A Phase II randomized controlled trial evaluated antithrombotic treatment with fesomersen in patients with kidney failure on hemodialysis.

Patients with kidney failure on hemodialysis (KF-HD) are at high risk for both atherothrombotic events and bleeding. This Phase IIb study evaluated the dose-response of fesomersen, an inhibitor of hepatic Factor XI expression, versus placebo, for bleeding and atherothrombosis in patients with KF-HD. Patients were randomized to receive fesomersen 40, 80, or 120 mg once-monthly, or matching placebo, for up to 12 months. The primary safety endpoint was a composite of major bleeding and clinically relevant non-major bleeding (MB/CRNMB). Exploratory endpoints included post-dialysis arterio-venous (AV)-access bleeding, major atherothrombotic events (composite of fatal or non-fatal myocardial infarction, ischemic stroke, acute limb ischemia/major amputation, systemic embolism, symptomatic venous thromboembolism), AV-access thrombosis, and clotting of the hemodialysis circuit. Of 308 participants randomized, 307 received study treatment and were analyzed. Fesomersen led to a dose-dependent and sustained reduction of steady-state median FXI levels by 53.6% (40 mg group), 71.3% (80 mg group), 86.0% (120 mg group), versus 1.9% in the placebo group. MB/CRNMB events occurred in 6.5% (40 mg group), 5.1% (80 mg group), 3.9% (120 mg group), and in 4.0% of those receiving placebo (pooled fesomersen versus placebo P = 0.78). Major atherothrombotic events occurred in 1 patient (1.3%) in each treatment arm. MB/CRNMB bleeding and post-dialysis AV-access bleeding were not related to predicted FXI levels. Lower predicted FXI levels were associated with reductions in hemodialysis circuit clotting (P = 0.002) and AV-access thrombosis (P = 0.014). In patients with KF-HD, fesomersen produced a dose-dependent reduction in FXI levels associated with similar rates of major bleeding compared with placebo. REGISTRATION: URL: https://www.clinicaltrials.gov; unique identifier: NCT04534114.

Befovacimab, an anti-tissue factor pathway inhibitor antibody: Early termination of the multiple-dose, dose-escalating Phase 2 study due to thrombosis.

INTRODUCTION: Befovacimab (formerly BAY 1093884) is a fully human monoclonal antibody able to bind to tissue factor pathway inhibitor (TFPI) and developed as a non-replacement therapy for individuals with haemophilia A/B, with or without inhibitors. AIM: To assess the safety of multiple escalating doses of befovacimab in individuals with severe haemophilia A/B with or without inhibitors. METHODS: In this non-randomised, open-label Phase 2 study (NCT03597022), adult males with <1% factor VIII or <2% factor IX and ≥4 bleeds in the previous six months were enrolled in three dose cohorts (100/225/400 mg). Participants received befovacimab subcutaneously once weekly. The primary endpoint was safety; secondary endpoints included annualised bleeding rate (ABR) and pharmacokinetics/pharmacodynamics (PK/PD) of befovacimab. RESULTS: A total of 24 participants (n = 8 in each dose cohort) were treated for 2-47 weeks. Patients treated with 100 mg and 225 mg doses of befovacimab demonstrated improved bleeding control compared with pre-study bleeding rates, with a dose-dependent effect. Dosing was suspended and the study prematurely terminated following three drug-related thrombotic serious adverse events (SAEs): two at the 225 mg dose and one at the 400 mg dose. These occurred in the absence of bleeding episodes or concomitant use of replacement/bypass therapies. No laboratory abnormalities were observed, and PK/PD data did not show correlation between SAE occurrence and levels of circulating befovacimab or free TFPI. CONCLUSION: Despite favourable initial results from preclinical and clinical studies, a positive safety profile of befovacimab was not confirmed. The lack of SAE-related laboratory abnormalities or differentiating PK/PD characteristics in participants experiencing SAEs raises concerns about the predictability of thrombosis following befovacimab treatment and emphasises the need for further investigation into the therapeutic window of anti-TFPI treatment.

Chronic diseases, chest computed tomography, and laboratory tests as predictors of severe respiratory failure and death in elderly Brazilian patients hospitalized with COVID-19: a prospective cohort study.

BACKGROUND: The primary risk factors for severe respiratory failure and death in the elderly hospitalized with COVID-19 remain unclear. OBJECTIVE: To determine the association of chronic diseases, chest computed tomography (CT), and laboratory tests with severe respiratory failure and mortality in older adults hospitalized with COVID-19. METHOD: This was a prospective cohort with 201 hospitalized older adults with COVID-19. Chronic diseases, chest CT, laboratory tests, and other data were collected within the first 48 h of hospitalization. Outcomes were progression to severe respiratory failure with the need of mechanical ventilation (SRF/MV) and death. RESULTS: The mean age was 72.7 ± 9.2 years, and 63.2% were men. SRF/MV occurred in 16.9% (p < 0.001), and death occurred in 8%. In the adjusted regression analyses, lung involvement over 50% [odds ratio (OR): 3.09 (1.03-9.28; 0.043)], C-reactive protein (CRP) > 80 ng/mL [OR: 2.97 (0.99-8.93; 0.052)], Vitamin D < 40 ng/mL [OR: 6.41 (1.21-33.88; 0.029)], and hemoglobin < 12 g/mL [OR: 3.32 (1.20-9.20; 0.020)] were independent predictors for SFR/MV, while chronic atrial fibrillation [OR: 26.72 (3.87-184.11; 0.001)], cancer history [OR:8.32 (1.28-53.91; 0.026)] and IL-6 > 40 pg/mL [OR:10.01 (1.66-60.13; 0.012)] were independent predictors of death. CONCLUSION: In hospitalized older adults with COVID-19, tomographic pulmonary involvement > 50%, anemia, vitamin D below 40 ng/mL, and CRP above 80 mg/L were independent risk factors for progression to SRF/MV. The presence of chronic atrial fibrillation, previous cancer, IL-6 > 40 pg/mL, and anemia were independent predictors of death.

Regenerative effect of platelet-rich plasma in the murine ischemic limbs.

AIMS: The purpose of this study was to investigate the effect of PPRP (pure PRP) and LPRP (PRP with leukocytes) on recovery from limb ischemia and on expression of growth factors involved in angiogenesis, myogenesis and fibrogenesis. MATERIAL AND METHODS: PPRP and LPRP prepared by centrifugation were added to cultures of C2C12 and NIH3T3 cells (1 or 10% PRPs) to evaluate alterations in cell metabolism and expression of growth factors by MTT, ELISA and RT-qPCR, respectively. To evaluate in vivo regenerative effects, PRPs were injected into the ischemic limbs of BALB/c mice and muscle mass/strength and histomorphometry were evaluated after 30 days. KEY FINDINGS: Mice treated with PRPs after limb ischemia showed an increase in the size of myofibers and muscle strength, reduced fibrosis and adipocytes, and decreased capillary density and necrosis scores compared to untreated mice. In cell culture, serum deprivation reduced the viability of C2C12 and NIH3T3 cells to about 50%, but the addition of 1% PRPs completely recovered this loss. Both PRPs, downregulated most of the tested genes; however, angiogenic gene Vegfa in C2C12 and the fibrogenic genes Col1a1 and Col3a1 in NIH3T3 cells were upregulated by LPRP. SIGNIFICANCE: PPRP and LPRP had similar effects in regulation of genes involved in angiogenesis, myogenesis and fibrogenesis. However, the presence of leucocytes did not significantly affect regenerative activities of PRP in the ischemic limb.

The association between low lean mass and osteoporosis increases the risk of weakness, poor physical performance and frailty in Brazilian older adults: data from SARCOS study.

PURPOSE: To characterize the phenotypes of older adults with low lean mass and osteoporosis, concomitantly or isolated, in regards to poor physical performance and frailty status. DESIGN: Cross-sectional analysis of the SARCopenia and OSteoporosis in Older Adults with Cardiovascular Diseases Study (SARCOS). SETTING: Outpatient geriatric cardiology clinic. PARTICIPANTS AND METHOD: 385 older adults underwent DXA analysis. Low lean mass was diagnosed according to FNIH and low BMD by a T-score ≤ -2.5 SD. Subjects were grouped into: I-Low lean mass and Osteoporosis (LLMO); II-Low lean mass (LLM); III-Osteoporosis (OP), and IV-Controls. Poor physical performance was diagnosed by weakness or slow walking speed or impaired mobility. Frailty was diagnosed by CHS criteria. RESULTS: The mean age was 78.22 ± 7.16 years. The prevalence of LLMO, LLM, and OP were 14.8%, 39.5%, and 19.2%, respectively. LLMO subjects were older, predominantly women, with a high percentage of body fat (HTBF). LLM was represented by obese men, while individuals with OP were preferably women, older and leaner. In a regression analyses, LLMO presented an OR: 6.42 (2.63‒15.65; p < 0.001) for weakness, OR: 2.55 (1.09‒5.95; p = 0.030) for impaired mobility, and OR: 14.75 (2.72‒79.94; p = 0.002) for frailty. After adjusting for HTBF, the OR for frailty, decreased to 7.25 (1.11-47.21; p = 0.038). LLM and OP were associated only with weakness with an OR: 3.06 (1.36-6.84; p = 0.006) and OR: 3.14 (1.29-7.62; p = 0.011), respectively. CONCLUSION: In Brazilian older community-dwelling outpatient adults, the phenotype characterized by low lean mass and osteoporosis presents a higher association with impaired mobility, weakness and frailty status compared to the others phenotyeps and controls. A high percentage of body fat presents a synergistic effect with low lean mass and osteoporosis phenotype in regards to frailty.

The effect of high doses of ω-3 fatty acid on the structure of the gastrocnemius muscle and on the lipidic profile of Wistar rats submitted to swimming.

OBJECTIVES: Evidence suggests that ω-3 fatty acids (FA) may have an anabolic effect on skeletal muscle. However, questions about dosage, frequency, combined protein supplementation, or different physical exercises remain unanswered. The aim of this study was to quantify by stereology whether supplementation with high dosages of ω-3 FA combined with swimming has an anabolic effect on the skeletal musculature and on the lipid profile of rats. METHODS: Sixty male Wistar rats were divided into four groups: placebo sedentary (PS), ω-3 FA sedentary (ω-3 S), placebo exercise (PE), and ω-3 FA exercise (ω-3 E). The animals in the PE and ω-3 E groups were submitted to swimming 5 d/wk, with an overload of 15% of body weight. The animals received ω-3 FA or olive oil (placebo) by gavage. After sacrifice, blood samples and the gastrocnemius muscle were collected for analysis. RESULTS: Results from this study did not show a difference in the cross-sectional areas of the gastrocnemius muscle between groups. The administration of high doses of ω-3 FA reduced plasmatic concentrations of low-density lipoprotein. Additionally, an interaction effect was observed between physical exercise and supplementation with ω-3 on levels of high-density lipoprotein. Therefore, the association between these two treatments increased high-density lipoprotein levels. CONCLUSIONS: The administration of high doses of ω-3 associated with physical activity may be beneficial in the treatment of dyslipidemia. High doses of ω-3 FA do not cause muscle mass alteration.

Dupla deficiência motora em um centro de reabilitação: hemiparesia após acidente vascular cerebral e amputação de membro inferior - Quem são eles? / Dual motor disability in an outpatient rehabilitation center: hemiparesis after stroke and lower limb amputation patients - Who are they?

Objetivo: Estimar a prevalência da dupla deficiência motora e identificar as características social, demográficas, clinicas e relacionadas á reabilitação desses indivíduos. Métodos: Estudo descritivo retrospectivo realizado em um centro de reabilitação com indivíduos com dupla deficiência motora decorrente de amputação de membro inferior associada à hemiparesia após acidente vascular cerebral (AVC). Características sociodemografica, clinica e relacionada a reabilitação foram coletadas através de consulta a prontuários. Resultados: A prevalência da dupla deficiência motora foi de 5,4%. Dos 76 indivíduos avaliados, 69,7% eram do sexo masculino, com média de idade de 65,6 (±9,3). A hipertensão arterial sistema estava presente em 96,1% dos indivíduos e 25% eram tabagistas. Mais que 73% dos pacientes tiveram o AVC prévio à amputação. O tempo entre as lesões foi, em mediana, de 23 meses, as sequelas foram ipsilaterais em 51,3% dos pacientes. Desses, 54 pacientes (71%) foram encaminhados para as terapias físicas. O tempo entre a dupla deficiência e o início da terapia foi de 28 meses, com tempo de reabilitação total de 14,3 meses. Ao fim do processo de reabilitação 36% alcançaram suas metas, mas 30% teve alta devido a falta de adesão ao tratamento. Conclusão: A prevalência da dupla deficiência motora devido a hemiparesia após AVC e amputação de membro inferior foi 5,4%, e a população estudada apresentou características singulares relacionada ao processo de reabilitação, como um longo tempo entre a ocorrência da dupla deficiência e o inicio da reabilitação, e um longe tempo na reabilitação.

Objectives: To estimate the prevalence of dual motor disability and to identify social, demographic, clinical and rehabilitation-related characteristics. Methods: Retrospective descriptive study in an outpatient rehabilitation center with individuals with dual motor disability from major lower limb amputation associated to post-stroke hemiparesis. Social demographic, clinical and rehabilitation characteristics data were collected from medical record. Results: The prevalence of dual motor disability was 5.4%. Seventy-six subjects were evaluated, 69.7% were male, with a mean age of 65.6 ± 9.3 years. Hypertension was present in 96.1% of subjects, and 25% were smokers. Over 73% of patients had had the stroke prior to amputation. Time elapsed between lesions had a median of 23 months, and sequelae were ipsilateral in 51.3% of patients. Of these, 54 patients (71%) were referred to physical therapy. The time interval between dual disability and the beginning of therapy was 28 months, with total rehabilitation time of 14.3 months. At rehabilitation completion, 36% achieved their goals but 30% were discharges consequent to lack of compliance. Conclusion: The prevalence of dual motor disability due to hemiparesis secondary to stroke and lower limb amputation in a rehabilitation center was 5.4%. Our population showed singular characteristics related to the rehabilitation process, such as a long time between the occurrence of dual disability and the beginning of rehabilitation, and long rehabilitation period.

Incidence of musculoskeletal injuries in soccer referees: a three-year study / Incidência de lesões musculoesqueléticas em árbitros de futebol: estudo de três anos / Incidencia de lesiones musculoesqueléticas en árbitros de fútbol: estudio de tres años

ABSTRACT Objectives To determine the incidence and intensity of pain and the areas most affected by injuries with musculoskeletal pain, and the incidence and severity of "injuries defined by time of leave" in games and training of soccer referees in a triennium. Methods An interview was conducted with 257 referees using a web application. With this tool, a monthly evaluation form was sent to the referees with questions that measured the incidence, location, and pain intensity of injuries with complaints of pain and time of leave, severity in games and training in the years 2012, 2013, and 2014. The numerical pain scale was used to classify the pain intensity of the lesions with pain complaint. Results There was no difference between the years studied in relation to injuries with pain complaints, both in games and in training. Mean values were 37.8/1,000 hours in games and 39.9/1,000 hours in training, with a mean incidence of " injuries defined by time of leave" of 3.7/1,000 hours in games. The difference was significantly higher in 2013 compared to 2012 and 2014, and in training, the average incidence was 3.5/1,000 hours, with a significantly higher difference in 2012 compared to 2013 and 2014. Conclusion Lesions with pain complaints did not present a significant difference in games compared to training; in the lesions by time of leave, the incidence in games was higher than in training, and the most frequent type of injury was low-degree muscle pain, predominantly in the thigh and triceps surae. Level of Evidence II; Prognostic Study - Investigating the Effect of Patient Characteristics on Disease Outcome.

RESUMO Objetivos Determinar a incidência e a intensidade álgica e os locais mais acometidos por lesões com dor musculoesquelética e incidência e gravidade das "lesões definidas por tempo de afastamento" em jogos e treinos de árbitros de futebol, em um triênio. Métodos Foram entrevistados 257 árbitros utilizando-se um aplicativo da web. Com essa ferramenta, foi enviada aos árbitros uma ficha de avaliação mensal com questões que mediam incidência, localização e intensidade álgica das lesões com queixas de dor e por tempo de afastamento, gravidade em jogos e treinos nos anos de 2012, 2013 e 2014. Para classificar a intensidade álgica das lesões com queixas utilizou-se a escala numérica de dor. Resultados Não houve diferença entre os anos estudados com relação às lesões com queixas de dor, tanto em jogos quanto em treinos. Os valores médios foram de 37,8/1.000 horas em jogos e 39,9/1.000 horas em treinos e a incidência média de "lesões definidas por tempo de afastamento" de 3,7/1.000 horas em jogos. A diferença foi significantemente maior em 2013 com relação a 2012 e 2014 e, em treinos, a incidência média foi de 3,5/1.000 horas com diferença significantemente superior em 2012 com relação a 2013 e 2014. Conclusão As lesões com queixas de dor não apresentaram diferença significante em jogos comparados com treinos; nas lesões por tempo de afastamento, a incidência em jogos foi maior do que em treinos, e o tipo de lesão mais frequente foi a muscular de grau leve, predominando na coxa e no tríceps sural. Nível de evidência II, Estudos diagnósticos - Investigação de um exame para diagnóstico.

RESUMEN Objetivos Determinar la incidencia y la intensidad del dolor y los lugares más afectados por lesiones con dolor musculoesquelético e incidencia y gravedad de las "lesiones definidas por tiempo de licencia" en juegos y entrenamientos de árbitros de fútbol en un trienio. Métodos Fueron entrevistados 257 árbitros utilizando una aplicación de la web. Con esta herramienta, se envió a los árbitros una ficha de evaluación mensual con cuestiones que medían incidencia, localización, intensidad de las lesiones con quejas de dolor y por tiempo de licencia, gravedad en juegos y entrenamientos en los años 2012, 2013 y 2014. Para clasificar la intensidad del dolor de las lesiones con quejas se utilizó la escala numérica de dolor. Resultados No hubo diferencia entre los años estudiados en relación a las lesiones con quejas de dolor, tanto en juegos como en entrenamientos. Los valores promedio fueron de 37,8/1.000 horas en juegos y 39,9/1.000 horas en entrenamientos, siendo la incidencia media de "lesiones definidas por tiempo de licencia" de 3,7/1.000 horas en juegos. La diferencia fue significantemente mayor en 2013 con respecto a 2012 y 2014 y en los entrenamientos, la incidencia media fue de 3,5/1.000 horas con una diferencia significantemente superior en 2012 con respecto a 2013 y 2014. Conclusión Las lesiones con quejas de dolor no presentaron diferencia significativa en juegos comparados a los entrenamientos; en las lesiones por tiempo de licencia, la incidencia en juegos fue mayor que en entrenamientos, y el tipo de lesión más frecuente fue la muscular de grado leve, predominio en el muslo y tríceps sural. Nivel de evidencia II, Estudios de diagnósticos - Investigación de un examen para diagnóstico.

Bicruciate lesion biomechanics, Part 2-treatment using a simultaneous tensioning protocol: ACL fixation first is better than PCL fixation first to restore tibiofemoral orientation.

PURPOSE: An uncommon technique for bicruciate ligament reconstruction involving simultaneous tensioning of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) grafts with ACL graft fixation first has been pointed out as superior to the "gold-standard" PCL graft fixation first. The purpose of this study was to compare tibiofemoral biomechanics between ACL fixation first and PCL fixation first in a simultaneous tensioning protocol for bicruciate ligament reconstruction. METHODS: 12 fresh-frozen cadaveric knees (six matched pairs) were tested using a custom testing system. Neutral tibial position representing tibiofemoral orientation, anterior-posterior (AP) tibial translation, varus-valgus laxity, and internal-external rotation were measured using a Microscribe 3DLX at 0°, 30°, 60°, and 90° of knee flexion. The following knee conditions were evaluated: intact, bicruciate deficient and following bicruciate reconstruction. A simultaneous tensioning protocol was used for bicruciate reconstruction and PCL fixation first was compared to ACL fixation first. PCL graft fixation was always performed at 90° of flexion and ACL graft fixation was always performed at full extension. RESULTS: ACL fixation first achieved a tibiofemoral orientation closer to the intact knee than PCL fixation first at 90° flexion (1.8 ± 1.6 mm versus 6.1 ± 3.2 mm, p = 0.016). PCL fixation first had a larger decrease in AP translation than ACL fixation first at 30° flexion (64.6 ± 3.5% vs. 58.3 ± 2.4%, p = 0.01). No significant differences were found for varus/valgus, external-internal rotation decrements after bicruciate reconstruction nor for AP translation, varus/valgus and internal/external rotation increase after bicruciate lesion comparing ACL fixation first to PCL fixation first. CONCLUSION: Bicruciate ligament reconstruction using a simultaneous tensioning protocol with ACL fixation first resulted in a closer to normal tibiofemoral orientation. This study will help guide surgeons in decision making for the graft tensioning protocol and fixation sequence in a bicruciate ligament reconstruction. LEVEL OF EVIDENCE: V therapeutic study.

Bicruciate lesion biomechanics, Part 1-Diagnosis: translations over 15 mm at 90° of knee flexion are indicative of a complete tear.

PURPOSE: Understanding the pathomechanics of a bicruciate injury (BI) is critical for its correct diagnosis and treatment. The purpose of this biomechanical study aims to quantify the effects of sequential sectioning of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) bundles on knee laxity. METHODS: Twelve cadaveric knees (six matched pairs) were used. Knee laxity measurements consisted of neutral tibial position, anterior-posterior translation, internal-external rotation, and varus-valgus angulation in different conditions: intact, ACL cut, incomplete BI (divided into two groups: anterolateral (AL) bundle intact or posteromedial (PM) bundle intact) and complete bicruciate tear. Data were collected using a Microscribe system at 0°, 30°, 60°, and 90° of knee flexion. RESULTS: In comparison to the intact knees, incomplete BI and complete BI showed a significant increase of total antero-posterior tibial translation. The largest significant increase was observed at 90° of flexion after a complete bicruciate resection (p < 0.001). A threshold difference greater than 15 mm from the intact could be used to identify a complete BI from an incomplete BI evaluating the total antero-posterior translation at 90°. All sectioned states had significant increases compared with the intact condition in internal-external rotation and varus-valgus stability at all tested flexion angles. CONCLUSION: Both incomplete and complete BI led to an important AP translation instability at all angles; however, full extension was the most stable position at all injured models. Total antero-posterior translation at 90° of knee flexion over 15 mm, in comparison to the intact condition, was indicative of a complete BI. Since the appropriate assessment of a combined ACL and PCL lesion remains a challenge, this study intends to assist its diagnosis. As BI's main antero-posterior instability occurred at 90°, a total antero-posterior drawer test is proposed to evaluate BI in the clinical setting. Total antero-posterior translation at 90° > 15 mm, in comparison to the intact condition or the contra-lateral non-injured knee, can be used to identify a complete from an incomplete BI.

Sex effects on the association between sarcopenia EWGSOP and osteoporosis in outpatient older adults: data from the SARCOS study

ABSTRACT Objective: The objective was to evaluate the association between sarcopenia (EWGSOP) and osteoporosis in older adults. Subjects and methods: This is a cross sectional analysis of a baseline evaluation of the SARCopenia and OSteoporosis in Older Adults with Cardiovascular Diseases Study (SARCOS). Three hundred and thirty-two subjects over 65 years of age were evaluated. Sarcopenia was determined by EWGSOP flowchart and Osteoporosis was established by WHO's criteria. Physical function, comorbidities and medications were evaluated. Results: Women were older (79.8 ± 7.2 years) than men (78.21 ± 6.7 years) (p = 0.042). Osteoporosis occurred in 24.8% of men, and in 42.7% of women (p < 0.001); sarcopenia occurred in 25.5% of men and in 17.7%, of women (p = 0.103). Osteoporosis was diagnosed in 68% of sarcopenic women, however only 20.7% (p = 0.009) of women with osteoporosis had sarcopenia; in older men, 44.7% of individuals with sarcopenia presented osteoporosis and 42.9% (p = 0.013) of men with osteoporosis showed sarcopenia. In an adjusted logistic regression analyses for sarcopenia, osteoporosis presented a statistically significant association with sarcopenia in men [OR: 2.930 (95% CI: 1.044-8.237; p = 0.041)] but not in women [OR: 2.081 (0.787-5.5; p = 0.142)]; in the adjusted logistic regression analyses for osteoporosis, a statistically significant association occurred in men [OR: 2.984 (95% CI: 1.144-7.809; p = 0.025)], but not in women [OR: 2.093 (0.962-3.714; p = 0.137)]. Conclusion: According to sex, there are significant differences in the association between sarcopenia EWGSOP and osteoporosis in outpatient older adults. It is strong and significant in males; in females, despite showing a positive trend, it was not statistically significant.

Perfil neuropsicológico de pacientes com amputação maior de membros inferiores por etiologia vascular / Neuropsychological aspects of a population of patients with vascular lower extremity amputations

Objetivo: O estudo objetivou traçar um perfil neuropsicológico breve de pacientes com amputação maior de membros inferiores por etiologia vascular e investigar a existência de correlações dos aspectos cognitivos com fatores sociodemográficos e clínicos. Método: Trata-se de um estudo transversal descritivo, realizado em um centro de reabilitação física de São Paulo - Brasil, em que foram aplicados: um instrumento de avaliação neuropsicológica breve (Neupsilin), um questionário de caracterização da amostra próprio e a Escala de Ansiedade e Depressão Hospitalar (HAD). Resultados: O desempenho cognitivo foi pior em funções que requerem habilidades aritméticas (42,2% dos pacientes com desempenho abaixo do esperado); percepção (46,3% dos pacientes abaixo do esperado); funções executivas, notadamente nas tarefas praxia construtiva (40,6% abaixo do esperado) e fluência verbal (35,9% abaixo do esperado), e linguagem (31,2% abaixo do esperado). Conclusão: O perfil cognitivo dos pacientes deste estudo revelou dificuldades relevantes das funções cognitivas avaliadas, especialmente em funções diretamente relacionadas à funcionalidade do paciente.

Objective: To describe the neuropsychological profile of patients with major lower limb amputation and to investigate the existence of correlations between these cognitive aspects, socio-demographic and clinical aspects. Method: This is a cross-sectional, analytic, descriptive study carried out at an outpatient rehabilitation center. The instruments used were Hospital Anxiety and Depression Scale (HADS), a brief neuropsychological assessment instrument (Neupsilin) along with a questionnaire to characterize the sample. Results: Cognitive performance was worse in functions that require arithmetic skills (42,2% of the patients underperformed); perception (46,3% underperformed); executive functions, notably in constructive praxis (40,6% underperformed) and verbal fluency (35,9% underperformed) and language (31,2% underperformed). The best performances were in spacial orientation (92,2% performed as expected) and verbal memory (87,5% performed as expected). Conclusion: The cognitive profile of these patients revealed alterations in most of the assessed cognitive functions, especially in functions directly related to functionalities of the patient.

Fragilidade é um preditor independente de morte precoce em idosos ambulatoriais com doenças cardiovasculares no Estudo SARCOS / Frailty is an independen t predictor of early death in elderly outpatients with cardiovascular disease in the SARCOS Study

Introdução: A fragilidade caracteriza-se pela perda da capacidade biológica e física de responder adequadamente ao estresse orgânico devido aos danos a diversos sistemas associados ao processo de envelhecimento. Entre os indivíduos com doenças cardiovasculares, a frequência da fragilidade é três vezes maior. Métodos: SARCOS é um estudo epidemiológico de coorte para avaliar a síndrome de vulnerabilidade com hospitalização e mortalidade em idosos ambulatoriais com doença cardiovascular (DCV). A fragilidade foi diagnosticada na presença de três ou mais dos seguintes critérios: perda de peso > 5%, velocidade de marcha reduzida, fraqueza muscular pela força de preensão, exaustão e perda de energia (levantar e sentar da cadeira cinco vezes). Resultados: Dos 169 pacientes avaliados, a fragilidade ocorreu em 19,5% (n=33). A média de idade foi de 78,3 ± 7,1 anos. A taxa mortalidade aos seis meses foi de 3% (n=5), sendo que 80% (n=4) eram frágeis e 20% (n=1) pré-frágeis (p=0,007). Na análise de regressão logística, a fragilidade mostrou ser um forte preditor de morte aos seis meses, com aumento de risco de 18 vezes quando comparado aos fortes (p=0,010), enquanto que entre as DCVs, a insuficiência cardíaca apresentou aumento de risco de quatro vezes (p=0,061). No modelo de interação entre a fragilidade e as DCVs, não houve diferença significativa da fragilidade em relação ao risco de morte. Conclusão: A fragilidade é um importante fator de risco de morte precoce em idosos ambulatoriais, independente e superior às doenças cardiovasculares crônicas mais frequentes que acometem essa população. A síndrome da fragilidade não apresenta sinergia com doenças cardiovasculares crônicas em relação ao risco de morte

Introduction: Frailty is characterized by the loss of the biological and physical capacity to respond adequately to organic stress as a result of damage to various systems associated with aging. The frequency of frailty is three times higher among individuals with cardiovascular disease. Methods: SARCOS is an epidemiological cohort study to evaluate vulnerability syndrome with hospitalization and mortality in elderly patients with cardiovascular disease (CVD). Frailty was diagnosed when three or more of the following criteria were present: Weight loss > 5%, slow walking speed, muscle weakness by the hand-grip test, exhaustion, and loss of energy (by the five times sit-to-stand test). Results: Of the 169 patients evaluated, frailty was present in 19.5%(n = 33). The mean age was 78.3 ± 7.1 years. The mortality rate at six months was 3% (n = 5), with 80% (n = 4) being frail and 20% (n = 1) pre-frail (p = 0.007). In the logistic regression analysis, frailty was shown to be a strong predictor of death at six months, with an 18-fold increase in risk when compared to strong individuals (p = 0.010), whereas among those with CVD, the heart failure presented a 4-fold increase in risk (p = 0.061). In the interaction model between frailty and CVD, there were no significant differences in frailty in relation to the risk of death. Conclusion: Frailty is an important risk factor for early death among outpatients, independent of, and higher than the most frequent chronic cardiovascular diseases that affect this population. Frailty syndrome was not correlated with chronic cardiovascular diseases, in relation to the risk of death

Anatomic Posterolateral Corner Reconstruction With Autografts.

Anatomic posterolateral corner reconstruction reproduces 3 main structures: the lateral collateral ligament, the popliteofibular ligament, and the popliteus tendon. The LaPrade technique reproduces all 3 main stabilizers. However, it requires a long graft, limiting its indication to clinical settings in which allograft tissue is available. We propose a surgical procedure that is a modification of the LaPrade technique using the same tunnel placement, hamstring autografts, and biceps augmentation when necessary. It relies on artificial graft lengthening provided by the loop of the suspensory fixation device fixed at the anterior tibial cortex. The final reconstruction reproduces the popliteus tendon with the bulkiest end of the semitendinosus; the popliteofibular ligament with a strand of the semitendinosus and a strand of the gracilis; and the lateral collateral ligament with a strand of the semitendinosus and a strand of the gracilis, which can also be augmented with a biceps strip.

Arte reabilitação em mulheres amputadas utilizando o mito de Pandora como recurso facilitador de autoestima e qualidade de vida / Art rehabilitation in amputee women with Pandora's myth as a self-esteem and quality of life facilitator resource

A amputação é um evento traumático que repercute intensamente na vida da pessoa acometida. A dificuldade em lidar com a nova realidade pode contribuir negativamente para a autoestima e reabilitação do indivíduo, afetando a sua qualidade de vida. A Arteterapia por meio dos recursos expressivos pode ser um canal facilitador e promotor de aspectos resilientes para a superação do trauma. Objetivo: Averiguar a influência da Arteterapia na autoestima e qualidade de vida em mulheres amputadas. Grupo formado por 8 mulheres amputadas, entre 35 a 65 anos. Método: Divididos em 2 grupos (4 indivíduos no grupo de intervenção e 4 indivíduos no grupo controle). Instrumentos de avaliação: WHOQOL- Bref (World Health Organization Quality of Life), Escala de Autoestima Rosemberg (EAR), o Desenho da Figura Humana e Relatos das Participantes. As atividades foram desenvolvidas com base no mito de Pandora, em 11 oficinas arteterapêuticas com 1 hora de duração, uma vez por semana no setor de Arte-Reabilitação, AACD ­ Ibirapuera, São Paulo. Resultados: Estatisticamente não foram observadas diferenças significantes entre os momentos inicial e final para os domínios de Whoqol Bref e EAR, em ambos os grupos; porém, o grupo intervenção apresenta um movimento de melhora na autoestima, especialmente no quesito autodepreciação. Qualitativamente foram observadas através do discurso das participantes melhorias de autoestima e possibilidade de melhoria na qualidade de vida das participantes. Conclusão: A arteterapia, junto com a equipe interdisciplinar, pode contribuir positivamente para o processo de reabilitação em mulheres amputadas ajudando a promover a autoestima e qualidade de vida.

Amputation is a traumatic event that has serious repercussions on the amputee's life. The difficulty in dealing with the new reality can contribute negatively to self-esteem and rehabilitation, affecting the patient's quality of life. The Art therapy, through its expressive resources, can be a facilitator and provide resilience to overcoming the trauma. Objective: The objective of this study is to investigate the influence of art therapy in self-esteem and quality of life in amputee women. Methods: A group of 8 amputees, aged 35-65 years were divided into 2 groups (4 in the experimental group and 4 in the control group). They were evaluated with the WHOQoL-Bref (World Health Organization Quality of Life), Rosenberg Self-Esteem Scale (RSE), Human Figure Drawing test and the participants' own Reports. The activities, based on the Pandora myth, were developed in 11 art therapy workshops sessions of one hour that were carried out once a week in the Art-Rehabilitation sector off AACD ­ Ibirapuera, São Paulo. Results: There was no statistically significant differences observed between the initial and final assessments of quality of life (WHOQoL-Bref) and RSE domains of both groups, however, the experimental group evidenced a tendency towards the improvement of self-esteem, especially in regards of self-depreciation. Qualitatively, improvements of self-esteem and the possibility of improving the participants' quality of life were also observed. Conclusion: Art Therapy, combined with interdisciplinary care, can contribute positively to the rehabilitation process of amputee women, by helping to promote better self-esteem and quality of life.

Quadriceps Strength Deficit at 6 Months After ACL Reconstruction Does Not Predict Return to Preinjury Sports Level.

BACKGROUND: There is a lack of literature-based objective criteria for return to sport after anterior cruciate ligament (ACL) injury. Establishing such objective criteria is crucial to improving return to sport after ACL reconstruction (ACLR). HYPOTHESES: Patients who return to their preinjury level of sport will have higher isokinetic, postural stability, and drop vertical jump test scores 6 months after surgery and greater patient satisfaction compared with those who did not. Additionally, quadriceps strength deficit cutoff values of 80% and 90% would differentiate patients who returned to preinjury sports level from those who did not. STUDY DESIGN: Cohort study. LEVEL OF EVIDENCE: Level 3. METHODS: A retrospective search was conducted to identify all patients who underwent ACLR and completed isokinetic evaluation, postural stability analysis, and drop vertical jump testing at 6 months postoperatively. Patients were asked to complete 3 questionnaires at a minimum 1 year after surgery. Chi-square and logistic regression analyses were used for categorical dependent variables, while the Student t test, Pearson correlation, or analyses of variance with Bonferroni post hoc testing were used for continuous dependent variables. A post hoc power analysis was completed. Based on the results regarding correlations between return to preinjury level and all other variables, effect sizes from 0.24 to 3.03 were calculated. With these effect sizes, an alpha of 0.05 and sample size of 58, a power ranging from 0.15 to 0.94 was calculated. RESULTS: The rates of return to preinjury level and to any sports activity were 53.4% and 84.4%. Those who were able to return to their preinjury level of sport (n = 33) showed significantly higher Lysholm (91.6 ± 9.7 vs 76.7 ± 15.4) and International Knee Documentation Committee (IKDC) (83.6 ± 10.6 vs 69.8 ± 14.6) values compared with those who were unable to return to their preinjury level of sport (n = 25) ( P < 0.001). No significant differences were found for the clinical evaluations between those who were and those who were not able to return at the same level for the clinical evaluations (isokinetic evaluation, postural stability, drop vertical jump test) ( P > 0.05). No significant differences were found when comparing quadriceps strength deficit with cutoff values of 80% and 90% for return to preinjury activity level (Tegner), Lysholm, and IKDC scores. CONCLUSION: Quadriceps strength deficit, regardless of cutoff value (80% or 90%), at 6 months after ACLR does not predict return to preinjury level of sport. Patients who returned to sport at their preinjury level were more satisfied with their reconstruction compared with those who did not. CLINICAL RELEVANCE: Quadriceps strength deficit is not a reliable predictor of return to sports, and therefore it should not be used as the single criterion in such evaluations.

Sex effects on the association between sarcopenia EWGSOP and osteoporosis in outpatient older adults: data from the SARCOS study.

OBJECTIVE: The objective was to evaluate the association between sarcopenia (EWGSOP) and osteoporosis in older adults. SUBJECTS AND METHODS: This is a cross sectional analysis of a baseline evaluation of the SARCopenia and OSteoporosis in Older Adults with Cardiovascular Diseases Study (SARCOS). Three hundred and thirty-two subjects over 65 years of age were evaluated. Sarcopenia was determined by EWGSOP flowchart and Osteoporosis was established by WHO's criteria. Physical function, comorbidities and medications were evaluated. RESULTS: Women were older (79.8 ± 7.2 years) than men (78.21 ± 6.7 years) (p = 0.042). Osteoporosis occurred in 24.8% of men, and in 42.7% of women (p < 0.001); sarcopenia occurred in 25.5% of men and in 17.7%, of women (p = 0.103). Osteoporosis was diagnosed in 68% of sarcopenic women, however only 20.7% (p = 0.009) of women with osteoporosis had sarcopenia; in older men, 44.7% of individuals with sarcopenia presented osteoporosis and 42.9% (p = 0.013) of men with osteoporosis showed sarcopenia. In an adjusted logistic regression analyses for sarcopenia, osteoporosis presented a statistically significant association with sarcopenia in men [OR: 2.930 (95% CI: 1.044-8.237; p = 0.041)] but not in women [OR: 2.081 (0.787-5.5; p = 0.142)]; in the adjusted logistic regression analyses for osteoporosis, a statistically significant association occurred in men [OR: 2.984 (95% CI: 1.144-7.809; p = 0.025)], but not in women [OR: 2.093 (0.962-3.714; p = 0.137)]. CONCLUSION: According to sex, there are significant differences in the association between sarcopenia EWGSOP and osteoporosis in outpatient older adults. It is strong and significant in males; in females, despite showing a positive trend, it was not statistically significant.

Hamstring Injuries in Professional Soccer Players: Extent of MRI-Detected Edema and the Time to Return to Play.

BACKGROUND: Discrepancies exist in the literature regarding the association of the extent of injuries assessed on magnetic resonance imaging (MRI) with recovery times. HYPOTHESIS: MRI-detected edema in grade 1 hamstring injuries does not affect the return to play (RTP). STUDY DESIGN: Retrospective cohort study. LEVEL OF EVIDENCE: Level 4. METHODS: Grade 1 hamstring injuries from 22 professional soccer players were retrospectively reviewed. The extent of edema-like changes on fluid-sensitive sequences from 1.5-T MRI were evaluated using craniocaudal length, percentage of cross-sectional area, and volume. The time needed to RTP was the outcome. Negative binomial regression analysis tested the measurements of MRI-detected edema-like changes as prognostic factors. RESULTS: The mean craniocaudal length was 7.6 cm (SD, 4.9 cm; range, 0.9-19.1 cm), the mean percentage of cross-sectional area was 23.6% (SD, 20%; range, 4.4%-89.6%), and the mean volume was 33.1 cm3 (SD, 42.6 cm3; range, 1.1-161.3 cm3). The mean time needed to RTP was 13.6 days (SD, 8.9 days; range, 3-32 days). None of the parameters of extent was associated with RTP. CONCLUSION: The extent of MRI edema in hamstring injuries does not have prognostic value. CLINICAL RELEVANCE: Measuring the extent of edema in hamstring injuries using MRI does not add prognostic value in clinical practice.

Magnetic resonance imaging-based morphological and alignment assessment of the patellofemoral joint and its relationship to proximal patellar tendinopathy.

OBJECTIVE: To assess the differences in morphology and alignment of the knee between patients with proximal patellar tendinopathy (PPT) and a control group, using MRI and focusing on the patellofemoral joint. METHODS: We retrospectively included 35 patients with clinically diagnosed and unequivocal findings of PPT on knee MRI, the case group. For the control group, we included 70 patients who underwent knee MRI for other reasons, with no clinical or MRI evidence of PPT. Patients and controls were matched for age and gender, with all subjects reporting frequent physical activity. MRIs were evaluated by two musculoskeletal radiologists, who assessed parameters of patellar morphology, trochlear morphology, patellofemoral alignment, and tibiofemoral alignment. The differences in parameters between cases and controls were assessed using Student's t test. Logistic regression was applied to assess the associations between the MRI parameters and the presence of PPT. RESULTS: The patellar height Insall-Salvati ratio was different between cases and controls (1.37 ± 0.21 vs. 1.24 ± 0.19; p = 0.003). The subchondral Wiberg angle was higher in cases than controls (136.8 ± 7.4 vs. 131.7 ± 8.8; p = 0.004). After applying logistic regression, significant associations with PPT were found [odds ratios (95% CI)] for patellar morphology [1.1 (1.0, 1.2)] and patellar height [1.3 (1.0, 1.7)]. CONCLUSIONS: Patellar height and the subchondral patellar Wiberg angle were greater in patients with PPT and significantly associated with PPT.

Is the Use of Spreaders an Accurate Method for Ligament Balancing?

BACKGROUND: To analyze 2 methods of manual spreader gap assessment accuracy, visual vs blinded, compared with a controlled tensioner in total knee arthroplasty. METHODS: Twenty-two fresh frozen cadaver knees were used to perform total knee arthroplasty by 22 surgeons. Extension and flexion gaps were measured with empirical manual force application with spreaders in 2 different manners: (1) surgeons were blinded to gap geometry formation-blind method group (BM) and (2) surgeons viewed them-viewing method group (VM). A tensioner was used to measure the corresponding ligament tension applied during spreader measurements and to measure the extension and flexion gaps with standard force of 100 and 80 N (tensioner method [TM]) in each femorotibial compartment. RESULTS: All measurements with spreaders (VM and BM) presented extension and flexion gaps oversized and asymmetric (P < .0001), when compared with the same gaps measured with the tensioner. Approximately 63% (P = <0.001) and 77.3% (P = .161) of the VM group and 68.2% (P = .018) and 77.3% (P = .161) of the BM group demonstrated asymmetry for extension and flexion gaps up to 3 mm to the TM. Gaps measured in the VM group presented results with slightly less oversizing and asymmetries than the measurements in the BM group compared with TM, although significantly different (P < .0001). CONCLUSION: The assessment of extension and flexion gaps with empirical manual applied force spreaders produced oversized and asymmetric gaps compared with the use of tensioner. No visual influence was observed during the spreader applied empirical manual force compared with the blinded assessment.