The use of FEIBA for refractory bleeding in cardiac surgery - a systematic review
Expert review of cardiovascular therapy. 2022
INTRODUCTION Significant blood loss during cardiac surgery is associated with a significant increase in morbidity and mortality. Factor Eight Inhibitor Bypassing Activity (FEIBA), a hemostatic bypassing agent mainly used in hemophiliac patients, has also been used for intractable surgical bleeding during cardiac surgical procedures in non-hemophiliac patients. However, concerns exist that its use may be linked to increased incidence of perioperative adverse effects including thrombotic complications. AREAS COVERED A systematic literature search was performed on MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials databases for all studies that reported the administration of FEIBA for treatment of bleeding during adult cardiac surgery in non-hemophiliac patients. After selecting of title and abstracts, two authors assessed the methodological quality of the full-text articles prior to final inclusion in the manuscript. EXPERT OPINION The safety profile of FEIBA was determined through an aggregate count of adverse events. Major complications included renal failure, re-operation for unresolved bleeding, postoperative mortality, and thromboembolic events. Overall, there is insufficient robust evidence to make a definitive conclusion about the safety or efficacy of using of FEIBA as a hemostatic agent in the setting of cardiac surgery.
Effects of perioperative erythropoietin administration on acute kidney injury and red blood cell transfusion in patients undergoing cardiac surgery: A systematic review and meta-analysis
BACKGROUND The renoprotective effects of erythropoietin (EPO) are well-known; however, the optimal timing of EPO administration remains controversial. Red blood cell (RBC) transfusion is an independent risk factor for cardiac surgery-associated acute kidney injury (CSA-AKI). We aimed to evaluate the efficacy of EPO on CSA-AKI and RBC transfusion according to the timing of administration. METHODS We searched the Cochrane Library, EMBASE, and MEDLINE databases for randomized controlled trials. The primary outcome was the incidence of CSA-AKI following perioperative EPO administration, and the secondary outcomes were changes in serum creatinine, S-cystatin C, S-neutrophil gelatinase-associated lipocalin, urinary neutrophil gelatinase-associated lipocalin, length of hospital and intensive care unit (ICU) stay, volume of RBC transfusion, and mortality. The subgroup analysis was stratified according to the timing of EPO administration in relation to surgery. RESULTS Eight randomized controlled trials with 610 patients were included in the study. EPO administration significantly decreased the incidence of CSA-AKI (odds ratio: 0.60, 95% confidence interval [CI]: 0.43-0.85, P = .004; I2 = 52%; P for heterogeneity = .04), intra-operative RBC transfusion (standardized mean difference: -0.30, 95% CI: -0.55 to -0.05, P = .02; I2 = 15%, P for heterogeneity = .31), and hospital length of stay (mean difference: -1.54 days, 95% CI: -2.70 to -0.39, P = .009; I2 = 75%, P for heterogeneity = .001) compared with control groups. Subgroup analyses revealed that pre-operative EPO treatment significantly reduced the incidence of CSA-AKI, intra-operative RBC transfusion, serum creatinine, and length of hospital and ICU stay. CONCLUSION Pre-operative administration of EPO may reduce the incidence of CSA-AKI and RBC transfusion, but not in patients administered EPO during the intra-operative or postoperative period. Therefore, pre-operative EPO treatment can be considered to improve postoperative outcomes by decreasing the length of hospital and ICU stay in patients undergoing cardiac surgery.
Patients undergoing cardiac surgery (8 studies, n= 610).
Perioperative erythropoietin (EPO).
EPO administration significantly decreased the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI), intra-operative red blood cell transfusion (standardized mean difference: -0.30), and hospital length of stay (mean difference: -1.54 days) compared with control groups. Subgroup analyses revealed that pre-operative EPO treatment significantly reduced the incidence of CSA-AKI, intra-operative red blood cell transfusion, serum creatinine, and length of hospital and intensive care unit stay.
Tranexamic acid reduces postoperative blood loss in Chinese pediatric patients undergoing cardiac surgery: A PRISMA-compliant systematic review and meta-analysis
BACKGROUND Tranexamic acid has been increasingly used for blood conservation in cardiac surgery. However, the evidence supporting the routine use of tranexamic acid in Chinese pediatric patients undergoing cardiac surgery remains weak. This meta-analysis aimed to systematically review the efficacy of tranexamic acid when applying to Chinese pediatric patients undergoing cardiac surgery. PARTICIPANTS Chinese pediatric patients undergoing cardiac surgery. INTERVENTIONS Tranexamic acid or control drugs (saline/blank). METHODS PUBMED, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Wanfang Data, and VIP Data till May 4, 2021, database search was updated on August 1. Primary outcomes of interest included postoperative bleeding, allogeneic transfusion, and reoperation for bleeding. Secondary outcomes of interest included postoperative recovery. For continuous/dichotomous variables, treatment effects were calculated as weighted mean difference (WMD)/odds ratio and 95% confidence interval. RESULTS A database search yielded 15 randomized controlled trials including 1641 patients, where 8 studies were allocated into non-cyanotic congenital group, 5 were allocated into cyanotic congenital group, and the other 2 were allocated into combined cyanotic/non-cyanotic group. This meta-analysis demonstrate that tranexamic acid administration can reduce the postoperative 24 hours blood loss in non-cyanotic, cyanotic, and combined cyanotic/non-cyanotic patients, the red blood cell transfusion in non-cyanotic and cyanotic patients, and the fresh frozen plasma transfusion in non-cyanotic and combined cyanotic/non-cyanotic patients. CONCLUSION This meta-analysis demonstrates that tranexamic acid is highly effective in reducing the blood loss in Chinese pediatric cardiac surgery, but it behaves poorly when it comes to the transfusion requirement. To further confirm this, more well-designed and adequately-powered randomized trials are needed.
A Meta-Analysis of Using Protamine for Reducing the Risk of Hemorrhage During Carotid Recanalization: Direct Comparisons of Post-operative Complications
Frontiers in pharmacology. 2022;13:796329
Background: Protamine can decrease the risk of hemorrhage during carotid recanalization. However, it may cause severe side effects. There is no consensus on the safety and efficacy of protamine during surgery. Thus, we conduct a comprehensive review and meta-analysis to compare the differences between the protamine and the no-protamine group. Method: We systematically obtained literature from Medline, Google Scholar, Cochrane Library, and PubMed electronic databases. All four databases were scanned from 1937 when protamine was first adopted as a heparin antagonist until February 2021. The reference lists of identified studies were manually checked to determine other eligible studies that qualify. The articles were included in this meta-analysis as long as they met the criteria of PICOS; conference or commentary articles, letters, case report or series, and animal observation were excluded from this study. The Newcastle-Ottawa Quality Assessment Scale and Cochrane Collaboration's tool are used to assess the risk of bias of each included observational study and RCT, respectively. Stata version 12.0 statistical software (StataCorp LP, College Station, Texas) was adopted as statistical software. When I (2) < 50%, we consider that the data have no obvious heterogeneity, and we conduct a meta-analysis using the fixed-effect model. Otherwise, the random-effect model was performed. Result: A total of 11 studies, consisting of 94,618 participants, are included in this study. Our analysis found that the rate of wound hematoma had a significant difference among protamine and no-protamine patients (OR = 0.268, 95% CI = 0.093 to 0.774, p = 0.015). Furthermore, the incidence of hematoma requiring re-operation (0.7%) was significantly lower than that of patients without protamine (1.8%). However, there was no significant difference in the incidence of stroke, wound hematoma with hypertension, transient ischemic attacks (TIA), myocardial infarction (MI), and death. Conclusion: Among included participants undergoing recanalization, the use of protamine is effective in reducing hematoma without increasing the risk of having other complications. Besides, more evidence-based performance is needed to supplement this opinion due to inherent limitations.
Effects of crystalloid and colloid priming strategies for cardiopulmonary bypass on colloid oncotic pressure and haemostasis: a meta-analysis
Interactive cardiovascular and thoracic surgery. 2022
OBJECTIVES Colloid oncotic pressure is an important factor in cardiac surgery, owing to its role in haemodilution. The effect of cardiopulmonary bypass prime fluids on the colloid oncotic pressure are unknown. In this study, the effect of crystalloid and colloid prime fluids, with or without retrograde autologous priming on the colloid oncotic pressure during elective cardiac surgery were evaluated. METHODS Randomized controlled trials and prospective clinical trials comparing crystalloid and colloid priming fluids or with retrograde autologous priming were selected. Primary outcome was the colloid oncotic pressure; secondary outcomes were fluid balance, fluid requirements, weight gain, blood loss, platelet count, and transfusion requirements. RESULTS From 1582 records, 29 eligible studies were identified. Colloid oncotic pressures were comparable between gelofusine and hydroxyethyl starch during bypass (mean difference [MD]: 0.69; 95% confidence interval [CI]: -2.05, 3.43; P = 0.621), after bypass (MD: -0.11; 95% CI: -2.54, 2.32; P = 0.930), and postoperative (MD: -0.61; 95% CI: -1.60, 0.38; P = 0.228). Fluid balance was lower with hydroxyethyl starch than with crystalloids. Retrograde autologous priming reduced transfusion requirements compared with crystalloids. Blood loss was comparable between groups. CONCLUSIONS Colloid oncotic pressures did not differ between crystalloids and colloids. As a result of increased transcapillary fluid movement, fluid balance was lower with hydroxyethyl starch than with crystalloids. Haematocrit and transfusion requirements were comparable between groups. However, the latter was lower when retrograde autologous priming was applied to crystalloid priming compared with crystalloids alone. Finally, no differences in blood loss were observed between the groups.
The Use of Thromboelastography in Percutaneous Coronary Intervention and Acute Coronary Syndrome in East Asia: A Systematic Literature Review
Journal of clinical medicine. 2022;11(13)
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.
Systematic review on transcaval embolization for type II endoleak after endovascular aortic aneurysm repair
Journal of vascular surgery. 2022
INTRODUCTION Persistent endoleak type II (ET II) after endovascular repair for aortic aneurysms is not always a begin condition and has been associated to sac expansion, rupture and re-intervention. A variety of different endovascular approaches are available for ET II treatment. The aim of this systematic review was to assess the currently available literature on transcaval embolization in ET II treatment after standard or complex endovascular aortic aneurysm repair. METHODS This systematic review protocol was registered to the PROSPERO (CRD42021289686). The Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement (PRISMA) guidelines and P.I.C.O. model was followed. A data search of the literature was conducted, using PubMed, EMBASE via Ovid and CENTRAL databases, until September 30, 2021. Only studies reporting on ET II embolization using the transcaval approach after endovascular aneurysm repair were included. Studies reporting on different type of endoleak treatment or other embolization approach were excluded. The quality of studies was assessed using the Newcastle-Ottawa Scale (NOS). Primary outcomes were technical success and freedom from ET II persistence during follow-up while secondary were any post-operative complication associated to transcaval embolization and need for re-intervention. RESULTS The search yielded 2,861 manuscripts in total. Eight manuscripts were included, reporting on 117 patients and 128 transcaval embolizations. The indication for treatment was ET II presence with sac expansion >5mm while in two studies the presence of persistent endoleak has set the indication to intervene. The technical success was 91.4% (117/128) while a variety of embolic materials were used including coils, thrombin, and glue. Three cases of deep vein thrombosis were recorded while the remaining morbidity and mortality were null. Follow-up was ranging between 0-25 months. Out of eight studies, persistent ET II rate was 12.8% and 18 re-interventions were performed (14.1%,); including ten transcaval coil embolizations (56%). Sac expansion was reported in 11 cases out of 3 studies (17%). Only one case of death, not associated to transcaval embolization, was recorded. CONCLUSIONS Transcaval embolization for ET II treatment presents a high technical success and low mortality in the early and mid-term period. The ET II persistence rate is low during the available 12-month follow-up.
Preradiosurgery embolization in reducing the postoperative hemorrhage rate for patients with cerebral arteriovenous malformations: a systematic review and meta-analysis
Neurosurgical review. 2021
Few studies have examined the postoperative hemorrhage rate of cerebral arteriovenous malformations (AVMs) treated by embolization prior to stereotactic radiosurgery. The objective of this analysis was to compare the postoperative hemorrhage rate between AVMs treated with and those treated without preradiosurgery embolization. A systematic search of the PubMed and Embase databases was performed with no restriction on the publication period. Based on Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we included studies with sufficient baseline and outcome data. The analysis was performed using Comprehensive Meta-Analysis (CMA) 2.0. Eleven studies comprising 2591 patients were eligible for analysis. There was no significant difference in the postoperative hemorrhage rate between patients who had undergone embolization followed by SRS and those who had undergone SRS alone (OR 1.140, 95% CI 0.851-1.526, p = 0.38). The obliteration rate was significantly lower in the E + SRS group than in the SRS group (OR 0.586, 95% CI 0.398-0.863, p = 0.007). No significant difference in permanent neurological deficits was identified between patients who had undergone embolization followed by SRS and those who had undergone SRS alone (OR 1.175, 95% CI 0.626-2.206, p = 0.616). Available data suggested that preradiosurgery embolization did not reduce the postoperative hemorrhage rate and resulted in a significantly lower obliteration rate than treatment with SRS alone.
Validation of the academic research consortium high bleeding risk criteria in patients undergoing percutaneous coronary intervention: A systematic review and meta-analysis of 10 studies and 67,862 patients
International journal of cardiology. 2021
BACKGROUND To assess the performance of the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in stratifying the risk of bleeding and ischaemic events after percutaneous coronary intervention (PCI). METHODS MEDLINE, COCHRANE, Web of Sciences, and SCOPUS were searched for studies aimed at validating the ARC-HBR criteria in patients treated with PCI. The primary outcome measure of this meta-analysis was major bleeding. RESULTS The analysis included 10 studies encompassing 67,862 patients undergoing PCI; the HBR definition was fulfilled in 44.7% of the cases. The risk of major bleeding was significantly higher in HBR vs. Non-HBR group (RR, 2.56, 95% CI 2.28-2.89). The average C-statistic was 0.64 (95% CI 0.60-0.68), indicating modest discrimination. The risk of intracranial hemorrhage, gastrointestinal bleeding, fatal bleeding, ischaemic stroke, cardiac death and all-cause death was higher in HBR vs. Non-HBR group. Despite a higher incidence of myocardial infarction and stent thrombosis in patients deemed at HBR, the rate of target lesion revascularization was comparable between groups (RR, 1.01, 95% CI 0.88-1.16). The mean effect size for the cumulative incidence of major bleeding exceeded the HBR cut-off value of 4% for all major criteria except one, and for two out of six minor criteria, namely age ≥ 75 years and moderate CKD. CONCLUSION The ARC-HBR definition identifies patients at higher risk of major bleeding and other adverse cardiovascular events after PCI. Almost all major criteria, but also two of the minor criteria, were individually associated with rates of major bleeding above 4% thus fulfilling the definition of major HBR criteria.
Optimal Stent Design for High Bleeding Risk Patients: Evidence From a Network Meta-Analysis
The Journal of invasive cardiology. 2021
OBJECTIVE To determine the best stent design for high bleeding risk (HBR) patients. BACKGROUND Polymer-free (PF) drug eluting stent (DES) devices have a proven benefit over bare-metal stent (BMS) devices in previous trials. It is unknown, however, whether polymer-based (PB)-DES devices are as safe as PF-DES devices. METHODS A network meta-analysis including all randomized controlled trials (RCTs) that compared different stent technology in HBR patients with a 1-month course of dual-antiplatelet therapy (DAPT) was performed. The main efficacy outcome was major adverse cardiac event (MACE) rate, defined as the composite of all-cause mortality, myocardial infarction (MI), and target-lesion revascularization (TLR). Secondary efficacy events included all-cause and cardiac mortality, MI, stroke, TLR, and target-vessel revascularization (TVR). Safety outcomes included all bleeding, major bleeding, and stent thrombosis (ST). RESULTS A total of 4 RCTs with 6456 patients were included. PF-DES and PB-DES yielded a reduced rate of MACE, MI, TLR, and TVR events compared with BMS (all P<.05). ST events were reduced in PB-DES compared with BMS (P=.01). No differences were found in all-cause death, cardiac death, or stroke events in PF-DES and PB-DES compared with BMS. Furthermore, no differences were found between PF-DES and PB-DES regarding any of the outcomes. CONCLUSION DES devices were associated with lower MACE and TVR rates compared with BMS, whereas there were no statistical differences in other efficacy endpoints. Also, PB-DES were associated with fewer ST events compared with BMS. There were no statistical differences between PB-DES and PF-DES with regard to any of the endpoints.