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Safety and efficacy of a kaolin-impregnated hemostatic gauze in cardiac surgery: A randomized trial
Mumtaz, M., Thompson, R. B., Moon, M. R., Sultan, I., Reece, T. B., Keeling, W. B., DeLaRosa, J.
JTCVS open. 2023;14:134-144
Abstract
OBJECTIVE A kaolin-based nonresorbable hemostatic gauze, QuikClot Control+, has demonstrated effective hemostasis and safety when used for severe/life-threatening (grade 3/4) internal organ space bleeding. We evaluated the efficacy and safety of this gauze for mild to moderate (grade 1-2) bleeding in cardiac surgery compared with control gauze. METHODS This was a randomized, controlled, single-blinded study of patients who underwent cardiac surgery between June 2020 and September 2021 across 7 sites with 231 subjects randomized 2:1 to QuikClot Control+ or control. The primary efficacy end point was hemostasis rate (ie, subjects achieving grade 0 bleed) through up to 10 minutes of bleeding site application, assessed using a semiquantitative validated bleeding severity scale tool. The secondary efficacy end point was the proportion of subjects achieving hemostasis at 5 and 10 minutes. Adverse events, assessed up to 30 days postsurgery, were compared between arms. RESULTS The predominant procedure was coronary artery bypass grafting, and 69.7% and 29.4% were sternal edge and surgical site (suture line)/other bleeds, respectively. Of the QuikClot Control+ subjects, 121 of 153 (79.1%) achieved hemostasis within 5 minutes, compared with 45 of 78 (58.4%) controls (P < .001). At 10 minutes, 137 of 153 patients (89.8%) achieved hemostasis compared with 52 of 78 controls (68.4%) (P < .001). At 5 and 10 minutes, hemostasis was achieved in 20.7% and 21.4% more QuikClot Control+ subjects, respectively, compared with controls (P < .001). There were no significant differences in safety or adverse events between treatment arms. CONCLUSIONS QuikClot Control+ demonstrated superior performance in achieving hemostasis for mild to moderate cardiac surgery bleeding compared with control gauze. The proportion of subjects achieving hemostasis was more than 20% higher in QuikClot Control+ subjects at both timepoints compared with controls, with no significant difference in safety outcomes.
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Efficacy of Harmonic Scalpel Versus Bipolar Diathermy in Hemorrhoidectomy: A Systematic Review and Meta-Analysis of Nine Randomized Controlled Trials
Albazee, E., Alenezi, A., Alenezi, M., Alabdulhadi, R., Alhubail, R. J., Ahmad Al Sadder, K., AlDabbous, F., Almutairi, A. N., Almutairi, S. N., Almutairi, A. N., et al
Cureus. 2023;15(2):e34734
Abstract
Hemorrhoidectomy is one of the most common surgical interventions to remove the third and fourth degrees of prolapse hemorrhoid. We carried out this systematic review and meta-analysis of the randomized controlled trials (RCTs) to comprehensively evaluate the efficacy of harmonic scalpel (HS) versus bipolar diathermy (BD) methods in terms of decreasing intraoperative and postoperative morbidities among patients undergoing hemorrhoidectomy. Suitable citations were found utilizing digital medical sources, including the CENTRAL, Web of Science, PubMed, Scopus, and Google Scholar, from inception until December 2022. Only RCTs that matched the inclusion requirements were selected. We used the updated Cochrane risk of bias (ROB) tool (version 2) to assess the quality of the involved citations. The Review Manager (version 5.4 for Windows) was used to perform the pooled analysis. Data were pooled and reported as mean difference (MD) or risk ratio (RR) with a 95% confidence interval (CI) in random-effects models. Overall, there was no significant difference between HS and BD in terms of decreasing intraoperative morbidities like operative time, intraoperative blood loss, mean duration of hospital stay, and mean duration of first bowel movement (P>0.05). Similarly, the rate of postoperative complications like pain, bleeding, urinary retention, anal stenosis, flatus incontinence, and wound edema; was similar in both groups with no significant difference (P>0.05). In conclusion, our pooled analysis revealed there was no substantial difference between HS and BD in terms of intraoperative and postoperative endpoints. Additional RCTs with larger sample sizes are needed to consolidate the power and quality of the presented evidence.
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Drugs to reduce bleeding and transfusion in major open vascular or endovascular surgery: a systematic review and network meta-analysis
Beverly A, Ong G, Kimber C, Sandercock J, Dorée C, Welton NJ, Wicks P, Estcourt LJ
The Cochrane database of systematic reviews. 2023;2(2):Cd013649
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Editor's Choice
Abstract
BACKGROUND Vascular surgery may be followed by internal bleeding due to inadequate surgical haemostasis, abnormal clotting, or surgical complications. Bleeding ranges from minor, with no transfusion requirement, to massive, requiring multiple blood product transfusions. There are a number of drugs, given systemically or applied locally, which may reduce the need for blood transfusion. OBJECTIVES To assess the effectiveness and safety of anti-fibrinolytic and haemostatic drugs and agents in reducing bleeding and the need for blood transfusion in people undergoing major vascular surgery or vascular procedures with a risk of moderate or severe (> 500 mL) blood loss. SEARCH METHODS We searched: Cochrane Central Register of Controlled Trials; MEDLINE; Embase; CINAHL, and Transfusion Evidence Library. We also searched the WHO ICTRP and ClinicalTrials.gov trial registries for ongoing and unpublished trials. Searches used a combination of MeSH and free text terms from database inception to 31 March 2022, without restriction on language or publication status. SELECTION CRITERIA We included randomised controlled trials (RCTs) in adults of drug treatments to reduce bleeding due to major vascular surgery or vascular procedures with a risk of moderate or severe blood loss, which used placebo, usual care or another drug regimen as control. DATA COLLECTION AND ANALYSIS We used standard Cochrane methods. Our primary outcomes were units of red cells transfused and all-cause mortality. Our secondary outcomes included risk of receiving an allogeneic blood product, risk of reoperation or repeat procedure due to bleeding, risk of a thromboembolic event, risk of a serious adverse event and length of hospital stay. We used GRADE to assess certainty of evidence. MAIN RESULTS We included 22 RCTs with 3393 participants analysed, of which one RCT with 69 participants was reported only in abstract form, with no usable data. Seven RCTs evaluated systemic drug treatments (three aprotinin, two desmopressin, two tranexamic acid) and 15 RCTs evaluated topical drug treatments (drug-containing bioabsorbable dressings or glues), including fibrin, thrombin, collagen, gelatin, synthetic sealants and one investigational new agent. Most trials were conducted in high-income countries and the majority of the trials only included participants undergoing elective surgery. We also identified two ongoing RCTs. We were unable to perform the planned network meta-analysis due to the sparse reporting of outcomes relevant to this review. Systemic drug treatments We identified seven trials of three systemic drugs: aprotinin, desmopressin and tranexamic acid, all with placebo controls. The trials of aprotinin and desmopressin were small with very low-certainty evidence for all of our outcomes. Tranexamic acid versus placebo was the systemic drug comparison with the largest number of participants (2 trials; 1460 participants), both at low risk of bias. The largest of these included a total of 9535 individuals undergoing a number of different higher risk surgeries and reported limited information on the vascular subgroup (1399 participants). Neither trial reported the number of units of red cells transfused per participant up to 30 days. Three outcomes were associated with very low-certainty evidence due to the very wide confidence intervals (CIs) resulting from small study sizes and low number of events. These were: all-cause mortality up to 30 days; number of participants requiring an allogeneic blood transfusion up to 30 days; and risk of requiring a repeat procedure or operation due to bleeding. Tranexamic acid may have no effect on the risk of thromboembolic events up to 30 days (risk ratio (RR) 1.10, 95% CI 0.88 to 1.36; 1 trial, 1360 participants; low-certainty evidence due to imprecision). There is one large ongoing trial (8320 participants) comparing tranexamic acid versus placebo in people undergoing non-cardiac surgery who are at high risk of requiring a red cell transfusion. This aims to complete recruitment in April 2023. This trial has primary outcomes of proportion of participants transfused with red blood cells and incidence of venous thromboembolism (DVT or PE). Topical drug treatments Most trials of topical drug treatments were at high risk of bias due to their open-label design (compared with usual care, or liquids were compared with sponges). All of the trials were small, most were very small, and few reported clinically relevant outcomes in the postoperative period. Fibrin sealant versus usual care was the topical drug comparison with the largest number of participants (5 trials, 784 participants). The five trials that compared fibrin sealant with usual care were all at high risk of bias, due to the open-label trial design with no measures put in place to minimise reporting bias. All of the trials were funded by pharmaceutical companies. None of the five trials reported the number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. The other three outcomes were associated with very low-certainty evidence with wide confidence intervals due to small sample sizes and the low number of events, these were: all-cause mortality up to 30 days; risk of requiring a repeat procedure due to bleeding; and risk of thromboembolic disease up to 30 days. We identified one large trial (500 participants) comparing fibrin sealant versus usual care in participants undergoing abdominal aortic aneurysm repair, which has not yet started recruitment. This trial lists death due to arterial disease and reintervention rates as primary outcomes. AUTHORS' CONCLUSIONS Because of a lack of data, we are uncertain whether any systemic or topical treatments used to reduce bleeding due to major vascular surgery have an effect on: all-cause mortality up to 30 days; risk of requiring a repeat procedure or operation due to bleeding; number of red cells transfused per participant up to 30 days or the number of participants requiring an allogeneic blood transfusion up to 30 days. There may be no effect of tranexamic acid on the risk of thromboembolic events up to 30 days, this is important as there has been concern that this risk may be increased. Trials with sample size targets of thousands of participants and clinically relevant outcomes are needed, and we look forward to seeing the results of the ongoing trials in the future.
PICO Summary
Population
Adults undergoing major vascular surgery or vascular procedures with a risk of moderate or severe blood loss (22 randomised controlled trials, n= 3,393).
Intervention
Drug treatments to reduce bleeding: anti-fibrinolytic and haemostatic drugs and agents.
Comparison
Placebo, usual care or another drug regimen.
Outcome
The primary outcomes were units of red blood cells transfused, all-cause mortality and thromboembolic events. There was too little data for a network meta-analysis. The reporting of outcomes was sparse. There was no evidence of increased risk of thromboembolic events with tranexamic acid [low certainty evidence]. The authors reported a need for larger trials with better reporting of post-surgical outcomes.
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Effect of red blood cell storage time in pediatric cardiac surgery patients: A subgroup analysis of a randomized controlled trial
Martin, S. M., Tucci, M., Spinella, P. C., Ducruet, T., Fergusson, D. A., Freed, D. H., Lacroix, J., Poirier, N., Sivarajan, V. B., Steiner, M. E., et al
JTCVS open. 2023;15:454-467
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Editor's Choice
Abstract
OBJECTIVE This study aimed to determine whether or not transfusion of fresh red blood cells (RBCs) reduced the incidence of new or progressive multiple organ dysfunction syndrome compared with standard-issue RBCs in pediatric patients undergoing cardiac surgery. METHODS Preplanned secondary analysis of the Age of Blood in Children in Pediatric Intensive Care Unit study, an international randomized controlled trial. This study included children enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial and admitted to a pediatric intensive care unit after cardiac surgery with cardiopulmonary bypass. Patients were randomized to receive either fresh (stored ≤7 days) or standard-issue RBCs. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days postrandomization or at pediatric intensive care unit discharge, or death. RESULTS One hundred seventy-eight patients (median age, 0.6 years; interquartile range, 0.3-2.6 years) were included with 89 patients randomized to the fresh RBCs group (median length of storage, 5 days; interquartile range, 4-6 days) and 89 to the standard-issue RBCs group (median length of storage, 18 days; interquartile range, 13-22 days). There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12 (95% CI, 0.81 to 1.54; P = .49) and an unadjusted absolute risk difference of 5.1% (95% CI, -9.5% to 19.8%; P = .49). CONCLUSIONS In neonates and children undergoing cardiac surgery with cardiopulmonary bypass, the use of fresh RBCs did not reduce the incidence of new or progressive multiple organ dysfunction syndrome compared with the standard-issue RBCs. A larger trial is needed to confirm these results.
PICO Summary
Population
Children admitted to a paediatric intensive care unit after cardiac surgery with cardiopulmonary bypass, enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial (ABC-PICU), (n= 178).
Intervention
Fresh (stored ≤7 days) red blood cells (RBCs), (n= 89).
Comparison
Standard-issue RBCs (n= 89).
Outcome
The authors performed a preplanned subgroup analysis of the ABC-PICU trial. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days post-randomization or at paediatric intensive care unit discharge, or death. There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12; 95% CI [0.81, 1.54] and an unadjusted absolute risk difference of 5.1%; 95% CI [-9.5%, 19.8%].
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A comparative study of stored arterial versus venous blood collected using the acute normovolemic hemodilution method in coronary artery bypass grafting patients in Iran
Mansouri, M., Yazdani, A., Masoumi, G., Mirmohammadsadeghi, M., Mirmohammadsadeghi, A.
Acute and critical care. 2023
Abstract
BACKGROUND In the present study, arterial and venous blood was collected from patients who were candidates for elective coronary artery bypass grafting (CABG); the blood was stored for 28 days and cellular, biomechanical, and hematological changes in blood were compared to determine whether stored arterial blood is superior to stored venous blood. METHODS The present follow-up comparative study included 60 patients >18 years of age, with hemoglobin >14 mg/dl and ejection fraction >40% who were candidates for CABG. After induction of anesthesia, 250 ml of arterial or venous blood was drawn from patients (arterial blood group and venous blood group). Laboratory blood samples were taken at specified times from the collected blood and re-injected into the patients after CABG. RESULTS Significant differences were observed in pH, partial pressure of carbon dioxide (PCO2), partial pressure of oxygen (PO2), bicarbonate (HCO3), and glucose values at several time points between the groups. Other parameters such as urea and creatinine did not show any significant differences between the groups. CONCLUSIONS Twenty-eight days of storage can have a negative effect on some of the cellular, biochemical, and hematological components of arterial and venous blood; however, the quality of stored arterial blood and venous blood does not differ significantly.
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Effect of minimally invasive versus conventional aortic root replacement on transfusion and postoperative wound complications in patients: A meta-analysis
Chen, Y., Yu, W., Jiang, Y., Gao, J., Xie, D., Yu, J., Li, W., Liu, Z., Xiong, J.
International wound journal. 2023
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Abstract
We examined whether small incision aortic root replacement could reduce the amount of blood transfusion during operation and the risk of postoperative complications. An extensive e-review of the 4 main databases (PubMed, Cochrane, Web of Science and EMBASE) was carried out to determine all the published trials by July 2023. The search terms used were associated with partial versus full sternotomy and aortic root. This analysis only included the study articles that compared partial and full sternotomy. After excluding articles based on titles or abstracts, selected full-text articles had reference lists searched for any potential further articles. We analysed a total of 2167 subjects from 10 comparable trials. The minimally invasive aortic root graft in breastbone decreased the duration of hospitalization (MD, -2.58; 95% CI, -3.15, -2.01, p < 0.0001) and intraoperative red blood cell transfusion (MD, -1.27; 95% CI, -2.34, -0.19, p = 0.02). However, there were no significant differences in wound infection (OR, 0.88; 95% CI, 0.16, 4.93, p = 0.88), re-exploration for bleeding (OR, 0.96; 95% CI, 0.60, 1.53, p = 0.86), intraoperative blood loss (MD, -259.19; 95% CI, -615.11, 96.73, p = 0.15) and operative time (MD, -7.39; 95% CI, -19.10, 4.32, p = 0.22); the results showed that the microsternotomy did not differ significantly from that of the routine approach. Small sternotomy may be an effective and safe substitute for the treatment of the aorta root. Nevertheless, the wide variety of data indicates that larger, well-designed studies are required to back up the current limited literature evidence showing a benefit in terms of complications like postoperative wound infections or the volume of intraoperative red blood cell transfusion.
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Does bone wax make sense in off-pump coronary surgery? A prospective randomized study
Sorm, Z., Vobornik, M., Dergel, M., Cermakova, E., Harrer, J., Gofus, J.
Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery. 2023;20(2):67-71
Abstract
INTRODUCTION The effect of bone wax on sternal infection and intraoperative bleeding in off-pump coronary surgery has not been reported in current literature. AIM: To prospectively evalute this in a cohort of high risk patients undergoing off-pump coronary artery surgery at our institution. The potential impact on cell saver utilization was also studied. MATERIAL AND METHODS A prospective randomized study was performed in 58 diabetic patients operated on for two-vessel coronary artery disease by the off-pump technique. They were randomly assigned to the wax or no-wax group. RESULTS There was no significant difference in intraoperative blood loss between the wax (550 ml) and no-wax group (750 ml; p = 0.0711). In multivariate analysis the absence (non-use) of bone wax (odds ratio = 3.9 (1.12-13.51), p = 0.027) and preoperative creatinin level (odds ratio = 1.1 (0.99-1.03), p = 0.03) were identified as independent predictors of blood loss ≥ 750 ml. The number of red blood cell units during hospital stay was similar in both groups (p = 0.42). Wound healing complications were not observed in either group. CONCLUSIONS The use of bone wax does not lead to a higher risk of sternal wound infection. It may reduce the risk of high intraoperative blood loss, thus avoiding the need of a cell saver during off-pump coronary surgery. However, this influence remains questionable.
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Low-Dose vasopressin and renal perfusion in pediatric cardiac surgery
Kumar, A., Ghotra, G. S., Raj, S., Tiwari, N., Ramamurthy, H. R.
Annals of cardiac anaesthesia. 2023;26(3):309-317
Abstract
BACKGROUND Congenital heart surgeries are associated with post-bypass renal and cardiac dysfunctions. The use of low-dose vasopressin has been found to be beneficial in adult cardiac surgeries. OBJECTIVE To assess the hemodynamic and renal effects of patients undergoing on-pump pediatric cardiac surgery under general anesthesia (GA) with low-dose vasopressin infusion. DESIGN Prospective randomized controlled study. SETTING Operation room and ICU, tertiary care teaching hospital. PATIENTS Fifty-five pediatric cardiac patients undergoing repair for congenital heart diseases (CHD). INTERVENTIONS Low-dose vasopressin infusion in the study group and placebo in the control group. MEASUREMENTS AND MAIN RESULTS Renal near-infrared spectroscopy (NIRS), serum NGAL, and inflammatory mediators-IL6 and IL8 along with other renal and hemodynamic parameters in the perioperative period were recorded. Diastolic blood pressure (DBP) and cardiac index were significantly higher in the vasopressin group. Inflammatory markers were significantly high in the immediate postoperative period in all patients which later stabilized in the next 48 h but showed similar trends in both groups. Low-dose vasopressin infusion did not improve either renal perfusion or function. The duration of mechanical ventilation and length of hospital stay, the incidence of AKI development, and transfusion requirements were marginally lower in the vasopressin group, although not significant. CONCLUSION Low-dose vasopressin infusion improved hemodynamics and showed a decreased incidence of complications. However, it failed to show any benefit of renal function and overall outcome in pediatric cardiac surgery.
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Platelet Function Testing Using Sonoclot and TEG6s as a Platelet Transfusion Prediction Tool in Open Heart Surgery
Sato, T., Edanaga, M., Yamakage, M., Harada, R., Kawaharada, N.
Cureus. 2023;15(11):e49131
Abstract
Introduction The point-of-care test (POCT) is useful for blood coagulation management during cardiovascular surgery. Although thromboelastography (TEG6s) has been reported to have targeted benefits for blood transfusion in cardiac surgery, Sonoclot analysis has not yet been fully validated. In this study, we evaluated the accuracy of Sonoclot, especially platelet function (PF) as a platelet concentrate (PC) transfusion parameter, compared to TEG6s in cardiovascular surgery. Methods This single-center, prospective, randomised trial was conducted at a university hospital. Forty-two adult patients who underwent elective cardiac surgery requiring cardiopulmonary bypass were included in this study between 2017 and 2021. The participants were randomly assigned to the Sonoclot (S) or Sonoclot and TEG6s (ST) groups. The amount of intraoperative PC was determined according to the POCT parameter values at the time of protamine administration. In addition, we investigated the correlation between PF parameters of POCT and platelet count at the end of surgery. Results There was no statistically significant difference in the intraoperative PC volume between the two groups. The Sonoclot PF parameter, PF, was moderately correlated with platelet count at the end of surgery (r=0.5449, p=0.009), and the TEG6s PF parameter showed a strong correlation with platelet count at the end of surgery (r=0.7744, p<0.001). Conclusion There was no statistically significant difference in platelet transfusion volume between the Sonoclot and TEG6s in this study. The correlation between the PF of the Sonoclot and platelet count was moderate. This study suggests that PF of Sonoclot may be a potentiating indicator of PF.
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Red Blood Cell Transfusion Guided by Hemoglobin Only or Integrating Perfusion Markers in Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis With Trial Sequential Analysis
Putaggio, A., Tigano, S., Caruso, A., La Via, L., Sanfilippo, F.
Journal of cardiothoracic and vascular anesthesia. 2023
Abstract
OBJECTIVE Strategies for red blood cell (RBC) transfusion in patients undergoing cardiac surgery have been traditionally anchored to hemoglobin (Hb) targets. A more physiologic approach would consider markers of organ hypoperfusion. DESIGN The authors conducted a systematic review and meta-analysis with trial sequential analysis of randomized controlled trials (RCTs). SETTING Cardiac surgery. PARTICIPANTS Adult patients. INTERVENTION RBC transfusion targeting only Hb levels compared with strategies combining Hb values with markers of organ hypoperfusion. MEASUREMENTS AND MAIN RESULTS Primary outcomes were the number of RBC units transfused, the number of patients transfused at least once, and the average number of transfusions. Secondary outcomes were postoperative complications, intensive care (ICU) and hospital lengths of stay, and mortality. Only 2 RCTs were included (n = 257 patients), and both used central venous oxygen saturation (ScvO(2)) as a marker of organ hypoperfusion (cut-off: <70% or ≤65%). A transfusion protocol combining Hb and ScvO(2) reduced the overall number of RBC units transfused (risk ratio [RR]: 1.57 [1.33-1.85]; p < 0.0001, I(2) = 0%), and the number of patients transfused at least once (RR: 1.33 [1.16-1.53]; p < 0.0001, I(2) = 41%), but not the average number of transfusions (mean difference [MD]: 0.18 [-0.11 to 0.47]; p = 0.24, I(2) = 66%), with moderate certainty of evidence. Mortality (RR: 1.29, [0.29-5.77]; p = 0.73, I(2) = 0%), ICU length-of-stay (MD: -0.06 [-0.58 to 0.46]; p = 0.81, I(2) = 0%), hospital length-of-stay (MD: -0.05 [-1.49 to 1.39];p = 0.95, I(2) = 0%), and all postoperative complications were not affected. CONCLUSIONS In adult patients undergoing cardiac surgery, a restrictive protocol integrating Hb values with a marker of organ hypoperfusion (ScvO(2)) reduces the number of RBC units transfused and the number of patients transfused at least once without apparent signals of harm. These findings were preliminary and warrant further multicentric research.