36 research outputs found

    Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

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    Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

    Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

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    BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

    Necessity of surgical retreatment in mandibular fractures after treatment by rigid internal fixation

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    As fraturas de mandíbula são freqüentes e o seu tratamento é por meio de fixação interna rígida. Complicações podem ocorrer após o tratamento das fraturas mandibulares levando a necessidade de reabordagem cirúrgica, havendo poucos estudos a esse respeito na literatura. A proposta deste estudo retrospectivo foi avaliar as características, os possíveis fatores de risco e os tipos de tratamento realizado em pacientes que necessitaram de reabordagem cirúrgica de fraturas de mandíbula tratadas com fixação interna rígida (FIR). Dentre 364 pacientes tratados por fraturas de mandíbula com FIR, houve 17 pacientes (4,7%) que necessitaram de reabordagem cirúrgica, tendo sido incluídos três pacientes provenientes de outros serviços, totalizando 20 casos com necessidade de nova cirurgia. Houve predomínio do gênero masculino, com idade média de 31,4 anos, sendo freqüentes o tabagismo e o etilismo. Foram freqüentes fraturas múltiplas e cominutivas nas regiões de corpo e ângulo mandibular, dente no traço e exposição intraoral da fratura. O tempo de espera para primeira cirurgia foi alto e o acesso extraoral e o sistema de fixação menos rígido 2.0 mm foram freqüentes. As complicações mais comuns foram dor, infecção e mobilidade anormal. Nas culturas bacterianas houve predomínio do Staphylococcus aureus e a imagem mais freqüente foi de reabsorção óssea difusa, seguida por parafuso solto, seqüestro ósseo, traço de fratura visível, fixação solta e placa fraturada. A reabordagem cirúrgica ocorreu em média de 7,5 meses após a primeira cirurgia e constou de remoção dos meios de fixação associada ou não a nova fixação ou ainda a remoção de seqüestro ósseo, sendo que apenas um caso necessitou de refratura. Histologicamente houve predomínio de osteomielite crônica. Os diagnósticos em ordem decrescente foram infecção, pseudoartrose, osteomielite e placa exposta, sendo que muitos pacientes tiveram mais de um diagnóstico. Foi destacada a freqüência de tabagismo e etilismo, fraturas múltiplas e cominutivas na região de corpo e ângulo mandibular, dente no traço, exposição intraoral, tempo de espera alto e acesso extraoral predispondo complicações das fraturas mandibulares e exames de imagem de reabsorção óssea, fixação e parafusos solto e seqüestro ósseo e diagnóstico histológico de osteomielite como característica dos casos requerendo nova cirurgia.Mandibular fractures are frequent and their treatment is through rigid internal fixation (RIF). Complications can occur after treatment of the mandibular fractures which may require a new surgical procedure, and there are a few studies about that in the literature. The purpose of this retrospective study was to evaluate the characteristics, possible risk factors, and the kinds of treatment did in patients which needed another surgery after treatment of mandibular fracture with RIF. From 364 patients with mandibular fractures treated by RIF, there were 17 patients (4.7%) with need of a new surgery, and 3 patients coming from another city were included, comprising a total of 20 patients who needed a new surgery. There was predominance of the male gender, with a mean age of 31.4 years, being frequent smoking and alcohol abuse. Multiple and comminuted fractures on the body and angle sites, teeth in the fracture line, and intraorally exposed fractures were frequent. Delay time to the first surgery was high, and extraoral approaches and system 2.0mm were predominant. The most common complications were pain, infection and abnormal mobility. In the bacterial culture there was predominance of Staphylococcus aureus, and the most frequent radiographic images were of diffuse bone resorption, loosening of screws, bone sequestration, fracture line visible, loose fixation, and fractured plate. A new surgery occurred with a mean of 7.5 months after the first intervention and comprised plate and screws removal associated or not to a new fixation or bone sequestra removal, and only a case the fracture needed to be osteotomized. Histologically there was predominance of chronic osteomyelitis. The diagnoses in decreasing order were infection, nonunion, osteomyelitis and exposed plate, although many patients had more than one diagnosis. It was evidenced the frequency of smoking and alcohol abuse, multiple and comminuted fracture on the body and angle regions, teeth in the fracture line, intraoral fracture exposition, high delay time and extraoral approaches predisposing complications of the mandibular fractures, and images showing bony resorption, loose hardware and bone sequestra, as well as histological diagnosis of osteomyelitis as characteristic of the cases requiring a new surgery

    Factors contributing to the surgical retreatment of mandibular fractures

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    The purpose of this retrospective study was to evaluate contributing factors in patients requiring surgical retreatment of mandibular fractures. Of all the patients with mandibular fractures who were treated using internal fixation at a trauma hospital over a seven-year period, 20 patients (4.7%) required a second surgery and thus composed the &#8220;reoperated&#8221; group. The control group comprised 42 consecutive patients with mandibular fractures who were treated at the same clinic and who healed without complications. Medical charts were reviewed for gender, age, substance abuse history, dental condition, etiology, location of fracture, degree of fragmentation, fracture exposure, teeth in the fracture line, associated facial fractures, polytrauma, time elapsed between trauma and initial treatment, surgical approach and fixation system. Statistical analyses were performed using the Statistical Package for Social Sciences (SPSS) version 20.0; descriptive statistics and the chi-squared test were used to determine differences between groups. Significant differences in substance abuse (p = 0.006), dental condition (p < 0.001), location of fracture (p = 0.010), degree of fragmentation (p = 0.003) and fracture exposure (p < 0.001) were found. With regard to age and time elapsed between trauma and initial treatment, older patients (31.4 years, SD = 11.1) and a delay in fracture repair (19.1 days, SD = 18.7) were more likely to be associated with reoperation. It was concluded that substance abuse, age, dental condition, location of fracture, degree of fragmentation, fracture exposure and the time between trauma and initial treatment should be considered contributing factors to the occurrence of complications that require surgical retreatment of mandibular fractures

    Outcomes in Newly Diagnosed Atrial Fibrillation and History of Acute Coronary Syndromes: Insights from GARFIELD-AF

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    BACKGROUND: Many patients with atrial fibrillation have concomitant coronary artery disease with or without acute coronary syndromes and are in need of additional antithrombotic therapy. There are few data on the long-term clinical outcome of atrial fibrillation patients with a history of acute coronary syndrome. This is a 2-year study of atrial fibrillation patients with or without a history of acute coronary syndromes

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    Analysis of Outcomes in Ischemic vs Nonischemic Cardiomyopathy in Patients With Atrial Fibrillation A Report From the GARFIELD-AF Registry

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    IMPORTANCE Congestive heart failure (CHF) is commonly associated with nonvalvular atrial fibrillation (AF), and their combination may affect treatment strategies and outcomes
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