Mitsutake Y.,Stanford University |
Ebner A.,Italian Hospital |
Yeung A.C.,Stanford University |
Taber M.D.,Heart Health |
And 2 more authors.
Catheterization and Cardiovascular Interventions | Year: 2015
Objective: To report our initial animal and human experience with a new multi-lumen catheter called MultiCross™ (Roxwood Medical, Inc.) in a porcine coronary model and patients with a chronic total occlusion (CTO). Methods: Preclinical safety study was done in the coronary vasculature of a porcine model. In a clinical setting, patients with a CTO of a coronary artery (n = 5) were enrolled. After an initial unsuccessful attempt using a conventional guidewire, operators could use the MultiCross system. The primary efficacy endpoint was successful recanalization (technical success) and the primary safety endpoint was serious adverse events through 30 days post-procedure. Results: The MultiCross catheter was used for all patients after failure of the initial attempt with a guidewire. Successful recanalization was achieved in all CTOs attempted (100%). No patients reported any adverse events at 30 days post-procedure. Conclusion: In this first-in-man experience, the MultiCross catheter has the potential to enhance crossing of CTOs. © 2014 Wiley Periodicals, Inc.
Schneider P.A.,Kaiser Foundation Hospital |
Giasolli R.,Intact Vascular |
Ebner A.,Italian Hospital |
Virmani R.,CV Path |
Granada J.F.,Skirball Research Center
JACC: Cardiovascular Interventions | Year: 2015
Objectives This study provides preliminary data on the safety and feasibility of the use of a novel focal implant for managing post-percutaneous transluminal balloon angioplasty (post-PTA) dissection. Background Post-PTA dissection of the lower extremity arteries is managed with stent placement. This provides an acceptable post-intervention result but has long-term disadvantages, such as in-stent restenosis. Focal treatment of post-PTA dissection and avoidance of stents are the objectives of the Tack-It (Intact Vascular, Inc., Wayne, Pennsylvania) device. Methods A preclinical study and first-in-human data are presented. Seven swine underwent superficial femoral artery device placement, with a self-expanding nitinol stent on 1 side and a series of 4 Tack-It devices on the other side. Specimens were harvested at 28 days. The clinical study included 15 limbs that underwent revascularization for critical limb ischemia (n = 9) or claudication (n = 6). Twenty-five lesions were treated in the superficial femoral (n = 8), popliteal (n = 7), and tibial (n = 10) arteries. Results The preclinical study demonstrated a reduction in stenosis with the Tack-It (16.8 ± 2.6%) compared with stents (46.4 ± 9.8%). Neointimal thickness and injury score decreased with the Tack-It. Clinically, Tack-It placement resulted in acute technical success with resolution of the post-PTA dissection in 100% of lesions. There were no device-related complications or major amputations. Eighteen of the 25 lesions were available for angiographic follow-up at 1-year, and patency was 83.3%. Conclusions Preclinical data suggest that the Tack-It device causes minimal vessel injury. Clinical use of the Tack-It to manage post-PTA dissection was safe and feasible in this early study and resulted in apposition of dissection flaps without stent placement. © 2015 American College of Cardiology Foundation.
Kaidar-Person O.,Technion - Israel Institute of Technology |
Kuten A.,Italian Hospital |
Belkacemi Y.,University Paris Est Creteil
Critical Reviews in Oncology/Hematology | Year: 2014
The current management of locally advanced breast cancer (LABC) is based on tri-modality treatment including chemotherapy, radiotherapy and surgery. The concept of preoperative concurrent or sequential chemoradiation for LABC was initially reported more than a decade ago; however this concept did not gain popularity because of the low benefit/risk ratio and the lack of strong data supporting the concept. The purpose of the current systematic review was to explore the published data about preoperative chemoradiation (sequential and/or concurrent) using whole breast irradiation in terms of toxicity and outcome. © 2014 Elsevier Ireland Ltd.
Dumonceau J.-M.,University of Geneva |
Macias-Gomez C.,Italian Hospital
World Journal of Gastroenterology | Year: 2013
Pseudocysts and biliary obstructions will affect approximately one third of patients with chronic pancreatitis (CP). For CP-related, uncomplicated, pancreatic pseudocysts (PPC), endoscopy is the first-choice therapeutic option. Recent advances have focused on endosonography- guided PPC transmural drainage, which tends to replace the conventional, duodenoscope-based coma immediately approach. Ancillary material is being tested to facilitate the endosonography-guided procedure. In this review, the most adequate techniques depending on PPC characteristics are presented along with supporting evidence. For CP-related biliary obstructions, endoscopy and surgery are valid therapeutic options. Patient co-morbidities (e.g. portal cavernoma) and expected patient compliance to repeat endoscopic procedures are important factors when selecting the most adapted option. Malignancy should be reasonably ruled out before embarking on the endoscopic treatment of presumed CP-related biliary strictures. In endoscopy, the gold standard technique consists of placing simultaneous, multiple, side-by-side, plastic stents for a oneyear period. Fully covered self-expandable metal stents are challenging this method and have provided 50% mid-term success. © 2013 Baishideng Publishing Group Co., Limited. All rights reserved.
Pires-Marczeski F.C.,National Institute for Infectious Disease |
Martinez V.P.,National Institute for Infectious Disease |
Nemirovsky C.,Italian Hospital |
Padula P.J.,National Institute for Infectious Disease
Journal of Medical Virology | Year: 2011
During the period 2007-2008 several epizootics of Yellow fever with dead of monkeys occurred in southeastern Brasil, Paraguay, and northeastern Argentina. In 2008 after a Yellow fever outbreak an exhaustive prevention campaign took place in Argentina using 17D live attenuated Yellow fever vaccine. This vaccine is considered one of the safest live virus vaccines, although serious adverse reactions may occur after vaccination, and vaccine-associated neurotropic disease are reported rarely. The aim of this study was to confirm two serious adverse events associated to Yellow fever vaccine in Argentina, and to describe the analysis performed to assess the origin of specific IgM against Yellow fever virus (YFV) in cerebrospinal fluid (CSF). Both cases coincided with the Yellow fever vaccine-associated neurotropic disease case definition, being clinical diagnosis longitudinal myelitis (case 1) and meningoencephalitis (case 2). Specific YFV antibodies were detected in CSF and serum samples in both cases by IgM antibody-capture ELISA. No other cause of neurological disease was identified. In order to obtain a conclusive diagnosis of central nervous system (CNS) infection the IgM antibody index (AI IgM) was calculated. High AI IgM values were found in both cases indicating intrathecal production of antibodies and, therefore, CNS post-vaccinal YFV infection could be definitively associated to YFV vaccination. © 2011 Wiley Periodicals, Inc.
Riphaus A.,Ruhr University Bochum |
Macias-Gomez C.,Italian Hospital |
Deviere J.,Erasme University Hospital |
Dumonceau J.-M.,University of Geneva
Digestive and Liver Disease | Year: 2012
Background: The use of propofol during colonoscopy has become more widespread. To increase availability while maintaining quality and decreasing costs, European Guidelines have been issued for non-anesthesiologist administration of propofol (NAAP). We aimed to assess the current use of propofol during screening colonoscopy. Methods: International survey. Results: Eighty-four questionnaires were collected from endoscopists practicing in 29 countries. Practices were most often located in high-volume community hospitals (Italy, Belgium, Spain, Netherlands in half cases). An anesthesiologist was regularly present in the Endoscopy Unit of 69.0% survey respondents. In low-risk (ASA classification, 1-2) patients, propofol, benzodiazepine. +. opioids and benzodiazepine alone were used in 45%, 31% and 14% of screening colonoscopies, respectively. Propofol was associated with the highest endoscopist satisfaction (score on a 10-point visual analogue scale, 9.2 ± 1.2 vs. 5.5 ± 1.9 and 4.7 ± 2.0 for benzodiazepine. +. opioids and benzodiazepine alone, respectively; P< 0.0001). NAAP was used by 29.9% of respondents in 9 countries and approximately two-thirds of other endoscopists would consider implementing NAAP. Main reasons for not considering NAAP implementation were medico-legal issues and cost. Conclusion: Propofol provides the highest endoscopist satisfaction but it is used in less than half of screening colonoscopies. Propofol is administered by non-anesthesiologists in one-third of settings; its implementation is foreseen by a majority of endoscopists who do not currently use it. © 2011.
Rajan D.K.,University of Toronto |
Ebner A.,Italian Hospital |
Desai S.B.,Baylor College of Medicine |
Rios J.M.,Baylor College of Medicine |
Cohn W.E.,Baylor College of Medicine
Journal of Vascular and Interventional Radiology | Year: 2015
Purpose Arteriovenous fistulae (AVFs) created by conventional surgical techniques are associated with suboptimal short- and long-term patency. This study investigated the feasibility of creating fistulae with a percutaneous system and evaluated the utility of percutaneous AVFs (pAVFs) in providing hemodialysis access. Materials and Methods From August 2012 to September 2013, a percutaneous system was used to attempt pAVF creation between the proximal ulnar artery and a closely associated ulnar vein in 33 patients. Technical success, adverse events, and time to pAVF maturity were recorded, as was clinical effectiveness at 6 months. Results A pAVF was successfully created in 32 of 33 patients (97%). Four patients died during the follow-up period from causes unrelated to the procedure; one patient was lost to follow-up. Of the remaining 27 patients, 24 were undergoing successful dialysis via their pAVF at 6 months. Two additional patients had usable access but did not initiate dialysis during the study. One spontaneous pAVF thrombosis occurred in a patient with preexisting central vein stenosis. Cumulative pAVF patency at 6 months was 96.2% (26 of 27; standard error, 3.8%). Mean time to pAVF maturation was 58 days (range, 37-168 d). There was one serious procedure-related adverse event and five minor procedure-related adverse events. Conclusions Although larger studies are required to validate efficacy in a wide range of patients, this study demonstrates hemodialysis access successfully created with an endovascular catheter-based system. Patency of pAVFs and time to maturation were superior to published results of surgical techniques. © 2015 SIR.
Fejerman N.,Juan P Garrahan Pediatric Hospital |
Caraballo R.,Juan P Garrahan Pediatric Hospital |
Cersosimo R.,Juan P Garrahan Pediatric Hospital |
Ferraro S.M.,Italian Hospital |
And 2 more authors.
Epilepsia | Year: 2012
Purpose: In children with symptomatic or idiopathic focal epilepsies, their disease may evolve into an epileptic encephalopathy related to continuous spike and wave during slow sleep (CSWS) or electrical status epilepticus during slow sleep (ESES). ESES syndrome implies serious risks of neuropsychologic impairment, and its treatment has frequently been disappointing. The aim of this study is to present our experience using sulthiame as add-on treatment in 53 patients with ESES syndrome that was refractory to other antiepileptic drugs (AEDs). Methods: Neurologic examinations, cerebral magnetic resonance imaging (MRI), and repeated prolonged sleep electroencephalography (EEG) studies were performed in all cases. Data about school achievements and or neuropsychological evaluations were obtained repeatedly during the follow-up of 1.5-16 years. Sulthiame was added in doses ranging between 5 and 30 mg/kg/day. Key Findings: Since add-on of sulthiame, 10 of 28 patients in the symptomatic group became seizure free: 4 patients with normal EEG studies and 6 with residual spikes. Nine of 28 patients showed a significant reduction in number of seizures and presented spikes but no ESES on EEG. The other nine cases showed neither clinical nor EEG improvement. A striking result was that 3 of 11 children with unilateral polymicrogyria and ESES syndrome became seizure free, and in another six a significant improvement in frequency of seizures and in EEG abnormalities seemed to be related to the add-on of sulthiame. Twenty-one of the 25 patients in the idiopathic group became seizure free and without ESES in <3 months after add on of sulthiame. In two of the patients the changes were seen in a few days. Significance: We understand that sulthiame may be effective as add-on treatment in children with ESES syndrome. © Wiley Periodicals, Inc. © 2012 International League Against Epilepsy.
Forastiero R.,University of Buenos Aires |
Martinuzzo M.,Italian Hospital
Expert Review of Clinical Immunology | Year: 2015
Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by clinical symptoms of vascular thrombosis and/or pregnancy morbidity in the presence of autoimmune antiphospholipid antibodies (aPL). Current laboratory APS criteria include the presence of at least one of the three relevant aPL: lupus anticoagulant, anticardiolipin antibodies and anti-β2 glycoprotein I antibodies. Therefore, patients could have a single aPL pattern or combinations of aPL. Evidence arising from clinical experience indicates that patients having the highest aPL titer and simultaneous aPL detected by different tests have a worse prognosis and a higher probability of recurrence of the APS clinical features. In recent years, an emerging role of multiple aPL positivity in the identification of high-risk patients with aPL/APS is evident. This paper will review the current knowledge on the clinical relevance of having single or multiple aPL positivity. © 2015 Taylor & Francis.
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 300.00K | Year: 2012
DESCRIPTION (provided by applicant): The clinical impact of the 5 million annual surveillance colonoscopies (follow up of previous neoplasia) is remarkably low (gt90% without significant neoplasia). Juxtaposed with this is the alarmingly frequent occurrence of colorectal cancers (CRCs) in between colonoscopies (interval cancers), especially in the proximal colon. The medico-legal and clinical consequences of interval CRCs lead to vast overuse of surveillance colonoscopy engendering unnecessary cost, complications etc. Fecal tests represent an attractive potential adjunct although the typical tests (occult blood, DNA, methylation) have a poor (~10-40%) sensitivity for advanced adenomas, the target of CRC prevention efforts. Our multidisciplinary CRC prevention group has developed a mucus layer fecal colonocyte biophotonics test that allows detection of both field carcinogenesis along with the less abundant tumor products. We have employed our ultrasensitive novel technology, partial wave spectroscopic microscopy (PWS). PWS allows, for the first time, a practical modality to quantify nanoscale architectural colonic epithelial alterations in preclinica models (PNAS, 2008). We have demonstrated that colonocyte PWS analysis has a ~90% accuracy of identifyingindividuals for colonic advanced adenomas throughout the colon (n=141) (Gastro, 2011). In order for Nanocytomics to commercialize fecal PWS for tailoring colonoscopic screening intervals, we propose to develop a high throughput instrument (phase 1) with milestones of accuracy and speed (lt 10 minutes per patient). Phase 2 will involve clinical trials in two common scenarios: 1. Determine whether a patient scheduled for colonoscopy can be safely postponed (n=200 training and 200 testing set) 2. Investigate whether a patient needs to have an expedited colonoscopy (n=250). These will be compared to conventional fecal tests (immunohistochemical and DNA). These studies will be instrumental to bridge the power of PWS to the clinical application off colonoscopic screening interval personalization thus representing a large and well defined commercial opportunity. Furthermore, identification of field carcinogenesis with PWS is a platform with clear applications for average risk CRC screening along with other cancers (lung, ovarian etc). PUBLIC HEALTH RELEVANCE: CRCs remain the second leading cause of cancer deaths among Americans. Colonoscopy can prevent CRCs by identifying and removing precursor lesions but this often obligates serial examinations. However, follow up colonoscopies (surveillance) are vastly overused and still allow a significant number of cancers to occur. Our goal is to leverage the remarkable sensitivity of the powerful new technology, PWS to develop a highly accurate minimally intrusivefecal test that could enable personalization of the procedure intervals.