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1.
Isr Med Assoc J ; 23(1): 48-51, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33443343

RESUMO

BACKGROUND: Adnexal torsion in pregnancy is often associated with functional adnexal cysts, especially in pregnancies conceived by ovulation induction (OI) or in-vitro fertilization (IVF). During laparoscopy for adnexal de-torsion, drainage of the functional cysts can be attempted, although this procedure may cause bleeding. OBJECTIVES: To investigate the characteristics of ovarian torsion in pregnancy associated with functional cysts and to compare the rate of torsion recurrence following de-torsion alone versus cyst drainage. METHODS: All cases of surgically diagnosed adnexal torsion occurring during pregnancy between January 2007 and April 2019 in our department were retrospectively analyzed. The cases of torsion associated with presumed functional ovarian cysts were selected. The rate of recurrent torsion during the same pregnancy was compared for de-torsion alone versus de-torsion and cyst aspiration. RESULTS: Of the 113 women who experienced adnexal torsion during pregnancy, 71 (67.0%) of torsion cases were caused by presumed functional ovarian cysts. Among women with torsion of functional ovarian cysts, the rate of torsion recurrence was significantly higher in patients who underwent de-torsion alone (n=28) compared to women who underwent aspiration and drainage of the ovarian cysts (n=43) (14.3% vs. 0, P = 0.021). There were no cases of intra- or post-operative bleeding in the study cohort. CONCLUSIONS: Functional ovarian cysts are the most common adnexal pathology encountered in pregnant women with torsion. Intra-operative cyst aspiration and drainage may reduce the risk of recurrent torsion. Further multi-center studies are required to validate our data prospectively.


Assuntos
Doenças dos Anexos , Drenagem/métodos , Cistos Ovarianos , Paracentese/métodos , Complicações na Gravidez , Doenças dos Anexos/diagnóstico , Doenças dos Anexos/etiologia , Doenças dos Anexos/cirurgia , Adulto , Feminino , Humanos , Cistos Ovarianos/complicações , Cistos Ovarianos/diagnóstico , Cistos Ovarianos/cirurgia , Gravidez , Complicações na Gravidez/diagnóstico , Complicações na Gravidez/etiologia , Complicações na Gravidez/cirurgia , Risco Ajustado/métodos , Prevenção Secundária/métodos , Anormalidade Torcional/diagnóstico , Anormalidade Torcional/etiologia , Anormalidade Torcional/cirurgia
3.
Trials ; 21(1): 920, 2020 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-33176886

RESUMO

OBJECTIVES: The primary objective is to test if heparin added to a standard regional anticoagulation protocol based on citrate is able to reduce dialysis circuit losses by clotting without increasing the risk of thrombocytopenia or bleeding, in patients with COVID-19 with acute kidney injury requiring dialysis. TRIAL DESIGN: Randomized, parallel-group, open-label trial, with two arms (ratio 1:1) comparing different continuous renal replacement therapy anticoagulation strategies. PARTICIPANTS: Eligibility conditions: All ICU patients of University of Sao Paulo General Hospital (Hospital das Clínicas), Brazil will be screened for eligibility conditions. Adults (> 18 years old) with confirmed COVID-19 and acute kidney injury requiring dialysis with agreement between ICU and nephrology teams for the introduction of renal continuous replacement therapy in daily ICU rounds. Continuous renal replacement therapy will be prescribed by consulting nephrologists based on standard clinical guidelines, including acute kidney injury with hemodynamic instability plus hyperkalemia, severe acidosis, volume overload, respiratory distress, multiorgan failure or some combination of these factors. DATA COLLECTION: Patients demographics and associated clinical data and comorbidities will be recorded at ICU entry. Demographic information will include the patient's age, sex, and admission dates. Clinical data comprise comorbidities, APACHE 2, SAPS 3, need for mechanical ventilation, and use of vasopressor drugs. Physiological data collected by the day of CRRT start will be vital signs, the arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) index, and serum creatinine, blood urea nitrogen, bilirubin, hemoglobin, hematocrit, platelets, white blood cell count levels and Peak D-dimer levels. Patients will be analyzed for the first 72h of CRRT, and they will be evaluated regarding clinical variables, filter patency and any adverse events that could be related to the anticoagulation choice, as bleeding (mild or major) or low platelets counts (<100.000 ui/uL) during treatment period. Mild and major bleeding will be defined by hemorrhagic event without clinical impact or hemoglobin (Hb) fall lesser than 1g/dL and hemorrhagic event with clinical impact or Hb fall higher than 1g/dL, respectively. EXCLUSION CRITERIA: Hypersensitivity to any of the substances going to be used in the study (Citric acid dextrosol 2.2% and unfractionated heparin); Previous diagnosis of coagulopathy or thrombophilia; Contraindication to the use of unfractionated heparin; Risk of citrate poisoning - (Lactate> 30 mg/dL, international normalized ratio > 2.5, Total bilirubin> 15 mg/dL); Pregnancy; Patients unlikely to survive for more than 24 hours. The trial is being undertaken at the University of Sao Paulo General Hospital (Hospital das Clinicas), Brazil. INTERVENTION AND COMPARATOR: Group A (control) - Patients on continuous renal replacement therapy (blood flow 150 ml/min, dose of 30 mL/Kg/h) receiving anticoagulation with sodium citrate at 4 mmol/L Group B (experiment): Patients on continuous hemodialysis (blood flow 150 mL/min, dose of 30 mL/Kg/h) receiving anticoagulation with sodium citrate at 4 mmol/L associated with unfractionated heparin at 10 U/Kg/h. MAIN OUTCOMES: The percentage of clotted dialyzers within 72 hours in each of the studied groups (Primary outcome) Secondary outcomes: Number of dialyzers used in the first 72 hours of dialysis protocol, Mortality in the first 72 h of dialysis protocol, Bleeding events (Major or minor) in the first 72 h of dialysis protocol, Thrombocytopenia (less than 50.000 platelets) proportion in the first 72 h of dialysis protocol, Dialysis efficiency (Urea sieving) - variation in urea sieving between the first, second and third days of dialysis protocol, Continuous renal replacement therapy pressures (Arterial, Venous, dialysate and pre-filter pressure) in the first 72 h of dialysis protocol, in-hospital mortality. RANDOMIZATION: RedCap→ randomization - 2 blocks randomization by D-dimer level (5000ng/dL cut-off) and catheter site (Right Internal Jugular versus other sites) with 1:1 allocation ratio. BLINDING (MASKING): No blinding - Open label format NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): Total number of patients 90 (45 per group) TRIAL STATUS: Trial version 2.0 - ongoing recruitment. First recruitment: June 29, 2020 Estimated date for last recruitment: December 31, 2020 TRIAL REGISTRATION: Responsible Party: University of Sao Paulo General Hospital (Hospital das Clinicas) ClinicalTrials.gov Identifier: NCT04487990 , registered July 27, 2020, ReBec www.ensaiosclinicos.gov.br/rg/RBR-45kf9p/ Other Study ID Numbers: U1111-1252-0194 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1) In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Assuntos
Lesão Renal Aguda , Infecções por Coronavirus , Monitoramento de Medicamentos/métodos , Heparina , Pandemias , Pneumonia Viral , Diálise Renal , Trombose/prevenção & controle , Lesão Renal Aguda/etiologia , Lesão Renal Aguda/terapia , Adulto , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Coagulação Sanguínea/efeitos dos fármacos , Infecções por Coronavirus/sangue , Infecções por Coronavirus/complicações , Infecções por Coronavirus/tratamento farmacológico , Feminino , Produtos de Degradação da Fibrina e do Fibrinogênio/análise , Hemoglobinas/análise , Hemorragia/etiologia , Hemorragia/prevenção & controle , Heparina/administração & dosagem , Heparina/efeitos adversos , Humanos , Masculino , Avaliação de Resultados em Cuidados de Saúde , Pneumonia Viral/sangue , Pneumonia Viral/complicações , Pneumonia Viral/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Diálise Renal/efeitos adversos , Diálise Renal/métodos , Risco Ajustado/métodos , Trombocitopenia/etiologia , Trombocitopenia/prevenção & controle , Trombose/complicações
4.
Oncology (Williston Park) ; 34(10): 432-441, 2020 10 09.
Artigo em Inglês | MEDLINE | ID: mdl-33058111

RESUMO

Worldwide incidence and mortality due to the coronavirus disease 2019 (COVID-19) pandemic is greatest in the United States, with the initial epicenter in New York. In Nassau County, New York, where we practice, our institution has had more than 2500 cases and has discharged from the hospital more than 1000 patients. As many academic and private institutions have swiftly shifted their clinical and research priorities to address the pandemic, data are emerging regarding both the impact of malignancy on COVID-19 outcomes as well as the challenges faced in assuring that cancer care remains unimpeded. Of concern, recent studies of cancer patients primarily in China and Italy have suggested that advanced malignancy is associated with increased susceptibility to severe COVID-19 infection. At present, more than 500 clinical trials are underway investigating the pathogenesis and treatment of COVID-19, including expanded use of oncology drugs, such as small molecular inhibitors of cytokine pathways. Here, we begin by reviewing the latest understanding of COVID-19 pathophysiology and then focus our attention on the impact of this virus on hematologic and oncologic practice. Finally, we highlight ongoing investigational treatment approaches that are so relevant to the care of oncology patients during this extraordinary pandemic.


Assuntos
Antineoplásicos , Betacoronavirus , Infecções por Coronavirus , Assistência à Saúde , Controle de Infecções , Oncologia , Neoplasias , Pandemias , Pneumonia Viral , Antineoplásicos/classificação , Antineoplásicos/farmacologia , Betacoronavirus/efeitos dos fármacos , Betacoronavirus/patogenicidade , Betacoronavirus/fisiologia , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Infecções por Coronavirus/virologia , Assistência à Saúde/organização & administração , Assistência à Saúde/normas , Assistência à Saúde/tendências , Drogas em Investigação/farmacologia , Humanos , Controle de Infecções/métodos , Controle de Infecções/organização & administração , Oncologia/métodos , Oncologia/normas , Neoplasias/epidemiologia , Neoplasias/terapia , New York/epidemiologia , Pandemias/prevenção & controle , Assistência ao Paciente/métodos , Assistência ao Paciente/normas , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , Pneumonia Viral/virologia , Risco Ajustado/métodos , Medição de Risco
6.
Am Heart J ; 228: 65-71, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32866927

RESUMO

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The "IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact" trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel-related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.


Assuntos
Doença da Artéria Coronariana , Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea , Complicações Pós-Operatórias , Risco Ajustado/métodos , Ultrassonografia de Intervenção , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/prevenção & controle , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Cirurgia Assistida por Computador/métodos , Ultrassonografia de Intervenção/economia , Ultrassonografia de Intervenção/métodos
7.
Am Heart J ; 228: 72-80, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32871327

RESUMO

BACKGROUND: The clinical value of intracoronary imaging for percutaneous coronary intervention (PCI) guidance is well acknowledged. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the most commonly used intravascular imaging to guide and optimize PCI in day-to-day practice. However, the comparative effectiveness of IVUS-guided versus OCT-guided PCI with respect to clinical end points remains unknown. METHODS AND DESIGN: The OCTIVUS study is a prospective, multicenter, open-label, parallel-arm, randomized trial comparing the effectiveness of 2 imaging-guided strategies in patients with stable angina or acute coronary syndromes undergoing PCI in Korea. A total of 2,000 patients are randomly assigned in a 1:1 ratio to either an OCT-guided PCI strategy or an IVUS-guided PCI strategy. The trial uses a pragmatic comparative effectiveness design with inclusion criteria designed to capture a broad range of real-world patients with diverse clinical and anatomical features. PCI optimization criteria are predefined using a common algorithm for online OCT or IVUS. The primary end point, which was tested for both noninferiority (margin, 3.1 percentage points for the risk difference) and superiority, is target-vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization) at 1 year. RESULTS: Up to the end of July 2020, approximately 1,200 "real-world" PCI patients have been randomly enrolled over 2 years. Enrollment is expected to be completed around the midterm of 2021, and primary results will be available by late 2022 or early 2023. CONCLUSION: This large-scale, multicenter, pragmatic-design clinical trial will provide valuable clinical evidence on the relative efficacy and safety of OCT-guided versus IVUS-guided PCI strategies in a broad population of patients undergoing PCI in the daily clinical practice.


Assuntos
Vasos Coronários/diagnóstico por imagem , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/prevenção & controle , Cirurgia Assistida por Computador/métodos , Tomografia de Coerência Óptica/métodos , Ultrassonografia de Intervenção/métodos , Pesquisa Comparativa da Efetividade , Angiografia Coronária/métodos , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Stents Farmacológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/efeitos adversos , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Complicações Pós-Operatórias/diagnóstico , Ensaios Clínicos Controlados Aleatórios como Assunto , Risco Ajustado/métodos
8.
Am Heart J ; 228: 109-115, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32882569

RESUMO

BACKGROUND: Patients aged ≥80 years are often treated with new-generation drug-eluting stents (DES), but data from randomized studies are scarce owing to underrepresentation in most trials. We assessed 1-year clinical outcome of octogenarians treated with new-generation DES versus younger patients. METHODS: We pooled patient-level data of 9,204 participants in the TWENTE, DUTCH PEERS, BIO-RESORT, and BIONYX (TWENTE I-IV) randomized trials. The main clinical end point was target vessel failure (TVF), a composite of cardiac death, target vessel-related myocardial infarction (MI), or clinically indicated target vessel revascularization. RESULTS: The 671 octogenarian trial participants had significantly more comorbidities. TVF was higher in octogenarians than in 8,533 patients <80 years (7.3% vs 5.3%, hazard ratio [HR]: 1.36, 95% CI: 1.0-1.83, P = .04). The cardiac death rate was higher in octogenarians (3.9% vs 0.8%, P < .001). There was no significant between-group difference in target vessel MI (2.3% vs 2.3%, P = .88) and repeat target vessel revascularization (1.9% vs 2.8%, P = .16). In multivariate analyses, age ≥ 80 years showed no independent association with TVF (adjusted HR: 1.04, 95% CI: 0.76-1.42), whereas the risk of cardiac death remained higher in octogenarians (adjusted HR: 3.38, 95% CI: 2.07-5.52, P < .001). In 6,002 trial participants, in whom data on major bleeding were recorded, octogenarians (n = 459) showed a higher major bleeding risk (5.9% vs 1.9%; HR: 3.08, 95% CI: 2.01-4.74, P < .001). CONCLUSIONS: Octogenarian participants in 4 large-scale randomized DES trials had more comorbidities and a higher incidence of the main end point TVF. Cardiac mortality was higher in octogenarians, whereas there was no increase in MI or target vessel revascularization rates. Treatment of octogenarian patients with new-generation DES appears to be safe and effective.


Assuntos
Stents Farmacológicos/classificação , Everolimo/farmacologia , Infarto do Miocárdio , Complicações Pós-Operatórias , Sirolimo/análogos & derivados , Sirolimo/farmacologia , Idoso de 80 Anos ou mais , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/cirurgia , Feminino , Humanos , Imunossupressores/farmacologia , Masculino , Infarto do Miocárdio/diagnóstico , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Intervenção Coronária Percutânea , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/mortalidade , Reoperação/métodos , Reoperação/estatística & dados numéricos , Risco Ajustado/métodos , Fatores de Risco , Resultado do Tratamento
9.
Am J Perinatol ; 37(13): 1377-1384, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-32898920

RESUMO

The novel coronavirus disease 2019 (COVID-19) pandemic has resulted in changes to perinatal and neonatal care, concentrating on minimizing risks of transmission to the newborn and health care staff while ensuring medical care is not compromised for both mother and infant. Current recommendations on infant care and feeding when mother has COVID-19 ranges from mother-infant separation and avoidance of human milk feeding, to initiation of early skin-to-skin contact and direct breastfeeding. Health care providers fearing risks of severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) maternal-infant transmission may veer toward restricted breastfeeding practices. We reviewed guidelines and published literature and propose three options for infant feeding depending on various scenarios. Option A involves direct breastfeeding with the infant being cared for by the mother or caregiver. In option B, the infant is cared for by another caregiver and receives mother's expressed milk. In the third option, the infant is not breastfed directly and does not receive mother's expressed milk. We recommend joint decision making by parents and the health care team. This decision is also flexible as situation changes. We also provide a framework for counseling mothers on these options using a visual aid and a corresponding structured training program for health care providers. Future research questions are also proposed. We conclude that evidence and knowledge about COVID-19 and breastfeeding are still evolving. Our options can provide a quick and flexible reference guide that can be adapted to local needs. KEY POINTS: · SARS-CoV-2 is unlikely transmitted via human milk.. · A shared decision making on infant feeding is the preferred approach.. · Mothers can safely breastfeed with appropriate infection control measures..


Assuntos
Aleitamento Materno/métodos , Infecções por Coronavirus , Controle de Infecções/métodos , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Leite Humano/virologia , Pandemias , Pneumonia Viral , Complicações Infecciosas na Gravidez , Betacoronavirus , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Aconselhamento/métodos , Tomada de Decisões , Feminino , Humanos , Recém-Nascido , Comportamento Materno , Mães/psicologia , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Gravidez , Complicações Infecciosas na Gravidez/epidemiologia , Complicações Infecciosas na Gravidez/prevenção & controle , Risco Ajustado/métodos
11.
Semin Arthritis Rheum ; 50(5): 1049-1054, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32911282

RESUMO

OBJECTIVE: To investigate the perceptions and behaviors of rheumatologists in the United States (US) regarding the risk of COVID-19 for their autoimmune patients and the subsequent management of immunosuppressive and anti-inflammatory medications. METHODS: We administered an online survey to a convenience sample of rheumatologists in the US from 4/8/20-5/4/20 via social media and group emails. Survey respondents provided demographic information such as, age, gender, state of practice, and practice type. We asked questions about COVID-19 risk in rheumatic patients, as well as their medication management during the pandemic. We conducted descriptive analysis and Multivariable regression models. RESULTS: 271 respondents completed the survey nationally. 48% of respondents either agreed or strongly agreed with the statement "Patients with rheumatic diseases are at a higher risk of COVID-19 irrespective of their immunosuppressive medications". 50% disagreed or strongly disagreed with the statement "The pandemic has led you to reduce the use/dosage/frequency of biologics", while 56% agreed or strongly agreed with the statement "The pandemic has led you to reduce the use/dosage/frequency of steroids". A third of respondents indicated that at least 10% of their patients had self-discontinued or reduced at least one immunosuppressive medication to mitigate their risk of COVID-19. Responses to these questions as well as to questions regarding NSAID prescription patterns were significantly different in the Northeast region of US compared to other regions. CONCLUSION: In this national sample of rheumatologists, there are variations regarding perceptions of patients' risk of COVID-19, and how to manage medications such as NSAIDs, biologics and steroids during the pandemic. These variations are more pronounced in geographical areas where COVID-19 disease burden was high.


Assuntos
Infecções por Coronavirus , Conduta do Tratamento Medicamentoso/estatística & dados numéricos , Pandemias , Pneumonia Viral , Doenças Reumáticas , Reumatologistas/estatística & dados numéricos , Risco Ajustado/métodos , Adulto , Atitude do Pessoal de Saúde , Betacoronavirus , Produtos Biológicos/uso terapêutico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Assistência à Saúde/tendências , Feminino , Glucocorticoides/uso terapêutico , Humanos , Masculino , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Área de Atuação Profissional/estatística & dados numéricos , Doenças Reumáticas/epidemiologia , Doenças Reumáticas/terapia , Medição de Risco , Percepção Social , Estados Unidos/epidemiologia
13.
R I Med J (2013) ; 103(8): 29-33, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32900009

RESUMO

In 2020, the COVID-19 pandemic has ravaged the world. Individuals with end-stage kidney disease (ESKD) are at higher risk due to impaired immunity, comorbid conditions, and dependence on travel to medical care settings. We review the salient features of COVID-19 in this population, including the risk of infection, disease course, changes in dialysis unit management, use of investigatory medications, access considerations, home dialysis, and capacity planning.


Assuntos
Infecções por Coronavirus , Unidades Hospitalares de Hemodiálise/organização & administração , Hemodiálise no Domicílio/métodos , Falência Renal Crônica , Pandemias , Pneumonia Viral , Diálise Renal/métodos , Risco Ajustado/métodos , Betacoronavirus , Comorbidade , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Transmissão de Doença Infecciosa/prevenção & controle , Humanos , Controle de Infecções/métodos , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/terapia , Inovação Organizacional , Pandemias/prevenção & controle , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle
14.
Obstet Gynecol ; 136(4): 792-801, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32925609

RESUMO

OBJECTIVE: To assess whether resting genital hiatus, perineal body, and total vaginal length measured intraoperatively at the conclusion of surgery are associated with prolapse recurrence 2 years after native tissue pelvic organ prolapse reconstruction. METHODS: This ancillary analysis of the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial included women who had an immediate postoperative pelvic organ prolapse quantification (POP-Q) examination and 2-year follow-up. Primary outcome was bothersome bulge symptoms. Secondary outcomes were anatomic failure, surgical failure (either anatomic failure or bothersome bulge symptoms), and sexual function. Descriptive statistics assessed relationships between postprocedure POP-Q measures and these four outcomes. Multivariable models were fit to the data to control for baseline differences in bivariate comparisons. Receiver operating characteristic curves were generated to identify an optimal genital hiatus cut point associated with bothersome bulge, and this threshold was explored. RESULTS: This analysis included 368 participants. Bivariate analyses identified age, body mass index, vaginal deliveries, baseline genital hiatus, perineal body, and advanced POP-Q stage (3 or higher vs 2) as clinically relevant variables to include in multivariable models. After adjusting for these variables, the association between immediate postoperative genital hiatus and bothersome bulge (adjusted odds ratio [aOR] 1.4; 95% CI 0.9-2.1) was not significant at the P<.05 level; however, immediate postoperative genital hiatus was associated with anatomic (aOR 1.6; 95% CI 1.1-2.3) and surgical failure (aOR 1.5; 95% CI 1.0-2.1). Immediate postoperative genital hiatus of 3.5 cm was the selected cutoff (area under the curve 0.58, 95% CI 0.50-0.66 from the bothersome bulge model). Women with genital hiatus 3.5 cm or greater were more likely to have anatomic and surgical failures at 2 years. No POP-Q measures were correlated with 2-year sexual function. CONCLUSION: A larger immediate postoperative genital hiatus measurement of 3.5 cm or greater is not associated with bothersome bulge symptoms or sexual dysfunction but is associated with anatomic and surgical failures 2 years after native tissue vaginal reconstructive surgery.


Assuntos
Procedimentos Cirúrgicos em Ginecologia , Prolapso de Órgão Pélvico , Complicações Pós-Operatórias/diagnóstico , Procedimentos Cirúrgicos Reconstrutivos , Risco Ajustado/métodos , Disfunções Sexuais Fisiológicas , Feminino , Seguimentos , Procedimentos Cirúrgicos em Ginecologia/efeitos adversos , Procedimentos Cirúrgicos em Ginecologia/métodos , Humanos , Pessoa de Meia-Idade , Avaliação de Processos e Resultados em Cuidados de Saúde , Diafragma da Pelve/cirurgia , Prolapso de Órgão Pélvico/diagnóstico , Prolapso de Órgão Pélvico/fisiopatologia , Prolapso de Órgão Pélvico/cirurgia , Prognóstico , Procedimentos Cirúrgicos Reconstrutivos/efeitos adversos , Procedimentos Cirúrgicos Reconstrutivos/métodos , Recidiva , Índice de Gravidade de Doença , Disfunções Sexuais Fisiológicas/diagnóstico , Disfunções Sexuais Fisiológicas/etiologia , Avaliação de Sintomas/métodos
15.
Obstet Gynecol ; 136(4): 745-755, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32925617

RESUMO

OBJECTIVE: To investigate subsequent birth rates, maternal and neonatal outcomes for women with a history of placenta accreta spectrum (placenta accreta, increta, and percreta). METHODS: A population-based record linkage study of women who had a first, second, or third birth in New South Wales from 2003 to 2016 was conducted. Data were obtained from birth and hospital records and death registrations. Women with a history of placenta accreta spectrum were matched to women without, on propensity score and parity, to compare outcomes with women who had similar risk profiles. Modified Poisson regression models were used to calculate adjusted relative risk (aRR) for a range of maternal and neonatal outcomes. RESULTS: We identified recurrent placenta accreta spectrum in 27/570 (4.7%, 95% CI 3.0-6.5%) of second and 9/119 (7.6%, 95% CI 2.8-12.3%) of third pregnancies after placenta accreta spectrum in the preceding birth, with an overall recurrence rate of 38/689 (5.5%, 95% CI 3.9-7.5%, compared with the population prevalence of 25.5/10,000 births (95% CI 24.6-26.4). Subsequent births after placenta accreta spectrum had higher risk of postpartum hemorrhage (aRR 1.51, 95% CI 1.19-1.92), transfusion (aRR 2.13, 95% CI 1.17-3.90), cesarean delivery (aRR 1.19, 95% CI 1.02-1.37), manual removal of placenta (aRR 6.92, 95% CI 3.81-12.55), and preterm birth (aRR 1.43, 95% CI 1.03-1.98), with lower risk of small for gestational age (aRR 0.64, 95% CI 0.43-0.96), compared with similar-risk births. CONCLUSION: Women with a history of placenta accreta spectrum have increased risk of maternal morbidity, preterm birth, and placenta accreta spectrum in the subsequent pregnancy compared with similar-risk women with no previous placenta accreta spectrum, although the absolute risks are generally low. These findings may be used to inform counseling of women on the risks of future pregnancies.


Assuntos
Cesárea , Parto Obstétrico , Histerectomia , Placenta Acreta , Hemorragia Pós-Parto , Nascimento Prematuro , Adulto , Austrália/epidemiologia , Transfusão de Sangue/estatística & dados numéricos , Cesárea/métodos , Cesárea/estatística & dados numéricos , Parto Obstétrico/efeitos adversos , Parto Obstétrico/métodos , Parto Obstétrico/estatística & dados numéricos , Feminino , Humanos , Histerectomia/métodos , Histerectomia/estatística & dados numéricos , Recém-Nascido , Masculino , Placenta Acreta/epidemiologia , Placenta Acreta/terapia , Hemorragia Pós-Parto/epidemiologia , Hemorragia Pós-Parto/etiologia , Hemorragia Pós-Parto/terapia , Gravidez , Resultado da Gravidez/epidemiologia , Gravidez de Alto Risco , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/etiologia , Sistema de Registros/estatística & dados numéricos , História Reprodutiva , Risco Ajustado/métodos , Fatores de Risco
16.
J Oncol Pharm Pract ; 26(7): 1732-1734, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32791938

RESUMO

Cancer patients are at higher risk to be infected with COVID-19 and to develop a more severe form. Breast cancer (BC) treatments, including chemotherapy (CT), targeted therapy and immunotherapy can weaken the immune system and possibly cause lung problems. For all these reasons Salah Azaiez Institute's department of Medical Oncology took drastic actions to protect patients. In this article we will discuss protocol adjustments taken during the COVID-19 pandemic for breast cancer patients.


Assuntos
Protocolos Antineoplásicos , Neoplasias da Mama , Controle de Doenças Transmissíveis , Infecções por Coronavirus , Oncologia/tendências , Pandemias , Administração dos Cuidados ao Paciente , Pneumonia Viral , Betacoronavirus , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/patologia , Neoplasias da Mama/terapia , Controle de Doenças Transmissíveis/métodos , Controle de Doenças Transmissíveis/organização & administração , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Feminino , Humanos , Estadiamento de Neoplasias , Inovação Organizacional , Pandemias/prevenção & controle , Administração dos Cuidados ao Paciente/métodos , Administração dos Cuidados ao Paciente/organização & administração , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Risco Ajustado/métodos , Telemedicina/métodos , Tunísia/epidemiologia
18.
J Am Coll Cardiol ; 76(16): 1815-1826, 2020 10 20.
Artigo em Inglês | MEDLINE | ID: mdl-32860872

RESUMO

BACKGROUND: Thromboembolic disease is common in coronavirus disease-2019 (COVID-19). There is limited evidence on the association of in-hospital anticoagulation (AC) with outcomes and postmortem findings. OBJECTIVES: The purpose of this study was to examine association of AC with in-hospital outcomes and describe thromboembolic findings on autopsies. METHODS: This retrospective analysis examined the association of AC with mortality, intubation, and major bleeding. Subanalyses were also conducted on the association of therapeutic versus prophylactic AC initiated ≤48 h from admission. Thromboembolic disease was contextualized by premortem AC among consecutive autopsies. RESULTS: Among 4,389 patients, median age was 65 years with 44% women. Compared with no AC (n = 1,530; 34.9%), therapeutic AC (n = 900; 20.5%) and prophylactic AC (n = 1,959; 44.6%) were associated with lower in-hospital mortality (adjusted hazard ratio [aHR]: 0.53; 95% confidence interval [CI]: 0.45 to 0.62 and aHR: 0.50; 95% CI: 0.45 to 0.57, respectively), and intubation (aHR: 0.69; 95% CI: 0.51 to 0.94 and aHR: 0.72; 95% CI: 0.58 to 0.89, respectively). When initiated ≤48 h from admission, there was no statistically significant difference between therapeutic (n = 766) versus prophylactic AC (n = 1,860) (aHR: 0.86; 95% CI: 0.73 to 1.02; p = 0.08). Overall, 89 patients (2%) had major bleeding adjudicated by clinician review, with 27 of 900 (3.0%) on therapeutic, 33 of 1,959 (1.7%) on prophylactic, and 29 of 1,530 (1.9%) on no AC. Of 26 autopsies, 11 (42%) had thromboembolic disease not clinically suspected and 3 of 11 (27%) were on therapeutic AC. CONCLUSIONS: AC was associated with lower mortality and intubation among hospitalized COVID-19 patients. Compared with prophylactic AC, therapeutic AC was associated with lower mortality, although not statistically significant. Autopsies revealed frequent thromboembolic disease. These data may inform trials to determine optimal AC regimens.


Assuntos
Anticoagulantes , Autopsia/estatística & dados numéricos , Infecções por Coronavirus , Hospitalização/estatística & dados numéricos , Pandemias , Pneumonia Viral , Profilaxia Pós-Exposição , Tromboembolia , Idoso , Anticoagulantes/classificação , Anticoagulantes/uso terapêutico , Betacoronavirus/isolamento & purificação , Coagulação Sanguínea , Infecções por Coronavirus/sangue , Infecções por Coronavirus/complicações , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/terapia , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Mortalidade Hospitalar , Humanos , Masculino , Cidade de Nova Iorque/epidemiologia , Avaliação de Processos e Resultados em Cuidados de Saúde , Pneumonia Viral/sangue , Pneumonia Viral/complicações , Pneumonia Viral/mortalidade , Pneumonia Viral/terapia , Profilaxia Pós-Exposição/métodos , Profilaxia Pós-Exposição/estatística & dados numéricos , Risco Ajustado/métodos , Tromboembolia/tratamento farmacológico , Tromboembolia/mortalidade , Tromboembolia/prevenção & controle , Tromboembolia/virologia
19.
Am Heart J ; 228: 1-7, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32739652

RESUMO

BACKGROUND: Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear. STUDY DESIGN: The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks ("bi-risk"). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization. CONCLUSIONS: OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.


Assuntos
Síndrome Coronariana Aguda , Aspirina , Clopidogrel , Hemorragia , Risco Ajustado/métodos , Acidente Vascular Cerebral , Síndrome Coronariana Aguda/complicações , Síndrome Coronariana Aguda/tratamento farmacológico , Síndrome Coronariana Aguda/cirurgia , Adulto , Aspirina/administração & dosagem , Aspirina/efeitos adversos , Clopidogrel/administração & dosagem , Clopidogrel/efeitos adversos , Método Duplo-Cego , Stents Farmacológicos/efeitos adversos , Terapia Antiplaquetária Dupla/efeitos adversos , Terapia Antiplaquetária Dupla/métodos , Feminino , Hemorragia/induzido quimicamente , Hemorragia/prevenção & controle , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/métodos , Inibidores da Agregação de Plaquetas/administração & dosagem , Inibidores da Agregação de Plaquetas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Acidente Vascular Cerebral/induzido quimicamente , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle
20.
Am Heart J ; 228: 27-35, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32745733

RESUMO

BACKGROUND: Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk. METHODS/DESIGN: The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life. DISCUSSION: The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis. TRIAL REGISTRATION: clinicaltrials.gov: NCT04160130.


Assuntos
Estenose da Valva Aórtica , Valva Aórtica , Próteses Valvulares Cardíacas , Complicações Pós-Operatórias , Qualidade de Vida , Risco Ajustado/métodos , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/cirurgia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/psicologia , Estenose da Valva Aórtica/cirurgia , Feminino , Nível de Saúde , Próteses Valvulares Cardíacas/efeitos adversos , Próteses Valvulares Cardíacas/classificação , Humanos , Avaliação de Processos e Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/fisiopatologia , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/psicologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Risco , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos
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