Abstract

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.

Abstract

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.

Abstract

BACKGROUND Large bore access procedures rely on vascular closure devices to minimize access site complications. Suture-based vascular closure devices (S-VCD) such as ProGlide and ProStar XL have been readily used, but recently, newer generation collagen-based vascular closure devices (C-VCD) such as MANTA have been introduced. Data on comparisons of these devices are limited. METHODS PubMed, Scopus and Cochrane were searched for articles on vascular closure devices using keywords, ("Vascular closure devices" OR "MANTA" OR "ProStar XL" OR "ProGlide") AND ("outcomes") that resulted in a total of 875 studies. Studies were included if bleeding or vascular complications as defined by Valve Academic Research Consortium-2 were compared between the two types of VCDs. The event level data were pooled across trials to calculate the Odds Ratio (OR) with 95% CI, and analysis was done with Review Manager 5.4 using random effects model. RESULTS Pooled analyses from these nine studies resulted in a total of 3410 patients, out of which 2855 were available for analysis. A total of 1229 received C-VCD and 1626 received S- VCD. Among the patients who received C-VCD, the bleeding complications (major and minor) were similar to patients who received S-VCD ((OR: 0.70 (0.35-1.39), p = 0.31, I(2) = 55%), OR: 0.92 (0.53-1.61), p = 0.77, I(2) = 65%)). The vascular complications (major and minor) in patients who received C-VCD were also similar to patients who received S-VCD ((OR: 1.01 (0.48-2.12), p = 0.98, I(2) = 52%), (OR: 0.90 (0.62-1.30), p = 0.56, I(2) = 35%)). CONCLUSIONS Bleeding and vascular complications after large bore arteriotomy closure with collagen-based vascular closure devices are similar to suture-based vascular closure devices.

Abstract

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.

Abstract

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.

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.

Abstract

OBJECTIVE This study aims to evaluate the anti-inflammatory effect of tranexamic acid (TXA) on adult cardiac surgical patients. METHODS PubMed, Embase, Ovid, Web of Science, CNKI, VIP, and WANFANG databases were systematically searched using the related keywords for cardiac surgical randomized controlled trials (RCTs) published from their inception to February 1, 2022. The primary outcomes were postoperative inflammatory biomarkers levels. The secondary outcomes were postoperative systemic inflammatory response syndrome and other major postoperative outcomes. The odds ratios and/or the weighted mean difference (WMD) with a 95% confidence interval (CI) were used to pool the data. RESULTS Ten RCTs with 770 adult cardiac surgical patients were included. Compared with placebo, TXA achieved statistically significant inhibition of the postoperative interleukin (IL)-6 level (postoperative 6 h: n = 6 trials; WMD -31.66; 95% CI: -45.90, -17.42; p < 0.0001; I (2 )= 93%; postoperative 24 h: n =  8 trials; WMD, -44.06; 95% CI: -69.21, -18.91; p = 0.006; I (2 )= 100%); IL-8 level postoperative 24 h, TNF-α level postoperative 24 h, NE level postoperative 6 h: n = 3 trials; WMD, -36.83; 95% CI: -68.84, -4.83; p = 0.02; I (2 )= 95%); tissue necrosis factor alpha (TNF-α) level (postoperative 6 h: n = 3 trials; WMD, -7.21; 95% CI: -12.41, -2.01; p = 0.007; I (2 )= 47%; postoperative 24 h: n = 5 trials; WMD, -10.02; 95% CI: -14.93, -5.12; p < 0.0001; I (2 )= 94%); and neutrophil elastase (NE) level (postoperative 6 h: n = 3 trials; WMD, -66.93; 95% CI: -111.94, -21.92; p = 0.004; I (2 )= 86%). However, TXA achieved no statistically significant influence on the postoperative 24 h NE level. CONCLUSIONS TXA had a significant anti-inflammatory effect in adult cardiac surgical patients, as evidenced by the reduction of multiple postoperative proinflammatory biomarkers levels, but these results should be interpreted carefully and cautiously, as only a limited number of studies were included and there was high heterogeneity between them. SYSTEMATIC REVIEW REGISTRATION https://www.crd.york.ac.uk/prospero/#recordDetails, identifier: CRD42022312919.

Abstract

BACKGROUND Hemostasis control after percutaneous endovascular procedures through the femoral approach remains challenging for catheterization laboratory nurses, given method variability. OBJECTIVE To summarize the available evidence on vascular devices efficacy dedicated to hemostasis control compared to the extrinsic compression after percutaneous procedures in the femoral vein or artery. METHODS A systematic review with meta-analysis of randomized clinical trials was conducted. We compared different hemostasis methods in adult patients who underwent diagnostic and/or therapeutic procedures through femoral access. The databases searched were PubMed, Embase, CINAHL and Cochrane CENTRAL, and updated on 03/2022. The outcomes included hematoma, pseudoaneurysm, bleeding, minor and major vascular complication, time to hemostasis, device failure, and manual compression repetition. The risk of bias was assessed using the Cochrane Risk of Bias Tool 1.0. Pooled effect sizes on continuous, categorical and proportion variables were estimated with the random effects model. The continuous variables were summarized as the difference between means weighted by the inverse of variance (WMD), and the categorical ones by the summary of relative risks (RR), estimated by the DerSimonian and Laird method. The Freeman-Tukey method was used to estimate the summary effect of proportions. RESULTS Fifty articles were included in the systematic review. When compared to extrinsic compression, vascular closure devices resulted in a relative risk reduction (RRR) for hematoma: RR 0.82 [95%CI 0.72 to 0.94] and in shorter time to hemostasis WMD -15.06 min [95%CI -17.56 to -12.56]; no association was observed between interventions with vascular closure devices and extrinsic compression for pseudoaneurysm, bleeding, minor and major vascular complications. Compared to extrinsic compression, sealant or gel type devices were compatible with a RRR for hematoma: RR 0.73 [95%CI 0.59 to 0.90]; and metal clip or staple type devices for pseudoaneurysm: RR 0.48 [95%CI 0.25 to 0.90]; and major vascular complication: RR 0.33 [95%CI 0.17 to 0.64]. For each 100 observations, the device failure rate for metal clip or staple was 3.28% [95%CI 1.69 to 6.27]; for suture 6.84% [95%CI 4.93 to 9.41]; for collagen 3.15% [95%CI 2.24 to 4.41]; and for sealant or gel 7.22% [95% CI 5.49 to 9.45]. CONCLUSIONS Vascular closure devices performed better in hemostasis control. The certainty of the evidence was rated as very low to moderate. REGISTRATION PROSPERO CRD42019140794.

Abstract

OBJECTIVES To determine the effect of intraoperative antifibrinolytics, including tranexamic acid (TXA), aminocaproic acid (EACA), or aprotinin, on bleeding in children undergoing cardiac surgery with cardiopulmonary bypass (CPB). DATA SOURCES Relevant articles were systematically searched from Ovid MEDLINE, Ovid EMBASE, CINAHL, Cochrane Library, and Web of Science to November 15, 2021. STUDY SELECTION Abstracts were screened, and full texts were reviewed using predetermined inclusion and exclusion criteria using the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guideline. DATA EXTRACTION A standardized data extraction tool was used. DATA SYNTHESIS Sixty-eight studies including 28,735 patients were analyzed. TXA compared with placebo resulted in a mean decrease in chest tube output of 9.1 mL/kg (95% CI, 6.0-12.3 mL/kg), I2 equals to 65.2%, p value of less than 0.001, platelet requirement of 2.9 mL/kg (95% CI, 0.1-5.8 mL/kg), I2=72.5%, p value less than 0.001 and plasma requirement of 4.0 mL/kg (95% CI, 0.6-7.2 mL/kg), I2 equals to 94.5%, p value less than0.001. Aprotinin compared with placebo resulted in a mean decrease in chest tube output of 4.3 mL/kg (2.4-6.2 mL/kg), I2 equals to 66.3%, p value of less than 0.001, platelet transfusion of 4.6 mL/kg (95% CI, 0.6-8.6 mL/kg), I2 equals to 93.6%, p value of less than 0.001, and plasma transfusion of 7.7 mL/kg (95% CI, 2.1-13.2 mL/kg), I2 equals to 95.3%, p value of less than 0.001. EACA compared with placebo resulted in a mean decrease in chest tube output of 9.2 mL/kg (2.3-21.0 mL/kg), I2 equals to 96.4%, p value of less than 0.001, RBC transfusion of 7.2 mL/kg (95% CI, 2.4-12.1 mL/kg), I2 equals to 94.5%, p value equals to 0.002, and platelet transfusion of 10.7 mL/kg (95% CI, 2.9-18.5 mL/kg), I2 equals to 0%, p value of less than 0.001. No statistical difference was observed in chest tube output when TXA was compared with aprotinin. Subgroup analysis of cyanotic patients showed a significant decrease in chest tube output, platelet requirement, and plasma requirement for patients receiving aprotinin. Overall, the quality of evidence was moderate. CONCLUSIONS Antifibrinolytics are effective at decreasing blood loss and blood product requirement in children undergoing cardiac surgery with CPB although the quality of evidence is only moderate.

Abstract

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.