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Ribichini F.,University of Verona | Romano M.,Azienda Ospedaliera Carlo Poma | Rosiello R.,Azienda Ospedaliera Carlo Poma | La Vecchia L.,Ospedale San Bortolo | And 25 more authors.
JACC: Cardiovascular Interventions | Year: 2013

Objectives This study sought to investigate the efficacy and performance of the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in the treatment of de novo coronary lesions in patients with 2- to 3-vessel multivessel coronary artery disease (MV-CAD). Background Drug-eluting stents (DES) have emerged as an alternative to conventional coronary artery bypass surgery in patients with MV-CAD although first-generation DES yielded inferior efficacy and safety compared with surgery. Methods Prospective, randomized (1:1), multicenter feasibility trial was designed to assess angiographic efficacy of EES compared with the TAXUS paclitaxel-eluting stent (PES) in 200 patients, and a prospective, open-label, single-arm, controlled registry was designed to analyze the clinical outcome of EES at 1-year follow-up in 400 MV-CAD patients. For the randomized trial, the primary endpoint was in-stent late loss at 9 months. For the registry, the primary endpoint was a composite of all-cause death, myocardial infarction, and ischemia-driven target vessel revascularization at 12 months. Results The primary endpoint per single lesion was significantly lower in the EES group compared with the PES group (-0.03 ± 0.49 mm vs. 0.23 ± 0.51 mm, p = 0.001). Similar results were observed when analyzing all lesions (0.05 ± 0.51 mm vs. 0.24 ± 0.50 mm, p < 0.001). Clinical outcome at 1 year yielded a composite of major adverse cardiac events of 9.2% in the single-arm registry, and 11.1% and 16.5% in the EES and PES randomized groups, respectively (p = 0.30). Conclusions The EXECUTIVE trial was a randomized pilot trial dedicated to the comparison of the efficacy of 2 different DES among patients with 2- to 3-vessel MV-CAD. The study shows lower in-stent late loss at 9 months with the EES XIENCE V compared with the PES TAXUS Libertè, and a low major adverse cardiac event rate at 1 year in patients with 2-to 3-vessel MV-CAD. (EXECUTIVE [EXecutive RCT: Evaluating XIENCE V in a Multi Vessel Disease]; NCT00531011) © 2013 by the American College of Cardiology Foundation.


Ribichini F.,University of Verona | Ansalone G.,Ospedale Generale Madre Vannini | Bartorelli A.,IRCCS Centro Cardiologico Monzino | Beqaraj F.,Ospedale Maria Vittoria | And 19 more authors.
Journal of Cardiovascular Medicine | Year: 2010

Background: Myocardial revascularization with drug-eluting stents (DESs) is emerging as an alternative to conventional coronary artery bypass surgery in patients with multivessel coronary artery disease (MV-CAD). First-generation DESs have yielded equivalent safety results at mid-term compared with surgery, but inferior efficacy in preventing the recurrence of ischemic symptoms. The outcome of percutaneous coronary intervention with a second-generation everolimus DES as compared with a paclitaxel DES in patients with MV-CAD has not been established. AIM OF THE STUDY: The aim of the study is the assessment of the efficacy and performance of the XIENCE V everolimus-eluting stent in the treatment of de-novo coronary artery lesions in patients with MV-CAD. STUDY DESIGN: The study is composed of two parts: a prospective, double arm, randomized multicenter trial to assess the angiographic efficacy of the XIENCE V everolimus-eluting coronary stent system (EECSS) compared with the Taxus Liberté Paclitaxel Eluting Coronary Stent System (Taxus Liberté Stent) and a prospective, open-label, single arm, controlled registry to analyze the clinical efficacy and safety of XIENCE V EECSS at mid-term and long-term follow-up in patients treated for MV-CAD. ENDPOINTS: For the EXECUTIVE randomized trial, the primary endpoint is in-stent late lumen loss at 9 months. For the EXECUTIVE registry, the primary endpoint is a composite of all death, myocardial infarction (Q-wave and non-Q-wave), and ischemia-driven target vessel revascularization at 12 months. The study will be conducted at 30 study centers in Italy and 600 patients will be enrolled in total: 200 patients will be enrolled (1: 1) in the randomized trial and 400 patients will enter the registry. SAMPLE SIZE: It was calculated that, assuming a mean in-stent late lumen loss of 0.20 ± 0.41 mm in the XIENCE V EECSS arm and 0.30 ± 0.53 mm in the Taxus Liberté stent arm, and a noninferiority margin delta of 0.12 (according to the SPIRIT III results), the analysis of 81 lesions per arm would provide over 90% power. Therefore, 200 patients will be enrolled to account for dropouts. Conclusion: The present study is expected to provide as yet unavailable information about the performance of second-generation stents in the specific setting of patients with MV-CAD. © 2010 Italian Federation of Cardiology.


Agodi A.,University of Catania | Voulgari E.,National and Kapodistrian University of Athens | Barchitta M.,University of Catania | Quattrocchi A.,University of Catania | And 8 more authors.
Journal of Hospital Infection | Year: 2014

Background: Infections caused by multidrug-resistant (MDR) Acinetobacter baumannii have become an important healthcare-associated problem, particularly in intensive care units (ICUs). Aim: To investigate the emergence of carbapenem- and colistin-resistant A.baumannii infections in two Sicilian hospitals. Methods: From October 2008 to May 2011, a period which included two Italian Nosocomial Infections Surveillance in ICUs network (SPIN-UTI) project surveys, all carbapenem-resistant A.baumannii isolates from the ICUs of two hospitals in Catania, Italy, were prospectively collected. Minimum inhibitory concentrations (MICs) were measured by agar dilution, and phenotypic testing for metallo-β-lactamase (MBL) production was performed. Carbapenem resistance genes and their genetic elements were identified by polymerase chain reaction and sequencing. Genotypic relatedness was assessed by pulsed-field gel electrophoresis (PFGE) and multi-locus sequence typing. Patient-based surveillance was conducted using the SPIN-UTI protocol and previous antibiotic consumption was recorded. Findings: Twenty-six carbapenem-resistant A.baumannii were identified. Imipenem and meropenem MICs ranged from 4 to >32mg/L, and 15 isolates exhibited high-level colistin resistance (MICs >32mg/L). PFGE demonstrated that all isolates belonged to a unique clonal type and were assigned to ST2 of the international clone II. They harboured an intrinsic blaOxA-51-like carbapenemase gene, blaOxA-82, which was flanked upstream by ISAba1. Conclusions: The dissemination of clonally related isolates of carbapenem-resistant A.baumannii in two hospitals is described. Simultaneous resistance to colistin in more than half of the isolates is a problem for effective antibiotic treatment. Prior carbapenem and colistin consumption may have acted as triggering factors. © 2014 The Healthcare Infection Society.


Agodi A.,University of Catania | Voulgari E.,National and Kapodistrian University of Athens | Barchitta M.,University of Catania | Politi L.,National and Kapodistrian University of Athens | And 6 more authors.
Journal of Clinical Microbiology | Year: 2011

From March 2009 to May 2009, 24 carbapenem-resistant Klebsiella pneumoniae isolates were recovered from 16 patients hospitalized in an Italian intensive care unit (ICU). All isolates contained KPC-3 carbapenemase and belonged to a single pulsed-field gel electrophoresis (PFGE) clone of multilocus sequence type 258 (designated as ST258). A multimodal infection control program was put into effect, and the spread of the KPC-3-producing K. pneumoniae clone was ultimately controlled without closing the ICU to new admissions. Reinforced infection control measures and strict monitoring of the staff adherence were necessary for the control of the outbreak. Copyright © 2011, American Society for Microbiology. All Rights Reserved.


Marraro G.A.,Ao Fatebenefratelli And Ophthalmiatric Hospital | Denaro C.,Azienda Ospedaliera Cannizzaro | Spada C.,Ao Fatebenefratelli And Ophthalmiatric Hospital | Luchetti M.,Ao Fatebenefratelli And Ophthalmiatric Hospital | Giansiracusa C.,Ao Fatebenefratelli And Ophthalmiatric Hospital
Journal of Clinical Monitoring and Computing | Year: 2010

Objective: Open lung and low tidal volume ventilation appear to be a promising ventilation for chest trauma as it can reduce ARDS and improve outcome. Local therapy (e.g. BAL) can be synergic to remove from the lung the debris, mitigate inflammatory cascade and avoid damage spreading to not compromised lung areas. Materials and methods: 44 pulmonary contused patients were randomized to receive broncho-suction and volume controlled low tidal volume ventilation-VCLTVV (Control Group) or the same ventilation plus medicated (saline + surfactant) BAL (Treatment Group). Tidal volume <10 ml/kg, PEEP of 10-12 cm H2O and PaO2 60-100 mm Hg and PaCO2 35-45 mm Hg were used in both groups. BAL was performed using a fiberscope. 4 boluses of 25 ml saline with 2.4 mg/ml of surfactant were introduced into each contused lobe in which, subsequently, 240 mg of surfactant was instilled. Results: All patients survived. In the Control Group 18 patients developed pneumonia, 5 ARDS and days of intubation were 11.50 (3.83) compared to 5.05 (1.21) of Treatment Group in which OI and PaO2/FiO2 significantly improved from 36 h. Conclusions: VCLTVV alone was not able to prevent ARDS and infection in the Control Group as the reduction of intubation. In the Treatment Group, VCLTVV and medicated BAL facilitated the removal of degradated lung material and recruited the contused lung regions, enabling the healing of the lung pathology. © 2009 Springer Science+Business Media, LLC.


Rundo L.,CNR Institute of Molecular Bioimaging and Physiology | Militello C.,CNR Institute of Molecular Bioimaging and Physiology | Vitabile S.,University of Palermo | Russo G.,CNR Institute of Molecular Bioimaging and Physiology | And 6 more authors.
Smart Innovation, Systems and Technologies | Year: 2016

MR Imaging is being increasingly used in radiation treatment planning as well as for staging and assessing tumor response. Leksell Gamma Knife® is a device for stereotactic neuro-radiosurgery to deal with inaccessible or insufficiently treated lesions with traditional surgery or radiotherapy. The target to be treated with radiation beams is currently contoured through slice-by-slice manual segmentation on MR images. This procedure is time consuming and operator-dependent. Segmentation result repeatability may be ensured only by using automatic/semi-automatic methods with the clinicians supporting the planning phase. In this paper a semi-automatic segmentation method, based on an unsupervised Fuzzy C-Means clustering technique, is proposed. The presented approach allows for the target segmentation and its volume calculation. Segmentation tests on 5 MRI series were performed, using both area-based and distance-based metrics. The following average values have been obtained: DS = 95.10, JC = 90.82, TPF = 95.86, FNF = 2.18, MAD = 0.302, MAXD = 1.260, H = 1.636. © Springer International Publishing Switzerland 2016.


Militello C.,CNR Institute of Molecular Bioimaging and Physiology | Rundo L.,CNR Institute of Molecular Bioimaging and Physiology | Vitabile S.,University of Palermo | Russo G.,CNR Institute of Molecular Bioimaging and Physiology | And 6 more authors.
International Journal of Imaging Systems and Technology | Year: 2015

Nowadays, radiation treatment is beginning to intensively use MRI thanks to its greater ability to discriminate healthy and diseased soft-tissues. Leksell Gamma Knife® is a radio-surgical device, used to treat different brain lesions, which are often inaccessible for conventional surgery, such as benign or malignant tumors. Currently, the target to be treated with radiation therapy is contoured with slice-by-slice manual segmentation on MR datasets. This approach makes the segmentation procedure time consuming and operator-dependent. The repeatability of the tumor boundary delineation may be ensured only by using automatic or semiautomatic methods, supporting clinicians in the treatment planning phase. This article proposes a semiautomatic segmentation method, based on the unsupervised Fuzzy C-Means clustering algorithm. Our approach helps segment the target and automatically calculates the lesion volume. To evaluate the performance of the proposed approach, segmentation tests on 15 MR datasets were performed, using both area-based and distance-based metrics, obtaining the following average values: Similarity Index=95.59%, Jaccard Index=91.86%, Sensitivity=97.39%, Specificity=94.30%, Mean Absolute Distance=0.246[pixels], Maximum Distance=1.050[pixels], and Hausdorff Distance=1.365[pixels]. © 2015 Wiley Periodicals, Inc. Int J Imaging Syst Technol, 25, 213-225, 2015 © 2015 Wiley Periodicals, Inc.


Caravaglios G.,Azienda Ospedaliera Cannizzaro | Muscoso E.G.,Azienda Ospedaliera Cannizzaro | Di Maria G.,Azienda Ospedaliera Cannizzaro | Costanzo E.,Azienda Ospedaliera Cannizzaro
Journal of Neural Transmission | Year: 2015

There are several evidences indicating that an impairment in attention-executive functions is present in prodromal Alzheimer’s disease and predict future global cognitive decline. In particular, the issue of temporal orienting of attention in patients with mild cognitive impairment (MCI) due to Alzheimer’s disease has been overlooked. The present research aimed to explore whether subtle deficits of cortical activation are present in these patients early in the course of the disease. We studied the upper-alpha event-related synchronization/desynchronization phenomenon during a paradigm of temporal orientation of attention. MCI patients (n = 27) and healthy elderly controls (n = 15) performed a task in which periodically omitted tones had to be predicted and their virtual onset time had to be marked by pressing a button. Single-trial responses were measured, respectively, before and after the motor response. Then, upper-alpha responses were compared to upper-alpha power during eyes-closed resting state. The time course of the task was characterized by two different behavioral conditions: (1) a pre-event epoch, in which the subject awaited the virtual onset of the omitted tone, (2) a post-event epoch (after button pressing), in which the subject was in a post-motor response condition. The principal findings are: (1) during the waiting epoch, only healthy elderly had an upper-alpha ERD at the level of both temporal and posterior brain regions; (2) during the post-motor epoch, the aMCI patients had a weaker upper-alpha ERS on prefrontal regions; (3) only healthy elderly showed a laterality effect: (a) during the waiting epoch, the upper-alpha ERD was greater at the level of the right posterior-temporal lead; during the post-motor epoch, the upper alpha ERS was greater on the left prefrontal lead. The relevance of these findings is that the weaker upper-alpha response observed in aMCI patients is evident even if the accuracy of the behavioral performance (i.e., button pressing) is still spared. This abnormal upper-alpha response might represent an early biomarker of the attention-executive network impairment in MCI due to Alzheimer’s disease. © 2014, Springer-Verlag Wien.


PubMed | Azienda Ospedaliera Cannizzaro
Type: Journal Article | Journal: Journal of neural transmission (Vienna, Austria : 1996) | Year: 2015

There are several evidences indicating that an impairment in attention-executive functions is present in prodromal Alzheimers disease and predict future global cognitive decline. In particular, the issue of temporal orienting of attention in patients with mild cognitive impairment (MCI) due to Alzheimers disease has been overlooked. The present research aimed to explore whether subtle deficits of cortical activation are present in these patients early in the course of the disease. We studied the upper-alpha event-related synchronization/desynchronization phenomenon during a paradigm of temporal orientation of attention. MCI patients (n = 27) and healthy elderly controls (n = 15) performed a task in which periodically omitted tones had to be predicted and their virtual onset time had to be marked by pressing a button. Single-trial responses were measured, respectively, before and after the motor response. Then, upper-alpha responses were compared to upper-alpha power during eyes-closed resting state. The time course of the task was characterized by two different behavioral conditions: (1) a pre-event epoch, in which the subject awaited the virtual onset of the omitted tone, (2) a post-event epoch (after button pressing), in which the subject was in a post-motor response condition. The principal findings are: (1) during the waiting epoch, only healthy elderly had an upper-alpha ERD at the level of both temporal and posterior brain regions; (2) during the post-motor epoch, the aMCI patients had a weaker upper-alpha ERS on prefrontal regions; (3) only healthy elderly showed a laterality effect: (a) during the waiting epoch, the upper-alpha ERD was greater at the level of the right posterior-temporal lead; during the post-motor epoch, the upper alpha ERS was greater on the left prefrontal lead. The relevance of these findings is that the weaker upper-alpha response observed in aMCI patients is evident even if the accuracy of the behavioral performance (i.e., button pressing) is still spared. This abnormal upper-alpha response might represent an early biomarker of the attention-executive network impairment in MCI due to Alzheimers disease.


PubMed | Regina Elena Cancer Institute, Medical Oncology Unit Ospedale S Giovanni Calibita Fatebenefratelli, Azienda Ospedaliera Cannizzaro, Catholic University of the Sacred Heart and 4 more.
Type: Journal Article | Journal: The Lancet. Oncology | Year: 2016

Risk of relapse or progression remains high in the treatment of most patients with epithelial ovarian cancer, and development of a molecular predictor could be a valuable tool for stratification of patients by risk. We aimed to develop a microRNA (miRNA)-based molecular classifier that can predict risk of progression or relapse in patients with epithelial ovarian cancer.We analysed miRNA expression profiles in three cohorts of samples collected at diagnosis. We used 179 samples from a Multicenter Italian Trial in Ovarian cancer trial (cohort OC179) to develop the model and 263 samples from two cancer centres (cohort OC263) and 452 samples from The Cancer Genome Atlas epithelial ovarian cancer series (cohort OC452) to validate the model. The primary clinical endpoint was progression-free survival, and we adapted a semi-supervised prediction method to the miRNA expression profile of OC179 to identify miRNAs that predict risk of progression. We assessed the independent prognostic role of the model using multivariable analysis with a Cox regression model.We identified 35 miRNAs that predicted risk of progression or relapse and used them to create a prognostic model, the 35-miRNA-based predictor of Risk of Ovarian Cancer Relapse or progression (MiROvaR). MiROvaR was able to classify patients in OC179 into a high-risk group (89 patients; median progression-free survival 18 months [95% CI 15-22]) and a low-risk group (90 patients; median progression-free survival 38 months [24-not estimable]; hazard ratio [HR] 185 [129-264], p=000082). MiROvaR was a significant predictor of progression in the two validation sets (OC263 HR 316, 95% CI 233-429, p<00001; OC452 HR 139, 95% CI 111-174, p=00047) and maintained its independent prognostic effect when adjusted for relevant clinical covariates using multivariable analyses (OC179: adjusted HR 148, 95% CI 103-213, p=0036; OC263: adjusted HR 309 [224-428], p<00001; and OC452: HR 141 [111-179], p=00047).MiROvaR is a potential predictor of epithelial ovarian cancer progression and has prognostic value independent of relevant clinical covariates. MiROvaR warrants further investigation for the development of a clinical-grade prognostic assay.AIRC and CARIPLO Foundation.

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