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Optimizing Safety and Success: The Advantages of Bloodless Cardiac Surgery. A Systematic Review and Meta-Analysis of Outcomes in Jehovah's Witnesses
Gemelli, M., Italiano, E. G., Geatti, V., Addonizio, M., Cao, I., Dimagli, A., Dokollari, A., Tarzia, V., Gallo, M., Ferrari, E., et al
Current problems in cardiology. 2023;:102078
Abstract
OBJECTIVE Transfusions are extremely frequent after cardiac surgery, and they have a considerable economic burden and impact on outcomes. Optimal patient blood management (PBM) could play a fundamental role in reducing the rate of transfusion and Jehovah's Witnesses (JW) represent the ideal surrogate study population. This meta-analysis compares outcomes of JWs and non-JWs' patients undergoing cardiac surgery, assessing the safety of a bloodless cardiac surgery. METHODS A scoping review was conducted using a search strategy for studies assessing outcomes of JW undergoing cardiac surgery. The primary outcome was perioperative mortality, and a random-effects meta-analysis was performed. RESULTS Ten studies were included in our meta-analysis, involving 780 JW patients refusing any type of transfusion ("JW") and 1182 patients accepting transfusion if needed ("non-JW"). 86% of non-JW patients received at least 1 transfusion. There was no significant difference in terms of perioperative mortality (OR 0.91; 95% CI 0.55 - 1.52; p = 0.72). The volume blood loss was significantly less in the JW (p = 0.001), while the rate of reoperation for bleeding was also lower, but not statistically significative, in the JW (p = 0.16). Both pre-operative and post-operative hemoglobin and hematocrit were significantly higher in the JW. CONCLUSIONS Bloodless cardiac surgery is safe and early outcomes are similar between JW and non-JW patients: optimal patient blood management is fundamental in guarantying these results. Further studies are needed to assess if a limitation of transfusion could have a positive long-term impact on outcomes.
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Cardiac surgery in Jehovah's Witnesses patients and association with peri-operative outcomes: a systematic review and meta-analysis
Vitolo M, Mei DA, Cimato P, Bonini N, Imberti JF, Cataldo P, Menozzi M, Filippini T, Vinceti M, Boriani G
Current problems in cardiology. 2023;:101789
Abstract
BACKGROUND Strategies for blood conservation, coupled with a careful preoperative assessment, may be applied to Jehovah's Witnesses (JW) patients who are candidates for cardiac surgery interventions. There is a need to assess clinical outcomes and safety of bloodless surgery in JW patients undergoing cardiac surgery. METHODS We performed a systematic review and meta-analysis of studies comparing JW patients with controls undergoing cardiac surgery. The primary endpoint was short-term mortality (in-hospital or 30-day mortality). Peri-procedural myocardial infarction, re-exploration for bleeding, pre-and post-operative Hb levels and cardiopulmonary bypass (CPB) time were also analyzed. RESULTS A total of 10 studies including 2,302 patients were included. The pooled analysis showed no substantial differences in terms of short-term mortality among the two groups (OR 1.13, 95% CI 0.74-1.73, I(2)=0%). There were no differences in peri-operative outcomes among JW patients and controls (OR 0.97, 95% CI 0.39-2.41, I(2)=18% for myocardial infarction; OR 0.80, 95% CI 0.51-1.25, I(2)=0% for re-exploration for bleeding). JW patients had a higher level of pre-operative Hb (Standardized Mean Difference [SMD] 0.32, 95% CI 0.06-0.57) and a trend toward a higher level of post-operative Hb (SMD 0.44, 95% CI -0.01-0.90). A slightly lower CPB time emerged in JWs compared with controls (SMD -0.11, 95% CI -0.30-0.07). CONCLUSIONS JW patients undergoing cardiac surgery, with avoidance of blood transfusions, did not have substantially different peri-operative outcomes compared with controls, with specific reference to mortality, myocardial infarction, and re-exploration for bleeding. Our results support the safety and feasibility of bloodless cardiac surgery, applying patient blood management strategies.
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Impact on Mortality and Major Bleeding of Radial Versus Femoral Artery Access for Coronary Angiography or Percutaneous Coronary Intervention: a Meta-analysis of Individual Patient Data from Seven Multicenter Randomized Clinical Trials
Gargiulo G, Giacoppo D, Jolly SS, Cairns J, Le May M, Bernat I, Romagnoli E, Rao SV, van Leeuwen MAH, Mehta SR, et al
Circulation. 2022
Abstract
BACKGROUND In some randomized controlled trials (RCTs), transradial (TRA) compared with transfemoral access (TFA) was associated with lower mortality in coronary artery disease patients undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter RCTs and whether these associations are modified by patient or operator characteristics. METHODS We performed an individual patient data meta-analysis of multicenter RCTs comparing TRA versus TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention (PCI) (PROSPERO; CRD42018109664). The primary outcome was all-cause mortality and the co-primary outcome was major bleeding at 30 days. The primary analysis was conducted by one-stage mixed-effects models based on the intention-to-treat cohort. The impact of access-site on mortality and major bleeding was further assessed by multivariable analysis. The relationship among access-site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment. RESULTS A total of 21,600 patients (TRA=10,775 vs. TFA=10,825) from 7 RCTs were included. Median age was 63.9 years, 31.9% were female, 95% presented with acute coronary syndrome (ACS), and 75.2% underwent PCI. All-cause mortality (1.6% vs. 2.1%; HR 0.77, 95% CI 0.63-0.95, p=0.012) and major bleeding (1.5% vs. 2.7%; OR 0.55, 95% CI 0.45- 0.67, p<0.001) were lower with TRA. Subgroup analyses for mortality showed consistent results, except for baseline hemoglobin ((pinteraction)=0.033), indicating that the benefit of TRA was substantial in patients with significant anemia, while it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention, and ancillary mechanisms are required to fully explain the causal association. CONCLUSIONS TRA is associated with lower all-cause mortality and major bleeding at 30 days, compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit.
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The Use of Thromboelastography in Percutaneous Coronary Intervention and Acute Coronary Syndrome in East Asia: A Systematic Literature Review
Xu O, Hartmann J, Tang YD, Dias J
Journal of clinical medicine. 2022;11(13)
Abstract
Dual antiplatelet therapy (DAPT), alongside percutaneous coronary intervention (PCI), is central to the prevention of ischemic events following acute coronary syndrome (ACS). However, response to therapy can vary due to several factors including CYP2C19 gene variation, which shows increased prevalence in East Asian populations. DAPT responsiveness can be assessed using techniques such as light transmission aggregometry (LTA), VerifyNow(®) and thromboelastography with the PlateletMapping(®) assay, and there is increasing focus on the utility of platelet function testing to guide individualized treatment. This systematic literature review of one English and three Chinese language databases was conducted to evaluate the evidence for the utility of thromboelastography in ACS/PCI in East Asia. The search identified 42 articles from the English language and 71 articles from the Chinese language databases which fulfilled the pre-determined inclusion criteria, including 38 randomized controlled trials (RCTs). The identified studies explored the use of thromboelastography compared to LTA and VerifyNow in monitoring patient responsiveness to DAPT, as well as predicting ischemic risk, with some studies suggesting that thromboelastography is better able to detect low DAPT response than LTA. Other studies, including one large RCT, described the use of thromboelastography in guiding the escalation of DAPT, with some evidence suggesting that such protocols reduce ischemic events without increasing the risk of bleeding. There was also evidence suggesting that thromboelastography can be used to identify individuals with DAPT hyporesponsiveness genotypes and could potentially guide treatment by adjusting therapy in patients depending on responsiveness.
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Systematic Review and Meta-Analysis of Diagnostic Test Accuracy Studies Evaluating Point-of-Care Tests of Coagulopathy in Cardiac Surgery
Woźniak, M. J., Abbasciano, R., Monaghan, A., Lai, F. Y., Corazzari, C., Tutino, C., Kumar, T., Whiting, P., Murphy, G. J.
Transfusion Medicine Reviews. 2021;35(1):7-15
Abstract
Treatment guidelines recommend the routine use of point-of-care diagnostic tests for coagulopathy in the management of cardiac surgery patients at risk of severe bleeding despite uncertainty as to their diagnostic accuracy. We performed a systematic review and meta-analysis of studies that evaluated the diagnostic accuracy of viscoelastometry, platelet function tests, and modified thromboelastography (TEG) tests, for coagulopathy in cardiac surgery patients. The reference standard included resternotomy for bleeding, transfusion of non-red cell components, or massive transfusion. We searched MEDLINE, EMBASE, CINAHL, and Clinical Trials.gov, from inception to June 2019. Study quality was assessed using QUADAS-2. Bivariate models were used to estimate summary sensitivity and specificity with (95% confidence intervals). All 29 studies (7440 participants) included in the data synthesis evaluated the tests as predictors of bleeding. No study evaluated their role in the management of bleeding. None was at low risk of bias. Four were judged as low concern regarding applicability. Pooled estimates of diagnostic accuracy were; Viscoelastic tests, 12 studies, sensitivity 0.61 (0.44, 0.76), specificity 0.83 (0.70, 0.91) with significant heterogeneity. Platelet function tests, 12 studies, sensitivity 0.63 (0.53, 0.72), specificity 0.75 (0.64, 0.84) with significant heterogeneity. TEG modification tests, 3 studies, sensitivity 0.80 (0.67, 0.89), specificity 0.76 (0.69, 0.82) with no evidence of heterogeneity. Studies reporting the highest values for sensitivity and specificity had important methodological limitations. In conclusion, we did not demonstrate predictive accuracy for commonly used point-of-care devices for coagulopathic bleeding in cardiac surgery. However, the certainty of the evidence was low.
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The effect of non-point-of-care haemostasis management protocol implementation in cardiac surgery: A systematic review
Boxma RPJ, Garnier RP, Bulte CSE, Meesters MI
Transfusion medicine (Oxford, England). 2021
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Abstract
OBJECTIVES This systematic review aims to outline the evidence on the implementation of a non-point-of-care (non-point-of-care [POC]) haemostasis management protocol compared to experience-based practice in adult cardiac surgery. BACKGROUND Management of coagulopathy in cardiac surgery is complex and remains highly variable among centres and physicians. Although various guidelines recommend the implementation of a transfusion protocol, the literature on this topic has never been systematically reviewed. METHODS PubMed, Embase, Cochrane Library, and Web of Science were searched from January 2000 till May 2020. RESULTS A total of seven studies (one randomised controlled trial [RCT], one prospective cohort study, and five retrospective studies) met the inclusion criteria. Among the six non-randomised, controlled studies, the risk of bias was determined to be serious to critical, and the one RCT was determined to have a high risk of bias. Five studies showed a significant reduction in red blood cells, fresh frozen plasma, and/or platelet transfusion after the implementation of a structural non-POC algorithm, ranging from 2% to 28%, 2% to 19.5%, and 7% to17%, respectively. One study found that fewer patients required transfusion of any blood component in the protocol group. Another study had reported a significantly increased transfusion rate of platelet concentrate in the haemostasis algorithm group. CONCLUSION Owing to the high heterogeneity and a substantial risk of bias of the included studies, no conclusion can be drawn on the additive value of the implementation of a cardiac-surgery-specific non-POC transfusion and haemostasis management algorithm compared to experience-based practice. To define the exact impact of a transfusion protocol on blood product transfusion, bleeding, and adverse events, well-designed prospective clinical trials are required.
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A Systematic Review of Thromboelastography Utilization in Vascular and Endovascular Surgery
Kim Y, Patel SS, McElroy IE, DeCarlo C, Bellomo TR, Majumdar M, Lella SK, Mohebali J, Dua A
Journal of vascular surgery. 2021
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Editor's Choice
Abstract
OBJECTIVE Thromboelastography (TEG) is diagnostic modality that analyzes real-time blood coagulation parameters. Clinically, TEG primarily allows for directed blood component resuscitation among patients with acute blood loss and coagulopathy. The utilization of TEG has been widely adopted in among other surgical specialties; however, its use in vascular surgery is less prominent. We aimed to provide an up-to-date review of TEG utilization in vascular and endovascular surgery. METHODS Using PRISMA guidelines, a literature review with the Medical Subject Headings (MeSH) terms "TEG and arterial events", "TEG and vascular surgery", "TEG and vascular", "TEG and endovascular surgery", "TEG and endovascular", "TEG and peripheral artery disease", "TEG and prediction of arterial events", "TEG and prediction of complications ", "TEG and prediction of thrombosis", "TEG and prediction of amputation", and "TEG and amputation" was performed in Cochrane and PubMed databases to identify all peer-reviewed studies of TEG utilization in vascular surgery, written between 2000-2021 in the English language. The free text and MeSH subheadings search terms included diagnosis, complications, physiopathology, surgery, mortality, and therapy to further restrict the articles. Studies were excluded if they were not in humans or pertaining to vascular or endovascular surgery. Additionally, case reports and studies with limited information regarding TEG utilization were excluded. Each study was independently reviewed by two researchers to assess for eligibility. RESULTS Of the 262 studies identified through the MeSH strategy, 15 studies met inclusion criteria and were reviewed and summarized. Literature on TEG utilization in vascular surgery spanned cerebrovascular disease (n=3), peripheral arterial disease (n=3), arteriovenous malformations (n=1), venous thromboembolic events (n=7), and perioperative bleeding and transfusion (n=1). In cerebrovascular disease, TEG may predict the presence and stability of carotid plaques, analyze platelet function before carotid stenting, and compare efficacy of antiplatelet therapy after stent deployment. In peripheral arterial disease, TEG has been used to predict disease severity and analyze the impact of contrast on coagulation parameters. In venous disease, TEG may predict hypercoagulability and thromboembolic events among various patient populations. Finally, TEG can be utilized in the postoperative setting to predict hemorrhage and transfusion requirements. CONCLUSIONS This systematic review provides an up-to-date summarization of TEG utilization in multiple facets of vascular and endovascular surgery.
PICO Summary
Population
Patients undergoing vascular and endovascular surgery (15 studies).
Intervention
Systematic review to provide an up-to-date summarization of thromboelastography (TEG).
Comparison
Outcome
Literature on TEG utilization in vascular surgery spanned cerebrovascular disease (n=3), peripheral arterial disease (n=3), arteriovenous malformations (n=1), venous thromboembolic events (n=7), and perioperative bleeding and transfusion (n=1). In cerebrovascular disease, TEG may predict the presence and stability of carotid plaques, analyse platelet function before carotid stenting, and compare efficacy of antiplatelet therapy after stent deployment. In peripheral arterial disease, TEG has been used to predict disease severity and analyse the impact of contrast on coagulation parameters. In venous disease, TEG may predict hypercoagulability and thromboembolic events among various patient populations.
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Diagnostic accuracy of viscoelastic point-of-care identification of hypofibrinogenaemia in cardiac surgical patients: A systematic review
Gibbs NM, Weightman WM
Anaesthesia and intensive care. 2020;:310057x20948868
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Editor's Choice
Abstract
Hypofibrinogenaemia during cardiac surgery may increase blood loss and bleeding complications. Viscoelastic point-of-care tests provide more rapid diagnosis than laboratory measurement, allowing earlier treatment. However, their diagnostic test accuracy for hypofibrinogenaemia has never been reviewed systematically. We aimed to systematically review their diagnostic test accuracy for the identification of hypofibrinogenaemia during cardiac surgery. Two reviewers assessed relevant articles from seven electronic databases, extracted data from eligible articles and assessed quality. The primary outcomes were sensitivity, specificity and positive and negative predictive values. A total of 576 articles were screened and 81 full texts were assessed, most of which were clinical agreement or outcome studies. Only 10 diagnostic test accuracy studies were identified and only nine were eligible (ROTEMdelta 7; TEG5000 1; TEG6S 1, n = 1820 patients) (ROTEM, TEM International GmbH, Munich, Germany; TEG, Haemonetics, Braintree, MA, USA). None had a low risk of bias. Four ROTEM studies with a fibrinogen threshold less than 1.5-1.6 g/l and FIBTEM threshold A10 less than 7.5-8 mm had point estimates for sensitivity of 0.61-0.88; specificity 0.54-0.94; positive predictive value 0.42-0.70; and negative predictive value 0.74-0.98 (i.e. false positive rate 30%-58%; false negative rate 2%-26%). Two ROTEM studies with higher thresholds for both fibrinogen (<2 g/l) and FIBTEM A10 (<9.5 mm) had similar false positive rates (25%-46%), as did the two TEG studies (15%-48%). This review demonstrates that there have been few diagnostic test accuracy studies of viscoelastic point-of-care identification of hypofibrinogenaemia in cardiac surgical patients. The studies performed so far report false positive rates of up to 58%, but low false negative rates. Further diagnostic test accuracy studies of viscoelastic point-of-care identification of hypofibrinogenaemia are required to guide their better use during cardiac surgery.
PICO Summary
Population
Cardiac surgery patients (9 studies, n= 1820).
Intervention
Viscoelastic point of care (POC) tests for the diagnostic test accuracy (DTA) for the identification of hypofibrinogenaemia ROTEM (n= 1692); TEG (n= 128).
Comparison
Laboratory standard.
Outcome
There were no high quality studies of the DTA of viscoelastic POC tests for the identification of hypofibrinogenaemia in cardiac surgical patients. All the 9 DTA studies included had a risk of bias in relation to patient selection, flow and timing of the tests, or blinding of test results. Viscoelastic POC identification of hypofibrinogenaemia, when compared to laboratory fibrinogen measurement was associated with high false positive rates. The studies performed so far report false positive rates of up to 58%, but low false negative rates.
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Viscoelastic Blood Tests Use in Adult Cardiac Surgery: Meta-Analysis, Meta-Regression, and Trial Sequential Analysis
Meco, M., Montisci, A., Giustiniano, E., Greco, M., Pappalardo, F., Mammana, L., Panisi, P., Roscitano, C., Cirri, S., Donatelli, F., et al
Journal of Cardiothoracic and Vascular Anesthesia. 2020;34(1):119-127
Abstract
OBJECTIVES Postoperative hemorrhage in cardiac surgery is a significant cause of morbidity and mortality. Standard laboratory tests fail as predictors for bleeding in the surgical setting. The use of viscoelastic (VE) hemostatic assays thromboelastography (TEG) and rotational thromboelastometry (ROTEM) could be an advantage in patients undergoing cardiac surgery. The objective of this meta-analysis was to analyze the effects (benefits and harms) of VE-guided transfusion practice in cardiac surgery patients. DESIGN A meta-analysis of randomized trials. SETTING For this study, PubMed, EMBASE, Scopus, and the Cochrane Collaboration database were searched, and only randomized controlled trials were included. A systematic review and meta-analysis were performed in accordance with the standards set forth by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement, using a random-effects model. PARTICIPANTS The study comprised adult cardiac surgery patients. INTERVENTIONS VE-hemostatic assays transfusion algorithm compared with transfusion algorithms based on clinicians' discretion. MEASUREMENTS AND MAIN RESULTS Seven comparative randomized controlled trials were considered, including a total of 1,035 patients (522 patients in whom a TEG- or ROTEM-based transfusion algorithm was used). In patients treated according to VE-guided algorithms, red blood cell (odds ratio 0.61; 95% confidence interval [CI]: 0.37-0.99; p: 0.04; I(2): 66%) and fresh frozen plasma transfusions (risk difference 0.22; 95% CI: 0.11-0.33; p < 0.0001; I(2): 79%) use was reduced; platelets transfusion was not reduced (odds ratio 0.61; 95% CI: 0.32-1.15; p: 0.12; I(2) 74%). CONCLUSIONS This study demonstrated that the use of VE assays in cardiac surgical patients is effective in reducing allogenic blood products exposure, postoperative bleeding at 12 and 24 hours after surgery, and the need for redo surgery unrelated to surgical bleeding.
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Use of Coagulation Point-of-Care Tests in the Management of Anticoagulation and Bleeding in Pediatric Cardiac Surgery: A Systematic Review
Bianchi P, Beccaris C, Norbert M, Dunlop B, Ranucci M
Anesth Analg. 2019
Abstract
Bleeding and coagulation management are essential aspects in the management of neonates and children undergoing cardiac surgery. The use of point-of-care tests (POCTs) in a pediatric setting is not as widely used as in the adult setting. This systematic review aims to summarize the evidence showed by the literature regarding the use of POCTs in children undergoing cardiac surgery. We included all studies examining the pediatric population (<18 years old) undergoing cardiac surgery in which the coagulation profile was assessed with POCTs. Three electronic databases (PubMed, Embase, and the Cochrane Controlled Clinical Trials register) were searched. Tests involved were heparin effect tests, viscoelastic tests, and platelet function tests. Due to the wide heterogeneity of the patients and tests studied, a formal meta-analysis was impossible, and the results are therefore presented through a systematic review. Eighty articles were found, of which 47 are presented in this review. At present, literature data are too weak to define POCTs as a "gold standard" for the treatment of perioperative bleeding in pediatric cardiac surgery. Nevertheless, introduction of POCTs into postoperative algorithms has shown to improve bleeding management, patient outcome, and cost efficiency.