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Objective: To analyze the clinical and cost outcomes of transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR) in heart failure (HF) patients. Methods: All 162 HF patients undergoing TEER for MR between January 2019 and March 2023 were included. A propensity-adjusted analysis was used to compare 32 systolic vs. 97 diastolic vs. 33 mixed (systolic + diastolic) HF patients. Systolic, diastolic, and mixed HF patients were defined according to AHA guidelines. The primary outcome was the long-term incidence of all-cause death and major adverse cardiovascular and cerebrovascular events (MACCEs, all-cause mortality + stroke + myocardial infarction + repeat intervention). Results: The mean age was 76.3 vs. 80.9 vs. 76 years old, and the mean ejection fraction (EF) was 39.5% vs. 59.8% vs. 39.7% in systolic vs. diastolic vs. mixed HF, respectively. Postoperatively, the diastolic vs. systolic HF group had a higher intensive care unit stay (21 vs. 0 h; HR 67.5 (23.7, 111.4)]; lower ventilation time [2 vs. 2.3 h; HR 49.4 (8.6, 90.2)]; lower EF [38% vs. 58.5%; HR 9.9 (3.7, 16.1)]. In addition, the diastolic vs. mixed HF groups had a lower incidence of EF < 50% (11 vs. 27 patients; HR 6.6 (1.6, 27.3) and a lower use of dialysis (one vs. three patients; HR 18.1 (1.1, 287.3), respectively. At a mean 1.6 years follow-up, all-cause death [HR 39.8 (26.2, 60.5)], MACCEs [HR 50.3 (33.7-75.1)], and new pacemaker implantations [HR 17.3 (8.7, 34.6)] were higher in the mixed group. There was no significant total hospital cost difference among the systolic (USD 106,859) vs. diastolic (USD 91,731) vs. mixed (USD 120,522) HF groups (p = 0.08). Conclusions: TEER for MR evidenced the worst postoperative and follow-up clinical outcomes in the mixed HF group compared to diastolic and systolic HF groups. No total hospital cost differences were observed.
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BACKGROUND: Excessive perioperative bleeding is associated with major complications in cardiac surgery, resulting in increased morbidity, mortality, and cost. METHODS: An international expert panel was convened to develop consensus statements on the control of bleeding and management of transfusion and to suggest key quality metrics for cardiac surgical bleeding. The panel reviewed relevant literature from the previous 10 years and used a modified RAND Delphi methodology to achieve consensus. RESULTS: The panel developed 30 consensus statements in 8 categories, including prioritizing control of bleeding, prechest closure checklists, and the need for additional quality indicators beyond reexploration rate, such as time to reexploration. Consensus was also reached on the need for a universal definition of excessive bleeding, the use of antifibrinolytics, optimal cessation of antithrombotic agents, and preoperative risk scoring based on patient and procedural factors to identify those at greatest risk of excessive bleeding. Furthermore, an objective bleeding scale is needed based on the volume and rapidity of blood loss accompanied by viscoelastic management algorithms and standardized, patient-centered blood management strategies reflecting an interdisciplinary approach to quality improvement. CONCLUSIONS: Prioritizing the timely control and management of bleeding is essential to improving patient outcomes in cardiac surgery. To this end, a cardiac surgical bleeding quality metric that is more comprehensive than reexploration rate alone is needed. Similarly, interdisciplinary quality initiatives that seek to implement enhanced quality indicators will likely lead to improved patient care and outcomes.
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BACKGROUND: Sex differences in severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) susceptibility, illness severity, and hospital course are widely acknowledged. The effects of sex on outcomes experienced by patients with severe Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) remains unknown. OBJECTIVES: To determine the effects of sex on ICU mortality in patients with COVID-19 METHODS: This retrospective analysis of an international multi-center prospective observational database included adults admitted to ICU for treatment of acute COVID-19 between 1st January 2020 and 30th June 2022. The primary outcome was ICU mortality. Multivariable Cox regression was used to ascertain the hazard of death (Hazard Ratio=HR) adjusted for pre-selected covariates. The secondary outcome was sex differences in complications of COVID-19 during hospital stay. RESULTS: Overall, 10,259 patients (3,314 females, 6,945 males) were included with a median age of 60 (interquartile range [IQR]=49-68) and 59 (IQR=49-67) years, respectively. Baseline characteristics were similar between sexes. More females were non-smokers (65% vs. 44 %, p < 0.01) and obese (39% vs. 30 %, p < 0.01), compared to males. Also, males received greater ICU intervention (mechanical ventilation, prone ventilation, vasopressors, and tracheostomy) than females. Males had a greater hazard of death (compared to females, HR=1.14; 95 % CI=1.02-1.26). Adjustment for complications during hospital stay did not alter the hazard of death (HR=1.16; 95 % CI=1.05-1.28). Males had a significantly elevated hazard of death among patients who received ECMO (HR=1.24; 95 % CI=1.01-1.53). Male sex was associated with cardiac arrest (adjusted OR [aOR]=1.37; 95 % CI=1.16-1.62) and PE (aOR=1.28; 95 % CI=1.06-1.55). CONCLUSION: Among patients admitted to ICU for severe COVID-19, males experienced higher severity of illness and more frequent intervention than females. Ultimately, the hazard of death was moderately elevated in males compared to females despite greater PE and cardiac arrest.
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COVID-19 , Estado Terminal , Mortalidade Hospitalar , Unidades de Terapia Intensiva , Humanos , COVID-19/epidemiologia , COVID-19/mortalidade , COVID-19/terapia , COVID-19/complicações , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos , Fatores Sexuais , Mortalidade Hospitalar/tendências , Unidades de Terapia Intensiva/estatística & dados numéricos , Cuidados Críticos/métodos , Cuidados Críticos/estatística & dados numéricos , SARS-CoV-2 , Índice de Gravidade de DoençaRESUMO
One and a half million cardiac surgeries are completed worldwide each year where undertreated postoperative pain increases the risk of patient morbidity and mortality. Patient-centered pain management is recommended to improve patient outcomes but there is insufficient information regarding how the patient views their role. The objective of this study is to explore cardiac surgery patients' perspectives on their role in postoperative pain management. This study used an interpretive phenomenological design and convenience sampling. Six participants who had undergone cardiac surgery were recruited from a cardiac rehabilitation program in Western Canada. The first author conducted semi-structured digitally recorded interviews. Sociodemographic characteristics and measures of anxiety and depression were also collected. Emergent thematic analysis of the qualitative data generated three themes: attitude, coping and care, and communication. The findings of this study address a gap in the literature with regard to patients' perceived roles in pain management. There is a complex relationship between patient attitude, coping and care, and communication which, in turn, influences how patients view their role within the pain management continuum. These themes contribute to the development of the patient role within the pain management continuum and form an integrated feedback loop. The patient's attitude contributes to their ability to cope with pain and participate in pain assessment and management. Furthermore, their ability to cope and desire to participate influences the development of their attitude. These findings may enhance providers' understanding of the patient's perspective and improve pain management outcomes.
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Adaptação Psicológica , Procedimentos Cirúrgicos Cardíacos , Manejo da Dor , Dor Pós-Operatória , Pesquisa Qualitativa , Humanos , Masculino , Feminino , Dor Pós-Operatória/psicologia , Pessoa de Meia-Idade , Idoso , Canadá , Comunicação , Entrevistas como Assunto , Medição da DorRESUMO
OBJECTIVES: Anemia has been associated with an increased risk of both cardiac arrest and stroke, frequent complications of COVID-19. The effect of hemoglobin level at ICU admission on a composite outcome of cardiac arrest or stroke in an international cohort of COVID-19 patients was investigated. DESIGN: Retrospective analysis of prospectively collected database. SETTING: A registry of COVID-19 patients admitted to ICUs at over 370 international sites was reviewed for patients diagnosed with cardiac arrest or stroke up to 30 days after ICU admission. Anemia was defined as: normal (hemoglobin ≥ 12.0 g/dL for women, ≥ 13.5 g/dL for men), mild (hemoglobin 10.0-11.9 g/dL for women, 10.0-13.4 g/dL for men), moderate (hemoglobin ≥ 8.0 and < 10.0 g/dL for women and men), and severe (hemoglobin < 8.0 g/dL for women and men). PATIENTS: Patients older than 18 years with acute COVID-19 infection in the ICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 6926 patients (median age = 59 yr, male = 65%), 760 patients (11.0%) experienced stroke (2.0%) and/or cardiac arrest (9.4%). Cardiac arrest or stroke was more common in patients with low hemoglobin, occurring in 12.8% of patients with normal hemoglobin, 13.3% of patients with mild anemia, and 16.7% of patients with moderate/severe anemia. Time to stroke or cardiac arrest by anemia status was analyzed using Cox proportional hazards regression with death as a competing risk. Covariates selected through clinical knowledge were age, sex, comorbidities (diabetes, hypertension, obesity, and cardiac or neurologic conditions), pandemic era, country income, mechanical ventilation, and extracorporeal membrane oxygenation. Moderate/severe anemia was associated with a higher risk of cardiac arrest or stroke (hazard ratio, 1.32; 95% CI, 1.05-1.67). CONCLUSIONS: In an international registry of ICU patients with COVID-19, moderate/severe anemia was associated with increased hazard of cardiac arrest or stroke.
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Anemia , COVID-19 , Parada Cardíaca , Hemoglobinas , Insuficiência Respiratória , Acidente Vascular Cerebral , Humanos , COVID-19/complicações , COVID-19/epidemiologia , COVID-19/sangue , Masculino , Feminino , Pessoa de Meia-Idade , Estudos Retrospectivos , Parada Cardíaca/epidemiologia , Parada Cardíaca/etiologia , Hemoglobinas/análise , Hemoglobinas/metabolismo , Idoso , Anemia/epidemiologia , Anemia/sangue , Insuficiência Respiratória/epidemiologia , Insuficiência Respiratória/etiologia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/sangue , Unidades de Terapia Intensiva , SARS-CoV-2 , Sistema de Registros , Fatores de Risco , AdultoRESUMO
PURPOSE: We aimed to compare the incidence of stroke in low-and middle-income countries (LMICs) versus high-income countries (HICs) in critically ill patients with COVID-19 and its impact on in-hospital mortality. METHODS: International observational study conducted in 43 countries. Stroke and mortality incidence rates and rate ratios (IRR) were calculated per admitted days using Poisson regression. Inverse probability weighting (IPW) was used to address the HICs vs. LMICs imbalance for confounders. RESULTS: 23,738 patients [20,511(86.4 %) HICs vs. 3,227(13.6 %) LMICs] were included. The incidence stroke/1000 admitted-days was 35.7 (95 %CI = 28.4-44.9) LMICs and 17.6 (95 %CI = 15.8-19.7) HICs; ischemic 9.47 (95 %CI = 6.57-13.7) LMICs, 1.97 (95 %CI = 1.53, 2.55) HICs; hemorrhagic, 7.18 (95 %CI = 4.73-10.9) LMICs, and 2.52 (95 %CI = 2.00-3.16) HICs; unspecified stroke type 11.6 (95 %CI = 7.75-17.3) LMICs, 8.99 (95 %CI = 7.70-10.5) HICs. In regression with IPW, LMICs vs. HICs had IRR = 1.78 (95 %CI = 1.31-2.42, p < 0.001). Patients from LMICs were more likely to die than those from HICs [43.6% vs 29.2 %; Relative Risk (RR) = 2.59 (95 %CI = 2.29-2.93), p < 0.001)]. Patients with stroke were more likely to die than those without stroke [RR = 1.43 (95 %CI = 1.19-1.72), p < 0.001)]. CONCLUSIONS: Stroke incidence was low in HICs and LMICs although the stroke risk was higher in LMICs. Both LMIC status and stroke increased the risk of death. Improving early diagnosis of stroke and redistribution of healthcare resources should be a priority. TRIAL REGISTRATION: ACTRN12620000421932 registered on 30/03/2020.
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COVID-19 , Estado Terminal , Países Desenvolvidos , Países em Desenvolvimento , Mortalidade Hospitalar , Insuficiência Respiratória , Acidente Vascular Cerebral , Humanos , COVID-19/epidemiologia , COVID-19/complicações , Feminino , Masculino , Acidente Vascular Cerebral/epidemiologia , Países em Desenvolvimento/estatística & dados numéricos , Estado Terminal/epidemiologia , Pessoa de Meia-Idade , Países Desenvolvidos/estatística & dados numéricos , Mortalidade Hospitalar/tendências , Incidência , Idoso , Insuficiência Respiratória/epidemiologia , Insuficiência Respiratória/etiologia , SARS-CoV-2RESUMO
AIM: The cardiac surgery-related ischemia-reperfusion-related oxidative stress triggers the release of cytotoxic reactive oxygen and nitrogen species, contributing to organ failure and ultimately influencing patients' short- and long-term outcomes. Selenium is an essential co-factor for various antioxidant enzymes, thereby contributing to the patients' endogenous antioxidant and anti-inflammatory defense mechanisms. Given these selenium's pleiotropic functions, we investigated the effect of a high-dose selenium-based anti-inflammatory perioperative strategy on functional recovery after cardiac surgery. MATERIALS AND METHODS: This prospective study constituted a nested sub-study of the SUSTAIN CSX trial, a double-blinded, randomized, placebo-controlled multicenter trial to investigate the impact of high-dose selenium supplementation on high-risk cardiac surgery patients' postoperative recovery. Functional recovery was assessed by 6-min walk distance, Short Form-36 (SF-36) and Barthel Index questionnaires. KEY FINDINGS: 174 patients were included in this sub-study. The mean age (SD) was 67.3 (8.9) years, and 78.7 % of the patients were male. The mean (SD) predicted 30-day mortality by the European System for Cardiac Operative Risk Evaluation II score was 12.6 % (9.4 %). There was no difference at hospital discharge and after three months in the 6-min walk distance between the selenium and placebo groups (131 m [IQR: not performed - 269] vs. 160 m [IQR: not performed - 252], p = 0.80 and 400 m [IQR: 299-461] vs. 375 m [IQR: 65-441], p = 0.48). The SF-36 and Barthel Index assessments also revealed no clinically meaningful differences between the selenium and placebo groups. SIGNIFICANCE: A perioperative anti-inflammatory strategy with high-dose selenium supplementation did not improve functional recovery in high-risk cardiac surgery patients.
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Anti-Inflamatórios , Procedimentos Cirúrgicos Cardíacos , Selênio , Humanos , Masculino , Feminino , Idoso , Procedimentos Cirúrgicos Cardíacos/métodos , Selênio/administração & dosagem , Selênio/farmacologia , Método Duplo-Cego , Pessoa de Meia-Idade , Estudos Prospectivos , Anti-Inflamatórios/farmacologia , Anti-Inflamatórios/administração & dosagem , Anti-Inflamatórios/uso terapêutico , Recuperação de Função Fisiológica/efeitos dos fármacos , Suplementos Nutricionais , Antioxidantes/administração & dosagem , Antioxidantes/farmacologia , Estresse Oxidativo/efeitos dos fármacosRESUMO
This year, we have again assembled an expert opinion on several key topics that pertain to the perioperative and critical care management of the cardiac surgery patient and for patients requiring extracorporeal membrane oxygenation. Approximately 1 in 3 patients undergoing cardiac surgery have diabetes mellitus; contemporary glycemic control management of these patients to minimize perioperative complications are reviewed. Goal directed fluid therapy remains an area on interest and controversy; the use of albumin as a resuscitation fluid and recent clinical trial data is reviewed. Delirium is characterized as an acute confusional state occurring in 20-25% of patients after cardiac surgery. Insights on integrating the whole interdisciplinary team, including the family, with the DELirium Team Approach (DELTA) program are discussed. Optimal management for refractory hypoxemia with venovenous extracorporeal membrane oxygenation (VV-ECMO) and the role of prone positioning remain a question. Data supporting this technique during VV-ECMO is reviewed-lastly, the contemporary management and supporting evidence for refractory postoperative vasoplegic shock after cardiopulmonary bypass is provided.
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BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is a rescue therapy in patients with severe acute respiratory distress syndrome (ARDS) secondary to COVID-19. While bleeding and thrombosis complicate ECMO, these events may also occur secondary to COVID-19. Data regarding bleeding and thrombotic events in COVID-19 patients on ECMO are sparse. METHODS: Using the COVID-19 Critical Care Consortium database, we conducted a retrospective analysis on adult patients with severe COVID-19 requiring ECMO, including centers globally from 01/2020 to 06/2022, to determine the risk of ICU mortality associated with the occurrence of bleeding and clotting disorders. RESULTS: Among 1,248 COVID-19 patients receiving ECMO support in the registry, coagulation complications were reported in 469 cases (38%), among whom 252 (54%) experienced hemorrhagic complications, 165 (35%) thrombotic complications, and 52 (11%) both. The hazard ratio (HR) for Intensive Care Unit mortality was higher in those with hemorrhagic-only complications than those with neither complication (adjusted HR = 1.60, 95% CI 1.28-1.99, p < 0.001). Death was reported in 617 of the 1248 (49.4%) with multiorgan failure (n = 257 of 617 [42%]), followed by respiratory failure (n = 130 of 617 [21%]) and septic shock [n = 55 of 617 (8.9%)] the leading causes. CONCLUSIONS: Coagulation disorders are frequent in COVID-19 ARDS patients receiving ECMO. Bleeding events contribute substantially to mortality in this cohort. However, this risk may be lower than previously reported in single-nation studies or early case reports. Trial registration ACTRN12620000421932 ( https://covid19.cochrane.org/studies/crs-13513201 ).
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BACKGROUND: Post-intensive care syndrome is a new or worsening persistent deterioration in cognitive, mental, and/or physical health following a prolonged admission to an intensive care unit. Post-intensive care syndrome remains underexplored following cardiac surgery, with a lack of understanding of the incidence and tools used to measure the symptoms. A scoping review was conducted to determine the incidence and to identify the tools commonly used to measure symptoms of post-intensive care syndrome following cardiac surgery. METHODS: The electronic databases Medline (Ovid), EMBASE (Ovid), PsycINFO (Ovid), Scopus, and CINAHL (EBSCOhost) and Google Scholar were searched with keywords and controlled vocabulary to describe both cardiac surgery and post-intensive care syndrome (cardiac surgical procedures, heart surgery, and post-intensive care symptoms) and symptoms (delirium, depression, mobility and quality of life). Included were articles written in English and published after 2005 that described cognitive, mental, and physical symptoms of post-intensive care syndrome following cardiac surgery. 3,131 articles were found, with 565 duplicates, leaving 2,566 articles to be screened. Of these, seven unique studies were included. RESULTS: Five studies explored cognitive health, three mental health, one cognitive and mental health, and none physical health. No identified studies reported the overall incidence of post-intensive care syndrome following cardiac surgery. The incidence of cognitive health issues ranged from 21% to 38%, and mental health issues ranged from 16% to 99%. In total, 17 different tools were identified - 14 for cognitive health and three for mental health. No identified studies used the same tools to measure symptoms. No single tool was found to measure all three domains. CONCLUSION: This scoping review identified a literature gap specific to the incidence and inconsistency of assessment tools for post-intensive care syndrome in cardiac surgery patients. CLINICAL IMPLICATIONS: This work impacts clinical practice for the bedside nurse by raising awareness of an emerging health issue.
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Procedimentos Cirúrgicos Cardíacos , Humanos , Incidência , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Unidades de Terapia Intensiva/organização & administração , Unidades de Terapia Intensiva/estatística & dados numéricos , Qualidade de Vida/psicologia , Estado TerminalRESUMO
BACKGROUND: Preoperative state anxiety (PSA) is distress and anxiety directly associated with perioperative events. PSA is associated with negative postoperative outcomes such as longer hospital length of stay, increased pain and opioid use, and higher rates of rehospitalization. Psychological prehabilitation, such as education, exposure to hospital environments, and relaxation strategies, has been shown to mitigate PSA; however, there are limited skilled personnel to deliver such interventions in clinical practice. Immersive virtual reality (VR) has the potential for greater accessibility and enhanced integration into an immersive and interactive experience. VR is rarely used in the preoperative setting, but similar forms of stress inoculation training involving exposure to stressful events have improved psychological preparation in contexts such as military deployment. OBJECTIVE: This study seeks to develop and investigate a targeted PSA intervention in patients undergoing oncological surgery using a single preoperative VR exposure. The primary objectives are to (1) develop a novel VR program for patients undergoing oncological surgery with general anesthesia; (2) assess the feasibility, including acceptability, of a single exposure to this intervention; (3) assess the feasibility, including acceptability, of outcome measures of PSA; and (4) use these results to refine the VR content and outcome measures for a larger trial. A secondary objective is to preliminarily assess the clinical utility of the intervention for PSA. METHODS: This study comprises 3 phases. Phase 1 (completed) involved the development of a VR prototype targeting PSA, using multidisciplinary iterative input. Phase 2 (data collection completed) involves examining the feasibility aspects of the VR intervention. This randomized feasibility trial involves assessing the novel VR preoperative intervention compared to a VR control (ie, nature trek) condition and a treatment-as-usual group among patients undergoing breast cancer surgery. Phase 3 will involve refining the prototype based on feasibility findings and input from people with lived experience for a future clinical trial, using focus groups with participants from phase 2. RESULTS: This study was funded in March 2019. Phase 1 was completed in April 2020. Phase 2 data collection was completed in January 2024 and data analysis is ongoing. Focus groups were completed in February 2024. Both the feasibility study and focus groups will contribute to further refinement of the initial VR prototype (phase 3), with the final simulation to be completed by mid-2024. CONCLUSIONS: The findings from this work will contribute to the limited body of research examining feasible and broadly accessible interventions for PSA. Knowledge gained from this research will contribute to the final development of a novel VR intervention to be tested in a large population of patients with cancer before surgery in a randomized clinical trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT04544618; https://www.clinicaltrials.gov/study/NCT04544618. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55692.
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Ansiedade , Estudos de Viabilidade , Neoplasias , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Ansiedade/prevenção & controle , Ansiedade/terapia , Neoplasias/cirurgia , Cuidados Pré-Operatórios/métodos , Angústia Psicológica , Estresse Psicológico , Realidade Virtual , Terapia de Exposição à Realidade Virtual/métodos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Background: Postoperative atrial fibrillation (POAF) is a prevalent complication following cardiac surgery that is associated with increased adverse events. Several guidelines and expert consensus documents have been published addressing the prevention and management of POAF. We aimed to develop an order set to facilitate widespread implementation and adoption of evidence-based practices for POAF following cardiac surgery. Methods: Subject matter experts were consulted to translate existing guidelines and literature into a sample turnkey order set (TKO) for POAF. Orders derived from consistent class I or IIA or equivalent recommendations across referenced guidelines and consensus manuscripts appear in the TKO in bold type. Selected orders that were inconsistently class I or IIA, class IIB, or supported by published evidence appear in italic type. Results: Preoperatively, the recommendation is to screen patients for paroxysmal or chronic atrial fibrillation and initiate appropriate treatment based on individual risk stratification for the development of POAF. This may include the administration of beta-blockers or amiodarone, tailored to the patient's specific risk profile. Intraoperatively, surgical interventions such as posterior pericardiotomy should be considered in selected patients. Postoperatively, it is crucial to focus on electrolyte normalization, implementation strategies for rate or rhythm control, and anticoagulation management. These comprehensive measures aim to optimize patient outcomes and reduce the occurrence of POAF following cardiac surgery. Conclusions: Despite the well-established benefits of implementing a multidisciplinary care pathway for POAF in cardiac surgery, its adoption and implementation remain inconsistent. We have developed a readily applicable order set that incorporates recommendations from existing guidelines.
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BACKGROUND: Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared with intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients. METHODS: We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis, when 75% of anticipated participants had completed follow up, the data and safety monitoring board recommended to terminate the trial, and upon unblinding, the operations committee stopped the trial for safety. RESULTS: Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group, and 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5% [95% CI, -0.9 to 0.03]; P=0.07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3% [95% CI, 5.2-11.5]; P=0.007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared with the intravenous group was 8.2% (95% CI, 3.4-12.9). CONCLUSIONS: Among patients undergoing cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared with intravenous tranexamic acid. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03954314.
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Administração Intravenosa , Administração Tópica , Antifibrinolíticos , Procedimentos Cirúrgicos Cardíacos , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos , Ácido Tranexâmico/uso terapêutico , Masculino , Feminino , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Idoso , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/efeitos adversos , Antifibrinolíticos/uso terapêutico , Pessoa de Meia-Idade , Convulsões/prevenção & controle , Convulsões/etiologia , Método Duplo-Cego , Resultado do Tratamento , Perda Sanguínea Cirúrgica/prevenção & controleRESUMO
OBJECTIVES: Surgical-site infections (SSIs) after cardiac surgery increase morbidity and mortality, consume health care resources, impair recovery, and diminish patients' quality of life. Numerous guidelines and expert consensus documents have been published to address the prevention and management of SSIs. Our objective is to integrate these documents into an order set that will facilitate the adoption and implementation of evidence-based best practices for preventing and managing SSIs after cardiac surgery. METHODS: Subject matter experts were consulted to translate existing guidelines and literature into a sample turnkey order set for SSI reduction. Orders derived from consistent class I, IIA, or equivalent recommendations across referenced guidelines and consensus manuscripts appear in the turnkey order set in bold type. Selected orders that were inconsistent class I or IIA, class IIB or otherwise supported by published evidence, were also included in italicized type. RESULTS: Preventative care begins with the preoperative identification of both modifiable and nonmodifiable SSI risks by health care providers. Assessment tools can be used to assist in identifying patients at a high risk of SSI. Preoperative recommendations include screening for and treating Staphylococcus aureus nasal carriage. Intraoperatively, tailored prophylactic intravenous antibiotics and maintaining blood glucose levels below 180 mg/dL are essential elements. Postoperative care includes maintaining normothermia, glucose control and patient engagement. CONCLUSIONS: Despite the well-documented advantages of a multidisciplinary care pathway for SSI in cardiac surgery, there are inconsistencies in its adoption and implementation. This article provides an order set that incorporates recommendations from existing guidelines to prevent SSI in the cardiac surgical population.
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PURPOSE OF REVIEW: Patients with advanced age and frailty require interventions for structural heart disease at an increasing rate. These patients typically experience higher rates of postoperative morbidity, mortality and prolonged hospital length of stay, loss of independence as well as associated increased costs to the healthcare system. Therefore, it is becoming critically important to raise awareness and develop strategies to improve clinical outcomes in the contemporary, high-risk patient population undergoing cardiacprocedures. RECENT FINDINGS: Percutaneous options for structural heart disease have dramatically improved the therapeutic options for some older, frail, high-risk patients; however, others may still require cardiac surgery. Minimally invasive techniques can reduce some of the physiologic burden experienced by patients undergoing surgery and improve recovery. Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) is a comprehensive, interdisciplinary, evidence-based approach to perioperative care. It has been shown to improve recovery and patient satisfaction while reducing complications and length of stay. SUMMARY: Combining minimally invasive cardiac surgery with enhanced recovery protocols may result in improved patient outcomes for a patient population at high risk of morbidity and mortality following cardiac surgery.