-Lyoung Kim, Hun Sik Park, In-Ho Chae, Moo Hyun Kim, Myung Ho Jeong, Seungwoon Rha, Chongjin Kim, Hae Young Kim, Taekjong Hong, Seung-Jea Tahk, Youngkwon Kim, Arija Busmane, Natalija Pontaga, Aldis Strelnieks, Iveta Mintale, Iveta Sime, Zaneta Petrulioniene, Roma Kavaliauskiene, Ruta Jurgaitiene, Gintare Sakalyte, Rimvydas Slapikas, Sigute Norkiene, Nerijus Misonis, Aleksandras Kibarskis, Raimondas Kubilius, Stojko Bojovski, Nensi Lozance, Aleksandar Kjovkaroski, Snezana Doncovska, Tiong Kiam Ong, Sazzli Kasim, Oteh Maskon, Balachandran Kandasamy, Houng B. Liew, Wan Mohd Izani Wan Mohamed, Armando García Castillo, Jorge Carrillo Calvillo, Pedro Fajardo Campos, Juan Carlos Núñez Fragoso, Edmundo Alfredo Bayram Llamas, Marco Antonio Alcocer Gamba, Jaime Carranza Madrigal, Luis Gerardo González Salas, Enrique López Rosas, Belinda González Díaz, Eduardo Salcido Vázquez, Alfredo Nacoud Ackar, Guillermo Antonio Llamas Esperón, Carlos Rodolfo Martínez Sánchez, María Guerrero De Leon, Rodrigo Suarez Otero, Guillermo Fanghänel Salmón, Jesús Antonio Pérez Ríos, José Angel Garza Ruíz, Robert W. Breedveld, Margriet Feenema-Aardema, Alida Borger-Van Der Burg, Pieter A.M. Hoogslag, Harry Suryapranata, Antonius Oomen, Paulus Van Haelst, Margriet Feenema-Aradema, Jacobijne J. Wiersma, Dirk Basart, Ruud M.A. Van Der Wal, Peter Zwart, Pascalle Monraats, Henricus Van Kesteren, Ioannis Karalis, Johan Jukema, Gerardus J.E. Verdel, Bart R.G. Brueren, Roland PTh Troquay, Eric P. Viergever, Nadea Y.Y. Al-Windy, Gerard L. Bartels, Jan H. Cornel, Walter R.M. Hermans, Johannes P.R. Herrman, Robert J. Bos, Reginald G.E.J. Groutars, Coenraad C. Van Der Zwaan, Refik Kaplan, Raymond Lionarons, Eelko Ronner, Bjorn E. Groenemeijer, Patrick N.A. Bronzwaer, Anho A.H. Liem, Bernard J.W.M. Rensing, Marcel J.J.A. Bokern, Remco Nijmeijer, Ferry M.R.J. Hersbach, Frank F. Willems, Antonius T.M. Gosselink, Saman Rasoul, John Elliott, Gerard Wilkins, Raewyn Fisher, Douglas Scott, Hamish Hart, Ralph Stewart, Scott Harding, Ian Ternouth, Nicholas Fisher, Samuel Wilson, Denise Aitken, Russell Anscombe, Laura Davidson, Tadeusz Tomala, Ottar Nygård, Jon Arne Sparby, Kjell Andersen, Lars Gullestad, Jarle Jortveit, Peter S. Munk, Erlend gyllensten Singsaas, Ulf Hurtig, Jorge R. Calderon Ticona, Julio R. Durand Velasquez, Sandra A. Negron Miguel, Enrique S. Sanabria Perez, Jesus M. Carrion Chambilla, Carlos A. Chavez Ayala, Reynaldo P. Castillo Leon, Rolando J. Vargas Gonzales, Jose D. Hernandez Zuniga, Luis A. Camacho Cosavalente, Jorge E. Bravo Mannucci, Javier Heredia Landeo, Nassip C. Llerena Navarro, Yudy M. Roldan Concha, Víctor E. Rodriguez Chavez, Henry A. Anchante Hernandez, Carlos A. Zea Nunez, Walter Mogrovejo Ramos, Arthur Ferrolino, Rosa Allyn G. Sy, Louie Tirador, Generoso Matiga, Raul Martin Coching, Alisa Bernan, Gregorio Rogelio, Dante D. Morales, Edgar Tan, Dennis Jose Sulit, Adrian Wlodarczak, Krystyna Jaworska, Grzegorz Skonieczny, Lidia Pawlowicz, Pawel Wojewoda, Benita Busz-Papiez, Janusz Bednarski, Aleksander Goch, Pawel Staneta, Elzbieta Dulak, Krzysztof Saminski, Wlodzimierz Krasowski, Wanda Sudnik, Aleksander Zurakowski, Marcin Skorski, Roman Lysek, Beata Miklaszewicz, Jacek Kubica, Jan Andrzej Lipko, Edyta Kostarska-Srokosz, Marek Piepiorka, Anna Drzewiecka, Ryszard Sciborski, Arkadiusz Stasiewski, Tomasz Blicharski, Leszek Bystryk, Michal Szpajer, Marek Korol, Tomasz Czerski, Ewa Mirek-Bryniarska, Jacek Gniot, Andrzej Lubinski, Jerzy Gorny, Edward Franek, Grzegorz Raczak, Hanna Szwed, Pedro Monteiro, Jose Mesquita Bastos, Helder H. Pereira, Dinis Martins, Filipe Seixo, Carlos Mendonça, Ana Botelho, Francisca Caetano, Bogdan Minescu, Octavian Istratoaie, Dan N. Tesloianu, Gabriel Cristian, Silviu Dumitrescu, Cristian G.C. Podoleanu, Mircea C.A. Constantinescu, Cristina M. Bengus, Constantin Militaru, Doina Rosu, Irinel R. Parepa, Adrian V. Matei, Tom M. Alexandru, Mihaela Malis, Ioan Coman, Rodica Stanescu-Cioranu, Doina Dimulescu, Yury Shvarts, Olga Orlikova, Zhanna Kobalava, Olga L. Barbarash, Valentin Markov, Nadezhda Lyamina, Alexander Gordienko, Konstantin Zrazhevsky, Alexander Y. Vishnevsky, Victor Gurevich, Raisa Stryuk, Nikita V. Lomakin, Igor Bokarev, Tatiana Khlevchuk, Sergey Shalaev, Larisa Khaisheva, Petr Chizhov, Inna Viktorova, Natalya Osokina, Vladimir Shchekotov, Evgenia Akatova, Galina Chumakova, Igor Libov, Mikhail I. Voevoda, Tatyana V. Tretyakova, Evgeny Baranov, Sergey Shustov, Sergey Yakushin, Ivan Gordeev, Niiaz Khasanov, Olga Reshetko, Tatiana Sotnikova, Olga Molchanova, Konstantin Nikolaev, Liudmila Gapon, Elena Baranova, Zaur Shogenov, Elena Kosmachova, Yuriy Karpov, Anton Povzun, Liudmila Egorova, Vadim V. Tyrenko, Igor G. Ivanov, Masterov Ilya, Sergey Kanorsky, Dragan Simic, Nikola Ivanovic, Goran Davidovic, Nebojsa Tasic, Milika R. Asanin, Stevo Stojic, Svetlana R. Apostolovic, Stevan Ilic, Biljana Putnikovic Tosic, Aleksandar Stankovic, Aleksandra Arandjelovic, Slavica Radovanovic, Branislava Todic, Jovan Balinovac, Dragan V. Dincic, Petar Seferovic, Ana Karadzic, Slobodan Dodic, Sinisa Dimkovic, Tamara Jakimov, Kian-Keong Poh, Hean Yee Ong, Justin Tang I-Shing, Karol Micko, Jan Nociar, Daniel Pella, Peter Fulop, Marian Hranai, Juraj Palka, Juraj Mazur, Ivan Majercák, Andrej Dzupina, František Fazekas, Jozef Gonsorcik, Viliam Bugan, Juraj Selecky, Gabriel Kamensky, Jaroslava Strbova, Rudolf Smik, Andrej Dukat, Peter Olexa, Ivan Žuran, Janez Poklukar, Nataša Černič Šuligoj, Matija Cevc, Henry P. Cyster, Naresh Ranjith, Clive Corbett, Junaid Bayat, Ellen Makoali Makotoko, Hendrik du Toit Theron, Ilse E. Kapp, Matthys M. de V Basson, Hanlie Lottering, Dina Van Aswegen, Louis J. Van Zyl, Peter J. Sebastian, Thayabran Pillay, Jan A. Saaiman, Patrick J. Commerford, Soraya Cassimjee, Garda Riaz, Iftikhar O. Ebrahim, Mahomed Sarvan, Joseph H. Mynhardt, Helmuth Reuter, Rajendran Moodley, Manuel Vida, Angel R. Cequier Fillat, Vicente Bodí Peris, Francisco Fuentes Jimenez, Francisco Marín, Jose M. Cruz Fernández, Rafael Jesus Hidalgo Urbano, Blas Gil-Extremera, Pablo Toledo, Fernando Worner Diz, David Garcia-Dorado, Andres Iñiguez, José Tuñón Fernández, Jose R. Gonzalez-Juanatey, Javier Fernandez Portales, Fernando Civeira Murillo, Laia Matas Pericas, Jose Luis Zamorano, Manuel De Mora Martin, Jordi Bruguera Cortada, Joaquin J. Alonso Martin, Jose Maria Serrano Antolin, José R. De Berrazueta Fernández, José Antonio Vázquez de Prada, Jose Francisco Díaz Fernández, José Alberto García Lledó, Juan Cosín Sales, Javier Botas Rodriguez, Gabriel Gusi Tragant, Amparo Benedicto, Carlos Gonzalez-Juanatey, Mercedes Camprubí Potau, Ignacio Plaza Perez, César Morís De La Tassa, Pablo Loma-Osorio Rincon, Javier Balaguer Recena, Juan M. Escudier, Antonio Coca Payeras, Norberto Alonso Orcajo, Pedro Valdivielso, Godwin Constantine, Ruvaiz Haniffa, Nirmali Tissera, Stanley Amarasekera, Chandrike Ponnamperuma, Nimali Fernando, Kaputella Fernando, Jayanthimala Jayawardena, Santharaj Wijeyasingam, Gotabhaya Ranasinghe, Ruvan Ekanayaka, Sepalika Mendis, Vajira Senaratne, Gnanamoorthy Mayurathan, Ajantha Rajapaksha, Thilak Sirisena, Jagath I. Herath, Naomali Amarasena, Stefan Berglund, Gundars Rasmanis, Ola Vedin, Nils Witt, Georgios Mourtzinis, Peter Nicol, Ole Hansen, Stefano Romeo, Steen Agergaard Jensen, Ingemar Torstensson, Ulf Ahremark, Torbjörn Sundelin, Tiziano Moccetti, Francois Mach, Ronald Binde, Oliver Gämperli, Wei-Chuan Tsai, Kwo-Chang Ueng, Wen-Ter Lai, Ming-En Liu, Juey-Jen Hwang, Wei-Hsian Yin, I-Chang Hsieh, Ming-Jer Hsieh, Wei Hsiang Lin, Jen-Yuan Kuo, Tsuei-Yuan Huang, Chih-Yuan Fang, Pinij Kaewsuwanna, Wasant Soonfuang, Woravut Jintapakorn, Apichard Sukonthasarn, Nattawut Wongpraparut, Krisada Sastravaha, Nakarin Sansanayudh, Wirash Kehasukcharoen, Dilok Piyayotai, Paiboon Chotnoparatpat, Ahmet Camsari, Hakan Kultursay, Bulent Mutlu, Murat Ersanli, Mustafa Demirtas, Cevat Kirma, Ertan Ural, Lale Koldas, Oleksandr Karpenko, Alexander Prokhorov, Ihor Vakaluyk, Halyna Myshanych, Dmytro Reshotko, Valeriy Batushkin, Leonid Rudenko, Ihor Kovalskyi, Mykola Kushnir, Vira Tseluyko, Yuriy Mostovoy, Mykola Stanislavchuk, Yulian Kyiak, Yuriy Karpenko, Yaroslav Malynovsky, Andriy Klantsa, Oles Kutniy, Ekaterina Amosova, Viktor Tashchuk, Oleh Leshchuk, Mykola Rishko, Mykola Kopytsya, Andriy Yagensky, Mykola Vatutin, Andriy Bagriy, Olga M. Barna, Olexiy Ushakov, Georgiy Dzyak, Borys Goloborodko, Anatolii Rudenko, Volodymyr Zheleznyy, Jasper Trevelyan, Azfar Zaman, Kaeng Lee, Andrew Moriarty, Rajesh K. Aggarwal, Piers Clifford, Yuk-Ki Wong, Syed M.R. Iqbal, Eduardas Subkovas, Denise Braganza, David Sarkar, Robert Storey, Huw Griffiths, Sam Mcclure, Rangasamy Muthusamy, Simon Smith, John Kurian, Terry Levy, Craig Barr, Honer Kadr, Robert Gerber, Audrius Simaitis, Handrean Soran, Anthony Mathur, Adrian Brodison, Mohammad Ayaz, Muhammad Cheema, Richard Oliver, Simon Thackray, Telal Mudawi, Gohar Rahman, Ayyaz Sultan, Timothy Reynolds, David Sharman, null david Sprigings, Rob Butler, Peter Wilkinson, Gregory Y.H. Lip, Julian Halcox, Sean Gallagher, Nicholas Ossei-Gerning, Gil Vardi, Duccio Baldari, David Brabham, Charles Treasure, Charles Dahl, Bruce Palmer, Alan Wiseman, Abul Khan, Sanjeev Puri, Ann Elizabeth Mohart, Carlos Ince, Enrique Flores, Scott Wright, Shi-Chi Cheng, Michael Rosenberg, William Rogers, Edward Kosinski, Les Forgosh, Jonathan Waltman, Misal Khan, Mohammad Shoukfeh, Georges Dagher, Patrick Cambier, Ira Lieber, Priya Kumar, Cara East, Perry Krichmar, Mian Hasan, Lindsey White, Thomas Knickelbine, Thomas Haldis, Eve Gillespie, Thomas Amidon, David Suh, Imran Arif, Mouhamad Abdallah, Faiq Akhter, Eric Carlson, Michael D'Urso, Fadi El-Ahdab, William Nelson, Katie Moriarty, Barry Harris, Steven Cohen, Luther Carter, Daniel Doty, Kenneth Sabatino, Tariq Haddad, Amir Malik, Sunder Rao, Angel Mulkay, Ion Jovin, Kim Klancke, Vinay Malhotra, Sai K. Devarapalli, Michael Koren, Harish Chandna, George Dodds, Tauqir Goraya, James Bengston, Matthew Janik, Joseph Moran, Andrew Sumner, John Kobayashi, William Davis, Shahram Yazdani, John Pasquini, Maitreya Thakkar, Amarnath Vedere, Wayne Leimbach, James Rider, Sarah fenton, Narendra Singh, Anil V. Shah, Denise Janosik, Carl Pepine, Brett Berman, Joseph Gelormini, Christopher Daniels, Kerensky Richard, Friederike Keating, Nicholas I. Kondo, Sanjay Shetty, Howard Levite, Winfried Waider, Theodore Takata, Mazen Abu-Fadel, Vipul Shah, Rahul Aggarwal, Mark Izzo, Anil Kumar, Brack Hattler, Rose Do, Chad Link, Anna Bortnick, George Kinzfogl, Arnold Ghitis, John Larry, Edward Teufel, Peter Kuhlman, Brent Mclaurin, Wenwu Zhang, Stephen Thew, Jalal Abbas, Matthew White, Othman Islam, Sumeet Subherwal, Nandkishore Ranadive, Babak Vakili, Christian Gring, David Henderson, Timothy Schuchard, Naim Farhat, Geoffrey Kline, Sharan Mahal, Jack Whitaker, Shawn Speirs, Rolf Andersen, Nizar Daboul, Phillip Horwitz, Firas Zahr, George Ponce, Zubair Jafar, Joseph Mcgarvey, Vipul Panchal, Stephen Voyce, Thomas Blok, William Sheldon, Masoud M. Azizad, Carsten Schmalfuss, Mark Picone, Robert Pederson, William Herzog, Keith Friedman, Jason Lindsey, Rosemary Nowins, Eichenlaub Timothy, Parilak Leonard, Norman Lepor, Mahfouz El Shahawy, Howard Weintraub, Anand Irimpen, Alvaro Alonso, Wade May, Daniels Christopher, Thomas Galski, Alan Chu, Freny Mody, Ebrahimi Ramin, Zachary Hodes, Joseph Rossi, Gregory Rose, James Fairlamb, Charles Lambert, Ajit Raisinghani, Antonio Abbate, George Vetrovec, Marilyn King, Charles Carey, Jaime Gerber, Liwa Younis, Hyeun Park, Mladen Vidovich, Thomas Knutson, Dennis Friedman, Fred Chaleff, Arthur Loussararian, Phillip Rozeman, Carey Kimmelstiel, Jeffrey Kuvin, Kevin Silver, Malcolm Foster, Glen Tonnessen, Andrey Espinoza, Mohamadali Amlani, Andreas Wali, Christopher Malozzi, Geert T. Jong, Clara Massey, Keattiyoat Wattanakit, Philip J. O'Donnell, Dinesh Singal, Naseem Jaffrani, Sridhar Banuru, Daniel Fisher, Mark Xenakis, Neal Perlmutter, Ravi Bhagwat, James Strader, Ronald Blonder, Ayim Akyea-Djamson, Ajay Labroo, Kwan Lee, H. John Marais, Edmund Claxton, Robert Weiss, Rohr Kathryn, Martin Berk, Peter Rossi, Parag Joshi, Amit Khera, Ajit S. Khaira, Greg Kumkumian, Steven Lupovitch, Joshua Purow, Stephen Welka, David Hoffman, Stuart Fischer, Eugene Soroka, Donald Eagerton, Samir Pancholy, Michael Ray, Norman Erenrich, Michael Farrar, Stewart Pollock, William J. French, Steve Diamantis, Douglas Guy, Lawrence Gimple, Mark Neustel, Steven Schwartz, Edward Pereira, Seals Albert, Douglas Spriggs, Janet Strain, Suneet Mittal, Anthony Vo, Majed Chane, Jason Hall, Nampalli Vijay, Kapildeo Lotun, F. Martin Lester, Ahed Nahhas, Theodore Pope, Paul Nager, Rakesh Vohra, Mukesh Sharma, Riyaz Bashir, Hinan Ahmed, Michael Berlowitz, Robert Fishberg, Robert Barrucco, Eric Yang, Michael Radin, Daniel Sporn, Dwight Stapleton, Steven Eisenberg, Joel Landzberg, Martin Mcgough, Samir Turk, Michael Schwartz, P. Sandy Sundram, Diwakar Jain, Mark Zainea, Carlos Bayron, Ronald Karlsberg, Suhail Dohad, Henry Lui, William Keen, Donald Westerhausen, Sandeep Khurana, Himanshu Agarwal, Jessica Birchem, William Penny, Mark Chang, Sherrill Murphy, John Henry, Branislav Schifferdecker, John M Gilbert, Gopal Chalavarya, Charles Eaton, John F. Schmedtje, Stuart Christenson, Imran Dotani, Douglas Denham, Alexander Macdonell, Paul Gibson, Aref Rahman, Tammam Al Joundi, Nizar Assi, Gary Conrad, Purushotham Kotha, Michael Love, Gregory Giesler, Howard Rubenstein, Dawood Gamil, Laura Akright, Justine Krawczyk, Joanne Cobler, Terry Wells, James Welker, Robert Foster, Richard Gilmore, Jay Anderson, Douglas Jacoby, Bill Harris, Geraldine Gardner, Ramprasad Dandillaya, Kishor Vora, John Kostis, John Hunter, David Laxson, Eric Ball, Flavia Egydio, Anelise Kawakami, Janaina Oliveira, Julianna Wozniak, Alexander Matthews, Caroline Ratky, Janine Valiris, Lisa Berdan, Anita Hepditch, Kirby Quintero, Tyrus Rorick, Melissa Westbrook, Andrea Pascual, Carla Rovito, Madeleine Bezault, Elodie Drouet, Tabassome Simon, Caroline Alsweiler, Anne Luyten, Julie Butters, Liddy Griffith, Michelle Shaw, Lena Grunberg, Shahidul Islam, Marie-France Brégeault, Nathalie Bougon, Douglas Faustino, Sylvie Fontecave, Judith Murphy, Melanie Verrier, null Veronique Agnetti, Dorthe Andersen, Emmy Badreddine, Mhamed Bekkouche, Cecile Bouancheau, Imane Brigui, Maddy Brocklehurst, Joseph Cianciarulo, Dawn Devaul, Szilvia Domokos, Cecile Gache, Caroline Gobillot, Severine Guillou, Jan Healy, Megan Heath, Gayatri Jaiwal, Carine Javierre, Julien Labeirie, Myriam Monier, Ulises Morales, Asmaa Mrabti, Bicky Mthombeni, Betim Okan, Lucile Smith, Jennifer Sheller, Sebastien Sopena, Valerie Pellan, Fadela Benbernou, Nafissa Bengrait, Maud Lamoureux, Katarina Kralova, Raphael Bejuit, Anthony Coulange, Christelle Berthou, Jérôme Repincay, Christelle Lorenzato, Alexis Etienne, Valerie Gouet, Virginie Loizeau, Mickael Normand, Anne Ourliac, Christelle Rondel, Antony Adamo, Pascale Beltran, Pauline Barraud, Helene Dubois-Gache, Benjamin Halle, Lamia Metwally, Maxime Mourgues, Marc Sotty, Marion Vincendet, Raluca Cotruta, Zhu Chengyue, Dominique Fournie-Lloret, Christine Morrello, Aurelie Perthuis, Patrick Picault, Isabelle Zobouyan, Helen M. Colhoun, Michael A. Dempsey, Mark A. McClanahan, Masira, and Laucevičius, Aleksandras
Subjects: Male, Acute coronary syndrome, medicine.medical_specialty, Cardiac & Cardiovascular Systems, Randomization, PCSK9 inhibitor, LOW-DENSITY-LIPOPROTEIN, Antibodies, Monoclonal, Humanized, acute coronary syndrom, Placebo, Gastroenterology, lipoprotein(a), Internal medicine, medicine, Humans, Low-density lipoprotein cholesterol, Aged, Alirocumab, RISK, low-density lipoprotein cholesterol, Science & Technology, biology, business.industry, PCSK9, PCSK9 Inhibitors, Hazard ratio, ALIROCUMAB, acute coronary syndrome, Cholesterol, LDL, Lipoprotein(a), Middle Aged, EFFICACY, medicine.disease, Cardiovascular Diseases, CARDIOVASCULAR-DISEASE, SAFETY, Cardiovascular System & Cardiology, biology.protein, Female, lipids (amino acids, peptides, and proteins), STATIN, low-density lipoprotein, cholesterol PCSK9 inhibitor, CORONARY, Cardiology and Cardiovascular Medicine, business, Life Sciences & Biomedicine, Mace
Abstract: Digital, Background Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. Objectives In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. Methods ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was 13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% CI: 0.72-0.92) and 0.89 (95% CI: 0.75-1.06), with Pinteraction = 0.43. Conclusions In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402), Ciencias Médicas y de la Salud
Published: 2021

40. Exome survey of individuals affected by VATER/VACTERL with renal phenotypes identifies phenocopies and novel candidate genes

Author: Rufeng Dai, Shrikant Mane, Marcello Scala, Shirlee Shril, Alina C. Hilger, Dervla M. Connaughton, Franziska Kause, Heidi L. Rehm, Bernd Hoppe, Gianluca Piatelli, Stefanie Märzheuser, Makiko Nakayama, Caroline M. Kolvenbach, Richard P. Lifton, Vincenzo Nigro, Luca Schierbaum, Thomas M. Kitzler, Friedhelm Hildebrandt, Eberhard Schmiedeke, Gabriel C. Dworschak, Sophia Schneider, Heiko Reutter, Annalaura Torella, Valeria Capra, Amelie T. van der Ven, Ronen Schneider, Nina Mann, Andrea Accogli, Kolvenbach, C. M., van der Ven, A. T., Kause, F., Shril, S., Scala, M., Connaughton, D. M., Mann, N., Nakayama, M., Dai, R., Kitzler, T. M., Schneider, R., Schierbaum, L., Schneider, S., Accogli, A., Torella, A., Piatelli, G., Nigro, V., Capra, V., Hoppe, B., Marzheuser, S., Schmiedeke, E., Rehm, H. L., Mane, S., Lifton, R. P., Dworschak, G. C., Hilger, A. C., Reutter, H., and Hildebrandt, F.
Subjects: Male, medicine.medical_specialty, Candidate gene, Heart Diseases, Tracheoesophageal fistula, Kidney, digestive system, Gastroenterology, Article, VATER/VACTERL association, 03 medical and health sciences, anorectal malformation (ARM), monogenic disease causation, Genes, X-Linked, Internal medicine, Exome Sequencing, Genetics, medicine, Humans, Genetic Predisposition to Disease, HSP90 Heat-Shock Proteins, Exome, Esophageal Atresia, Genetics (clinical), Exome sequencing, Genetic Association Studies, 030304 developmental biology, Phenocopy, Hemizygote, Homeodomain Proteins, 0303 health sciences, business.industry, exome sequencing (WES), 030305 genetics & heredity, Receptors, Interleukin, medicine.disease, VACTERL association, Phenotype, digestive system diseases, Anorectal Malformations, 3. Good health, DNA-Binding Proteins, Cytoskeletal Proteins, congenital anomalies of the kidneys and urinary tract (CAKUT), HOXD13, Female, business, Tracheoesophageal Fistula, Transcription Factors
Abstract: INTRODUCTION: The acronym VATER/VACTERL refers to the rare non-random association of the following component features (CFs): vertebral defects (V), anorectal malformations (ARM) (A), cardiac anomalies (C), tracheoesophageal fistula with or without esophageal atresia (TE), renal malformations (R), and limb anomalies (L). For the clinical diagnosis the presence of at least three CFs is required, individuals presenting with only two CFs have been categorized as VATER/VACTERL-like. The majority of VATER/VACTERL individuals displays a renal phenotype. Hitherto, variants in FGF8, FOXF1, HOXD13, LPP, TRAP1, PTEN and ZIC3 have been associated with the VATER/VACTERL association; however, large-scale re-sequencing could only confirm TRAP1 and ZIC3 as VATER/VACTERL disease genes, both associated with a renal phenotype. METHODS: In this study, we performed exome sequencing in 21 individuals and their families with a renal VATER/VACTERL or VATER/VACTERL-like phenotype to identify potentially novel genetic causes. RESULTS: Exome analysis identified biallelic and X-chromosomal hemizygous potentially pathogenic variants in six individuals (29%) in B9D1, FREM1, ZNF157, SP8, ACOT9, and TTLL11, respectively. The online tool GeneMatcher revealed another individual with a variant in ZNF157. CONCLUSION: Our study suggests six biallelic and X-chromosomal hemizygous VATER/VACTERL disease gene implicating all six genes in the expression of human renal malformations.
Published: 2021

41. Bi-allelic KARS1 pathogenic variants affecting functions of cytosolic and mitochondrial isoforms are associated with a progressive and multisystem disease

Author: Paola Goffrini, Felice D'Arco, Enrico Baruffini, Adeline Vanderver, Tamison Jewett, Enrico Bertini, Anya Revah-Politi, Eirik Bratland, Vandana Shashi, Alessandra D'Amico, Camilla Ceccatelli Berti, Vimla Aggarwal, Silvia Maitz, Kwame Anyane-Yeboa, Tara H. Stamper, Francesco Canonico, Gabriel S Kupchik, Andreas Benneche, César Augusto Pinheiro Ferreira Alves, Daniela Longo, Gerarda Cappuccio, Annalaura Torella, Vincenzo Nigro, Nicola Brunetti-Pierri, Marjo S van der Knaap, Siren Berland, Jennifer A. Sullivan, Pediatrics, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Functional Genomics, Cappuccio, G., Ceccatelli Berti, C., Baruffini, E., Sullivan, J., Shashi, V., Jewett, T., Stamper, T., Maitz, S., Canonico, F., Revah-Politi, A., Kupchik, G. S., Anyane-Yeboa, K., Aggarwal, V., Benneche, A., Bratland, E., Berland, S., D'Arco, F., Alves, C. A., Vanderver, A., Longo, D., Bertini, E., Torella, A., Nigro, V., D'Amico, A., van der Knaap, M. S., Goffrini, P., Brunetti Pierri, N., and Brunetti-Pierri, N.
Subjects: Lysine-tRNA Ligase, Male, Mitochondrion, lysyl-transfer RNA synthetase, Cohort Studies, Cytosol, KARS, lysyl‐transfer RNA synthetase, Child, Research Articles, Muscular Dystrophie, Genetics (clinical), Allele, Genetics, 0303 health sciences, Progressive microcephaly, Homozygote, 030305 genetics & heredity, Phenotype, Mitochondria, Pedigree, Isoenzymes, mitochondrial disease, Child, Preschool, Transfer RNA, Disease Progression, Microcephaly, Female, KARS1, Research Article, Human, Gene isoform, Adolescent, Mitochondrial disease, Saccharomyces cerevisiae, Biology, 03 medical and health sciences, SDG 3 - Good Health and Well-being, medicine, Humans, Abnormalities, Multiple, Alleles, 030304 developmental biology, Organisms, Genetically Modified, Leukodystrophy, Brain Diseases, Metabolic, Inborn, Infant, LysRS, medicine.disease, Isoenzyme, Cohort Studie
Abstract: KARS1 encodes a lysyl-transfer RNA synthetase (LysRS) that links lysine to its cognate tRNA. Two different KARS1 isoforms exert functional effects in cytosol and mitochondria. Bi-allelic pathogenic variants in KARS1 have been associated to sensorineural hearing and visual loss, neuropathy, seizures, and leukodystrophy. We report the clinical, biochemical and neuroradiological features of nine individuals with KARS1-related disorder carrying 12 different variants with nine of them being novel. The consequences of these variants on the cytosol and/or mitochondrial LysRS were functionally validated in yeast mutants. Most cases presented with severe neurological features including congenital and progressive microcephaly, seizures, developmental delay/intellectual disability, and cerebral atrophy. Oculo-motor dysfunction and immuno-hematological problems were present in six and three cases, respectively. A yeast growth defect of variable severity was detected for most variants on both cytosolic and mitochondrial isoforms. The detrimental effects of two variants on yeast growth were partially rescued by lysine supplementation. Congenital progressive microcephaly, oculo-motor dysfunction and immuno-hematological problems are emerging phenotypes in KARS1-related disorders. The data in yeast emphasize the role of both mitochondrial and cytosolic isoforms in the pathogenesis of KARS1-related disorder and supports the therapeutic potential of lysine supplementation at least in a subset of patients. This article is protected by copyright. All rights reserved.
Published: 2021

42. An Alu-mediated duplication in NMNAT1, involved in NAD biosynthesis, causes a novel syndrome, SHILCA, affecting multiple tissues and organs

Author: Andrea Superti-Furga, Carlo Rivolta, Francesco Testa, Nicola Bedoni, Marta Corton, Federica Lanza, Nicola Brunetti-Pierri, Mirella Filocamo, Francesca Simonelli, Mathieu Quinodoz, Susanna Lualdi, Giovanni Morana, Sandro Banfi, Annalaura Torella, Vincenzo Nigro, Carmen Ayuso, Maja Di Rocco, Michele Pinelli, Tudp, Gerarda Cappuccio, Bedoni, N., Quinodoz, M., Pinelli, M., Cappuccio, G., Torella, A., Nigro, V., Testa, F., Simonelli, F., Corton, M., Lualdi, S., Lanza, F., Morana, G., Ayuso, C., Di Rocco, M., Filocamo, M., Banfi, S., Brunetti-Pierri, Nicola, Superti-Furga, A., Rivolta, C., Bedoni, Nicola, Quinodoz, Mathieu, Pinelli, Michele, Cappuccio, Gerarda, Torella, Annalaura, Nigro, Vincenzo, Testa, Francesco, Simonelli, Francesca, Corton, Marta, Lualdi, Susanna, Lanza, Federica, Morana, Giovanni, Ayuso, Carmen, Di Rocco, Maja, Filocamo, Mirella, Banfi, Sandro, Superti-Furga, Andrea, and Rivolta, Carlo
Subjects: Male, Adolescent, Hearing Loss, Sensorineural, Leber Congenital Amaurosis, Biology, Osteochondrodysplasias, medicine.disease_cause, Mice, 03 medical and health sciences, Exon, 0302 clinical medicine, Intellectual Disability, NMNAT1, Gene duplication, Genetics, medicine, Animals, Humans, Genetic Predisposition to Disease, Nicotinamide-Nucleotide Adenylyltransferase, Child, Molecular Biology, Gene, Genetics (clinical), Exome sequencing, 030304 developmental biology, Whole genome sequencing, 0303 health sciences, Mutation, Retinal Degeneration, Haplotype, Infant, Exons, General Medicine, NAD, Pedigree, Disease Models, Animal, Child, Preschool, 030217 neurology & neurosurgery
Abstract: We investigated the genetic origin of the phenotype displayed by three children from two unrelated Italian families, presenting with a previously unrecognized autosomal recessive disorder that included a severe form of spondylo-epiphyseal dysplasia, sensorineural hearing loss, intellectual disability and Leber congenital amaurosis (SHILCA), as well as some brain anomalies that were visible at the MRI. Autozygome-based analysis showed that these children shared a 4.76 Mb region of homozygosity on chromosome 1, with an identical haplotype. Nonetheless, whole-exome sequencing failed to identify any shared rare coding variants, in this region or elsewhere. We then determined the transcriptome of patients’ fibroblasts by RNA sequencing, followed by additional whole-genome sequencing experiments. Gene expression analysis revealed a 4-fold downregulation of the gene NMNAT1, residing indeed in the shared autozygous interval. Short- and long-read whole-genome sequencing highlighted a duplication involving 2 out of the 5 exons of NMNAT1 main isoform (NM_022787.3), leading to the production of aberrant mRNAs. Pathogenic variants in NMNAT1 have been previously shown to cause non-syndromic Leber congenital amaurosis (LCA). However, no patient with null biallelic mutations has ever been described, and murine Nmnat1 knockouts show embryonic lethality, indicating that complete absence of NMNAT1 activity is probably not compatible with life. The rearrangement found in our cases, presumably causing a strong but not complete reduction of enzymatic activity, may therefore result in an intermediate syndromic phenotype with respect to LCA and lethality.
Published: 2020
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43. ACE2 gene variants may underlie interindividual variability and susceptibility to COVID-19 in the Italian population

Author: Benetti, E., Tita, R., Spiga, O., Ciolfi, A., Birolo, G., Bruselles, A., Doddato, G., Giliberti, A., Marconi, C., Musacchia, F., Pippucci, T., Torella, A., Trezza, A., Valentino, F., Baldassarri, M., Brusco, A., Asselta, R., Bruttini, M., Furini, S., Seri, M., Nigro, V., Matullo, G., Tartaglia, M., Mari, F., Frullanti, E., Fallerini, C., Daga, S., Croci, S., Amitrano, S., Fava, F., Montagnani, F., Di Sarno, L., Tommasi, A., Palmieri, M., Emiliozzi, A., Fabbiani, M., Rossetti, B., Zanelli, G., Bergantini, L., D’Alessandro, M., Cameli, P., Bennet, D., Anedda, F., Marcantonio, S., Scolletta, S., Franchi, F., Mazzei, M. A., Conticini, E., Cantarini, L., Frediani, B., Tacconi, D., Feri, M., Scala, R., Spargi, G., Corridi, M., Nencioni, C., Caldarelli, G. P., Spagnesi, M., Piacentini, P., Bandini, M., Desanctis, E., Canaccini, A., Spertilli, C., Donati, A., Guidelli, L., Croci, L., Verzuri, A., Anemoli, V., Ognibene, A., Vaghi, M., D’Arminio Monforte, A., Merlini, E., Mondelli, M. U., Mantovani, S., Ludovisi, S., Girardis, M., Venturelli, S., Sita, M., Cossarizza, A., Antinori, A., Vergori, A., Rusconi, S., Siano, M., Gabrieli, A., Riva, A., Francisci, D., Schiaroli, E., Scotton, P. G., Andretta, F., Panese, S., Scaggiante, R., Parisi, S. G., Castelli, F., Quiros-Roldan, M. E., Magro, P., Minardi, C., Castelli, D., Polesini, I., Della Monica, M., Piscopo, C., Capasso, M., Russo, R., Andolfo, I., Iolascon, A., Carella, M., Castori, M., Merla, G., Aucella, F., Raggi, P., Marciano, C., Perna, R., Bassetti, M., Di Biagio, A., Sanguinetti, M., Masucci, L., Gabbi, C., Valente, S., Guerrini, S., Meloni, I., Mencarelli, M. A., Rizzo, C. L., Bargagli, E., Mandalà, M., Giorli, A., Salerni, L., Fiorentino, G., Zucchi, P., Parravicini, P., Menatti, E., Baratti, S., Trotta, T., Giannattasio, F., Coiro, G., Lena, F., Coviello, D. A., Mussini, C., Renieri, A., Pinto, A. M., GEN-COVID Multicenter Study, Benetti, E., Tita, R., Spiga, O., Ciolfi, A., Birolo, G., Bruselles, A., Doddato, G., Giliberti, A., Marconi, C., Musacchia, F., Pippucci, T., Torella, A., Trezza, A., Valentino, F., Baldassarri, M., Brusco, A., Asselta, R., Bruttini, M., Furini, S., Seri, M., Nigro, V., Matullo, G., Tartaglia, M., Mari, F., Frullanti, E., Fallerini, C., Daga, S., Croci, S., Amitrano, S., Fava, F., Montagnani, F., Di Sarno, L., Tommasi, A., Palmieri, M., Emiliozzi, A., Fabbiani, M., Rossetti, B., Zanelli, G., Bergantini, L., D'Alessandro, M., Cameli, P., Bennet, D., Anedda, F., Marcantonio, S., Scolletta, S., Franchi, F., Mazzei, M. A., Conticini, E., Cantarini, L., Frediani, B., Tacconi, D., Feri, M., Scala, R., Spargi, G., Corridi, M., Nencioni, C., Caldarelli, G. P., Spagnesi, M., Piacentini, P., Bandini, M., Desanctis, E., Canaccini, A., Spertilli, C., Donati, A., Guidelli, L., Croci, L., Verzuri, A., Anemoli, V., Ognibene, A., Vaghi, M., D'Arminio Monforte, A., Merlini, E., Mondelli, M. U., Mantovani, S., Ludovisi, S., Girardis, M., Venturelli, S., Sita, M., Cossarizza, A., Antinori, A., Vergori, A., Rusconi, S., Siano, M., Gabrieli, A., Riva, A., Francisci, D., Schiaroli, E., Scotton, P. G., Andretta, F., Panese, S., Scaggiante, R., Parisi, S. G., Castelli, F., Quiros-Roldan, M. E., Magro, P., Minardi, C., Castelli, D., Polesini, I., Della Monica, M., Piscopo, C., Capasso, M., Russo, R., Andolfo, I., Iolascon, A., Carella, M., Castori, M., Merla, G., Aucella, F., Raggi, P., Marciano, C., Perna, R., Bassetti, M., Di Biagio, A., Sanguinetti, M., Masucci, L., Gabbi, C., Valente, S., Guerrini, S., Meloni, I., Mencarelli, M. A., Rizzo, C. L., Bargagli, E., Mandala, M., Giorli, A., Salerni, L., Fiorentino, G., Zucchi, P., Parravicini, P., Menatti, E., Baratti, S., Trotta, T., Giannattasio, F., Coiro, G., Lena, F., Coviello, D. A., Mussini, C., Renieri, A., Pinto, A. M., Benetti E., Tita R., Spiga O., Ciolfi A., Birolo G., Bruselles A., Doddato G., Giliberti A., Marconi C., Musacchia F., Pippucci T., Torella A., Trezza A., Valentino F., Baldassarri M., Brusco A., Asselta R., Bruttini M., Furini S., Seri M., Nigro V., Matullo G., Tartaglia M., Mari F., Frullanti E., Fallerini C., Daga S., Croci S., Amitrano S., Fava F., Montagnani F., Di Sarno L., Tommasi A., Palmieri M., Emiliozzi A., Fabbiani M., Rossetti B., Zanelli G., Bergantini L., D'Alessandro M., Cameli P., Bennet D., Anedda F., Marcantonio S., Scolletta S., Franchi F., Mazzei M.A., Conticini E., Cantarini L., Frediani B., Tacconi D., Feri M., Scala R., Spargi G., Corridi M., Nencioni C., Caldarelli G.P., Spagnesi M., Piacentini P., Bandini M., Desanctis E., Canaccini A., Spertilli C., Donati A., Guidelli L., Croci L., Verzuri A., Anemoli V., Ognibene A., Vaghi M., D'Arminio Monforte A., Merlini E., Mondelli M.U., Mantovani S., Ludovisi S., Girardis M., Venturelli S., Sita M., Cossarizza A., Antinori A., Vergori A., Rusconi S., Siano M., Gabrieli A., Riva A., Francisci D., Schiaroli E., Scotton P.G., Andretta F., Panese S., Scaggiante R., Parisi S.G., Castelli F., Quiros-Roldan M.E., Magro P., Minardi C., Castelli D., Polesini I., Della Monica M., Piscopo C., Capasso M., Russo R., Andolfo I., Iolascon A., Carella M., Castori M., Merla G., Aucella F., Raggi P., Marciano C., Perna R., Bassetti M., Di Biagio A., Sanguinetti M., Masucci L., Gabbi C., Valente S., Guerrini S., Meloni I., Mencarelli M.A., Rizzo C.L., Bargagli E., Mandala M., Giorli A., Salerni L., Fiorentino G., Zucchi P., Parravicini P., Menatti E., Baratti S., Trotta T., Giannattasio F., Coiro G., Lena F., Coviello D.A., Mussini C., Renieri A., Pinto A.M., Elisa, F., Chiara, F., Sergio, D., Susanna, C., Sara, A., and Francesca, F.
Subjects: Male, inter individual variability, medicine.disease_cause, Whole Exome Sequencing, genetic background, angiotensin converting enzyme 2, Cohort Studies, 0302 clinical medicine, Databases, Genetic, Missense mutation, Genetics(clinical), Viral, Internalization, Frameshift Mutation, Genetics (clinical), Exome sequencing, media_common, Coronavirus, Genetics, 0303 health sciences, Mutation, Protein Stability, Aged, Angiotensin-Converting Enzyme 2, Betacoronavirus, COVID-19, Coronavirus Infections, Female, Genetic Predisposition to Disease, Humans, Italy, Middle Aged, Molecular Dynamics Simulation, Mutation, Missense, Pandemics, Peptidyl-Dipeptidase A, Pneumonia, Viral, SARS-CoV-2, Spike Glycoprotein, Coronavirus, Spike Glycoprotein, 030220 oncology & carcinogenesis, Human, media_common.quotation_subject, Biology, Article, Frameshift mutation, 03 medical and health sciences, Databases, Genetic, Genome assembly algorithms, Exome Sequencing, medicine, Allele, Gene, 030304 developmental biology, Betacoronaviru, Pandemic, Coronavirus Infection, Pneumonia, Viral infection, Cohort Studie, Missense, Spike Glycoprotein, Coronaviru
Abstract: In December 2019, an initial cluster of interstitial bilateral pneumonia emerged in Wuhan, China. A human-to-human transmission was assumed and a previously unrecognized entity, termed coronavirus disease-19 (COVID-19) due to a novel coronavirus (SARS-CoV-2) was described. The infection has rapidly spread out all over the world and Italy has been the first European country experiencing the endemic wave with unexpected clinical severity in comparison with Asian countries. It has been shown that SARS-CoV-2 utilizes angiotensin converting enzyme 2 (ACE2) as host receptor and host proteases for cell surface binding and internalization. Thus, a predisposing genetic background can give reason for interindividual disease susceptibility and/or severity. Taking advantage of the Network of Italian Genomes (NIG), here we mined whole-exome sequencing data of 6930 Italian control individuals from five different centers looking forACE2variants. A number of variants with a potential impact on protein stability were identified. Among these, three more common missense changes, p.(Asn720Asp), p.(Lys26Arg), and p.(Gly211Arg) were predicted to interfere with protein structure and stabilization. Rare variants likely interfering with the internalization process, namely p.(Leu351Val) and p.(Pro389His), predicted to interfere with SARS-CoV-2 spike protein binding, were also observed. Comparison ofACE2WES data between a cohort of 131 patients and 258 controls allowed identifying a statistically significant (Pvalue
Published: 2020

44. Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial

Author: Kausik K Ray, Helen M Colhoun, Michael Szarek, Marie Baccara-Dinet, Deepak L Bhatt, Vera A Bittner, Andrzej J Budaj, Rafael Diaz, Shaun G Goodman, Corinne Hanotin, Robert A Harrington, J Wouter Jukema, Virginie Loizeau, Renato D Lopes, Angèle Moryusef, Jan Murin, Robert Pordy, Arsen D Ristic, Matthew T Roe, José Tuñón, Harvey D White, Andreas M Zeiher, Gregory G Schwartz, Philippe Gabriel Steg, Gregory G. Schwartz, Ph. Gabriel Steg, Deepak L. Bhatt, Vera A. Bittner, Shaun G. Goodman, Robert A. Harrington, J. Wouter Jukema, Harvey D. White, Andreas M. Zeiher, Pierluigi Tricoci, Matthew T. Roe, Kenneth W. Mahaffey, Jay M. Edelberg, Guillaume Lecorps, William J. Sasiela, Jean-François Tamby, Philip E. Aylward, Heinz Drexel, Peter Sinnaeve, Mirza Dilic, Renato D. Lopes, Nina N. Gotcheva, Juan-Carlos Prieto, Huo Yong, Patricio López-Jaramillo, Ivan Pećin, Zeljko Reiner, Petr Ostadal, Margus Viigimaa, Markku S. Nieminen, Vakhtang Chumburidze, Nikolaus Marx, Nicolas Danchin, Evangelos Liberopoulos, Pablo Carlos Montenegro Valdovinos, Hung-Fat Tse, Robert Gabor Kiss, Denis Xavier, Doron Zahger, Marco Valgimigli, Takeshi Kimura, Hyo Soo Kim, Sang-Hyun Kim, Andrejs Erglis, Aleksandras Laucevicius, Sasko Kedev, Khalid Yusoff, Gabriel Arturo Ramos López, Marco Alings, Sigrun Halvorsen, Roger M. Correa Flores, Andrzej Budaj, Joao Morais, Maria Dorobantu, Yuri Karpov, Arsen D. Ristic, Terrance Chua, Zlatko Fras, Anthony J. Dalby, H. Asita de Silva, Emil Hagström, Ulf Landmesser, Chern-En Chiang, Piyamitr Sritara, Sema Guneri, Alexander Parkhomenko, Kausik K. Ray, Patrick M. Moriarty, Robert Vogel, Bernard Chaitman, Sheryl F. Kelsey, Anders G. Olsson, Jean-Lucien Rouleau, Maarten L. Simoons, Karen Alexander, Chiara Meloni, Robert Rosenson, Eric J.G. Sijbrands, John H. Alexander, Luciana Armaganijan, Akshay Bagai, Maria Cecilia Bahit, J. Matthew Brennan, Shaun Clifton, Adam D. DeVore, Shalonda Deloatch, Sheila Dickey, Keith Dombrowski, Grégory Ducrocq, Zubin Eapen, Patricia Endsley, Arleen Eppinger, Robert W. Harrison, Connie Ng Hess, Mark A. Hlatky, Joseph Dedrick Jordan, Joshua W. Knowles, Bradley J. Kolls, David F. Kong, Sergio Leonardi, Linda Lillis, David J. Maron, Jill Marcus, Robin Mathews, Rajendra H. Mehta, Robert J. Mentz, Humberto Graner Moreira, Chetan B. Patel, Sabrina Bernardez-Pereira, Lynn Perkins, Thomas J. Povsic, Etienne Puymirat, William Schuyler Jones, Bimal R. Shah, Matthew W. Sherwood, Kenya Stringfellow, Darin Sujjavanich, Mustafa Toma, Charlene Trotter, Sean Van Diepen, Matthew D. Wilson, Andrew T. Yan, Lilia B. Schiavi, Marcelo Garrido, Andrés F. Alvarisqueta, Sonia A. Sassone, Anselmo P. Bordonava, Alberto E. Alves De Lima, Jorge M. Schmidberg, Ernesto A. Duronto, Orlando C. Caruso, Leonardo P. Novaretto, Miguel Angel Hominal, Oscar R. Montaña, Alberto Caccavo, Oscar A. Gomez Vilamajo, Alberto J. Lorenzatti, Luis R. Cartasegna, Gustavo A. Paterlini, Ignacio J. Mackinnon, Guillermo D. Caime, Marcos Amuchastegui, Oscar Salomone, Oscar R. Codutti, Horacio O. Jure, Julio OE Bono, Adrian D. Hrabar, Julio A. Vallejos, Rodolfo A. Ahuad Guerrero, Federico Novoa, Cristian A. Patocchi, Cesar J. Zaidman, Maria E. Giuliano, Ricardo D. Dran, Marisa L. Vico, Gabriela S. Carnero, Pablo N. Guzman, Juan C. Medrano Allende, Daniela F. 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Palmer, B, Wiseman, A, Puri, S, Mohart, A, Ince, C, Flores, E, Wright, S, Cheng, S, Rosenberg, M, Rogers, W, Kosinski, E, Forgosh, L, Waltman, J, Khan, M, Shoukfeh, M, Dagher, G, Cambier, P, Lieber, I, Kumar, P, East, C, Krichmar, P, Hasan, M, White, L, Knickelbine, T, Haldis, T, Gillespie, E, Amidon, T, Suh, D, Arif, I, Abdallah, M, Akhter, F, Carlson, E, D'Urso, M, El-Ahdab, F, Nelson, W, Moriarty, K, Harris, B, Cohen, S, Carter, L, Doty, D, Sabatino, K, Haddad, T, Malik, A, Rao, S, Mulkay, A, Jovin, I, Klancke, K, Malhotra, V, Devarapalli, S, Koren, M, Chandna, H, Dodds III, G, Goraya, T, Bengston, J, Janik, M, Moran, J, Sumner, A, Kobayashi, J, Davis, W, Yazdani, S, Pasquini, J, Thakkar, M, Vedere, A, Leimbach, W, Rider, J, Fenton, S, Singh, N, Shah, A, Janosik, D, Pepine, C, Berman, B, Gelormini, J, Daniels, C, Richard, K, Keating, F, Kondo, N, Shetty, S, Levite, H, Waider, W, Takata, T, Abu-Fadel, M, Shah, V, Izzo, M, Kumar, A, Hattler, B, Do, R, Link, C, Bortnick, A, Kinzfogl III, G, Ghitis, A, Larry, J, Teufel, E, Kuhlman, P, Mclaurin, B, Zhang, W, Thew, S, Abbas, J, White, M, Islam, O, Subherwal, S, Ranadive, N, Vakili, B, Gring, C, Henderson, D, Schuchard, T, Farhat, N, Kline, G, Mahal, S, Whitaker, J, Speirs, S, Andersen, R, Daboul, N, Horwitz, P, Zahr, F, Ponce, G, Jafar, Z, Mcgarvey, J, Panchal, V, Voyce, S, Blok, T, Sheldon, W, Azizad, M, Schmalfuss, C, Picone, M, Pederson, R, Herzog, W, Friedman, K, Lindsey, J, Nowins, R, Timothy, E, Leonard, P, Lepor, N, El Shahawy, M, Weintraub, H, Irimpen, A, Alonso, A, May, W, Christopher, D, Galski, T, Chu, A, Mody, F, Ramin, E, Hodes, Z, Rossi, J, Rose, G, Fairlamb, J, Lambert, C, Raisinghani, A, Abbate, A, Vetrovec, G, King, M, Carey, C, Gerber, J, Younis, L, Vidovich, M, Knutson, T, Friedman, D, Chaleff, F, Loussararian, A, Rozeman, P, Kimmelstiel, C, Kuvin, J, Silver, K, Foster, M, Tonnessen, G, Espinoza, A, Amlani, M, Wali, A, Malozzi, C, Jong, G, Massey, C, Wattanakit, K, O'Donnell, P, Singal, D, Jaffrani, N, Banuru, S, Fisher, D, Xenakis, M, Perlmutter, N, Bhagwat, R, Strader, J, Blonder, R, Akyea-Djamson, A, Labroo, A, Marais, H, Claxton, E, Weiss, R, Kathryn, R, Berk, M, Joshi, P, Khera, A, Khaira, A, Kumkumian, G, Lupovitch, S, Purow, J, Welka, S, Hoffman, D, Fischer, S, Soroka, E, Eagerton, D, Pancholy, S, Ray, M, Erenrich, N, Farrar, M, Pollock, S, French, W, Diamantis, S, Guy, D, Gimple, L, Neustel, M, Schwartz, S, Pereira, E, Albert, S, Spriggs, D, Strain, J, Mittal, S, Vo, A, Chane, M, Hall, J, Vijay, N, Lotun, K, Lester, F, Nahhas, A, Pope, T, Nager, P, Vohra, R, Sharma, M, Bashir, R, Ahmed, H, Berlowitz, M, Fishberg, R, Barrucco, R, Yang, E, Radin, M, Sporn, D, Stapleton, D, Eisenberg, S, Landzberg, J, Mcgough, M, Turk, S, Schwartz, M, Sundram, P, Jain, D, Zainea, M, Bayron, C, Karlsberg, R, Dohad, S, Lui, H, Keen, W, Westerhausen, D, Khurana, S, Agarwal, H, Birchem, J, Penny, W, Chang, M, Murphy, S, Henry, J, Schifferdecker, B, Gilbert, J, Chalavarya, G, Eaton, C, Schmedtje, J, Christenson, S, Dotani, I, Denham, D, Macdonell, A, Gibson, P, Rahman, A, Al Joundi, T, Assi, N, Conrad, G, Kotha, P, Love, M, Giesler, G, Rubenstein, H, Gamil, D, Akright, L, Krawczyk, J, Cobler, J, Wells, T, Welker, J, Foster, R, Gilmore, R, Anderson, J, Jacoby, D, Gardner, G, Dandillaya, R, Vora, K, Kostis, J, Hunter, J, Laxson, D, Ball, E, Egydio, F, Kawakami, A, Oliveira, J, Wozniak, J, Matthews, A, Ratky, C, Valiris, J, Berdan, L, Hepditch, A, Quintero, K, Rorick, T, Westbrook, M, Pascual, A, Rovito, C, Bezault, M, Drouet, E, Simon, T, Alsweiler, C, Luyten, A, Butters, J, Griffith, L, Shaw, M, Grunberg, L, Islam, S, Bregeault, M, Bougon, N, Faustino, D, Fontecave, S, Murphy, J, Verrier, M, Agnetti, V, Andersen, D, Badreddine, E, Bekkouche, M, Bouancheau, C, Brigui, I, Brocklehurst, M, Cianciarulo, J, Devaul, D, Domokos, S, Gache, C, Gobillot, C, Guillou, S, Healy, J, Heath, M, Jaiwal, G, Javierre, C, Labeirie, J, Monier, M, Morales, U, Mrabti, A, Mthombeni, B, Okan, B, Smith, L, Sheller, J, Sopena, S, Pellan, V, Benbernou, F, Bengrait, N, Lamoureux, M, Kralova, K, Scemama, M, Bejuit, R, Coulange, A, Berthou, C, Repincay, J, Lorenzato, C, Etienne, A, Gouet, V, Normand, M, Ourliac, A, Rondel, C, Adamo, A, Beltran, P, Barraud, P, Dubois-Gache, H, Halle, B, Metwally, L, Mourgues, M, Sotty, M, Vincendet, M, Cotruta, R, Chengyue, Z, Fournie-Lloret, D, Morrello, C, Perthuis, A, Picault, P, Zobouyan, I, Dempsey, M, Mcclanahan, M, ODYSSEY OUTCOMES Comm Investigato, and Ege Üniversitesi
Subjects: Male, BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences, STATIN THERAPY, blood-glucose, Endocrinology, Diabetes and Metabolism, GUIDELINES, PCSK9, 0302 clinical medicine, Endocrinology, GENETIC-VARIANTS, Cardiovascular Disease, Diabetes Complication, Aged Antibodies, Monoclonal, Humanized / therapeutic use* Cardiovascular Diseases / blood Cardiovascular Diseases / prevention & control* Diabetes Complications / blood Diabetes Complications / prevention & control* Female Humans Male Middle Aged Substances, Clinical endpoint, Medicine, guidelines, 030212 general & internal medicine, Prediabetes, Myocardial infarction, myocardial-infarction, genetic-variants, statin therapy, risk, pcsk9, association, liraglutide, evolocumab, RISK, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti, BLOOD-GLUCOSE, ASSOCIATION, Middle Aged, Cardiovascular Diseases, Female, Life Sciences & Biomedicine, Human, medicine.medical_specialty, Acute coronary syndrome, PCSK9 inhibitor, acute coronary syndrome, lipoprotein(a), low-density lipoprotein cholesterol, 030209 endocrinology & metabolism, Antibodies, Monoclonal, Humanized, Diabetes Complications, Endocrinology & Metabolism, 03 medical and health sciences, Diabetes mellitus, Internal medicine, Internal Medicine, Humans, Aged, Alirocumab, diabetes, PCSK9, hyperlipidemia, Science & Technology, ODYSSEY OUTCOMES Committees and Investigators, business.industry, Unstable angina, EVOLOCUMAB, medicine.disease, MYOCARDIAL-INFARCTION, LIRAGLUTIDE, Human medicine, business
Abstract: Doi, Yasuji/0000-0002-8368-0827; galvani, marcello/0000-0001-5897-667X; Gislason, Gunnar H/0000-0002-0548-402X; Taskinen, Marja-Riitta/0000-0002-6229-3588; Sherwood, Matthew/0000-0002-4305-5883; Malynovsky, Yaroslav V/0000-0002-9118-1104; Viktorova, vic-inna@mail.ru I.A./0000-0001-8728-2722; bastos, jose/0000-0002-9526-3123; Yang, Eric H/0000-0003-4889-7454; Rudenko, Anatoliy Viktorovich/0000-0003-1099-1613; Novotny, Vojtech/0000-0003-3521-9945; Nikolaev, Konstantin/0000-0003-4601-6203; Reshetko, Olga/0000-0003-3107-7636; Leonardi, Sergio/0000-0002-4800-6132; Muenzel, Thomas/0000-0001-5503-4150; Ushakov, Alexei V/0000-0002-7020-4442; Tse, Hung Fat/0000-0002-9578-7808; Podoleanu, Cristian/0000-0001-9987-2519; Raffel, Owen C/0000-0001-5470-7050; Khasanov, Niiaz/0000-0002-7760-0763; Chumakova, Galina A/0000-0002-2810-6531; Ersanli, Murat/0000-0003-1847-3087; cornel, jan hein/0000-0002-1006-2112; Abbate, Antonio/0000-0002-1930-785X; Racca, Vittorio/0000-0002-4465-3789; Urina-Triana, Miguel A/0000-0001-6003-4622; Rasputina, Lesia/0000-0003-1230-4039; Racca, Vittorio/0000-0002-4465-3789; Reis, Gilmar/0000-0002-4847-1034; Sandhu, Manjinder/0000-0003-2538-2079; Keskin, Kudret/0000-0002-9049-1530; PAREPA, IRINEL/0000-0002-7571-9015; Manakshe, Gajendra/0000-0002-4983-4271; Nicolau, Jose C/0000-0002-9680-3689; Strelnieks, Aldis/0000-0003-3493-2562; Budaj, Andrzej/0000-0002-6395-2098; Marin, Francisco/0000-0001-7246-7708; Wongpraparut, Nattawut/0000-0002-1541-3313; Yuan, Zuyi/0000-0002-4141-0298; Jeong, Myung Ho/0000-0003-2424-810X; Mostovoy, Yuriy/0000-0002-7041-1230; Pepine, Carl/0000-0002-6011-681X; Lopez-Jaramillo, Patricio/0000-0002-9122-8742; Garcia-Lledo, Alberto/0000-0002-8986-2584; Tesloianu, Nicolae-Dan/0000-0002-1007-3022; Kosmacheva, Elena/0000-0001-8600-0199; Kunz Sebba Barroso Souza, Weimar/0000-0002-1265-1930; Katz, Amos/0000-0003-0422-934X; Tunon, Jose/0000-0002-1373-0999; Acevedo, Monica/0000-0002-7989-6633; Hove, Jens/0000-0002-5600-5623; Yakushin, Sergey/0000-0001-7202-742X; Gonzalez Juanatey, Jose Ramon/0000-0001-9681-3388; Lyamina, Nadezhda/0000-0001-6939-3234; Aylward, Philip/0000-0002-5358-8552; Apostolovic, Svetlana/0000-0001-9015-297X; Airaksinen, Juhani/0000-0002-0193-568X; Nahhas, Prof. Dr. Ahmed/0000-0002-2887-8187; Barbarash, Olga/0000-0002-4642-3610, WOS: 000475553300016, PubMed: 31272931, Background After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1.4-1.8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes. Methods ODYSSEY OUTCOMES was a randomised, double-blind, placebo-controlled trial, done at 1315 sites in 57 countries, that compared alirocumab with placebo in patients who had been admitted to hospital with an acute coronary syndrome (myocardial infarction or unstable angina) 1-12 months before randomisation and who had raised concentrations of atherogenic lipoproteins despite use of high-intensity statins. Patients were randomly assigned (1: 1) to receive alirocumab or placebo every 2 weeks; randomisation was stratified by country and was done centrally with an interactive voice-response or web-response system. Alirocumab was titrated to target LDL cholesterol concentrations of 0.65-1.30 mmol/L. in this prespecified analysis, we investigated the effect of alirocumab on cardiovascular events by glycaemic status at baseline (diabetes, prediabetes, or normoglycaemia)-defined on the basis of patient history, review of medical records, or baseline HbA(1c) or fasting serum glucose-and risk of new-onset diabetes among those without diabetes at baseline. the primary endpoint was a composite of death from coronary heart disease, non-fatal myocardial infarction, fatal or non-fatal ischaemic stroke, or unstable angina requiring hospital admission. ODYSSEY OUTCOMES is registered with ClinicalTrials. gov, number NCT01663402. Findings At study baseline, 5444 patients (28.8%) had diabetes, 8246 (43.6%) had prediabetes, and 5234 (27.7%) had normoglycaemia. There were no significant differences across glycaemic categories in median LDL cholesterol at baseline (2.20-2.28 mmol/L), after 4 months' treatment with alirocumab (0.80 mmol/L), or after 4 months' treatment with placebo (2.25-2.28 mmol/L). in the placebo group, the incidence of the primary endpoint over a median of 2.8 years was greater in patients with diabetes (16.4%) than in those with prediabetes (9.2%) or normoglycaemia (8.5%); hazard ratio (HR) for diabetes versus normoglycaemia 2.09 (95% CI 1.78-2.46, p, Sanofi; Regeneron Pharmaceuticals, Sanofi and Regeneron Pharmaceuticals.
Published: 2019

45. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

Author: Jitendra PS. Sawhney, Veerappa A. Kothiwale, Vikas Bisne, Rajashekhar Durgaprasad, Praveen Jadhav, Manoj Chopda, Velam Vanajakshamma, Ramdhan Meena, Govindan Vijayaraghavan, Kamaldeep Chawla, Jagan Allu, Karen S. Pieper, A. John Camm, Ajay K. Kakkar, Jean-Pierre Bassand, David A. Fitzmaurice, Samuel Z. Goldhaber, Shinya Goto, Sylvia Haas, Werner Hacke, Lorenzo G. Mantovani, Frank Misselwitz, Alexander G.G. Turpie, Martin van Eickels, Freek W.A. Verheugt, Gloria Kayani, Keith A.A. Fox, Bernard J. Gersh, Hector Lucas Luciardi, Harry Gibbs, Marianne Brodmann, Frank Cools, Antonio Carlos Pereira Barretto, Stuart J. Connolly, Alex Spyropoulos, John Eikelboom, Ramon Corbalan, Dayi Hu, Petr Jansky, Jørn Dalsgaard Nielsen, Hany Ragy, Pekka Raatikainen, Jean-Yves Le Heuzey, Harald Darius, Matyas Keltai, Sanjay Kakkar, Jitendra Pal Singh Sawhney, Giancarlo Agnelli, Giuseppe Ambrosio, Yukihiro Koretsune, Carlos Jerjes Sánchez Díaz, Hugo Ten Cate, Dan Atar, Janina Stepinska, Elizaveta Panchenko, Toon Wei Lim, Barry Jacobson, Seil Oh, Xavier Viñolas, Marten Rosenqvist, Jan Steffel, Pantep Angchaisuksiri, Ali Oto, Alex Parkhomenko, Wael Al Mahmeed, David Fitzmaurice, D.Y. Hu, K.N. Chen, Y.S. Zhao, H.Q. Zhang, J.Z. Chen, S.P. Cao, D.W. Wang, Y.J. Yang, W.H. Li, Y.H. Yin, G.Z. Tao, P. Yang, Y.M. Chen, S.H. He, Ying Wang, Yong Wang, G.S. Fu, X. Li, T.G. Wu, X.S. Cheng, X.W. Yan, R.P. Zhao, M.S. Chen, L.G. Xiong, P. Chen, Y. Jiao, Y. Guo, L. Xue, F.Z. Wang, H. Li, Z.M. Yang, C.L. Bai, J. Chen, J.Y. Chen, X. Chen, S. Feng, Q.H. Fu, X.J. Gao, W.N. Guo, R.H. He, X.A. He, X.S. Hu, X.F. Huang, B. Li, J. Li, L. Li, Y.H. Li, T.T. Liu, W.L. Liu, Y.Y. Liu, Z.C. Lu, X.L. Luo, T.Y. Ma, J.Q. Peng, X. Sheng, X.J. Shi, Y.H. Sun, G. Tian, K. Wang, L. Wang, R.N. Wu, Q. Xie, R.Y. Xu, J.S. Yang, L.L. Yang, Q. Yang, Y. Ye, H.Y. Yu, J.H. Yu, T. Yu, H. Zhai, Q. Zhan, G.S. Zhang, Q. Zhang, R. Zhang, Y. Zhang, W.Y. Zheng, B. Zhou, Z.H. Zhou, X.Y. Zhu, S. Kakkar, J.P.S. Sawhney, P. Jadhav, R. Durgaprasad, A.G. Ravi Shankar, R.K. Rajput, K. Bhargava, R. Sarma, A. Srinivas, D. Roy, U.M. Nagamalesh, M. Chopda, R. Kishore, G. Kulkarni, P. Chandwani, R.A. Pothiwala, M. Padinhare Purayil, S. Shah, K. Chawla, V.A. Kothiwale, B. Raghuraman, G. Vijayaraghavan, V.M. Vijan, G. Bantwal, V. Bisne, A. Khan, J.B. Gupta, S. Kumar, D. Jain, S. Abraham, D. Adak, A. Barai, H. Begum, P. Bhattacharjee, M. Dargude, D. Davies, B. Deshpande, P. Dhakrao, V. Dhyani, S. Duhan, M. Earath, A. Ganatra, S. Giradkar, V. Jain, R. Karthikeyan, L. Kasala, S. Kaur, S. Krishnappa, A. Lawande, B. Lokesh, N. Madarkar, R. Meena, P. More, D. 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A., Andersson, A., Malmqvist, L., Martinsson, B., Bernsten, F., Engdahl, J., Thulin, J., Hot-Bjelac, A., Stalby, P., Aaröe, H., Ahbeck, E., Ahlmark, H., Al-Khalili, F., Bonkowski, G., Dzeletovic, S., Ekstrand, A. -B., Eriksson, G. -B., Floren, K., Grässjö, C., Hahn, S., Jaensson, P., Jansson, B., Jansson, J. -H., Kangert, R. -M., Koch, A., Kusiak, D., Lettenström, A., Lindberg, A., Lindholm, C. -J., Mannermyr, A., Mansson, K., Millborg, M., Nilsson, C., Ohlin, A. -M., Olofsson, A., Osberg, A., Pedersen, A., Risbecker, K., Rosenberg, K., Samuelsson, J., Shayesteh, M., Skoglund, K., Stjernberg, M., Thorsen, C., Steffel, J., Beer, J. H., Debrunner, J., Amstutz, D., Bruegger, J., Elise, G., Grau, A., Guinand, A., Henriette, I., Saga, E., Winnik, S., Parkhomenko, A., Rudyk, I., Tseluyko, V., Karpenko, O., Zhurba, S., Kraiz, I., Kupnovytska, I., Serediuk, N., Mostovoy, Y., Ushakov, O., Koval, O., Kovalskyi, I., Svyshchenko, Y., Sychov, O., Stanislavchuk, M., Kraydashenko, O., Yagensky, A., Tykhonova, S., Fushtey, I., Belegai, R., Berko, G., Burdeuna, L., Chabanna, O., Daniuk, I., Ivanov, A., Kamenska, E., Kaplan, P., Khyzhnyak, O., Kizim, S., Matova, O., Medentseva, O., Mochonyi, V., Mospan, M., Nemtsova, V., Ovdiienko, T., Palamarchuk, O., Pavelko, M., Petrovskyy, R., Plevak, D., Proshak, O., Pyvovar, S., Rasputina, L., Romanenko, O., Romanova, O., Sapatyi, A., Shumakov, O., Stets, R., Todoriuk, L., Varenov, V., Fitzmaurice, D., Chauhan, N., Goodwin, D., Saunders, P., Evans, R., Leese, J., Jhittay, P. S., Ross, A., Kainth, M. S., Pickavance, G., Mcdonnell, J., Williams, A., Gooding, T., Wagner, H., Suryani, S., Singal, A., Sircar, S., Bilas, R., Hutchinson, P., Wakeman, A., Stokes, M., Paul, N., Aziz, M., Ramesh, C., Wilson, P., Franklin, S., Fairhead, S., Thompson, J., St Joseph, V., Taylor, G., Tragen, D., Seamark, D., Paul, C., Richardson, M., Jefferies, A., Sharp, H., Jones, H., Giles, C., Page, M., Oginni, O., Aldegather, J., Wetherwell, S., Lumb, W., Evans, P., Scouller, F., Macey, N., Stipp, Y., West, R., Thurston, S., Wadeson, P., Matthews, J., Pandya, P., Gallagher, A., Railton, T., Sinha, B., Russell, D., Davies, J. A., Ainsworth, P., Jones, C. P., Weeks, P., Eden, J., Kernick, D., Murdoch, W., Lumley, L., Patel, R. P., Wong, S. W., Saigol, M., Ladha, K., Douglas, K., Cumberlidge, D. F., Bradshaw, C., Van Zon, G., Jones, K. P., Thomas, M. J., Watson, E., Sarai, B., Ahmad, N., Willcock, W., Cairns, J., Sathananthan, S., de Kare-Silver, N., Gilliland, A., Strieder, E., Howitt, A., Vishwanathan, B., Bird, N., Gray, D., Clark, M., Bisatt, J., Litchfield, J., Fisher, E., Fooks, T., Kelsall, A. R., Alborough, E., Wakeling, J., Parfitt, M., Milne, K., Rogers, S., Priyadharshan, R., Oliver, J. L., Davies, E., Abushal, S., Jacobs, M., Hutton, C., Walls, N. I., Thompson, R., Chigbo, C., Zaidi, S. M. A., Howard, M., Butter, K. C., Barrow, S., Little, H., Haq, I. U., Gibbons, L., Glencross, S., Mcleod, A. J., Poland, K., Mulholland, C., Warke, A., Conn, P., Burns, G., Smith, R. N., Lowe, S., Kamath, R., Dau, H. S., Webster, J., Hodgins, I., Vercoe, S., Roome, P. C., Pinnock, H., Patel, J. R. A., Ali, A., Hart, N., Davies, R., Stuart, E., Neden, C. A., Danielsen, M., Heath, R., Sharma, P., Galloway, S., Hawkins, C., Oliver, R., Aylward, M., Mannion, S., Braddick, M., Edwards, D., Rothwell, A. C., Sabir, A., Choudhary, F., Khalaque, S., Wilson, A., Peters, S., Coulson, W., Roberts, N., Heer, A., Coates, S., Ward, B., Jackson, D., Walton, S., Shepherd, D., Sterry, M., Wong, T., Boon, M., Bunney, R., Haria-Shah, R., Baron, R. T., Davies, S., Schatzberger, T., Hargreaves, N., Stephenson, T., Choi, H., Batson, R., Lucraft, L., Myhill, T., Estifano, S., Geatch, D., Wilkinson, J., Veale, R., Forshaw, K., Davies, T., Zaman, K., Vinson, P., Liley, C., Bandrapalli, M., Mcginty, P., Wastling, R., Mceleny, P., Beattie, A., Cooke, P., Wong, M., Gunasegaram, J., Pugsley, M., Ahmad, S., A'Court, C., Ayers, J., Bennett, J., Cartwright, S., Dobson, S., Dooldeniya, C., Flynn, A., Fox, R., Goram, J., Halpin, A., Hay, A., Jacobs, P., Jeffers, L., Lomax, L., Munro, I., Muvva, R., Nadaph, M., Powell, K., Randfield, S., Redpath, D., Reed, R., Rickenbach, M., Rogers, G., Saunders, P. B., Seamark, C., Shewring, J., Simmons, P., Simper, H., Stoddart, H., Sword, A., Thomas, N., Thomson, A., Gibbs, H., Blenkhorn, A., Singh, B., Van Gaal, W., Abhayaratna, W., Lehman, R., Roberts-Thomson, P., Kilian, J., Coulshed, D., Catanchin, A., Colquhoun, D., Kiat, H., Eccleston, D., French, J., Zimmett, L., Ayres, B., Phan, T., Blombery, P., Crimmins, D., O'Donnell, D., Choi, A., Astridge, P., Arstall, M., Jepson, N., Binnekamp, M., Lee, A., Rogers, J., Starmer, G., Carroll, P., Faunt, J., Aggarwala, A., Barry, L., Batta, C., Beveridge, R., Black, A., Bonner, M., Boys, J., Buckley, E., Campo, M., Carlton, L., Connelly, A., Conway, B., Cresp, D., Dimitri, H., Dixon, S., Dolman, M., Duroux, M., Eskandari, M., Eslick, R., Ferreira-Jardim, A., Fetahovic, T., Fitzpatrick, D., Geraghty, R., Gibbs, J., Grabek, T., Modi, M. H., Hayes, K., Hegde, M. P., Hesketh, L., Hoffmann, B., Jacobson, B., Johnson, K., Juergens, C., Kassam, I., Lawlor, V., Lehman, M., Lehman, S., Leung, D., Mackay, S., Mackenzie, M., Mccarthy, C., Mcintosh, C., Mckeon, L., Morrison, H., Mussap, C., Myers, J. -D., Nagalingam, V., Oldfield, G., O'May, V., Palmer, J., Parsons, L., Patching, K., Patching, T., Paul, V., Plotz, M., Preston, S., Rashad, H., Ratcliffe, M., Raynes, S., Rose, J., Sanders, L., Seremetkoska, M., Setio, H., Shone, S., Shrestha, P., Singh, C., Singleton, C., Stoyanov, N., Sutcliffe, S., Swaraj, K., Tarrant, J., Thompson, S., Tsay, I. M., Vorster, M., Waldman, A., Wallis, L., Wilford, E., Wong, K., Connolly, S. J., Spyropoulos, A., Eikelboom, J., Luton, R., Gupta, M., Pandey, A. S., Cheung, S., Leader, R., Beaudry, P., Ayala-Paredes, F., Berlingieri, J., Heath, J., Poirier, G., Du Preez, M., Nadeau, R., Dresser, G., Dhillon, R., Hruczkowski, T., Schweitzer, B., Coutu, B., Angaran, P., Macdonald, P., Vizel, S., Fikry, S., Parkash, R., Lavoie, A., Cha, J., Ramjattan, B., Bonet, J., Ahmad, K., Aro, L., Aves, T., Beaudry, K., Bergeron, C., Bigcanoe, J., Bignell, N., Breakwell, L., Burke, E., Carroll, L., Clarke, B., Cleveland, T., Daheb, S., Dehghani, P., Denis, I., Djaidani, Z., Dorian, P., Douglass, S., Dunnigan, J., Ewert, A., Farquhar, D., Fearon, A., Ferleyko, L., Fournier, D., Fox, B., Grenier, M. -C., Gulliver, W., Haveman, K., Hines, C., Hines, K., Jackson, A. M., Jean, C., Jethoo, G., Kahlon, R., Kelly, S., Kim, R., Korley, V., Kornder, J., Kwan, L., Largy, J., Lewis, C., Lewis, S., Mangat, I., Moor, R., Navratil, J., Neas, I., Otis, J., Otis, R., Pandey, M., Petrie, F., Pinter, A., Raines, M., Roberts, P., Robinson, M., Sas, G., Schulman, S., Snell, L., Spearson, S., Stevenson, J., Trahey, T., Wong, S., Wright, D., Ragy, H., Abd El-Aziz, A., Abou Seif, S. K., El Din, M. G., El Etriby, S., Elbahry, A., El-Etreby, A., Elkhadem, M., Katta, A., Khairy, T., Mowafy, A., Nawar, M., Ohanissian, A., Reda, A., Reda, M., Salem, H., Sami, N., Samir, S., Setiha, M., Sobhy, M., Soliman, A., Taha, N., Tawfik, M., Zaatout, E., Kettles, D., Bayat, J., Siebert, H., Horak, A., Kelfkens, Y., Garda, R., Pillay, T., Guerra, M., van Zyl, L., Theron, H., Murray, A., Louw, R., Greyling, D., Mntla, P., Ueckermann, V., Loghdey, R., Ismail, S., Ahmed, F., Engelbrecht, J., Ramdass, A., Maharajh, S., Oosthuysen, W., Angel, G., Bester, C., Booysen, M., Boshoff, C., Cannon, C., Cassimjee, S., Chami, C., Conway, G., Davids, A., de Meyer, L., Du Plessis, G., Ellis, T., Henley, L., Karsten, M., Loyd, E., Marks, J., Mavhusa, L., Mostert, M., Page, A., Rikhotso, L., Salie, M., Sasto, J., Shaik, F., Skein, A., Smith, L., Tarr, G., Tau, T., van Zyl, F., Al Mahmeed, W., Yousef, G., Agrawal, A., Nathani, M., Ibrahim, M., Esheiba, E. M., Singh, R., Naguib, A., Abu-Mahfouz, M., Al Omairi, M., Al Naeemi, A., Maruthanayagam, R., Bazargani, N., Wassef, A., Gupta, R., Khan, M., Subbaraman, B., Abdul, A., Al Mulla, A., El Bardisy, S., Haridas, P., Jadhav, S., Magdaluyo, K., Makdad, M., Maqsood, I., Mohamed, R., Sharma, N., Sharma, R., Thanzeel, M., Goldhaber, S. Z., Canosa, R., Rama, P., Blumberg, E., Garcia, J., Mullen, P., Wilson, V., Quick, A., Ferrick, K., Kutayli, W. M., Cox, M., Franco, M., Falkowski, S., Mendelson, R., Williams, M., Miller, S., Beach, S., Alfieri, A., Gutowski, T., Haque, I., Reddy, R., Ahmed, W., Delafontaine, P., Diercks, D., Theodoro, D., Remmel, K., Alberts, M., Ison, R., Noveck, H., Duffy, P., Pitta, S., Nishijima, D., Treasure, C., Asafu-Adjaye, N., Ball, K., Bartlett, M., Bentley, M., Bowers, S., Brown, A., Browne, A., Cameron-Watts, J., Canova, M., Cassidy, D., Cervellione, K., Congal, S., Depauw, J., Dickerson, A., Eley, M., Evans, L., Felpel, S., Ferdinand, K., Fielder, D., Gentry, P., Haideri, A., Hakimi, F., Harbour, T., Hartranft, E., Hawkins, B., Headlee, M., Henson, L., Herrick, C., Hicks, T., Jasinski, S., Jones, A., Jones, L., Jones, P., Karl, S., Keeling, M., Kerr, J., Knowles, P., Langdon, J., Lay, M., Lee, J. A., Lincoln, T., Malone, E., Merliss, A., Merritt, D., Minardo, J., Mooso, B., Orosco, C., Palumbo, V., Parker, M., Parrott, T., Paserchia, S., Pearl, G., Peterson, J., Pickelsimer, N., Purcell, T., Raynor, J., Raziano, S., Richard, C., Richardson, T., Robertson, C., Sage, A., Sanghera, T., Shaw, P., Shoemaker, J., Smith, K., Stephanie, B., Thatcher, A., Theobald, H., Thompson, N., Treasure, L., Tripti, T., Verdi, C., and Worthy, V.
Subjects: Registrie, Male, Time Factors, Anticoagulant therapy, Arrhythmia, Atrial fibrillation, GARFIELD-AF, 030204 cardiovascular system & hematology, Electrocardiography, 0302 clinical medicine, Risk Factors, Anticoagulant therapy, Arrhythmia, Atrial fibrillation, GARFIELD-AF, Aged, Atrial Fibrillation, Female, Follow-Up Studies, Humans, Incidence, India, Prevalence, Prognosis, Prospective Studies, Survival Rate, Thromboembolism, Registries, Risk Assessment, Medicine, 030212 general & internal medicine, Prospective cohort study, Incidence (epidemiology), cardiovascular system, medicine.symptom, Cardiology and Cardiovascular Medicine, Risk assessment, Human, medicine.medical_specialty, Time Factor, RD1-811, Prognosi, Follow-Up Studie, 03 medical and health sciences, Internal medicine, Diseases of the circulatory (Cardiovascular) system, cardiovascular diseases, Risk factor, Survival rate, Fibrillation, business.industry, Risk Factor, ta3121, medicine.disease, Clinical trial, Prospective Studie, RC666-701, Surgery, Clinical and Preventive Cardiology, business
Abstract: Background: The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. Methods and results: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012–2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P
Published: 2018

46. Physiological and Sport-Specific Comparison Between Division I and Division II Italian Male Field Hockey Players

Author: Federico Nigro, Matteo Cortesi, Luca Gubellini, Sandro Bartolomei, Filippo Treno, Franco Merni, Simone Ciacci, Gabriele Semprini, and Bartolomei, S, Nigro, F, Gubellini, L, Ciacci, S, Merni, F, Treno, F, Cortesi, M, Semprini, G.
Subjects: Adult, Male, Field hockey, media_common.quotation_subject, Physical fitness, Aptitude, Physical Therapy, Sports Therapy and Rehabilitation, Athletic Performance, 010501 environmental sciences, 01 natural sciences, Young Adult, 03 medical and health sciences, Grip strength, 0302 clinical medicine, Hand strength, Humans, Orthopedics and Sports Medicine, 0105 earth and related environmental sciences, Mathematics, media_common, Hand Strength, business.industry, 030229 sport sciences, General Medicine, Anthropometry, Division (mathematics), Body Height, Hockey, Italy, anthropometry, match-related performances, dribbling test, Physical Fitness, Body Composition, Analysis of variance, business, Demography
Abstract: Bartolomei, S, Nigro, F, Gubellini, L, Ciacci, S, Merni, F, Treno, F, Cortesi, M, and Semprini, G. Physiological and sport-specific comparison between Division I and Division II Italian male field hockey players. J Strength Cond Res 33(11): 3123-3128, 2019-The purpose of this study was to compare the anthropometric and performance profiles of Division I (D1) and Division II (D2) Italian field hockey players. Fifteen DI players and 15 D2 players (age = 25.4 ± 5.2 years; body mass = 78.5 ± 9.0 kg; and body height = 179.6 ± 7.8 cm) were assessed on one occasion for anthropometry, body composition, physiological measurements, and sport-specific skills. Differences between the 2 groups were evaluated using a 1-way analysis of variance. Pearson correlations were used to examine relationships between the different measurements. Significantly (p = 0.039) lower percentages of body fat were found on D1 group compared with D2 group (-3.5%). A significant difference between the groups were noted for shooting accuracy (p = 0.013), with the D1 group performing 14.5% better than the DII group. No significant differences between the groups were found for shooting speed (p = 0.103) and slalom and dribbling performances (p = 0.292 and p = 0.416, respectively). Physiological assessments did not show any significant differences between the groups. Large correlations (r = 0.73; p < 0.001) were found between shooting speed and accuracy. Moderate correlations were observed between the shooting speed and the hand grip strength, in particular of the left hand (r = 0.61; p = 0.007). Results of this study indicate that the difference between D1 and D2 players may be more related to technical factors than to physical fitness. Ball control, however, may not be a limiting factor in D2 players.
Published: 2019

47. The fuzzy future: Time horizon, memory failures, and emotional distress in gambling disorder

Author: Francesca D’Olimpio, Maria Ciccarelli, Marina Cosenza, Giovanna Nigro, Nigro, Giovanna, D'Olimpio, Francesca, Ciccarelli, Maria, and Cosenza, Marina
Subjects: Adult, Male, Time perspective, Adolescent, retrospective memory, prospective memory, Medicine (miscellaneous), Time horizon, Psychological Distress, Toxicology, Negative affectivity, Young Adult, Memory, Retrospective memory, time perspective, Prospective memory, medicine, Humans, Correlation of Data, Path analysis (statistics), Aged, Psychological Tests, habitual player, Middle Aged, gambling, Affect, Psychiatry and Mental health, Clinical Psychology, Consideration of future consequences, Time Perception, depression, Anxiety, Female, medicine.symptom, Psychology, Clinical psychology
Abstract: This study aimed to first investigate the interplay among self-rated ability in both retrospective and prospective memory, time perspective, and negative affectivity to gambling severity. Two hundred and three habitual players took part in the study. Participants were administered the South Oaks Gambling Screen (SOGS), the Consideration of Future Consequences scale (CFC-14), the Prospective and Retrospective Memory Questionnaire (PRMQ), as well as the Depression, Anxiety and Stress Scales-21 (DASS-21). Overall, data indicated that the higher the involvement in gambling, the higher the depression levels and the shorter the time horizon. The results of linear regression analysis showed that, along with gender, years of education, depression, and inattention to the future consequences of actual behavior, the negative self-perception of prospective memory functioning represents a significant predictor of gambling severity. Finally, to clarify if depression was on the path from prospective memory to gambling severity or if prospective memory was the mediator of the impact of depression on gambling severity, data were submitted to path analysis. Results indicated that depression has a direct effect on gambling severity and mediates the association between prospective memory and gambling involvement. The relation between gambling severity and prospective memory scores suggests that impairment in prospective memory plays a key role in adult problematic gambling.
Published: 2019

48. Cardiac diseases as a predictor warning of hereditary muscle diseases. The case of laminopathies

Author: D’ambrosio, P., Petillo, R., Annalaura Torella, Papa, A. A., Palladino, A., Orsini, C., Ergoli, M., Passamano, L., Novelli, A., Nigro, V., Politano, L., D'Ambrosio, P, Petillo, R, Torella, A, Papa, Aa, Palladino, A, Orsini, C, Ergoli, M, Passamano, L, Novelli, A, Nigro, V, and Politano, L.
Subjects: Adult, Male, Adolescent, Heart Diseases, laminopathies, risk stratification, Middle Aged, Lamin Type A, Pedigree, Young Adult, Muscular Diseases, Mutation, Humans, Original Article, Female, genetic counselling, laminopathie
Abstract: Mutations in the LMNA gene are associated with a wide spectrum of disease phenotypes, ranging from neuromuscular, cardiac and metabolic disorders to premature aging syndromes. Skeletal muscle involvement may present with different phenotypes: limb-girdle muscular dystrophy type 1B or LMNA-related dystrophy; autosomal dominant Emery-Dreifuss muscular dystrophy; and a congenital form of muscular dystrophy, frequently associated with early onset of arrhythmias. Heart involvement may occur as part of the muscle involvement or independently, regardless of the presence of the myopathy. Notably conduction defects and dilated cardiomyopathy may exist without a muscle disease. This paper will focus on cardiac diseases presenting as the first manifestation of skeletal muscle hereditary disorders such as laminopathies, inspired by two large families with cardiovascular problems long followed by conventional cardiologists who did not suspect a genetic muscle disorder underlying these events. Furthermore it underlines the need for a multidisciplinary approach in these disorders and how the figure of the cardio-myo-geneticist may play a key role in facilitating the diagnostic process, and addressing the adoption of appropriate prevention measures.
Published: 2019

49. Clinical Performance of Apixaban vs. Vitamin K Antagonists in Patients with Atrial Fibrillation Undergoing Direct Electrical Current Cardioversion: A Prospective Propensity Score-Matched Cohort Study

Author: Antonio Cassese, Paolo Golino, Giulia Arena, Gerardo Nigro, Andrea Antonio Papa, Antonio D'Onofrio, Anna Rago, Vincenzo Russo, Maria Cristina Giada Magliocca, Rago, Anna, Papa, Andrea Antonio, Cassese, Antonio, Arena, Giulia, Magliocca, Maria Cristina Giada, D’Onofrio, Antonio, Golino, Paolo, Nigro, Gerardo, and Russo, Vincenzo
Subjects: Male, medicine.medical_specialty, Vitamin K, Pyridones, medicine.drug_class, medicine.medical_treatment, Embolism, Electric Countershock, Hemorrhage, 030204 cardiovascular system & hematology, Transesophageal echocardiogram, Cardioversion, 03 medical and health sciences, 0302 clinical medicine, Fibrinolytic Agents, Thromboembolism, Internal medicine, Atrial Fibrillation, medicine, Humans, Pharmacology (medical), Prospective Studies, 030212 general & internal medicine, Propensity Score, Prospective cohort study, Stroke, Aged, medicine.diagnostic_test, business.industry, Anticoagulants, Atrial fibrillation, General Medicine, Middle Aged, Vitamin K antagonist, medicine.disease, Propensity score matching, Cardiology, Pyrazoles, Female, Apixaban, Cardiology and Cardiovascular Medicine, business, Factor Xa Inhibitors, medicine.drug
Abstract: Introduction: Atrial fibrillation (AF) is associated with an increased risk of thromboembolic events. Objectives: This study compared the long-term efficacy and safety of apixaban with that of uninterrupted vitamin K antagonist (VKA) therapy in patients with AF scheduled for transesophageal echocardiogram (TEE)-guided direct current cardioversion (DCC) from June 2014 to September 2016. Methods: We enrolled consecutive patients with persistent nonvalvular AF scheduled to undergo DCC. Patients received apixaban 5 mg or 2.5 mg twice daily (bid) or VKA at therapeutic doses for at least 3 weeks before and 4 weeks after DCC. All patients underwent anamnestic, clinical, electrocardiographic, and echocardiographic evaluation at each follow-up visit and were followed-up for 12 months. The primary efficacy endpoint was the composite of stroke/transient ischemic attack and systemic embolism. The primary safety endpoint was major bleeding. Results: After propensity score matching, comparative treatment groups comprised 182 (75.8%) patients receiving apixaban 5 mg bid and 182 receiving VKA. A low incidence of atrial thrombus (0.5%) at TEE was found in both groups. The acute cardioversion success rate was 86.1% in the apixaban group (156/181) and 83.9% in the VKA group (152/181). During the follow-up period, a similarly low incidence of thromboembolic events (1.1%) was reported in both groups; the bleeding safety profile tended to favor apixaban over VKA (1.1 vs. 1.6%; p = 0.3). Conclusions: Newly initiated anticoagulation with apixaban in patients with nonvalvular AF scheduled for TEE-guided DCC seems to be as effective and safe as uninterrupted VKA therapy during 12 months of follow-up.
Published: 2019

50. Monitoring the effectiveness of hypothermia in perinatal asphyxia infants by urinary S100B levels

Author: Bashir Moataza, Immacolata Savarese, Ekaterina Baryshnikova, Iman Iskander, Francesca Romana Pluchinotta, Andrea Dotta, Diego Gazzolo, Alessandra Conio, Natalia Chukhlantseva, Francesco Nigro, Micaela Colivicchi, Luigi Anastasia, Hala Mufeed, Patrizia Ianniello, Hanna Aboulgar, Darek Gruzfeld, Giorgio Ivani, Iliana Bersani, Fabio Galvano, Maria Kornacka, Lucia Gabriella Tina, Licia Lugli, Fabrizio Ferrari, Laura D. Serpero, Giovanni Livolti, Bersani, I., Ferrari, F., Lugli, L., Ivani, G., Conio, A., Moataza, B., Aboulgar, H., Mufeed, H., Iskander, I., Kornacka, M., Gruzfeld, D., Dotta, A., Savarese, I., Chukhlantseva, N., Tina, L. G., Nigro, F., Livolti, G., Galvano, F., Serpero, L., Colivicchi, M., Ianniello, P., Pluchinotta, F., Anastasia, L., Baryshnikova, E., and Gazzolo, D.
Subjects: Male, media_common.quotation_subject, Urinary system, Clinical Biochemistry, Encephalopathy, S100 Calcium Binding Protein beta Subunit, Urine, S100B, Severity of Illness Index, Urination, 03 medical and health sciences, 0302 clinical medicine, Hypothermia, Induced, 030225 pediatrics, Intensive care, Humans, Medicine, Retrospective Studies, media_common, Immunoassay, Asphyxia, business.industry, Biochemistry (medical), Infant, Newborn, Brain, Electroencephalography, asphyxia, General Medicine, Hypothermia, medicine.disease, Perinatal asphyxia, hypothermia, neonate, Case-Control Studies, Anesthesia, Hypoxia-Ischemia, Brain, Female, medicine.symptom, business, Biomarkers, 030217 neurology & neurosurgery
Abstract: Background Perinatal asphyxia is a major cause of mortality and morbidity in neonates: The aim of the present study was to investigate, by means of longitudinal assessment of urinary S100B, the effectiveness of hypothermia, in infants complicated by perinatal asphyxia and hypoxic-ischemic encephalopathy. Methods We performed a retrospective case-control study in 108 asphyxiated infants, admitted to nine tertiary departments for neonatal intensive care from January 2004 to July 2017, of whom 54 underwent hypothermia treatment and 54 did not. The concentrations of S100B protein in urine were measured using an immunoluminometric assay at first urination and 4, 8, 12, 16, 20, 24, 48, 72, 96, 108 and 120 h after birth. The results were correlated with the achievement of S100B levels within normal ranges at 72 h from hypothermia treatment. Routine laboratory parameters, longitudinal cerebral function monitoring, cerebral ultrasound and neurologic patterns were assessed according to standard protocols. Results Higher S100B concentrations were found in hypothermia-treated infants in both moderate (up to 12 h) and severe (up to 24 h) hypoxic-ischemic encephalopathy. S100B levels returned to normal ranges starting from 20 h of hypothermia treatment in moderate and from 36 h in severe hypoxic-ischemic encephalopathy. Conclusions The present results offer additional support to the usefulness of longitudinal neuro-biomarkers monitoring in asphyxiated infants treated by hypothermia. The pattern of S100B concentrations during hypothermia supports the need for further investigations aimed at reconsidering the time-window for patient recruitment and treatment, and the optimal duration of the cooling and rewarming phases of the hypothermia procedure.
Published: 2019

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