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Randomized Controlled Trial to Compare Stapled Hemorroidopexy Plus Ligation Anopexy With Stapled Hemorroidepexy for Managing Grade III and IV Hemorroidal Disease
Elshazly, W. G., Abo Elros, M. A., Ali, A. S., Radwan, A. M.
Diseases of the colon and rectum. 2024
Abstract
BACKGROUND Despite the benefits of the Stapled hemorrhoidopexy in the short term, management of prolapsing hemorrhoids, the long-term results are still insufficient, regarding recurrent prolapse and patient satisfaction so in our current study we add ligation anopexy to stapled hemorroidopexy. OBJECTIVE Valuation of adding ligation anopexy to stapled hemorroidopexy in improving short and long-term results in the treatment of grade III-IV hemorrhoids. DATA SOURCES Between January 2018 and January 2020 we recruited 124 patients with grade III-IV hemorrhoids, at Alexandria main university hospital. STUDY SELECTION Randomized controlled trial. INTERVENTIONS One hundred twenty-four patients were blindly randomized into two equal groups, stapled hemorrhoidopexy (group I) and stapled hemorrhoidopexy plus ligation anopexy (group II). MAIN OUTCOME MEASURES Recurrence of hemorrhoids and patient satisfaction after a follow-up period of at least two years. RESULTS The average operating time was noticeably less in stapled hemorroidopexy group. Meanwhile, postoperative pain, analgesia requirement, hemorrhoids symptoms score, return to work, complications rate, and quality of life 1 month after surgery were similar. Following a mean follow-up of 36 months (interval, 24-47), group I, 10 patients (16%) complained of recurrent external swelling and/or prolapse compared to 3 patients (5%) in group II (p = 0.0368) requiring redo surgery. No redo-surgery was required in group II, furthermore, long-term patient satisfaction was significantly better in group II. LIMITATIONS Longer follow-up needed and single-center experience. CONCLUSIONS Stapled hemorroidopexy compared to stapled hemorroidopexy plus ligation anopexy were similar at short-term results as regard complications rate, hemorrhoids symptoms score, return to work, and quality of life. Long-term results were significantly better as regard recurrence of external swelling and/or prolapse and patient satisfaction after stapled hemorroidopexy plus ligation anopexy. See Video Abstract. TRIAL REGISTRATION NUMBER Pan African Clinical Trials Registry identifier PACTR20180100293130.
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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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Intravenous iron administration before cardiac surgery reduces red blood cell transfusion in patients without anaemia
Friedman, T., Dann, E. J., Bitton-Worms, K., Makhoul, M., Glam, R., Weis, A., Tam, D. Y., Bolotin, G.
British journal of anaesthesia. 2023
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Editor's Choice
Abstract
BACKGROUND Reducing the need for blood transfusion among patients undergoing cardiac surgery FLA reduce postoperative complications and mortality. Our study aimed to assess the effects of administering preoperative i.v. ferric carboxymaltose on postoperative red cell transfusion requirements in patients without anaemia undergoing on-pump cardiac surgery. METHODS This double-blind, randomised, placebo-controlled trial was conducted between October 2016 and November 2019, with a follow-up period of up to 6 weeks after surgery. Patients without anaemia who underwent on-pump cardiac surgery were included as participants and administered i.v. iron in the form of ferric carboxymaltose or placebo once, 24-72 h before surgery. The primary outcome was the number of red cell units transfused during the first four postoperative days, and the secondary outcome measures were blood haemoglobin concentrations at 4 days and 6 weeks after surgery. RESULTS The 200 patients included were randomly assigned to the ferric carboxymaltose (n=102) and placebo (n=98) groups. By postoperative Day 4, a significantly lower mean number of red cell units were transfused in the ferric carboxymaltose than in the placebo group, 0.3 (0.8) vs 1.6 (4.4), respectively; P=0.007. The mean haemoglobin concentrations on postoperative Day 4 were 9.7 (1) g dl(-1) and 9.3 (1) g dl(-1), respectively (P=0.03). Corresponding values at 6 weeks after surgery were 12.6 (1.4) g dl(-1) and 11.8 (1.5) g dl(-1), respectively (P=0.012). CONCLUSIONS In patients without anaemia undergoing on-pump cardiac surgery, treatment with a single dose of 1000 mg ferric carboxymaltose i.v. 1-3 days before surgery significantly reduced the need for red cell transfusions and increased the postoperative haemoglobin concentration. CLINICAL TRIAL REGISTRATION NCT02939794.
PICO Summary
Population
Patients without anaemia who underwent on-pump cardiac surgery (n= 200).
Intervention
Ferric carboxymaltose (n= 102).
Comparison
Placebo (n= 98).
Outcome
By postoperative day 4, a significantly lower mean number of red cell units were transfused in the ferric carboxymaltose than in the placebo group, 0.3 (0.8) vs. 1.6 (4.4), respectively. The mean haemoglobin concentrations on postoperative day 4 were 9.7 (1) g dl(-1) and 9.3 (1) g dl(-1), respectively. Corresponding values at 6 weeks after surgery were 12.6 (1.4) g dl(-1) and 11.8 (1.5) g dl(-1), respectively.
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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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Free full text
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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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Topical and Intravenous Tranexamic Acid in Acyanotic Children Undergoing Congenital Heart Surgery: A Randomized Clinical Trial
Bigdelian H, Montazeri M, Sedighi M, Mansouri M, Amanollahi A
The Journal of surgical research. 2023;288:64-70
Abstract
INTRODUCTION Postoperative bleeding is a common complication in congenital heart surgery. We aimed to evaluate effects of topical and intravenous tranexamic acid (TXA) administration on postoperative hemoglobin and bleeding in children with acyanotic congenital heart disease (CHD). METHODS In this randomized clinical trial, 50 acyanotic CHD children were allocated into two groups of topical (n = 25) and infusion (n = 25). Children in the infusion group were given intravenous TXA 50 mg/kg(-1) after sternotomy. Children in topical group were given 50 mg/kg(-1) TXA added to 20 mL of saline intrapericardially before sternal closure. Primary endpoint of study was comparison of postoperative hemoglobin and bleeding between topical and infusion groups. A linear mixed model (LMM) was used to estimate longitudinal changes in postoperative endpoints. RESULTS We did not observe significant differences in children's characteristics between two groups. Also, intraoperative and postoperative outcomes did not differ between two groups but children with intravenous TXA experienced significantly longer intubation time than topical children (P = 0.047). LMM analysis revealed that postoperative bleeding in topical group was lower compared to infusion group (P = 0.036). Also, age of children had a significant effect on mean changes of hemoglobin during postoperative care (β = -0.27, P = 0.030). No children died and none had serious postoperative complications such as seizures and reoperation. CONCLUSIONS We found that topical TXA is not superior to intravenous administration in management of blood loss. Also, no additional effect was found about topical TXA in further reducing transfusion rates and postoperative complications in acyanotic CHD children undergoing cardiac surgery.
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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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Cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate for Treating Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients
Abrahamyan L, Tomlinson G, Callum J, Carcone S, Grewal D, Bartoszko J, Krahn M, Karkouti K
JAMA surgery. 2023
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Free full text
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Editor's Choice
Abstract
IMPORTANCE Excessive bleeding requiring fibrinogen replacement is a serious complication of cardiac surgery. However, the relative cost-effectiveness of the 2 available therapies-fibrinogen concentrate and cryoprecipitate-is unknown. OBJECTIVE To determine cost-effectiveness of fibrinogen concentrate vs cryoprecipitate for managing active bleeding in adult patients who underwent cardiac surgery. DESIGN, SETTING, AND PARTICIPANTS A within-trial economic evaluation of the Fibrinogen Replenishment in Surgery (FIBERS) randomized clinical trial (February 2017 to November 2018) that took place at 4 hospitals based in Ontario, Canada, hospitals examined all in-hospital resource utilization costs and allogeneic blood product (ABP) transfusion costs incurred within 28 days of surgery. Participants included a subset of 495 adult patients from the FIBERS trial who underwent cardiac surgery and developed active bleeding and acquired hypofibrinogenemia requiring fibrinogen replacement. INTERVENTIONS Fibrinogen concentrate (4 g per dose) or cryoprecipitate (10 units per dose) randomized (1:1) up to 24 hours postcardiopulmonary bypass. MAIN OUTCOMES AND MEASURES Effectiveness outcomes included number of ABPs administered within 24 hours and 7 days of cardiopulmonary bypass. ABP transfusion (7-day) and in-hospital resource utilization (28-day) costs were evaluated and a multivariable net benefit regression model built for the full sample and predefined subgroups. RESULTS Patient level costs for 495 patients were evaluated (mean [SD] age 59.2 [15.4] years and 69.3% male.) Consistent with FIBERS, ABP transfusions and adverse events were similar in both treatment groups. Median (IQR) total 7-day ABP cost was CAD $2280 (US dollars [USD] $1697) (CAD $930 [USD $692]-CAD $4970 [USD $3701]) in the fibrinogen concentrate group and CAD $2770 (USD $1690) (IQR, CAD $1140 [USD $849]-CAD $5000 [USD $3723]) in the cryoprecipitate group. Median (interquartile range) total 28-day cost was CAD $38 180 (USD $28 431) $(IQR, CAD $26 350 [USD $19 622]-CAD $65 080 [USD $48 463]) in the fibrinogen concentrate group and CAD $38 790 (USD $28 886) (IQR, CAD $26 180 [USD $19 495]-CAD $70 380 [USD $52 409]) in the cryoprecipitate group. After exclusion of patients who were critically ill before surgery (11%) due to substantial variability in costs, the incremental net benefit of fibrinogen concentrate vs cryoprecipitate was positive (probability of being cost-effective 86% and 97% at $0 and CAD $2000 (USD $1489) willingness-to-pay, respectively). Net benefit was highly uncertain for nonelective and patients with critical illness. CONCLUSIONS AND RELEVANCE Fibrinogen concentrate is cost-effective when compared with cryoprecipitate in most bleeding adult patients who underwent cardiac surgery with acquired hypofibrinogenemia requiring fibrinogen replacement. The generalizability of these findings outside the Canadian health system needs to be verified.
PICO Summary
Population
A subset of patients enrolled in the FIBERS trial who underwent cardiac surgery and experienced bleeding resulting in acquired hyperfibrinogenemia (n= 495).
Intervention
Fibrinogen concentrate (n= 251).
Comparison
Cryoprecipitate (n= 244).
Outcome
Patient level costs were evaluated. Median (interquartile range (IQR)) total 7-day allogeneic blood product (ABP) cost was CAD $2,280 (US dollars [USD] $1,697) (CAD $930 [USD $692]-CAD $4,970 [USD $3,701]) in the fibrinogen concentrate group and CAD $2,770 (USD $1,690) (IQR, CAD $1,140 [USD $849]-CAD $5,000 [USD $3,723]) in the cryoprecipitate group. Median (IQR) total 28-day cost was CAD $38,180 (USD $28 431) (IQR, CAD $26,350 [USD $19,622]-CAD $65,080 [USD $48,463]) in the fibrinogen concentrate group and CAD $38,790 (USD $28,886) (IQR, CAD $26,180 [USD $19,495]-CAD $70,380 [USD $52,409]) in the cryoprecipitate group. After exclusion of patients who were critically ill before surgery (11%) due to substantial variability in costs, the incremental net benefit of fibrinogen concentrate vs. cryoprecipitate was positive (probability of being cost-effective 86% and 97% at $0 and CAD $2,000 (USD $1,489) willingness-to-pay, respectively). Net benefit was highly uncertain for nonelective and patients with critical illness.
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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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Effect of Retrograde Autologous Priming on Coagulation Assessed by Rotation Thromboelastometry in Patients Undergoing Valvular Cardiac Surgery
Ko, S. H., Nan, Z., Soh, S., Shim, J. K., Lee, H. W., Kwak, Y. L., Song, J. W.
Journal of cardiothoracic and vascular anesthesia. 2023
Abstract
OBJECTIVES To investigate the effect of retrograde autologous priming (RAP) on coagulation function using rotation thromboelastometry (ROTEM) in patients undergoing valvular cardiac surgery. DESIGN A prospective, randomized, patient- and outcome assessor-blinded study. SETTING At a single-center university hospital. PARTICIPANTS Patients aged 20 years or older undergoing valvular cardiac surgery. INTERVENTIONS A total of 104 patients were allocated to the RAP or control group (1:1 ratio). In the RAP group, the prime was displaced into the collection bag before bypass initiation. ROTEM was performed at the induction of anesthesia, at the beginning of rewarming, and after the reversal of heparinization. Allogeneic plasma products and platelet concentrates were transfused according to ROTEM-based algorithms. MEASUREMENTS AND MAIN RESULTS An average volume of 635 ± 114 mL was removed using RAP (from the 1,600 mL initial prime volume). The hematocrit 10 minutes after cardiopulmonary bypass (CPB) was 24.7 ± 3.5% in the control group, and 26.1 ± 4.1% in the RAP group (p = 0.330). ROTEM, including EXTEM, INTEM, and FIBTEM, showed prolonged clotting time and decreased maximal clot firmness after CPB in both groups without intergroup differences. The number of patients who received intraoperative erythrocytes (27% v 25%, control versus RAP, p = 0.823), fresh frozen plasma (14% v 8%, control versus RAP, p = 0.339), cryoprecipitate (21% v 12%, control versus RAP, p = 0.185), or platelet concentrate transfusion (19% v 12%, control versus RAP, p = 0.277) did not differ between the groups. CONCLUSIONS Cardiopulmonary bypass induced impaired coagulation function on ROTEM. However, RAP did not improve coagulation function when compared with conventional priming in patients undergoing valvular cardiac surgery.