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7. Intravenously administered gene therapy for neuronopathic Gaucher disease

Author

Massaro, Giulia

Subjects
615.1
Abstract

Gaucher disease is a lysosomal storage disorder caused by mutations in the GBA1 gene encoding the enzyme glucocerebrosidase (GCase). Deficiency of GCase causes the accumulation of its substrate glucosylceramide in both visceral organs and the brain. Enzyme replacement therapy is successfully used to ameliorate the visceral pathology, however there is no treatment available for the lethal neurodegeneration. This research focuses on Gaucher disease type II, the most acute neuronopathic form, in which the neuropathology results in death during early infancy. The aim of this project is to intravenously administer adeno-associated viral vector (AAV) based gene therapy to a GCase-deficient mouse model of acute neuronopathic Gaucher disease and assess improvement in lifespan, behaviour, brain and visceral pathology. The untreated Gba1 knock-out mice die 12-14 days after birth following severe neurodegeneration. The AAV vector carrying the functional human GBA1 gene under control of a ubiquitous promoter was intravenously administered to neonatal knock-out mice, with treated animals showing a significant increase in their lifespan (p=0.0081). Since the animals did not develop any evident pathological symptoms, they were sacrificed at 55 days of age for a short-term study. The neuropathology was ameliorated and several of the most affected areas of the brain were partially rescued. The analysis of liver, spleen, lung and heart tissues revealed promising improvements in the visceral pathology. A consequent long-term study was performed on 180-day-old treated mice, with the aim to compare intravenous and intracranial administration of the viral vector. In order to enhance the therapeutic effects of the treatment and improve gene expression in the central nervous system, a novel construct where the GBA1 gene is controlled by a neuron-specific promoter was administered to neonatal knock-out mice. The severe neurodegeneration was further rescued and the life span of treated animals increased. Together, these encouraging results demonstrate that gene therapy could provide an effective treatment for the neuronopathic form of Gaucher disease, for which therapeutic needs are currently unmet.

Published
2018

9. Engineering an Autonucleolytic Mammalian Suspension Host Cell Line to Reduce DNA Impurity Levels in Serum-Free Lentiviral Process Streams

Author

Howe, Geoffrey, primary, Wasmuth, Matthew, additional, Emanuelle, Pamela, additional, Massaro, Giulia, additional, Rahim, Ahad A., additional, Ali, Sadfer, additional, Rivera, Milena, additional, Ward, John, additional, Keshavarz-Moore, Eli, additional, Mason, Chris, additional, and Nesbeth, Darren N., additional

Published
2024
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13. PPAR-gamma agonist pioglitazone recovers mitochondrial quality control in fibroblasts from PITRM1-deficient patients

Author

Di Donfrancesco, Alessia, primary, Berlingieri, Christian, additional, Giacomello, Marta, additional, Frascarelli, Chiara, additional, Magalhaes Rebelo, Ana Paula, additional, Bindoff, Laurence A., additional, Reeval, Segel, additional, Renbaum, Paul, additional, Santorelli, Filippo M., additional, Massaro, Giulia, additional, Viscomi, Carlo, additional, Zeviani, Massimo, additional, Ghezzi, Daniele, additional, Bottani, Emanuela, additional, and Brunetti, Dario, additional

Published
2023
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16. Fetal gene therapy for neurodegenerative disease of infants

Author

Massaro, Giulia, Mattar, Citra N. Z., Wong, Andrew M. S., Sirka, Ernestas, Buckley, Suzanne M. K., Herbert, Bronwen R., Karlsson, Stefan, Perocheau, Dany P., Burke, Derek, Heales, Simon, Richard-Londt, Angela, Brandner, Sebastian, Huebecker, Mylene, Priestman, David A., Platt, Frances M., Mills, Kevin, Biswas, Arijit, Cooper, Jonathan D., Chan, Jerry K. Y., Cheng, Seng H., Waddington, Simon N., and Rahim, Ahad A.

Published
2018
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18. Risk factors for Gram-negative bacterial infection of cardiovascular implantable electronic devices: multicentre observational study (CarDINe Study)

Author

Pascale, Renato, primary, Toschi, Alice, additional, Aslan, Abdullah Tarik, additional, Massaro, Giulia, additional, Maccaro, Angelo, additional, Fabbricatore, Davide, additional, Dell'Aquila, Andrea, additional, Ripa, Marco, additional, Işık, Mehmet Emirhan, additional, Kızmaz, Yeşim Uygun, additional, Iacopino, Saverio, additional, Camici, Marta, additional, Perna, Francesco, additional, Akinosoglou, Karolina, additional, Karruli, Arta, additional, Papadimitriou-Olivgeris, Matthaios, additional, Kayaaslan, Bircan, additional, Bilir, Yeşim Aybar, additional, Evren Özcan, Emin, additional, Turan, Oğuzhan Ekrem, additional, Işık, Muhammed Cihan, additional, Pérez-Rodríguez, María Teresa, additional, Yagüe, Belén Loeches, additional, Quirós, Alejandro Martín, additional, Yılmaz, Mesut, additional, Petersdorf, Sabine, additional, De Potter, Tom, additional, Durante-Mangoni, Emanuele, additional, Akova, Murat, additional, Curnis, Antonio, additional, Gibertoni, Dino, additional, Diemberger, Igor, additional, Scudeller, Luigia, additional, Viale, Pierluigi, additional, Giannella, Maddalena, additional, Caroccia, Natascia, additional, Fanì, Francesca, additional, Arbizzani, Federica, additional, Ramanathan, Ramsiya, additional, Scarpellini, Paolo, additional, Marzi, Alessandra, additional, Mazzone, Patrizio, additional, Placentino, Filippo, additional, Sammarini, Giulia, additional, Tenti, Elena, additional, Leventopulos, George, additional, Domenichini, Giulia, additional, Şahin, Meyha, additional, Suárez-Varela, Milagros, additional, and Villegas, Elkin González, additional

Published
2023
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23. Sinus rhythm restoration with electrical cardioversion: acute effect of shock configuration and subsequent modifications in peripheral flow and sleep

Author

Massaro, Giulia and Diemberger, Igor

Subjects
MED/11 Malattie dell'apparato cardiovascolare
Abstract

Atrial fibrillation (AF) is a widespread arrhythmia, associated with higher risk of stroke, sleep disorders and dementia. In some conditions, electrical cardioversion (ECV) represents the best choice for rhythm control. Nowadays, there is a growing interest in developing new devices for screening and monitoring of AF patients. We aimed to improve acute efficacy of ECV procedure and to explore the feasibility of the use of new wearable devices for monitoring in candidates to AF ECV. We compared antero-apical pads vs antero-posterior patches approach for AF ECV, and we elaborated a decision algorithm to improve acute efficacy. After, we evaluated the feasibility of the use of new wearable devices for monitoring of candidates to AF ECV. In particular, we analysed the effect of AF ECV on heart rate variability and vascular age parameters derived from PPG signals registered with Empatica (CE 1876/MDD 93/42/EEC), and on EEG pattern registered with Neurosteer (Israel). From December 2005 to September 2019, 492 patients were enrolled. We evaluated acute efficacy of the two approaches for AF ECV and we elaborated a decision algorithm based on body surface area, weight, and height. The decision algorithm improved first shock efficacy (93.2% vs. 87.2%, p=0.025). From 1st November 2021 to 1st April 2022, 24 patients were enrolled in PPEEG-AF pilot study. Considering vascular age parameters, a significant reduction in TPR and a wave was observed (p

Published
2022

24. Prognostic value of renal failure in patients undergoing transvenous lead extraction: single centre experience and systematic review of the literature

Author

Massaro, Giulia, primary, Spadotto, Alberto, additional, Canovi, Luca, additional, Martignani, Cristian, additional, Ziacchi, Matteo, additional, Angeletti, Andrea, additional, Galie, Nazzareno, additional, Boriani, Giuseppe, additional, Biffi, Mauro, additional, and Diemberger, Igor, additional

Published
2022
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25. PROSPECTIVE STUDY ON PHOTOPLETYSMOGRAPHIC AND ELECTROENCEPHALOGRAPHIC SIGNALS FOR THE MONITORING OF CANDIDATES TO ELECTRICAL CARDIOVERSION OF ATRIAL ARRHYTHMIAS (PPEEG-AF PILOT STUDY).

Author

MASSARO, GIULIA, MOSCATO, SERENA, SPAGNI, STEFANO, DALL'OLIO, LORENZO, BELÀ, REBECCA, SPADOTTO, ALBERTO, FRISONI, JESSICA, BIFFI, MAURO, GALIÈ, NAZZARENO, CHIARI, LORENZO, CASTELLANI, GASTONE, and DIEMBERGER, IGOR

Subjects
*ATRIAL fibrillation, *ATRIAL flutter, *PHOTOPLETHYSMOGRAPHY, *HEART beat, *ELECTRIC countershock, *TRANSIENT ischemic attack, *ATRIAL arrhythmias, *ELECTROENCEPHALOGRAPHY, *CONGESTIVE heart failure
Abstract

Atrial fibrillation (AF) is the most common arrhythmia, and its incidence is constantly increasing. It is associated with higher stroke risk and the presence of sleep disorders and dementia. The choice between rhythm and rate control in AF patients remains a debated topic, and it should be tailored on specific patient characteristics. In specific situations, electrical cardioversion (ECV) for rhythm control represents the preferred choice; in particular, in patients affected by cardiopathy and/or heart failure. Because of relevant AF social costs, there is a growing interest in developing new devices for large-scale screening and monitoring programs in patients affected or at risk of AF, to reduce the incidence of disabling events. The aim of this study was to evaluate the feasibility of the use of a set-up for multi-parametric monitoring of candidates to AF ECV. In particular, new technologies were exploited for photoplethysmographic (PPG) and electroencephalographic (EEG) signal registration, integrated with clinical and instrumental data. We analyzed the effect of AF ECV on heart rate variability (HRV) and vascular age parameters derived from PPG signals registered with Empatica (CE 1876/MDD 93/42/EEC; Empatica S.r.l, Milan, Italy), and on EEG sleep pattern registered with Neurosteer (IEC 60601-1-2; Neurosteer Inc., Herzliya, Israel). 24 patients were enrolled, 75% males, mean age 6 5. 6 ± 8. 5 years. HRV analyses considering time frames registered before and after ECV showed a significant reduction of most variables (p < 0.001), only LF/HF ratio did not differ significantly. Considering HRV parameters, comparisons between PPG signals registered during day or night before and after ECV showed a significant difference in SD1/SD2 ratio (p=0.035) and HF (p = 0. 0 0 2). Regarding vascular age parameters, a significant reduction was observed in both turning point ratio (TPR) and a wave after ECV (p < 0. 0 0 1). Moreover, we observed that patients with Mini-Mental State Examination (MMSE) ≤28 presented higher values of TPR (6 5. 9 ± 1. 6 versus 6 4. 2 ± 1. 4 , p = 0. 0 3 5) and CHA2DS2-VASc score (congestive heart failure, hypertension, age, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age, sex category) (2. 9 ± 0. 9 versus 1. 7 ± 1. 2 , p=0.022). Considering sleep patterns, a tendency to higher coherence was observed in registrations acquired during AF than in presence of sinus rhythm, or considering signals registered before and after ECV for each patient. In conclusion, the use of this new setup of multiparametric monitoring of candidates to ECV showed significant modifications on vascular age parameters derived from PPG signals measured before and after ECV. Moreover, a possible AF effect on sleep pattern registered with Neurosteer was noticed, but more data are necessary to confirm these preliminary results. [ABSTRACT FROM AUTHOR]

Published
2023
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26. Personalizing configuration for atrial fibrillation external electrical cardioversion to improve first shock efficacy

Author

Massaro, Giulia, primary, Spagni, Stefano, additional, Martignani, Cristian, additional, Bettazzoni, Luca, additional, Spadotto, Alberto, additional, Ziacchi, Matteo, additional, Biffi, Mauro, additional, Galiè, Nazzareno, additional, Boriani, Giuseppe, additional, Frisoni, Jessica, additional, and Diemberger, Igor, additional

Published
2022
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28. Comparison Between First Line Target Therapy and Immunotherapy in Different Prognostic Categories of BRAF Mutant Metastatic Melanoma Patients: An Italian Melanoma Intergroup Study

Author

Marconcini, Riccardo, primary, Fava, Paolo, additional, Nuzzo, Amedeo, additional, Manacorda, Simona, additional, Ferrari, Marco, additional, De Rosa, Francesco, additional, De Tursi, Michele, additional, Tanda, Enrica Teresa, additional, Consoli, Francesca, additional, Minisini, Alessandro, additional, Pimpinelli, Nicola, additional, Morgese, Francesca, additional, Bersanelli, Melissa, additional, Tucci, Marco, additional, Saponara, Maristella, additional, Parisi, Alessandro, additional, Ocelli, Marcella, additional, Bazzurri, Serena, additional, Massaro, Giulia, additional, Morganti, Riccardo, additional, Ciardetti, Isabella, additional, and Stanganelli, Ignazio, additional

Published
2022
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31. Safety and Tolerability of COVID-19 Vaccines in Patients with Cancer: A Single Center Retrospective Analysis

Author

Nuzzo, Amedeo, primary, Manacorda, Simona, additional, Sammarco, Enrico, additional, Sbrana, Andrea, additional, Bazzurri, Serena, additional, Paolieri, Federico, additional, Manfredi, Fiorella, additional, Mercinelli, Chiara, additional, Ferrari, Marco, additional, Massaro, Giulia, additional, Bonato, Adele, additional, Salfi, Alessia, additional, Galli, Luca, additional, Morganti, Riccardo, additional, Antonuzzo, Andrea, additional, Cremolini, Chiara, additional, and Masi, Gianluca, additional

Published
2022
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32. Sinus rhythm restoration with electrical cardioversion: acute effect of shock configuration and subsequent modifications in peripheral flow and sleep.

Author

Diemberger, Igor, Massaro, Giulia <1986>, Diemberger, Igor, and Massaro, Giulia <1986>

Abstract

Atrial fibrillation (AF) is a widespread arrhythmia, associated with higher risk of stroke, sleep disorders and dementia. In some conditions, electrical cardioversion (ECV) represents the best choice for rhythm control. Nowadays, there is a growing interest in developing new devices for screening and monitoring of AF patients. We aimed to improve acute efficacy of ECV procedure and to explore the feasibility of the use of new wearable devices for monitoring in candidates to AF ECV. We compared antero-apical pads vs antero-posterior patches approach for AF ECV, and we elaborated a decision algorithm to improve acute efficacy. After, we evaluated the feasibility of the use of new wearable devices for monitoring of candidates to AF ECV. In particular, we analysed the effect of AF ECV on heart rate variability and vascular age parameters derived from PPG signals registered with Empatica (CE 1876/MDD 93/42/EEC), and on EEG pattern registered with Neurosteer (Israel). From December 2005 to September 2019, 492 patients were enrolled. We evaluated acute efficacy of the two approaches for AF ECV and we elaborated a decision algorithm based on body surface area, weight, and height. The decision algorithm improved first shock efficacy (93.2% vs. 87.2%, p=0.025). From 1st November 2021 to 1st April 2022, 24 patients were enrolled in PPEEG-AF pilot study. Considering vascular age parameters, a significant reduction in TPR and a wave was observed (p<0.001). Considering sleep patterns, a tendency to higher coherence was observed in registrations acquired during AF, or considering signals registered for each patient independently from AF. The new decision algorithm improved acute efficacy and reduced costs associated with adhesive patches. Significant modifications were observed on vascular age parameters measured before and after ECV, and a possible AF effect on sleep pattern was noticed. More data are necessary to confirm these preliminary results.

Published
2022

34. Bridging the future of cardiac stimulation: physiologic or leadless pacing?

Author

Piemontese, Giuseppe Pio, primary, Toniolo, Sebastiano, primary, Biffi, Mauro, primary, Capobianco, Claudio, primary, Bartoli, Lorenzo, primary, Sorrentino, Sergio, primary, Minguzzi, Alessandro, primary, Angeletti, Andrea, primary, Statuto, Giovanni, primary, Ziacchi, Matteo, primary, Martignani, Cristian, primary, Massaro, Giulia, primary, Diemberger, Igor, primary, and Spadotto, Alberto, primary

Published
2022
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39. Use of Diltiazem in Chronic Rate Control for Atrial Fibrillation: A Prospective Case-Control Study.

Author

Diemberger, Igor, Spadotto, Alberto, Massaro, Giulia, Amadori, Martina, Damaschin, Liviu, Martignani, Cristian, Ziacchi, Matteo, Biffi, Mauro, Galiè, Nazzareno, and Boriani, Giuseppe

Subjects
ATRIAL fibrillation, FLECAINIDE, CALCIUM antagonists, DILTIAZEM, CASE-control method, HEART failure patients, LONGITUDINAL method
Abstract

Simple Summary: Recent ESC Atrial Fibrillation guidelines introduced some changes in the options for rate control, such as the possibility to combine beta-blockers and non-dihydropyridine calcium channel blockers to address the need for a personalised pharmacologic rate control treatment for AF. However, there are limited data on this topic. This real-world prospective observational study aims to explore the prognostic impact of a patient-specific therapy for rate control in atrial fibrillation, including the use of non-dihydropyridine calcium channel blockers in patients with heart failure or in combination with beta-blockers, compared to standard rate control therapy, as defined by previous ESC guidelines. We performed an analysis of 1112 patients on exclusive rate control treatment referred to our University Hospital. Our results showed no difference in the one-year overall survival in the patient-specific therapy group compared to the standard treatment group. The use of non-dihydropyridine calcium channel blockers for rate control in patients with atrial fibrillation, either alone or in combination with beta-blockers, showed clinical benefit in selected patients, including a group of subjects with heart failure. Future controlled studies are needed to confirm our findings and identify subjects who will obtain greater benefit from such patient-specific rate-control strategies. Atrial fibrillation (AF) is a multifaceted disease requiring personalised treatment. The aim of our study was to explore the prognostic impact of a patient-specific therapy (PT) for rate control, including the use of non-dihydropyridine calcium channel blockers (NDDC) in patients with heart failure (HF) or in combination with beta-blockers (BB), compared to standard rate control therapy (ST), as defined by previous ESC guidelines. This is a single-centre prospective observational registry on AF patients who were followed by our University Hospital. We included 1112 patients on an exclusive rate control treatment. The PT group consisted of 125 (11.2%) patients, 93/125 (74.4%) of whom were prescribed BB + NDCC (±digoxin), while 85/125 (68.0%) were HF patients who were prescribed NDCC, which was diltiazem in all cases. The patients treated with a PT showed no difference in one-year overall survival compared to those with an ST. Notably, the patients with HF in ST had a worse prognosis (p < 0.001). To better define this finding, we performed three sensitivity analyses by matching each patient in the PT subgroups with three subjects from the ST cohort, showing an improved one-year survival of the HF patients treated with PT (p = 0.039). Our results suggest a potential outcome benefit of NDCC for rate control in AF patients, either alone or in combination with BB and in selected patients with HF. [ABSTRACT FROM AUTHOR]

Published
2023
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40. Cimicifuga racemosa isopropanolic extract for menopausal symptoms: an observational prospective case–control study

Author

Guida, Maurizio, primary, Raffone, Antonio, additional, Travaglino, Antonio, additional, Neola, Daniele, additional, Reppuccia, Sabrina, additional, Borgo, Maria, additional, Vitale, Clorinda, additional, Limone, Andrea, additional, D’Alessandro, Pietro, additional, Massaro, Giulia, additional, and Mollo, Antonio, additional

Published
2021
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44. Percutaneous Mitral Valve Repair with the MitraClip System in the Current Clinical Practice

Author

Sorrentino, Sergio, primary, Berardini, Alessandra, additional, Statuto, Giovanni, additional, Angeletti, Andrea, additional, Massaro, Giulia, additional, Capobianco, Claudio, additional, Piemontese, Giuseppe Pio, additional, Spadotto, Alberto, additional, Toniolo, Sebastiano, additional, Caponetti, Angelo Giuseppe, additional, Ditaranto, Raffaello, additional, Parisi, Vanda, additional, Minnucci, Matteo, additional, Ferrara, Valentina, additional, Galiè, Nazzareno, additional, and Biagini, Elena, additional

Published
2021
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45. Cardiac Stimulation in the Third Millennium: Where Do We Head from Here?

Author

Biffi, Mauro, primary, Spadotto, Alberto, additional, Piemontese, Giuseppe Pio, additional, Toniolo, Sebastiano, additional, Bartoli, Lorenzo, additional, Sorrentino, Sergio, additional, Minguzzi, Alessandro, additional, Massaro, Giulia, additional, Capobianco, Claudio, additional, and Statuto, Giovanni, additional

Published
2021
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50. First‐trimester screening based on cell‐free DNA vs combined screening: A randomized clinical trial on women's experience

Author

Migliorini, Sonia, primary, Saccone, Gabriele, additional, Silvestro, Fiora, additional, Massaro, Giulia, additional, Arduino, Bruno, additional, D'Alessandro, Pietro, additional, Petti, Maria Teresa, additional, Paino, Jessica Anna Cinzia, additional, Guida, Maurizio, additional, Locci, Mariavittoria, additional, and Zullo, Fulvio, additional

Published
2020
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