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Immunity, Inflammation and Disease Mar 2023Since publishing successful clinical trial results of mRNA coronavirus disease 2019 (COVID-19) vaccines in December 2020, multiple reports have arisen about... (Review)
Review
BACKGROUND AND OBJECTIVES
Since publishing successful clinical trial results of mRNA coronavirus disease 2019 (COVID-19) vaccines in December 2020, multiple reports have arisen about cardiovascular complications following the mRNA vaccination. This study provides an in-depth account of various cardiovascular adverse events reported after the mRNA vaccines' first or second dose including pericarditis/myopericarditis, myocarditis, hypotension, hypertension, arrhythmia, cardiogenic shock, stroke, myocardial infarction/STEMI, intracranial hemorrhage, thrombosis (deep vein thrombosis, cerebral venous thrombosis, arterial or venous thrombotic events, portal vein thrombosis, coronary thrombosis, microvascular small bowel thrombosis), and pulmonary embolism.
METHODS
A systematic review of original studies reporting confirmed cardiovascular manifestations post-mRNA COVID-19 vaccination was performed. Following the PRISMA guidelines, electronic databases (PubMed, PMC NCBI, and Cochrane Library) were searched until January 2022. Baseline characteristics of patients and disease outcomes were extracted from relevant studies.
RESULTS
A total of 81 articles analyzed confirmed cardiovascular complications post-COVID-19 mRNA vaccines in 17,636 individuals and reported 284 deaths with any mRNA vaccine. Of 17,636 cardiovascular events with any mRNA vaccine, 17,192 were observed with the BNT162b2 (Pfizer-BioNTech) vaccine, 444 events with mRNA-1273 (Moderna). Thrombosis was frequently reported with any mRNA vaccine (n = 13,936), followed by stroke (n = 758), myocarditis (n = 511), myocardial infarction (n = 377), pulmonary embolism (n = 301), and arrhythmia (n = 254). Stratifying the results by vaccine type showed that thrombosis (80.8%) was common in the BNT162b2 cohort, while stroke (39.9%) was common with mRNA-1273 for any dose. The time between the vaccination dosage and the first symptom onset averaged 5.6 and 4.8 days with the mRNA-1273 vaccine and BNT162b2, respectively. The mRNA-1273 cohort reported 56 deaths compared to the 228 with BNT162b2, while the rest were discharged or transferred to the ICU.
CONCLUSION
Available literature includes more studies with the BNT162b2 vaccine than mRNA-1273. Future studies must report mortality and adverse cardiovascular events by vaccine types.
Topics: Humans; 2019-nCoV Vaccine mRNA-1273; BNT162 Vaccine; COVID-19; COVID-19 Vaccines; Myocardial Infarction; Myocarditis; Pulmonary Embolism; Stroke; Thrombocytopenia; Thrombosis
PubMed: 36988252
DOI: 10.1002/iid3.807 -
Acta Neurologica Scandinavica Jan 2022Cerebral venous thrombosis (CVT) is caused by partial or complete occlusion of the major cerebral venous sinuses or the smaller feeding cortical veins which predispose... (Meta-Analysis)
Meta-Analysis Review
Cerebral venous thrombosis (CVT) is caused by partial or complete occlusion of the major cerebral venous sinuses or the smaller feeding cortical veins which predispose to the risk of venous infarction and hemorrhage. Current guidelines recommend treating CVT with either low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) followed by an oral vitamin K antagonist (VKA) for 3-12 months. Direct oral anticoagulants (DOACs) have already established benefit over warfarin as a long-term treatment of symptomatic venous thromboembolic disorder like deep vein thrombosis (DVT), and pulmonary embolism (PE) given its equal efficacy and better safety profile. The benefit of DOACs over warfarin as a long-term anticoagulation for CVT has likewise been extensively studied, yet it has not been approved as first-line therapy in the current practice. We therefore performed a systematic review and meta-analysis of relevant studies to generate robust evidence regarding the safety and efficacy of DOACs in CVT. This meta-analysis demonstrates that the use of DOACs in CVT has similar efficacy and safety compared to VKAs with better recanalization rate.
Topics: Administration, Oral; Anticoagulants; Heparin; Heparin, Low-Molecular-Weight; Humans; Venous Thromboembolism; Venous Thrombosis
PubMed: 34287841
DOI: 10.1111/ane.13506 -
Radiology Feb 2021Background The association of pulmonary embolism (PE) with deep vein thrombosis (DVT) in patients with coronavirus disease 2019 (COVID-19) remains unclear, and the... (Meta-Analysis)
Meta-Analysis
Background The association of pulmonary embolism (PE) with deep vein thrombosis (DVT) in patients with coronavirus disease 2019 (COVID-19) remains unclear, and the diagnostic accuracy of D-dimer tests for PE is unknown. Purpose To conduct meta-analysis of the study-level incidence of PE and DVT and to evaluate the diagnostic accuracy of D-dimer tests for PE from multicenter individual patient data. Materials and Methods A systematic literature search identified studies evaluating the incidence of PE or DVT in patients with COVID-19 from January 1, 2020, to June 15, 2020. These outcomes were pooled using a random-effects model and were further evaluated using metaregression analysis. The diagnostic accuracy of D-dimer tests for PE was estimated on the basis of individual patient data using the summary receiver operating characteristic curve. Results Twenty-seven studies with 3342 patients with COVID-19 were included in the analysis. The pooled incidence rates of PE and DVT were 16.5% (95% CI: 11.6, 22.9; = 0.93) and 14.8% (95% CI: 8.5, 24.5; = 0.94), respectively. PE was more frequently found in patients who were admitted to the intensive care unit (ICU) (24.7% [95% CI: 18.6, 32.1] vs 10.5% [95% CI: 5.1, 20.2] in those not admitted to the ICU) and in studies with universal screening using CT pulmonary angiography. DVT was present in 42.4% of patients with PE. D-dimer tests had an area under the receiver operating characteristic curve of 0.737 for PE, and D-dimer levels of 500 and 1000 μg/L showed high sensitivity (96% and 91%, respectively) but low specificity (10% and 24%, respectively). Conclusion Pulmonary embolism (PE) and deep vein thrombosis (DVT) occurred in 16.5% and 14.8% of patients with coronavirus disease 2019 (COVID-19), respectively, and more than half of patients with PE lacked DVT. The cutoffs of D-dimer levels used to exclude PE in preexisting guidelines seem applicable to patients with COVID-19. © RSNA, 2020 See also the editorial by Woodard in this issue.
Topics: Humans; Computed Tomography Angiography; COVID-19; Fibrin Fibrinogen Degradation Products; Pulmonary Embolism; SARS-CoV-2; Venous Thrombosis; Multicenter Studies as Topic
PubMed: 33320063
DOI: 10.1148/radiol.2020203557 -
Physical Therapy Aug 2022No matter the practice setting, physical therapists work with patients who are at risk for or who have a history of venous thromboembolism (VTE). In 2016, the first...
No matter the practice setting, physical therapists work with patients who are at risk for or who have a history of venous thromboembolism (VTE). In 2016, the first clinical practice guideline (CPG) addressing the physical therapist management of VTE was published with support by the American Physical Therapy Association's Academy of Cardiovascular and Pulmonary Physical Therapy and Academy of Acute Care, with a primary focus on lower extremity deep vein thrombosis (DVT). This CPG is an update of the 2016 CPG and contains the most current evidence available for the management of patients with lower extremity DVT and new key action statements (KAS), including guidance on upper extremity DVT, pulmonary embolism, and special populations. This document will guide physical therapist practice in the prevention of and screening for VTE and in the management of patients who are at risk for or who have been diagnosed with VTE. Through a systematic review of published studies and a structured appraisal process, KAS were written to guide the physical therapist. The evidence supporting each action was rated, and the strength of statement was determined. Clinical practice algorithms based on the KAS were developed that can assist with clinical decision-making. Physical therapists, along with other members of the health care team, should implement these KAS to decrease the incidence of VTE, improve the diagnosis and acute management of VTE, and reduce the long-term complications of VTE.
Topics: Evidence-Based Practice; Humans; Physical Therapists; Pulmonary Embolism; Risk Factors; Upper Extremity Deep Vein Thrombosis; Venous Thromboembolism
PubMed: 35567347
DOI: 10.1093/ptj/pzac057 -
Journal of Clinical Medicine Jan 2023Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with high morbidity and mortality. AF treatment is guided by a patient-provider risk-benefit... (Review)
Review
BACKGROUND
Atrial fibrillation (AF) is the most common cardiac arrhythmia associated with high morbidity and mortality. AF treatment is guided by a patient-provider risk-benefit discussion regarding drug versus ablation or combination. Thermal ablation has a high rate of adverse events compared to pulsed field ablation (PFA). In this systematic review, we aimed to determine the safety and efficacy of PFA.
METHODS
The electronic search for relevant articles in English was completed in PubMed, PubMed Central, Cochrane library, Scopus, and Embase databases till July 2022. The screening was completed via the use of Covidence software. The risk of bias assessment and data extraction from the included studies was performed, and the narrative synthesis was performed accordingly.
RESULTS
A total of six studies were selected for review and 1897 patients receiving PFA were involved in these studies. Our review was focused on pulmonary vein isolation success, major adverse events, and arrhythmia recurrence. Successful pulmonary vein isolation (PVI) was completed in 100% of cases except in two studies. In one of them, six out of seven patients (86%) in the epicardial cohort had successful PVI. In the MANIFEST-PF survey, the acute PVI success rate was 99.9%. The major complications were rare and included pericardial tamponade, vascular complications requiring surgery, and stroke. The atrial arrhythmia recurrence was higher in the thermal group than in the PFA group (39% vs. 11%).
CONCLUSIONS
The success rate of PVI by PFA is high, and major adverse events are low. PFA is found to decrease the recurrence of atrial arrhythmia compared to thermal ablation. Substantial randomized controlled trials (RCTs) are needed to validate the efficacy and safety of PFA over conventional methods.
PubMed: 36675649
DOI: 10.3390/jcm12020719 -
JAMA Internal Medicine Mar 2020Patients undergoing total hip replacement (THR) and total knee replacement (TKR) receive venous thromboembolism (VTE) pharmacoprophylaxis. It is unclear which... (Meta-Analysis)
Meta-Analysis
Clinical Effectiveness and Safety of Aspirin for Venous Thromboembolism Prophylaxis After Total Hip and Knee Replacement: A Systematic Review and Meta-analysis of Randomized Clinical Trials.
IMPORTANCE
Patients undergoing total hip replacement (THR) and total knee replacement (TKR) receive venous thromboembolism (VTE) pharmacoprophylaxis. It is unclear which anticoagulant is preferable. Observational data suggest aspirin provides effective VTE prophylaxis.
OBJECTIVE
To assess the effectiveness and safety of aspirin for VTE prophylaxis after THR and TKR.
DATA SOURCES
A systematic review and meta-analysis was performed of randomized clinical trials (RCTs), with no language restrictions, from inception to September 19, 2019, using MEDLINE, Embase, Web of Science, Cochrane Library, and bibliographic searches. The computer-based searches combined terms and combinations of keywords related to the population (eg, hip replacement, knee replacement, hip arthroplasty, and knee arthroplasty), drug intervention (eg, aspirin, heparin, clexane, dabigatran, rivaroxaban, and warfarin), and outcome (eg, venous thromboembolism, deep vein thrombosis, pulmonary embolism, and bleeding) in humans.
STUDY SELECTION
This study included RCTs assessing the effectiveness and safety of aspirin for VTE prophylaxis compared with other anticoagulants in adults undergoing THR and TKR. The RCTs with a placebo control group were excluded. The searches and study selection were independently performed.
DATA EXTRACTION AND SYNTHESIS
This study followed PRISMA recommendations and used the Cochrane Collaboration's risk of bias tool. Data were screened and extracted independently by both reviewers. Study-specific relative risks (RRs) were aggregated using random-effects models. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach.
MAIN OUTCOMES AND MEASURES
The primary outcome was any postoperative VTE (asymptomatic or symptomatic). Secondary outcomes were adverse events associated with therapy, including bleeding.
RESULTS
Of 437 identified articles, 13 RCTs were included (6060 participants; 3466 [57.2%] women; mean age, 63.0 years). The RR of VTE after THR and TKR was 1.12 (95% CI, 0.78-1.62) for aspirin compared with other anticoagulants. Comparable findings were observed for deep vein thrombosis (DVT) (RR, 1.04; 95% CI, 0.72-1.51) and pulmonary embolism (PE) (RR, 1.01; 95% CI, 0.68-1.48). The risk of adverse events, including major bleeding, wound hematoma, and wound infection, was not statistically significantly different in patients receiving aspirin vs other anticoagulants. When analyzing THRs and TKRs separately, there was no statistically significant difference in the risk of VTE, DVT, and PE between aspirin and other anticoagulants. Aspirin had a VTE risk not statistically significantly different from low-molecular-weight heparin (RR, 0.76; 95% CI, 0.37-1.56) or rivaroxaban (RR, 1.52; 95% CI, 0.56-4.12). The quality of the evidence ranged from low to high.
CONCLUSIONS AND RELEVANCE
In terms of clinical effectiveness and safety profile, aspirin did not differ statistically significantly from other anticoagulants used for VTE prophylaxis after THR and TKR. Future trials should focus on noninferiority analysis of aspirin compared with alternative anticoagulants and cost-effectiveness.
Topics: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Aspirin; Fibrinolytic Agents; Humans; Postoperative Complications; Treatment Outcome; Venous Thromboembolism
PubMed: 32011647
DOI: 10.1001/jamainternmed.2019.6108 -
The Cochrane Database of Systematic... Oct 2021Stroke is the third leading cause of early death worldwide. Most ischaemic strokes are caused by a blood clot blocking an artery in the brain. Patient outcomes might be... (Review)
Review
BACKGROUND
Stroke is the third leading cause of early death worldwide. Most ischaemic strokes are caused by a blood clot blocking an artery in the brain. Patient outcomes might be improved if they are offered anticoagulants that reduce their risk of developing new blood clots and do not increase the risk of bleeding. This is an update of a Cochrane Review first published in 1995, with updates in 2004, 2008, and 2015.
OBJECTIVES
To assess the effectiveness and safety of early anticoagulation (within the first 14 days of onset) for people with acute presumed or confirmed ischaemic stroke. Our hypotheses were that, compared with a policy of avoiding their use, early anticoagulation would be associated with: • reduced risk of death or dependence in activities of daily living a few months after stroke onset; • reduced risk of early recurrent ischaemic stroke; • increased risk of symptomatic intracranial and extracranial haemorrhage; and • reduced risk of deep vein thrombosis and pulmonary embolism.
SEARCH METHODS
We searched the Cochrane Stroke Group Trials Register (August 2021); the Cochrane Database of Systematic Reviews (CDSR); the Cochrane Central Register of Controlled Trials (CENTRAL; 2021, Issue 7), in the Cochrane Library (searched 5 August 2021); MEDLINE (2014 to 5 August 2021); and Embase (2014 to 5 August 2021). In addition, we searched ongoing trials registries and reference lists of relevant papers. For previous versions of this review, we searched the register of the Antithrombotic Trialists' (ATT) Collaboration, consulted MedStrategy (1995), and contacted relevant drug companies.
SELECTION CRITERIA
Randomised trials comparing early anticoagulant therapy (started within two weeks of stroke onset) with control in people with acute presumed or confirmed ischaemic stroke.
DATA COLLECTION AND ANALYSIS
Two review authors independently selected trials for inclusion, assessed trial quality, and extracted data. We assessed the overall certainty of the evidence for each outcome using RoB1 and GRADE methods.
MAIN RESULTS
We included 28 trials involving 24,025 participants. Quality of the trials varied considerably. We considered some studies to be at unclear or high risk of selection, performance, detection, attrition, or reporting bias. Anticoagulants tested were standard unfractionated heparin, low-molecular-weight heparins, heparinoids, oral anticoagulants, and thrombin inhibitors. Over 90% of the evidence is related to effects of anticoagulant therapy initiated within the first 48 hours of onset. No evidence suggests that early anticoagulation reduced the odds of death or dependence at the end of follow-up (odds ratio (OR) 0.98, 95% confidence interval (CI) 0.92 to 1.03; 12 RCTs, 22,428 participants; high-certainty evidence). Similarly, we found no evidence suggesting that anticoagulant therapy started within the first 14 days of stroke onset reduced the odds of death from all causes (OR 0.99, 95% CI 0.90 to 1.09; 22 RCTs, 22,602 participants; low-certainty evidence) during the treatment period. Although early anticoagulant therapy was associated with fewer recurrent ischaemic strokes (OR 0.75, 95% CI 0.65 to 0.88; 12 RCTs, 21,665 participants; moderate-certainty evidence), it was also associated with an increase in symptomatic intracranial haemorrhage (OR 2.47; 95% CI 1.90 to 3.21; 20 RCTs, 23,221 participants; moderate-certainty evidence). Similarly, early anticoagulation reduced the frequency of symptomatic pulmonary emboli (OR 0.60, 95% CI 0.44 to 0.81; 14 RCTs, 22,544 participants; high-certainty evidence), but this benefit was offset by an increase in extracranial haemorrhage (OR 2.99, 95% CI 2.24 to 3.99; 18 RCTs, 22,255 participants; moderate-certainty evidence).
AUTHORS' CONCLUSIONS
Since the last version of this review, four new relevant studies have been published, and conclusions remain consistent. People who have early anticoagulant therapy after acute ischaemic stroke do not demonstrate any net short- or long-term benefit. Treatment with anticoagulants reduced recurrent stroke, deep vein thrombosis, and pulmonary embolism but increased bleeding risk. Data do not support the routine use of any of the currently available anticoagulants for acute ischaemic stroke.
Topics: Activities of Daily Living; Anticoagulants; Brain Ischemia; Heparin; Humans; Ischemic Stroke; Stroke; Systematic Reviews as Topic
PubMed: 34676532
DOI: 10.1002/14651858.CD000024.pub5 -
Journal of Vascular Surgery. Venous and... Nov 2022Hospital-acquired venous thromboembolism (VTE, including pulmonary embolism [PE] and deep vein thrombosis [DVT]) is a preventable cause of hospital death. The Caprini... (Review)
Review
OBJECTIVE
Hospital-acquired venous thromboembolism (VTE, including pulmonary embolism [PE] and deep vein thrombosis [DVT]) is a preventable cause of hospital death. The Caprini risk assessment model (RAM) is one of the most commonly used tools to assess VTE risk. The RAM is operationalized in clinical practice by grouping several risk scores into VTE risk categories that drive decisions on prophylaxis. A correlation between increasing Caprini scores and rising VTE risk is well-established. We assessed whether the increasing VTE risk categories assigned on the basis of recommended score ranges also correlate with increasing VTE risk.
METHODS
We conducted a systematic review of articles that used the Caprini RAM to assign VTE risk categories and that reported corresponding VTE rates. A Medline and EMBASE search retrieved 895 articles, of which 57 fulfilled inclusion criteria.
RESULTS
Forty-eight (84%) of the articles were cohort studies, 7 (12%) were case-control studies, and 2 (4%) were cross-sectional studies. The populations varied from postsurgical to medical patients. There was variability in the number of VTE risk categories assigned by individual studies (6 used 5 risk categories, 37 used 4, 11 used 3, and 3 used 2), and in the cutoff scores defining the risk categories (scores from 0 alone to 0-10 for the low-risk category; from ≥5 to ≥10 for high risk). The VTE rates reported for similar risk categories also varied across studies (0%-12.3% in the low-risk category; 0%-40% for high risk). The Caprini RAM is designed to assess composite VTE risk; however, two studies reported PE or DVT rates alone, and many of the other studies did not specify the types of DVTs analyzed. The Caprini RAM predicts VTE at 30 days after assessment; however, only 17 studies measured outcomes at 30 days; the remaining studies had either shorter or longer follow-ups (0-180 days).
CONCLUSIONS
The usefulness of the Caprini RAM is limited by heterogeneity in its implementation across centers. The score-derived VTE risk categorization has significant variability in the number of risk categories being used, the cutpoints used to define the risk categories, the outcome being measured, and the follow-up duration. This factor leads to similar risk categories being associated with different VTE rates, which impacts the clinical and research implications of the results. To enhance generalizability, there is a need for studies that validate the RAM in a broad population of medical and surgical patients, identify standardized risk categories, define risk of DVT and PE as distinct end points, and measure outcomes at standardized follow-up time points.
Topics: Humans; Pulmonary Embolism; Retrospective Studies; Risk Assessment; Risk Factors; Venous Thromboembolism; Venous Thrombosis
PubMed: 35926802
DOI: 10.1016/j.jvsv.2022.05.003 -
Journal of the American College of... May 2023Catheter ablation of atrial fibrillation (AF) is a commonly performed procedure. However, it is associated with potentially significant complications. Reported...
BACKGROUND
Catheter ablation of atrial fibrillation (AF) is a commonly performed procedure. However, it is associated with potentially significant complications. Reported procedure-related complication rates are highly variable, depending in part on study design.
OBJECTIVES
The purpose of this systematic review and pooled analysis was to determine the rate of procedure-related complications associated with catheter ablation of AF using data from randomized control trials and to assess temporal trends.
METHODS
MEDLINE and EMBASE databases were searched from January 2013 to September 2022 for randomized control trials that included patients undergoing a first ablation procedure of AF using either radiofrequency or cryoballoon (PROSPERO, CRD42022370273).
RESULTS
A total of 1,468 references were retrieved, of which 89 studies met inclusion criteria. A total of 15,701 patients were included in the current analysis. Overall and severe procedure-related complication rates were 4.51% (95% CI: 3.76%-5.32%) and 2.44% (95% CI: 1.98%-2.93%), respectively. Vascular complications were the most frequent type of complication (1.31%). The next most common complications were pericardial effusion/tamponade (0.78%) and stroke/transient ischemic attack (0.17%). The procedure-related complication rate during the most recent 5-year period of publication was significantly lower than during the earlier 5-year period (3.77% vs 5.31%; P = 0.043). The pooled mortality rate was stable over the 2 time periods (0.06% vs 0.05%; P = 0.892). There was no significant difference in complication rate according to pattern of AF, ablation modality, or ablation strategies beyond pulmonary vein isolation.
CONCLUSIONS
Procedure-related complications and mortality rates associated with catheter ablation of AF are low and have declined in the past decade.
Topics: Humans; Atrial Fibrillation; Cardiac Tamponade; Catheter Ablation; Databases, Factual; Ischemic Attack, Transient
PubMed: 37225362
DOI: 10.1016/j.jacc.2023.03.418