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1.
Heart Lung ; 58: 21-27, 2022 Nov 04.
Artigo em Inglês | MEDLINE | ID: mdl-36343565

RESUMO

BACKGROUND: Some studies suggest that patients with pulmonary hypertension (PH) may be at higher risk of complications and death after noncardiac surgery. However, the magnitude of these associations is unclear. OBJECTIVES: To determine the associations between PH and adverse outcomes after noncardiac surgery. METHODS: We searched PUBMED and EMBASE for studies published from January 1970 to April 2022. We included studies that reported the association between PH and one or more outcomes of interest occurring after noncardiac surgery. Data were pooled using random-effects models and reported as summary odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Eighteen studies met eligibility criteria (n=18,214,760). PH was independently associated with mortality (adjusted odds ratio [OR] 2.09; 95% CI, 1.51-2.90; I2=98%; 8 studies). PH was associated with a higher unadjusted risk of deep venous thrombosis (OR 4.02; 95% CI, 2.14-7.54; I2=85%; 3 studies), pulmonary embolism (OR 4.16; 95% CI, 3.23-5.36; I2=69%; 7 studies), myocardial infarction (OR 1.49; 95% CI, 1.44-1.54; I2=0%; 5 studies), congestive heart failure or cardiogenic shock (OR 3.37; 95% CI, 1.73-6.60; I2=34%; 5 studies), length of hospital stay (mean difference 1.97 days; 95% CI, 0.81-3.12; I2=99%; 5 studies), and delayed extubation (OR 5.98; 95% CI, 1.70-21.02; I2=3%; 3 studies). PH was associated with lower unadjusted risk of postoperative stroke (OR 0.93; 95% CI, 0.88-0.98; I2=0%; 3 studies). CONCLUSION: PH is a predictor of morbidity and mortality after noncardiac surgery. High quality studies are needed to determine effective strategies for reducing postoperative complications in this population.

2.
Contemp Clin Trials ; 122: 106963, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36252935

RESUMO

Centralized statistical monitoring is sometimes employed as an alternative to onsite monitoring for randomized control trials. Current central monitoring methods have limitations, in that they are relatively resource intensive and do not necessarily generalize to studies where an irregularity pattern has not been observed before. Machine learning has been effective in detecting irregularities in industries such as finance and manufacturing, but to date none have been applied to clinical trials. We conducted a pilot study for the use of machine learning to identify center-level irregularities in data from multicenter clinical trials. We employed unsupervised machine learning methods, which do not rely on labelled data, and therefore allow for the automated discovery of previously unseen irregularity patterns while maintaining flexibility when applied to new data with different structures. This pilot study employs unsupervised machine learning to compute distance matrices between centres, which we used to produce centre-level continuous features. We then used a one-class support vector machine to learn the underlying distribution of each data set to identify data that was substantially different from these distributions. We evaluated our approach against current automatable centralized monitoring methods on two trials with known irregularities. While current approaches performed well on one trial (AUROC 0.752 for monitoring vs. 0.584 for machine learning), our techniques performed substantially better on the other (AUROC 0.140 for monitoring vs 0.728 for machine learning). The results of this pilot study suggest both the feasibility and the potential value of a machine learning-based approach to irregularity detection in RCTs.


Assuntos
Aprendizado de Máquina , Humanos , Projetos Piloto , Ensaios Clínicos Controlados Aleatórios como Assunto
4.
CJC Open ; 4(10): 840-847, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-36254332

RESUMO

Background: Perioperative atrial fibrillation (POAF) after cardiac surgery is associated with an increased risk of stroke. However, the efficacy and safety of using anticoagulation therapy in this population are unknown. Methods: We performed a systematic review and meta-analysis of studies comparing use of anticoagulation therapy vs no anticoagulation therapy in patients with POAF after cardiac surgery. Outcomes included arterial thromboembolism (ie, stroke ± systemic embolism) and bleeding. Data were pooled using fixed-effects models. We reported summary risk ratios (RRs) for studies with multivariable adjustment and estimated absolute risk differences with 95% confidence intervals (CIs). Results: Nine observational studies met eligibility criteria. No randomized trials were identified. Of the 254,200 POAF patients included, 27.3% received anticoagulation. Six studies reported outcomes after long-term follow-up (median 5.0 years; range 4.2-10.0). The risk of arterial thromboembolism was lower in patients receiving anticoagulation therapy (RR 0.83; 95% CI, 0.69-0.99; I2 = 57%; P = 0.04; 6 studies). The estimated short-term and long-term absolute risk reductions in arterial thromboembolism with use of anticoagulation therapy were 0.8% (95% CI, 0.4-1.4) and 2 events per 1000 person-years (95% CI, 0-4), respectively. The risk of bleeding was higher in patients receiving anticoagulation therapy (RR 3.22; 95% CI, 2.82-3.68; I2 = 98%; P < 0.001; 2 studies). The estimated short-term and long-term absolute risk increases in bleeding with use of anticoagulation therapy were 0.5% (95% CI, 0.4-0.6) and 42 events per 1000 person-years (95% CI, 35-51), respectively. Conclusions: Use of anticoagulation therapy is associated with a small reduction in the risk of arterial thromboembolism, but also an increased risk of bleeding. Randomized controlled trials are needed to address this issue.


Introduction: La fibrillation auriculaire périopératoire (FAPO) après l'intervention chirurgicale au cœur est associée à une augmentation du risque d'accident vasculaire cérébral (AVC). Toutefois, on ne connaît pas l'efficacité et l'innocuité de la l'anticoagulothérapie de cette population. Méthodes: Nous avons réalisé une revue systématique et une méta-analyse d'études qui comparaient l'utilisation de l'anticoagulothérapie vs l'absence d'anticoagulothérapie chez les patients atteints de FAPO après l'intervention chirurgicale au cœur. Les résultats étaient notamment la thromboembolie artérielle (c.-à-d. l'AVC ± l'embolie systémique) et les hémorragies. Nous avons regroupé les données à l'aide de modèles à effets fixes. Nous avons rapporté les risques relatifs (RR) sommaires d'études avec l'ajustement multivarié et l'estimation des différences du risque absolu avec des intervalles de confiance (IC) à 95 %. Résultats: Neuf études observationnelles répondaient aux critères d'admissibilité. Aucun essai à répartition aléatoire n'a été trouvé. Parmi les 254 200 patients atteints de FAPO sélectionnés, 27,3 % avaient reçu une anticoagulation. Six études révélaient des résultats après le suivi à long terme (médiane 5,0 ans ; fourchette 4,2-10,0). Le risque de thromboembolie artérielle était plus faible chez les patients qui avaient reçu une anticoagulothérapie (RR 0,83 ; IC à 95 %, 0,69-0,99 ; I2 = 57 % ; P = 0,04 ; six études). Les estimations de réduction du risque absolu à court terme et à long terme lors de thromboembolie artérielle avec l'utilisation de l'anticoagulothérapie étaient respectivement de 0,8 % (IC à 95 %, 0,4-1,4) et de deux événements par 1000 personnes-années (IC à 95 %, 0-4). Le risque d'hémorragie était plus élevé chez les patients qui avaient reçu une anticoagulothérapie (RR 3,22 ; IC à 95 %, 2,82-3,68 ; I2 = 98 % ; P < 0,001 ; deux études). Les estimations d'augmentation du risque absolu à court terme et à long terme des hémorragies avec l'utilisation de l'anticoagulothérapie étaient respectivement de 0,5 % (IC à 95 %, 0,4-0,6) et de 42 événements par 1000 personnes-années (IC à 95 %, 35-51). Conclusions: L'utilisation de l'anticoagulothérapie est associée à une réduction minime du risque de thromboembolie artérielle, mais aussi à une augmentation du risque d'hémorragie. Des essais cliniques à répartition aléatoire sont nécessaires pour aborder cette question.

5.
Syst Rev ; 11(1): 229, 2022 Oct 25.
Artigo em Inglês | MEDLINE | ID: mdl-36284336

RESUMO

BACKGROUND: Cluster randomized trials (CRTs) are becoming an increasingly important design. However, authors of CRTs do not always adhere to requirements to explicitly identify the design as cluster randomized in titles and abstracts, making retrieval from bibliographic databases difficult. Machine learning algorithms may improve their identification and retrieval. Therefore, we aimed to develop machine learning algorithms that accurately determine whether a bibliographic citation is a CRT report. METHODS: We trained, internally validated, and externally validated two convolutional neural networks and one support vector machine (SVM) algorithm to predict whether a citation is a CRT report or not. We exclusively used the information in an article citation, including the title, abstract, keywords, and subject headings. The algorithms' output was a probability from 0 to 1. We assessed algorithm performance using the area under the receiver operating characteristic (AUC) curves. Each algorithm's performance was evaluated individually and together as an ensemble. We randomly selected 5000 from 87,633 citations to train and internally validate our algorithms. Of the 5000 selected citations, 589 (12%) were confirmed CRT reports. We then externally validated our algorithms on an independent set of 1916 randomized trial citations, with 665 (35%) confirmed CRT reports. RESULTS: In internal validation, the ensemble algorithm discriminated best for identifying CRT reports with an AUC of 98.6% (95% confidence interval: 97.8%, 99.4%), sensitivity of 97.7% (94.3%, 100%), and specificity of 85.0% (81.8%, 88.1%). In external validation, the ensemble algorithm had an AUC of 97.8% (97.0%, 98.5%), sensitivity of 97.6% (96.4%, 98.6%), and specificity of 78.2% (75.9%, 80.4%)). All three individual algorithms performed well, but less so than the ensemble. CONCLUSIONS: We successfully developed high-performance algorithms that identified whether a citation was a CRT report with high sensitivity and moderately high specificity. We provide open-source software to facilitate the use of our algorithms in practice.


Assuntos
Algoritmos , Aprendizado de Máquina , Humanos , MEDLINE , Ensaios Clínicos Controlados Aleatórios como Assunto , Descritores , Máquina de Vetores de Suporte
7.
J Psychosom Res ; 162: 111036, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36116291

RESUMO

OBJECTIVE: Preoperative distress is commonly experienced by surgical patients and is associated with adverse health-related outcomes. Research suggests preoperative distress may be elevated among cancer surgery patients relative to other surgical groups and there appears to be greater recognition of the adverse impacts of distress for these patients. This study examined associations between preoperative distress and postoperative healthcare-related correlates (e.g., length of stay, re-hospitalization) among a large, mixed surgical sample, and separately among cancer surgery patients with active cancer. METHODS: We analyzed secondary data from the Vascular Events In Non-cardiac Surgery Patients Cohort Evaluation (VISION) study - Mental Health Supplement (N = 997; n = 370 active cancer/cancer surgery). The Kessler 6-item Psychological Distress Scale assessed preoperative distress on the day of surgery. Multivariable regressions examined associations between distress and healthcare-related correlates. For significant relationships, we examined associations between anxiety and depressive subscales of distress with the correlates of interest. RESULTS: Among the full surgical sample, after adjustment, preoperative distress was associated with a greater length of stay (b = 0.01, 95% CI [0.00-0.02], R2 = 0.15, f2 = 0.18) and increased odds of re-hospitalization (AOR = 1.07, 95%CI [1.01-1.13]). Results were comparable among cancer surgery patients (length of stay: b = 0.02, re-hospitalization: AOR = 1.11). Post-hoc analyses revealed associations between anxiety symptoms and re-hospitalization (AOR range: 1.13-1.26) and between depressive symptoms and length of hospital stay (b range: 0.02-0.04, R2 range: 0.07-0.15, f2 range: 0.07-0.18). CONCLUSIONS: Findings suggest preoperative distress may be associated with greater postoperative healthcare needs. Results support the importance of screening for distress in the perioperative period.


Assuntos
Neoplasias , Angústia Psicológica , Ansiedade/diagnóstico , Ansiedade/epidemiologia , Ansiedade/etiologia , Atenção à Saúde , Humanos , Tempo de Internação , Neoplasias/complicações , Neoplasias/cirurgia
9.
Trials ; 23(1): 772, 2022 Sep 12.
Artigo em Inglês | MEDLINE | ID: mdl-36096826

RESUMO

BACKGROUND: Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. METHODS AND DESIGN: The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. RESULTS: The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention's National Healthcare Safety Network reporting criteria (2017). All participants' surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. CONCLUSION: This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.


Assuntos
Anti-Infecciosos Locais , Fraturas Expostas , Anti-Infecciosos Locais/efeitos adversos , Clorexidina/efeitos adversos , Fraturas Expostas/cirurgia , Humanos , Povidona-Iodo/efeitos adversos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/prevenção & controle , Estados Unidos , Água
10.
J Orthop Trauma ; 36(12): 604-609, 2022 Dec 01.
Artigo em Inglês | MEDLINE | ID: mdl-36037426

RESUMO

OBJECTIVE: To determine the association of elevated troponin levels with time to surgery and the risk of mortality and other key clinical outcomes among elderly patients with hip fracture who had measured troponin levels at hospital admission. DESIGN: Retrospective cohort study. SETTING: Single academic trauma center. PATIENTS: We included 299 consecutive patients 60 years of age or older with a hip fracture and cardiac troponin levels measured at the time of hospital admission. INTERVENTION: Patients with elevated cardiac troponin levels at hospital admission (n = 43) compared with patients with normal troponin levels at admission (n = 256). MAIN OUTCOME MEASURES: Time to surgery, 90-day mortality, and major complications within 90 days of injury. RESULTS: The median age of the cohort was 80 years (interquartile range, 70-87 years), 59% were female, and 86% were living independently before their injury. Elevated troponin levels were associated with a 21-hour [95% confidence interval (CI), 12 to 32, P < 0.001] increase in the median time from admission to surgery (43 vs. 22 hours). Elevated troponin levels were also associated with a 14% (95% CI, 0% to 29%, P = 0.01) absolute increase in 90-day mortality (28% vs. 14%). Patients with elevated troponins were 15% (95% CI, -1% to 30%, P = 0.06) more likely to have a major complication (37% vs. 23%); however, the difference did not reach statistical significance. CONCLUSIONS: Among patients with a hip fracture and measured troponin levels, elevated troponin levels were associated with significant delays in surgery and increased 90-day mortality. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Fraturas do Quadril , Troponina , Humanos , Feminino , Idoso , Idoso de 80 Anos ou mais , Masculino , Estudos Retrospectivos , Fraturas do Quadril/diagnóstico , Fraturas do Quadril/cirurgia , Hospitalização , Centros de Traumatologia
12.
Eur J Cardiothorac Surg ; 62(1)2022 06 15.
Artigo em Inglês | MEDLINE | ID: mdl-35678560

RESUMO

OBJECTIVES: We used individual patient data from 4 of the largest contemporary coronary bypass surgery trials to evaluate differences in long-term outcomes when radial artery (RA), right internal thoracic artery (RITA) or saphenous vein graft (SVG) are used to complement the left internal thoracic artery-to-left anterior descending graft. METHODS: Primary outcome was all-cause mortality. Secondary outcome was a composite of major adverse cardiac and cerebrovascular events (all-cause mortality, myocardial infarction and stroke). Propensity score matching and Cox regression were used to reduce the effect of treatment selection bias and confounders. RESULTS: A total of 10 256 patients (1510 RITA; 1385 RA; 7361 SVG) were included. The matched population consisted of 1776 propensity score-matched triplets. The mean follow-up was 7.9 ± 0.1, 7.8 ± 0.1 and 7.8 ± 0.1 years in the RITA, RA and SVG cohorts respectively. All-cause mortality was significantly lower in the RA versus the SVG [hazard ratio (HR) 0.62, 95% confidence interval (CI): 0.51-0.76, P = 0.003] and the RITA group (HR 0.59, 95% CI 0.48-0.71, P = 0.001). Major adverse cardiac and cerebrovascular event rate was also lower in the RA group versus the SVG (HR 0.78, 95% CI 0.67-0.90, P = 0.04) and the RITA group (HR 0.75, 95% CI 0.65-0.86, P = 0.02). Results were consistent in the Cox-adjusted analysis and solid to hidden confounders. CONCLUSIONS: In this pooled analysis of 4 large coronary bypass surgery trials, the use of the RA was associated with better clinical outcomes when compared to SVG and RITA.


Assuntos
Doença da Artéria Coronariana , Artéria Torácica Interna , Ponte de Artéria Coronária/métodos , Doença da Artéria Coronariana/cirurgia , Humanos , Artéria Torácica Interna/transplante , Artéria Radial/transplante , Estudos Retrospectivos , Veia Safena/transplante , Resultado do Tratamento
13.
Br J Anaesth ; 129(3): 336-345, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-35753807

RESUMO

BACKGROUND: We compared baseline characteristics and outcomes and evaluated the subgroup effects of randomised interventions by sex in males and females in large international perioperative trials. METHODS: Nine randomised trials and two cohort studies recruiting adult patients, conducted between 1995 and 2020, were included. Baseline characteristics and outcomes common to six or more studies were evaluated. Regression models included terms for sex, study, and an interaction between the two. Comparing outcomes without adjustment for baseline characteristics represents the 'total effect' of sex on the outcome. RESULTS: Of 54 626 participants, 58% were male and 42% were female. Females were less likely to have ASA physical status ≥3 (56% vs 64%), to smoke (15% vs 23%), have coronary artery disease (21% vs 32%), or undergo vascular surgery (10% vs 23%). The pooled incidence of death was 1.6% in females and 1.8% in males (risk ratio [RR] 0.92; 95% confidence interval [CI]: 0.81-1.05; P=0.20), of myocardial infarction was 4.2% vs 4.5% (RR 0.92; 95% CI: 0.81-1.03; P=0.10), of stroke was 0.5% vs 0.6% (RR 1.03; 95% CI: 0.79-1.35; P=0.81), and of surgical site infection was 8.6% vs 8.3% (RR 1.03; 95% CI: 0.79-1.35; P=0.70). Treatment effects of three interventions demonstrated statistically significant effect modification by sex. CONCLUSIONS: Females were in the minority in all included studies. They were healthier than males, but outcomes were comparable. Further research is needed to understand the reasons for this discrepancy. CLINICAL TRIAL REGISTRATION: International Registry of Meta-Research (UID: IRMR_000011; 5 January 2021).


Assuntos
Doença da Artéria Coronariana , Infarto do Miocárdio , Acidente Vascular Cerebral , Adulto , Feminino , Nível de Saúde , Humanos , Masculino , Infarto do Miocárdio/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Cytotherapy ; 24(6): 629-638, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35396169

RESUMO

BACKGROUND AIMS: Early-phase cell therapy clinical trials depend on patient and physician involvement, yet barriers can impede their participation. METHODS: To optimize engagement for a planned cell therapy trial to prevent perioperative cardiac complications, the authors conducted semi-structured interviews with at-risk patients and physicians who could potentially be involved in the study. The authors used the theoretical domains framework to systematically identify potential barriers and enablers. RESULTS: Forty-one interviews were conducted to reach data saturation, and four overall potential barriers to participation (themes) were identified. Theme 1 emphasizes that patients and physicians need accessible information to better understand the benefits and risks of the novel therapy and trial procedures and to address misconceptions. Theme 2 underscores the need for clarity on whether the trial's primary purpose is safety or efficacy, as this may influence patient and physician decisions. Theme 3 recognizes the resource and logistic realities for patients (e.g., convenient follow-up appointments) and physicians (e.g., personnel to assist in trial procedures, competing priorities). Theme 4 describes the importance of social influences (e.g., physicians and family, peers/colleagues) that may affect decisions to participate and the importance of patient preferences (e.g., availability of physicians to discuss the trial, including caregivers in discussions). CONCLUSIONS: Prospectively addressing these issues may help optimize feasibility prior to conducting an expensive, resource-intensive trial.


Assuntos
Médicos , Terapia Baseada em Transplante de Células e Tecidos , Humanos
15.
Anesth Analg ; 135(5): 1021-1030, 2022 11 01.
Artigo em Inglês | MEDLINE | ID: mdl-35417425

RESUMO

BACKGROUND: Two trials reported that a high inspiratory oxygen fraction (F io2 ) does not promote myocardial infarction or death. Observational studies can provide larger statistical strength, but associations can be due to unobserved confounding. Therefore, we evaluated the association between intraoperative F io2 and cardiovascular complications in a large international cohort study to see if spurious associations were observed. METHODS: We included patients from the Vascular events In noncardiac Surgery patIents cOhort evaluatioN (VISION) study, who were ≥45 years of age, scheduled for overnight hospital admission, and had intraoperative F io2 recorded. The primary outcome was myocardial injury after noncardiac surgery (MINS), and secondary outcomes included mortality and pneumonia, all within 30 postoperative days. Data were analyzed with logistic regression, adjusted for many baseline cardiovascular risk factors, and illustrated in relation to findings from 2 recent controlled trials. RESULTS: We included 6588 patients with mean age of 62 years of whom 49% had hypertension. The median intraoperative F io2 was 0.46 (5%-95% range, 0.32-0.94). There were 808 patients (12%) with MINS. Each 0.10 increase in median F io2 was associated with a confounder-adjusted increase in odds for MINS: odds ratio (OR), 1.17 (95% confidence interval [CI], 1.12-1.23; P < .0001). MINS occurred in contrast with similar frequencies and no significant difference in controlled trials (2240 patients, 194 events), in which patients were given 80% vs 30% oxygen. Mortality was 2.4% and was not significantly associated with a median F io2 (OR, 1.07; 95% CI, 0.97-1.19 per 0.10 increase; P = .18), and 2.9% of patients had pneumonia (OR, 1.05; 95% CI, 0.95-1.15 per 0.10 increase; P = .34). CONCLUSIONS: We observed an association between intraoperative F io2 and risk of myocardial injury within 30 days after noncardiac surgery, which contrasts with recent controlled clinical trials. F io2 was not significantly associated with mortality or pneumonia. Unobserved confounding presumably contributed to the observed association between F io2 and myocardial injury that is not supported by trials.


Assuntos
Traumatismos Cardíacos , Infarto do Miocárdio , Humanos , Pessoa de Meia-Idade , Estudos de Coortes , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Traumatismos Cardíacos/etiologia , Infarto do Miocárdio/etiologia , Oxigênio , Fatores de Risco
16.
N Engl J Med ; 386(21): 1986-1997, 2022 05 26.
Artigo em Inglês | MEDLINE | ID: mdl-35363452

RESUMO

BACKGROUND: Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS: We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The primary safety outcome was myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular outcome, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS: A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.67 to 0.87; absolute difference, -2.6 percentage points; 95% CI, -3.8 to -1.4; two-sided P<0.001 for superiority). A composite cardiovascular outcome event occurred in 649 of 4581 patients (14.2%) in the tranexamic acid group and in 639 of 4601 patients (13.9%) in the placebo group (hazard ratio, 1.02; 95% CI, 0.92 to 1.14; upper boundary of the one-sided 97.5% CI, 1.14; absolute difference, 0.3 percentage points; 95% CI, -1.1 to 1.7; one-sided P = 0.04 for noninferiority). CONCLUSIONS: Among patients undergoing noncardiac surgery, the incidence of the composite bleeding outcome was significantly lower with tranexamic acid than with placebo. Although the between-group difference in the composite cardiovascular outcome was small, the noninferiority of tranexamic acid was not established. (Funded by the Canadian Institutes of Health Research and others; POISE-3 ClinicalTrials.gov number, NCT03505723.).


Assuntos
Antifibrinolíticos , Ácido Tranexâmico , Antifibrinolíticos/efeitos adversos , Antifibrinolíticos/uso terapêutico , Canadá , Hemorragia/etiologia , Hemorragia/prevenção & controle , Humanos , Procedimentos Cirúrgicos Operatórios , Trombose/induzido quimicamente , Trombose/tratamento farmacológico , Ácido Tranexâmico/efeitos adversos , Ácido Tranexâmico/uso terapêutico
17.
N Engl J Med ; 386(9): 827-836, 2022 03 03.
Artigo em Inglês | MEDLINE | ID: mdl-35235725

RESUMO

BACKGROUND: Consensus recommendations regarding the threshold levels of cardiac troponin elevations for the definition of perioperative myocardial infarction and clinically important periprocedural myocardial injury in patients undergoing cardiac surgery range widely (from >10 times to ≥70 times the upper reference limit for the assay). Limited evidence is available to support these recommendations. METHODS: We undertook an international prospective cohort study involving patients 18 years of age or older who underwent cardiac surgery. High-sensitivity cardiac troponin I measurements (upper reference limit, 26 ng per liter) were obtained 3 to 12 hours after surgery and on days 1, 2, and 3 after surgery. We performed Cox analyses using a regression spline that explored the relationship between peak troponin measurements and 30-day mortality, adjusting for scores on the European System for Cardiac Operative Risk Evaluation II (which estimates the risk of death after cardiac surgery on the basis of 18 variables, including age and sex). RESULTS: Of 13,862 patients included in the study, 296 (2.1%) died within 30 days after surgery. Among patients who underwent isolated coronary-artery bypass grafting or aortic-valve replacement or repair, the threshold troponin level, measured within 1 day after surgery, that was associated with an adjusted hazard ratio of more than 1.00 for death within 30 days was 5670 ng per liter (95% confidence interval [CI], 1045 to 8260), a level 218 times the upper reference limit. Among patients who underwent other cardiac surgery, the corresponding threshold troponin level was 12,981 ng per liter (95% CI, 2673 to 16,591), a level 499 times the upper reference limit. CONCLUSIONS: The levels of high-sensitivity troponin I after cardiac surgery that were associated with an increased risk of death within 30 days were substantially higher than levels currently recommended to define clinically important periprocedural myocardial injury. (Funded by the Canadian Institutes of Health Research and others; VISION Cardiac Surgery ClinicalTrials.gov number, NCT01842568.).


Assuntos
Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Infarto do Miocárdio/diagnóstico , Complicações Pós-Operatórias/diagnóstico , Troponina I/sangue , Idoso , Valva Aórtica/cirurgia , Biomarcadores/sangue , Procedimentos Cirúrgicos Cardíacos/mortalidade , Ponte de Artéria Coronária/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/sangue , Infarto do Miocárdio/etiologia , Infarto do Miocárdio/mortalidade , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/mortalidade , Estudos Prospectivos , Valores de Referência
19.
Can J Cardiol ; 38(8): 1189-1200, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35247468

RESUMO

BACKGROUND: Patent foramen ovale (PFO) is a common congenital cardiac abnormality. Risk of stroke increases perioperatively, but the association of PFO with perioperative stroke risk remains unclear. We conducted a systematic review to inform the risk of perioperative stroke in patients with PFO undergoing surgery. METHODS: Embase, MEDLINE, and Cochrane databases were searched from inception to January 2020. We described methods used for establishing PFO and perioperative stroke diagnosis. We conducted meta-analyses to obtain pooled estimates for risk of stroke in patients with and without PFO in different surgical populations. RESULTS: Ten articles with a total of 20,858,011 patients met the eligibility criteria. Prevalence of PFO ranged from 0.06% to 1.4% based on International Classification of Diseases (ICD)-code diagnosis and from 10.4% to 40.4% based on echocardiography diagnosis. Perioperative stroke was observed in 0% to 25% of patients with PFO, and 0% to 16.7% without PFO. Studies that used echocardiography to diagnose PFO found no association between PFO and perioperative stroke. Studies that used ICD codes found strong association but were highly heterogeneous. PFO was not associated with a risk of perioperative stroke in cardiac and transplantation surgeries. While the adjusted odds ratios for stroke were substantial for orthopaedic, general, genitourinary, neurologic, and thoracic surgeries (with PFO status established based on ICD codes), data heterogeneity and quality of data create significant uncertainty. CONCLUSIONS: In conclusion, PFO is likely a risk factor for perioperative stroke in selected types of surgeries. However, this is based on very low-quality evidence. Rigorous prospective studies are needed to further investigate this relationship.


Assuntos
Forame Oval Patente , Acidente Vascular Cerebral , Ecocardiografia , Forame Oval Patente/complicações , Forame Oval Patente/epidemiologia , Forame Oval Patente/cirurgia , Humanos , Razão de Chances , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologia
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