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1. COVID-19 Vaccination Willingness and Hesitancy in Patients With Inflammatory Bowel Diseases: Analysis of Determinants in a National Survey of the Italian IBD Patients’ Association

Author

Simona Radice, Francesco Conforti, Claudio Costantino, Marina Aloi, Ferdinando Ficari, S. Leone, A. Armuzzi, Francesco Manguso, Andrea Costantino, Giammarco Mocci, Maurizio Vecchi, Loris Pironi, Ambrogio Orlando, Daniele Noviello, Alessandra Tongiorgi, Fernando Rizzello, Fabrizio Bossa, Flavio Caprioli, Costantino A., Noviello D., Conforti F.S., Aloi M., Armuzzi A., Bossa F., Ficari F., Leone S., Manguso F., Mocci G., Orlando A., Pironi L., Radice S., Rizzello F., Tongiorgi A., Costantino C., Vecchi M., Caprioli F., and Costantino Andrea, Noviello Daniele, Conforti Francesco Simone, Aloi Marina, Armuzzi Alessandro, Bossa Fabrizio, Ficari Ferdinando, Leone Salvo, Manguso Francesco, Mocci Giammarco, Orlando Amrbogio, Pironi Loris, Radice Simona, Rizzello Fernando, Tongiorgi Alessandra, Costantino Claudio, Vecchi Maurizio, Caprioli Flavio

Subjects
medicine.medical_specialty, 2019-20 coronavirus outbreak, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), IBD, Brief Report - Clinical, Internal medicine, medicine, Humans, Immunology and Allergy, In patient, AcademicSubjects/MED00260, SARS-CoV-2, business.industry, Vaccination, Gastroenterology, COVID-19, Inflammatory Bowel Diseases, COVID-19 Vaccines Human, IBD, Crohn, Ulcerative Colitis, Vaccination, Covid 19, Sars-Cov 2, COVID-19 vaccine, vaccine hesitancy, business
Abstract

The coronavirus disease 2019 (COVID-19) pandemic has not finished yet, and the most promising option towards its ending is widespread vaccination. Because patients with inflammatory bowel diseases (IBDs), namely Crohn’s disease (CD) and ulcerative colitis (UC), often require immune-modifying treatment, which might increase the risk of opportunistic infection,1 their vaccination history for several infectious diseases is routinely checked, and when inadequate, vaccination is performed at diagnosis or ideally before immune suppressive treatment is started.1 However, IBD patients were not found to be at an increased risk of developing COVID-19 or of experiencing a more severe disease course.2

Published
2021
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2. Differential Expression of CB1 Cannabinoid Receptor and Cannabinoid Receptor Interacting Protein 1a in Labor

Author

Jie Zhang, Liliya M. Yamaleyeva, Brian C. Brost, Anna G McDonald, Melissa L. Kozakiewicz, Allyn C. Howlett, and Sandra Leone-Kabler

Subjects
Pharmacology, medicine.medical_specialty, Cannabinoid receptor, medicine.diagnostic_test, Myometrium, Anandamide, Biology, Endocannabinoid system, chemistry.chemical_compound, Real-time polymerase chain reaction, medicine.anatomical_structure, Endocrinology, Complementary and alternative medicine, Western blot, chemistry, Internal medicine, Placenta, medicine, Immunohistochemistry, lipids (amino acids, peptides, and proteins), Pharmacology (medical)
Abstract

Background: The endocannabinoid system is present in multiple organ systems and is involved in smooth muscle regulation, immune function, neuroendocrine modulation, and metabolism of tissues. Limited data are available regarding the presence and role of this system in reproductive tissues. Components of the endocannabinoid system have been identified in myometrial and placental tissues. However, no study has investigated differential expression of the endocannabinoid system in labor. Objectives: The purpose of this study was to identify and quantify two components of the endocannabinoid system, the CB1 cannabinoid receptor and cannabinoid receptor interacting protein 1a (CRIP1a) in uterine and placental tissues, and to determine if there is differential expression in tissues exposed to labor. We hypothesized that CB1 cannabinoid receptor concentration would be altered in uterine and placental tissue exposed to labor compared with tissues not exposed to labor. Study Design: Uterine and placental tissue samples were collected in nine laboring and 11 nonlaboring women undergoing cesarean delivery. CB1 cannabinoid receptor and CRIP1a presence and quantification were evaluated using western blot, immunohistochemistry, and real-time quantitative polymerase chain reaction. Statistical comparisons of laboring and nonlaboring subjects were made for uterine and placental tissue using a Mann-Whitney test. Results: Immunohistochemistry demonstrated positive staining for CB1 cannabinoid receptors and CRIP1a in uterine tissue. The protein abundance of CB1 cannabinoid receptor in uterine tissue was significantly lower in tissues exposed to labor (p=0.01). The protein abundance of CRIP1a was lower in uterine tissue exposed to labor but did not reach statistical significance (p=0.06). mRNA expression of CB1 cannabinoid receptor (p=0.20) and CRIP1a (p=0.63) did not differ in labored compared with nonlabored uterine tissues. Conclusions: Our findings of diminished protein density of CB1 cannabinoid receptor in uterine tissue exposed to labor support the hypothesis that the endocannabinoid system plays a role in parturition. Our data add to the growing body of evidence indicating the endocannabinoid system is of importance for successful reproduction and support the need for additional research investigating this complex system as it pertains to labor. ClinicalTrials.gov ID: NCT03752021.

Published
2022
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3. Chest CT–derived pulmonary artery enlargement at the admission predicts overall survival in COVID-19 patients: insight from 1461 consecutive patients in Italy

Author

Alberto Monello, Gianluigi Patelli, Tommaso Nannini, Gianmarco Iannopollo, Antonio Esposito, Francesco De Cobelli, Anna Palmisano, Piergiorgio Turchio, Giovanni Landoni, Chiara Gnasso, Gianluca Pontone, Luisa Di Mare, Carlo Tacchetti, Clelia Di Serio, Antonio Colombo, Sandro Sironi, Marco Loffi, Fabio Ciceri, Andrea Biagi, Elisabetta Mancini, Daniele Andreini, Riccardo Leone, Pietro Sergio, Alberto Zangrillo, Giacomo Monti, Gianni Casella, Paola M.V. Rancoita, Alberto Cereda, Davide Vignale, Guglielmo Gallone, Francesco Giannini, Valeria Nicoletti, Davide Ippolito, Marco Toselli, Esposito, A, Palmisano, A, Toselli, M, Vignale, D, Cereda, A, Rancoita, P, Leone, R, Nicoletti, V, Gnasso, C, Monello, A, Biagi, A, Turchio, P, Landoni, G, Gallone, G, Monti, G, Casella, G, Iannopollo, G, Nannini, T, Patelli, G, Di Mare, L, Loffi, M, Sergio, P, Ippolito, D, Sironi, S, Pontone, G, Andreini, D, Mancini, E, Di Serio, C, De Cobelli, F, Ciceri, F, Zangrillo, A, Colombo, A, Tacchetti, C, Giannini, F, Esposito, Antonio, Palmisano, Anna, Toselli, Marco, Vignale, Davide, Cereda, Alberto, Rancoita, Paola Maria Vittoria, Leone, Riccardo, Nicoletti, Valeria, Gnasso, Chiara, Monello, Alberto, Biagi, Andrea, Turchio, Piergiorgio, Landoni, Giovanni, Gallone, Guglielmo, Monti, Giacomo, Casella, Gianni, Iannopollo, Gianmarco, Nannini, Tommaso, Patelli, Gianluigi, Di Mare, Luisa, Loffi, Marco, Sergio, Pietro, Ippolito, Davide, Sironi, Sandro, Pontone, Gianluca, Andreini, Daniele, Mancini, Elisabetta Maria, Di Serio, Clelia, De Cobelli, Francesco, Ciceri, Fabio, Zangrillo, Alberto, Colombo, Antonio, Tacchetti, Carlo, and Giannini, Francesco

Subjects
Male, Thorax, medicine.medical_specialty, 030204 cardiovascular system & hematology, 030218 nuclear medicine & medical imaging, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine.artery, Humans, Medicine, Radiology, Nuclear Medicine and imaging, Lung volumes, Aged, Retrospective Studies, medicine.diagnostic_test, SARS-CoV-2, business.industry, Tomography, X-ray computed, Hazard ratio, COVID-19, Interventional radiology, General Medicine, medicine.disease, Pulmonary hypertension, Pulmonary artery, Pneumonia, Italy, Hypertension, pulmonary, Radiology Nuclear Medicine and imaging, Chest, Female, Radiology, business, Cohort study
Abstract

Objectives Enlarged main pulmonary artery diameter (MPAD) resulted to be associated with pulmonary hypertension and mortality in a non-COVID-19 setting. The aim was to investigate and validate the association between MPAD enlargement and overall survival in COVID-19 patients. Methods This is a cohort study on 1469 consecutive COVID-19 patients submitted to chest CT within 72 h from admission in seven tertiary level hospitals in Northern Italy, between March 1 and April 20, 2020. Derivation cohort (n = 761) included patients from the first three participating hospitals; validation cohort (n = 633) included patients from the remaining hospitals. CT images were centrally analyzed in a core-lab blinded to clinical data. The prognostic value of MPAD on overall survival was evaluated at adjusted and multivariable Cox’s regression analysis on the derivation cohort. The final multivariable model was tested on the validation cohort. Results In the derivation cohort, the median age was 69 (IQR, 58–77) years and 537 (70.6%) were males. In the validation cohort, the median age was 69 (IQR, 59–77) years with 421 (66.5%) males. Enlarged MPAD (≥ 31 mm) was a predictor of mortality at adjusted (hazard ratio, HR [95%CI]: 1.741 [1.253–2.418], p p = 0.005), together with male gender, old age, high creatinine, low well-aerated lung volume, and high pneumonia extension (c-index [95%CI] = 0.826 [0.796–0.851]). Model discrimination was confirmed on the validation cohort (c-index [95%CI] = 0.789 [0.758–0.823]), also using CT measurements from a second reader (c-index [95%CI] = 0.790 [0.753;0.825]). Conclusion Enlarged MPAD (≥ 31 mm) at admitting chest CT is an independent predictor of mortality in COVID-19. Key Points •Enlargement of main pulmonary artery diameter at chest CT performed within 72 h from the admission was associated with a higher rate of in-hospital mortality in COVID-19 patients. •Enlargement of main pulmonary artery diameter (≥ 31 mm) was an independent predictor of death in COVID-19 patients at adjusted and multivariable regression analysis. •The combined evaluation of clinical findings, lung CT features, and main pulmonary artery diameter may be useful for risk stratification in COVID-19 patients.

Published
2020
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4. Recapture of the Sapien-3 Delivery System After Transversal Balloon Rupture Using a Whole Percutaneous Femoral Approach

Author

Antonio Bruno, Mateusz Orzalkiewicz, Carlo Savini, Cinzia Marrozzini, Francesco Saia, Mauro Gargiulo, Enrico Gallitto, Alessandro Leone, Nazzareno Galiè, Nevio Taglieri, Rodolfo Pini, Davide Pacini, Gianluca Faggioli, Tullio Palmerini, Gabriele Ghetti, Bruno, Antonio Giulio, Taglieri, Nevio, Saia, Francesco, Pini, Rodolfo, Gallitto, Enrico, Ghetti, Gabriele, Orzalkiewicz, Mateusz, Marrozzini, Cinzia, Faggioli, Gianluca, Gargiulo, Mauro, Leone, Alessandro, Savini, Carlo, Pacini, Davide, Galié, Nazzareno, and Palmerini, Tullio

Subjects
medicine.medical_specialty, Percutaneous, business.industry, Aortic Valve Stenosis, bailout techniquesballoon ruptureSAPIEN3snaringTAVR, Prosthesis Design, Balloon, Surgery, Transcatheter Aortic Valve Replacement, Treatment Outcome, Aortic Valve, Heart Valve Prosthesis, Transversal (combinatorics), Humans, Medicine, Delivery system, Cardiology and Cardiovascular Medicine, business
Abstract

A 57-year-old man with severe aortic valve stenosis at high surgical risk underwent transcatheter valve replacement with a 29-mm Edwards Sapien-3 valve (Edwards Lifesciences). The valve was successfully implanted using the right femoral access, but at the end of the deployment the balloon ruptured (Videos 1 and 2) and could not be retrieved from the e-Sheath. The Commander delivery system was then readvanced in the aorta over the wire (Video 3), which was snared and externalized using a 25-mm AndraSnare (Andramed GmbH) inserted through the left femoral artery using a 25-cm-long 22-F Cook sheath (Cook Medical) (Figure 1). Then, the Commander was pushed over the wire, across the aortic bifurcation, making the ruptured balloon get into the Cook sheath (Figure 2). The Commander was then truncated (Figure 3), and the ruptured balloon proximal part attached to the pusher/balloon catheter unit was retrieved through the eSheath (Figure 4). Then, the ruptured balloon distal part attached to the inner balloon shaft was pushed forward such that it could be externalized through the left femoral sheath, cut (Figure 5), and finally pulled back with the wire through the eSheath (Figure 6).

Published
2021
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5. Inflammatory bowel disease position statement of the Italian Society of Colorectal Surgery (SICCR): ulcerative colitis

Author

Pellino, G., Keller, D. S., Sampietro, G. M., Carvello, M., Celentano, V., Coco, C., Colombo, F., Geccherle, A., Luglio, G., Rottoli, M., Scarpa, M., Sciaudone, G., Sica, G., Sofo, L., Zinicola, R., Leone, S., Danese, S., Spinelli, A., Delaini, G., Selvaggi, F., Angriman, I., Caprino, P., Dicandido, F., Diruscio, M., Laureti, S., Poggioli, G., Rizzo, G., Roda, G., Sacchetti, F., Scaringi, S., Sensi, B., Variola, A., Pellino, C. G., Delaini, G. G., Pellino, G, Keller, D S, Sampietro, G M, Carvello, M, Celentano, V, Coco, C, Colombo, F, Geccherle, A, Luglio, G, Rottoli, M, Scarpa, M, Sciaudone, G, Sica, G, Sofo, L, Zinicola, R, Leone, S, Danese, S, Spinelli, A, Delaini, G, Selvaggi, F, Pellino, G., Keller, D. S., Sampietro, G. M., Carvello, M., Celentano, V., Coco, C., Colombo, F., Geccherle, A., Luglio, G., Rottoli, M., Scarpa, M., Sciaudone, G., Sica, G., Sofo, L., Zinicola, R., Leone, S., Danese, S., Spinelli, A., Delaini, G., Selvaggi, F., Angriman, I., Caprino, P., Dicandido, F., Diruscio, M., Laureti, S., Poggioli, G., Rizzo, G., Roda, G., Sacchetti, F., Scaringi, S., Sensi, B., Variola, A., Pellino, C. G., and Delaini, G. G.

Subjects
Position statement, medicine.medical_specialty, IBD, 030230 surgery, Inflammatory bowel disease, 03 medical and health sciences, UC, 0302 clinical medicine, Humans, Medicine, Surgical treatment, IPAA, Pouch, Ulcerative colitis, business.industry, Proctocolectomy, Restorative, Gastroenterology, Colitis, Inflammatory Bowel Diseases, medicine.disease, Colorectal surgery, Infammatory bowel disease · IBD · Ulcerative colitis · UC · IPAA · Pouch, Settore MED/18, Italy, Family medicine, Colitis, Ulcerative, 030211 gastroenterology & hepatology, Surgery, business, Colorectal Surgery, Colorectal surgeons
Abstract

The Italian Society of Colorectal Surgery (SICCR) promoted the project reported here, which consists of a Position State‑ ment of Italian colorectal surgeons to address the surgical aspects of ulcerative colitis management. Members of the society were invited to express their opinions on several items proposed by the writing committee, based on evidence available in the literature. The results are presented, focusing on relevant points. The present paper is not an alternative to available guidelines; rather, it ofers a snapshot of the attitudes of SICCR surgeons about the surgical treatment of ulcerative colitis. The committee was able to identify some points of major disagreement and suggested strategies to improve the quality of available data and acceptance of guidelines.

Published
2020
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6. The rewarding effects of alcohol after bariatric surgery: do they change and are they associated with pharmacokinetic changes?

Author

Ross D. Crosby, James E. Mitchell, Lauren M. Schaefer, Kristine J. Steffen, Gail A. Kerver, Lynnette M. Leone, Scott G. Engel, Greg T. Smith, and John Gunstad

Subjects
medicine.medical_specialty, Alcohol Drinking, Gastric bypass, Gastric Bypass, Bariatric Surgery, Alcohol, Alcohol use disorder, medicine.disease_cause, Article, chemistry.chemical_compound, Pharmacokinetics, medicine, Humans, Ethanol, Gastric bypass surgery, business.industry, medicine.disease, United States, Obesity, Morbid, Surgery, Alcoholism, Increased risk, chemistry, Empirical examination, business, Weight Loss Surgery
Abstract

BACKGROUND: Research shows that surgery patients who have undergone Roux-en-Y gastric bypass (RYGB) are at increased risk for an alcohol use disorder (AUD). However, the mechanisms through which this increased risk is incurred are poorly understood. A host of variables have been proposed as potentially causal in developing AUDs, but empirical examination of many of these variables in human samples is lacking. OBJECTIVES: Our objective was to examine the extent to which alcohol pharmacokinetics (PK), the rewarding effects of alcohol, and the relationship between these variables change from before to after weight loss surgery. SETTING: Large healthcare facility in the Midwest United States METHODS: Thirty-four participants completed assessments prior to, and one year after, RYGB. They completed laboratory sessions and provided data on the PK of alcohol and the extent to which alcohol was reinforcing to them at each timepoint. RESULTS: Findings show that the PK effects of alcohol (p

Published
2022
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7. Policy Recommendations to Eliminate Tobacco Use and Improve Health from the American Thoracic Society Tobacco Action Committee

Author

Thomas Carr, Frank T. Leone, Krishna P. Reddy, Ilona Jaspers, Dona Upson, Theo J. Moraes, Elif Dagli, Anne C. Melzer, Farzad Moazed, Hasmeena Kathuria, Sarah E. Bauer, Gary Ewart, Sucharita Kher, Michelle N. Eakin, and Jamie L. Garfield

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Tobacco use, business.industry, Health Policy, Tobacco Use Disorder, United States, Tobacco Use, Policy, Action (philosophy), Family medicine, Perspective, Tobacco, medicine, Humans, Smoking Cessation, business
Published
2022
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8. HPV 16 and 18 contribute to development of anal dysplasia in HIV infection irrespective of gender and sexual orientation

Author

Paolo Bonfanti, Francesca Sabbatini, Alessandro Soria, Nicola Squillace, Elisa Colella, Andrea Marco Tamburini, Adriana Di Lucia, Marco Braga, Giuseppe Lapadula, Davide Paolo Bernasconi, Biagio Eugenio Leone, Marianna Rossi, Annalisa Cavallero, Sergio Malandrin, Ambrogio Brenna, Squillace, N, Bernasconi, D, Lapadula, G, Soria, A, Sabbatini, F, Colella, E, Rossi, M, Tamburini, A, Leone, B, Brenna, A, Malandrin, S, Cavallero, A, Di Lucia, A, Braga, M, and Bonfanti, P

Subjects
Male, HPV, medicine.medical_specialty, Genotype, Sexual Behavior, Anal Canal, HIV Infections, Lower risk, Logistic regression, anal cytologic abnormalitie, Men who have sex with men, Sexual and Gender Minorities, Risk Factors, Interquartile range, Internal medicine, Prevalence, medicine, Humans, Pharmacology (medical), Homosexuality, Male, Papillomaviridae, Human papillomavirus 16, business.industry, Health Policy, Papillomavirus Infections, HPV infection, HIV, virus diseases, Anal dysplasia, Odds ratio, medicine.disease, Confidence interval, HPV 16 and 18, Infectious Diseases, Female, business
Abstract

Objectives: The aim of the present study was too investigate prevalence and persistence of human papilloma virus (HPV) and cytological abnormalities (CAs) in the anal swabs of people living with HIV (PLWH): men who have sex with men (MSM), men who have sex with women (MSW) and women (W). Methods: Between March 2010 and January 2019, an anal swab for cytological and HPV genotyping tests was offered to all PLWH attending our clinic. Logistic regression analysis was conducted to identify predictors of infection. Results: In all, 354 PLWH were screened: 174 MSM, 90 MSW and 61 W. Prevalence of at least one high-risk (HR) HPV was higher in MSM (91%) and W (85%) than in MSW (77%) (P < 0.05). Cytological abnormalities were found in 21.1% of the entire population. At multivariable regression analysis a lower risk for HPV infection was found for W than for MSM [odds ratio = 0.24 (95% confidence interval: 0.115–0.513)] and for MSW than for MSM [0.37 (0.180–0.773)] and there was a significantly higher risk of CAs in PLWH with HPV 16 and 18 [3.3 (1.04–10.49)]. A total of 175 PLWH (103 MSM, 33 MSW and 26 W) had at least one follow-up visit (T1) after a median (interquartile range) follow-up of 3.6 (2.1–5.7) years. The acquisition rate of HR-HPV was high, with 66.7% of PLWH negative for HR-HPV at T0 who became positive at T1 (P < 0.001). The prevalence of CAs was stable (20.6%). A significant association between CAs at T1 and persistence of HPV-16 and/or 18 was found (P < 0.05). Conclusions: HPV 16 and 18 are associated with the presence and development of CAs irrespective of sexual orientation.

Published
2021
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9. Two Decades of Abdominal Aortic Endovascular Repair With the Anatomical FiXation at the Aortic Bifurcation in a Large Single-Center Experience

Author

Nicola Leone, Tea Covic, Giuseppe Saitta, Roberto Silingardi, Francesco Andreoli, Mattia Migliari, Stefano Gennai, Gennai S., Andreoli F., Saitta G., Leone N., Migliari M., Covic T., and Silingardi R.

Subjects
medicine.medical_treatment, Aneurysm neck, 030204 cardiovascular system & hematology, migration, Single Center, Endovascular aneurysm repair, endovascular aneurysm repair, 0302 clinical medicine, Retrospective Studie, Stent, aneurysm neck, 030212 general & internal medicine, Aged, 80 and over, fixation, Endovascular Procedures, abdominal aortic aneurysm, aneurysm, aneurysm sac, bifurcated stent-graft, endograft, endoleak, Middle Aged, Abdominal aortic aneurysm, Blood Vessel Prosthesi, Treatment Outcome, medicine.anatomical_structure, Stents, Cardiology and Cardiovascular Medicine, Human, medicine.medical_specialty, Prosthesis Design, Aortography, Blood Vessel Prosthesis Implantation, 03 medical and health sciences, Fixation (surgical), Aneurysm, medicine, Humans, Radiology, Nuclear Medicine and imaging, Aged, Retrospective Studies, business.industry, Aortic bifurcation, medicine.disease, Blood Vessel Prosthesis, Surgery, business, Aortic Aneurysm, Abdominal
Abstract

Objective: The introduction of new endograft models improved long-term results of abdominal aortic aneurysm (AAA) endovascular repair (EVAR), but most of them maintained an old and unchanged design: a short body and long legs shifting up the flow divider. This study assessed the long-term results of EVAR with unimodular endoprosthesis fixed at the aorto-iliac bifurcation (Anatomical FiXation), in a large, unselected cohort. Materials and Methods: In a single-center, retrospective cohort study, 623 patients selectively treated between 1999 and 2016, were analyzed. Follow-up protocol included at least a computed tomography angiography within 3 months and a duplex ultrasound and clinical exam yearly. All enrolled patients were analyzed by 2020. The primary outcomes were technical success, clinical success, and survival. Secondary outcomes included survival-free from late-open-conversion (LOC), reintervention, and endoleaks. Results: Median age was 74±11 years and the follow-up 93±54 months. The technical success was achieved in 99.4% and the 30-day clinical success was 98.4%. A 5-year clinical success of 97.7% was registered and at 10 years success was 96.7%. The overall survival at 1, 5, 10, and 15 years was 92.4%, 79.5%, 64.9%, and 45.5%, respectively. Six (0.98%) AAA-related death were registered, 3 caused by infection of the endograft and 3 for secondary rupture. LOCs were 9 (1.47%) and reintervention-free survival at 1, 5, 10, and 15 years were 88.4%, 78.0%, 76.2%, and 74.6%, respectively. Freedom from endoleaks was 88.8% at 1 year and 72.7% at 15 years. A total of 63 high-flow endoleaks were registered (43 type I, 7 type IIIa, 12 type IIIb, and 1 type Ib+IIIb). No migrations were recorded, and the graft limb thrombosis rate was 1.14%. From a multivariate analysis resulted that long-term clinical success appeared to be reduced in patients affected by diabetes [odds ratio (OR) 0.24; p=0.04] and in presence of calcified and thrombotic iliac accesses (OR 0.16; p=0.006). Conclusion: EVAR with the Anatomical FiXation was confirmed to be safe, feasible, and effective to prevent AAA rupture in the long term as well. However, the overall survival remains afflicted by cardiovascular accident. The original concept of unibody bifurcated design allowed a very low rate of graft thrombosis and zeroed the risk of migration and related reintervention.

Published
2021
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10. Epicardial adipose tissue characteristics, obesity and clinical outcomes in COVID-19: A post-hoc analysis of a prospective cohort study

Author

Riccardo Leone, Alberto Zangrillo, Valeria Nicoletti, Luigi di Filippo, Guglielmo Gallone, Fabio Ciceri, Francesco De Cobelli, Paolo G. Camici, Antonio Secchi, Antonella Castagna, Rebecca De Lorenzo, Annalisa Ruggeri, Emanuele Bosi, Anna Palmisano, Giovanni Landoni, Patrizia Rovere-Querini, Moreno Tresoldi, Antonio Esposito, Caterina Conte, Davide Vignale, Conte, Caterina, Esposito, Antonio, De Lorenzo, Rebecca, Di Filippo, Luigi, Palmisano, Anna, Vignale, Davide, Leone, Riccardo, Nicoletti, Valeria, Ruggeri, Annalisa, Gallone, Guglielmo, Secchi, Antonio, Bosi, Emanuele, Tresoldi, Moreno, Castagna, Antonella, Landoni, Giovanni, Zangrillo, Alberto, De Cobelli, Francesco, Ciceri, Fabio, Camici, Paolo, and Rovere-Querini, Patrizia

Subjects
Male, Endocrinology, Diabetes and Metabolism, Medicine (miscellaneous), 030204 cardiovascular system & hematology, Overweight, law.invention, 0302 clinical medicine, Risk Factors, law, Medicine, Visceral fat, Hospital Mortality, Prospective Studies, Prospective cohort study, Adiposity, Nutrition and Dietetics, Middle Aged, Prognosis, Intensive care unit, Cardiac injury, Italy, Predictive value of tests, Female, Radiography, Thoracic, medicine.symptom, Cardiology and Cardiovascular Medicine, Pericardium, medicine.medical_specialty, 030209 endocrinology & metabolism, Intra-Abdominal Fat, Risk Assessment, Article, 03 medical and health sciences, Predictive Value of Tests, Internal medicine, Diabetes mellitus, Epicardial adipose tissue, Post-hoc analysis, Humans, Obesity, Aged, Inflammation, SARS-CoV-2, business.industry, Proportional hazards model, COVID-19, medicine.disease, Tomography, X-Ray Computed, business
Abstract

Background and aims Obesity-related cardiometabolic risk factors associate with COVID-19 severity and outcomes. Epicardial adipose tissue (EAT) is associated with cardiometabolic disturbances, is a source of proinflammatory cytokines and a marker of visceral adiposity. We investigated the relation between EAT characteristics and outcomes in COVID-19 patients. Methods and results This post-hoc analysis of a large prospective investigation included all adult patients (≥18 years) admitted to San Raffaele University Hospital in Milan, Italy, from February 25th to April 19th, 2020 with confirmed SARS-CoV-2 infection who underwent a chest computed tomography (CT) scan for COVID-19 pneumonia and had anthropometric data available for analyses. EAT volume and attenuation (EAT-At, a marker of EAT inflammation) were measured on CT scan. Primary outcome was critical illness, defined as admission to intensive care unit (ICU), invasive ventilation or death. Cox regression and regression tree analyses were used to assess the relationship between clinical variables, EAT characteristics and critical illness. One-hundred and ninety-two patients were included (median [25th-75th percentile] age 60 years [53-70], 76% men). Co-morbidities included overweight/obesity (70%), arterial hypertension (40%), and diabetes (16%). At multivariable Cox regression analysis, EAT-At (HR 1.12 [1.04-1.21]) independently predicted critical illness, while increasing PaO2/FiO2 was protective (HR 0.996 [95% CI 0.993; 1.00]). CRP, plasma glucose on admission, EAT-At and PaO2/FiO2 identified five risk groups that significantly differed with respect to time to death or admission to ICU (log-rank p, Graphical abstract Image 1

Published
2021
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11. Predictors of adherence to composite therapy after acute coronary syndromes

Author

Federica Ilardi, Eugenio Stabile, Salvatore Chianese, Attilio Leone, Iginio Colaiori, Michele Franzese, Brunella Puzone, Luigi Di Serafino, Anna Franzone, Arturo Alfani, Carmine Morisco, Martina Scalise, Monica Annunziata, Giovanni Esposito, Raffaele Piccolo, Marisa Avvedimento, Plinio Cirillo, Bruno Trimarco, Donato Gerardi, Pierluigi Nappi, Stabile, Eugenio, Franzese, Michele, Chianese, Salvatore, Alfani, Arturo, Gerardi, Donato, Colaiori, Iginio, Annunziata, Monica, Nappi, Pierluigi, Scalise, Martina, Di Serafino, Luigi, Puzone, Brunella, Avvedimento, Marisa, Leone, Attilio, Ilardi, Federica, Piccolo, Raffaele, Franzone, Anna, Cirillo, Plinio, Morisco, Carmine, Trimarco, Bruno, and Esposito, Giovanni

Subjects
Male, Acute coronary syndrome, medicine.medical_specialty, medicine.medical_treatment, Angiotensin-Converting Enzyme Inhibitors, Medication Adherence, Angiotensin Receptor Antagonists, Risk Factors, Internal medicine, Secondary Prevention, Humans, Medicine, Registries, Acute Coronary Syndrome, Medical prescription, business.industry, Coronary Care Units, Percutaneous coronary intervention, Cardiovascular Agents, General Medicine, Middle Aged, medicine.disease, University hospital, Patient Discharge, Italy, Logistic analysis, Coronary care unit, Female, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Cardiology and Cardiovascular Medicine, business, Index hospitalization, Platelet Aggregation Inhibitors, Cohort study
Abstract

AIMS Adherence to medical therapy following acute coronary syndrome (ACS) affects a patient's prognosis. In this cohort study, we sought to assess the factors that could affect a patient's adherence to therapy after ACS. METHODS We prospectively collected information from patients (N = 964) hospitalized at the coronary care unit of the Federico II University Hospital, from 1 January 2015 to 30 June 2017, for ACS. Adherence to three classes of drugs including statins, antiplatelets [dual or single antiplatelet agent (SAPT)] and angiotensin-converting enzyme inhibitors/angiotensin receptor blockers (ACE-I/ARB) and their composites were assessed at 1 month, 1 and 2 years after discharge. RESULTS At 30 days adherence to prescribed therapy was 94.4% for dual antiplatelet therapy (DAPT), 78.2% for statins, 92.7% for ACE-I/ARB and 70.7% for multitherapy. At 1 year, it was 91.1% for DAPT, 81.2% for ACE-I/ARB, 84.9% for statins and 71.4% for multitherapy. At 2 years, it was 97.1% for SAPT, 78.1% for ACE-I/ARB, 91.8% for statins, 72.8% for multitherapy. Multivariable logistic analysis demonstrated that at each time point, a telephone follow-up assessment predicts nonadherence to multitherapy and that a percutaneous coronary intervention at the index hospitalization is an independent predictor of adherence to composite therapy at 1 month and 1 year. CONCLUSION Up to 2 years after ACS, three out of four patients are adherent to multitherapy prescription; percutaneous coronary intervention during the index hospitalization improves a patient's adherence, whereas telephone follow-up is associated with reduced adherence to multitherapy.Campania Salute Network Registry (Clinical Trials.gov Identifier: NCT02211365).

Published
2021
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12. Home-based exercise program improves normal Right Ventricle function in Renal Transplant Recipients

Author

Vittorio Bini, Gianni Pedrizzetti, Elena Zappelli, Melissa Orlandi, Beatrice Leone, Laura Stefani, Orlandi, M., Bini, V., Leone, B., Zappelli, E., Pedrizzetti, G., Stefani, L., Orlandi, Melissa, Bini, Vittorio, Leone, Beatrice, Zappelli, Elena, Pedrizzetti, Gianni, and Stefani, Laura

Subjects
medicine.medical_specialty, Heart Ventricles, Transplant Recipient, Physical Therapy, Sports Therapy and Rehabilitation, Physical exercise, Speckle tracking echocardiography, Heart Ventricle, Internal medicine, medicine, Humans, Ventricular Function, Orthopedics and Sports Medicine, Home based exercise, Exercise Therapy, Transplant Recipients, Kidney Transplantation, Ventricular Function, Right, Normal range, Ventricular function, business.industry, Intensity (physics), Right, medicine.anatomical_structure, Cardiac mechanics, Renal transplant, Ventricle, Cardiology, business, Human
Abstract

Background: Right ventricular function is strongly associated with clinical outcomes in populations at high cardiovascular risk. Renal Transplant Recipients have multiple coexisting comorbidities potentially involved in the biventricular dysfunction including the right ventricular chamber. Speckle tracking echocardiography is recently used to investigate the normal function of this chamber. The study aims to verify whether global longitudinal strain carries clinical and prognosis implications in the renal transplant recipients during 1 year of regular unsupervised physical activity and compared to a control group. Methods: a group of 50 transplant recipients, aged 49.6±11.5 was submitted for 1 year to a moderate intensity of mixed exercise. All the subjects were followed by echocardiographic exam every 6 months, only 25 subjects with a high quality of image were investigated by 2D Speckle tracking strain analysis with the measurement calculated at T0, T6, and T12 months. Results: renal transplant recipients started with low values of right ventricle global longitudinal strain compared to health controls; it increased significantly (p

Published
2022

13. Characteristics and patterns of care of endometrial cancer before and during COVID-19 pandemic

Author

Giorgio Bogani, Giovanni Scambia, Chiara Cimmino, Francesco Fanfani, Barbara Costantini, Matteo Loverro, Gabriella Ferrandina, Fabio Landoni, Luca Bazzurini, Tommaso Grassi, Domenico Vitobello, Gabriele Siesto, Anna Myriam Perrone, Vanna Zanagnolo, Pierandrea De Iaco, Francesco Multinu, Fabio Ghezzi, Jvan Casarin, Roberto Berretta, Vito A Capozzi, Errico Zupi, Gabriele Centini, Antonio Pellegrino, Silvia Corso, Guido Stevenazzi, Serena Montoli, Anna Chiara Boschi, Giuseppe Comerci, Pantaleo Greco, Ruby Martinello, Francesco Sopracordevole, Giorgio Giorda, Tommaso Simoncini, Marta Caretto, Enrico Sartori, Federico Ferrari, Antonio Cianci, Giuseppe Sarpietro, Maria Grazia Matarazzo, Fulvio Zullo, Giuseppe Bifulco, Michele Morelli, Annamaria Ferrero, Nicoletta Biglia, Fabio Barra, Simone Ferrero, Umberto Leone Roberti Maggiore, Stefano Cianci, Vito Chiantera, Alfredo Ercoli, Giulio Sozzi, Angela Martoccia, Sergio Schettini, Teresa Orlando, Francesco G Cannone, Giuseppe Ettore, Andrea Puppo, Martina Borghese, Canio Martinelli, Ludovico Muzii, Violante Di Donato, Lorenza Driul, Stefano Restaino, Alice Bergamini, Giorgio Candotti, Luca Bocciolone, Francesco Plotti, Roberto Angioli, Giulia Mantovani, Marcello Ceccaroni, Chiara Cassani, Mattia Dominoni, Laura Giambanco, Silvia Amodeo, Livio Leo, Raphael Thomasset, Diego Raimondo, Renato Seracchioli, Mario Malzoni, Franco Gorlero, Martina Di Luca, Enrico Busato, Sami Kilzie, Andrea Dell'Acqua, Giovanna Scarfone, Paolo Vercellini, Marco Petrillo, Salvatore Dessole, Giampiero Capobianco, Andrea Ciavattini, Giovanni Delli Carpini, Luca Giannella, Liliana Mereu, Saverio Tateo, Flavia Sorbi, Massimiliano Fambrini, Stefania Cicogna, Federico Romano, Giuseppe Ricci, Giuseppe Trojano, Roberto Consonni, Simona Cantaluppi, Antonio Lippolis, Raffaele Tinelli, Giovanni D'Ippolito, Lorenzo Aguzzoli, Vincenzo D Mandato, Stefano Palomba, Davide Calandra, Maurizio Rosati, Cinzia Gallo, Daniela Surico, Valentino Remorgida, Francesco Ruscitto, Paolo Beretta, Pierluigi Benedetti Panici, Francesco Raspagliesi, Bogani G., Scambia G., Cimmino C., Fanfani F., Costantini B., Loverro M., Ferrandina G., Landoni F., Bazzurini L., Grassi T., Vitobello D., Siesto G., Perrone A.M., Zanagnolo V., De Iaco P., Multinu F., Ghezzi F., Casarin J., Berretta R., Capozzi V.A., Zupi E., Centini G., Pellegrino A., Corso S., Stevenazzi G., Montoli S., Boschi A.C., Comerci G., Greco P., Martinello R., Sopracordevole F., Giorda G., Simoncini T., Caretto M., Sartori E., Ferrari F., Cianci A., Sarpietro G., Matarazzo M.G., Zullo F., Bifulco G., Morelli M., Ferrero A., Biglia N., Barra F., Ferrero S., Maggiore U.L.R., Cianci S., Chiantera V., Ercoli A., Sozzi G., Martoccia A., Schettini S., Orlando T., Cannone F.G., Ettore G., Puppo A., Borghese M., Martinelli C., Muzii L., Di Donato V., Driul L., Restaino S., Bergamini A., Candotti G., Bocciolone L., Plotti F., Angioli R., Mantovani G., Ceccaroni M., Cassani C., Dominoni M., Giambanco L., Amodeo S., Leo L., Thomasset R., Raimondo D., Seracchioli R., Malzoni M., Gorlero F., Di Luca M., Busato E., Kilzie S., Dell'acqua A., Scarfone G., Vercellini P., Petrillo M., Dessole S., Capobianco G., Ciavattini A., Delli Carpini G., Giannella L., Mereu L., Tateo S., Sorbi F., Fambrini M., Cicogna S., Romano F., Ricci G., Trojano G., Consonni R., Cantaluppi S., Lippolis A., Tinelli R., D'ippolito G., Aguzzoli L., Mandato V.D., Palomba S., Calandra D., Rosati M., Gallo C., Surico D., Remorgida V., Ruscitto F., Beretta P., Panici P.B., Raspagliesi F., Bogani, Giorgio, Scambia, Giovanni, Cimmino, Chiara, Fanfani, Francesco, Costantini, Barbara, Loverro, Matteo, Ferrandina, Gabriella, Landoni, Fabio, Bazzurini, Luca, Grassi, Tommaso, Vitobello, Domenico, Siesto, Gabriele, Perrone, Anna Myriam, Zanagnolo, Vanna, De Iaco, Pierandrea, Multinu, Francesco, Ghezzi, Fabio, Casarin, Jvan, Berretta, Roberto, Capozzi, Vito A, Zupi, Errico, Centini, Gabriele, Pellegrino, Antonio, Corso, Silvia, Stevenazzi, Guido, Montoli, Serena, Boschi, Anna Chiara, Comerci, Giuseppe, Greco, Pantaleo, Martinello, Ruby, Sopracordevole, Francesco, Giorda, Giorgio, Simoncini, Tommaso, Caretto, Marta, Sartori, Enrico, Ferrari, Federico, Cianci, Antonio, Sarpietro, Giuseppe, Matarazzo, Maria Grazia, Zullo, Fulvio, Bifulco, Giuseppe, Morelli, Michele, Ferrero, Annamaria, Biglia, Nicoletta, Barra, Fabio, Ferrero, Simone, Leone Roberti Maggiore, Umberto, Cianci, Stefano, Chiantera, Vito, Ercoli, Alfredo, Sozzi, Giulio, Martoccia, Angela, Schettini, Sergio, Orlando, Teresa, Cannone, Francesco G, Ettore, Giuseppe, Puppo, Andrea, Borghese, Martina, Martinelli, Canio, Muzii, Ludovico, Di Donato, Violante, Driul, Lorenza, Restaino, Stefano, Bergamini, Alice, Candotti, Giorgio, Bocciolone, Luca, Plotti, Francesco, Angioli, Roberto, Mantovani, Giulia, Ceccaroni, Marcello, Cassani, Chiara, Dominoni, Mattia, Giambanco, Laura, Amodeo, Silvia, Leo, Livio, Thomasset, Raphael, Raimondo, Diego, Seracchioli, Renato, Malzoni, Mario, Gorlero, Franco, Di Luca, Martina, Busato, Enrico, Kilzie, Sami, Dell'Acqua, Andrea, Scarfone, Giovanna, Vercellini, Paolo, Petrillo, Marco, Dessole, Salvatore, Capobianco, Giampiero, Ciavattini, Andrea, Delli Carpini, Giovanni, Giannella, Luca, Mereu, Liliana, Tateo, Saverio, Sorbi, Flavia, Fambrini, Massimiliano, Cicogna, Stefania, Romano, Federico, Ricci, Giuseppe, Trojano, Giuseppe, Consonni, Roberto, Cantaluppi, Simona, Lippolis, Antonio, Tinelli, Raffaele, D'Ippolito, Giovanni, Aguzzoli, Lorenzo, Mandato, Vincenzo D, Palomba, Stefano, Calandra, Davide, Rosati, Maurizio, Gallo, Cinzia, Surico, Daniela, Remorgida, Valentino, Ruscitto, Francesco, Beretta, Paolo, Benedetti Panici, Pierluigi, Raspagliesi, Francesco, Bogani, G., Scambia, G., Cimmino, C., Fanfani, F., Costantini, B., Loverro, M., Ferrandina, G., Landoni, F., Bazzurini, L., Grassi, T., Vitobello, D., Siesto, G., Perrone, A. M., Zanagnolo, V., De Iaco, P., Multinu, F., Ghezzi, F., Casarin, J., Berretta, R., Capozzi, V. A., Zupi, E., Centini, G., Pellegrino, A., Corso, S., Stevenazzi, G., Montoli, S., Boschi, A. C., Comerci, G., Greco, P., Martinello, R., Sopracordevole, F., Giorda, G., Simoncini, T., Caretto, M., Sartori, E., Ferrari, F., Cianci, A., Sarpietro, G., Matarazzo, M. G., Zullo, F., Bifulco, G., Morelli, M., Ferrero, A., Biglia, N., Barra, F., Ferrero, S., Leone Roberti Maggiore, U., Cianci, S., Chiantera, V., Ercoli, A., Sozzi, G., Martoccia, A., Schettini, S., Orlando, T., Cannone, F. G., Ettore, G., Puppo, A., Borghese, M., Martinelli, C., Muzii, L., Di Donato, V., Driul, L., Restaino, S., Bergamini, A., Candotti, G., Bocciolone, L., Plotti, F., Angioli, R., Mantovani, G., Ceccaroni, M., Cassani, C., Dominoni, M., Giambanco, L., Amodeo, S., Leo, L., Thomasset, R., Raimondo, D., Seracchioli, R., Malzoni, M., Gorlero, F., Di Luca, M., Busato, E., Kilzie, S., Dell'Acqua, A., Scarfone, G., Vercellini, P., Petrillo, M., Dessole, S., Capobianco, G., Ciavattini, A., Delli Carpini, G., Giannella, L., Mereu, L., Tateo, S., Sorbi, F., Fambrini, M., Cicogna, S., Romano, F., Ricci, G., Trojano, G., Consonni, R., Cantaluppi, S., Lippolis, A., Tinelli, R., D'Ippolito, G., Aguzzoli, L., Mandato, V. D., Palomba, S., Calandra, D., Rosati, M., Gallo, C., Surico, D., Remorgida, V., Ruscitto, F., Beretta, P., Benedetti Panici, P., Raspagliesi, F., Bogani, G, Scambia, G, Cimmino, C, Fanfani, F, Costantini, B, Loverro, M, Ferrandina, G, Landoni, F, Bazzurini, L, Grassi, T, Vitobello, D, Siesto, G, Perrone, A, Zanagnolo, V, De Iaco, P, Multinu, F, Ghezzi, F, Casarin, J, Berretta, R, Capozzi, V, Zupi, E, Centini, G, Pellegrino, A, Corso, S, Stevenazzi, G, Montoli, S, Boschi, A, Comerci, G, Greco, P, Martinello, R, Sopracordevole, F, Giorda, G, Simoncini, T, Caretto, M, Sartori, E, Ferrari, F, Cianci, A, Sarpietro, G, Matarazzo, M, Zullo, F, Bifulco, G, Morelli, M, Ferrero, A, Biglia, N, Barra, F, Ferrero, S, Leone Roberti Maggiore, U, Cianci, S, Chiantera, V, Ercoli, A, Sozzi, G, Martoccia, A, Schettini, S, Orlando, T, Cannone, F, Ettore, G, Puppo, A, Borghese, M, Martinelli, C, Muzii, L, Di Donato, V, Driul, L, Restaino, S, Bergamini, A, Candotti, G, Bocciolone, L, Plotti, F, Angioli, R, Mantovani, G, Ceccaroni, M, Cassani, C, Dominoni, M, Giambanco, L, Amodeo, S, Leo, L, Thomasset, R, Raimondo, D, Seracchioli, R, Malzoni, M, Gorlero, F, Di Luca, M, Busato, E, Kilzie, S, Dell'Acqua, A, Scarfone, G, Vercellini, P, Petrillo, M, Dessole, S, Capobianco, G, Ciavattini, A, Delli Carpini, G, Giannella, L, Mereu, L, Tateo, S, Sorbi, F, Fambrini, M, Cicogna, S, Romano, F, Ricci, G, Trojano, G, Consonni, R, Cantaluppi, S, Lippolis, A, Tinelli, R, D'Ippolito, G, Aguzzoli, L, Mandato, V, Palomba, S, Calandra, D, Rosati, M, Gallo, C, Surico, D, Remorgida, V, Ruscitto, F, Beretta, P, Benedetti Panici, P, Raspagliesi, F, Maggiore, U. L. R., and Panici, P. B.

Subjects
medicine.medical_specialty, endometrial neoplasms, Coronavirus disease 2019 (COVID-19), Endometrial Cancer, COVID-19, Uterine cancer, SARS-CoV-2, covid-19, endometrial cancer, sars-cov-2, uterine cancer, female, humans, pandemics, retrospective studies, NO, Retrospective Studie, Pandemic, medicine, Patterns of care, Obstetrics, business.industry, Endometrial cancer, Obstetrics and Gynecology, General Medicine, medicine.disease, Endometrial Neoplasms, Settore MED/40 - GINECOLOGIA E OSTETRICIA, Oncology, Original Article, Female, business, Human
Abstract

Objective Coronavirus disease 2019 (COVID-19) outbreak has correlated with the disruption of screening activities and diagnostic assessments. Endometrial cancer (EC) is one of the most common gynecological malignancies and it is often detected at an early stage, because it frequently produces symptoms. Here, we aim to investigate the impact of COVID-19 outbreak on patterns of presentation and treatment of EC patients. Methods This is a retrospective study involving 54 centers in Italy. We evaluated patterns of presentation and treatment of EC patients before (period 1: March 1, 2019 to February 29, 2020) and during (period 2: April 1, 2020 to March 31, 2021) the COVID-19 outbreak. Results Medical records of 5,164 EC patients have been retrieved: 2,718 and 2,446 women treated in period 1 and period 2, respectively. Surgery was the mainstay of treatment in both periods (p=0.356). Nodal assessment was omitted in 689 (27.3%) and 484 (21.2%) patients treated in period 1 and 2, respectively (p, Synopsis The prevalence of patients with early-stage endometrial cancer (EC) has been lower during coronavirus disease 2019 (COVID-19) pandemic than before its onset. Further evidence is needed to assess the impact of COVID-19 pandemic on survival outcomes of EC patients.

Published
2022

14. Clues and pitfalls in the diagnostic approach to cardiac masses: are pseudo-tumours truly benign?

Author

Ornella Leone, Carmine Pizzi, Davide Pacini, Pasquale Paolisso, Paola Rucci, Alberto Foà, Luca Di Marco, Luca Bergamaschi, Nazzareno Galiè, Foa A., Paolisso P., Bergamaschi L., Rucci P., Di Marco L., Pacini D., Leone O., Galie N., Pizzi C., Foà, Alberto, Paolisso, Pasquale, Bergamaschi, Luca, Rucci, Paola, Di Marco, Luca, Pacini, Davide, Leone, Ornella, Galié, Nazzareno, and Pizzi, Carmine

Subjects
Cardia tumours, pseudotumours, malignat, prognosis, medicine.medical_specialty, Text mining, Epidemiology, business.industry, Neoplasms, cardiovascular system, Humans, Medicine, Radiology, Cardiac masses, Cardiology and Cardiovascular Medicine, business
Abstract

Cardiac masses encompass a wide spectrum of clinico-pathological entities, including benign and malignant—both primary and secondary—tumours.1,2 A fourth, extremely heterogenous subgroup, is represented by pseudo-tumours,3,4 which are non-neoplastic lesions—such as thrombi, calcifications, cysts, or valvular nodules—not included in the current World Health Organization classification of cardiac tumours.2 It appears, therefore, essential to correctly address the masses’ nature in order to identify the ideal therapeutic management.5

Published
2021
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15. Tumor subtypes and survival in male breast cancer

Author

Bernardo Amadeo Leone, Nan Lin, Sara M. Tolaney, Carlos Teodoro Vallejo, Eric P. Winer, Julieta Leone, Jose Pablo Leone, and Rachel A. Freedman

Subjects
0301 basic medicine, Oncology, Cancer Research, Univariate analysis, medicine.medical_specialty, education.field_of_study, Multivariate analysis, Proportional hazards model, business.industry, Hazard ratio, Population, medicine.disease, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Breast cancer, 030220 oncology & carcinogenesis, Male breast cancer, Internal medicine, medicine, Stage (cooking), skin and connective tissue diseases, business, education
Abstract

Male breast cancer is an uncommon disease, and population-based information regarding prognostic factors is limited. Most cases are hormone receptor (HR) positive; however, the association of tumor subtype with overall survival (OS) and breast cancer-specific survival (BCSS) is unclear. Using SEER data, we identified men with invasive breast cancer between 2010 and 2017 with known HR and HER2 status. We examined tumor subtypes by patient characteristics and performed multivariate Cox proportional hazards analyses to determine the associations of each variable with OS and BCSS. We included 2389 men with a median follow-up of 43 months (IQR 19–68). Median age was 66 years. Tumor subtype distribution was 84.1% HR+/HER2−, 12.7% HR+/HER2+ , 0.8% HR−/HER2+, and 2.3% triple-negative (TN). In univariate analysis, OS at 5 years was 76.5% for HR+/HER2−, 65.1% for HR+/HER2+ , 84.2% for HR-/HER2+, and 48.1% for TN (p

Published
2021
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16. 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
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17. Twenty-year risks of breast cancer-specific mortality for stage III breast cancer in the surveillance, epidemiology, and end results registry

Author

Carlos Teodoro Vallejo, Sara M. Tolaney, Nan Lin, Bernardo Amadeo Leone, Eric P. Winer, Julieta Leone, Nabihah Tayob, Jose Pablo Leone, Michael J. Hassett, and Rachel A. Freedman

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, business.industry, Disease, medicine.disease, Primary tumor, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Breast cancer, 030220 oncology & carcinogenesis, Internal medicine, Epidemiology, Surveillance, Epidemiology, and End Results, medicine, Stage IIIC, Stage (cooking), business, Cause of death
Abstract

We aimed to report the 20-year risk of breast cancer-specific mortality (BCSM), report the risk of BCSM conditional on having survived 5 years, and identify factors associated with late deaths in stage III breast cancer. Using Surveillance, Epidemiology, and End Results data, we included women with stage III breast cancer diagnosed from 1990 to 2005. We excluded women with unknown hormone receptor (HR) status, women who did not undergo resection of the primary tumor or axillary nodes, or unknown cause of death. We estimated risks of BCSM using cumulative incidence function and used Fine and Gray regression to identify factors associated with late deaths. Final sample was 36,500 patients with 14 years of median follow-up. For each stage subgroup, the risk of BCSM at 20 years was significantly higher for HR-negative vs HR-positive tumors (IIIA: 49.8% vs 43.2%, P

Published
2021
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18. Abstract PS6-13: Population-based tool to estimate residual risks of breast cancer specific mortality (BCSM) and non-BCSM

Author

Nan Lin, Sara M. Tolaney, Bernardo Amadeo Leone, Carlos Teodoro Vallejo, Julieta Leone, Rachel A. Freedman, Jose Pablo Leone, Michael J. Hassett, Eric P. Winer, and Nabihah Tayob

Subjects
Residual risk, Oncology, Cancer Research, medicine.medical_specialty, business.industry, Internal medicine, medicine, Population based, Breast cancer specific, business
Abstract

Background: The risk of breast cancer death persists for at least 20 years from diagnosis. Most reports describing this risk have been based on selected patients (pts) enrolled into clinical trials. These studies report absolute risks at fixed timepoints (i.e. 10 or 20 years) and do not consider the dynamic changes in risks over time. The aim of this study was to develop a tool to calculate residual risks of BCSM and non-BCSM based on individual pt and tumor characteristics, at any given time after breast cancer diagnosis. Methods: Using data from the Surveillance, Epidemiology, and End Results (SEER) program, we identified women diagnosed with non-metastatic invasive breast cancer between 1990-2005, with one primary cancer in their lifetime, and known hormone receptor (HR) status. We estimated the effect of baseline clinical and pathologic variables known to be prognostic, including pt age, HR status, tumor size (T), nodal status (N), and tumor grade, on residual cumulative risks of BCSM and non-BCSM over time. The tool generates the residual death risk (RDR), which is a nonparametric estimate of the cumulative risk of BCSM and non-BCSM by year 20 after any given time from initial diagnosis, among patients defined by baseline clinical and pathologic variables using the method of Gray (1988) implemented in the cmprsk package in R. Results: We included 235,015 pts (median follow-up = 14 years). Among all breast cancer deaths, the proportion occurring after 5 years was 60% for HR+ vs 24% for HR- (p BCSMnon-BCSMAll-cause mortality% Event-FreeCumulative risk (%)Cumulative risk (%)Cumulative risk (%)at 5 yat 10 yy 5-20y 0-20y 0-20y 0-20Nodal status by HR status (any T)HR+N097.293.98.610.633.243.8N192.183.920.025.225.550.8N281.566.236.145.621.266.8N367.749.150.163.116.179.2HR-N089.285.47.317.022.739.7N174.268.312.234.317.051.3N257.049.320.053.514.568.0N340.733.526.268.79.378.0Tumor size among N0 onlyHR+T1a99.097.64.25.030.435.4T1b98.997.25.15.934.440.2T1c97.694.38.710.532.943.3HR-T1a97.394.74.97.323.030.3T1b95.191.96.210.527.137.7T1c91.787.97.514.823.037.8 Citation Format: Jose P Leone, Sara M Tolaney, Bernardo A Leone, Rachel A Freedman, Michael J Hassett, Julieta Leone, Carlos T Vallejo, Eric P Winer, Nancy U Lin, Nabihah Tayob. Population-based tool to estimate residual risks of breast cancer specific mortality (BCSM) and non-BCSM [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-13.

Published
2021
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19. The clinical spectrum of pulmonary thromboembolism in patients with coronavirus disease-2019 (COVID-19) pneumonia: A European case series

Author

Andreas Kortgen, Samuel Buschbeck, Marc Leone, V. Marco Ranieri, Yasser Sakr, Giacinto Pizzilli, Tommaso Tonetti, Laurent Zieleskiewicz, Manuela Giovini, Gary Duclos, Elio Antonucci, Michael Bauer, Sakr Y., Giovini M., Leone M., Pizzilli G., Kortgen A., Bauer M., Tonetti T., Duclos G., Zieleskiewicz L., Buschbeck S., Ranieri V.M., Antonucci E., Jena University Hospital [Jena], Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), University of Bologna/Università di Bologna, Technische Universität Dresden = Dresden University of Technology (TU Dresden), Service Anesthésie et Réanimation [Hôpital Nord - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), and Assistance Publique - Hôpitaux de Marseille (APHM)

Subjects
medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Critical Care and Intensive Care Medicine, medicine.disease_cause, Article, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Internal medicine, Medicine, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, In patient, Thromboprophylaxis, ComputingMilieux_MISCELLANEOUS, Coronavirus, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, SARS-CoV-2, business.industry, Pulmonary embolism, COVID-19, 030208 emergency & critical care medicine, medicine.disease, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Pneumonia, 030228 respiratory system, Concomitant, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Thromboprophylaxi, Complication, business, Venous thromboembolism
Abstract

Purpose To describe the clinical characteristics and outcomes of coronavirus disease-2019 (COVID-19)-associated pulmonary thromboembolism (PTE). Materials and methods A case series of five patients, representing the clinical spectrum of COVID-19 associated PTE. Patients were admitted to four hospitals in Germany, Italy, and France. Infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) was confirmed using a real-time reverse transcription polymerase chain reaction test. Results The onset of PTE varied from 2 to 4 weeks after the occurrence of the initial symptoms of SARS-CoV-2 infection and led to deterioration of the clinical picture in all cases. PTE was the primary reason for hospital admission after a 2-week period of self-isolation at home (1 patient) and hospital readmission after initial uncomplicated hospital discharge (2 patients). Three of the patients had no past history of clinically relevant risk factors for venous thromboembolism (VTE). Severe disease progression was associated with concomitant increases in IL-6, ferritin, and D-Dimer levels. The outcome from PTE was related to the extent of vascular involvement, and associated complications. Conclusion PTE is a potential life-threatening complication, which occurs frequently in patients with COVID-19. Intermediate therapeutic dose of anticoagulants and extend thromboprophylaxis are necessary after meticulous risk-benefit assessment., Highlights • Pulnonary thromboembolism (PTE) is a frequent life-threatening complication in patients with coronavirsus disease-2019 (COVID-19). • The onset of PTE varies from 2 to 4 weeks after the occurrence of the initial symptoms and may occur during home self-isolation or after hospital discharge of primarily uncomplicated hospital admission. • PTE may occur in patients without clinically relevant past history of risk factors for venous thromboembolism and in those receiving standard prophylactic anticoagulation. • Intermediate therapeutic dose of anticoagulants and extend thromboprophylaxis are necessary in these patients after meticulous risk-benefit assessment.

Published
2021
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20. Long-Term Safety and Efficacy Data of Golodirsen in Ambulatory Patients with Duchenne Muscular Dystrophy Amenable to Exon 53 Skipping: A First-in-human, Multicenter, Two-Part, Open-Label, Phase 1/2 Trial

Author

Ashish Dugar, Eugenio Mercuri, Xiaodong Wang, Volker Straub, Baoguang Han, Daniela Leone, Navid Khan, Dan Wang, Erica Koenig, Laurent Servais, Andreea Mihaela Seferian, Michela Guglieri, Mariacristina Scoto, Francesco Muntoni, University of Oxford, Institut de Myologie, Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Liège (CHU-Liège), Université de Liège, Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Newcastle University [Newcastle], Newcastle Upon Tyne Hospitals NHS Foundation Trust, University College of London [London] (UCL), Great Ormond Street Hospital for Children [London] (GOSH), Sarepta Therapeutics, University of Oxford [Oxford], I-Motion Institut [CHU Trousseau], Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Association française contre les myopathies (AFM-Téléthon)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Università cattolica del Sacro Cuore [Roma] (Unicatt), Fondazione 'Policlinico Universitario A. Gemelli' [Rome], and Gestionnaire, Hal Sorbonne Université

Subjects
Duchenne muscular dystrophy, medicine.medical_specialty, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, Population, Oligonucleotides, Walk Test, golodirsen, Biochemistry, Dystrophin, 03 medical and health sciences, FEV1/FVC ratio, 0302 clinical medicine, Internal medicine, Multicenter trial, Drug Discovery, Genetics, medicine, Clinical endpoint, Humans, education, Molecular Biology, 030304 developmental biology, 0303 health sciences, education.field_of_study, business.industry, [SDV.NEU.NB] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, Exons, medicine.disease, Original Papers, Exon skipping, 3. Good health, Clinical trial, Muscular Dystrophy, Duchenne, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Ambulatory, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, Molecular Medicine, business, 030217 neurology & neurosurgery, exon skipping
Abstract

The aim of this Phase 1/2, 2-part, multicenter trial was to report clinical safety and efficacy of long-term golodirsen treatment among ambulatory patients with exon 53 skip-amenable Duchenne muscular dystrophy (DMD). Part 1 was a 12-week, randomized, double-blind, placebo-controlled, dose-titration study followed by 9-week safety review. Part 2 was a 168-week, open-label evaluation of golodirsen 30 mg/kg. Part 1 primary endpoint was safety. Part 2 primary endpoints were dystrophin protein expression and 6-minute walk test (6MWT); secondary endpoints were percent predicted forced vital capacity (FVC%p) and safety. Post hoc ambulation analyses used mutation-matched external natural history controls. All patients from Part 1 (golodirsen, n = 8; placebo, n = 4) plus 13 additional patients entered Part 2; 23 completed the study. Adverse events were generally mild, nonserious, and unrelated to golodirsen, with no safety-related discontinuations or deaths. Golodirsen increased dystrophin protein (16.0-fold; P

Published
2022
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21. Association of severe childhood infections with depression and intentional self-harm in adolescents and young adults

Author

Henrik Larsson, Brian M. D’Onofrio, Paul Lichtenstein, Sarah E. Bergen, Amy Leval, Marica Leone, and Ralf Kuja-Halkola

Subjects
Adult, Pediatrics, medicine.medical_specialty, Adolescent, Immunology, Population, Cohort Studies, Young Adult, 03 medical and health sciences, Behavioral Neuroscience, 0302 clinical medicine, Risk Factors, Humans, Medicine, Family, 030212 general & internal medicine, Young adult, Child, education, Depression (differential diagnoses), Proportional Hazards Models, education.field_of_study, Depression, Endocrine and Autonomic Systems, business.industry, Hazard ratio, Absolute risk reduction, 3. Good health, Relative risk, Etiology, business, Self-Injurious Behavior, 030217 neurology & neurosurgery, Cohort study
Abstract

Early-life infections have been linked with subsequent depression and self-harm. Examination of specific groups of infections and the role of familial factors may elucidate this observed relationship. We addressed these considerations in our investigations of the association of severe childhood infections with the risks of depression and self-harm in adolescence and early-adulthood. This population-based cohort study included all individuals born in Sweden between 1982 and 1996, with follow-up through 2013 (N = 1,506,070). Severe childhood infections were identified using inpatient and outpatient diagnoses from birth through age 12. Any infection as well as specific groups of infections were investigated. We examined diagnoses of depression and self-harm within inpatient and outpatient care and death by self-harm between ages 13 and 31. Cox proportional hazards regression models were used to estimate absolute risks, hazard ratios (HRs), and 95% CIs. When adjusting for sex and birth year, individuals exposed to any childhood infection demonstrated increased absolute risk differences for both outcomes (2.42% [95% CI, 0.41–4.43%] of being diagnosed with depression up until age 31, and 0.73% [−2.05% to 3.51%] of self-harm up until age 31) and increased relative risks (HR, 1.22 [1.20–1.24] for depression and HR, 1.29 [1.25–1.32] for self-harm). When controlling for unmeasured factors shared between family members by comparing discordant siblings, no strong association persisted. Our findings show that childhood infections may not be involved in the etiology of later depression and self-harm, and highlight the importance of identifying these genetic and environmental familial risk factors, which may serve as targets for interventions.

Published
2022
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22. TCRαβ/CD19 depleted HSCT from an HLA-haploidentical relative to treat children with different nonmalignant disorders

Author

Daria Pagliara, Donato Amodio, Francesca Del Bufalo, Giuseppina Li Pira, Luisa Strocchio, Michela Falco, Giovanna Leone, Daniela Pende, Alice Bertaina, Marco Andreani, Rita Maria Pinto, Valentina Bertaina, Emilia Boccieri, Mattia Algeri, Pietro Merli, Franco Locatelli, Angela Mastronuzzi, Matteo Di Nardo, and Federica Galaverna

Subjects
medicine.medical_specialty, Transplantation Conditioning, Adolescent, Clinical Trials and Observations, medicine.medical_treatment, Thalassemia, Receptors, Antigen, T-Cell, alpha-beta, Graft vs Host Disease, chemical and pharmacologic phenomena, Hematopoietic stem cell transplantation, immune system diseases, Internal medicine, HLA-haploidentical transplant, Medicine, Humans, Cumulative incidence, Prospective Studies, Aplastic anemia, Prospective cohort study, Child, business.industry, Incidence (epidemiology), Hematopoietic Stem Cell Transplantation, Infant, Hematology, medicine.disease, Transplantation, surgical procedures, operative, Treatment Outcome, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Child, Preschool, business, Complication
Abstract

Key Points TCRαβ/CD19-depleted HLA-haploidentical HSCT is an effective strategy for children with several nonmalignant disorders.Patients given this type of transplant benefit from a low incidence of GVHD and TRM, with graft failure being the main obstacle., Visual Abstract, Several nonmalignant disorders (NMDs), either inherited or acquired, can be cured by allogeneic hematopoietic stem cell transplantation (HSCT). Between January 2012 and April 2020, 70 consecutive children affected by primary immunodeficiencies, inherited/acquired bone marrow failure syndromes, red blood cell disorders, or metabolic diseases, lacking a fully matched donor or requiring urgent transplantation underwent TCRαβ/CD19-depleted haploidentical HSCT from an HLA-partially matched relative as part of a prospective study. The median age at transplant was 3.5 years (range 0.3-16.1); the median time from diagnosis to transplant was 10.5 months (2.7 for SCID patients). Primary engraftment was obtained in 51 patients, while 19 and 2 patients experienced either primary or secondary graft failure (GF), the overall incidence of this complication being 30.4%. Most GFs were observed in children with disease at risk for this complication (eg, aplastic anemia, thalassemia). All but 5 patients experiencing GF were successfully retransplanted. Six patients died of infectious complications (4 had active/recent infections at the time of HSCT), the cumulative incidence of transplant-related mortality (TRM) being 8.5%. Cumulative incidence of grade 1-2 acute GVHD was 14.4% (no patient developed grade 3-4 acute GVHD). Only one patient at risk developed mild chronic GVHD. With a median follow-up of 3.5 years, the 5-year probability of overall and disease-free survival was 91.4% and 86.8%, respectively. In conclusion, TCRαβ/CD19-depleted haploidentical HSCT from an HLA-partially matched relative is confirmed to be an effective treatment of children with NMDs. Prompt donor availability, low incidence of GVHD, and TRM make this strategy an attractive option in NMDs patients. The study is registered at ClinicalTrial.gov as NCT01810120.

Published
2022

23. Supraclavicular artery fascial flap (SAFF): a valuable tool in salvage total laryngectomy and hemipharyngolaryngectomy

Author

Mario Bussi, Andrea Martone, Leone Giordano, Livio Presutti, Michael Ghirelli, Francesco Mattioli, Matteo Fermi, Davide Di Santo, Mattioli F., Fermi M., Martone A., Ghirelli M., Giordano L., Di Santo D., Bussi M., and Presutti L.

Subjects
Male, medicine.medical_specialty, Arterie, Supraclavicular artery, medicine.medical_treatment, laringectomia di salvataggio, arteria sovraclaveare, Salvage laryngectomy, pharyngocutaneous fistula, Laryngectomy, Pharyngocutaneous Fistula, lembi peduncolati, Pedicled flap, pedicled flap, Chart review, fistola faringocutanea, Humans, Medicine, chemoradiation, Pharyngocutaneoufistula, business.industry, Chemoradiation, Middle Aged, Arteries, chemioradioterapia, Neck dissection, Pedicled Flap, salvage laryngectomy, Surgery, Radiation therapy, General Energy, medicine.anatomical_structure, Otorhinolaryngology, Fascial flap, supraclavicular artery, business, Human, Head and Neck, Artery
Abstract

To describe the surgical technique of the supraclavicular artery fascial flap (SAFF) and outcomes in neopharyngeal covering with overlay technique during salvage total laryngectomy for residual or recurrent carcinoma after chemo/radiation treatment.Chart review of patients treated between October 2018 and February 2019 at two tertiary care hospitals. Variables extracted from patient records were age, gender, history of chemo/radiation therapy, neck dissection, surgical and postoperative complications. Outcomes measured were surgical time, postoperative complications and flap failure, oral intake start and patient discharge.Ten male patients were included. Median age was 64 years. All patients underwent salvage total laryngectomy and neopharyngeal covering with SAFF. Mean flap harvest time was 25 minutes. No surgical complications or flap failure were recorded. Oral intake was started on a median of post-operative day 10. No cases of pharyngocutaneous fistula were encountered.SAFF is a reliable, easy and quick to harvest flap, which provides a good alternative to other pedicled and free flaps for hypopharyngeal coverage in laryngeal salvage surgery. Donor site morbidity is almost null and postoperative complications are very rare.Lembo peduncolato di fascia sovraclaveare: utile strumento nella laringectomia ed emifaringolaringectomia totale di salvataggio.Descrivere la tecnica chirurgica del lembo SAFF e le sue applicazioni e risultati nella ricostruzione faringea durante laringectomia di salvataggio per SCC persistenti dopo trattamento chemio/radioterapico.Analisi retrospettiva di pazienti trattati fra 10/2018 e 02/2019 in due centri ospedalieri di terzo livello. Le variabili analizzate sono età, sesso, precedente chemio/radioterapia, svuotamento laterocervicale, complicanze intra e post-operatorie. I risultati valutati sono tempo chirurgico, complicanze post-operatorie, fallimento del lembo, tempo d’inizio dell’alimentazione per os e durata della degenza.Sono stati inclusi 10 pazienti maschi. L’età mediana era 64 anni. Il tempo mediano di allestimento del lembo è stato di 25 minuti. Non sono state registrate complicanze intra o post-operatorie. L’inizio mediano dell’alimentazione per os è stato in decima giornata post-operatoria. Non sono stati osservati casi di fistolizzazione faringo-cutanea.Il SAFF è un lembo affidabile, facile e rapido da allestire, che offre una valida alternativa ad altri lembi peduncolati e liberi per la copertura ipofaringea nella chirurgia laringea di salvataggio. La morbilità del sito donatore è praticamente nulla e le complicanze post-operatorie sono molto rare.

Published
2021
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25. Higher motor cortical excitability linked to greater cognitive dysfunction in Alzheimer's disease: results from two independent cohorts

Author

Daniel Z. Press, Peter J. Fried, Stephanie S. Buss, Siddhesh Zadey, Katherine McDonald, and Alvaro Pascual-Leone

Subjects
Male, 0301 basic medicine, Oncology, Aging, medicine.medical_specialty, medicine.medical_treatment, Disease, Neuropsychological Tests, Article, 03 medical and health sciences, Cognition, 0302 clinical medicine, Alzheimer Disease, Internal medicine, medicine, Humans, Dementia, Cognitive Dysfunction, Aged, Retrospective Studies, Motor threshold, business.industry, General Neuroscience, Motor Cortex, Middle Aged, medicine.disease, Transcranial Magnetic Stimulation, Pathophysiology, Transcranial magnetic stimulation, Cross-Sectional Studies, 030104 developmental biology, Cortical Excitability, Cohort, Female, Neurology (clinical), Disease assessment, Geriatrics and Gerontology, business, 030217 neurology & neurosurgery, Developmental Biology
Abstract

Prior studies have reported increased cortical excitability in people with Alzheimer’s disease (AD), but findings have been inconsistent, and how excitability relates to dementia severity remains incompletely understood. The objective of this study was to investigate the association between a transcranial magnetic stimulation (TMS) measure of motor cortical excitability and measures of cognition in AD. A retrospective cross-sectional analysis tested the relationship between resting motor threshold (RMT) and the Alzheimer’s Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) across two independent samples of AD participants (a discovery cohort, n=22 and a larger validation cohort, n=129) and a control cohort of cognitively normal adults (n=26). RMT was correlated with ADAS-Cog in the discovery-AD cohort (n=22, β=−.70, p

Published
2021
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26. Cardiorespiratory responses to isolated dance steps in young girls

Author

Gabriela Cristina dos Santos, Gianluca Leone Caetano, Juliana Lopes Teodoro, Ronei Silveira Pinto, Josianne Rodrigues-Krause, Alvaro Reischak-Oliveira, Jéssica do Nascimento Queiroz, and Rodrigo Leal-Menezes

Subjects
medicine.medical_specialty, Dance, business.industry, Physical therapy, medicine, Physical Therapy, Sports Therapy and Rehabilitation, Orthopedics and Sports Medicine, Cardiorespiratory fitness, business
Published
2021
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27. The Triple-Layer Patch Technique for Postinfarction Ventricular Septal Rupture

Author

Mariafrancesca Fiorentino, Davide Pacini, Luca Botta, Antonino Loforte, Alessandro Leone, and Antonino Costantino

Subjects
Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Comorbidity, Ventricular Septal Rupture, Risk Factors, Internal medicine, Humans, Medicine, Myocardial infarction, Cardiac Surgical Procedures, Pandemics, Postinfarction Ventricular Septal Rupture, Aged, business.industry, Cardiogenic shock, cardiogenic shock, Cardiac Rupture, COVID-19, Prostheses and Implants, medicine.disease, Heart failure, Cardiology, Female, Surgery, Cardiology and Cardiovascular Medicine, business, Complication, Shunt (electrical)
Abstract

Postinfarction ventricular septal rupture (VSR) represents a well-known mechanical complication of myocardial infarction, determining cardiogenic shock with high mortality rates. Surgical correction requires significant expertise to avoid cardiac rupture, uncontrollable bleeding, residual shunts, heart failure, and death. In the last year, we observed a substantial increase of VSR at our hospital, related to the delayed presentation of people with acute chest pain to the emergency departments during the coronavirus disease 2019 pandemic. We discuss our innovative triple-layer patch technique in a recent consecutive series of 8 patients. This technique proved effective in all patients, with no residual shunt or cardiac rupture.

Published
2021
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28. A Smartphone App-Based Application Enabling Remote Assessments of Standing Balance During the COVID-19 Pandemic and Beyond

Author

On-Yee Lo, Hao Zhu, Junhong Zhou, Thomas G. Travison, Natalia Gouskova, Wanting Yu, Lewis A. Lipsitz, Xin Jiang, Brad Manor, and Alvaro Pascual-Leone

Subjects
medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Computer Networks and Communications, Computer science, Intraclass correlation, Computer Science Applications, Postural control, Acceleration, Standing balance, Physical medicine and rehabilitation, Hardware and Architecture, Signal Processing, Smartphone app, medicine, Task analysis, Reliability (statistics), Information Systems
Abstract

Assessments of postural control provide important insights into health. We created a smartphone App-based assessment of standing posture—completed with the phone placed in the user’s pocket—to enable remote monitoring of the function while minimizing the need for in-person assessment or contact. We tested the reliability of App-derived postural sway metrics, as well as their sensitivity to age and task conditions. Fifteen older and 15 younger adults completed two separate laboratory visits. They followed multimedia instructions provided by the App to complete three 30-s trials of eyes-open (EO), eyes-closed (EC), and dual-task (DT) standing. Sway data were recorded by the App and a force plate. Participants also used the App to complete the assessment in their homes on three separate days. Sway path length and root-mean square were derived from the angular velocity and acceleration acquired from phone’s internal motion sensor, and from the center-of-pressure signal from force plate. App-derived path length and root-mean-square of acceleration and angular velocity across conditions demonstrated moderate-to-excellent test–retest reliability (intraclass correlation coefficients (ICCs) = 0.69 − 0.97) for both younger and older adults. Reliability was comparable to metrics derived from the force plate (ICCs = 0.44 − 0.93). As expected, App-derived sway outcomes exhibited somewhat greater variability when tested across days at home (ICCs = 0.14 − 0.79). All App-derived metrics were sensitive to age ( $F>43.8$ , $p ) and testing condition ( $F>31.8$ , $p ) in both laboratory and home settings, revealing that the smartphone App enabled reliable and sensitive assessment of standing posture in both healthy younger and older adults.

Published
2021
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29. Intracoronary bolus of glycoprotein IIb/IIIa inhibitor as bridging or adjunctive strategy to oral P2Y12 inhibitor load in the modern setting of ST-elevation myocardial infarction

Author

Rocco A. Montone, Cristina Aurigemma, Enrico Romagnoli, Gaetano Di Stefano, Carlo Piccinni, Stefano Migliaro, Felicita Andreotti, A. Buffon, Daniele Rodolico, Mattia Galli, George Besis, Rocco Vergallo, Domenico D'Amario, Antonio Maria Leone, Francesco Burzotta, Carlo Trani, Giampaolo Niccoli, Filippo Crea, and Attilio Restivo

Subjects
medicine.medical_specialty, education.field_of_study, business.industry, medicine.medical_treatment, Population, Percutaneous coronary intervention, medicine.disease, Internal medicine, Antithrombotic, medicine, Cardiology, Myocardial infarction, Bolus (digestion), Cardiology and Cardiovascular Medicine, Glycoprotein IIb/IIIa, education, business, Stroke, TIMI
Abstract

Background In the acute management of ST-elevation myocardial infarction (STEMI), glycoprotein IIb/IIIa inhibitors (GPIs) bolus not followed by intravenous infusion is potentially advantageous given their fast onset and offset of action, but clinical evidence in a contemporary setting is limited. Methods We collected data from consecutive STEMI patients admitted to the cardiac catheterization laboratory of the Fondazione Policlinico Universitario A. Gemelli from October 2017 to September 2019. Results Out of 423 consecutive STEMI patients, 297 met the inclusion and exclusion criteria and were included in the study. Of them, 107/297 (36%) received an intracoronary GPI bolus-only during primary percutaneous coronary intervention (PPCI) not followed by intravenous infusion and 190/297 (64%) received standard antithrombotic therapy. Of the 107 GPI-treated, 22/107 (21%) had P2Y12 inhibitor pre-treatment (adjunctive strategy) and 85/107 (79%) did not (bridging strategy). During hospital staying, there was no difference in the primary safety endpoint of TIMI major+minor bleeding (p=0.283), TIMI major (p=0.267) or TIMI minor (p=0.685) bleeding between groups. No stroke event occurred in the GPI group. Despite patients receiving GPI having a significantly higher intraprocedural ischemic burden, no significant differences were found in the efficacy outcomes between groups. Consistent findings were observed for patients receiving GPIs bolus before (bridging strategy) or after (adjunctive strategy) P2Y12 inhibitors, compared to those receiving standard therapy. Multivariate logistic regression analyses did not find any independent predictors significantly associated to the primary and secondary composite endpoints. Conclusions In a contemporary real-world population of STEMI patients undergoing PPCI, the use of intracoronary GPIs bolus-only in selected patients at high ischemic risk is safe and could represent a useful antithrombotic strategy both in those pre-treated and in those naive to P2Y12 inhibitors.

Published
2023
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30. Practice patterns regarding drains management in breast surgery: Results of a survey of Senonetwork Italia breast centers

Author

M. Trunfio, C. Cabula, F. Leone, S. Mancini, Dante Palli, Nicolò Scuderi, Corrado Rubino, Corrado Tinterri, F. D'Errico, A. Bafile, Francesca Rovera, Samuele Massarut, M. G. Lazzaretti, Manuela Roncella, C. Amanti, P. Zagarese, R. Giovanazzi, G. Lolli, Laura Biganzoli, D. Francesconi, Z. Arnez, Carlo Alberto Magni, M. Passamonti, Daniele Generali, M. Monti, F. Caruso, S. Burlizzi, S. Abonante, Annalisa Curcio, A. Massocco, A. Pellegrini, A. Huscher, Marina Bortul, Roberto Murgo, G. Pagani, Giovanni Tazzioli, G. Scalco, E. Cianchetti, Lucio Fortunato, M. Mirri, Andrea Sanguinetti, P. Frittelli, L. Manca, F. Ricci, F. Svegliati, P. Mainente, C. Caponi, Antonio Rulli, Diego Ribuffo, S. Folli, Fabio Corsi, C. Andreoli, P. Bravetti, F. Pellini, M. G. Pacquola, Lorenzo Menghini, Antonio Frassoldati, Daniele Friedman, P. Stefanini, L. Ambrosiani, C. Battaglia, A. Paduos, E. Manna, C. M. Ressa, M. Barbero, T. Pallara, F. Pietribiasi, O. Custodero, A. Bianchi, M. Saturno, Mario Taffurelli, C. Cedolini, G. Papaccio, C. Pagliari, B. Ballardini, E. M. Ruggeri, P. Persichetti, Massimo Grassi, Adele Sgarella, Vittorio Altomare, G. Mondini, Pallara, T., Fortunato, L., Folli, S., Roncella, M., Scuderi, N., Friedman, D., Arnez, Z., Ribuffo, D., Manna, E., Persichetti, P., Abonante, S, Altomare, V, Amanti, C, Ambrosiani, L, Andreoli, C, Bafile, A, Ballardini, B, Barbero, M, Battaglia, C, Bianchi, A, Biganzoli, L, Bortul, M, Bravetti, P, Burlizzi, S, Cabula, C, Caponi, C, Caruso, F, Cedolini, C, Cianchetti, E, Corsi, F, Curcio, A, Custodero, O, D'Errico, F, Francesconi, D, Frassoldati, A, Frittelli, P, Generali, D, Giovanazzi, R, Grassi, Mm, Huscher, A, Lazzaretti, Mg, Leone, F, Lolli, G, Magni, C, Mainente, P, Manca, L, Mancini, S, Massarut, S, Massocco, A, Menghini, L, Mirri, M, Mondini, G, Monti, M, Murgo, R, Pacquola, Mg, Paduos, A, Pagani, G, Pagliari, C, Palli, D, Papaccio, G, Passamonti, M, Pellegrini, A, Pellini, F, Pietribiasi, F, Ressa, Cm, Ricci, F, Rovera, F, Rubino, C, Ruggeri, Em, Rulli, A, Sanguinetti, A, Saturno, M, Scalco, G, Sgarella, A, Stefanini, P, Svegliati, F, Taffurelli, M, Tazzioli, G, Tinterri, C, Trunfio, M, Zagarese, P., Pallara T., Fortunato L., Folli S., Roncella M., Scuderi N., Friedman D., Arnez Z., Ribuffo D., Manna E., Persichetti P., Abonante S., Altomare V., Amanti C., Ambrosiani L., Andreoli C., Bafile A., Ballardini B., Barbero M., Battaglia C., Bianchi A., Biganzoli L., Bortul M., Bravetti P., Burlizzi S., Cabula C., Caponi C., Caruso F., Cedolini C., Cianchetti E., Corsi F., Curcio A., Custodero O., D'Errico F., Francesconi D., Frassoldati A., Frittelli P., Generali D., Giovanazzi R., Grassi M.M., Huscher A., Lazzaretti M.G., Leone F., Lolli G., Magni C., Mainente P., Manca L., Mancini S., Massarut S., Massocco A., Menghini L., Mirri M., Mondini G., Monti M., Murgo R., Pacquola M.G., Paduos A., Pagani G., Pagliari C., Palli D., Papaccio G., Passamonti M., Pellegrini A., Pellini F., Pietribiasi F., Ressa C.M., Ricci F., Rovera F., Rubino C., Ruggeri E.M., Rulli A., Sanguinetti A., Saturno M., Scalco G., Sgarella A., Stefanini P., Svegliati F., Taffurelli M., Tazzioli G., Tinterri C., Trunfio M., and Zagarese P.

Subjects
medicine.medical_specialty, Breast surgery, medicine.medical_treatment, MEDLINE, Breast Neoplasms, NO, Breast cancer, Internal Medicine, medicine, Humans, Breast, Practice Patterns, Physicians', Mastectomy, drains management, Practice patterns, business.industry, General surgery, breast surgery, Senonetwork Italia breast centers, medicine.disease, drains management, breast surgery, Senonetwork Italia breast centers, Oncology, Drainage, NA, Female, Surgery, business
Abstract

Surgery for breast cancer has changed in the last few decades in favor of more conservative approaches, without compromising loco‐regional control and survival. Common immediate complications fol ‐lowing breast surgery are hematoma, seroma, and wound infection.1Traditionally, surgeons have implemented the use of closed‐suction drains in this setting with the aim of preventing these complications, which can cause discomfort, morbidity, increased follow‐up visits,and possible delay in the beginning of adjuvant therapies.2 On the other hand, potential benefits of performing breast procedures without using a drain have been increasingly considered.3 There is lack of modern and official guidelines on use of drains in breast sur ‐gery, with no consensus regarding their management and the appro‐priate use of antibiotics in this setting. Almost all reports agree withthe use of drains after breast procedures, especially if they are asso‐ciated with reconstruction or axillar lymph node dissection (ALND), but an extreme variability is reported regarding practice patterns.4A national survey regarding the management of drains afterbreast cancer surgery was sent by email on January 2018 to all Breast Centers (BC) registered with Senonetwork Italia. Data col ‐lected by the administrative office of Senonetwork were de‐iden‐tified and exported for statistical analysis. A Steering Committeecomposed of general surgeons and plastic surgeons was appointedto coordinate the survey, which consisted of 22 multiple choicequestions, designed to inquire about surgeons' demographics, use of drains after breast procedures with and without reconstructionand/or ALND, antibiotic use and to characterize drain managementin their clinical practice.

Published
2020
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31. Accuracy of global and regional longitudinal strain at peak of dobutamine stress echocardiography to detect significant coronary artery disease

Author

Adriana Postolache, Federica Ilardi, Giovanni Esposito, Patrick Marechal, Attilio Leone, Roberta Esposito, Ciro Santoro, Patrizio Lancellotti, Anna Sannino, Eugenio Stabile, Marisa Avvedimento, Raluca Elena Dulgheru, Plinio Cirillo, Giuseppe Giugliano, Ilardi, F., Santoro, C., Marechal, P., Dulgheru, R., Postolache, A., Esposito, R., Giugliano, G., Sannino, A., Avvedimento, M., Leone, A., Cirillo, P., Stabile, E., Lancellotti, P., and Esposito, G.

Subjects
Male, medicine.medical_specialty, Longitudinal strain, Dobutamine stress echocardiography, Coronary Artery Disease, 030204 cardiovascular system & hematology, Severity of Illness Index, 030218 nuclear medicine & medical imaging, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Predictive Value of Tests, Dobutamine, medicine.artery, Internal medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, Prospective Studies, Circumflex, Cardiac imaging, Aged, Speckle tracking, Original Paper, business.industry, Coronary Stenosis, Reproducibility of Results, Middle Aged, medicine.disease, Stenosis, medicine.anatomical_structure, Italy, Adrenergic beta-1 Receptor Agonists, Regional longitudinal strain, Right coronary artery, Cardiology, Feasibility Studies, Female, Cardiology and Cardiovascular Medicine, business, Echocardiography, Stress, Anterior myocardial ischemia, Artery
Abstract

Dobutamine stress echocardiography (DSE) is sensitive but subjective diagnostic tool to detect inducible ischemia. Nowadays, speckle tracking allows an objective quantification of regional wall function. We aimed to investigate the feasibility and accuracy of global (GLS) and regional longitudinal strain (RLS) during DSE to detect significant coronary stenosis (SCS). We conducted a prospective observational multicenter study including patients undergoing DSE for suspected SCS. 50 patients with positive DSE underwent coronary angiography. Besides visual regional wall motion score index (WMSI), GLS and RLS were determined at rest and at peak stress by Automated Function Imaging. DSE GLS feasibility was 96%. Among 35 patients with SCS, 12 patients were affected by multivessel disease, 18 had stenosis of left anterior descending artery (LAD), 18 of left circumflex (LCX) and 15 of right coronary artery (RCA). At peak stress, both GLS reduction (p = 0.037) and WMSI worsening (p = 0.04) showed significant agreement with coronary angiography for detecting SCS. When single lesion was considered, peak stress GLS and LAD RLS were lower in the obstructed LAD regions than in normo-perfused territories (17.4 ± 5.5 vs. 20.5 ± 4.4%, p = 0.03; 17.1 ± 7.6 vs. 21.6 ± 5.5%, p

Published
2021
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32. Bortezomib, thalidomide, and dexamethasone followed by double autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GIMEMA-MMY-3006): long-term follow-up analysis of a randomised phase 3, open-label study

Author

Paola Tacchetti, Lucia Pantani, Francesca Patriarca, Maria Teresa Petrucci, Elena Zamagni, Luca Dozza, Monica Galli, Francesco Di Raimondo, Claudia Crippa, Mario Boccadoro, Simona Barbato, Patrizia Tosi, Franco Narni, Vittorio Montefusco, Nicoletta Testoni, Antonio Spadano, Carolina Terragna, Norbert Pescosta, Giulia Marzocchi, Claudia Cellini, Piero Galieni, Sonia Ronconi, Marco Gobbi, Lucio Catalano, Antonio Lazzaro, Giovanni De Sabbata, Clotilde Cangialosi, Fabrizio Ciambelli, Pellegrino Musto, Francesca Elice, Michele Cavo, Renato Fanin, Roberto Foa', Alessandro Rambaldi, Giuseppe Rossi, Pietro Leoni, Paolo Corradini, Giuseppe Torelli, Giuseppe Fioritoni, Sergio Cortelazzo, Giorgio Lambertenghi Deliliers, Giorgio La Nasa, Alfonso Zaccaria, Paolo De Fabritiis, Nicola Cascavilla, Alberto Bosi, Gianpietro Semenzato, Luigi Gugliotta, Filippo Gherlinzoni, Emanuele Angelucci, Massimo Fabrizio Martelli, Maria Concetta Petti, Giuseppe Leone, Angelo Michele Carella, Fabio Ciceri, Armando Santoro, Felicetto Ferrara, Francesco Nobile, Alfonso Maria D'Arco, Alessandro Levis, Luciano Guardigni, Andrea Gallamini, Pier Paolo Fattori, Sergio Morandi, Dino Amadori, Bruno Rotoli, Salvatore Mirto, Giorgio Paladini, Ruggero Mozzana, Graziella Pinotti, Francesco Rodeghiero, Nicola Cantore, Vincenzo Pavone, Enrico Maria Pogliani, Anna Marina Liberati, Ignazio Majolino, Sergio Amadori, Francesco Lauria, Massimo Aglietta, Giovanni Quarta, Sergio Storti, Fortunato Morabito, Silvana Franca Capalbo, Alessandro Massimo Gianni, Vincenzo Mettivier, Vittorio Rizzoli, Carlo Bernasconi, Giuseppe Visani, Michele Pizzuti, Giacinto La Verde, Giuseppe Avvisati, Maurizio Longinotti, Eugenio Gallo, Franco Dammacco, Domenico Russo, Andrea Bacigalupo, Caterina Musolino, Tacchetti P., Pantani L., Patriarca F., Petrucci M.T., Zamagni E., Dozza L., Galli M., Di Raimondo F., Crippa C., Boccadoro M., Barbato S., Tosi P., Narni F., Montefusco V., Testoni N., Spadano A., Terragna C., Pescosta N., Marzocchi G., Cellini C., Galieni P., Ronconi S., Gobbi M., Catalano L., Lazzaro A., De Sabbata G., Cangialosi C., Ciambelli F., Musto P., Elice F., Cavo M., Fanin R., Foa' R., Rambaldi A., Rossi G., Leoni P., Corradini P., Torelli G., Fioritoni G., Cortelazzo S., Lambertenghi Deliliers G., La Nasa G., Zaccaria A., De Fabritiis P., Cascavilla N., Bosi A., Semenzato G., Gugliotta L., Gherlinzoni F., Angelucci E., Martelli M.F., Petti M.C., Leone G., Carella A.M., Ciceri F., Santoro A., Ferrara F., Nobile F., D'Arco A.M., Levis A., Guardigni L., Gallamini A., Fattori P.P., Morandi S., Amadori D., Rotoli B., Mirto S., Paladini G., Mozzana R., Pinotti G., Rodeghiero F., Cantore N., Pavone V., Pogliani E.M., Liberati A.M., Majolino I., Amadori S., Lauria F., Aglietta M., Quarta G., Storti S., Morabito F., Capalbo S.F., Gianni A.M., Mettivier V., Rizzoli V., Bernasconi C., Visani G., Pizzuti M., La Verde G., Avvisati G., Longinotti M., Gallo E., Dammacco F., Russo D., Bacigalupo A., and Musolino C.

Subjects
Adult, Male, medicine.medical_specialty, Transplantation Conditioning, Adolescent, Phases of clinical research, Transplantation, Autologous, Dexamethasone, Bortezomib, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, GIMEMA-MMY-3006 trial, bortezomib, thalidomide, dexamethasone, VTD, double autologous haematopoietic stem-cell transplantation, multiple myeloma, Multiple myeloma, Aged, Intention-to-treat analysis, business.industry, Hazard ratio, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, medicine.disease, Thalidomide, Transplantation, Regimen, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, business, Follow-Up Studies, 030215 immunology, medicine.drug
Abstract

Background: The phase 3 GIMEMA-MMY-3006 trial, which compared bortezomib, thalidomide, and dexamethasone (VTD) combination therapy with thalidomide and dexamethasone (TD) as induction therapy before and consolidation therapy after double autologous haematopoietic stem-cell transplantation (HSCT) for newly diagnosed multiple myeloma, showed the superiority of the triplet regimen over the doublet in terms of increased complete response rate and improved progression-free survival. We report the results from the final analysis of the study. Methods: In this randomised, open-label, phase 3 study, patients aged 18–65 years with previously untreated symptomatic multiple myeloma and a Karnofsky Performance Status of 60% or higher were enrolled at 73 centres in Italy. Patients were randomised (1:1) by a web-based system to receive three 21-day cycles of thalidomide (100 mg daily orally for the first 14 days and 200 mg daily thereafter) plus dexamethasone (total 320 mg per cycle; 40 mg on days 1–2, 4–5, 8–9, and 11–12 in the VTD regimen, and 40 mg on days 1–4 and 9–12 in the TD regimen), either alone (TD group) or with bortezomib (1·3 mg/m2 intravenously on days 1, 4, 8, and 11; VTD group). After double autologous HSCT, patients received two 35-day cycles of either the VTD or TD regimen, according to random assignment, as consolidation therapy. The primary outcome was the rate of complete response and near complete response after induction (already reported). In this updated analysis we assessed long-term progression-free survival and overall survival (secondary endpoints of the study) with an extended 10-year median follow-up, and analysed the variables influencing survival. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, NCT01134484. Findings: Between May 10, 2006, and April 30, 2008, 480 patients were enrolled and randomly assigned to receive VTD (241 patients) or TD (239 patients). Six patients withdrew consent before start of treatment. 236 (99 [42%] women) in the VTD group and 238 (102 [43%] women) in the TD group were included in the intention-to-treat analysis. The data cutoff date for this analysis was May 31, 2018. Median follow-up for surviving patients was 124·1 months (IQR 117·2–131·7). The 10-year progression-free survival estimate for patients in the VTD group was 34% (95% CI 28–41) compared with 17% (13–23) for the TD group (hazard ratio [HR] 0·62 [95% CI 0·50–0·77]; p

Published
2020
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33. Fulminant Versus Acute Nonfulminant Myocarditis in Patients With Left Ventricular Systolic Dysfunction

Author

Emeline M. Van Craenenbroeck, Maria Frigerio, Sean Pinney, Victor Garcia-Hernando, Akihiro Isotani, Akinori Sawamura, Jessica Artico, Barry H. Greenberg, Luciano Potena, Piero Gentile, Sherin Hashem, Fabrizio Oliva, Claudia Raineri, Paolo G. Camici, Santiago Montero, Giacomo Veronese, Yoh Arita, Manlio Cipriani, Florent Huang, Enrico Fabris, Alessandro Sionis, Palak Shah, Alberto Foà, Oscar Ö. Braun, Hiroaki Shimokawa, Matthieu Schmidt, Ornella Leone, Marco Merlo, Toyoaki Murohara, Anuradha Lala, Paola Sormani, Caroline M. Van De Heyning, Michela Brambatti, Enrico Ammirati, Takahiro Okumura, Andrea Garascia, Koichiro Sugimura, Marisa Varrenti, Eric Adler, Rajiv Patel, Kaoru Hirose, Kimberly N. Hong, Tatsuo Aoki, Gianfranco Sinagra, Duccio Petrella, Valentina Agostini, Ammirati, E., Veronese, G., Brambatti, M., Merlo, M., Cipriani, M., Potena, L., Sormani, P., Aoki, T., Sugimura, K., Sawamura, A., Okumura, T., Pinney, S., Hong, K., Shah, P., Braun, O., Van de Heyning, C. M., Montero, S., Petrella, D., Huang, F., Schmidt, M., Raineri, C., Lala, A., Varrenti, M., Foa, A., Leone, O., Gentile, P., Artico, J., Agostini, V., Patel, R., Garascia, A., Van Craenenbroeck, E. M., Hirose, K., Isotani, A., Murohara, T., Arita, Y., Sionis, A., Fabris, E., Hashem, S., Garcia-Hernando, V., Oliva, F., Greenberg, B., Shimokawa, H., Sinagra, G., Adler, E. D., Frigerio, M., Camici, P. G., Ammirati E., Veronese G., Brambatti M., Merlo M., Cipriani M., Potena L., Sormani P., Aoki T., Sugimura K., Sawamura A., Okumura T., Pinney S., Hong K., Shah P., Braun O., Van de Heyning C.M., Montero S., Petrella D., Huang F., Schmidt M., Raineri C., Lala A., Varrenti M., Foà Alberto., Leone O., Gentile P., Artico J., Agostini V., Patel R., Garascia A., Van Craenenbroeck E.M., Hirose K., Isotani A., Murohara T., Arita Y., Sionis A., Fabris E., Hashem S., Garcia-Hernando V., Oliva F., Greenberg B., Shimokawa H., Sinagra G., Adler E.D., Frigerio M., Camici P.G., Ammirati, E, Veronese, G, Brambatti, M, Merlo, M, Cipriani, M, Potena, L, Sormani, P, Aoki, T, Sugimura, K, Sawamura, A, Okumura, T, Pinney, S, Hong, K, Shah, P, Braun, O, Van de Heyning, C, Montero, S, Petrella, D, Huang, F, Schmidt, M, Raineri, C, Lala, A, Varrenti, M, Foa, A, Leone, O, Gentile, P, Artico, J, Agostini, V, Patel, R, Garascia, A, Van Craenenbroeck, E, Hirose, K, Isotani, A, Murohara, T, Arita, Y, Sionis, A, Fabris, E, Hashem, S, Garcia-Hernando, V, Oliva, F, Greenberg, B, Shimokawa, H, Sinagra, G, Adler, E, Frigerio, M, and Camici, P

Subjects
Adult, Male, Inotrope, medicine.medical_specialty, Myocarditis, eosinophilic myocarditi, Prognosi, Fulminant, medicine.medical_treatment, Myocarditi, fulminant myocarditis, 030204 cardiovascular system & hematology, Severity of Illness Index, acute myocarditis, endomyocardial biopsy, eosinophilic myocarditis, giant cell myocarditis, outcome, Endomyocardial biopsy, Ventricular Dysfunction, Left, 03 medical and health sciences, 0302 clinical medicine, Retrospective Studie, Internal medicine, giant cell myocarditi, Humans, Medicine, In patient, 030212 general & internal medicine, Retrospective Studies, Heart transplantation, fulminant myocarditi, business.industry, Middle Aged, Prognosis, medicine.disease, acute myocarditi, Acute myocarditis, Acute Disease, Circulatory system, Cardiology, Female, Human medicine, Cardiology and Cardiovascular Medicine, business, Human
Abstract

BACKGROUND Fulminant myocarditis (FM) is a form of acute myocarditis characterized by severe left ventricular systolic dysfunction requiring inotropes and/or mechanical circulatory support. A single-center study found that a patient with FM had better outcomes than those with acute nonfulminant myocarditis (NFM) presenting with left ventricular systolic dysfunction, but otherwise hemodynamically stable. This was recently challenged, so disagreement still exists. OBJECTIVES This study sought to provide additional evidence on the outcome of FM and to ascertain whether patient stratification based on the main histologic subtypes can provide additional prognostic information. METHODS A total of 220 patients (median age 42 years, 46.3% female) with histologically proven acute myocarditis (onset of symptoms

Published
2019
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34. Current status of COVID-19 treatment: An opinion review

Author

Sveva Di Franco, Stephen Petrou, Sebastiano Leone, Maria Caterina Pace, Maria Beatrice Passavanti, Marco Fiore, Aniello Alfieri, Giovanni Damiani, Di Franco, Sveva, Alfieri, Aniello, Petrou, Stephen, Damiani, Giovanni, Passavanti, Maria Beatrice, Pace, Maria Caterina, Leone, Sebastiano, and Fiore, Marco

Subjects
0301 basic medicine, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Opinion review, medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronaviru, medicine.disease_cause, Targeted therapy, law.invention, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Tocilizumab, Randomized controlled trial, law, Pandemic, medicine, 030212 general & internal medicine, Enoxaparin, Intensive care medicine, Coronavirus, Antiviral drugs, SARS-CoV-2, business.industry, Antiviral drug, COVID-19, Eculizumab, Treatment, Clinical trial, 030104 developmental biology, chemistry, business, Hydroxychloroquine
Abstract

The pandemic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has garnered the attention of scientists worldwide in the search for an effective treatment while also focusing on vaccine development. Several drugs have been used for the management of coronavirus disease 2019 (COVID-19), which has affected many hospitals and health centers worldwide. Statistically significant results are lacking on the effectiveness of the experimented drugs in reducing COVID-19 morbidity or mortality, as there are very few published randomized clinical trials. Despite this, the literature offers some material for study and reflection. This opinion review attempts to address three burning questions on COVID-19 treatment options. (1) What kind of studies are currently published or ongoing in the treatment of patients with COVID-19? (2) What drugs are currently described in the literature as options of treatment for patients affected by the infection? And (3) Are there specific clinical manifestations related to COVID-19 that can be treated with a customized and targeted therapy? By answering these questions, we wish to create a summary of current COVID-19 treatments and the anti-COVID-19 treatments proposed in the recent clinical trials developed in the last 3 mo, and to describe examples of clinical manifestations of the SARS-CoV-2 infection with a cause-related treatment.

Published
2020
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35. Relationship between atrophic gastritis, serum ghrelin and body mass index

Author

Palma Aurelia Iacovazzi, Franco Bazzoli, Amanda Vestito, Rocco Maurizio Zagari, Mario Correale, Carla Maria Leone, Alba Panarese, A. Romiti, Pasqua Letizia Pesole, Panarese A., Romiti A., Iacovazzi P.A., Leone C.M., Pesole P.L., Correale M., Vestito A., Bazzoli F., and Zagari R.M.

Subjects
Gastritis, Atrophic, medicine.medical_specialty, Atrophic gastritis, Autoimmune Gastritis, Gastroenterology, Body Mass Index, Helicobacter Infections, BMI, 03 medical and health sciences, Total Ghrelin, 0302 clinical medicine, Internal medicine, Humans, Medicine, serum ghrelin, Antrum, autoimmune gastriti, Helicobacter pylori, Hepatology, business.industry, digestive, oral, and skin physiology, Histology, medicine.disease, Ghrelin, atrophic gastriti, Gastric Mucosa, Gastritis, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, medicine.symptom, business, Body mass index
Abstract

Objective Atrophic gastritis may affect circulating ghrelin levels and, indirectly, body mass index. The aim of this study was to investigate the relationship between atrophic gastritis, focusing on autoimmune atrophic gastritis and advanced stages of atrophic gastritis, serum ghrelin levels and BMI. Methods Sixty-three patients, of whom 18 had autoimmune atrophic gastritis, 27 non-autoimmune antrum and corpus atrophic gastritis, and 18 non-atrophic gastritis or antrum-limited atrophic gastritis (control group) were assessed. All participants underwent endoscopy with multiple gastric biopsies. Atrophic gastritis was diagnosed by histology, classified according to the Updated Sydney System and staged by the Operative Link on Gastritis Assessment (OLGA) Classification. Total serum ghrelin, body weight and height were measured. Results Compared with control patients (144.6 ± 111 pg/ml), mean serum level of total ghrelin was higher in patients with autoimmune atrophic gastritis (226.08 ± 243.03 pg/ml, P = 0.65) and lower in those with both antrum and corpus atrophic gastritis (74.51 ± 37.38 pg/ml, P = 0.12), although differences were not statistically significant. Serum ghrelin decreased in patients with advanced OLGA stages of atrophic gastritis. In non-obese patients BMI was significantly lower in those with both antrum and corpus atrophic gastritis than in control patients (23.1 ± 1.8 vs. 24.5 ± 1.6, P = 0.01), also after adjustment for age and sex (P = 0.02); BMI was positively correlated with serum total ghrelin (r = 0.51, P < 0.001). Conclusion Advanced stages of atrophic gastritis, but not autoimmune atrophic gastritis, seem to be associated with lower serum levels of ghrelin and lower BMI. In non-obese patients, BMI was positively correlated with total serum ghrelin.

Published
2020
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36. Chronic lymphocytic leukemia management in Italy during the COVID-19 pandemic: a Campus CLL report

Author

Cuneo, A., Scarfo, L., Reda, G., Varettoni, M., Quaglia, F. M., Marchetti, M., De Paoli, L., Re, F., Pietrasanta, D., Rigolin, G. M., Orsucci, L., Ibatici, A., Gattei, V., Mauro, F. R., Trentin, L., Laurenti, L., Marasca, R., Foa, R., Angeletti, I., Chiurazzi, F., Del Poeta, G., Rosaria De Paolis, M., Farina, L., Ferrari, A., Gentile, M., Gottardi, D., Gozzetti, A., Leone, M., Levato, L., Maccaferri, M., Malerba, L., Motta, M., Murru, R., Nocilli, L., Olivieri, J., Stefoni, V., Cuneo, A., Scarfo', L., Reda, G., Varettoni, M., Quaglia, F. M., Marchetti, M., De Paoli, L., Re, F., Pietrasanta, D., Rigolin, G. M., Orsucci, L., Ibatici, A., Gattei, V., Mauro, F. R., Trentin, L., Laurenti, L., Marasca, R., Foa, R., Angeletti, I., Chiurazzi, F., Del Poeta, G., Rosaria De Paolis, M., Farina, L., Ferrari, A., Gentile, M., Gottardi, D., Gozzetti, A., Leone, M., Levato, L., Maccaferri, M., Malerba, L., Motta, M., Murru, R., Nocilli, L., Olivieri, J., and Stefoni, V.

Subjects
Aged, Aged, 80 and over, Betacoronavirus, COVID-19, Coronavirus Infections, Disease Management, Humans, Italy, Leukemia, Lymphocytic, Chronic, B-Cell, Middle Aged, Pandemics, Pneumonia, Viral, SARS-CoV-2, Chronic lymphocytic leukemia, Biochemistry, chemistry.chemical_compound, Pandemic, 80 and over, Viral, Chronic, Disease management (health), Letter to Blood, Leukemia, Hematology, Lymphocytic, Ibrutinib, CLL, COVID-19, Campus CLL, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Immunology, Cancer therapy, NO, Internal medicine, medicine, business.industry, B-Cell, Pneumonia, Cell Biology, Campus CLL, medicine.disease, Settore MED/15 - MALATTIE DEL SANGUE, chemistry, business, CLL
Published
2020
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37. An open‐label dose escalation study evaluating tolerability and safety of a single 5‐days course of temozolomide in dogs with advanced cancer

Author

Laura Marconato, Riccardo Finotello, Carla Rohrer Bley, Vito F. Leone, and Laura Marconato, Carla Rohrer Bley, Vito F Leone, Riccardo Finotello

Subjects
Male, Oncology, medicine.medical_specialty, Dose, 040301 veterinary sciences, DLT, canine, 0403 veterinary science, 03 medical and health sciences, Dogs, 0302 clinical medicine, Neoplasms, Internal medicine, Glioma, Temozolomide, Animals, Medicine, Dog Diseases, Dosing, Adverse effect, Antineoplastic Agents, Alkylating, Dose-Response Relationship, Drug, General Veterinary, business.industry, 04 agricultural and veterinary sciences, medicine.disease, Advanced cancer, MTD, phase 1, Tolerability, 030220 oncology & carcinogenesis, Toxicity, Female, temozolomide, business, medicine.drug
Abstract

Temozolomide is a novel oral alkylating agent that has schedule-dependent clinical activity in human malignant glioma and metastatic melanoma. Little is known about the efficacy of temozolomide in the treatment of canine solid cancers, where broad range of dosages have been used but no maximally tolerated dose (MTD) had been established. The aim of this this open-label, dose-escalating study was to determine MTD and dose-limiting toxicity (DLT) of a single temozolomide cycle in dogs with advanced solid tumours. Temozolomide was administered as a 5-days course starting at 70 mg/m2 , using escalation of 10 mg/m2 increments with 3 dogs per dose level. MTD was established based on the number of dogs experiencing DLT assessed after 1 cycle. Safety evaluation was performed 10 days after dosing. Thirty-three client-owned dogs were enrolled. MTD was established at 150 mg/m2 and the most frequent adverse events (AEs) were hematologic and hepatic, followed by gastrointestinal, with the majority being self-resolving and of mild grade. VCOG grade 3 hepatic toxicity and grade 4 thrombocytopenia were defined as DLTs at 160 mg/m2 . A subcohort of dogs received multiple temozolomide doses on a 4-week cycle and no cumulative toxicity was documented. Conclusions of this study define temozolomide MTD at 150 mg/m2 when given once daily over 5 days. Future trials on the efficacy of temozolomide administered at its MTD are warranted.

Published
2020
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38. Initial Invasive or Conservative Strategy for Stable Coronary Disease

Author

Maron D. J., Hochman J. S., Reynolds H. R., Bangalore S., O'Brien S. M., Boden W. E., Chaitman B. R., Senior R., Lopez-Sendon J., Alexander K. P., Lopes R. D., Shaw L. J., Berger J. S., Newman J. D., Sidhu M. S., Goodman S. G., Ruzyllo W., Gosselin G., Maggioni A. P., White H. D., Bhargava B., Min J. K., John Mancini G. B., Berman D. S., Picard M. H., Kwong R. Y., Ali Z. A., Mark D. B., Spertus J. A., Krishnan M. N., Elghamaz A., Moorthy N., Hueb W. A., Demkow M., Mavromatis K., Bockeria O., Peteiro J., Miller T. D., Szwed H., Doerr R., Keltai M., Selvanayagam J. B., Gabriel Steg P., Held C., Kohsaka S., Mavromichalis S., Kirby R., Jeffries N. O., Harrell F. E., Rockhold F. W., Broderick S., Bruce Ferguson T., Williams D. O., Harrington R. A., Stone G. W., Rosenberg Y, ISCHEMIA Research Group: Joseph Ricci, A Tello Montoliu, A I Robero Aniorte, Abbey Mulder, Abhay A Laddu, Abhinav Goyal, Abhishek Dubey, Abhishek Goyal, Abigail Knighton, Abraham Oomman, Adam J Jaskowiak, Adam Kolodziej, Adam Witkowski, Adnan Hameed, Adriana Anesini, Afshan Hussain, Agne Juceviciene, Agne Urboniene, Agnes Jakal, Agnieszka Szramowska, Ahmad Khairuddin, Ahmed Abdel-Latif, Ahmed Adel, Ahmed Aljzeeri, Ahmed Kamal, Ahmed Talaat, Aimee Mann, Aira Contreras, Ajit Kumar, V K Kumar, Akemi Furukawa, Akshay Bagai, Akvile Smigelskaite, Alain Furber, Alain Rheault, Alaine Melanie Loehr, Alan Rosen, Albert Varga, Albertina Qelaj, Alberto Barioli, Aldo Russo, Alec Moorman, Alejandro Gisbert, Aleksandra Fratczak, Aleksandras Laucevicius, Alena Kuleshova, Alessandro Sionis, Alexander A Sirker, Alexander M Chernyavskiy, Alexandra Craft, Alexandra Vazquez, Alexandre Ciappina Hueb, Alexandre S Colafranseschi, Alexandre Schaan de Quadros, Alexandre Tognon, Ali Alghamdi, Alice Manica Muller, Aline Nogueira Rabaça, Aline Peixoto Deiro, Alison Hallam, Allegra Stone, Allison Schley, Almudena Castro, Alvaro Rabelo Ales, Amanda Germann, Amanda O'Malley, Amar Uxa, Amarachi Ojajuni, Amarino C Oliveira Jr, Amber B Hull, Ambuj Roy, Amer Zarka, Amir Janmohamed, Ammani Brown, Ammy Malinay, Amparo Martinez Monzonis, Amy J Richards, Amy Iskandrian, Amy Ollinger, Ana D Djordjevic-Dikic, Ana Fernández Martínez, Ana Gomes Almeida, Ana Paula Batista, Ana Rita Francisco, Ana S Mladenovic, Ana Santana, Anam Siddiqui, Anastasia M Kuzmina-Krutetskaya, Andras Vertes, Andre S Sousa, Andre Gabriel, André Schmidt, Andrea M Lundeen, Andrea Bartykowszki, Andrea Lorimer, Andrea Mortara, Andrea Pascual, Andreia Coelho, Andreia Rocha, Andrés García-Rincón, Andrew G Howarth, Andrew J Moriarty, Andrew Docherty, Andrew Starovoytov, Andrew Zurick, Andrzej Łabyk, Andrzej Swiatkowski, Andy Lam, Anelise Kawakami, Angela Hoye, Angela Kim, Angelique Smit, Angelo Nobre, Anil V Shah, Anja 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Bermudez, Eapen Punnoose, Edgar L Tay, Edgar Karanjah, Edoardo Verna, Eduardo Hernandez-Rangel, Edward D Nicol, Edward O McFalls, Edward T Martin, Edyta Kaczmarska, Ekaterina I Lubinskaya, Elena A Demchenko, Elena Refoyo Salicio, Eli Feen, Elihú Durán-Cortés, Elisabeth M Janzen, Elise L Hannemann, Elise van Dongen, Elissa Restelli Piloto, Eliza Kaplan, Elizabeta Srbinovska Kostovska, Elizabeth Capasso-Gulve, Elizabeth Congdon, Elizabeth Ferguson, Elizaveta V Zbyshevskaya, Ellen Magedanz, Ellie Fridell, Ellis W Lader, Elvin Kedhi, Emanuela Racca, Emilie Tachot, Emily DeRosa, Encarnación Alonso-Álvarez, Eric Nicollet, Eric Peterson, Erick Alexánderson Rosas, Erick Donato Morales, Erin Orvis, Ermina Moga, Estelle Montpetit, Estevao Figueiredo, Eugene Passamani, Eugenia Nikolsky, Eunice Yeoh, Evgeniy I Kretov, Ewa Szczerba, Ewelina Wojtala, Expedito Eustáquio Ribeiro Silva, F Marin Ortuño, Fabio R Farias, Fabio Fimiani, Fabrizio Rolfo, Fa-Chang Yu, Fadi Hage, Fadi Matar, Fahim Haider 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Niedzwiecka, J David Knight, Jacek Kusmierek, Jackie M White, Jackie Chow, Jacob Udell, Jacqueline E Tamis-Holland, Jacqueline Fannon, Jacquelyn A Quin, Jacquelyn Do, Jaekyeong Heo, Jakub Maksym, James E Davies, James H O'Keefe Jr, James J Jang, James Cha, James Harrison, James Hirsch, James Stafford, James Tatoulis, Jamie Rankin, Jan Henzel, Jan Orga, Jana Tancredi, Janaina Oliveira, Jane Burton, Jane Eckstein, Jane Marucci, Janet P Knight, Janet Blount, Janet Halliday, Janetta Kourzenkova, Janitha Raj, Jan-Malte Sinning, Jaqueline Pozzibon, Jaroslaw Drozdz, Jaroslaw Karwowski, Jason D Glover, Jason Loh Kwok, Jason T Call, Jason Linefsky, Jassira Gomes, Jati Anumpa, Javier J Garcia, Javier Courtis, Jay Meisner, K Jayakumar, Jayne Scales, Jean E Denaro, Jean Michel Juliard, Jean Ho, Jeanette K Stansborough, Jean-Michel Juliard, Jeanne Russo, Jeannette J M Schoep, Jeet Thambyrajah, Jeff Leimberger, Jeffery A Breall, Jeffrey A Kohn, Jeffrey C Milliken, Jeffrey Anderson, Jeffrey Blume, Jeffrey Kanters, Jeffrey Lorin, Jeffrey Moses, Jelena J Stepanovic, Jelena Celutkiene, Jelena Djokic, Jelena Stojkovic, Jenne M Jose, Jenne Manchery, Jennifer A Mull, Jennifer H Czerniak, Jennifer L Stanford, Jennifer Gillis, Jennifer Horst, Jennifer Isaacs, Jennifer Langdon, Jennifer Thomson, Jennifer Tomfohr, Jennifer White, Jen-Yuan Kuo, Jeremy Rautureau, Jerome Fleg, Jessica Berg, Jessica Rodriguez, Jessica Waldron, Jhina Patro, Jia Li, Jiajia Mao, Jiamin Liu, Jian'an Wang, Jianhua Li, Jianxin Zhang, Jie Qi, Jihyun Lyo, Jill Marcus, Jim Blankenship, Jing Zhang, Jingjing Liu, Jing-Yao Fan, Jiun-Yi Li, Jiwan Pradhan, Jiyan Chen, J M Rivera Caravaca, Jo Evans, Joan Garcia Picart, Joan Hecht, Joanna Jaroch, Joanna Zalewska, Joanne Kelly, Joanne Taaffe, João Reynaldo Abbud, João V Vitola, Joaquín V Peñafiel, Jocelyne Benatar, Jody Bindeman, Joe Sabik, Joel Klitch, Johann Christopher, Johannes Aspberg, John D Friedman, John F Beltrame, John F Heitner, John Joseph Graham, John R Davies, John Doan, John Kotter, John Kurian, John Mukai, John Pownall, Jolanta Sobolewska, Jon Kobashigawa, Jonathan L Goldberg, Jonathan W Bazeley, Jonathan Byrne, Jonathan Himmelfarb, Jonathan Leipsic, Jonean Thorsen, Jorge F Trejo Gutierrez, Jorge Escobedo, Jorik Timmer, José A Ortega-Ramírez, José Antonio Marin-Neto, Jose D Salas, Jose Enrique Castillo, Jose Francisco Saraiva, José J Cuenca-Castillo, Jose L Diez, José Luis Narro Villanueva, José Luiz da Vieira, José M Flores-Palacios, Jose Ramon Gonzalez, Jose Seijas Amigo, Jose Fragata, Josep Maria Padró, Josheph F X McGarvey Jr, Joseph Hannan, Joseph Sacco, Joseph Sweeny, Joseph Wiesel, Josephine D Abraham, Joshua P Loh, Joy Burkhardt, Joyce R White, Joyce Riestenberg-Smith, Judit Sebo, Judith L Meadows, Judith Wright, Judy Mae Foltz, Judy Hung, Judy Otis, Juergen Stumpf, Jui-Peng Tsai, Julia S Dionne, Julia de Aveiro Morata, Julie Bunke, Julie Morrow, Julio César Figal, Jun Fujita, Jun Jiang, Junhua Li, Junqing Yang, Juntima Euathrongchit, Jyotsna Garg, K Manjula Rani, K Preethi, Kaatje Goetschalckx, Kai Eggers, Kamalakar Surineni, Kanae Hirase, T R Kapilamoorthy, Karen Calfas, Karen Gratrix, Karen Hallett, Karen Hultberg, Karen Nugent, Karen Petrosyan, Karen Swan, Karolina Kryczka, Karolina Wojtczak-Soska, Karolina Wojtera, Karsten Lenk, Karthik Ramasamy, Katarzyna Łuczak, Katarzyna Malinowska, Kate Pointon, Kate Robb, Katherine Martin, Kathleen Claes, Kathryn Carruthers, Kathy E Siegel, Katia Drouin, Katie Fowler-Lehman, Kavita Rawat, Kay Rowe, Keiichi Fukuda, Keith A A Fox, Ken Mahaffey, Kendra Unterbrink, Kenneth Giedd, Kerrie Van Loo, Kerry Lee, Kerstin Bonin, Kevin R Bainey, Kevin T Harley, Kevin Anstrom, Kevin Chan, Kevin Croce, Kevin Landolfo, Kevin Marzo, Keyur Patel, Khaled Abdul-Nour, Khaled Alfakih, Khaled Dajani, Khaled Ziada, Khaula Baloch, Khrystyna Kushniriuk, Kian-Keong Poh, Kim F Ireland, Kim Holland, Kimberly Ann Byrne, Kimberly E Halverson, Kimberly Elmore, Kimberly Miller-Cox, Kiran Reddy, Kirsten J Quiles, Kirsty Abercrombie, Klaus Matschke, Konrad Szymczyk, Koo Hui Chan, Kotiboinna Preethi, Kozhaya Sokhon, Krissada Meemuk, Kristian Thygesen, Kristin M Salmi, Kristin Newby, Kristina Wippler, Kristine Arges, Kristine Teoh, Krystal Etherington, Krystyna Łoboz-Grudzień, Krzysztof W Reczuch, Krzysztof Bury, Krzysztof Drzymalski, Krzysztof Kukuła, Kuo-Tzu Sung, Kurt Huber, Ladda Douangvila, Lance Sullenberger, Larissa Miranda Trama, Laszlone Matics, Laura Drew, Laura Flint, Laura Keinaite, Laura Sarti, Laurel Kolakaluri, Lawrence M Phillips, Lawrence Friedman, Lawrence Phillips, Lazar Velicki, Leah Howell, Leandro C Maranan, Leanne Cox, Ledjalem Daba, Lei Zhang, Lekshmi Dharmarajan, Leo Bockeria, Leonardo Pizzol Caetano, Leonardo Bridi, Leonid L Bershtein, Leszek Sokalski, Li Hai Yan, Li Li, Lia Nijmeijer, Lidia Sousa, Lihong Xu, Lihua Zhang, Lili Zhang, Lilia Schiavi, Lilian Mazza Barbosa, Lillian L Khor, Lina Felix-Stern, Linda L Hall, Linda M Hollenweger, Linda Arcand, Linda Davidson-Ray, Linda Schwarz, Lindsey N Sikora, Lingping Chi, Lino Patricio, Liping Zhang, Lisa Chaytor, Lisa Hatch, Lisa McCloy, Lisa Wong, Liselotte Persson, Lixin Jiang, Liz Low, Ljiljana Pupic, Loïc Bière, Lorenzo Monti, Lori Christensen, Lori Pritchard, Loriane Black, Lori-Ann Desimone, Lori-Ann Larmand, Lorraine McGregor, Louise Morby, Louise Thomson, Luc Harvey, Luciana de Pádua Baptista, Lucilla Garcia, Ludivine Eliahou, Ludmila Helmer, Luis F Smidt, Luis Bernanrdes, Luis Guzman, Luiz A Carvalho, Luyang Xiong, Lynette L Teo, Lynn M Neeson, Lynne Winstanley, M Barbara Srichai-Parsia, M Quintana Giner, M Sowjanya Reddy, M Valdés Chávarri, M Grazia Rossi, Maarten Simoons, Maayan Konigstein, Maciej Lesiak, Maciej Olsowka, Mafalda Selas, Magalie Corfias, Magdalena Madero Rovalo, Magdalena Łanocha, Magdalena Miller, Magdalena Misztal-Teodorczyk, Magdalena Rantinella, Magdy Abdelhamid, Magnolia Jimenez, Mahboob Alam, Mahevamma Mylarappa, Mahfouz El Shahawy, Mahmoud Mohamed, Mahmud Al-Bustami, Majo X Joseph, Malgorzata Frach, Małgorzta Celińska-Spodar, Malte Helm, Manas Chacko, Mandy Murphy, Manitha Vinod, Manjula Rani, Manu Dhawan, Manuela Mombelli, Marcel Weber, Marcello Galvani, Marcelo Jamus Rodrigues, Marcia F Dubin, Marcia F Werner Bayer, Marcin Szkopiak, Marco Antonio Monsalve, Marco Bizzaro Santos, Marco Magnoni, Marco Marini, Marco Sicuro, Marco Zenati, Marcos Valério Coimbra Resende, Marek Roik, Margalit Bentzvi, Margaret Gilsenan, Margaret Iraola, Margot C Quinn, Maria A Alfonso, Maria Antonieta Pereira Moraes, María Dolores Martínez-Ruíz, María Fernanda Canales, Maria Inês Caetano, Maria P Corral, Maria Pérez García, Maria Victoria Actis, Maria Aguirre, Maria Andreasson, Maria Aprile, Maria Colton, Maria Eugenia Martin, Maria Lasala, Maria Lorenzo, Maria Posada, Maria Shier, Maria Thottam, Mariana V Furtado, Mariana Yumi Okada, Marianna D A Dracoulakis, Marianne De Andrade, Mariano Rubio, Marie Essermark, Marielle Scherrer-Crosbie, Marija T Petrovic, Marija Zdravkovic, Marilyn Black, Marina Garcia, Mario J Garcia, Mariola Szulik, Marisa Orgera, Mark A de Belder, Mark Harbinson, Mark Hyun, Mark Peterson, Mark Xavier, Marlowe Mosley, Marta Capinha, Marta Marcinkiewicz-Siemion, Marta Swiderek, Martha Meyer, Martina Ceseri, Martina Tricoli, Marvin Kronenberg, Mary Williams, Mary Ann Champagne, Mary Colleen Rogge, Mary R Soltau, Mary Streif, Massimo Villella, Massoud Leesar, Matei Claudia, Mateusz Solecki, Matías Nicolás Mungo, Matthew Wall Jr, Matthew Budoff, Matthew Jezior, Matthew Luckie, Matthias Friedrich, Mauren P Haeffner, Maximilian Tscharre, Max-Paul Winter, Mayana Almeida, Mayil S Krishnam, Mayuri Patel, Meenakshi Mishra, Megan Manocchia, Meghana Kakade, Melanie J Munro, Melissa D Chaplin, Melissa LeFevre, Mervyn Andiapen, Michael A Gibson, Michael B Rubens, Michael C Turner, Michael D Shapiro, Michael W Lee, Michael Berlowitz, Michael Davidson, Michael Mack, Michael McDaniel, Michael Mumma, Michal Wlodarczyk, Michel G Khouri, Michel S Slama, Michele Rawlins, Michelle M Bonner, Michelle M Seib, Michelle Chang, Michelle Crowder, Michelle Dixon, Michelle Mayon, Michelle McEvoy, Michelle Yee, Miguel M Fernandes, Miguel Nobre Menezes, Miguel Souto Bayarri, Miguel Barrero, Mikhail T Torosoff, Milan R Dobric, Milan Dobric, Milica Nikola Dekleva, Milind Avdhoot Gadkari, Millie Gomez, Min Tun Kyaw, Miriam Brooks, Miroslav Stevo Martinovic, Mitchel B Lustre, Mohammad Tariq Vakani, Mohammad El-Hajjar, Mohammed Al-Amoodi, Mohammed Hussain, Mohammed Saleem, Moisés Blanco-Calvo, Moisés Jiménez-Santos, Mona Bhatia, Monica Rosca, Monika Laukyte, Montserrat Gracida Blanca, Montserrat Vila Perales, Mouaz H Al-Mallah, Moysés de Oliveira Filho, Mpiko Ntsekhe, Muhamed Saric, Mulei Chen, Myriam Brousseau, Myrthes Emy Takiuti, Nada Cemerlic-Adjic, Nadia Asif, Nadia Gakou, Nafisa Hussain, Nana O Katamadze, Nancy L Clapp, Nancy Aedy, Nandita Nataraj, Nanette K Wenger, Naomi Uchida, Nasrul Ismail, Natalia S Oliveira, Natalia de Carvalho Maffei, Natalie Spitzer, Natasha C Putnam, Naved Aslam, Neamat Mowafy, Neeraj Pandit, Neeraj Parakh, Nevena Garcevic, Ngaire Meadows, Nhi N Tran, Nicholas Danchin, Nicki Lakeman, Nicola Johnston, Nicolas W Shammas, Nicole Saint Vrestil, Nicole Deming, Nier Zhong, Niket Patel, Nikola N Boskovic, Nikolaos Karogiannis, Nikos Werner, Nina Johnston, Ning Zhang, Ning Zhou, Niree Hindoyan, Nirmal Kumar, Nitika Chadha, Nitish Naik, Nodira Aripova, Noloyiso Mtana, Nona A Eskelson, Noor Syamira Mokhtar, Noppon Taksaudom, Nor Asiah Basri, Nora Marchelletta, Norma Hogg, Nungshi Jungla, Nuno Ferreira, Oksana A Lubyanaya, Olga B Nikolaeva, Olga Cañavate, Olga Sobrino, Olga Walesiak, Olga Walter, Olga Zdończyk, Olivia J Lim, Olivia Anaya, Olivia Mancilla, Olivier Dubourg, Olugbenga Bello, Omar Almousalli, Omar Thompson, Oni Olurinde, Or Harel, Osama Raheem, Oscar Méndiz, Óscar Prada-Delgado, Oz Shapira, P Christian Schulze, Pachara Panpunuan, Pal Maurovich-Horvat, Pallav Garg, Paloma Moraga, Pam Singh, Pamela Julian, Pamela Ouyang, Pamela Sigel, Pamela Woodard, Panpan Zhou, Paola Emanuela Poggio, Paola Smanio, Paolo Calabro, Paramjit Jeetley, Pascal Goube, Patricia K Nguyen, Patricia Alarie, Patricia Arakelian, Patricia Arsenault, Patricia Blaise, Patricia Brito, Patricia Cowper, Patricia Endsley, Patricia Mieses, Patrick B Alexander, Patrick Donnelly, Patrick Wilmot, Patrycja Lebioda, Paul C Gordon, Paul Der Mesropian, Paul Galiwango, Paul Hauptman, Paul Kennedy, Paula Beardsley, Paula García-González, Paulo Cury Rezende, Paulo Ricardo Caramori, Pavel S Kozlov, Pedro Canas Silva, Pedro Gabriel Melo Barros E Silva, Pedro Píccaro de Oliveira, Pedro Carvalho, Pedro Modas, Pedro Rio, Peeyush Jain, Peiyu He, Peter A McCullough, Peter H Stone, Peter M Pollak, Peter Douglass, Peter Henriksen, Peter OKane, Peter Ong, Philip Jones, Philip Rogal, Philippe Généreux, Philippe Menasche, Philippe Rheault, Phoebe Goold, Pierre Gervais, Pierre Michaud, Pilar Calvillo, Ping Chai, Piotr Jakubowski, Piotr Pruszczyk, Piotr Slomka, Piyamitr Sritara, Poay-Huan Loh, Poonam Sonawane, Pouneh Samadi, Pragnesh P Parikh, Prakash Deedwania, Pranav M Patel, Praneeth Polamuri, Pratiksha Sharma, Precilia Vasquez, Preeti Kamath, Prince Thomas, Priyadarshani Arambam, Puja K Mehta, Purvez Grant, Pushpa Naik, Qi Zhong, Qian Zhao, Qiang Zhou, Qianqian Yuan, Qin Yu, Qingxian Li, Qiulan Xie, Qiutang Zeng, R J Vindhya, R James Gerlach, Rachel King, Rada Vučić, Radmila Lyubarova, Radoslaw Pracon, Raewyn Fisher, Rafael Beyar, Rafael Diaz, Rafael Selgas, Raffaele Bugiardini, Raffaele Fanelli, Raisa Kavalakkat, V S Rajalekshmi, Rajat S Barua, Rajeev Menon, Rajesh Gopalan Nair, Rajesh Francis, Rajiv Narang, Rakesh Yadav, Ralph Alan Huston, T Ramakrishnan, Ramesh de Silva, Rami El Mahmoud, Ramiro Carvalho, Ramon de Jesús-Pérez, Ramona Stevens, Ran Leng, Ranjan Kachru, Ranjit Kumar Nath, Raquel Sanchez, Raven R Dwyer, Raven Lee, Ray Wyman, Raymond C Wong, Raymond W Little, Raymundo Ocaranza Sanchez, Rebecca J Wimmer, Rebecca Bariciano, Rebecca Otis, Rebekah R Herrmann, Reem Yunis, Reinette Hampson, Renato Abdala Karam, Renee C Hessian, Renee Kaneshiro, Reshma Ravindran, Reto Andreas Gamma, Reyna Bhandari, Reza Arsanjani, Ricardo L Lopes, Ricardo Mendes Oliveira, Ricardo Costa, Richa Bhatt, Richard F Davies, Richard H J Trimlett, Richard Goldweit, Rik Hermanides, Rine Nakanishi, Rinu R Sidh, Risha Patel, Rita Coram, Rizwan A Siddiqui, Rob S Beanlands, Robert J Hamburger, Robert K Riezebos, Robert M Donnino, Robert Bojar, Robert Chilton, Robert Guyton, Robert Henderson, Robert Kornberg, Robert Leber, Robert Mao, Robert Stenberg, Roberta P Santos, Roberto René Favaloro, Roberto Amati, Rodolfo G S D Lima, Rodrigo J Cerci, Rogerio Tumelero, Rohit Tandon, Roma Tewari, Romalisa Miranda-Peats, Ron Wald, Ronald A Mastouri, Ronald G Morford, Ronald G Schwartz, Ronald P Pedalino, Rongrong Hu, Ronnell A Hansen, Ronny A Cohen, Rory Hachamovitch, Rosa Homem, Rosa Sandonato, Rosane Laimer, Rosann Gans, Roxanne Yost, Roy Mathew, Rubén Baleón-Espinosa, Ruben Ramos, Rubine Gevorgyan, Rui Ferreira, Rui Jing, Ruth Pérez-Fernández, S K Dwivedi, S Ramakrishnan, Saadat Khan, Sabahat Bokhari, Sabu Thomas, Sadath Lubna, Sajeeda Parveen Khan, Sajeev Chakanalil Govindan, Saket Girotra, Saleem Kassam, Sallie Canada, Salvador Cruz-Flores, Samaa Mohamed, Samantha Ly, Sameh El Kaffas, Samia Massalha, Sampoornima Setty, Samuel Nwosu, Sandeep Seth, Sandeep Singh, Sander R Niehe, Sandra M Rivest, Sandra S Zier, Sandra Ahoud, Sandy Carr, Sanjay Ganapathi, Sanjay Shetty, Sanjeev Sharma, Santa Jimenez, Santhosh Satheesh, Santiago A Garcia, Sara Fernandez, Sara Karlsson, Sara Salkind, Sara Temiyasathit, Sarah Medina Rodriguez, Sarah Beaudry, Sarah Hadjih, Sarah Williams, Sarah Zahrani, Sarju Ralhan, Sasa Hinic, Sasko Kedev, Satinder Singh, Satoshi Yasuda, Satvic Cholenahally Manjunath, Sau Lee, Scott M Kaczkowski, Scott Kinlay, Sean W Hayes, Sebastian Sobczak, Senait Asier, Sergey A Sayganov, Seth I Sokol, Shaheen Pandie, Shaiful Azmi Yahaya, Shamir Mehta, Shao-Ping Nie, Sharad Chandra, Sharder Islam, Sharon Tai, Sheetal Rupesh Karwa, Sheri Ussery, Sheromani Bajaj, Sherron C Crook, Shigeyuki Nishimura, Shintaro Nakano, Shirin Heydari, Shiv Kumar Choudhary, Shivali Patel, Shobana Ganesan, Shruti Pandey, Shuyang Zhang, Shweta Hande, Siddharth Gadage, Sik-Yin V Tan, Silvia Zottis Poletti, Silvia Riera, Silvia Valbuena, Simon Walsh, Simona Maspoli, Simone Savaris, Si-Ting Feng, So Yang Cho, Solomon Yakubov, Songlin Zhu, Songtao Wang, Sonia Guerrero, Sonika Gupta, Sonja Salinger Martinovic, Sonya Brons, Sorin Brener, Sothinathan Gurunathan, Souheil Saba, Soundarya Nayak, Sowjanya Reddy, Srinivasa Potluri, Sriram Sudarshan, Srun Kuanprasert, Stacie Van Oosterhout, Stamatios Lerakis, Stanley E Cobos, Stefan C Bertog, Stefan M Simović, Stefan Weikl, Stefano Di Marco, Stefano Provasoli, Stephanie A Tirado, Stephanie C Boer, Stephanie M Lane, Stephanie Ferket, Stephanie Kelly, Stephanie Wasmiller, Stephen H McKellar, Stephen P Hoole, Stephen Fremes, Stephen Preston, Steve Leung, Steven A Fein, Steven J Lindsay, Steven P Sedlis, Steven Giovannone, Steven Michael, Steven Weitz, Stijn van Vugt, Subhash Banerjee, Sudhir Naik, Suellen Hosino, Sukie Desire, Sukit Yamwong, Suku T Thambar, Sulagna Mookherjee, Suman Singh, Sundeep Mishra, Sunil Kumar Verma, Supap Kulthawong, Supatchara Khwakhong, Surendra Naik, Suresh Babu, Surin Woragidpoonpol, Suryaprakash Narayanappa, Susan Derbyshire, Susan Gent, Susan Mathus, Susan Milbrandt, Susan Moore, Susan Regan, Susan Stinson, Susan Webber, Susana Silva, Susanna Stevens, Susanne Gruensfelder, Suthara Aramcharoen, Suvarna Kolhe, Suzana Tavares, Suzanne Arnold, Suzanne Welsh, Svetlana Apostolovic, Swapna Kunhunny, Ta-Chuan Hung, Taissa Zappernick, Tali Sharir, Talita Silva, Tamara Colaiácovo Soares, Tapan Umesh Pillay, Tarun K Mittal, Tatiana Trifonova, Tauane Bello Duarte, Tauqir Huk, Téodora Dutoiu, Terrance Chua, Terry Weyand, Thabitha Charles, Theodoros Kofidis, Theresa McCreary, Thierry Lefevre, Thippeekaa Arumairajah, Thitipong Tepsuwan, Thomas J Mulhearn, Thomas M Meyer, Thomas P Rocco, Thomas R Downes, Thomas Crain, Thomas Haldis, Thomas Mathew, Thomas Redick, Thounaojam Indira Devi, Thuraia Nageh, Tia Cauthren, Tiago Silva, Tiffany Little, Tijana Andric, Tina Harding, Titus Lau, Tiziana Formisano, Tiziano Moccetti, Tomasz Ciurus, Tomasz Mazurek, Tomasz Tarchalski, Toshiyuki Nagai, Tri Tran, Tricia Youn, Trish Tucker, Trudie Milner, Tuhina Bose, Tushar Kotecha, Udo Sechtem, Uma S Valeti, Umberto Cucchini, Umesh Badami, Upendra Kaul, V K Bahl, V S Narain, Valentina Casali, Valeria Godoy, Valerie Robesyn, Vamshi P Priya, Vandana Yadav, Vera McKinney, Veronica De Lenges, Veronica Tinnirello, Vicente Miro, Victor Navarro, Victoria Gumerova, Victoria Hernandez, Vidya Seeratan, Vijay Kumar, Vikentiy Y Kozulin, Viktoria Bulkley, Vilmar Veiga Jr, Vincent Setang, C P Vineeth, Virginai Pubull Nuñez, Virginia Fernández-Figares, Vitor Gomes, Viviana Gabriel, Viviane Dos Santos, Viviane Almeida, Vlad A Iliescu, Vladan Mudrenovic, Vladimir Dzavik, Vojislav L Giga, Walter Enrique Mogrovejo, Wan Xian Chan, Wanda C Marfori, Wanda Parker, Warangkana Mekara, Wassim Nona, Wayne Old, Wayne Pennachi, Weerachai Nawarawong, Wei Chen, Wei Su, Weibing Xing, Wei-Ren Lan, Wenda Crawford, Wendy L Stewart, Wendy Drewes, Wenhua Lin, William B Abernethy, William D Salerno, William F Fearon, William Vergoni, William Weintraub, Winnie C Sia, Wlodzimierz J Musial, Xacobe Flores-Ríos, Xavier Garcia-Moll Marimon, Xi Su, Xiang Ma, Xiangqiong Gu, Xiao Wang, Xiaomei Li, Xiaowei Yao, Xin Fu, Xin Su, Xin Zeng, Xinchun Yang, Xiuhong Li, Xuehua Fang, Xutong Wang, Yaming Geng, Yan Yan, Yanek Pépin-Dubois, Yanfu Wang, Yang Wang, Yanmeng Tian, Yaping Huang, Yechen Han, Yesenia Zambrano, Yi-Hsuan Yang, Ying Tung Sia, Yining Yang, Yitong Ma, Yolayfi Peralta, Yongjian Wu, Yu Kunwu, Yu Zhao, Yudong Peng, Yueh-Hung Lin, Yulan Zhao, Yumei Dong, Yunhai Zhao, Yutthaphan Wannasopha, Yvonne Taul, Zakir Sahul, Zalina Kudzoeva, Zbigniew Kalarus, Zeljko Z Markovic, Zhen Huang, Zheng Ji, Zhenyu Liu, Zhou Yue, Zhulin Zhang, Zhuxi Li, Zile Singh Meharwal, Ziliang Bai, Zixiang Yu, Zohra Huda, Zoltan Davidovits

Subjects
Male, Cardiac Catheterization, Computed Tomography Angiography, medicine.medical_treatment, Myocardial Ischemia, Coronary Disease, Coronary Artery Disease, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Coronary Angiography, ISCHEMIA Research Group, law.invention, Angina, Coronary artery disease, 0302 clinical medicine, Randomized controlled trial, law, Cardiovascular Disease, Myocardial Revascularization, 030212 general & internal medicine, Coronary Artery Bypass, 11 Medical and Health Sciences, Cardiac catheterization, General Medicine, Middle Aged, humanities, Cardiovascular Diseases, Cardiology, Female, Human, medicine.medical_specialty, Ischemia, Article, 03 medical and health sciences, Geriatric cardiology, Percutaneous Coronary Intervention, General & Internal Medicine, Internal medicine, medicine, Humans, Angina, Unstable, Aged, business.industry, Coronary Artery Bypa, Percutaneous coronary intervention, Bayes Theorem, medicine.disease, Heart failure, Quality of Life, business
Abstract

BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Published
2020
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39. Influence of Thoracic Endovascular Repair on Aortic Morphology in Patients Treated for Blunt Traumatic Aortic Injuries: Long Term Outcomes in a Multicentre Study

Author

Elisa Munari, Nicola Tusini, Francesco Andreoli, Roberto Silingardi, Stefano Gennai, Nicola Leone, Raffaella Nice Berchiolli, Luigi Marcheselli, Luciana Arcuri, Gennai S., Leone N., Andreoli F., Munari E., Berchiolli R., Arcuri L., Tusini N., Marcheselli L., and Silingardi R.

Subjects
Male, Time Factors, Thoracic, medicine.medical_treatment, Aorta, Thoracic, 030204 cardiovascular system & hematology, 030230 surgery, Wounds, Nonpenetrating, Endovascular aneurysm repair, 0302 clinical medicine, Retrospective Studie, 80 and over, Thoracic aorta, Young adult, Aorta, Computed tomography angiography, Aged, 80 and over, medicine.diagnostic_test, Thoracic Injurie, Endovascular Procedures, Middle Aged, Blood Vessel Prosthesi, Treatment Outcome, Italy, Wounds, Female, Cardiology and Cardiovascular Medicine, Human, Adult, medicine.medical_specialty, Time Factor, Thoracic Injuries, Vascular Remodeling, Prosthesis Design, Endovascular technique, Blood Vessel Prosthesis Implantation, Young Adult, 03 medical and health sciences, Blunt, Median follow-up, Blood vessel prosthesis, medicine.artery, Blunt injury, medicine, Nonpenetrating, Humans, Aged, Retrospective Studies, Endovascular Procedure, business.industry, Retrospective cohort study, Vascular System Injuries, Blood Vessel Prosthesis, Surgery, business, Vascular System Injurie
Abstract

Objective: The aim of this study was to evaluate aortic remodelling and associated complications in patients treated by thoracic endovascular aneurysm repair (TEVAR) for blunt traumatic aortic injuries (BTAI). Methods: This was a retrospective, observational, multicentre study. Remodelling was considered as aortic diameter variations of >2 mm and distal graft and aortic axis angle modification measured by computed tomography angiography (CTA). The predefined levels of measurement were the proximal end of the graft (D1: landing in zone [LZ] 2; D2: LZ 3); distal end (D3); and control measurement (D4) 15 mm beyond D3. Survival, procedure, graft, and/or radiation exposure related complications were registered. CTA was required within three months and at one, six, and 10 years post-operatively. Results: Between 2004 and 2017 52 patients were treated; 47 were included for remodelling analysis (five immediate deaths were excluded); median age was 47 years (range 20–80 years). Mean TEVAR oversizing was 19.6% ± 9.7% (range 5%–35%). Following a median follow up of 67.4 ± 56.1 months (range 14–153 months) survival at one, three, six, and 10 years was 90.4% (standard error [SE] 4.1%), 88.3% (SE 4.5%) 84.8% (SE 5.5%), and 84.8% (SE 5.5%), respectively. There were no procedure/graft related complications except for one late intramural haematoma that required re-intervention. Freedom from aortic remodelling at one, six, and 10 years was 85.1% (SE 5.2%), 30.9% (SE 8.6%), and 24.7% (SE 8.8%), respectively. The increase in D1/D2 and D3 diameters were influenced by time from intervention (both p

Published
2020
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40. Patellar instability: will my patella dislocate again?

Author

Daniel W. Green, Nicolas Pascual-Leone, and Henry B. Ellis

Subjects
Joint Instability, musculoskeletal diseases, medicine.medical_specialty, Tibia, business.industry, Patellar Dislocation, Patella, Recurrent dislocation, musculoskeletal system, Surgery, Nonoperative treatment, Patellofemoral Joint, Patella dislocation, Pediatrics, Perinatology and Child Health, medicine, Humans, In patient, Child, business, Healthcare providers, Pediatric population, Patient factors
Abstract

Purpose of the review The incidence of patellar instability in pediatric patients ranges is 50-100 in 100,000 patients per year. Risk of recurrent dislocations however has been cited from 8.6% to 88% depending on individual patient factors. This manuscript highlights the demographical, historical, and anatomic factors associated with recurrent patellar instability following a first-time patella dislocation in the pediatric population. Recent findings In recent years, various studies have focused on identifying risk factors for recurrent patellar instability following a primary patellar dislocation. A mix of patient factors, including age of first dislocation, patella alta, elevated tibial tubercle to trochlear groove and trochlear dysplasia have all been noted in the literature, which have helped to develop various scoring tools to predict recurrent dislocation following nonoperative treatment. Summary Risk of recurrent patellar instability in patients who have previously suffered a patellar dislocation can be due to many factors. These risk factors should be used and applied to a variety of risk scores in order to provide physicians and healthcare providers with a tool to counsel patients and families on their patellar redislocation risk and help guide further management.

Published
2021
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41. COVID-19 vaccination in pregnant and lactating women: a systematic review

Author

Maria Familiari, Martino Ruggieri, Raffaele Falsaperla, and Guido Leone

Subjects
medicine.medical_specialty, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), breastfeeding, Immunology, Population, Breastfeeding, Review, lactation, Antibodies, Viral, Pregnancy, Drug Discovery, Pandemic, medicine, Humans, Adverse effect, education, Pandemics, Pharmacology, education.field_of_study, Reactogenicity, business.industry, Obstetrics, Vaccination, Infant, Newborn, COVID-19, vaccines, medicine.disease, Molecular Medicine, Female, Systematic Review, business, Immunity, Maternally-Acquired
Abstract

Introduction The concern of undergoing vaccination during pregnancy and lactation, in absence of data on safety and efficacy in these target populations, is subject of ongoing debate nationally and internationally. However, the only real prophylactic strategy against COVID-19 is still mass vaccination, which means to vaccinate infants and pregnant and lactating women. Areas covered This is a systematic review aiming to evaluate the safety and the efficacy of COVID-19 vaccines in pregnant and lactating women and their newborns. We did advanced research on PubMed and Google Scholar, and searched for any evidence also on ClinicalTrials.gov. Results refer to a timeline going until 12 June 2021. Expert opinion Our efforts must be directed to vaccine more and more population groups which have been preliminarily excluded from the vaccination campaign. Studies have not so far highlighted plausible adverse effects in vaccinated pregnant women or in their newborns. Reactogenicity across lactating and pregnant women does not seem to differ from general population. Likewise, abortion rate does not differ from non-vaccinated pregnant women studied before the COVID-19 pandemic. It also seems that a major amount of anti-SARS-CoV-2 immunoglobulins is transferred through the placenta and the breastmilk to the newborn, providing humoral immunity.

Published
2021
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42. Sham-derived effects and the minimal reliability of theta burst stimulation

Author

Recep Ali Ozdemir, Davide Momi, Ali Jannati, Mouhsin M. Shafi, Peter J. Fried, Pierre Boucher, Emiliano Santarnecchi, M J Burke, and Alvaro Pascual-Leone

Subjects
Adult, Male, medicine.medical_specialty, Repeat visit, Adolescent, Brain activity and meditation, medicine.medical_treatment, Science, CTBS, Long-Term Potentiation, Neuromuscular Junction, Stimulation, Article, Physical medicine and rehabilitation, Initial visit, medicine, Humans, Theta Rhythm, Multidisciplinary, Excitability, business.industry, Brain, Reproducibility of Results, Similar time, Middle Aged, Evoked Potentials, Motor, Transcranial Magnetic Stimulation, Transcranial magnetic stimulation, Theta burst, Medicine, Female, business
Abstract

Theta-burst stimulation (TBS) is a patterned form of repetitive transcranial magnetic stimulation (rTMS) that has been used to induce long-term modulation (plasticity) of corticospinal excitability in a drastically shorter duration protocol than conventional rTMS protocols. In this study we tested the reliability of the effects of two well defined TBS protocols, continuous TBS (cTBS) and intermittent TBS (iTBS), especially in relation to sham TBS, within and across the same 24 participants. All TBS protocols were repeated after approximately 1 month to assess the magnitude and reliability of the modulatory effects of each TBS protocol. Baseline and post-TBS changes in motor evoked potentials (MEP—measure of corticospinal excitability) amplitudes were compared across the cTBS, iTBS and sham TBS protocols and between the initial and retest visits. Overall, across participants, at the initial visit, iTBS facilitated MEPs as compared to baseline excitability, with sham eliciting the same effect. cTBS did not show a significant suppression of excitability compared to baseline MEPs at either visit, and even facilitated MEPs above baseline excitability at a single time point during the repeat visit. Otherwise, effects of TBS were generally diminished in the repeat visit, with iTBS and sham TBS replicating facilitation of MEPs above baseline excitability at similar time points. However, no protocol demonstrated consistent intra-individual modulation of corticospinal excitability upon retest. As the first study to test both iTBS and cTBS against sham TBS across repeat visits, our findings challenge the efficacy and reliability of TBS protocols and emphasize the importance of accounting for sham effects of TBS. Furthermore, given that therapeutic effects of TBS are hypothetically derived from consistent and repeated modulation of brain activity, the non-replicability of plasticity and sham effects call into question these basic mechanisms.

Published
2021

43. Microablative Fractional CO2 Laser for Vulvovaginal Atrophy in Women With a History of Breast Cancer: A Pilot Study at 4-week Follow-up

Author

Marta Parma, Arianna Casiraghi, Stefano Salvatore, Massimo Candiani, Umberto Leone Roberti Maggiore, Rebecca Degliuomini, Rossella E. Nappi, Stavros Athanasiou, and Alessandro F. Ruffolo

Subjects
0301 basic medicine, Cancer Research, medicine.medical_specialty, Visual analogue scale, business.industry, Cancer, medicine.disease, Menopause, 03 medical and health sciences, Sexual intercourse, 030104 developmental biology, 0302 clinical medicine, Breast cancer, Oncology, Quality of life, 030220 oncology & carcinogenesis, Internal medicine, medicine, Sexual function, Prospective cohort study, business
Abstract

Background Breast cancer (BC) is the most common female cancer worldwide. Menopausal symptoms are a well-known side effect in women with BC and have a significant negative impact on quality of life (QoL) and sexuality. Nowadays, hormonal replacement therapy and local estrogens are the most common prescriptions to treat vulvovaginal (VVA) symptoms. However, in women with a history of BC, proper therapy for such conditions remains an often inadequately addressed clinical problem. A treatment with microablative fractional CO2 laser (MLT) can produce a remodeling of the vaginal connective tissue without causing damage to the surrounding tissue. The aim of this pilot study is to assess the efficacy and safety of MLT for treating VVA symptoms in women with a history of BC at 20-week follow-up since the first laser treatment. Patients and Methods Women with BC and VVA symptoms were enrolled in the study and treated with 5 laser applications (one every 4 weeks). The rate of satisfied patients at 20 weeks of follow-up was evaluated with a 5-point Likert scale. Changes of the Vaginal Health Index (VHI) after treatment was compared with baseline. Effects of the laser treatment on VVA symptoms was measured using a 10-cm visual analog scale (VAS). Changes in overall QoL were assessed with a generic QoL questionnaire: the Short Form 12 (SF-12) that we analyzed considering its physical (PCS12) and mental (MCS12) domains. Sexual function was evaluated by the Female Sexual Function Index (FSFI). Results In this prospective cohort study, we enrolled 40 women with a history of BC and who currently were or (Group 2) who had been (Group 1) on treatment with endocrine therapy for their condition. Six (15.0%) women were very satisfied, 25 (62.5%) were satisfied, 6 (15.0%) were uncertain, and 3 (7.5%) were dissatisfied with the MLT. VVA symptoms and VHI improved significantly at 20 weeks from baseline (P .05). In terms of QoL measured by the SF-12, the PCS12 and the MCS12 significantly improved at the 20-week follow-up. A significant improvement in total FSFI and in all domains was reported in both study groups (P .05). Conclusion MLT was safe and effective in treating VVA symptoms in women with a history of BC, irrespective of being previously or currently on endocrine therapies.

Published
2021
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44. VP34.05: The influence of maternal hemodynamics on neonatal birthweight in pregnancies complicated by gestational diabetes compared to low‐risk controls

Author

Hatem A Mousa, N. Walkinshaw, M.W. Osman, K. Melhuish, David R. Webb, F. Leone, A. Clark, Thompson G. Robinson, Asma Khalil, and A. Anness

Subjects
Gestational diabetes, medicine.medical_specialty, Reproductive Medicine, Radiological and Ultrasound Technology, business.industry, Obstetrics, Maternal hemodynamics, medicine, Obstetrics and Gynecology, Radiology, Nuclear Medicine and imaging, General Medicine, medicine.disease, business
Published
2021
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45. Hepatic Liquoric Cyst as a Complication of Ventriculoperitoneal Shunt Insertion: A Case Report

Author

Nivaldo S. Almeida, Arlindo Ugulino Netto, Lucas Freitas, Davi Coutinho Marcelino Guerra Leone, Kauê Franke, Eduardo Vieira de Carvalho Júnior, Hildo Azevedo-Filho, Diego Pereira de Melo Oliveira, Lívio Pereira de Macêdo, Pierre Vansant Oliveira Eugenio, and Igor Vilela Faquini

Subjects
medicine.medical_specialty, RD1-811, business.industry, macromolecular substances, medicine.disease, Shunt (medical), Hydrocephalus, Surgery, Catheter, medicine.anatomical_structure, Cerebrospinal fluid, Peritoneum, cerebrospinal fluid pseudocyst, ventriculoperitoneal shunt, Medicine, Cyst, Neurology (clinical), Hepatic Cyst, business, Complication, hepatic cyst
Abstract

Background The ventriculoperitoneal shunt (VPS) procedure is still the most used technique for management of hydrocephalus. This article reports a case of hepatic cerebrospinal fluid (CSF) pseudocyst as a rare, but important, complication of the VPS insertion. Case Description An 18-year-old male presented to the hospital complaining of temporal headache and visual turbidity for approximately 3 months with a history of VPS insertion for treatment of hydrocephalus and revision of the valve in adolescence. The diagnosis was based on abdominal imaging, demonstrating an extra-axial hepatic CSF pseudocyst free from infection. Following the diagnosis, the management of the case consisted in the removal and repositioning of the catheter on the opposite site of the peritoneum. Conclusion The hepatic CSF pseudocyst is an infrequent complication of VPS procedure, but it needs to be considered when performing the first evaluation of the patient. Several techniques are considered efficient for the management of this condition, the choice must be made based on the variables of each individual case.

Published
2021
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46. Multitarget Transcranial Electrical Stimulation for Freezing of Gait: A Randomized Controlled Trial

Author

Veronique G.J.M. VanderHorst, Lewis A. Lipsitz, Jeffrey M. Hausdorff, Natalia Gouskova, Nir Giladi, Talia Herman, Alvaro Pascual-Leone, Brad Manor, Thomas G. Travison, and Moria Dagan

Subjects
medicine.medical_specialty, Parkinson's disease, genetic structures, medicine.medical_treatment, Prefrontal Cortex, Stimulation, Transcranial Direct Current Stimulation, law.invention, Physical medicine and rehabilitation, Double-Blind Method, Randomized controlled trial, law, Humans, Daily living, Medicine, Gait, Gait Disorders, Neurologic, Transcranial direct-current stimulation, business.industry, Motor Cortex, Parkinson Disease, medicine.disease, Neurology, Test performance, Neurology (clinical), Primary motor cortex, business
Abstract

Background Treatments of freezing of gait (FOG) in Parkinson's disease are suboptimal. Objective The aim of this study was to evaluate the effects of multiple sessions of transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex and primary motor cortex (M1) on FOG. Methods Seventy-seven individuals with Parkinson's disease and FOG were enrolled in a double-blinded randomized trial. tDCS and sham interventions comprised 10 sessions over 2 weeks followed by five once-weekly sessions. FOG-provoking test performance (primary outcome), functional outcomes, and self-reported FOG severity were assessed. Results Primary analyses demonstrated no advantage for tDCS in the FOG-provoking test. In secondary analyses, tDCS, compared with sham, decreased self-reported FOG severity and increased daily living step counts. Among individuals with mild-to-moderate FOG severity, tDCS improved FOG-provoking test time and self-report of FOG. Conclusions Multisession tDCS targeting the left dorsolateral prefrontal cortex and M1 did not improve laboratory-based FOG-provoking test performance. Improvements observed in participants with mild-to-moderate FOG severity warrant further investigation. © 2021 International Parkinson and Movement Disorder Society.

Published
2021
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47. Single or dual antiplatelet therapy after transcatheter aortic valve implantation. A meta-analysis of randomized controlled trials

Author

Jorge Sanz-Sánchez, and Giulio G. Stefanini, Pier Pasquale Leone, Gennaro Petriello, Carlo Andrea Pivato, Bernhard Reimers, Damiano Regazzoli, Mauro Chiarito, and Gianluigi Condorelli

Subjects
Antithrombotic therapy, medicine.medical_specialty, Transcatheter aortic, Aspirin, business.industry, Antiplatelet therapy, Bleeding, DUAL (cognitive architecture), law.invention, TAVI, Randomized controlled trial, law, Meta-analysis, Internal medicine, Cardiology, Medicine, Cardiology and Cardiovascular Medicine, business
Abstract

Introduction and objectives: Current expert consensus guidelines recommend dual antiplatelet therapy (DAPT) with aspirin and clopidogrel as antithrombotic strategy after transcatheter aortic valve implantation (TAVI) in patients without an indication for long-term oral anticoagulation. However, these recommendations have not been developed based on the results of large randomized clinical trials. The objective of this study is to compare single antiplatelet therapy (SAPT) to DAPT in patients without an indication for long-term anticoagulation after TAVI. Methods: The PubMed, Embase, and the main international conference proceedings were reviewed in the search for randomized controlled trials comparing SAPT to DAPT after TAVI. Data were pooled using a meta-analysis and a random-effects model. The primary endpoint was life-threatening or major bleeding. Results: Four trials enrolling 1086 patients were included. Compared to patients treated with DAPT, those treated with SAPT showed a lower risk of life-threatening or major bleeding (OR, 0.44; 95%CI, 0.27-0.70), and any bleeding (OR, 0.51; 95%CI, 0.36-0.71). No differences were observed between patients treated with SAPT compared to those treated with DAPT regarding all-cause mortality (OR, 1.01; 95%CI, 0.61-1.68), myocardial infarction (OR, 0.50; 95%CI 0.17-1.41), and stroke (OR, 0.98; 95%CI, 0.54-1.77). Conclusions: In patients without an indication for long-term anticoagulation undergoing TAVI, single antiplatelet therapy with aspirin compared to DAPT is associated with a lower risk of life-threatening or major bleeding and a comparable risk of all-cause mortality, myocardial infarction, and stroke.

Published
2021

48. The Term Newborn

Author

Wanda Abreu and Tina A. Leone

Subjects
medicine.medical_specialty, Neonatal intensive care unit, business.industry, Delivery room, Breastfeeding, Obstetrics and Gynecology, Disease, Infant newborn, Triage, Term (time), Pediatrics, Perinatology and Child Health, Medicine, business, Intensive care medicine
Abstract

Term newborn infants without significant medical problems usually transition from fetal to newborn life without medical assistance. Infants requiring therapy often need care in a neonatal intensive care unit as opposed to a well-baby unit. Infants with unclear physiologic status or disease that may require therapies in the immediate newborn period may benefit from a period of observation with close monitoring before admission to a well-baby unit. Whenever possible, providing care for a newborn infant in an area that provides care for the newborn and mother together in the same room facilitates adaptation to normal breastfeeding and family bonding.

Published
2021
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49. Targeted Therapies for Breast Cancer Brain Metastases

Author

Jose Pablo Leone and Ayse Ece Cali Daylan

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Population, Breast Neoplasms, Blood–brain barrier, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Breast cancer, Internal medicine, Humans, Medicine, Molecular Targeted Therapy, Epidermal growth factor receptor, education, PI3K/AKT/mTOR pathway, education.field_of_study, biology, Brain Neoplasms, business.industry, medicine.disease, Metastatic breast cancer, Vascular endothelial growth factor, Clinical trial, 030104 developmental biology, medicine.anatomical_structure, chemistry, 030220 oncology & carcinogenesis, biology.protein, Female, business
Abstract

The management of breast cancer, the most common cancer in the female population, has changed dramatically over years with the introduction of newer therapies. An increased incidence of brain metastases in recent years has created a challenge for oncologists because this population continues to have a poorer prognosis compared to metastatic breast cancer without central nervous system involvement. Historically, the exclusion of breast cancer patients with brain metastases from clinical trials has made treatment options even more limited. Nonetheless, more recently, this unmet need has been recognized by basic and clinical researchers and has led to the development of targeted therapies with better blood-brain barrier penetration and intracranial efficacy. Here we review targeted therapies directed at human epidermal growth factor receptor type 2 (HER2), vascular endothelial growth factor (VEGF), mammalian target of rapamycin (mTOR), epidermal growth factor receptor (EGFR), cyclin-dependent kinase 4 and 6 (CDK4/6) and poly(ADP-ribose) polymerase (PARP) for breast cancer patients with brain metastases. These therapies aim to be more efficacious and less toxic to represent a paradigm shift in the management of breast cancer brain metastases.

Published
2021
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50. Prenatal Exposure to BPA: The Effects on Hepatic Lipid Metabolism in Male and Female Rat Fetuses

Author

Alessandro Leone, Marco Segatto, Simona Bertoli, Arianna Mazzoli, Luisa Cigliano, Valentina Pallottini, Claudia Tonini, Maurizio Mandalà, Laura Barberio, Tonini, C., Segatto, M., Bertoli, S., Leone, A., Mazzoli, A., Cigliano, L., Barberio, L., Mandala, M., Pallottini, V., Tonini, Claudia, Segatto, Marco, Bertoli, Simona, Leone, Alessandro, Mazzoli, Arianna, Cigliano, Luisa, Barberio, Laura, Mandalà, Maurizio, and Pallottini, Valentina

Subjects
0301 basic medicine, Male, Chemical compound, bisphenol A, 010501 environmental sciences, 01 natural sciences, Rats, Sprague-Dawley, chemistry.chemical_compound, Bisphenol A, Pregnancy, TX341-641, Fetu, 3-hydroxy 3-methylglutaryl coenzyme A reductase, acyl coenzyme A carboxylase, bisphenol A, cholesterol, fatty acids, fetuses, liver, Benzhydryl Compound, Nutrition and Dietetics, Fetuse, Lipid, Lipids, Cholesterol, Liver, In utero, Prenatal Exposure Delayed Effects, Female, hormones, hormone substitutes, and hormone antagonists, medicine.medical_specialty, endocrine system, Offspring, Acyl coenzyme A carboxylase, liver, fatty acids, Prenatal Exposure Delayed Effect, Article, 3-hydroxy 3-methylglutaryl coenzyme A reductase, Fatty acids, Fetuses, Animals, Benzhydryl Compounds, Estrogen Receptor alpha, Fetus, Inflammation, Lipid Metabolism, Phenols, 03 medical and health sciences, Internal medicine, medicine, Prenatal exposure, 0105 earth and related environmental sciences, Phenol, Nutrition. Foods and food supply, business.industry, Animal, urogenital system, cholesterol, Metabolism, Fatty acid, Rats, 030104 developmental biology, Endocrinology, chemistry, Hepatic lipid, fetuses, acyl coenzyme A carboxylase, Sprague-Dawley, business, Food Science
Abstract

Bisphenol A (BPA) is an organic chemical compound widely used for manufacturing plastics. BPA exposure originates principally from the diet, but it can also originate from dermal contact. In over 90% of individuals, including pregnant women, BPA is detectable in several body fluids. The effects of this exposure on the fetus are under active investigation in several research laboratories. The aim of our work was to study the impact of prenatal exposure to BPA in the liver of rat fetuses from a sex-dependent point of view. We particularly investigated the effects of prenatal BPA exposure on hepatic lipids because of their crucial role, not only for the liver, but also for the whole-body functions. Our results demonstrate that the liver of rat fetuses, in utero exposed to a very low dose of BPA (2.5 µg/kg/day), displays significant modulations with regard to proteins involved in cholesterol and fatty acid biosynthesis and trafficking. Moreover, an impact on inflammatory process has been observed. All these effects are dependent on sex, being observable only in female rat fetuses. In conclusion, this work demonstrates that maternal exposure to BPA compromises hepatic lipid metabolism in female offspring, and it also reveals the perspective impact of BPA on human health at doses currently considered safe.

Published
2021

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