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The inferior vena cava (IVC) and superior vena cava are the main conduits of the systemic venous circulation into the right atrium. Developmental or procedural interruptions of vena cava might predispose to stasis and deep vein thrombosis (DVT) distal to the anomaly and may impact the subsequent rate of pulmonary embolism (PE). This study aimed to review the various etiologies of developmental or procedural vena cava interruption and their impact on venous thromboembolism. A systematic search was performed in PubMed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines per each clinical question. For management questions with no high-quality evidence and no mutual agreements between authors, Delphi methods were used. IVC agenesis is the most common form of congenital vena cava interruption, is associated with an increased risk of DVT, and should be suspected in young patients with unexpected extensive bilateral DVT. Surgical techniques for vena cava interruption (ligation, clipping, and plication) to prevent PE have been largely abandoned due to short-term procedural risks and long-term complications, although survivors of prior procedures are occasionally encountered. Vena cava filters are now the most commonly used method of procedural interruption, frequently placed in the infrarenal IVC. The most agreed-upon indication for vena cava filters is for patients with acute venous thromboembolism and coexisting contraindications to anticoagulation. Familiarity with different forms of vena cava interruption and their local and systemic adverse effects is important to minimize complications and thrombotic events.
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Tromboembolia Venosa , Humanos , Tromboembolia Venosa/etiologia , Veia Cava Inferior/anormalidadesRESUMO
Right ventricular (RV) failure is a critical cause of morbidity and mortality in patients presenting with pulmonary embolism (PE). The presentation of RV failure is based on the combination of clinical findings, laboratory abnormalities, and imaging evidence. An improved understanding of the pathophysiology of RV dysfunction following PE has given rise to more accurate risk stratification and broader therapeutic approaches. A subset of patients with PE develop chronic RV dysfunction with or without pulmonary hypertension. In this review, we focus on the impact of PE on the RV and its implications for risk stratification, prognosis, acute management, and long-term therapy.
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Embolia Pulmonar , Disfunção Ventricular Direita , Humanos , Prognóstico , Embolia Pulmonar/diagnóstico , Doença Aguda , Disfunção Ventricular Direita/diagnóstico , Disfunção Ventricular Direita/etiologiaRESUMO
Direct oral anticoagulants (DOACs) have become the preferred option for treatment of venous thromboembolism due to their favorable profile compared with other agents such as vitamin K antagonists or low-molecular-weight heparin. However, findings from randomized controlled trials suggest efficacy and/or safety concerns with DOAC use in some clinical contexts. This illustrated review will summarize indications where DOACs have proven efficacy and safety, situations where they fall short, and situations where uncertainty remains compared with other treatments for venous thromboembolism.
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INTRODUCTION: Pregnancy may contribute to an excess risk of thrombotic or cardiovascular events. COVID-19 increases the risk of these events, although the risk is relatively limited among outpatients. We sought to determine whether outpatient pregnant women with COVID-19 are at a high risk for cardiovascular or thrombotic events. MATERIALS & METHODS: We analyzed pregnant outpatients with COVID-19 from the multicenter CORONA-VTE-Network registry. The main study outcomes were a composite of adjudicated venous or arterial thrombotic events, and a composite of adjudicated cardiovascular events. Events were assessed 90 days after the COVID-19 diagnosis and reported for non-pregnant women ≤45 years, and for men ≤45 years, as points of reference. RESULTS: Among 6585 outpatients, 169 were pregnant at diagnosis. By 90-day follow-up, two pregnant women during the third trimester had lower extremity venous thrombosis, one deep and one superficial vein thrombosis. The cumulative incidence of thrombotic events was 1.20 % (95 % confidence interval [CI]: 0.0 to 2.84 %). Respective rates were 0.47 % (95 % CI: 0.14 % to 0.79 %) among non-pregnant women, and 0.49 % (95 % CI: 0.06 % to 0.91 %) among men ≤45 years. No non-thrombotic cardiovascular events occurred in pregnant women. The rates of cardiovascular events were 0.53 % (95 % CI: 0.18 to 0.87) among non-pregnant women, and 0.68 % (95 % CI: 0.18 to 1.18) in men aged ≤45 years. CONCLUSIONS: Thrombotic and cardiovascular events are rare among outpatients with COVID-19. Although a higher event rate among outpatient pregnant women cannot be excluded, the absolute event rates are low and do not warrant population-wide cardiovascular interventions to optimize outcomes.
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COVID-19 , Pacientes Ambulatoriais , Trombose , Humanos , COVID-19/complicações , COVID-19/epidemiologia , Gravidez , Feminino , Adulto , Pacientes Ambulatoriais/estatística & dados numéricos , Trombose/etiologia , Trombose/epidemiologia , Masculino , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/etiologia , Fatores de Risco , Pessoa de Meia-Idade , Sistema de Registros , SARS-CoV-2 , Complicações Infecciosas na Gravidez/epidemiologia , Incidência , Trombose Venosa/epidemiologia , Trombose Venosa/etiologiaRESUMO
For most patients, direct oral anticoagulants (DOACs) are preferred over vitamin K antagonists for stroke prevention in atrial fibrillation and for venous thromboembolism treatment. However, randomized controlled trials suggest that DOACs may not be as efficacious or as safe as the current standard of care in conditions such as mechanical heart valves, thrombotic antiphospholipid syndrome, and atrial fibrillation associated with rheumatic heart disease. DOACs do not provide a net benefit in conditions such as embolic stroke of undetermined source. Their efficacy is uncertain for conditions such as left ventricular thrombus, catheter-associated deep vein thrombosis, cerebral venous sinus thrombosis, and for patients with atrial fibrillation or venous thrombosis who have end-stage renal disease. This paper provides an evidence-based review of randomized controlled trials on DOACs, detailing when they have demonstrated efficacy and safety, when DOACs should not be the standard of care, where their safety and efficacy are uncertain, and areas requiring further research.
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Fibrilação Atrial , Trombose , Tromboembolia Venosa , Trombose Venosa , Humanos , Administração Oral , Anticoagulantes/uso terapêutico , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Trombose/tratamento farmacológico , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/tratamento farmacológico , Vitamina K , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Despite widely available risk stratification tools, safe and effective anticoagulants, and guideline recommendations, anticoagulation for stroke prevention in atrial fibrillation (AF) is under-prescribed in ambulatory patients. To assess the impact of alert-based computerized decision support (CDS) on anticoagulation prescription in ambulatory patients with AF and high-risk for stroke, we conducted this randomized controlled trial. METHODS: Patients with AF and CHA2DS2-VASc score ≥ 2 who were not prescribed anticoagulation and had a clinic visit at Brigham and Women's Hospital were enrolled. Patients were randomly allocated, according to Attending Physician of record, to intervention (alert-based CDS) versus control (no notification). The primary efficacy outcome was the frequency of anticoagulant prescription. RESULTS: The CDS tool assigned 395 and 403 patients to the alert and control groups, respectively. Alert patients were more likely to be prescribed anticoagulation within 48 h of the clinic visit (15.4 % vs. 7.7 %, p < 0.001) and at 90 days (17.2 % vs. 9.9 %, p < 0.01). Direct oral anticoagulants were the predominantly prescribed form of anticoagulation. No significant differences were observed in stroke, TIA, or systemic embolic events (0 % vs. 0.8 %, p = 0.09), symptomatic VTE (0.5 % vs. 1 %, p = 0.43), all-cause mortality (2 % vs. 0.7 %, p = 0.12), or major adverse cardiovascular events (2.8 % vs. 2.5 %, p = 0.79) at 90 days. CONCLUSIONS: An alert-based CDS strategy increased a primary efficacy outcome of anticoagulation in clinic patients with AF and high-risk for stroke who were not receiving anticoagulation at the time of the office visit. The study was likely underpowered to assess an impact on clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier- NCT02958943.
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Fibrilação Atrial , Embolia , Acidente Vascular Cerebral , Humanos , Feminino , Fibrilação Atrial/complicações , Fibrilação Atrial/tratamento farmacológico , Anticoagulantes/uso terapêutico , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/etiologia , Acidente Vascular Cerebral/prevenção & controle , Fatores de RiscoRESUMO
BACKGROUND: The efficacy and safety of direct oral anticoagulants (DOACs) for patients with thrombotic antiphospholipid syndrome remain controversial. OBJECTIVES: The authors performed a systematic review and meta-analysis of randomized controlled trials that compared DOACs with vitamin K antagonists (VKAs). METHODS: We searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials through April 9, 2022. The 2 main efficacy outcomes were a composite of arterial thrombotic events and venous thromboembolic events (VTEs). The main safety outcome was major bleeding. Random effects models with inverse variance were used. RESULTS: Our search retrieved 253 studies. Four open-label randomized controlled trials involving 472 patients were included (mean control-arm time-in-therapeutic-range 60%). All had proper random sequence generation and adequate allocation concealment. Overall, the use of DOACs compared with VKAs was associated with increased odds of subsequent arterial thrombotic events (OR: 5.43; 95% CI: 1.87-15.75; P < 0.001, I2 = 0%), especially stroke, and the composite of arterial thrombotic events or VTE (OR: 4.46; 95% CI: 1.12-17.84; P = 0.03, I2 = 0%). The odds of subsequent VTE (OR: 1.20; 95% CI: 0.31-4.55; P = 0.79, I2 = 0%), or major bleeding (OR: 1.02; 95% CI: 0.42-2.47; P = 0.97; I2 = 0%) were not significantly different between the 2 groups. Most findings were consistent within subgroups. CONCLUSIONS: Patients with thrombotic antiphospholipid syndrome randomized to DOACs compared with VKAs appear to have increased risk for arterial thrombosis. No significant differences were observed between patients randomized to DOACs vs VKAs in the risk of subsequent VTE or major bleeding.
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Anticoagulantes , Síndrome Antifosfolipídica , Fibrinolíticos , Vitamina K , Humanos , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Síndrome Antifosfolipídica/tratamento farmacológico , Fibrinolíticos/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Hemorragia/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombose/epidemiologia , Tromboembolia Venosa/epidemiologia , Vitamina K/antagonistas & inibidoresRESUMO
BACKGROUND: Contemporary pulmonary embolism (PE) research, in many cases, relies on data from electronic health records (EHRs) and administrative databases that use International Classification of Diseases (ICD) codes. Natural language processing (NLP) tools can be used for automated chart review and patient identification. However, there remains uncertainty with the validity of ICD-10 codes or NLP algorithms for patient identification. METHODS: The PE-EHR+ study has been designed to validate ICD-10 codes as Principal Discharge Diagnosis, or Secondary Discharge Diagnoses, as well as NLP tools set out in prior studies to identify patients with PE within EHRs. Manual chart review by two independent abstractors by predefined criteria will be the reference standard. Sensitivity, specificity, and positive and negative predictive values will be determined. We will assess the discriminatory function of code subgroups for intermediate- and high-risk PE. In addition, accuracy of NLP algorithms to identify PE from radiology reports will be assessed. RESULTS: A total of 1,734 patients from the Mass General Brigham health system have been identified. These include 578 with ICD-10 Principal Discharge Diagnosis codes for PE, 578 with codes in the secondary position, and 578 without PE codes during the index hospitalization. Patients within each group were selected randomly from the entire pool of patients at the Mass General Brigham health system. A smaller subset of patients will also be identified from the Yale-New Haven Health System. Data validation and analyses will be forthcoming. CONCLUSIONS: The PE-EHR+ study will help validate efficient tools for identification of patients with PE in EHRs, improving the reliability of efficient observational studies or randomized trials of patients with PE using electronic databases.
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Embolia Pulmonar , Humanos , Reprodutibilidade dos Testes , Embolia Pulmonar/diagnóstico , Registros Eletrônicos de Saúde , Valor Preditivo dos Testes , Classificação Internacional de Doenças , AlgoritmosRESUMO
PURPOSE: Anticoagulants often cause adverse drug events (ADEs), comprised of medication errors and adverse drug reactions, in patients. Our study objective was to determine the clinical characteristics, types, severity, cause, and outcomes of anticoagulation-associated ADEs from 2015-2020 (a contemporary period following implementation of an electronic health record, infusion device technology, and anticoagulant dosing nomograms) and to compare them with those of a historical period (2004-2009). METHODS: We reviewed all anticoagulant-associated ADEs reported as part of our hospital-wide safety system. Reviewers classified type, severity, root cause, and outcomes for each ADE according to standard definitions. Reviewers also assessed events for patient harm. Patients were followed up to 30 days after the event. RESULTS: Despite implementation of enhanced patient safety technology and procedure, ADEs increased in the contemporary period. In the contemporary period, we found 925 patients who had 984 anticoagulation-associated ADEs, including 811 isolated medication errors (82.4%); 13 isolated adverse drug reactions (1.4%); and 160 combined medication errors, adverse drug reactions, or both (16.2%). Unfractionated heparin was the most frequent ADE-related anticoagulant (77.7%, contemporary period vs 58.3%, historical period). The most frequent anticoagulation-associated medication error in the contemporary period was wrong rate or frequency of administration (26.1%, n = 253), with the most frequent root cause being prescribing errors (21.3%, n = 207). The type, root cause, and harm from ADEs were similar between periods. CONCLUSIONS: We found that anticoagulation-associated ADEs occurred despite advances in patient safety technologies and practices. Events were common, suggesting marginal improvements in anticoagulant safety over time and ample opportunities for improvement.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Heparina , Humanos , Heparina/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Erros de Medicação , Pacientes , Anticoagulantes/efeitos adversosRESUMO
BACKGROUND: Coronavirus disease 2019 (COVID-19) is associated with excess risk of cardiovascular and thrombotic events in the early post-infection period and during convalescence. Despite the progress in our understanding of cardiovascular complications, uncertainty persists with respect to more recent event rates, temporal trends, association between vaccination status and outcomes, and findings within vulnerable subgroups such as older adults (aged 65 years or older), or those undergoing hemodialysis. Sex-informed findings, including results among pregnant and breastfeeding women, as well as adjusted comparisons between male and female adults are similarly understudied. METHODS: Adult patients, aged ≥18 years, with polymerase chain reaction-confirmed COVID-19 who received inpatient or outpatient care at the participating centers of the registry are eligible for inclusion. A total of 10,000 patients have been included in this multicenter study, with Brigham and Women's Hospital (Boston, MA) serving as the coordinating center. Other sites include Beth Israel Deaconess Medical Center, Anne Arundel Medical Center, University of Virginia Medical Center, University of Colorado Health System, and Thomas Jefferson University Health System. Data elements will be ascertained manually for accuracy. The two main outcomes are 1) a composite of venous or arterial thrombotic events, and 2) a composite of major cardiovascular events, defined as venous or arterial thrombosis, myocarditis or heart failure with inpatient treatment, new atrial fibrillation/flutter, or cardiovascular death. Clinical outcomes are adjudicated by independent physicians. Vaccination status and time of inclusion in the study will be ascertained for subgroup-specific analyses. Outcomes are pre-specified to be reported separately for hospitalized patients versus those who were initially receiving outpatient care. Outcomes will be reported at 30-day and 90-day follow-up. Data cleaning at the sites and the data coordinating center and outcomes adjudication process are in-progress. CONCLUSIONS: The CORONA-VTE-Network study will share contemporary information related to rates of cardiovascular and thrombotic events in patients with COVID-19 overall, as well as within key subgroups, including by time of inclusion, vaccination status, patients undergoing hemodialysis, the elderly, and sex-informed analyses such as comparison of women and men, or among pregnant and breastfeeding women.
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COVID-19 , Trombose , Tromboembolia Venosa , Idoso , Humanos , Feminino , Masculino , Adolescente , Adulto , SARS-CoV-2 , Antivirais/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Trombose/tratamento farmacológico , Vacinação/efeitos adversosRESUMO
Pulmonary embolism (PE) continues to represent a significant health care burden and its incidence is steadily increasing worldwide. Constantly evolving therapeutic options and the rarity of randomized controlled trial data to drive clinical guidelines impose challenges on physicians caring for patients with PE. Recently, PE response teams have been developed and recommended to help address these issues by facilitating a consensus among local experts while advocating the management of acute PE according to each individual patient profile. In this review, we focus on the clinical challenges supporting the need for a PE response team, report the current evidence for their implementation, assess their impact on PE management and outcomes, and address unanswered questions and future directions.
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BACKGROUND: The American College of Surgeons-Trauma Quality Improvement Program (ACS-TQIP) database is one of the most widely used databases for trauma research. We aimed to critically appraise the quality of the methodological reporting of ACS-TQIP studies. STUDY DESIGN: The ACS-TQIP bibliography was queried for all studies published between January 2018 and January 2021. The quality of data reporting was assessed using the Strengthening the Reporting of Observational studies in Epidemiology-Reporting of Studies Conducted Using Observational Routinely Collected Health Data (STROBE-RECORD) statement and the JAMA Surgery checklist. Three items from each tool were not applicable and thus excluded. The quality of reporting was compared between high- and low-impact factor (IF) journals (cutoff for high IF is >90th percentile of all surgical journals). RESULTS: A total of 118 eligible studies were included; 12 (10%) were published in high-IF journals. The median (interquartile range) number of criteria fulfilled was 5 (4-6) for the STROBE-RECORD statement (of 10 items) and 5 (5-6) for the JAMA Surgery checklist (of 7 items). Specifically, 73% of studies did not describe the patient population selection process, 61% did not address data cleaning or the implications of missing values, and 76% did not properly state inclusion/exclusion criteria and/or outcome variables. Studies published in high-IF journals had remarkably higher quality of reporting than those in low-IF journals. CONCLUSION: The methodological reporting quality of ACS-TQIP studies remains suboptimal. Future efforts should focus on improving adherence to standard reporting guidelines to mitigate potential bias and improve the reproducibility of published studies.
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Lista de Checagem , Cirurgiões , Humanos , Melhoria de Qualidade , Reprodutibilidade dos Testes , Projetos de PesquisaRESUMO
OBJECTIVES: This study aims to assess the incidence of incidental activity in the gallbladder and the factors that may contribute to it in a large cohort of patients undergoing 18F-fluorodeoxyglucose-PET/CT for cancer evaluation. METHODS: 8096 PET/CTs were retrospectively reviewed. Data pertaining to patient demographics and PET/CT parameters were collected. Patients' records were reviewed for gallbladder disorders for up to 3 years after the exam. The presence/absence of gallbladder uptake was visually assessed. Findings were classified as focal, diffuse increased and diffuse increased wall uptake, or no uptake. Volumetric measurements of the gallbladder and SUVmax of the gallbladder, liver and blood pool were measured. Chi-square and Student's t-test were used for statistical analysis. RESULTS: 54 cases (0.67%) of incidental gallbladder uptake were detected (uptake group). 162 exams without uptake were selected as control (no uptake group). The injection-to-scan interval, SUVmax of the liver and blood pool, and the gallbladder volume did not differ significantly between both groups. Higher blood glucose levels were observed in the uptake (109.9 ± 32.5) vs. no uptake group (97.4 ± 18) (p = 0.01), with levels >150 mg/dL more common in the uptake group (p = 0.004). The incidence of gallbladder disease within 3 years after imaging was higher for the uptake group (12/36) compared to the no uptake group (15/115) (p = 0.02). Diffuse increased wall uptake was more likely in the group who later developed a pathology (4/12) (p = 0.03). CONCLUSION: Incidental gallbladder uptake in patients is independent of the injected FDG dose, injection-to-scan interval or gallbladder volume, but may be related to blood glucose level. There's a higher incidence of gallbladder pathology three years after the exam particularly in cases of diffuse increased wall uptake.