Abstract

INTRODUCTION Topical hemostatic agents have been used to reduce bleeding rates after endoscopic submucosal dissection (ESD) for gastric cancer. However, to date, no review has summarized evidence on their efficacy. MATERIAL AND METHODS PubMed, Embase, ScienceDirect, CENTRAL, and Google Scholar were searched for studies comparing bleeding rates after ESD with and without local hemostatic agents. RESULTS Eleven studies were included. The studies used polyglycolic acid (PGA) sheets and fibrin glue, fibrin glue, oxidized regenerated cellulose, polysaccharide hemostatic powder, or polyethylene oxide adhesive. Meta-analysis revealed a statistically significant reduction in the risk of delayed bleeding with the use of PGA sheets & fibrin glue (six studies; RR: 0.35 95% CI: 0.20, 0.63 p = 0.0005). However, meta-analysis of two studies showed no difference in the risk of bleeding based on the use of fibrin glue (RR: 0.44 95% CI: 0.03, 7.17 p = 0.56). Scarce data were available for the remaining hemostatic agents. CONCLUSION A large number of different hemostatic agents have been used to reduce the risk of bleeding after ESD for gastric cancer. Observational studies indicate that the use of PGA with fibrin glue could reduce the risk of bleeding after ESD. However, evidence for other agents was too scarce to derive conclusions.

Abstract

OBJECTIVE The purpose of this meta-analysis is to evaluate the effect of the application of platelet-rich plasma (PRP) in spinal fusion surgery on the fusion rate of the spine. METHODS A comprehensive search of the PubMed, Embase, Cochrane Library, and Science Direct databases was conducted to identify randomized control trials (RCTs) or observational cohort studies that evaluated the efficacy and safety of PRP in spinal fusion. Data on final fusion rate, changes in the visual analog scale (VAS), estimated blood loss (EBL), and operative time was collected from the eligible studies for meta-analysis. Patients were divided into PRP and non-PRP groups according to whether PRP was used during the spinal fusion procedure. RESULTS According to the selection criteria, 4 randomized controlled trials and 8 cohort studies with 833 patients and 918 levels were included. The outcomes indicated that PRP application is associated with a lower fusion rat (OR = 0.62, 95% CI: (0.43, 0.89), P = 0.009) at final follow-up (>24 months). Subgroup analysis showed a lower rate of spinal fusion in the PRP group compared to the non-PRP group (OR = 0.35, 95% CI: (0.21, 0.58), P < 0.001) when spinal fusion was assessed using only anterior-posterior radiographs. When the bone graft material was a combination of autologous bone + artificial bone, the spinal fusion rate was lower in the PRP group than in the non-PRP group (OR = 0.34, 95% CI: (0.16, 0.71), P = 0.004). The PRP and non-PRP groups showed no significant differences in VAS changes at the 24th postoperative month (WMD = 0.36, 95% CI: (-0.37, 1.09), P = 0.33); Application of PRP does not reduce the estimated blood loss (WMD = -86.03, 95% CI: (-188.23, 16.17), P = 0.10). In terms of operation time, using PRP does not prolong operation time (WMD = -3.74, 95% CI: (-20.53, 13.04), P = 0.66). CONCLUSION Compared with bone graft fusion alone, PRP cannot increase the rate of spinal fusion. Inappropriate methods of spinal fusion assessment or mixing PRP with artificial/allograft bone may have been responsible for the lower rate of spinal fusion in the PRP group. SYSTEMATIC REVIEW REGISTRATION doi: 10.37766/inplasy2022.5.0055.

Abstract

BACKGROUND Although tranexamic acid (TXA) has been shown to reduce bleeding in joint replacement procedures, its effectiveness for anterior cruciate ligament reconstruction (ACLR) has not been widely reported. PURPOSE To evaluate the effectiveness of TXA to reduce postoperative hemarthrosis and improve clinical outcomes after ACLR. STUDY DESIGN Systematic review; Level of evidence, 2. METHODS A systematic review of the literature following the PRISMA guidelines (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) was performed; literature retrieval was carried out using the MEDLINE, Embase, and Cochrane Library electronic databases. The inclusion criteria were comparative studies in English that reported the administration of intravenous or intra-articular TXA versus other modalities or placebo in patients undergoing ACLR. RESULTS Six studies comprising 418 patients who were treated with TXA were included. Heterogeneity among studies did not allow for the pooling of data. Five studies showed decreased drainage volume in the first 24 or 48 hours postoperatively as compared with control (ACLR with no TXA). Four studies showed lower hemarthrosis grades and visual analog scale scores in TXA versus control in the early postoperative period, although this difference was not evident at 4 weeks postoperatively. No studies showed differences in infection, deep venous thrombosis, or adverse events between the TXA and control groups. CONCLUSION The current best available evidence suggests that TXA administration at the time of ACLR results in decreased intra-articular bleeding (measured using a drainage system), hemarthrosis grade, and pain when compared with control.

Abstract

BACKGROUND Intraoperative blood salvage autotransfusion(IBSA) has been widely used in a variety of surgeries, but the use of IBSA in hepatocellular carcinoma (HCC) patients undergoing liver transplantation (LT) is controversial. Numerous studies have reported that IBSA used during LT for HCC is not associated with adverse oncologic outcomes. This systematic review and meta-analysis aims to estimate the clinical prognosis of IBSA for patients with H+CC undergoing LT. METHODS MEDLINE, Embase, Web of Science, and Cochrane Library were searched for articles describing IBSA in HCC patients undergoing LT from the date of inception until May 1, 2022, and a meta-analysis was performed. Study heterogeneity was assessed by I(2) test. Publication bias was evaluated by funnel plots, Egger's and Begg's test. RESULTS 12 studies enrolling a total of 2253 cases (1374 IBSA and 879 non-IBSA cases) are included in this meta-analysis. The recurrence rate(RR) at 5-year(OR=0.75; 95%CI, 0.59-0.95; P=0.02) and 7-year(OR=0.65; 95%CI, 0.55-0.97; P=0.03) in the IBSA group is slightly lower than non-IBSA group. There are no significant differences in the 1-year RR(OR=0.77; 95% CI, 0.56-1.06; P=0.10), 3-years RR (OR=0.79; 95% CI, 0.62-1.01; P=0.06),1-year overall survival outcome(OS) (OR=0.90; 95% CI, 0.63-1.28; P=0.57), 3-year OS(OR=1.16; 95% CI, 0.83-1.62; P=0.38), 5-year OS(OR=1.04; 95% CI, 0.76-1.40; P=0.82),1-year disease-free survival rate(DFS) (OR=0.80; 95%CI, 0.49-1.30; P=0.36), 3-year DFS(OR=0.99; 95%CI, 0.64-1.55; P=0.98), and 5-year DFS(OR=0.88; 95%CI, 0.60-1.28; P=0.50). Subgroup analysis shows a difference in the use of leukocyte depletion filters group of 5-year RR(OR=0.73; 95%CI, 0.55-0.96; P=0.03). No significant differences are found in other subgroups. CONCLUSIONS IBSA provides comparable survival outcomes relative to allogeneic blood transfusion and does not increase the tumor recurrence for HCC patients after LT. SYSTEMATIC REVIEW REGISTRATION https://www.crd.york.ac.uk/prospero/, identifier CRD42022295479.

Abstract

BACKGROUND Cardiac surgery with cardiopulmonary bypass induces a profound inflammatory response that, when severe, can lead to multiorgan system dysfunction. Preliminary data suggest that administration of hydroxyethyl starch (HES) solutions may mitigate an inflammatory response and improve pulmonary function. Our goal was to examine the effect of 6% HES 130/0.4 versus 5% human albumin given for intravascular plasma volume replacement on the perioperative inflammatory response and pulmonary function in patients undergoing cardiac surgery. METHODS This was a subinvestigation of a blinded, parallel-group, randomized clinical trial of patients undergoing elective aortic valve replacement surgery at the Cleveland Clinic main campus, titled "Effect of 6% Hydroxyethyl Starch 130/0.4 on Kidney and Haemostatic Function in Cardiac Surgical Patients." Of 141 patients who were randomized to receive either 6% HES 130/0.4 or 5% human albumin for intraoperative plasma volume replacement, 135 patients were included in the data analysis (HES n = 66, albumin n = 69). We assessed the cardiopulmonary bypass-induced inflammatory response end points by comparing the 2 groups' serum concentrations of tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and macrophage migration inhibitory factor (MIF), measured at baseline and at 1 and 24 hours after surgery. We also compared the 2 groups' postoperative pulmonary function end points, including the ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (Pao2:Fio2 ratio), dynamic lung compliance, oxygenation index (OI), and ventilation index (VI) at baseline, within 1 hour of arrival to the intensive care unit, and before tracheal extubation. The differences in the postoperative levels of inflammatory response and pulmonary function between the HES and albumin groups were assessed individually in linear mixed models. RESULTS Serum concentrations of the inflammatory markers (TNF-α, IL-6, MIF) were not significantly different (P ≥ .05) between patients who received 6% HES 130/0.4 or 5% albumin, and there was no significant heterogeneity of the estimated treatment effect over time (P ≥ .15). The results of pulmonary function parameters (Pao2:Fio2 ratio, dynamic compliance, OI, VI) were not significantly different (P ≥ .05) between groups, and there was no significant heterogeneity of the estimated treatment effect over time (P ≥ .15). CONCLUSIONS Our investigation found no significant difference in the concentrations of inflammatory markers and measures of pulmonary function between cardiac surgical patients who received 6% HES 130/0.4 versus 5% albumin.

Abstract

OBJECTIVE To explore the effect of individualized blood pressure (BP)-lowering treatment on the outcomes of elderly patients with severe intracerebral hemorrhage (ICH). METHODS We performed an exploratory analysis of Controlling Hypertension After Severe Cerebrovascular Event (CHASE) trial, which was a multicenter, randomized, controlled clinical trial. Patients with severe ischemic or hemorrhagic stroke (defined as GCS ≤ 12 or NIHSS ≥ 11) were randomized into individualized versus standard BP-lowering treatment in CHASE trial. In this exploratory analysis, patients with severe ICH were included. The primary outcome was the percentage of patients with 90-day functional independence defined as modified Rankin Scale (mRS) ≤2. RESULTS We included 242 patients with severe ICH in the present analysis, consisting of 142 patients aged <65 years and 100 patients aged ≥65 years. There were significant differences between patients aged ≥65 years and <65 years in the proportion of functional independence (47.9% vs. 15.0%, P < 0.001) and good outcome (73.9% vs. 50.0%, P < 0.001) at day 90. In patients aged ≥65 years, the adjusted individualized BP-lowering treatment had an unequivocal effect on the functional independence at day 90 (21.6% vs. 8.2%, odds ratio [OR]: 4.309, 95% confidence interval [CI]: 1.040-17.859, P = 0.044) and improved the neurological deficits at discharge (∆ NIHSS ≥ 4: 64.7% vs. 34.7%, OR: 4.300, 95% CI: 1.599-11.563, P = 0.004). INTERPRETATION Compared with the younger counterparts, the elderly patients (≥65 years) with acute severe ICH might benefit more from individualized BP-lowering treatment.

Abstract

Whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients having cardiac surgery remains unclear. We tested the hypotheses that intra-operative administration of a third-generation starch does not worsen postoperative kidney function or haemostasis in cardiac surgical patients compared with human albumin 5%. This triple-blind, non-inferiority, clinical trial randomly allocated patients aged 40-85 who underwent elective aortic valve replacement, with or without coronary artery bypass grafting, to plasma volume replacement with 6% starch 130/0.4 vs. 5% human albumin. Our primary outcome was postoperative urinary neutrophil gelatinase-associated lipocalin concentrations, a sensitive and early marker of postoperative kidney injury. Secondarily, we evaluated urinary interleukin-18; acute kidney injury using creatinine RIFLE criteria, coagulation measures, platelet count and function. Non-inferiority (delta 15%) was assessed with correction for multiple comparisons. We enrolled 141 patients (69 starch, 72 albumin) as planned. Results of the primary analysis demonstrated that postoperative urine neutrophil gelatinase-associated lipocalin (median (IQR [range])) was slightly lower with hydroxyethyl starch (5 (1-68 [0-996]) ng.ml(-1) ) vs. albumin (5 (2-74 [0-1604]) ng.ml(-1) ), although not non-inferior [ratio of geometric means (95%CI) 0.91 (0.57, 1.44); p = 0.15] due to higher than expected variability. Urine interleukin-18 concentrations were reduced, but interleukin-18 and kidney injury were again not non-inferior. Of 11 individual coagulation measures, platelet count and function, nine were non-inferior to albumin. Two remaining measures, thromboelastographic R value and arachidonic acid-induced platelet aggregation, were clinically similar but with wide confidence intervals. Starch administration during cardiac surgery produced similar observed effects on postoperative kidney function, coagulation, platelet count and platelet function compared with albumin, though greater than expected variability and wide confidence intervals precluded the conclusion of non-inferiority. Long-term mortality and kidney function appeared similar between starch and albumin.

Abstract

OBJECTIVE This study aimed to compare the effects of intravenous, topical and combined routes of tranexamic acid (TXA) administration on blood loss and transfusion requirements in patients undergoing total knee arthroplasty (TKA) and total hip arthroplasty (THA). DESIGN This was a meta-analysis of randomised controlled trials (RCT) wherein the weighted mean difference (WMD) and relative risk (RR) were used for data synthesis applied in the random effects model. Stratified analyses based on the surgery type, region, intravenous and topical TXA dose and transfusion protocol were also conducted. The main outcomes included intraoperative and total blood loss volume, transfusion rate, low postoperative haemoglobin (Hb) level and postoperative Hb decline. However, the secondary outcomes included length of hospital stay (LOS) and/or occurrence of venous thromboembolism (VTE). SETTING We searched the PubMed, Embase and Cochrane CENTRAL databases for RCTs that compared different routes of TXA administration. PARTICIPANTS Patients undergoing TKA or THA. INTERVENTIONS Intravenous, topical or combined intravenous and topical TXA. RESULTS Twenty-six RCTs were selected, and the intravenous route did not differ substantially from the topical route with respect to the total blood loss volume (WMD=30.92, p=0.31), drain blood loss (WMD=-34.53, p=0.50), postoperative Hb levels (WMD=-0.01, p=0.96), Hb decline (WMD=-0.39, p=0.08), LOS (WMD=0.15, p=0.38), transfusion rate (RR=1.08, p=0.75) and VTE occurrence (RR=1.89, p=0.15). Compared with the combined-delivery group, the single-route group had significantly increased total blood loss volume (WMD=198.07, p<0.05), greater Hb decline (WMD=0.56, p<0.05) and higher transfusion rates (RR=2.51, p<0.05). However, no significant difference was noted in the drain blood loss, postoperative Hb levels and VTE events between the two groups. The intravenous and topical routes had comparable efficacy and safety profiles. CONCLUSIONS The combination of intravenous and topical TXA was relatively more effective in controlling bleeding without increased risk of VTE.

Abstract

PURPOSE In the total hip arthroplasty (THA), the optimal administration route of tranexamic acid (TXA) remains controversial. This study was designed to investigate the impact of topical injection of TXA on blood loss during primary unilateral THA as well as short-term safety and adverse side effects compared with intravenous administration of TXA. MATERIAL AND METHODS In this study, 75 patients who underwent unilateral THA were randomly divided into 3 groups receiving intra-articular TXA (IA group), intravenous TXA (IV group) or no TXA (control group C). Blood loss, postoperative drainage, covert blood loss, total blood volume, the number of blood transfusions after surgery and transfusion rate, incidence of deep venous thrombosis and pulmonary embolism were recorded and evaluated in the three groups after 1 week and 1 month. RESULTS There were significant differences in the quantity of postoperative drainage, covert blood loss, total blood volume, the number of blood transfusions after surgery and transfusion rates between the three groups (P < 0.05), but blood loss during surgery showed no significant differences among the three groups (P > 0.05). In the IV group, 1 patient suffered from deep venous thrombosis of the lower limbs and in the C group, 2 patients suffered from superficial venous thrombosis of the lower limbs 2 and 4 days after surgery, respectively. In the IA group no complications occurred during the follow-up period. CONCLUSION Preoperative intravenous TXA and postoperative topical TXA significantly reduced postoperative blood loss and transfusion rates among the patients who underwent primary unilateral THA and the short-term safety was good. The data suggest that topical injection of TXA is safer and more effective, without postoperative complications.