Tranexamic Acid to Prevent Obstetrical Hemorrhage after Cesarean Delivery.

BACKGROUND: Prophylactic use of tranexamic acid at the time of cesarean delivery has been shown to decrease the calculated blood loss, but the effect on the need for blood transfusions is unclear. METHODS: We randomly assigned patients undergoing cesarean delivery at 31 U.S. hospitals to receive either tranexamic acid or placebo after umbilical-cord clamping. The primary outcome was a composite of maternal death or blood transfusion by hospital discharge or 7 days post partum, whichever came first. Key secondary outcomes were estimated intraoperative blood loss of more than 1 liter (prespecified as a major secondary outcome), interventions for bleeding and related complications, the preoperative-to-postoperative change in the hemoglobin level, and postpartum infectious complications. Adverse events were assessed. RESULTS: A total of 11,000 participants underwent randomization (5529 to the tranexamic acid group and 5471 to the placebo group); scheduled cesarean delivery accounted for 50.1% and 49.2% of the deliveries in the respective groups. A primary-outcome event occurred in 201 of 5525 participants (3.6%) in the tranexamic acid group and in 233 of 5470 (4.3%) in the placebo group (adjusted relative risk, 0.89; 95.26% confidence interval [CI], 0.74 to 1.07; P = 0.19). Estimated intraoperative blood loss of more than 1 liter occurred in 7.3% of the participants in the tranexamic acid group and in 8.0% of those in the placebo group (relative risk, 0.91; 95% CI, 0.79 to 1.05). Interventions for bleeding complications occurred in 16.1% of the participants in the tranexamic acid group and in 18.0% of those in the placebo group (relative risk, 0.90; 95% CI, 0.82 to 0.97); the change in the hemoglobin level was -1.8 g per deciliter and -1.9 g per deciliter, respectively (mean difference, -0.1 g per deciliter; 95% CI, -0.2 to -0.1); and postpartum infectious complications occurred in 3.2% and 2.5% of the participants, respectively (relative risk, 1.28; 95% CI, 1.02 to 1.61). The frequencies of thromboembolic events and other adverse events were similar in the two groups. CONCLUSIONS: Prophylactic use of tranexamic acid during cesarean delivery did not lead to a significantly lower risk of a composite outcome of maternal death or blood transfusion than placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT03364491.).

Evaluation of a novel Cardiac Peri-Operative Transfusion Trigger Scoring system in patients with coronary artery disease.

BACKGROUND: A simple and accurate scoring system to guide perioperative blood transfusion in patients with coronary artery disease (CAD) undergoing cardiac surgery is lacking. The trigger point for blood transfusions for these patients may be different from existing transfusion guidelines. This study aimed to evaluate the safety and efficacy of a new scoring strategy for use in guiding transfusion decisions in patients with CAD. METHODS: A multicenter randomized controlled trial was conducted at three third-level grade-A hospitals from January 2015 to May 2018. Data of 254 patients in a Cardiac Peri-Operative Transfusion Trigger Score (cPOTTS) group and 246 patients in a group receiving conventional evaluation of the need for transfusion (conventional group) were analysed. The requirements for transfusion and the per capita consumption of red blood cells (RBCs) were compared between groups. RESULTS: Baseline characteristics of the two groups were comparable. Logistic regression analyses revealed no significant differences between the two groups in primary outcomes (1-year mortality and perioperative ischemic cardiac events), secondary outcomes (shock, infections, and renal impairment), ICU admission, and ICU stay duration. However, patients in the cPOTTS group had significantly shorter hospital stays, lower hospital costs, lower utilization rate and lower per capita consumption of transfused RBCs than controls. Stratified analyses revealed no significant differences between groups in associations between baseline characteristics and perioperative ischemic cardiac events, except for hemofiltration or dialysis and NYHA class in I. CONCLUSIONS: This novel scoring system offered a practical and straightforward guideline of perioperative blood transfusion in patients with CAD. Trial registration chiCTR1800016561(2017/7/19).

Impact of Perioperative Massive Transfusion on Long Term Outcomes of Liver Transplantation: a Retrospective Cohort Study.

Background: Liver transplantation (LT) is associated with a significant risk of intraoperative hemorrhage and massive blood transfusion. However, there are few relevant reports addressing the long-term impacts of massive transfusion (MT) on liver transplantation recipients. Aim: To assess the effects of MT on the short and long-term outcomes of adult liver transplantation recipients. Methods: We included adult patients who underwent liver transplantation at West China Hospital from January 2011 to February 2015. MT was defined as red blood cell (RBC) transfusion of ≥10 units within 48 hours since the application of LT. Preoperative, intraoperative and postoperative information were collected for data analyzing. We used one-to-one propensity-matching to create pairs. Kaplan-Meier survival analysis was used to compare long-term outcomes of LT recipients between the MT and non-MT groups. Univariate and multivariate logistic regression analyses were performed to evaluate the risk factors associated with MT in LT. Results: Finally, a total of 227 patients were included in our study. After propensity score matching, 59 patients were categorized into the MT and 59 patients in non-MT groups. Compared with the non-MT group, the MT group had a higher 30-day mortality (15.3% vs 0, p=0.006), and a higher incidence of postoperative complications, including postoperative pulmonary infection, abdominal hemorrhage, pleural effusion and severe acute kidney injury. Furthermore, MT group had prolonged postoperative ventilation support (42 vs 25 h, p=0.007) and prolonged durations of ICU (12.9 vs 9.5 d, p<0.001) stay. Multivariate COX regression indicated that massive transfusion (OR: 2.393, 95% CI: 1.164-4.923, p=0.018) and acute rejection (OR: 7.295, 95% CI: 2.108-25.246, p=0.02) were significant risk factors affecting long-term survivals of LT patients. The 1-year and 3-year survival rates patients in MT group were 82.5% and 67.3%, respectively, while those of non-MT group were 93.9% and 90.5%, respectively. The MT group exhibited a lower long-term survival rate than the non-MT group (HR: 2.393, 95% CI: 1.164-4.923, p<0.001). Finally, the multivariate logistic regression revealed that preoperative hemoglobin <118 g/L (OR: 5.062, 95% CI: 2.292-11.181, p<0.001) and intraoperative blood loss ≥1100 ml (OR: 3.212, 95% CI: 1.586-6.506, p = 0.001) were the independent risk factor of MT in patients undergoing LT. Conclusion: Patients receiving MT in perioperative periods of LT had worse short-term and long-term outcomes than the non-MT patients. Massive transfusion and acute rejection were significant risk factors affecting long-term survivals of LT patients, and intraoperative blood loss of over 1100 ml was the independent risk factor of MT in patients undergoing LT. The results may offer valuable information on perioperative management in LT recipients who experience high risk of MT.

Protamine use in transcarotid artery revascularization is associated with lower risk of bleeding complications without higher risk of thromboembolic events.

OBJECTIVE: Recent studies have found that transcarotid artery revascularization (TCAR) is associated with lower risk of stroke or death compared with transfemoral carotid artery stenting but higher risk of bleeding complications, presumably associated with the need for an incision. Heparin anticoagulation is universally used during TCAR, so protamine use may reduce bleeding complications. However, the safety and effectiveness of protamine use in TCAR are unknown. We therefore evaluated the impact of protamine use on perioperative outcomes after TCAR in the Vascular Quality Initiative TCAR Surveillance Project. METHODS: We performed a retrospective review of patients undergoing TCAR in the Vascular Quality Initiative TCAR Surveillance Project from September 2016 to April 2019. We assessed in-hospital outcomes using propensity score-matched cohorts of patients who did and did not receive protamine. The primary efficacy end point was access site bleeding complications, and the primary safety end point was in-hospital stroke or death. Secondary end points included the individual end points of stroke, death, transient ischemic attack, myocardial infarction, congestive heart failure exacerbation, and hemodynamic instability. RESULTS: Of the 5144 patients undergoing TCAR, all patients received heparin and 4072 (79%) patients received protamine. We identified 944 matched pairs of patients who did and did not receive protamine. Protamine use was associated with a significantly lower risk of bleeding complications (2.8% vs 8.3%; relative risk [RR], 0.33; 95% confidence interval [CI], 0.21-0.52; P < .001), including bleeding that resulted in interventional treatment (1.0% vs 3.6%; RR, 0.26; 95% CI, 0.13-0.54; P < .001) and in blood transfusion (1.2% vs 3.9%; RR, 0.30; 95% CI, 0.15-0.58; P <.001). There were no statistically significant differences in in-hospital stroke or death for patients who received protamine and those who did not (1.6% vs 2.2%; RR, 0.71; 95% CI, 0.37-1.39; P = .32); however, there was a trend toward lower risk of stroke for patients who received protamine (1.1% vs 2.0%; RR, 0.53; 95% CI, 0.24-1.13; P = .09). There were also no statistically significant differences in the rates of transient ischemic attack (0.4% vs 1.1%; RR, 0.40; 95% CI, 0.13-1.28; P = .11), myocardial infarction (0.4% vs 0.8%; RR, 0.50; 95% CI, 0.15-1.66; P = .25), heart failure exacerbation (0.4% vs 0.3%; RR, 1.33; 95% CI, 0.30-5.96; P = .71), or postoperative hypotensive hemodynamic instability (16% vs 15%; RR, 1.06; 95% CI, 0.83-1.35; P = .50) with protamine use. CONCLUSIONS: Protamine can be safely used in TCAR to reduce the risk of perioperative bleeding complications without increasing the risk of thrombotic events.

Transfusion Timing and Postoperative Myocardial Infarction and Death in Patients Undergoing Common Vascular Procedures.

BACKGROUND: Perioperative allogenic blood transfusions, specifically packed red bloods cells (pRBC), after vascular surgery procedures are modifiable risk factors that are associated with increased cardiovascular events and 30-day mortality. The aim of this study is to evaluate the effect of transfusion timing (intraoperative vs. postoperative) on the rate of postoperative myocardial infarction (POMI) and death. METHODS: Six surgical and endovascular modules within the Vascular Quality Initiative (VQI) from 2013 to 2017 were reviewed at a single institution. Transfusion data on elective and urgent cases were abstracted and all patients who underwent inpatient procedures had routine postoperative troponin/ECG testing. The primary endpoint was POMI utilizing the American Heart Association's third universal definition for myocardial infarction. These criteria include the detection of a rise/and or fall of cTnT with at least one value above the 99th percentile and with at least one of the following 1) symptoms of acute myocardial ischemia, 2) new ischemic ECG changes, 3) development of pathological Q waves, 4) imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with ischemic etiology. The secondary endpoint was 30-day all-cause mortality. Multivariable logistic regression analysis was utilized to evaluate the risk of transfusions on POMI and death. RESULTS: We identified 1,154 cases for analysis (299 abdominal aortic aneurysm [EVAR], 117 infrainguinal bypasses, 127 open abdominal aortic aneurysm [AAA], 41 suprainguinal bypasses, 168 thoracic endovascular aortic repair [TEVAR], and 402 peripheral vascular interventions). Overall, the POMI rate was 2% and mortality 1%. Rates of POMI differed by procedure type (P = 0.04), where infrainguinal bypass had the highest rate of POMI at 4%. Death rates did not vary by type of procedure (P = 0.89). Mean number of intraoperative pRBC and postoperative pRBC transfusion was higher for patients with POMI (intraop: 1.3 vs. 0.3, postop: 1.8 vs. 0.4, both P < 0.01) and death (intraop: 1.4 vs. 0.3, postop: 2.5 vs. 0.4, both P < 0.01). In addition, older age and coronary artery disease (CAD) were associated with POMI on univariate analysis. On multivariable analysis for POMI, CAD (odds ratio [OR] = 5.15, 95% confidence interval [CI] [2.00-13.24], P < 0.001), receiving both an intraoperative and postoperative transfusion (OR = 6.20, 95% CI [1.78-21.55], P < 0.01) as well as a postoperative transfusion only (OR = 5.70, 95% CI [1.81-17.94], P < 0.01) compared to no transfusion were associated with higher odds of POMI; however intraoperative transfusion only was not (OR = 3.42, 95% CI [0.88-13.31], P = 0.08). On multivariable analysis, increasing age of the patient was associated with higher odds of death (OR = 1.08, 95% CI [1.01-1.15], P = 0.02) and statin use was highly protective (OR = 0.27, 95% CI [0.10-0.74], P = 0.01), but any intraoperative or postoperative transfusion compared to no transfusion was not associated with death after adjustment. CONCLUSIONS: In our series with routine postoperative troponin screening in the inpatient setting, the use of an isolated postoperative transfusion as well as cases requiring both an intraoperative and postoperative transfusion was associated with POMI. However, isolated intraoperative transfusion was not associated with POMI, and we did not identify an association of transfusion with 30-day mortality. These data suggest that the perioperative setting of transfusions is important in its impact on postoperative outcomes and needs to be accounted for when evaluating transfusion outcomes and indications.

Patient blood management in obstetrics - Review.

Patient blood management (PBM) aims to reduce red blood cell transfusion, minimize preoperative anemia, reduce intraoperative blood loss as well as optimize hemostasis, and individually manage postoperative anemia. Benefits include improved clinical outcome with a reduction in patient morbidity and mortality, but also lower hospital costs and shorter hospital length of stay. To date, it has been successfully implemented in several medical specialties, such as cardiac, trauma and orthopedic surgery. In obstetrics, postpartum hemorrhage (PPH) is one of the leading causes of maternal mortality. PBM has the potential to improve outcome of mother and child. However, pregnancy and childbirth pose a special challenge to PBM, and several adaptations compared to PBM in elective surgery are necessary. To date, awareness of the clinical advantages of PBM among obstetricians and midwifes regarding PBM and its concept in PPH is limited. In the following review, we therefore aim to present the current status quo in PBM in obstetrics and its challenges in the clinical routine.

Late-Onset Malignant Neoplasms and Their Prognostic Factors after Abdominal Aortic Aneurysm Repair.

BACKGROUND: Little is known about late-onset primary malignant neoplasms after repair of abdominal aortic aneurysms (AAAs) despite malignancy being one of the primary causes of late death. We investigated the incidence and prognostic factors related to the occurrence of malignancy after AAA repair. METHODS: We performed a retrospective analysis of 589 patients who underwent AAA repair, including 264 endovascular AAA repairs and 325 open surgical repairs; 482 patients had no history of previous malignancy or concomitant malignancy, 72 had previous malignancy, and 35 had concomitant malignancy in remission at the time of AAA repair. The cumulative incidence rates of late-onset malignancy occurrence and cancer death were estimated using the cumulative incidence function in the presence of competing risks, that is, noncancer death, and prognostic factors were investigated using the Fine-Gray hazard model. RESULTS: After hospital discharge, 128 malignancies occurred in 116 patients. Overall cumulative incidence rates of late-onset malignancy occurrence at 1, 3, 5, and 10 years were 4.0%, 11.7%, 18.2%, and 38.1%, respectively. Multivariate analysis revealed that significant prognostic factors for late-onset malignancy included history of previous malignancy, current smoker, higher intraoperative blood loss, absence of allogeneic blood transfusion, lower C-reactive protein levels, and lower serum high-density lipoprotein-cholesterol levels. The type of surgical procedures for AAA repair did not affect the occurrence of malignancy. In addition, current smoker and higher intraoperative blood loss significantly increased the risk of cancer death. CONCLUSIONS: Current smoker and higher intraoperative blood loss were independent risk factors for late-onset malignancy after AAA repair. Late-onset malignancy after AAA repair should be monitored among patients at high risk and requires aggressive management to improve long-term survival.

Characteristics Associated With Mortality in 372 Patients Receiving Low-Dose Recombinant Factor VIIa (rFVIIa) for Cardiac Surgical Bleeding.

OBJECTIVE: Activated recombinant factor VII (rFVIIa) has been used to treat cardiac surgical bleeding in an off-label manner. This observational report analyzes the outcomes with use of a low dose and early administration of rFVIIa for cardiac surgical bleeding. DESIGN: A retrospective, observational study. SETTING: Single-center, tertiary care cardiothoracic surgical setting. PARTICIPANTS: A total of 6,862 patients underwent cardiac surgery from January 2012 to January 2018. Of those, 372 patients received rFVIIa perioperatively. INTERVENTIONS: An institutional policy directed low-dose, incremental aliquots of intravenous rFVIIa (0.5-1 mg). Characteristics and outcomes were compared among patients who survived (n = 328) and patients who died (n = 44). MEASUREMENTS AND MAIN RESULTS: The median dose of rFVIIa was low at 13.29 µg/kg. Higher doses were given to patients who died (15.79 µg/kg v 12.99 µg/kg; p = 0.0133). Patients who died received more blood and component transfusions (median 9 products in those who died v 6 products in survivors; p = 0.0022), although the median transfusion requirement for all patients was 6 units per patient. The rate of reoperation was not different in the 2 groups. Mortality was associated with emergent/urgent surgical procedures (p = 0.0282), type of surgical procedure with aortic procedures being highest risk (p = 0.0014), cardiogenic shock (p = 0.0028), postoperative renal failure (p = 0.0035), postoperative cardiac arrest (p = 0.0006), and ischemic stroke (p = 0.0084). CONCLUSION: Mortality after life-threatening cardiac surgical bleeding treated with rFVIIa was more common in aortic procedures and emergent and urgent surgeries. Lower doses of rFVIIa than previously reported may achieve bleeding cessation because overall blood component transfusions were low in this cohort.

Impact of MELD Score-Based Organ Allocation on Mortality, Bleeding, and Transfusion in Liver Transplantation: A Before-and-After Observational Cohort Study.

OBJECTIVE: The goal of this study was to evaluate the effect of the Model for End-Stage Liver Disease (MELD)-based allocation system on mortality, bleeding, and transfusion requirement in orthotopic liver transplantation (OLT). DESIGN: OLTs were studied for this observational study (before-and-after observational cohort study). SETTING: One community hospital. PARTICIPANTS: The study comprised 686 patients who underwent 750 consecutive OLTs. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: Patients who underwent OLT in the MELD era had an adjusted lower 1-year mortality (adjusted odds ratio 0.45 [0.24-0.83]) compared with patients who underwent OLT the pre-MELD era. No significant difference in 1-month mortality was observed. Other variables with a significant effect on 1-year mortality in multivariate analysis were preoperative international normalized ratio, intraoperative use of a phlebotomy, total intraoperative volume of crystalloid infused, and retransplantation. Blood loss was greater in the MELD era (median difference 200 mL; p < 0.001), as were red blood cell, fresh frozen plasma, and cryoprecipitate transfusions. More patients in the MELD era received at least 1 transfusion (27% v 20%; p = 0.024). CONCLUSION: The MELD allocation system did not affect 1-month mortality, but a decrease in 1-year mortality was demonstrated. Blood loss and transfusions increased during OLTs performed in the MELD era. The role of other variables should be explored further to explain postoperative morbidity and mortality.

Shifts of Transfusion Demand in Cardiac Surgery After Implementation of Rotational Thromboelastometry-Guided Transfusion Protocols: Analysis of the HEROES-CS (HEmostasis Registry of patiEntS in Cardiac Surgery) Observational, Prospective Open Cohort Database.

OBJECTIVES: Rotational thromboelastometry (ROTEM)-guided transfusion algorithms in cardiac surgery have been proven to be successful in reducing blood loss in randomized controlled trials. Using an institutional hemostasis registry of patients in cardiac surgery (HEROES-CS), the authors hypothesized that the use of ROTEM-guided transfusion algorithms would save blood products and overall costs in cardiac surgery in every day practice. DESIGN: Observational, prospective open cohort database. SETTING: Single-center academic hospital. PARTICIPANTS: Cardiac surgery patients. INTERVENTIONS: Implementation of ROTEM-guided bleeding management. MEASUREMENTS AND MAIN RESULTS: A classical-guided algorithm and a ROTEM-guided algorithm were used for patient blood management in 2 cohorts. Primary outcome was the use and amount of blood products and hemostatic medication. Secondary outcomes were amount of rethoracotomies, length of stay, and 30-day mortality. Finally, costs and savings were calculated. The classical-guided cohort comprised 204 patients, and ROTEM-guided cohort comprised 151 patients. Baseline characteristics showed excellent similarities after propensity score matching of 202 patients. Blood loss was lower after ROTEM guidance (p < 0.001). Absolute risk reduction was 17% for red blood cells (p = 0.024), 12% for fresh frozen plasma (p = 0.019), and 4% for thrombocyte concentrates (p = 0.582). More tranexamic acid was given, but not more fibrinogen concentrate, while desmopressin was given less often. Hospital length of stay was reduced by an overall median of 2 and a mean of 4 days (p < 0.001). Mortality and rethoracotomy rates were not affected. Potential savings were about €4,800 ($5,630) per patient. CONCLUSIONS: Implementation of a ROTEM-guided transfusion algorithm in cardiac surgery patients reduced the use of blood products and hemostatic medication, hereby saving costs. Reductions in mortality and rethoracotomy rates could not be found.

[Mortality after high-risk surgery in Jehovah's Witness patients]. / Letalität nach operativen Risikoeingriffen bei Zeugen Jehovas.

BACKGROUND: Jehovah's Witness (JW) patients strictly refuse allogeneic blood transfusion for religious reasons. Nevertheless, JW also wish to benefit from modern therapeutic concepts including major surgical procedures without facing an excessive risk of death. The Northwest Hospital in Frankfurt am Main Germany is a confidential clinic of JW and performs approximately 100 surgical interventions per year on this patient group. MATERIAL AND METHODS: A retrospective analysis of closed medical cases performed in the years 2008-2018 at the Northwest Hospital aimed to clarify (1) the frequency of surgical procedures in JW patients associated with a statistical allogeneic transfusion risk (presence of preoperative anemia and/or in-house transfusion probability >10%) during this time period, (2) the degree of acceptance of strategies avoiding blood transfusion by JW and (3) the anemia-related postoperative mortality rate in JW patients. RESULTS: In the 11- year observation period 123 surgical procedures with a relevant allogeneic transfusion risk were performed in 105 JW patients. Anemia according to World Health Organization (WHO) criteria was present in 44% of cases on the day of surgery. Synthetic and recombinant drugs (tranexamic acid, desmopressin, erythropoetin, rFVIIa) were generally accepted, acute normovolemic hemodilution (ANH) in 92% and cell salvage in 96%. Coagulation factor concentrates extracted from human plasma and therefore generally refused by JW so far, were accepted by 83% of patients following detailed elucidation. Out of 105 JW patients 7 (6.6%) died during the postoperative hospital stay. In 4 of the 7 fatal cases the cause of death could be traced back to severe postoperative anemia. CONCLUSION: Given optimal management JW patients can undergo major surgery without an excessive risk of death. The 6.6% in-hospital mortality observed in this institution was in the range of the 4% generally observed after surgery in Europe. The majority of JW patients accepted a variety of blood conservation strategies following appropriate elucidation. This also included coagulation factor concentrates extracted from human plasma enabling an effective treatment of even severe bleeding complications. In this analysis postoperative hemoglobin concentrations below 6 g/dl in older JW patients were associated with a high mortality risk due to anemia.

Comparison of Two Major Perioperative Bleeding Scores for Cardiac Surgery Trials: Universal Definition of Perioperative Bleeding in Cardiac Surgery and European Coronary Artery Bypass Grafting Bleeding Severity Grade.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Research into major bleeding during cardiac surgery is challenging due to variability in how it is scored. Two consensus-based clinical scores for major bleeding: the Universal definition of perioperative bleeding and the European Coronary Artery Bypass Graft (E-CABG) bleeding severity grade, were compared in this substudy of the Transfusion Avoidance in Cardiac Surgery (TACS) trial. METHODS: As part of TACS, 7,402 patients underwent cardiac surgery at 12 hospitals from 2014 to 2015. We examined content validity by comparing scored items, construct validity by examining associations with redo and complex procedures, and criterion validity by examining 28-day in-hospital mortality risk across bleeding severity categories. Hierarchical logistic regression models were constructed that incorporated important predictors and categories of bleeding. RESULTS: E-CABG and Universal scores were correlated (Spearman ρ = 0.78, P < 0.0001), but E-CABG classified 910 (12.4%) patients as having more severe bleeding, whereas the Universal score classified 1,729 (23.8%) as more severe. Higher E-CABG and Universal scores were observed in redo and complex procedures. Increasing E-CABG and Universal scores were associated with increased mortality in unadjusted and adjusted analyses. Regression model discrimination based on predictors of perioperative mortality increased with additional inclusion of the Universal score (c-statistic increase from 0.83 to 0.91) or E-CABG (c-statistic increase from 0.83 to 0.92). When other major postoperative complications were added to these models, the association between Universal or E-CABG bleeding with mortality remained. CONCLUSIONS: Although each offers different advantages, both the Universal score and E-CABG performed well in the validity assessments, supporting their use as outcome measures in clinical trials.

Incidence and Epidemiology of Perioperative Transfusion-Related Pulmonary Complications in Pediatric Noncardiac Surgical Patients: A Single-Center, 5-Year Experience.

BACKGROUND: Transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO) are the leading causes of transfusion-related fatalities. While these transfusion-related pulmonary complications (TRPCs) have been well detailed in adults, their burden in pediatric subsets remains poorly defined. We sought to delineate the incidence and epidemiology of pediatric TRPCs after intraoperative blood product transfusion. METHODS: In this retrospective cohort study, we evaluated all consecutive pediatric patients receiving intraoperative blood product transfusions during noncardiac surgeries between January 2010 and December 2014. Exclusion criteria were cyanotic heart disease, preoperative respiratory insufficiency, extracorporeal membrane oxygenation, and American Society of Anesthesiologists physical status VI. Medical records were electronically screened to identify those with evidence of hypoxemia, and in whom a chest x-ray was obtained within 24 hours of surgery. Records were then manually reviewed by 2 physicians to determine whether they met diagnostic criteria for TACO or TRALI. Disagreements were adjudicated by a third senior physician. RESULTS: Of 19,288 unique pediatric surgical patients, 411 were eligible for inclusion. The incidence of TRPCs was 3.6% (95% confidence interval [CI], 2.2-5.9). TACO occurred in 3.4% (95% CI, 2.0-5.6) of patients, TRALI was identified in 1.2% (95% CI, 0.5-2.8), and 1.0% (95% CI, 0.4-2.5) had evidence for both TRALI and TACO. Incidence was not different between males (3.4%) and females (3.8%; P = .815). Although a trend toward an increased incidence of TRPCs was observed in younger patients, this did not reach statistical significance (P = .109). Incidence was comparable across subsets of transfusion volume (P = .184) and surgical specialties (P = .088). Among the 15 patients experiencing TRPCs, red blood cells were administered to 13 subjects, plasma to 3, platelets to 3, cryoprecipitate to 2, and autologous blood to 3. Three patients with TRCPs were transfused mixed blood components. CONCLUSIONS: TRPCs occurred in 3.6% of transfused pediatric surgical patients, with the majority of cases attributable to TACO, congruent with adult literature. The frequency of TRPCs was comparable between genders and across surgical procedures and transfusion volumes. The observed trend toward increased TRPCs in younger children warrants further consideration in future investigations. Red blood cell administration was the associated component for the majority of TRPCs, although platelets demonstrated the highest risk per component transfused. Mitigation of perioperative risk associated with TRPCs in pediatric patients is reliant on further multiinstitutional studies powered to examine patterns and predictors of this highly morbid entity.

Evaluating the Effect on Mortality of a No-Tranexamic acid (TXA) Policy for Cardiovascular Surgery.

OBJECTIVES: The authors stopped using tranexamic acid (TXA) in April 2013. The present study aimed to examine the impact of a "no-TXA-use" policy by comparing the adverse effects of TXA and clinical outcomes before and after the policy change in patients undergoing cardiovascular surgery. DESIGN: A single center retrospective cohort study. SETTING: A single cardiovascular center. PARTICIPANTS: Patients undergoing cardiovascular surgery between January 2008 and July 2015 (n = 3,535). INTERVENTIONS: Patients' outcomes before and after the policy change were compared to evaluate the effects of the change. MEASUREMENTS AND MAIN RESULTS: The seizure rate decreased significantly after the policy change (6.9% v 2.7%, p < 0.001). However, transfusion volumes and blood loss volumes increased significantly after the policy change (1,840 mL v 2,030 mL, p = 0.001; 1,250 mL v 1,372 mL, p < 0.001, respectively). Thirty-day mortality was not statistically different (1.6% v 1.4%, p = 0.82), nor were any of the other outcomes. Propensity-matched analysis and segmented regression analysis showed similar results. CONCLUSIONS: The mortality rate remained the same even though the seizure rate decreased after the policy change. Blood loss volume and transfusion volume both increased after the policy change. TXA use provides an advantageous benefit by reducing the need for blood transfusion.

Nonelective Left-Sided Colon Cancer Resections are Associated with Worse Postoperative and Oncological Outcomes: A Propensity-Matched Study.

Background: Emergency general surgery patients are at significant risk of postoperative complications and mortality compared with their elective counterparts. Although challenged by some studies, increasing evidence shows that emergency colectomy for cancer is associated with worse early postoperative and long-term outcomes. Methods: We have included all patients with colon cancer admitted to the Emergency Hospital of Bucharest between January 2011 and January 2016. SELECTION CRITERIA: (1) colon tumor; (2) left-sided localization of the tumor; (3) pathology exam revealing adenocarcinoma. EXCLUSION CRITERIA: (1) rectal cancers; (2) benign pathology (e.g. diverticulitis). Results: We included 615 patients with left-sided colon cancer. 275 (44.7%) patients presented complicated disease. The complication was represented by obstruction in 205 (33.3%) patients (OG), hemorrhage in 55 (8.9%) patients (HG), and perforation in 15 (2.4%) patients (PG). The anastomotic leakage rate was similar between obstructive and elective cases (6.2% versus 6.5%, P 0.05), but was significantly higher for hemorrhagic patients (16%) (P=0.046). The 30-day complication rate and mortality were significantly higher in emergency patients (P 0.05). Conclusions: We found significant worse short- and long-term outcomes for patients with nonelective left-sided colon cancer resections. Correlating the ominous prognosis with the high incidence of the complicated disease, we may emphasize the impact on de complicated colon cancer on the general population.

Vascular surgery: An essential hospital resource in modern health care.

OBJECTIVE: In modern health care, vascular surgeons frequently serve as a unique resource to other surgical specialties for vascular exposure, repair, reconstruction, or control. These services occur both in planned and unplanned clinical settings. We analyzed the frequency, outcomes, and value of vascular services in this setting to other surgical specialties and the hospital. METHODS: Intraoperative planned and unplanned vascular surgery operative consultations were reviewed over a 3-year period (2013-2016). Patient demographics, requesting surgical specialty, indication and type of vascular intervention, and work relative value units generated were recorded. Univariate and multivariate analysis of factors affecting a composite outcome of in-hospital and 30-day mortality or morbidity, or both, was performed. RESULTS: Seventy-six vascular surgery intraoperative consultations were performed, of which 56% of the consultations were unplanned. The most common unplanned consultation was for bleeding (33%). The aorta and lower extremity were the most common vascular beds requiring vascular services. The mean work relative value units generated per vascular surgery intervention was 23.8. In-hospital and 30-day mortality was 9.2%. No difference in mortality and morbidity was found between planned and unplanned consultations. Factors associated with the composite mortality/morbidity outcome were coronary artery disease (P = .002), heart failure (P = .02), total operative blood loss (P = .009), consultation for limb ischemia (P = .013), and vascular consultation for the lower extremity (P = .01). On multivariate analysis, high operative blood loss (>5000 mL) remained significant (P = .04), and coronary artery disease approached significance (P = .06). CONCLUSIONS: The need for vascular surgery services is frequent, involves diverse vascular beds, and occurs commonly in an unplanned setting. When requested, vascular surgery services effectively facilitate the completion of the nonvascular procedure, even those associated with significant intraoperative blood loss. Vascular surgery services are essential to other surgical specialties and the hospital in today's modern health care environment.

Perioperative clopidogrel is associated with increased bleeding and blood transfusion at the time of lower extremity bypass.

OBJECTIVE: Controversy persists surrounding the perceived bleeding risk associated with perioperative clopidogrel use in patients undergoing lower extremity bypass (LEB). The purpose of this study was to examine the LEB bleeding risk and clinical sequelae associated with clopidogrel. METHODS: All LEBs in the Vascular Quality Initiative (VQI) from 2008 to 2014 were studied. The exposure was perioperative clopidogrel. Primary outcomes were blood transfusion, estimated blood loss ≥500 mL, and reoperation for bleeding. Secondary outcomes included mean operative time, major cardiac events, respiratory complications, infectious complications, and in-hospital mortality. Univariate and multivariable analyses were used to analyze patients on the basis of clopidogrel use and its association with outcomes. Nonparametric test for trend and Mantel-Haenszel methods were used to analyze association of clopidogrel use with blood transfusion and secondary outcomes. RESULTS: Among the LEB cohort (N = 9179), 28% (n = 2544) were taking clopidogrel and 72% (n = 6635) were not. Patients taking clopidogrel were more likely to have coronary disease, prior coronary intervention, abnormal findings on stress test, and aspirin use (P < .001 for all). Patients taking clopidogrel were more likely to receive blood transfusion (38% vs 24%; P < .001) and to have estimated blood loss ≥500 mL (21% vs 12%; P < .001). Reoperation for bleeding rates were similar (0.9% vs 1.1%; P = .9). Clopidogrel use was also associated with increased mean operative times (244 minutes vs 232 minutes; P < .001) as well as with cardiac complications (8.8% vs 6.5%; P = .001), respiratory complications (2.5% vs 1.6%; P = .007), and in-hospital mortality (1.3% vs 0.8%; P = .03). Multivariable analysis demonstrated that clopidogrel was associated with increased risk of 1- or 2-unit blood transfusion (odds ratio [OR], 1.8; 95% confidence interval [CI], 1.5-2.1; P < .001) and >2-unit blood transfusion (OR, 2.0; 95% CI, 1.7-2.5; P < .001). Major cardiac events (OR, 1.2; 95% CI, 1.0-1.5; P = .05) and respiratory complications (OR, 1.4; 95% CI, 1.0-2.0; P = .03) were also independently associated with clopidogrel use. Weighted Mantel-Haenszel ORs controlling for blood transfusion amount revealed no remaining effect of clopidogrel on major cardiac events (OR, 1.1; P = .4) or respiratory complications (OR, 1.0; P = .8). CONCLUSIONS: Perioperative clopidogrel use in LEB surgery is associated with increased blood loss and blood transfusion. Associated clinical sequelae include increased cardiac and pulmonary complications. Accordingly, surgeons should consider discontinuation of perioperative clopidogrel when it is clinically appropriate unless it is strongly indicated at the time of LEB.

Descriptive characteristics and in-hospital mortality of critically bleeding patients requiring massive transfusion: results from the Australian and New Zealand Massive Transfusion Registry.

BACKGROUND AND OBJECTIVES: Critically bleeding patients requiring massive transfusion (MT) are clinically challenging, and limited data exist to support management decisions. This study describes patient characteristics, transfusion support and clinical outcomes from the Australian and New Zealand (NZ) Massive Transfusion Registry (ANZ-MTR). MATERIALS AND METHODS: Retrospective, cohort study of all adult patients receiving MT (≥5 units red blood cells [RBC] in 4 h) at participating ANZ-MTR hospitals, 2011-2015. Mortality information was collected from the Australian National Death Index and NZ Ministry of Health. Associations between patient characteristics and outcomes were modelled using logistic regression. RESULTS: A total of 3560 MT cases were identified. For in-hospital deaths, cardiothoracic surgery was the most frequent bleeding context (24·5%) followed by trauma (18·3%). Age (OR = 1·03; 95% CI: 1·02-1·04), more comorbidities (OR = 1·14; 95% CI: 1·09-1·21), larger volume of RBC in first 24 h from MT onset (OR = 1·04; 95% CI: 1·02-1·06), higher platelet to RBC ratio at 4 h (OR = 2·76; 95% CI: 1·14-6·65) and higher activated partial thromboplastin time (OR = 1·02; 95% CI: 1·01-1·03) were associated with in-hospital mortality. CONCLUSION: Patients with more comorbidities, older age, traumatic or surgical bleeding or requiring more blood components had higher in-hospital mortality. These findings provide a basis to evaluate and monitor practice relating to optimal use of blood products, variation in transfusion practices and patient outcomes, and also enable benchmarking of hospital performance for management of MT in specific patient groups.

Massive Transfusion in Cardiac Surgery: The Impact of Blood Component Ratios on Clinical Outcomes and Survival.

BACKGROUND: Cardiac surgery is the most common setting for massive transfusion in medically advanced countries. Studies of massive transfusion after injury suggest that the ratios of administered plasma and platelets (PLT) to red blood cells (RBCs) affect mortality. Data from the Red Cell Storage Duration Study (RECESS), a large randomized trial of the effect of RBC storage duration in patients undergoing complex cardiac surgery, were analyzed retrospectively to investigate the association between blood component ratios used in massively transfused patients and subsequent clinical outcomes. METHODS: Massive transfusion was defined as those who had ≥6 RBC units or ≥8 total blood components. For plasma, high ratio was defined as ≥1 plasma unit:1 RBC unit. For PLT transfusion, high ratio was defined as ≥0.2 PLT doses:1 RBC unit; PLT dose was defined as 1 apheresis PLT or 5 whole blood PLT equivalents. The clinical outcomes analyzed were mortality and the change in the Multiple Organ Dysfunction Score (ΔMODS) comparing the preoperative score with the highest composite score through the earliest of death, discharge, or day 7. Outcomes were compared between patients transfused with high and low ratios. Linear and Cox regression were used to explore relationships between predictors and continuous outcomes and time to event outcomes. RESULTS: A total of 324 subjects met the definition of massive transfusion. In those receiving high plasma:RBC ratio, the mean (SE) 7- and 28-day ΔMODS was 1.24 (0.45) and 1.26 (0.56) points lower, (P = .007 and P = .024), respectively, than in patients receiving lower ratios. In patients receiving high PLT:RBC ratio, the mean (SE) 7- and 28-day ΔMODS were 1.55 (0.53) and 1.49 (0.65) points lower (P = .004 and P = .022), respectively. Subjects who received low-ratio plasma:RBC transfusion had excess 7-day mortality compared with those who received high ratio (7.2% vs 1.7%, respectively, P = .0318), which remained significant at 28 days (P = .035). The ratio of PLT:RBCs was not associated with differences in mortality. CONCLUSIONS: This analysis found that in complex cardiac surgery patients who received massive transfusion, there was an association between the composition of blood products used and clinical outcomes. Specifically, there was less organ dysfunction in those who received high-ratio transfusions (plasma:RBCs and PLT:RBCs), and lower mortality in those who received high-ratio plasma:RBC transfusions.

Hypotensive Epidural Anesthesia Reduces Blood Loss in Pelvic and Sacral Bone Tumor Resections.

BACKGROUND: Resection of pelvic and sacral tumors can cause severe blood loss, complications, and even postoperative death. Hypotensive epidural anesthesia has been used to mitigate blood loss after elective arthroplasty, but to our knowledge, it has not been studied as an approach that might make resection of pelvic and sacral tumors safer. QUESTIONS/PURPOSES: The purposes of this study were (1) to compare the blood loss and blood product use for patients undergoing pelvic and sacral tumor surgery under standard anesthesia or hypotensive epidural anesthesia; (2) to assess the frequency of end-organ damage with the two techniques; and (3) to compare 90-day mortality between the two techniques. METHODS: Between 2000 and 2014, 285 major pelvic and sacral resections were performed at one center. A total of 174 (61%) had complete data sets for analysis of blood loss, transfusion use, complications, and mortality at 90 days. Of those, 102 (59%) underwent hypotensive epidural anesthesia, whereas the remainder received standard anesthetic care. The anesthetic approach was determined by the anesthetists in charge of the case with hypotensive epidural anesthesia exclusively performed by one of two subspecialty trained anesthetists as their routine for major pelvic or sacral surgery. The groups were comparable in terms of potential confounding variables such as age, gender, tumor volume, and operation performed. Hypotensive epidural anesthesia was defined as a technique using an extensive epidural block up to T2-3 dermatome, peripherally administered low-concentration intravenous adrenaline infusion, and using unimpeded spontaneous respiration to achieve controlled hypotension, precise rate control of the heart, and enhanced velocity of venous return, all aggregated thus to minimize blood loss during pelvic surgery while preserving vital perfusion. The groups were assessed for perioperative blood loss calculated from pre- and postsurgery hemoglobin and transfusion use as well as postoperative complications, morbidity, and mortality at 90 days. RESULTS: There was less mean blood loss in the hypotensive epidural anesthesia group (1457 mL, SD 1721, 95% confidence interval [CI], 1114-1801 versus 2421 mL, SD 2297, 95% CI, 1877-2965; p = 0.003). Patients in the hypotensive epidural anesthesia group on average received fewer packed red cell transfusions (2.7 units, SD 2.9, 95% CI, 2.1-3.2 versus 3.9 units, SD 4.4, 95% CI, 2.9-5.0; p = 0.03). There were no differences in the proportions of patients experiencing end-organ injury (7%, n = seven of 102 versus 6%, n = four of 72; p = 0.72). With the numbers available, there was no difference in 90-day mortality rate between groups (1.9%, n = two of 102 versus 1.3%, n = one of 72; p = 0.77). CONCLUSIONS: We found that hypotensive epidural anesthesia resulted in less blood loss, fewer transfusions, and no apparent increase in serious complications in pelvic and sacral tumor surgery performed in the setting of a high-volume tertiary sarcoma referral hospital. We recommend that further collaborative studies be undertaken to confirm our results with hypotensive epidural anesthesia in surgery for pelvic tumors. LEVEL OF EVIDENCE: Level III, therapeutic study.