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Ibrain 2022Whether restarting anticoagulation (RA) treatment after intracranial hemorrhage (ICH) is still controversial. We performed a systematic review and meta-analysis to... (Review)
Review
Whether restarting anticoagulation (RA) treatment after intracranial hemorrhage (ICH) is still controversial. We performed a systematic review and meta-analysis to summarize the relationship between anticoagulation after ICH with the recurrence of hemorrhagic events, ischemic events, and long-term mortality. Medline, Embase, and the Cochrane Central Register of Controlled Trials, from inception to November 2020. We searched the published medical literature to ensure cohort studies involving ICH associated with anticoagulation in adults. Primary outcomes were long-term mortality, hemorrhagic events, and ischemic events (myocardial infarction, pulmonary embolism, ischemic stroke, or systemic embolization). We concluded seven retrospective cohorts, including 1876 intracranial hemorrhage patients with indications of anticoagulation. The ratio of the anticoagulant restart was 35.3% (664n). RA was associated with a significantly lower incidence of recurrent ischemic events (pooled odds ratio [OR] 0.29, 95% confidence interval [CI] 0.19% to 0.45%, = 0.97) and death events (pooled OR 0.56, 95% CI 0.40%-0.79%, = 0.27). There is no evidence that early recovery of anticoagulation (within 2 weeks or 1 month) is associated with the occurrence of hemorrhagic events (within 2 weeks: pooled OR 0.80, 95% CI 0.3-2.12, = 0.52 vs. within 1 month: pooled OR 1.14, 95% CI 0.77-1.68, = 0.82). Based on these, recovery of anticoagulation after ICH is beneficial for long-term mortality and recurrence of ischemic events. The meta-analysis showed a resumption of oral anticoagulation within 2 weeks or 1 month in patients who had a cerebral hemorrhage was beneficial and did not increase the risk of hemorrhagic events and reduced the occurrence of ischemic and fatal endpoint events.
PubMed: 37786745
DOI: 10.1002/ibra.12060 -
The Cochrane Database of Systematic... Jun 2020Cardiogenic shock (CS) is a state of critical end-organ hypoperfusion due to a primary cardiac disorder. For people with refractory CS despite maximal vasopressors,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cardiogenic shock (CS) is a state of critical end-organ hypoperfusion due to a primary cardiac disorder. For people with refractory CS despite maximal vasopressors, inotropic support and intra-aortic balloon pump, mortality approaches 100%. Mechanical assist devices provide mechanical circulatory support (MCS) which has the ability to maintain vital organ perfusion, to unload the failing ventricle thus reduce intracardiac filling pressures which reduces pulmonary congestion, myocardial wall stress and myocardial oxygen consumption. This has been hypothesised to allow time for myocardial recovery (bridge to recovery) or allow time to come to a decision as to whether the person is a candidate for a longer-term ventricular assist device (VAD) either as a bridge to heart transplantation or as a destination therapy with a long-term VAD.
OBJECTIVES
To assess whether mechanical assist devices improve survival in people with acute cardiogenic shock.
SEARCH METHODS
We searched CENTRAL, MEDLINE (Ovid), Embase (Ovid) and Web of Science Core Collection in November 2019. In addition, we searched three trials registers in August 2019. We scanned reference lists and contacted experts in the field to obtain further information. There were no language restrictions.
SELECTION CRITERIA
Randomised controlled trials on people with acute CS comparing mechanical assist devices with best current intensive care management, including intra-aortic balloon pump and inotropic support.
DATA COLLECTION AND ANALYSIS
We performed data collection and analysis according to the published protocol. Primary outcomes were survival to discharge, 30 days, 1 year and secondary outcomes included, quality of life, major adverse cardiovascular events (30 days/end of follow-up), dialysis-dependent (30 days/end of follow-up), length of hospital stay and length of intensive care unit stay and major adverse events. We used the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness, and publication bias) to assess the quality of a body of evidence as it relates to the studies which contribute data to the meta-analyses for the prespecified outcomes Summary statistics for the primary endpoints were risk ratios (RR), hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CIs).
MAIN RESULTS
The search identified five studies from 4534 original citations reviewed. Two studies included acute CS of all causes randomised to treatment using TandemHeart percutaneous VAD and three studies included people with CS secondary to acute myocardial infarction who were randomised to Impella CP or best medical management. Meta-analysis was performed only to assess the 30-day survival as there were insufficient data to perform any further meta-analyses. The results from the five studies with 162 participants showed mechanical assist devices may have little or no effect on 30-day survival (RR of 1.01 95% CI 0.76 to 1.35) but the evidence is very uncertain. Complications such as sepsis, thromboembolic phenomena, bleeding and major adverse cardiovascular events were not infrequent in both the MAD and control group across the studies, but these could not be pooled due to inconsistencies in adverse event definitions and reporting. We identified four randomised control trials assessing mechanical assist devices in acute CS that are currently ongoing.
AUTHORS' CONCLUSIONS
There is no evidence from this review of a benefit from MCS in improving survival for people with acute CS. Further use of the technology, risk stratification and optimising the use protocols have been highlighted as potential reasons for lack of benefit and are being addressed in the current ongoing clinical trials.
Topics: Acute Disease; Coronary Care Units; Heart-Assist Devices; Humans; Length of Stay; Quality of Life; Renal Dialysis; Shock, Cardiogenic
PubMed: 32496607
DOI: 10.1002/14651858.CD013002.pub2 -
Open Heart Nov 2023Literature supports associations between common respiratory tract infections (RTIs) and risk of cardiovascular diseases, yet the importance of RTIs for cardiovascular... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
Literature supports associations between common respiratory tract infections (RTIs) and risk of cardiovascular diseases, yet the importance of RTIs for cardiovascular risk management remains less understood. This systematic review and meta-analysis aimed to estimate the causal effects of RTIs on occurrence of cardiovascular diseases in the general population.
METHODS
MEDLINE and EMBASE were systematically searched up to 4 November 2022. Eligible were all aetiological studies evaluating risk of cardiovascular outcomes after exposure to common RTIs within any follow-up duration. Evidence was pooled using random-effects models if data allowed. The ROBINS-E and GRADE approaches were used to rate risk of bias and certainty of evidence, respectively. All assessments were performed in duplicate.
RESULTS
We included 34 studies (65 678 650 individuals). Most studies had a high risk of bias. COVID-19 likely increases relative risk (RR (95% CI)) of myocardial infarction (3.3 (1.0 to 11.0)), stroke (3.5 (1.2 to 10)), pulmonary embolism (24.6 (13.5 to 44.9)) and deep venous thrombosis (7.8 (4.3 to 14.4)) within 30 days after infection (GRADE: moderate) and about twofold within 1 year (GRADE: low to moderate). Other RTIs also likely increase the RR of myocardial infarction (2.9 (95% CI 1.8 to 4.9)) and stroke (2.6 (95% CI 1.1 to 6.4)) within 30 days (GRADE: moderate), and to a lesser extent with longer follow-up.
CONCLUSIONS
RTIs likely increase the risk of cardiovascular diseases about 1.5-5 fold within 1 month after infection. RTIs may, therefore, have clinical relevance as target for cardiovascular risk management, especially in high-risk populations.
PROSPERO REGISTRATION NUMBER
CRD42023416277.
Topics: Humans; Cardiovascular Diseases; Risk Factors; Respiratory Tract Infections; Myocardial Infarction; Stroke; Heart Disease Risk Factors
PubMed: 38016788
DOI: 10.1136/openhrt-2023-002501 -
BMC Infectious Diseases May 2024Thromboembolic (TE) complications [myocardial infarction (MI), stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE)] are common causes of mortality in...
Thromboembolic (TE) complications [myocardial infarction (MI), stroke, deep vein thrombosis (DVT), and pulmonary embolism (PE)] are common causes of mortality in hospitalised COVID-19 patients. Therefore, this review was undertaken to explore the incidence of TE complications and mortality associated with TE complications in hospitalised COVID-19 patients from different studies. A literature search was performed using ScienceDirect and PubMed databases using the MeSH term search strategy of "COVID-19", "thromboembolic complication", "venous thromboembolism", "arterial thromboembolism", "deep vein thrombosis", "pulmonary embolism", "myocardial infarction", "stroke", and "mortality". There were 33 studies included in this review. Studies have revealed that COVID-19 patients tend to develop venous thromboembolism (PE:1.0-40.0% and DVT:0.4-84%) compared to arterial thromboembolism (stroke:0.5-15.2% and MI:0.8-8.7%). Lastly, the all-cause mortality of COVID-19 patients ranged from 4.8 to 63%, whereas the incidence of mortality associated with TE complications was between 5% and 48%. A wide range of incidences of TE complications and mortality associated with TE complications can be seen among hospitalized COVID-19 patients. Therefore, every patient should be assessed for the risk of thromboembolic complications and provided with an appropriate thromboprophylaxis management plan tailored to their individual needs.
Topics: Humans; COVID-19; Thromboembolism; Hospitalization; Pulmonary Embolism; SARS-CoV-2; Incidence; Venous Thromboembolism; Stroke; Myocardial Infarction; Venous Thrombosis
PubMed: 38730292
DOI: 10.1186/s12879-024-09374-1 -
Anesthesiology Research and Practice 2021Atrial fibrillation (AF) occurs in 16-30% of patients after cardiac and thoracic surgery and can lead to serious complications like hypoperfusion of vital organs,...
Incidence, Risk Factors, and Outcomes of Perioperative Atrial Fibrillation following Noncardiothoracic Surgery: A Systematic Review and Meta-Regression Analysis of Observational Studies.
BACKGROUND
Atrial fibrillation (AF) occurs in 16-30% of patients after cardiac and thoracic surgery and can lead to serious complications like hypoperfusion of vital organs, pulmonary edema, and myocardial infarction. The evidence on risk factors and complications associated with perioperative AF after noncardiothoracic surgery is limited.
METHODS
The primary objective was to determine demographic and clinical risk factors for new-onset atrial fibrillation associated with noncardiothoracic surgery. A secondary aim was to identify the incidence and odds of perioperative complications associated with the new-onset atrial fibrillation. A systematic search within multiple databases was conducted for studies that explicitly reported on new-onset atrial fibrillation after noncardiothoracic surgery. We reported data on demographics, comorbidities, and perioperative complications as mean difference (MD) or odds ratios (OR) and corresponding 95% confidence interval (CI) using random effects models. A two-sided value of less than 0.05 was considered significant. We performed meta-regression and sensitivity analysis of various subgroups to confirm the inference of our findings.
RESULTS
Eleven studies reporting on 121,517 patients were included, of whom 2,944 developed perioperative AF (incidence rate: 3.7%; 95% CI: 2.3%--6.2%). Advanced age (AF group versus control group: 69.36 ± 10.5 versus 64.37 ± 9.53 years; MD: 4.06; 95% CI: 1.67--6.44; =0.0009), male gender (52.85% versus 43.59%; OR: 1.08; 95% CI: 0.54 to 1.62; : 84%; < 0.0001), preoperative hypertension (60.42% versus 56.51%; OR: 1.15; 95% CI: 1.08 to 1.23; : 0%; < 0.00001), diabetes mellitus (22.6% versus 23.04%; OR: 0.97; 95% CI: 0.89 to 1.05; : 0; < 0.00001), and cardiac disease (30.64% versus 8.49%; OR: 2.3; 95% CI: 0.28 to 4.31; : 93%; =0.03) were found to be significant predictors for perioperative AF. The AF group was at increased odds of developing postoperative cardiac complications (34.1% versus 5%; OR: 5.44; 95% CI: 0.49 to 10.39; : 82%; =0.03), postoperative stroke (0.5% versus 0.1%; OR: 3; 95% CI: 0.65 to 5.35; : 0%; =0.01), and mortality (7.40% versus 1.92%; OR: 3.58; 95% CI: 0.14 to 7.02; : 0%; =0.04). Study quality assessment by meta-regression and sensitivity analysis of the various subgroups did not affect the final inference of the results.
CONCLUSION
We identified advanced age, male gender, preoperative hypertension, diabetes mellitus, and cardiac disease as important risk factors for perioperative atrial fibrillation. The atrial fibrillation group was at increased odds for postoperative cardiac complications, stroke, and higher mortality, emphasizing the need for risk stratification and close monitoring.
PubMed: 34007270
DOI: 10.1155/2021/5527199 -
The Western Journal of Emergency... Mar 2024Intra-arrest transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) have been introduced in adult patients with cardiac arrest (CA). Whether the...
INTRODUCTION
Intra-arrest transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) have been introduced in adult patients with cardiac arrest (CA). Whether the diagnostic performance of TTE or TEE is superior during resuscitation is unclear. We conducted a systematic review following PRISMA guidelines.
METHODS
We searched databases from PubMed, Embase, and Google Scholar and evaluated articles with intra-arrest TTE and TEE in adult patients with non-traumatic CA. Two authors independently screened and selected articles for inclusion; they then dual-extracted study characteristics and target conditions (pericardial effusion, aortic dissection, pulmonary embolism, myocardial infarction, hypovolemia, left ventricular dysfunction, and sonographic cardiac activity). We performed quality assessment using the Quality Assessment of Diagnostic Accuracy Studies Version 2 criteria.
RESULTS
A total of 27 studies were included: 14 studies with 2,145 patients assessed TTE; and 16 with 556 patients assessed TEE. A high risk of bias or applicability concerns in at least one domain was present in 20 studies (74%). Both TTE and TEE found positive findings in nearly one-half of the patients. The etiology of CA was identified in 13% (271/2,145), and intervention was performed in 38% (102/271) of patients in the TTE group. In patients who received TEE, the etiology was identified in 43% (239/556), and intervention was performed in 28% (68/239). In the TEE group, a higher incidence regarding the etiology of CA was observed, particularly for those with aortic dissection. However, the outcome of those with aortic dissection in the TEE group was poor.
CONCLUSION
While TEE could identify more causes of CA than TTE, sonographic cardiac activity was reported much more in the TTE group. The impact of TTE and TEE on the return of spontaneous circulation and further survival was still inconclusive in the current dataset.
Topics: Adult; Humans; Echocardiography; Echocardiography, Transesophageal; Ventricular Dysfunction, Left; Resuscitation; Aortic Dissection
PubMed: 38596913
DOI: 10.5811/westjem.18440 -
The Cochrane Database of Systematic... Jun 2023Pelvic, hip, and long bone fractures can result in significant bleeding at the time of injury, with further blood loss if they are treated with surgical fixation. People... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Pelvic, hip, and long bone fractures can result in significant bleeding at the time of injury, with further blood loss if they are treated with surgical fixation. People undergoing surgery are therefore at risk of requiring a blood transfusion and may be at risk of peri-operative anaemia. Pharmacological interventions for blood conservation may reduce the risk of requiring an allogeneic blood transfusion and associated complications.
OBJECTIVES
To assess the effectiveness of different pharmacological interventions for reducing blood loss in definitive surgical fixation of the hip, pelvic, and long bones.
SEARCH METHODS
We used a predefined search strategy to search CENTRAL, MEDLINE, PubMed, Embase, CINAHL, Transfusion Evidence Library, ClinicalTrials.gov, and the WHO International Clinical Trials Registry Platform (ICTRP) from inception to 7 April 2022, without restrictions on language, year, or publication status. We handsearched reference lists of included trials to identify further relevant trials. We contacted authors of ongoing trials to acquire any unpublished data.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of people who underwent trauma (non-elective) surgery for definitive fixation of hip, pelvic, and long bone (pelvis, tibia, femur, humerus, radius, ulna and clavicle) fractures only. There were no restrictions on gender, ethnicity, or age. We excluded planned (elective) procedures (e.g. scheduled total hip arthroplasty), and studies published since 2010 that had not been prospectively registered. Eligible interventions included: antifibrinolytics (tranexamic acid, aprotinin, epsilon-aminocaproic acid), desmopressin, factor VIIa and XIII, fibrinogen, fibrin sealants, and non-fibrin sealants.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial eligibility and risk of bias, and extracted data. We assessed the certainty of the evidence using GRADE. We did not perform a network meta-analysis due to lack of data.
MAIN RESULTS
We included 13 RCTs (929 participants), published between 2005 and 2021. Three trials did not report any of our predefined outcomes and so were not included in quantitative analyses (all were tranexamic acid versus placebo). We identified three comparisons of interest: intravenous tranexamic acid versus placebo; topical tranexamic acid versus placebo; and recombinant factor VIIa versus placebo. We rated the certainty of evidence as very low to low across all outcomes. Comparison 1. Intravenous tranexamic acid versus placebo Intravenous tranexamic acid compared to placebo may reduce the risk of requiring an allogeneic blood transfusion up to 30 days (RR 0.48, 95% CI 0.34 to 0.69; 6 RCTs, 457 participants; low-certainty evidence) and may result in little to no difference in all-cause mortality (Peto odds ratio (Peto OR) 0.38, 95% CI 0.05 to 2.77; 2 RCTs, 147 participants; low-certainty evidence). It may result in little to no difference in risk of participants experiencing myocardial infarction (risk difference (RD) 0.00, 95% CI -0.03 to 0.03; 2 RCTs, 199 participants; low-certainty evidence), and cerebrovascular accident/stroke (RD 0.00, 95% CI -0.02 to 0.02; 3 RCTs, 324 participants; low-certainty evidence). We are uncertain if there is a difference between groups for risk of deep vein thrombosis (Peto OR 2.15, 95% CI 0.22 to 21.35; 4 RCTs, 329 participants, very low-certainty evidence), pulmonary embolism (Peto OR 1.08, 95% CI 0.07 to 17.66; 4 RCTs, 329 participants; very low-certainty evidence), and suspected serious drug reactions (RD 0.00, 95% CI -0.03 to 0.03; 2 RCTs, 185 participants; very low-certainty evidence). No data were available for number of red blood cell units transfused, reoperation, or acute transfusion reaction. We downgraded the certainty of the evidence for imprecision (wide confidence intervals around the estimate and small sample size, particularly for rare events), and risk of bias (unclear or high risk methods of blinding and allocation concealment in the assessment of subjective measures), and upgraded the evidence for transfusion requirement for a large effect. Comparison 2. Topical tranexamic acid versus placebo We are uncertain if there is a difference between topical tranexamic acid and placebo for risk of requiring an allogeneic blood transfusion (RR 0.31, 95% CI 0.08 to 1.22; 2 RCTs, 101 participants), all-cause mortality (RD 0.00, 95% CI -0.10 to 0.10; 1 RCT, 36 participants), risk of participants experiencing myocardial infarction (Peto OR 0.15, 95% CI 0.00 to 7.62; 1 RCT, 36 participants), cerebrovascular accident/stroke (RD 0.00, 95% CI -0.06 to 0.06; 1 RCT, 65 participants); and deep vein thrombosis (Peto OR 1.11, 95% CI 0.07 to 17.77; 2 RCTs, 101 participants). All outcomes reported were very low-certainty evidence. No data were available for number of red blood cell units transfused, reoperation, incidence of pulmonary embolism, acute transfusion reaction, or suspected serious drug reactions. We downgraded the certainty of the evidence for imprecision (wide confidence intervals around the estimate and small sample size, particularly for rare events), inconsistency (moderate heterogeneity), and risk of bias (unclear or high risk methods of blinding and allocation concealment in the assessment of subjective measures, and high risk of attrition and reporting biases in one trial). Comparison 3. Recombinant factor VIIa versus placebo Only one RCT of 48 participants reported data for recombinant factor VIIa versus placebo, so we have not presented the results here.
AUTHORS' CONCLUSIONS
We cannot draw conclusions from the current evidence due to lack of data. Most published studies included in our analyses assessed the use of tranexamic acid (compared to placebo, or using different routes of administration). We identified 27 prospectively registered ongoing RCTs (total target recruitment of 4177 participants by end of 2023). The ongoing trials create six new comparisons: tranexamic acid (tablet + injection) versus placebo; intravenous tranexamic acid versus oral tranexamic acid; topical tranexamic acid versus oral tranexamic acid; different intravenous tranexamic acid dosing regimes; topical tranexamic acid versus topical fibrin glue; and fibrinogen (injection) versus placebo.
Topics: Humans; Tranexamic Acid; Hemorrhage; Hemostatics; Fibrinogen; Pulmonary Embolism; Venous Thrombosis; Stroke; Myocardial Infarction; Arthroplasty, Replacement; Transfusion Reaction; Fractures, Bone
PubMed: 37272509
DOI: 10.1002/14651858.CD013499.pub2 -
Anatolian Journal of Cardiology Oct 2022Nonbacterial thrombotic endocarditis is characterized by the presence of organized thrombi on cardiac valves, often associated with hypercoagulable states. There is a...
BACKGROUND
Nonbacterial thrombotic endocarditis is characterized by the presence of organized thrombi on cardiac valves, often associated with hypercoagulable states. There is a paucity of data regarding the predictors of mortality in patients with nonbacterial thrombotic endocarditis. Our primary aim was to identify predictors of in-hospital mortality in patients with nonbacterial thrombotic endocarditis.
METHODS
A systematic literature review of all published cases and case series was performed until May 2018 according to Preferred Reporting Items for Systematic Review and Meta-analyses statement guidelines. We applied random forest machine learning model to identify predictors of in-patient mortality in patients with nonbacterial thrombotic endocarditis.
RESULTS
Our search generated a total of 163 patients (mean age, 46 ± 17 years; women, 69%) with newly diagnosed nonbacterial thrombotic endocarditis. The in-hospital mortality rate in the study cohort was 30%. Among the patients who died in the hospital, initial presentation of pulmonary embolism (12.2 vs. 2.6%), splenic (38.7 vs. 10.5%), and renal (40.8 vs. 9.6%) infarcts were higher compared to patients alive at the time of discharge. Higher rates of malignancy (71.4 vs. 39.4%, P = .0003) and lower rates of antiphospholipid syndrome (8.1 vs. 48.2%, P = .0001) were noted in deceased patients. Random forest machine learning analysis showed that older age, presence of antiphospholipid syndrome, splenic infarct, renal infarct, peripheral thromboembolism, pulmonary embolism, myocardial infarction, and mitral valve regurgitation were significantly associated with increased risk of in-hospital mortality.
CONCLUSION
Patients admitted with nonbacterial thrombotic endocarditis have a high rate of in-hospital mortality. Factors including older age, presence of antiphospholipid syndrome, splenic/renal infarct, lower limb thromboembolism, pulmonary embolism, myocardial infarction, and mitral valve regurgitation were significantly associated with increased risk of in-hospital mortality in patients with nonbacterial thrombotic endocarditis.
Topics: Adult; Antiphospholipid Syndrome; Endocarditis, Non-Infective; Female; Humans; Middle Aged; Mitral Valve Insufficiency; Myocardial Infarction; Pulmonary Embolism; Thromboembolism
PubMed: 36052565
DOI: 10.5152/AnatolJCardiol.2022.1282 -
Trends in Endocrinology and Metabolism:... Dec 2020Coronavirus disease 2019 (COVID-19) patients with pre-existing cardiovascular disease (CVD) or with cardiovascular complications have a higher risk of mortality. The...
Coronavirus disease 2019 (COVID-19) patients with pre-existing cardiovascular disease (CVD) or with cardiovascular complications have a higher risk of mortality. The main cardiovascular complications of COVID-19 include acute cardiac injury, acute myocardial infarction (AMI), myocarditis, arrhythmia, heart failure, shock, and venous thromboembolism (VTE)/pulmonary embolism (PE). COVID-19 can cause cardiovascular complications or deterioration of coexisting CVD through direct or indirect mechanisms, including viral toxicity, dysregulation of the renin-angiotensin-aldosterone system (RAAS), endothelial cell damage and thromboinflammation, cytokine storm, and oxygen supply-demand mismatch. We systematically review cardiovascular manifestations, histopathology, and mechanisms of COVID-19, to help to formulate future research goals and facilitate the development of therapeutic management strategies.
Topics: Angiotensin-Converting Enzyme 2; Arrhythmias, Cardiac; COVID-19; Cardiovascular Diseases; Cytokine Release Syndrome; Heart Diseases; Heart Failure; Humans; Hypoxia; Myocardial Infarction; Myocarditis; Pulmonary Embolism; Renin-Angiotensin System; SARS-CoV-2; Shock; Troponin; Venous Thromboembolism
PubMed: 33172748
DOI: 10.1016/j.tem.2020.10.001 -
British Journal of Anaesthesia Jan 2021Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are...
BACKGROUND
Adverse cardiovascular events are a leading cause of perioperative morbidity and mortality. The definitions of perioperative cardiovascular adverse events are heterogeneous. As part of the international Standardized Endpoints in Perioperative Medicine initiative, this study aimed to find consensus amongst clinical trialists on a set of standardised and valid cardiovascular outcomes for use in future perioperative clinical trials.
METHODS
We identified currently used perioperative cardiovascular outcomes by a systematic review of the anaesthesia and perioperative medicine literature (PubMed/Ovid, Embase, and Cochrane Library). We performed a three-stage Delphi consensus-gaining process that involved 55 clinician researchers worldwide. Cardiovascular outcomes were first shortlisted and the most suitable definitions determined. These cardiovascular outcomes were then assessed for validity, reliability, feasibility, and clarity.
RESULTS
We identified 18 cardiovascular outcomes. Participation in the three Delphi rounds was 100% (n=19), 71% (n=55), and 89% (n=17), respectively. A final list of nine cardiovascular outcomes was elicited from the consensus: myocardial infarction, myocardial injury, cardiovascular death, non-fatal cardiac arrest, coronary revascularisation, major adverse cardiac events, pulmonary embolism, deep vein thrombosis, and atrial fibrillation. These nine cardiovascular outcomes were rated by the majority of experts as valid, reliable, feasible, and clearly defined.
CONCLUSIONS
These nine consensus cardiovascular outcomes can be confidently used as endpoints in clinical trials designed to evaluate perioperative interventions with the goal of improving perioperative outcomes.
Topics: Cardiovascular Diseases; Clinical Trials as Topic; Consensus; Delphi Technique; Endpoint Determination; Humans; Perioperative Care; Perioperative Medicine; Postoperative Complications; Research Design
PubMed: 33092804
DOI: 10.1016/j.bja.2020.09.023