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Brignole M.,Arrhythmologic Center | Moya A.,Hospital Universitario Vall dHebron | Andresen D.,Vivantes Klinikum Am Urban | Blanc J.J.,Brest University Hospital Center | And 7 more authors.
Circulation | Year: 2012

Background-The efficacy of cardiac pacing for prevention of syncopal recurrences in patients with neurally mediated syncope is controversial. We wanted to determine whether pacing therapy reduces syncopal recurrences in patients with severe asystolic neurally mediated syncope. Methods and Results-Double-blind, randomized placebo-controlled study conducted in 29 centers in the Third International Study on Syncope of Uncertain Etiology (ISSUE-3) trial. Patients were 40 years, had experienced 3 syncopal episodes in the previous 2 years. Initially, 511 patients, received an implantable loop recorder; 89 of these had documentation of syncope with 3 s asystole or 6 s asystole without syncope within 12±10 months and met criteria for pacemaker implantation; 77 of 89 patients were randomly assigned to dual-chamber pacing with rate drop response or to sensing only. The data were analyzed on intention-to-treat principle. There was syncope recurrence during follow-up in 27 patients, 19 of whom had been assigned to pacemaker OFF and 8 to pacemaker ON. The 2-year estimated syncope recurrence rate was 57% (95% CI, 40-74) with pacemaker OFF and 25% (95% CI, 13-45) with pacemaker ON (log rank: P=0.039 at the threshold of statistical significance of 0.04). The risk of recurrence was reduced by 57% (95% CI, 4-81). Five patients had procedural complications: lead dislodgment in 4 requiring correction and subclavian vein thrombosis in 1 patient. Conclusions-Dual-chamber permanent pacing is effective in reducing recurrence of syncope in patients 40 years with severe asystolic neurally mediated syncope. The observed 32% absolute and 57% relative reduction in syncope recurrence support this invasive treatment for the relatively benign neurally mediated syncope. Clinical Trial Registration-URL: http://www. clinicaltrials.gov. Unique identifier: NCT00359203. © 2012 American Heart Association, Inc.


Vallejo Llamas J.C.,Hospital Universitario Central Of Asturias | Ruiz-Camps I.,Hospital Universitario Vall dHebron
Enfermedades Infecciosas y Microbiologia Clinica | Year: 2012

Invasive fungal infection (IFI), caused by both yeasts and moulds, is a persistent problem, with high morbidity and mortality rates among patients on chemotherapy for haematology diseases, and hematopoietic stem cell transplant recipients. Management of IFI in these types of patients has become highly complex with the advent of new antifungals and diagnostic tests, resulting in different therapeutic strategies (prophylactic, empirical, pre-emptive, and targeted). A proper assessment of the risk for IFI of each individual patient appears to be critical in order to use the best prophylactic and therapeutic approach, and to increase the survival rates. Among the available antifungals, the most frequently used are fluconazole, mould-active azoles (itraconazole, posaconazole, voriconazole), candins (anidulafungin, caspofungin, micafungin), and amphotericin B (particularly its lipids formulations). Specific recommendations for use and the criteria for selection of antifungal agents are discussed in this paper. © 2012 Elsevier España, S.L. All rights reserved.


Afdhal N.,Beth Israel Deaconess Medical Center | Zeuzem S.,Goethe University Frankfurt | Kwo P.,Indiana University | Chojkier M.,University of California at San Diego | And 20 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: In phase 2 studies, treatment with the all-oral combination of the nucleotide polymerase inhibitor sofosbuvir and the NS5A inhibitor ledipasvir resulted in high rates of sustained virologic response among previously untreated patients with hepatitis C virus (HCV) genotype 1 infection. METHODS: We conducted a phase 3, open-label study involving previously untreated patients with chronic HCV genotype 1 infection. Patients were randomly assigned in a 1:1:1:1 ratio to receive ledipasvir and sofosbuvir in a fixed-dose combination tablet once daily for 12 weeks, ledipasvir-sofosbuvir plus ribavirin for 12 weeks, ledipasvir-sofosbuvir for 24 weeks, or ledipasvir-sofosbuvir plus ribavirin for 24 weeks. The primary end point was a sustained virologic response at 12 weeks after the end of therapy. RESULTS: Of the 865 patients who underwent randomization and were treated, 16% had cirrhosis, 12% were black, and 67% had HCV genotype 1a infection. The rates of sustained virologic response were 99% (95% confidence interval [CI], 96 to 100) in the group that received 12 weeks of ledipasvir-sofosbuvir; 97% (95% CI, 94 to 99) in the group that received 12 weeks of ledipasvir-sofosbuvir plus ribavirin; 98% (95% CI, 95 to 99) in the group that received 24 weeks of ledipasvir-sofosbuvir; and 99% (95% CI, 97 to 100) in the group that received 24 weeks of ledipasvir-sofosbuvir plus ribavirin. No patient in either 12-week group discontinued ledipasvir- sofosbuvir owing to an adverse event. The most common adverse events were fatigue, headache, insomnia, and nausea. CONCLUSIONS: Once-daily ledipasvir-sofosbuvir with or without ribavirin for 12 or 24 weeks was highly effective in previously untreated patients with HCV genotype 1 infection. (Funded by Gilead Sciences; ION-1 ClinicalTrials.gov number NCT01701401.) Copyright © 2014 Massachusetts Medical Society.


Di Cosimo S.,University of Barcelona | Di Cosimo S.,Hospital Universitario Vall dHebron
Targeted Oncology | Year: 2011

Trastuzumab is regarded as the foundation of care for HER2-positive breast cancer as it has revolutionized the treatment of this disease across all settings. Although generally well tolerated, patients may develop symptomatic or asymptomatic cardiotoxicity, forcing a discontinuation of treatment, therefore preventing patients from benefiting from maximal disease control. Evolving research supports that trastuzumab-induced cardiotoxicity may be prevented or at least minimized by a number of prophylactic measures, such as identification of patients at risk and close monitoring. Optimized chemotherapy regimens, scheduling and formulations also contribute to minimizing cardiac adverse events. Equally important, if cardiotoxicity develops, medical interventions are now available that facilitate the reintroduction of trastuzumab once normal cardiac function has been restored. Awareness of this still-evolving information may lead to optimal use of trastuzumab, especially in combination regimens, maximizing antitumor benefit, while minimizing risk. © Springer-Verlag 2011.


Piqueras-Carrasco J.,Hospital Universitario Vall dHebron
Revista Espanola de Medicina Legal | Year: 2014

Mushroom poisonings, caused by accidental intake of toxic species, occur every year during their growing season. From the cause of the ingestion to the application of extreme medical treatments such as liver transplantation, through the first diagnostic work up, referral to the emergency department and hospital admission in some cases, these poisonings are likely to have medico-legal implications. This paper provides an update on the subject of mushroom poisoning, which will help to improve their management and additionally highlight various important aspects from a forensic perspective. Diverse clinical, diagnostic and therapeutic matters of mushroom poisonings are depicted, including some new syndromes recently described. © 2013 Asociacion Nacional de Medicos Forenses. Publicado por Elsevier Espana, S.L. Todos losderechos reservados.


The European Cubicin® Outcome Registry and Experience (EU-CORE) is a retrospective, non-interventional, multicenter database of daptomycin use in several European countries. This database provides information on the routine use of this antibiotic to treat various infections caused by Gram-positive microorganisms. This article describes the demography, clinical characteristics, and outcomes of patients treated in Spanish hospitals participating in the EUCORE database, as well as the types of infection and causal pathogens involved. Overall, most indications and dosing regimens of daptomycin were within the health authorities' approved criteria, although the antibiotic was sometimes used for other clinical situations and at doses higher than those currently established. Daptomycin was mainly used as rescue therapy, and the efficacy and safety of the drug were very high. The experience gained with the EUCORE database suggests that daptomycin may be suitable for application in potentially severe infections caused by several species of Gram-positive microorganisms. © 2010 Elsevier España, S.L. All rights reserved.


Medeiros M.D.,Institute Microcirugia Ocular | Navarro R.,Institute Microcirugia Ocular | Garcia-Arumi J.,Institute Microcirugia Ocular | Garcia-Arumi J.,Hospital Universitario Vall dHebron | And 2 more authors.
Investigative Ophthalmology and Visual Science | Year: 2013

PURPOSE. To evaluate the effectiveness of a single intravitreal injection of dexamethasone implant, over 6 months in patients with recalcitrant CME due to Irvine-Gass syndrome. METHODS. Retrospective review of the medical records of nine patients with refractory macular edema (ME) due to Irvine-Gass syndrome, who underwent a single intravitreal injection of dexamethasone implant, Ozurdex, between November 2010 and January 2012, at the Instituto de Microcirurgia Ocular, Barcelona, Spain. All patients underwent a complete ophthalmic evaluation, including best-corrected visual acuity (BCVA) using standardized ETDRS charts, tonometry, fluorescein angiography, and spectral-domain optical coherence tomography with foveal thickness (FT) measurement. RESULTS. The mean duration of CME before treatment with Ozurdex was 9.1 months (range, 6-13 months). At baseline, the mean FT was 542.22 ± 134.78 μm. Mean (SD) values of FT did decrease to 350.88 ± 98.71 μm (P = 0.001) at month 1 and 319.22 ± 60.96 μm (P = 0.002) at month 3. Data on the 6-month follow-up showed a mild increase 398.33 ± 127.89 lm (P = 0.031). The mean (SD) change from baseline FT was 191.33 μm (a decrease value of 35%) at month 1, and 223.00 μm (decrease value of 41%) and 143.89 μm (decrease value of 26%) at month 3 and month 6, respectively. The baseline BCVA data were 0.62 ± 0.15 logarithm of the minimum angle of resolution (logMAR). The mean BCVA improved to 0.47 ± 0.21 logMAR (P = 0.008) and 0.37 ± 0.24 logMAR (P = 0.001) after month 1 and month 3, respectively. At the last visit (6-month follow-up), the mean BCVA was 0.37 6 ±.26 logMAR (P = 0.002). CONCLUSIONS. In this study, both mean FT and mean BCVA had improved from baseline by 1 month after treatment with a dexamethasone implant, and the improvement remained statistically significant throughout the 6-month study. © 2013 The Association for Research in Vision and Ophthalmology, Inc.


Rubio I.T.,Hospital Universitario Vall dHebron
European Journal of Surgical Oncology | Year: 2016

Sentinel lymph node biopsy has replaced axillary lymph node dissection (ALND) in those patients with clinically node negative axilla and nowadays, patients with low burden disease in the SLNs may spare an ALND without compromising their oncologic outcomes. In the last decade, indications of neoadjuvant treatment (NAT) have been extended to patients with operable disease and with the use of targeted therapies, rates of pathologic complete response (pCR) after NAT have increased. In the neoadjuvant setting, SLN after NAT is feasible and accurate in clinically node negative patients and it has been explored in different randomized prospective studies in patients with clinically positive axilla in the continuous effort to avoid the morbidity of ALND. The importance of identifying patients with residual axillary disease may serve not only as indicator for selecting patients with pCR to be spared an ALND but also for selecting patients for additional therapy. Future research is needed to more accurately identify residual axillary disease and the SLN after NAT is the driver for this achievement. © 2015 Elsevier Ltd.


Pelaez R.B.,Hospital Universitario Vall dHebron
Nutricion Hospitalaria | Year: 2013

The disease-related malnutrition (DRE) is a highly prevalent problem that has become one of the major Public Health problems in our Health System. The DRE is very complex problem with multifactorial etiology, which directly involved the disease itself, accompanied of modifiable factors that can modulate it (hospitalization, health care professionals and politics health care professionals) Malnutrition has a very direct impact on the outcome of the disease, increasing morbidity, mortality and health expenditure disease-generated. Intervention strategies must be coordinated, and include Nutritional Risk Screening programs linked to specific Nutritional Treatment Plans. Once implemented nutritional treatment, the program must ensure the tracking and monitoring of treatment efficacy in different levels of care (inpatient, residential centers, primary care). We discuss some quality strategies related to success in the implementation of such programs.


Ruiz-Camps I.,Hospital Universitario Vall dHebron
Enfermedades Infecciosas y Microbiologia Clinica | Year: 2011

The frequency of invasive fungal infections, and specifically invasive aspergillosis, has increased in the last few decades. Despite the development of new antifungal agents, these infections are associated with high mortality, ranging from 40% to 80%, depending on the patient and the localization of the infection. To reduce these figures, several therapeutic strategies have been proposed, including combination therapy. Most of the available data on the efficacy of these combinations are from experimental models, in vitro data and retrospective observational studies or studies with a small number of patients that have included both patients in first-line treatment and those receiving rescue therapy; in addition there are many patients with possible forms of aspergillosis and few with demonstrated or probable forms. To date, there is no evidence that combination therapy has significantly higher efficacy than monotherapy; however, combination therapy could be indicated in severe forms of aspergillosis, or forms with central nervous involvement or extensive pulmonary involvement with respiratory insufficiency, etc. Among the combinations, the association of an echinocandin - the group that includes micafungin - with voriconazole or liposomal amphotericin B seems to show synergy. These combinations are those most extensively studied in clinical trials and therefore, although the grade of evidence is low, are recommended by the various scientific societies. © 2011 Elsevier España S.L.

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