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Buenos Aires, Argentina

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. Source


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. Source


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. Source


Sanchez-Cuadrado I.,University Institute of La Paz | Lassaletta L.,University Institute of La Paz | Perez-Mora R.M.,University Institute of La Paz | Zernotti M.,Sanatorio Allende Clinic | And 3 more authors.
Annals of Otology, Rhinology and Laryngology | Year: 2013

Objectives: We evaluated the quality of life following cochlear implantation in elderly postlingually deaf adults. Methods: Data were studied concerning demographics and audiometric evaluation in postlingually deaf adults at least 60 years of age who underwent cochlear implantation in 3 institutions. The Glasgow Benefit Inventory was used to quantify the quality of life. The patients were divided into 2 groups (those less than 70 years of age and those at least 70 years of age), and the results were also compared to those of younger adult cochlear implant recipients (less than 60 years of age). Results: Eighty-one patients were included in this study. The mean age at implantation was 68 years (range, 60 to 82 years). Cochlear implantation significantly improved the patients' audiometric outcomes (pure tone average and speech perception; p < 0.05). The Glasgow Benefit Inventory showed a benefit overall (+36) and on the individual subscales (+49, +20, and +1). The difference in quality of life was not significant between those less than 70 and those at least 70 years of age (p = 0.90). The results were similar to those of younger postlingually deaf implant recipients. Conclusions: Elderly cochlear implant users experience an improvement in their quality of life, with outcomes similar to those achieved in younger adults. Particular attention must be paid to the possibility of age-related conditions in the elderly that may increase the risks of surgery. © 2013 Annals Publishing Company. Source


Iglesias D.,Argentine Society of Mountain Medicine | Iglesias D.,University of Buenos Aires | Gomez Rosso L.,University of Buenos Aires | Vainstein N.,Italian Hospital | And 3 more authors.
Clinical Biochemistry | Year: 2015

Aims: The aim of this study was to evaluate the effects of acute hypobaric hypoxia (HH) on vascular reactivity and biochemical markers associated with endothelial function (EF). Main methods: Ten healthy subjects were exposed to a simulated altitude of 4,000. meters above sea level for 4. hours in a hypobaric chamber. Vascular reactivity was measured by the flow-mediated vasodilatation (FMVD) test. Endothelin-1, high sensitive-C reactive protein (hsCRP), vascular cell adhesion molecule 1, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), paraoxonase and adiponectin levels, and FMVD were evaluated before and after the exposure. Key findings: Subjects were young (age: 32±6years), lean [body mass index: 23.9±2.0kg/m2, waist circumference: 77(IQR: 72-80) cm], and presented normal clinical and biochemical parameters. No significant changes were evidenced in FMVD in response to HH (pre: 0.45 (0.20-0.70) vs. during: 0.50 (0.20-1.22) mm; p=0.594). On the other hand, endothelin-1 (+54%, p<0.05), hsCRP (+37%, p<0.001), IL-6 (+75%, p<0.05), TNF-α (+75%, p<0.05), and adiponectin (-39%, p<0.01) levels were significantly altered post-HH. FMVD was increased in 7 subjects, and it was decreased in 3 individuals during HH exposure. Interestingly, when EF biomarkers were compared between these two subgroups of subjects, only post exposure-adiponectin levels were significantly different (49±5 vs. 38±6μg/ml, respectively, p<0.05). Significance: HH exposure had an effect on endothelin-1, adiponectin, hsCRP, IL-6, and TNF-α concentration. However, adiponectin was the only biomarker associated with an altered vascular reactivity. © 2015 The Canadian Society of Clinical Chemists. Source

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