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1. A cost-of-illness study of spina bifida in Italy

Author

Colombo GL, Di Matteo S, Vinci M, Gatti C, Pascali MP, De Gennaro M, Macrellino E, Mosiello G, Redaelli T, Schioppa F, and Dieci C

Subjects
Medicine (General), R5-920, Therapeutics. Pharmacology, RM1-950
Abstract

Giorgio L Colombo,1,2 Sergio Di Matteo,2 Marta Vinci,3 Claudia Gatti,4 Maria Paola Pascali,5 Mario De Gennaro,6 Elena Macrellino,7 Giovanni Mosiello,5 Tiziana Redaelli,7 Francesca Schioppa,7 Cristina Dieci8 1University of Pavia, Department of Drug Sciences, School of Pharmacy, Pavia, Italy; 2S.A.V.E. Studi Analisi Valutazioni Economiche, Milan, Italy; 3Associazione Walter Vinci Onlus, Milan, Italy; 4Centro Spina Bifida, Azienda Ospedaliera di Parma, Parma, Italy; 5Centro Spina Bifida, Ospedale Pediatrico Bambino Gesù, Rome, Italy; 6Ospedale Pediatrico Bambino Gesù, O.C. di Urodinamica, Rome, Italy; 7Centro Spina Bifida, Ospedale Niguarda Milan, Italy; 8ASBI Associazione Spina Bifida Italia, Piacenza, Italy Introduction: Spina bifida (SB) is a congenital malformation of the spinal cord, nerves, and adjacent covering structures, with different levels of severity and functional disability. The economic cost of spina bifida and its prevention using folic acid have never been estimated in Italy. This study was conducted to define the cost of illness of SB in Italy. Methods: A retrospective multicenter observational study on the social cost of patients with SB was carried out in three SB centers in Italy. Cost data were collected relating to the 12 months preceding the enrollment time (T0), and subsequently 3 months after the T0 time (±20 days) through a case report form designed to collect the relevant information on the costs incurred during the period considered. The data for all patients were analyzed through multivariate analysis on the main parameters. Results: We enrolled 128 patients equally divided between males and females, with a mean age of 13 years (minimum, 0; maximum, 29). Diagnosis was mostly postnatal, with 64 cases diagnosed at birth and 33 cases diagnosed subsequently. The lesion severity levels, as defined in the inclusion criteria, were walking (52 patients); walking with simple orthoses (33 patients); walking with complex orthoses (16 patients); and nonwalking, (25 patients). The anatomic type identified is open SB in most cases (84 patients), followed by closed SB (37 patients) and SB occulta (3 patients). The most significant cost per year was for assistive devices, for a total of 4307.00 €, followed by hospitalization (907.00 €), examinations (592.00 €), and drug therapy (328.00 €). Cost breakdown by age range shows that the highest costs are incurred in the 0–4 age range. The highest cost was for cases of open SB (12,103.00 €). The cost/degree of severity ratio showed that the highest cost was for nonwalking patients (14,323.00 €), followed by patients walking with complex orthoses (13,799.00 €). Conclusion: The data from this study show that the mean total cost for a patient with SB was 11,351.00 € per year. Based on data provided by the Italian Institute of Health, we can estimate a total annual social cost of about 60 million Euros per year for SB in Italy. Cost of illness was correlated with age and degree of severity of SB. Keywords: spina bifida, cost of illness, pharmacoeconomics, cost analysis

Published
2013

10. Definition, diagnosis and management of fetal lower urinary tract obstruction: consensus of the ERKNet CAKUT-Obstructive Uropathy Work Group

Author

Capone, V., Persico, N., Berrettini, A., Decramer, S., Marco, E.A. De, Palma, D., Familiari, A., Feitz, W., Herthelius, M., Kazlauskas, V., Liebau, M., Manzoni, G. de, Maternik, M., Mosiello, G., Schanstra, J.P., Walle, J. Vande, Wühl, E., Ylinen, E., Zurowska, A., Schaefer, F., Montini, G., Capone, V., Persico, N., Berrettini, A., Decramer, S., Marco, E.A. De, Palma, D., Familiari, A., Feitz, W., Herthelius, M., Kazlauskas, V., Liebau, M., Manzoni, G. de, Maternik, M., Mosiello, G., Schanstra, J.P., Walle, J. Vande, Wühl, E., Ylinen, E., Zurowska, A., Schaefer, F., and Montini, G.

Abstract

Item does not contain fulltext, Fetal lower urinary tract obstruction (LUTO) is associated with high mortality and postnatal morbidity caused by lung hypoplasia and impaired kidney function. Specific diagnostic features that can guide clinical approach and decisions are lacking; thus, the European Reference Network for Rare Kidney Diseases established a work group to develop recommendations regarding the clinical definition, diagnosis and management of prenatally detected LUTO. The work group recommends the use of antero-posterior diameter of renal pelvis as the most reliable parameter for suspecting obstructive uropathies and for suspecting prenatal LUTO in the presence of fetal megacystis. Regarding prenatal and postnatal prognosis of fetuses with LUTO, the risk of fetal and neonatal death depends on the presence of oligohydramnios or anhydramnios before 20 weeks' gestation, whereas the risk of kidney replacement therapy cannot be reliably foreseen before birth. Parents of fetuses with LUTO must be referred to a tertiary obstetric centre with multidisciplinary expertise in prenatal and postnatal management of obstructive uropathies, and vesico-amniotic shunt placement should be offered in selected instances, as it increases perinatal survival of fetuses with LUTO.

Published
2022

27. Short versus mid-long-term outcome of transanal irrigation in children with spina bifida and anorectal malformations

Author

Ausili, E, Marte, A, Brisighelli, G, Midrio, P, Mosiello, G, La Pergola, E, Lombardi, L, Iacobelli, Bd, Caponcelli, E, Meroni, M, Leva, E, Rendeli, Claudia, Rendeli, C (ORCID:0000-0002-5948-1617), Ausili, E, Marte, A, Brisighelli, G, Midrio, P, Mosiello, G, La Pergola, E, Lombardi, L, Iacobelli, Bd, Caponcelli, E, Meroni, M, Leva, E, Rendeli, Claudia, and Rendeli, C (ORCID:0000-0002-5948-1617)

Abstract

PurposeWe assessed short- and mid-long-term clinical efficacy of transanal irrigation (TAI) and its effect on the quality of life of children with spina bifida (SB) and anorectal malformations (ARM).MethodsSeventy-four pediatric patients (age 6-17years) with SB and ARM with neurogenic bowel dysfunction were enrolled for a prospective and multicentric study. Patients were evaluated before the beginning of TAI (T0), after 3months (T1) and after at least 2years (range 24-32months) (T2) using a questionnaire assessing bowel function, the Bristol scale, and two validated questionnaires on quality of life: the CHQ-PF50 questionnaire for the parents of patients aged 6-11years and the SF36 questionnaires for patients aged between 12 and 18years.ResultsSeventy-two patients completed TAI program in T1, and 67 continued into T2. Bowel outcomes (constipation and fecal incontinence) improved in both the SB and the ARM groups in the short and mid-long term. In both groups at T1 and T2, parents and children reported an improvement in quality of life and there was a significant increase of stool form types 4 and 5 as described by the Bristol scale. Common adverse effects during the study were similar at T1 and T2 without serious complications.ConclusionsWe observed a sustained improvement in bowel management and quality of life in SB and ARM children during the study, more significant in the short term than in mid-long term. To maintain success rates in the mid-long term and to reduce the dropout rate, we propose patient training and careful follow-ups.

Published
2018

32. Effet des anticorps anti-facteur de croissance administrés localement sur la formation d'hyperplasie néointimale dans les prothèses en polytétrafluoroéthylène expansé

Author

Alessandra Cucina, Simonetta Iacovitti, Mosiello G, Valeria Borrelli, Antonino Cavallaro, Ursula Basile, Luca di Marzo, and Paolo Sapienza

Subjects
business.industry, Medicine, Electrical and Electronic Engineering, business, Molecular biology, Atomic and Molecular Physics, and Optics
Abstract

Le blocage selectif du facteur de croissance de derive plaquettaire (PDGF-BB), du facteur de croissance basique de fibroblaste (bFGF), et du facteur de croissance transformant β1 (TGF-β1) par des anticorps specifiques enduits dans des greffes de polytetrafluoroethylene expanse (ePTFE) peut diminuer l'hyperplasie neointimale. Soixante porcs ont ete divises en deux groupes ( n = 30), puis divises en cinq sous-groupes. Le groupe 1 avait subi une interposition iliaque bilaterale d'ePTFE enduit de Matrigel™. Trois sous-groupes (A, B, et C) ont recu un anticorps monoclonal specifique contre PDGF-BB, bFGF, ou TGF-β1. Un groupe (D) a recu tous les anticorps, et un autre groupe (E) a servis de controle (isotypes non immunes d'immunoglobulines G [IgG]). Le groupe 2 avait subi une interposition iliaque bilaterale d'ePTFE couvert de cellules endotheliales (CE) dans la Matrigel. Trois sous-groupes (A, B, et C) ont recu un anticorps specifique contre PDGF-BB, bFGF, ou TGF-β1. Un groupe (D) a recu tous les anticorps, et un autre groupe (E) a servis de controle (isotypes non immunes d'immunoglobulines G [IgG]). La microscopie photonique et l'immunohistomarquage ont prouve que la formation d'hyperplasie neointimale etait sensiblement reduite dans les sous-groupes D compares aux autres ( p p p p p

Published
2009

33. The Effect of Locally Administered Anti-Growth Factor Antibodies on Neointimal Hyperplasia Formation in Expanded Polytetrafluoroethylene Grafts

Author

Antonino Cavallaro, Alessandra Cucina, Valeria Borrelli, Mosiello G, Simonetta Iacovitti, Ursula Basile, Paolo Sapienza, and Luca di Marzo

Subjects
Swine, medicine.medical_treatment, Basic fibroblast growth factor, Becaplermin, Immunoglobulin G, chemistry.chemical_compound, Coated Materials, Biocompatible, Polytetrafluoroethylene, Cells, Cultured, Platelet-Derived Growth Factor, Neointimal hyperplasia, biology, Antibodies, Monoclonal, Proto-Oncogene Proteins c-sis, General Medicine, Immunohistochemistry, Drug Combinations, Models, Animal, Female, Fibroblast Growth Factor 2, Proteoglycans, Collagen, Cardiology and Cardiovascular Medicine, medicine.drug_class, Blotting, Western, Enzyme-Linked Immunosorbent Assay, Prosthesis Design, Monoclonal antibody, Iliac Artery, Transforming Growth Factor beta1, Andrology, Blood Vessel Prosthesis Implantation, Organ Culture Techniques, medicine, Animals, Cell Proliferation, Matrigel, Hyperplasia, business.industry, Growth factor, Endothelial Cells, medicine.disease, Blood Vessel Prosthesis, chemistry, Immunology, Microscopy, Electron, Scanning, biology.protein, Surgery, Laminin, Tunica Intima, business, Transforming growth factor
Abstract

The selective blockage of platelet-derived growth factor BB (PDGF-BB), basic fibroblast growth factor (bFGF), and transforming growth factor beta1 (TGF-beta1) by specific antibodies coated into expanded polytetrafluoroethylene (ePTFE) grafts may diminish neointimal hyperplasia. Sixty pigs were divided into two groups (n = 30 each) and then further divided into five subgroups. Group 1 had a bilateral iliac artery ePTFE interposition graft precoated with Matrigel. Three subgroups (A, B, and C) received a specific monoclonal antibody against PDGF-BB, bFGF, or TGF-beta1. One (D) received all antibodies, and one served as control (nonimmune immunoglobulin G [IgG] isotypes) (E). Group 2 had a bilateral iliac artery endothelial cell (EC)-seeded ePTFE interposition graft precoated with Matrigel. Three subgroups (A, B, and C) received a specific antibody against PDGF-BB, bFGF, or TGF-beta1. One (D) received all antibodies, and one served as control (nonimmune IgG isotypes) (E). Light microscopy and immunohistochemical stain showed that neointimal hyperplasia formation was significantly reduced in subgroups D compared to the others (p < 0.05). In subgroups D, the different precoating influenced neointimal hyperplasia formation. It was more pronounced in the prosthesis precoated with EC and Matrigel (p < 0.05). In organ culture, the amount of PDGF-BB, bFGF, and TGF-beta1 release was reduced in subgroup D animals compared to the others (p < 0.05). In subgroups D, the release of PDGF-BB, bFGF, and TGF-beta1 depended on ePTFE seeding. A higher amount of these growth factors was released in the prostheses precoated with EC and Matrigel (p < 0.05), and the bromodeoxyuridine labeling index confirmed higher incorporation in this subgroup (p < 0.001). The combined use of locally administered anti-PDGF-BB, bFGF, and TGF-beta1 monoclonal antibodies reduces neointimal hyperplasia formation.

Published
2009

34. Efecto de la administración local de anticuerpos anti-factor del crecimiento sobre la hiperplasia neointimal en injertos de PTFE

Author

Alessandra Cucina, Ursula Basile, Mosiello G, Luca di Marzo, Valeria Borrelli, Paolo Sapienza, Antonino Cavallaro, and Simonetta Iacovitti

Subjects
General Computer Science
Abstract

La neutralizacion selectiva del factor de crecimiento BB derivado de las plaquetas (PDGF-BB), el factor basico de crecimiento fibroblastico (bFGF), y el factor de crecimiento transformante beta 1 (TGF-beta 1 ) mediante anticuerpos especificos administrados localmente a injertos de politetrafluoroetileno expandido (PTFEe) puede disminuir la hiperplasia neointimal. Se dividieron 60 cerdos en dos grupos (n = 30 cada uno) y, a continuacion, se dividieron adicionalmente en cinco subgrupos. El grupo 1 se sometio a la colocacion de un injerto de interposicion PTFEe pretratado con Matrigel® en la arteria iliaca bilateral. Tres subgrupos (A, B y C) recibieron un anticuerpo monoclonal especifico anti-PDGF-BB, bFGF o TGF-beta 1 . Otro (D) recibio todos los anticuerpos y el otro sirvio como control (sin isotipos inmunes de inmunoglobulina G [IgG]) (E). El grupo 2 se sometio a la implantacion de un injerto de interposicion de PTFEe pretratado con Matrigel® sobre el que se sembraron celulas endoteliales (CE) de arteria iliaca bilateral. Tres subgrupos (A, B y C) recibieron un anticuerpo especifico frente a PDGF-BB, bFGF o TGF-beta 1 . Uno (D) recibio todos los anticuerpos y uno sirvio como control (sin isotipos inmunes IgG) (E). La microscopia optica y la tincion inmunohistoquimica revelaron que la formacion de hiperplasia neointimal se redujo significativamente en los subgrupos D comparados con los otros (p 1 en los animales del subgrupo D comparado con los otros (p 1 dependio del pretratamiento de PTFEe. Se libero una mayor cantidad de estos factores de crecimiento en las protesis pretratadas con CE y Matrigel (p 1 , administrados localmente, reduce la formacion de hiperplasia neointimal.

Published
2009

36. TIMP-2 Modulates Neointimal Formation in Experimental ePTFE Arterial Grafts

Author

Antonino Cavallaro, Giuseppe Cavallaro, Giorgio De Toma, Alessandra Cucina, Mosiello G, Andrea Polistena, Bruto Randone, and Pierpaolo Coluccia

Subjects
Male, Neointima, Pathology, medicine.medical_specialty, Reconstructive surgery, TIMP-2, neointima, arterial graft, Antineoplastic Agents, Matrix Metalloproteinase Inhibitors, Matrix (biology), Muscle, Smooth, Vascular, Extracellular matrix, Postoperative Complications, medicine.artery, medicine, Animals, Thoracic aorta, Aorta, Abdominal, Polytetrafluoroethylene, Tissue Inhibitor of Metalloproteinase-2, business.industry, Abdominal aorta, Antibodies, Monoclonal, Immunohistochemistry, Blood Vessel Prosthesis, Extracellular Matrix, Rats, Surgery, medicine.anatomical_structure, Rats, Inbred Lew, eptfe grafts, extracellular matrix, timp-2, Matrix Metalloproteinase 2, Endothelium, Vascular, Tunica Intima, business, Extracellular Matrix Degradation, Artery
Abstract

Background In vascular reconstructive surgery, myointimal hyperplasia contributes to the adverse outcome of synthetic grafts. This phenomenon is because of unregulated extracellular matrix degradation and remodeling, and excessive smooth muscle cell proliferation and migration. Matrix metallopreoteinase 2 (MMP-2) is known as an important contributor to these events. The aims of our study was to investigate the effects of selective MMP-2 inhibitor (TIMP-2) in endothelialization rate, SMC proliferation, and myointimal hyperplasia in experimental ePTFE arterial grafts. Methods In 20 male Lewis rats, a 1-cm long ePTFE graft has been inserted at the level of the abdominal aorta. Animals were randomized in two groups (10 animals each): group A received six subcutaneous inoculations of TIMP-2 (2.5 μg) after surgery, group B received only the vehicle of TIMP-2. Results Neointimal thickness, as well as SMC density, were augmented in group B, whereas endothelial cells density was augmented in group A, and these findings were statistically significant. In group A SMC were better organized, just like SMC of thoracic aorta. In group B SMC were no organized. Furthermore, anti-TIMP-2 and anti-MMP-2 coloration revealed higher levels of TIMP-2 and lower levels of MMP-2 in group A versus group-B. Conclusions Use of TIMP-2 affects the neointimal formation of experimental e-PTFE arterial grafts, leading to a better-organized neointima, with improved endothelialization.

Published
2007

37. Peristeen®transanal irrigation in paediatric patients with anorectal malformations and spinal cord lesions: a multicentre Italian study

Author

Midrio, P., primary, Mosiello, G., additional, Ausili, E., additional, Gamba, P., additional, Marte, A., additional, Lombardi, L., additional, Iacobelli, B. D., additional, Caponcelli, E., additional, Marrello, S., additional, Meroni, M., additional, Brisighelli, G., additional, Leva, E., additional, and Rendeli, C., additional

Published
2016
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41. Isolated Fetal Ascites Secondary to Persistent Urogenital Sinus

Author

Camanni, D., Zaccara, A., Capitanucci, M. L., Mosiello, G., Capolupo, I., Iacobelli, B. D., and De Gennaro, M.

Subjects
Article Subject
Abstract

Objective. To present a case of isolated ascites secondary due to urogenital abnormalities (urogenital sinus) without any other prenatal ultrasound marker. Method. A 36-year-old woman with prenatal isolated ascites delivered a female baby, weighing 2.285 g; ascites was drained at birth and the baby underwent several episodes of urinary retention prior to undergoing X-ray investigations. Results. A voiding cystourethrogram revealed a short urogenital sinus: a vesicostomy was performed. A vaginoscopy revealed double vagina with a large posterior vagina. A posterior sagittal anorectal pull-through with genitoplasty was performed at 2 years old with 1-year follow-up. Conclusions. Though rare, a urogenital abnormality is to be suspected in fetal ascites cases with negative viral tests and no cardiac anomalies. The most common ultrasound marker of such abnormalities (fluid filled cavity) may be missing because of complete drainage of urine through the tubes into peritoneum.

Published
2009
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46. An unusual case of synovial cyst of the hip joint presenting as femoral vessels compression and severe lower limb edema

Author

Enrico Moroni, Marco Colasanti, Mosiello G, L. Di Marzo, F. Postacchini, and Paolo Sapienza

Subjects
Male, musculoskeletal diseases, medicine.medical_specialty, Lower limb edema, Peripheral vascular surgery, Femoral vein, Leg edema, Femoral vein compression, Constriction, Pathologic, Surgical removal, International literature, medicine, Humans, Synovial cyst, Aged, Medicine(all), Unusual case, Patient affected, business.industry, Compression (physics), Surgery, femoral vein, Synovial cyst, femoral vein, edema, Lower Extremity, Hip Joint, Radiology, Cardiology and Cardiovascular Medicine, business, edema
Abstract

Introduction Synovial cyst of the hip joint causing the compression of the femoral vein is a rare occurrence. We carefully reviewed the international literature collecting 26 additional cases. Report A case of a patient affected with synovial cyst of the hip joint causing the compression of the femoral vein and severe lower limb edema is presented. Discussion The treatment of choice of synovial cyst compressing the femoral vein is surgical removal.

Published
2006

50. [Vertebral schisis in enuretic children: preliminary results of a statistical analysis]

Author

Ml, Capitanucci, Colaiacomo M, Massimiliano Silveri, Silvano A, Mosiello G, and De Gennaro M

Subjects
Male, Adolescent, Data Interpretation, Statistical, Urinary Bladder, Humans, Female, Urography, Enuresis, Child, Spine, Congenital Abnormalities
Abstract

It is well known that vertebral schisis is frequent in enuretic children but the true incidence in the normal population is not clear, because all series published are referred to children with associated urinary anomalies, who were submitted to voiding cystography and or intravenous pyelography. This determine a statistical bias. The aim of our study was to compare the prevalence of vertebral schisis in enuretic children and in the general pediatric population. Therefore, we chose 142 enuretic children without associated urological or neurological anomalies and a control group of 152 children, assumed as general population, who were submitted to spinal X-rays during screening for scoliosis or congenital dysplasia of the hip. Vertebral schisis was found in 65% (93/142) of enuretics and in 18% (28/152) of control group children. Maximum association between enuresis and vertebral schisis was found in primary monosymptomatic nocturnal enuresis (82%), while minimum association was found in children with secondary enuresis (57%). The difference in percentage of association enuresis-schisis was statistically significant between enuretics and control group and between primary monosymptomatic and secondary enuresis (p0.001). The results of this paper are simply add knowledges on the prevalence of the sacral schisis in enuretic children. But, to speculate the different prevalence in different types of enuresis, the results should confirm that the phenomenon of enuresis is multifactorial and the primary monosymptomatic and secondary enuresis have different etiological factor.

Published
1998

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