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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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An Individualized Red Blood Cell Transfusion Strategy Using Pediatric Perioperative-Transfusion-Trigger Score Reduced Perioperative Blood Exposure for Children: A Randomized Controlled Clinical Trial
Luo Z, Li Y, Li X, Liao R
Therapeutics and clinical risk management. 2023;19:229-237
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Editor's Choice
Abstract
OBJECTIVE The optimal red blood cell transfusion strategy for children remains unclear. We developed an individualized red blood cell transfusion strategy for children and tested the hypothesis that transfusion guided by this strategy could reduce blood exposure, without increasing perioperative complications in children. METHODS In this randomized controlled clinical trial, 99 children undergoing noncardiac surgeries who had blood loss of more than 20% total blood volume were randomly assigned to an individualized-strategy group using Pediatric Perioperative-Transfusion-Trigger Score or a control group. The amount of transfused red blood cell was counted, and patients were followed up for postoperative complications within 30 days. RESULTS Twenty-six children (53.1%) in the individualized-strategy group received transfusion perioperatively, as compared with 37 children (74%) in the control group (p < 0.05). During surgery, children in the individualized-strategy group were exposed to fewer transfusions than in the control group (0.87±1.03 vs 1.33±1.20 Red-Blood-Cell units per patient, p = 0.02). The incidence of severe complications in the individualized-strategy group had a lower trend compared to the control group (8.2% vs 18%, p = 0.160). No significant difference was found in the other outcomes. CONCLUSION This trial proved that red blood cell transfusion guided by the individualized strategy reduced perioperative blood exposure in children, without increasing the incidence of severe complications. This conclusion needs to be reaffirmed by larger-scale, multicenter clinical trials.
PICO Summary
Population
Children undergoing non-cardiac surgery who had blood loss of more than 20% total blood volume (n= 99).
Intervention
Individualized red blood cell (RBC) transfusion strategy using Pediatric Perioperative-Transfusion-Trigger Score (individualized-strategy group, n= 49).
Comparison
RBC transfusion initiated when the patient’s haemoglobin concentration was lower than 8g per deciliter, or lower than 10g per deciliter for newborns (control group, n= 50).
Outcome
Twenty-six children (53.1%) in the individualized-strategy group received transfusion perioperatively, as compared with 37 children (74%) in the control group. During surgery, children in the individualized-strategy group were exposed to fewer transfusions than in the control group (0.87±1.03 vs. 1.33±1.20 red blood cell units per patient). The incidence of severe complications in the individualized-strategy group had a lower trend compared to the control group (8.2% vs. 18%). No significant difference was found in the other outcomes.
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Refraining from Packed Red Blood Cells in Cardiopulmonary Bypass Priming as a Method of Neuroprotection in Pediatric Cardiac Surgery
Ivkin AA, Grigoriev E, Sinitskaya AV
Journal of clinical medicine. 2023;12(4)
Abstract
Congenital heart defect (CHD) surgeries are performed with cardiopulmonary bypass (CPB) and are complicated by several factors that affect the child's brain. However, to date, the number of studies on brain protection in cardiac surgery remains small. The aim of this study was to assess the impact of refraining from using packed red blood cells (PRBCs) in priming solutions in children with congenital defects (CHDs) who require surgical interventions using CPB to prevent brain injury in the postoperative period. MATERIAL AND METHODS This study included 40 children, and the mean age was 14 (12-22.5) months and the mean weight was 8.8 (7.25-11) kg. All patients underwent CHD closure using CPB. The patients were divided into two groups depending on the use of PRBCs in the priming solution. Brain injury was assessed using three specific blood serum markers, namely S100 calcium-binding protein β (S100β), neuron-specific enolase (NSE) and glial fibrillary acidic protein (GFAP) before surgery, after the completion of CPB and 16 h after surgery (first, second and third control points). Markers of systemic inflammatory response were also analyzed, including interleukin-1, -6, -10 and tumor necrosis factor alpha (TNF-α). A clinical assessment of brain injury was carried out using a valid, rapid, observational tool for screening delirium in children of this age group, i.e., "Cornell Assessment of Pediatric Delirium". RESULTS Factors of the intra- and postoperative period were analyzed, such as hemoglobin levels, oxygen delivery (cerebral tissue oxygenation, blood lactate level and venous oxygen saturation) and indicators of organ dysfunction (creatinine, urea, bilirubin levels, duration of CPB and length of stay in the ICU). Following the procedure, there were no significant differences between the groups and all indicators were within the reference values, thus demonstrating the safety of CHD closure without transfusion. Moreover, the highest level of specific markers of brain injury were noted immediately after the completion of CPB in both groups. The concentration of all three markers was significantly higher in the group with transfusion after the completion of CPB. Moreover, GFAP levels were higher in the transfusion group and 16 h after surgery. CONCLUSIONS The results of the study show the safety and effectiveness of brain injury prevention strategies that consist of not conducting PRBC transfusion.
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A physiology-based trigger score to guide perioperative transfusion of allogeneic red blood cells: A multicentre randomised controlled trial
Lu K, Huang Z, Liang S, Pan F, Zhang C, Wei J, Wei H, Wang Y, Liao R, Huang A, et al
Transfusion medicine (Oxford, England). 2022
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Editor's Choice
Abstract
BACKGROUND Restrictive blood transfusion is recommended by major guidelines for perioperative management, but requires objective assessment at 7-10 g/dl haemoglobin (Hb). A scoring system that considers the physiological needs of the heart may simply the practice and reduce transfusion. METHODS Patients (14-65 years of age) undergoing non-cardiac surgery were randomised at a 1:1 ratio to a control group versus a Perioperative Transfusion Trigger Score (POTTS) group. POTTS (maximum of 10) was calculated as 6 plus the following: adrenaline infusion rate (0 for no infusion, 1 for ≤0.05 μg·kg(-1) ·min(-1) , and 2 for higher rate), FiO(2) to keep SpO(2) at ≥95% (0 for ≤35%, 1 for 36%-50%, and 2 for higher), core temperature (0 for <38°C, 1 for 38-40°C, and 2 for higher), and angina history (0 for no, 1 for exertional, and 2 for resting). Transfusion is indicated when actual Hb is lower than the calculated POTTS in individual patients. Transfusion in the control group was based on the 2012 American Association for Blood Banks (AABB) guideline. The primary outcome was the proportion of the patients requiring transfusion of allogeneic red blood cells (RBCs) during the perioperative period (until discharge from hospital), as assessed in the intention-to-treat (ITT) population (all randomised subjects). RESULT A total of 864 patients (mean age 44.4 years, 244 men and 620 women) were enrolled from December 2017 to January 2021 (433 in the control and 431 in the POTTS group). Baseline Hb was 9.2 ± 1.8 and 9.2 ± 1.7 g/dl in the control and POTTS groups, respectively. In the ITT analysis, the proportion of the patients receiving allogeneic RBCs was 43.9% (190/433) in the control group versus 36.9% (159/431) in the POTTS group (p = 0.036). Lower rate of allogeneic RBCs transfusion in the POTTS group was also evident in the per-protocol analysis (42.8% vs. 35.5%, p = 0.030). Transfusion volume was 4.0 (2.0, 6.0) and 3.5 (2.0, 5.5) units (200 ml/unit) in the control and POTTS groups, respectively (p = 0.25). The rate of severe postoperative complications (Clavien-Dindo grade IIIa and higher) was 3.9% in the control group versus 1.2% in the POTTS group (p = 0.010). CONCLUSION Transfusion of allogeneic RBCs based on the POTTS was safe and reduced the transfusion requirement in patients undergoing non-cardiac surgery.
PICO Summary
Population
Patients (14-65 years old) undergoing non-cardiac surgery (n= 864).
Intervention
Transfusion based on a perioperative transfusion trigger score (POTTS), (n= 431).
Comparison
Restrictive transfusion (n= 433).
Outcome
In the intention to treat analysis, the proportion of the patients receiving allogeneic red blood cells (RBCs) was 43.9% (190) in the restrictive group vs. 36.9% (159) in the POTTS group. Lower rate of allogeneic RBCs transfusion in the POTTS group was also evident in the per-protocol analysis (42.8% vs. 35.5%). Transfusion volume was 4.0 (2.0, 6.0) and 3.5 (2.0, 5.5) units (200 ml/unit) in the restrictive and POTTS groups, respectively. The rate of severe post-operative complications was 3.9% in the restrictive group vs. 1.2% in the POTTS group.
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Red blood cell transfusion threshold after pediatric cardiac surgery: A systematic review and meta-analysis
Deng X, Wang Y, Huang P, Luo J, Xiao Y, Qiu J, Yang G
Medicine. 2019;98(11):e14884
Abstract
BACKGROUND Restrictive red blood cell transfusion strategy is implemented to minimize risk following allogeneic blood transfusion in adult cardiac surgery. However, it is still unclear if it can be applied to pediatric cardiac patients. The purpose of this systematic review and meta-analysis was to determine the effect of postoperative restrictive transfusion thresholds on clinical outcomes based on up-to-date results of randomized controlled trials (RCTs) and observational studies in pediatric cardiac surgery. METHOD We searched for RCTs and observational studies in the following databases: the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, and ClinicalTrials.gov from their inception to October 26, 2017. We also searched reference lists of published guidelines, reviews, and relevant articles, as well as conference proceedings. No language restrictions were applied and no observational study met the inclusion criteria. RESULTS Four RCTs on cardiac surgery involving 454 patients were included. There were no differences in the pooled fixed effects of intensive care unit (ICU) stay between the liberal and restrictive transfusion thresholds (standardized mean difference SMD, 0.007; 95% confidence interval CI, -0.18-0.19; P = .94). There were also no differences in the length of hospital stay (SMD, -0.062; 95% CI, -0.28-0.15; P = .57), ventilation duration (SMD, -0.015; 95% CI, -0.25-0.22; P = .90), mean arterial lactate level (SMD, 0.071; 95% CI, -0.22-0.36; P = .63), and mortality (risk ratio, 0.49; 95% CI, 0.13-1.94; P = .31). There was no inter-trial heterogeneity for any pooled analysis. Publication bias was tested using Egger, Begg, or the trim-and-fill test, and the results indicated no significant publication bias. CONCLUSION Evidence from RCTs in pediatric cardiac surgery, though limited, showed non-inferiority of restrictive thresholds over liberal thresholds in length of ICU stay and other outcomes following red blood cell transfusion. Further high-quality RCTs are necessary to confirm the findings.
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Longitudinal Changes in Disability Rating Scale Scores: A Secondary Analysis Among Patients With Severe TBI Enrolled in the Epo Clinical Trial
Benoit JS, Hannay HJ, Yamal JM, Francis DJ, Aisiku I, Robertson C
Journal of the International Neuropsychological Society : JINS. 2019;25(3):293-301
Abstract
OBJECTIVES Long-term neurological response to treatment after a severe traumatic brain injury (sTBI) is a dynamic process. Failure to capture individual heterogeneity in recovery may impact findings from single endpoint sTBI randomized controlled trials (RCT). The present study re-examined the efficacy of erythropoietin (Epo) and transfusion thresholds through longitudinal modeling of sTBI recovery as measured by the Disability Rating Scale (DRS). This study complements the report of primary outcomes in the Epo sTBI RCT, which failed to detect significant effects of acute treatment at 6 months post-injury. METHODS We implemented mixed effects models to characterize the recovery time-course and to examine treatment efficacy as a function of time post-injury and injury severity. RESULTS The inter-quartile range (25th-75th percentile) of DRS scores was 20-28 at week1; 8-24 at week 4; and 3-17 at 6 months. TBI severity group was found to significantly interact with Epo randomization group on mean DRS recovery curves. No significant differences in DRS recovery were found in transfusion threshold groups. CONCLUSIONS This study demonstrated the value of taking a comprehensive view of recovery from sTBI in the Epo RCT as a temporally dynamic process that is shaped by both treatment and injury severity, and highlights the importance of the timing of primary outcome measurement. Effects of Epo treatment varied as a function of injury severity and time. Future studies are warranted to understand the possible moderating influence of injury severity on treatment effects pertaining to sTBI recovery. (JINS, 2019, 25, 293-301).
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Comparison of hemoglobin and hematocrit levels at 1, 4 and 24h after red blood cell transfusion
Karndumri K, Tantiworawit A, Hantrakool S, Fanhchaksai K, Rattarittamrong E, Limsukon A, Pruksakorn D, Karndumri S, Rattanathammethee T, Chai-Adisaksopha C, et al
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2019
Abstract
Previous studies have shown that equilibration following a red cell transfusion had occurred by 24h. A shorter time to follow the hemoglobin (Hb) and hematocrit (Hct) after transfusion may help physicians to provide earlier and more pertinent treatment. This was a prospective study conducted from December 2014 to August 2015. This research aimed to determine the equilibration time point of the level of Hb and Hct after one unit red blood cell (RBC) transfusion. Patients were randomized into three groups and Hb level and Hct were assessed at one, four or 24h after transfusion. The mean differences in Hb level and Hct before and after transfusion were compared between each group. Sixty patients were eligible for enrollment onto this study; 20 patients were therefore allocated to each group. The median age was 51 years old, male predominating (83.33%). The most common indication for transfusion was post-operative anemia (88.33%). There were no significant differences between the baseline characteristics baseline Hb, Hct and volume of RBC transfusion in each group. The mean differences in Hb (g/dl)/Hct (%) level at the different time points of one, four and 24h were 1.21/3.62, 1.19/3.63, and 0.95/3.09 respectively (P=0.109 and P=0.398, respectively). The equilibration of Hb and Hct did not differ between one, four and 24h after a RBC transfusion. The target Hb and Hct can be determined at one hour after transfusion.
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Outcomes using a conservative versus liberal red blood cell transfusion strategy in infants requiring cardiac operation
Cholette JM, Swartz MF, Rubenstein J, Henrichs KF, Wang H, Powers KS, Daugherty LE, Alfieris GM, Gensini F, Blumberg N
The Annals of Thoracic Surgery. 2016;103((1):):206-214
Abstract
BACKGROUND The optimal hemoglobin for infants after cardiac operation is unknown. Red blood cells (RBCs) are commonly transfused to maintain high hemoglobin concentrations in the absence of a clinical indication. We hypothesized that infants can be managed with a postoperative conservative RBC transfusion strategy, resulting in lower daily hemoglobin concentrations, without evidence of impaired oxygen delivery (ie, lactate, arteriovenous oxygen difference [avO2diff]), or adverse clinical outcomes. METHODS Infants weighing 10 kg or less undergoing biventricular repair or palliative (nonseptated) operation were randomly assigned to either a postoperative conservative or liberal transfusion strategy. Conservative group strategy was RBC transfusion for a hemoglobin less than 7.0 g/dL for biventricular repairs or less than 9.0 g/dL for palliative procedures plus a clinical indication. Liberal group strategy was RBC transfusion for hemoglobin less than 9.5 g/dL for biventricular repairs or less than 12 g/dL for palliative procedures regardless of clinical indication. RESULTS After the operation of 162 infants (82 conservative [53 biventricular, 29 palliative], 80 liberal [52 biventricular, 28 palliative]), including 12 Norwood procedures (6 conservative, 6 liberal), daily hemoglobin concentrations were significantly lower within the conservative group than the liberal group by postoperative day 1 and remained lower for more than 10 days. The percentage of patients requiring a RBC transfusion, number of transfusions, and volume of transfusions were all significantly lower within the conservative group. Despite lower hemoglobin concentrations within the conservative group, lactate, avO2diff, and clinical outcomes were similar. CONCLUSIONS Infants undergoing cardiac operation can be managed with a conservative RBC transfusion strategy. Clinical indications should help guide the decision for RBC transfusion even in this uniquely vulnerable population. Larger multicenter trials are needed to confirm these results, and focus on the highest risk patients would be of great interest.
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Longer RBC storage duration is associated with increased postoperative infections in pediatric cardiac surgery
Cholette, J. M., Pietropaoli, A. P., Henrichs, K. F., Alfieris, G. M., Powers, K. S., Phipps, R., Spinelli, S. L., Swartz, M., Gensini, F., Daugherty, L. E., et al
Pediatric Critical Care Medicine : A Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. 2015;16(3):227-35
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Abstract
OBJECTIVES Infants and children undergoing open heart surgery routinely require multiple RBC transfusions. Children receiving greater numbers of RBC transfusions have increased postoperative complications and mortality. Longer RBC storage age is also associated with increased morbidity and mortality in critically ill children. Whether the association of increased transfusions and worse outcomes can be ameliorated by use of fresh RBCs in pediatric cardiac surgery for congenital heart disease is unknown. INTERVENTIONS One hundred and twenty-eight consecutively transfused children undergoing repair or palliation of congenital heart disease with cardiopulmonary bypass who were participating in a randomized trial of washed versus standard RBC transfusions were evaluated for an association of RBC storage age and clinical outcomes. To avoid confounding with dose of transfusions and timing of infection versus timing of transfusion, a subgroup analysis of patients only transfused 1-2 units on the day of surgery was performed. MEASUREMENTS AND MAIN RESULTS Mortality was low (4.9%) with no association between RBC storage duration and survival. The postoperative infection rate was significantly higher in children receiving the oldest blood (25-38 d) compared with those receiving the freshest RBCs (7-15 d) (34% vs 7%; p = 0.004). Subgroup analysis of subjects receiving only 1-2 RBC transfusions on the day of surgery (n = 74) also demonstrates a greater prevalence of infections in subjects receiving the oldest RBC units (0/33 [0%] with 7- to 15-day storage; 1/21 [5%] with 16- to 24-day storage; and 4/20 [20%] with 25- to 38-day storage; p = 0.01). In multivariate analysis, RBC storage age and corticosteroid administration were the only predictors of postoperative infection. Washing the oldest RBCs (> 27 d) was associated with a higher infection rate and increased morbidity compared with unwashed RBCs. DISCUSSION Longer RBC storage duration was associated with increased postoperative nosocomial infections. This association may be secondary in part, to the large doses of stored RBCs transfused, from single-donor units. Washing the oldest RBCs was associated with increased morbidity, possibly from increased destruction of older, more fragile erythrocytes incurred by washing procedures. Additional studies examining the effect of RBC storage age on postoperative infection rate in pediatric cardiac surgery are warranted.
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Safety and effects of two red blood cell transfusion strategies in pediatric cardiac surgery patients: a randomized controlled trial
de Gast-Bakker DH, de Wilde RB, Hazekamp MG, Sojak V, Zwaginga JJ, Wolterbeek R, de Jonge E, Gesink-van der Veer BJ
Intensive Care Medicine. 2013;39((11):):2011-9.
Abstract
OBJECTIVE To investigate the safety and effects of a restrictive red blood cell (RBC) transfusion strategy in pediatric cardiac surgery patients. DESIGN Randomized controlled trial. SETTING Pediatric ICU in an academic tertiary care center, Leiden University Medical Center, Leiden, The Netherlands. PATIENTS One hundred seven patients with non-cyanotic congenital heart defects between 6weeks and 6years of age. One hundred three patients underwent corrective surgery on cardiopulmonary bypass. INTERVENTIONS Prior to surgery patients were randomly assigned to one of two groups with specific RBC transfusion thresholds: Hb 10.8g/dl (6.8mmol/l) and Hb 8.0g/dl (5.0mmol/l). MEASUREMENTS Length of stay in hospital (primary outcome), length of stay in PICU, duration of ventilation (secondary outcome), incidence of adverse events and complications related to randomization (intention to treat analysis). RESULTS In the restrictive transfusion group, mean volume of transfused RBC was 186 (+/-70) ml per patient and in the liberal transfusion group 258 (+/-87) ml per patient, (95% CI 40.6-104.6), p<0.001. Length of hospital stay was shorter in patients with a restrictive RBC transfusion strategy: median 8 (IQR 7-11) vs. 9 (IQR 7-14) days, p=0.047. All other outcome measures and incidence of adverse effects were equal in both RBC transfusion groups. Cost of blood products for the liberal transfusion group was 438.35 (+/-203.39) vs. 316.27 (+/-189.96) euros (95% CI 46.61-197.51) per patient in the restrictive transfusion group, p=0.002. CONCLUSIONS For patients with a non-cyanotic congenital heart defect undergoing elective cardiac surgery, a restrictive RBC transfusion policy (threshold of Hb 8.0g/dl) during the entire perioperative period is safe, leads to a shorter hospital stay and is less expensive.