Liaw Y.-F.,Chang Gung University |
Sheen I.-S.,Chang Gung University |
Lee C.-M.,Chang Gung University |
Akarca U.S.,Ege University |
And 15 more authors.
Hepatology | Year: 2011
Data are limited on the safety and effectiveness of oral antivirals other than lamivudine and adefovir dipivoxil for treatment of chronic hepatitis B (CHB) in patients with decompensated liver disease. This Phase 2, double-blind study randomized 112 patients with CHB and decompensated liver disease to receive either tenofovir disoproxil fumarate (TDF; n = 45), emtricitabine (FTC)/TDF (fixed-dose combination; n = 45), or entecavir (ETV; n = 22). The primary endpoint was safety; more specifically, tolerability failure (adverse events resulting in permanent treatment discontinuation) and confirmed serum creatinine increase ≥0.5 mg/dL from baseline or confirmed serum phosphorus <2 mg/dL. Patients with insufficient viral suppression (e.g., confirmed HBV DNA ≥400 copies/mL at week 8 or 24) could begin open-label FTC/TDF but were considered failures in this interim week 48 analysis for efficacy endpoints. Tolerability failure was infrequent across arms: 6.7% TDF, 4.4% FTC/TDF, and 9.1% ETV (P = 0.622) as were confirmed renal parameters meeting threshold 8.9%, 6.7%, and 4.5% (P = 1.000), respectively. Six patients died (none considered related to study drug) and six received liver transplants (none had HBV recurrence). The adverse event and laboratory profiles were consistent with advanced liver disease and complications, with no unexpected safety signals. At week 48, HBV DNA was <400 copies/mL (69 IU/mL) in 70.5% (TDF), 87.8% (FTC/TDF), and 72.7% (ETV) of patients. Proportions with normal alanine aminotransferase were: 57% (TDF), 76% (FTC/TDF), and 55% (ETV). Hepatitis B e antigen (HBeAg) loss/seroconversion occurred in 21%/21% (TDF), 27%/13% (FTC/TDF), and 0%/0% (ETV). Child-Turcotte-Pugh and Modification for End-stage Liver Disease scores improved in all groups. Conclusion: All treatments were well tolerated in patients with decompensated liver disease due to CHB with improvement in virologic, biochemical, and clinical parameters. © 2010 American Association for the Study of Liver Diseases.
Bossone E.,University of Salerno |
Corteville D.C.,University of Michigan |
Harris K.M.,Abbott Laboratories |
Suzuki T.,University of Tokyo |
And 12 more authors.
Circulation | Year: 2013
BACKGROUND - Stroke is a highly dreaded complication of type A acute aortic dissection (TAAAD). However, little data exist on its incidence and association with prognosis. METHODS AND RESULTS - We evaluated 2202 patients with TAAAD (mean age 62±14 years, 1487 [67.5%] men) from the International Registry of Acute Aortic Dissection to determine the incidence and prognostic impact of stroke in TAAAD. Stroke was present at arrival in 132 (6.0%) patients with TAAAD. These patients were older (65±12 versus 62±15 years; P=0.002) and more likely to have hypertension (86% versus 71%; P=0.001) or atherosclerosis (29% versus 22%; P=0.04) than patients without stroke. Chest pain at arrival was less common in patients with stroke (70% versus 82%; P<0.001), and patients with stroke presented more often with syncope (44% versus 15%; P<0.001), shock (14% versus 7%; P=0.005), or pulse deficit (51% versus 29%; P≤0.001). Arch vessel involvement was more frequent among patients with stroke (68% versus 37%; P<0.001). They had less surgical management (74% versus 85%; P<0.001). Hospital stay was significantly longer in patients with stroke (median 17.9 versus 13.3 days; P<0.001). In-hospital complications, such as hypotension, coma, and malperfusion syndromes, and in-hospital mortality (adjusted odds ratio, 1.62; 95% confidence interval, 0.99-2.65) were higher among patients with stroke. Among hospital survivors, follow-up mortality was similar between groups (adjusted hazard ratio, 1.15; 95% confidence interval, 0.46-2.89). CONCLUSIONS - Stroke occurred in >1 of 20 patients with TAAAD and was associated with increased in-hospital morbidity but not long-term mortality. Whether aggressive early invasive interventions will reduce negative outcomes remains to be evaluated in future studies. © 2013 American Heart Association, Inc.
Harris K.M.,Abbott Laboratories |
Braverman A.C.,University of Washington |
Eagle K.A.,University of Michigan |
Woznicki E.M.,University of Michigan |
And 12 more authors.
Circulation | Year: 2012
Background-Acute aortic intramural hematoma (IMH) is an important subgroup of aortic dissection, and controversy surrounds appropriate management. Methods and Results-Patients with acute aortic syndromes in the International Registry of Acute Aortic Dissection (1996-2011) were evaluated to examine differences between patients (based on the initial imaging test) with IMH or classic dissection (AD). Of 2830 patients, 178 had IMH (64 type A [42%], 90 type B [58%], and 24 arch). Patients with IMH were older and presented with similar symptoms, such as severe pain. Patients with type A IMH were less likely to present with aortic regurgitation or pulse deficits and were more likely to have periaortic hematoma and pericardial effusion. Although type A IMH and AD were managed medically infrequently, type B IMH were more frequently treated medically. Overall in-hospital mortality was not statistically different for type A IMH compared to AD (26.6% versus 26.5%; P=0.998); type A IMH managed medically had significant mortality (40.0%), although less than classic AD (61.8%; P=0.195). Patients with type B IMH had a hospital mortality that was less but did not differ significantly (4.4% versus 11.1%; P=0.062) from classic AD. One-year mortality was not significantly different between AD and IMH. Conclusions-Acute IMH has similar presentation to classic AD but is more frequently complicated with pericardial effusions and periaortic hematoma. Patients with IMH have a mortality that does not differ statistically from those with classic AD. A small subgroup of type A IMH patients are managed medically and have a significant in-hospital mortality. © 2012 American Heart Association, Inc.
Pape L.A.,University of Massachusetts Medical School |
Awais M.,University of Michigan |
Awais M.,Botsford Hospital |
Woznicki E.M.,University of Michigan |
And 14 more authors.
Journal of the American College of Cardiology | Year: 2015
Background Diagnosis, treatment, and outcomes of acute aortic dissection (AAS) are changing. Objectives This study examined 17-year trends in the presentation, diagnosis, and hospital outcomes of AAD from the International Registry of Acute Aortic Dissection (IRAD). Methods Data from 4,428 patients enrolled at 28 IRAD centers between December 26, 1995, and February 6, 2013, were analyzed. Patients were divided according to enrollment date into 6 equal groups and by AAD type: A (n = 2,952) or B (n = 1,476). Results There was no change in the presenting complaints of severe or worst-ever pain for type A and type B AAD (93% and 94%, respectively), nor in the incidence of chest pain (83% and 71%, respectively). Use of computed tomography (CT) for diagnosis of type A increased from 46% to 73% (p < 0.001). Surgical management for type A increased from 79% to 90% (p < 0.001). Endovascular management of type B increased from 7% to 31% (p < 0.001). Type A in-hospital mortality decreased significantly (31% to 22%; p < 0.001), as surgical mortality (25% to 18%; p = 0.003). There was no significant trend in in-hospital mortality in type B (from 12% to 14%). Conclusions Presenting symptoms and physical findings of AAD have not changed significantly. Use of chest CT increased for type A. More patients in both groups were managed with interventional procedures: surgery in type A and endovascular therapy in type B. A significant decrease in overall in-hospital mortality was seen for type A but not for type B. © 2015 American College of Cardiology Foundation.
Harris K.M.,Abbott Laboratories |
Strauss C.E.,Abbott Laboratories |
Strauss C.E.,University of Minnesota |
Eagle K.A.,University of Michigan |
And 10 more authors.
Circulation | Year: 2011
BACKGROUND: In acute aortic dissection, delays exist between presentation and diagnosis and, once diagnosed, definitive treatment. This study aimed to define the variables associated with these delays. METHODS AND RESULTS-: Acute aortic dissection patients enrolled in the International Registry of Acute Aortic Dissection (IRAD) between 1996 and January 2007 were evaluated for factors contributing to delays in presentation to diagnosis and in diagnosis to surgery. Multiple linear regression was performed to determine relative delay time ratios (DTRs) for individual correlates. The median time from arrival at the emergency department to diagnosis was 4.3 hours (quartile 1-3, 1.5-24 hours; n=894 patients) and from diagnosis to surgery was 4.3 hours (quartile 1-3, 2.4-24 hours; n=751). Delays in acute aortic dissection diagnosis occurred in female patients; those with atypical symptoms that were not abrupt or did not include chest, back, or any pain; patients with an absence of pulse deficit or hypotension; or those who initially presented to a nontertiary care hospital (all P<0.05). The largest relative DTRs were for fever (DTR=5.11; P<0.001) and transfer from nontertiary hospital (DTR=3.34; P<0.001). Delay in time from diagnosis to surgery was associated with a history of previous cardiac surgery, presentation without abrupt or any pain, and initial presentation to a nontertiary care hospital (all P<0.001). The strongest factors associated with operative delay were prolonged time from presentation to diagnosis (DTR=1.35; P<0.001), race other than white (DTR=2.25; P<0.001), and history of coronary artery bypass surgery (DTR=2.81; P<0.001). CONCLUSIONS-: Improved physician awareness of atypical presentations and prompt transport of acute aortic dissection patients could reduce crucial time variables. © 2011 American Heart Association, Inc.
Pons F.,University of the Sea |
Orsola A.,Hospital General Universitari Vall dHebron |
Morote J.,Hospital General Universitari Vall dHebron |
Bellmunt J.,University of the Sea
Current Oncology Reports | Year: 2011
Variant forms of bladder cancer are non-urothelial neoplasms or urothelial carcinomas mixed with other histologies. Compared to pure urothelial carcinoma, they all present with a high stage and grade. Prognosis is variable and there is a lack of evidence regarding the ideal treatment approach, because of their relative infrequency and the noninclusion in bladder cancer randomized trials. Despite this, basic recommendations can be extracted from case series. In the present report, existent literature about variant forms of bladder cancer is reviewed with focus on the most frequent: squamous cell, adenocarcinoma, small cell, micropapillary, sarcomatoid, and lymphoepithelioma-like. © 2011 Springer Science+Business Media, LLC.
Zafon C.,Hospital General Universitari Vall dHebron |
Creus C.,Hospital General Universitari Vall dHebron
Acta Diabetologica | Year: 2013
The incidence of type 2 diabetes mellitus increases with age. However, there are few data about the most adequate type of insulin, or the most adequate insulin regimen, for elderly patients with diabetes. The present study compared insulin regimens in patients aged more than 70 years (100 subjects) with those aged less than 70 years (73 subjects) who attended a diabetes outpatient clinic. The weight, body mass index, diabetes-associated chronic complications, other cardiovascular risk factors, type of insulin, insulin regimen, total daily dose of insulin, weight-adjusted total daily dose of insulin, concomitant treatment with oral hypoglycaemic agents (OHA) and glycosylated haemoglobin (HbA1c) were compared between the two groups. Although both groups had the same level of metabolic control (HbA1c: 7.66 ± 0.91 in the elderly group vs. 7.62 ± 0.96 in the younger group), we have found that elderly subjects were more likely to be treated with a simple regimen, as shown by a higher use of basal insulin (15% in young patients and 41% in the elderly group; P < 0.001), lower use of fast-acting insulin (32.8% vs. 15%; P = 0.005), and fewer daily injections (45% vs. 22% received at least three injections each day; P = 0.001). There were no differences in the use of OHA; however, the majority of young patients were treated with metformin, whereas repaglinide was most commonly used in the elderly group. In conclusion, in everyday clinical practice, elderly subjects were treated with the simplest regimen and achieved the same level of metabolic control as young diabetic patients. © 2011 Springer-Verlag.
Matas M.,Hospital General Universitari Vall dHebron |
Dominguez Gonzalez J.M.,Hospital General Universitari Vall dHebron |
Montull E.,Sanofi S.A.
Annals of Vascular Surgery | Year: 2013
Background: Antiplatelet treatment prevents cardiovascular events and thrombosis during the endovascular surgery procedure. The aim of this study is to analyze the different antiplatelet treatment used in endovascular procedures in Spain. Methods: In this investigation we included observational, retrospective, and multicenter study patients who underwent arterial endovascular therapy in 2006 or in the first 3 months of 2007, and follow-up of at least 1 year. The following data were collected: the usual epidemiologic variables, history of cardiovascular disease (coronary, cerebrovascular, or peripheral artery disease), risk factors, endovascular procedure performed, blood pressure, ethiology of arterial disease, the pre-operative antiaggregant treatment, and antiplatelet therapy used at 1 month and 1 year after the procedure. Results: A total of 1,557 patients were evaluated, of whom 84.3% were male. In addition 72.1% were hypertensive, 53.1% dyslipidemic, and 43.3% diabetic. From these patients, 32.6% presented with ischemic cardiomyopathy, 17.9% had a cerebral vascular history, and 35.3% had peripheral arterial disease. The most common etiology was occlusive disease (76.9%), the most commonly treated arterial sector was iliac (33.4%), and the most frequent procedure was stent angioplasty (46.9%). In the preoperative period, 75.1% of the patients were given antiplatelet therapy (89% simple antiplatelet treatment), 62.9% in the perioperative period, and 93.8% at 1 month after surgery (37.3% double antiaggregation). Antiplatelet treatment was administered previously to 86.2% of patients with history of cerebrovascular disease and to 88% of those with coronary disease. In the femoropopliteal sector 76.1% patients were receiving antiaggregation treatment before the procedure (11.1% double). However, 1 month later, double antiaggregation therapy was increased (45.3%), especially in the angioplasty and stent. In the iliac sector, 43.1% of patients with arterial stenosis and 38.2% of patients with complete arterial occlusion treated with angioplasty and stent continued receiving double antiaggregation 1 month after the procedure. In the carotid territory, 65.7% of patients treated with stent were receiving double antiplatelet treatment 1 month after the procedure. Conclusions: We believe it is necessary to create consensus committees to perform clinical practice evidence-based guidelines to formalize antiaggregation treatment in endovascular procedures. © 2013 Elsevier Inc. All rights reserved.
Galve E.,Hospital General Universitari Vall dHebron |
Sambola A.,Hospital General Universitari Vall dHebron |
Saldana G.,Hospital General Universitari Vall dHebron |
Quispe I.,Hospital General Universitari Vall dHebron |
And 4 more authors.
Heart | Year: 2010
Objective: To examine the mid-term and long-term outcomes in patients with obstructive hypertrophic cardiomyopathy (HCM) submitted to pacing. Design Prospective, observational study. Setting Single, non-referral centre. Patients and intervention Fifty patients (62±11 years) with HCM refractory to medical treatment, all in New York Heart Association (NYHA) class III or IV, and with a rest gradient >50 mm Hg underwent a dual-chamber pacemaker implantation. Patients were followed-up for up to 10 years (mean 5.0±2.9, range 0.6-10.1). Results: During the first year of follow-up, rest gradients decreased (baseline 86±29 mm Hg; 3 months 55±37; l year 41±26; p=0.0001). NYHA class improved, as well as exercise tolerance (baseline 281±112 m; 3 months 334±106 m; 1 year 348±78 m; p<0.0001). The physical and mental components of the quality of life instrument SF-36 also improved. Left ventricular wall thickness remained unchanged, while ejection fraction decreased (baseline 76±10%; 3 months 74±8%; 1 year 66±13%; p=0.002). During the long-term follow-up, an additional reduction in obstruction was found (final rest gradient 28±24 mm Hg, p<0.02). Those patients who did not improve to NYHA class I or II and continued to have obstruction were given other treatments (six,alcohol ablation; three, surgical myectomy). Conclusions: Pacing in HCM results in a significant reduction in obstruction, improvement of symptoms and exercise capacity that is progressive and may be achieved after a long period of time. In this series, only 18% of cases needed a more aggressive treatment to relieve residual obstruction and obtain a satisfactory symptomatic status. In conclusion, these results emphasise the need for new controlled studies of pacing with a longer follow-up.
Garcia-Bennett J.,Hospital General Universitari Vall dHebron |
Olive C.S.,Hospital General Universitari Vall dHebron |
Rivas A.,Hospital General Universitari Vall dHebron |
Dominguez-Oronoz R.,Hospital General Universitari Vall dHebron |
Huguet P.,Hospital General Universitari Vall dHebron
Skeletal Radiology | Year: 2012
Objective: Few articles have been published regarding the imaging characteristics of soft tissue solitary fibrous tumors (SFT). The aim of this study is to describe the radiological features in a series of nine patients and to compare these results with pathological and clinical outcome. Subjects and methods Nine cases of soft tissue SFT, confirmed by an experienced tumor pathologist, were studied with imaging techniques (US and MRI). Tumor location, size, morphology, local invasion, vascularity, MRI signal intensities, and dynamic contrast-enhancement patterns were recorded. Tumors were subclassified into cellular, fibrous, and giant cell forms histologically. Results: The most common findings were a well-defined, polylobulated mass that tended to displace adjacent structures. The extremities were the most frequent site of presentation. The tumors showed high vascularity in all imaging studies. The radiological features that correlated better with malignant criteria were tumor size, heterogeneous signal intensity, and heterogeneous uptake of contrast on MRI. On dynamic contrast-enhanced (DCE) sequences, three tumors showed a biphasic curve (type IV) and one a progressive uptake curve (type II). The latter recurred twice after extensive local surgery and was classified as a giant cell variant. Conclusion In this study a retrospective review of nine new cases of soft tissue SFT was carried out. The presence of a large solid, highly vascularized mass with a prominent vascular pedicle that displaces adjacent structures may suggest the diagnosis of an SFT. DCE sequences might help identify those tumors with worse clinical outcome, but a study with a larger series of patients is needed.© ISS 2012.