Importance Patients undergoing cardiac surgery with cardiopulmonary bypass often require platelet transfusions for bleeding. Platelets are routinely stored at room temperature (20-24 °C) for up to 5 to 7 days; however, cold storage (1-6 °C) may allow for increased storage duration without loss of hemostatic function. Objective To determine the maximum cold-storage duration, up to 21 days, for which cold-stored platelets (CSPs) are noninferior or superior in hemostatic efficacy to room-temperature platelets (RTPs) when transfused in actively bleeding patients undergoing cardiac surgery with cardiopulmonary bypass. Design, Setting, and Participants A phase 3, multicenter, randomized, partially blinded, adaptive, noninferiority, storage duration–ranging trial conducted in pediatric and adult patients undergoing cardiac surgery with planned cardiopulmonary bypass at 27 sites in the US and Australia from December 2021 to March 2025. Statistical analysis was conducted from September 9 to October 3, 2025. Intervention Patients were randomized 2:1 to receive CSPs with a maximum of 21 days of storage vs RTPs with a maximum of 7 days of storage. Main Outcomes and Measures The primary outcome was a hemostatic efficacy score with values ranging from 1 to 5 and higher values indicating greater bleeding. The noninferiority margin was 1 point. The success criterion was met if at least 1 cold-storage duration of 7 days or more had a posterior probability of noninferiority of at least 97.5%. The secondary outcome was 24-hour chest tube output. Results Of the 1000 patients who underwent platelet transfusion, 989 were included in the primary analysis (650 CSPs and 339 RTPs). The cohort had a mean (SD) age of 42.1 (30.1) years and 67.8% were male. CSPs were noninferior to RTPs for the primary outcome, with a probability of greater than 99.9% for all cold-storage durations. Pooled across storage durations, CSPs had a mean difference from RTPs of 0.09 (95% credible interval, −0.06 to 0.23). Median (IQR) chest tube output at 24 hours (8.9 mL/kg [5.2-15.4] for CSPs vs 8.4 mL/kg [5.5-15.9] for RTPs; difference in medians, 0.4 [95% CI, −1.0 to 1.5]) was not statistically different between study groups. In a post hoc analysis, as all storage durations were noninferior, considering the CSPs as a single group, the hemostatic efficacy score was similar between both groups: mean (SD) of 3.08 (1.15) CSPs vs 2.99 (1.10) RTPs. There were no differences in venous or arterial thrombotic events, transfusion-associated adverse events, acute respiratory distress syndrome, kidney failure, septic shock, and mortality between the study groups, except for increased reexploration rates in the CSP group. Conclusions and Relevance For patients undergoing cardiac surgery, CSPs stored up to 21 days are noninferior to RTPs for the control of active surgical bleeding. Use of CSPs may allow for increased availability of platelets by reducing wastage and shortages and may allow for incorporation of platelets into inventory at locations where platelets cannot be maintained due to the 5- to 7-day shelf life of RTPs. Trial Registration ClinicalTrials.gov Identifier: NCT04834414
BACKGROUND:Preoperative anemia is associated with adverse outcomes in cardiac surgery, yet it remains unclear what proportion of this association is mediated through red blood cell (RBC) transfusions. METHODS:This is a historical observational cohort study of adults undergoing coronary artery bypass grafting or valve surgery on cardiopulmonary bypass at an academic medical center between May 1, 2008, and May 1, 2018. A mediation analysis framework was used to evaluate the associations between preoperative anemia and postoperative outcomes, including a primary outcome of acute kidney injury (AKI). Intraoperative RBC transfusions were evaluated as mediators of preoperative anemia and outcome relationships. The estimated total effect, average direct effect of preoperative anemia, and percent of the total effect mediated through transfusions are presented with 95% confidence intervals and P -values. RESULTS:A total of 4117 patients were included, including 1234 (30%) with preoperative anemia. Overall, 437 of 4117 (11%) patients went on to develop AKI, with a greater proportion of patients having preoperative anemia (219 of 1234 [18%] vs 218 of 2883 [8%]). In multivariable analyses, the presence of preoperative anemia was associated with increased postoperative AKI (6.4% [4.2%-8.7%] absolute difference in percent with AKI, P < .001), with incremental decreases in preoperative hemoglobin concentrations displaying greater AKI risk (eg, 11.9% [6.9%-17.5%] absolute increase in probability of AKI for preoperative hemoglobin of 9 g/dL compared to a reference of 14 g/dL, P < .001). The association between preoperative anemia and postoperative AKI was primarily due to direct effects of preoperative anemia (5.9% [3.6%-8.3%] absolute difference, P < .001) rather than mediated through intraoperative RBC transfusions (7.5% [-4.3% to 21.1%] of the total effect mediated by transfusions, P = .220). Preoperative anemia was also associated with longer hospital durations (1.07 [1.05-1.10] ratio of geometric mean length of stay, P < .001). Of this total effect, 38% (22%, 62%; P < .001) was estimated to be mediated through subsequent intraoperative RBC transfusion. Preoperative anemia was not associated with reoperation or vascular complications. CONCLUSIONS:Preoperative anemia was associated with higher odds of AKI and longer hospitalizations in cardiac surgery. The attributable effects of anemia and transfusion on postoperative complications are likely to differ across outcomes. Future studies are necessary to further evaluate mechanisms of anemia-associated postoperative organ injury and treatment strategies.
OBJECTIVES:To retrospectively assess the incidence and severity of perioperative protamine reactions in adult patients with documented history of fish allergy. DESIGN:Retrospective observational study. SETTING:Large academic tertiary referral center. PARTICIPANTS:Adults with fish allergies undergoing surgeries involving protamine, between January 1, 2008, and March 1, 2018. INTERVENTIONS:Perioperative protamine administration in patients with documented fish allergy. MEASUREMENTS AND MAIN RESULTS:Perioperative protamine and anaphylactic reactions were reviewed. A diagnosis of anaphylaxis or protamine reaction was based on clinical suspicion, perioperative events, and postoperative evaluations. Among 214 patients, 2 cases (<1%) of anaphylaxis or protamine reactions occurred. Cardiac procedures were most common (67%). The median intraoperative heparin dosage was 46,000 IU, and the median protamine dosage was 310 mg. Nearly all patients (99%) were admitted to the intensive care unit postoperatively, with a median hospital stay of 6.5 days (interquartile range, 5.2-14.6 days). There were 3 deaths (1%) within 30 days, and 15 (7%) within 1 year. CONCLUSIONS:The study findings suggest that in patients with a history of fish allergy, cross-reactivity with protamine is unlikely, as anaphylaxis and/or protamine reactions were rare in this patient population in the perioperative environment. Based on these findings, this study does not recommend avoiding protamine solely based on a history of fish allergy when heparin reversal is required during surgery.
Thrombin generation (TG) is reduced after cardiac surgery using cardiopulmonary bypass (CPB), contributing to coagulopathy and bleeding. Plasma transfusion or four-factor prothrombin complex concentrate (PCC) are commonly used to treat coagulopathic bleeding after CPB without knowledge of how each may restore TG. To determine the effect of PCC infusion on restoration of thrombin generation compared with plasma transfusion, we performed a laboratory-based secondary analysis of a randomized, controlled trial of adult patients undergoing cardiac surgery to assess efficacy and safety of 4 F-PCC versus plasma for treatment of perioperative coagulopathic bleeding after CPB. Participants were randomized to receive either PCC (15 IU/kg) or plasma (10–15 ml/kg) after separation from CPB. Participant blood samples were obtained at pre-specified serial timepoints, with laboratory assays for TG and factor levels subsequently performed. The primary outcome was change in thrombin generation (TG) parameters after each randomized treatment through postoperative day 5. Secondary outcomes included serially derived clotting factor levels. Of 100 randomized participants, 99 were included in this laboratory analysis (PCC group, N = 51; plasma group, N = 48). After treatment, participants in the PCC group compared with those in the plasma group showed higher endogenous thrombin potential (ETP, Median, Interquartile range, IQR: 688 [371–1069] vs. 1088 [550–1691] nM minutes, P = 0.01), a greater increase din ETP (P = 0.002) and peak TG (P = 0.01) in the timepoints between heparin reversal and after treatment administration. Both groups demonstrated similar values in all TG assays by postoperative day 1 (P > 0.05). The PCC group also demonstrated higher levels of proteins C, S, and Factors II, VII, IX and X, early after treatment (P < 0.001 for all comparisons). Antithrombin levels were initially higher in the plasma group after treatment (Median, IQR: 66
OBJECTIVE:To examine the analgesic efficacy of postoperative deep parasternal intercostal plane (DPIP) blocks for patients having cardiac surgery via median sternotomy. DESIGN:This single-center retrospective study compared patients receiving bilateral DPIP blocks with a matched cohort of patients not receiving DPIP blocks. SETTING:Large quaternary referral center. PARTICIPANTS:Adult patients admitted to the authors' institution from January 1, 2016, to August 14, 2020, for elective cardiac surgery via median sternotomy. INTERVENTIONS:Patients received ultrasound-guided bilateral DPIP blocks. MEASUREMENTS AND MAIN RESULTS:A total of 113 patients received a DPIP block; 3,461 patients did not. The estimated multiplicative change in cumulative opioid consumption through 24 hours was 0.42 (95% CI 0.32-0.56; p < 0.001), indicating that patients receiving DPIP blocks required 60% fewer opioids than patients who did not. Proportional odds ratios for the average pain score on postoperative day (POD) 0 was 0.46 (95% CI 0.32-0.65; p < 0.001), and POD 1 was 0.67 (95% CI 0.47-0.94; p = 0.021), indicating lower pain scores for patients receiving blocks. The exploratory analysis identified an inverse correlation between DPIP blocks and atrial fibrillation incidence (2% v 15%; inverse probability of treatment weighting odds ratio 0.088, 95% CI 0.02-0.41; p = 0.002). CONCLUSIONS:The use of DPIP blocks in patients undergoing cardiac surgery via median sternotomy was associated with less opioid use and improved pain scores in the early postoperative period compared with patients not receiving blocks. Prospective randomized controlled studies should further elucidate the efficacy and risks of DPIP blocks in cardiac surgery.
Editor—Unexpected perioperative cardiac arrest is a devastating outcome for the patient, their family, and the healthcare team. Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a significant cause of heart failure that can complicate the intraoperative period with ventricular arrhythmias. This uncommon disease, initially reported in the 1970s, has an incidence of 1 in 5000, and can be present in otherwise asymptomatic individuals. 1 Gandjbakhch E. Redheuil A. Pousset F. Charron P. Frank R. Clinical diagnosis, imaging, and genetics of arrhythmogenic right ventricular cardiomyopathy/dysplasia. J Am Coll Cardiol. 2018; 72: 784-804 Crossref PubMed Scopus (155) Google Scholar , 2 Corrado D. Link M.S. Calkins H. Arrhythmogenic right ventricular cardiomyopathy. N Engl J Med. 2017; 376: 61-72 Crossref PubMed Scopus (366) Google Scholar , 3 Gupta R. Tichnell C. Murray B. et al. Comparison of features of fatal versus nonfatal cardiac arrest in patients with arrhythmogenic right ventricular dysplasia/cardiomyopathy. Am J Cardiol. 2017; 120: 111-117 Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar It is likely that an anaesthetist will encounter patients with this condition during their career. We cared for a young adult on the path to becoming a professional basketball player who suffered an unexpected cardiac arrest during practice. After managing this patient's anaesthesia from automatic implantable cardioverter defibrillator (AICD) implantation through an orthotopic heart transplant, we decided to study the perioperative implications of this condition in more depth.
Purpose Central venous catheters (CVCs) and pulmonary artery catheters (PACs) containing chlorhexidine, silver sulfadiazine, or latex can cause perioperative anaphylaxis. We examined the incidence of and outcomes associated with anaphylaxis caused by CVCs/PACs. Methods In a historical cohort study, we retrospectively identified adult patients fitted with CVCs/PACs at the Mayo Clinics in Minnesota, Arizona, and Florida from 1 January 2008 to 1 March 2018. Potential and confirmed cases of perioperative anaphylactic reactions were individually reviewed and classified. Results During the study period, 39,505 procedures were performed during which CVCs/PACs were inserted. Of these, 2,937 patients with pre-existing chlorhexidine, sulfonamide (sulfa), and/or latex allergies had CVCs/PACs inserted that contained these substances. Perioperative anaphylaxis, in which CVCs/PACs were the confirmed or potential causative agent, occurred during 53 procedures. Seven patients had a preoperatively reported sulfa or latex allergy; no patients had a preoperative chlorhexidine allergy. Six of the seven patients with reported allergies to sulfa or latex had a CVC/PAC inserted that contained these substances. Twenty-four patients with anaphylaxis had postoperative allergic disease consultation; ten of these (42%) underwent skin testing. Conclusion Perioperative anaphylactic reactions related to CVCs/PACs containing chlorhexidine, silver sulfadiazine, or latex were rare in this large historical cohort study. We identified 2,937 patients with pre-existing chlorhexidine, sulfa, and/or latex allergies and had CVCs/PACs inserted that contained these substances. Although few cases of perioperative anaphylaxis attributable to these substances were observed in patients with corresponding allergies, the potential for substantial complication exists. Providers should be aware of the potential for these hidden exposures.
PERIOPERATIVE COAGULOPATHY and bleeding in patients undergoing cardiac surgery are common, particularly among those undergoing complex surgery. The etiology of microvascular bleeding in some patients is complex and related to blood exposure to cardiopulmonary bypass components, surgical, and/or patient-specific factors. Treatment of clinically significant microvascular bleeding requires laboratory evaluation to help guide targeted therapy. When coagulation factor deficiency–associated bleeding is the culprit, historic therapy has been with allogeneic plasma transfusion. This treatment is less-than-ideal for several reasons: (1) the risk of transfusion-associated complications (eg, transfusion-associated lung injury, transfusion-associated circulatory overload, infection, etc); (2) the degree of hemodilution seen with modest plasma transfusion volumes can lead to further red blood cell transfusions simply to restore the pretransfusion hematocrit levels; and (3) the amount of coagulation factor activity increase per mL of plasma transfused is small; hence large transfusion volumes are often required to “normalize” the defect, which can be particularly problematic to patients with ventricular dysfunction. In the past decade or more, the off-label use of factor concentrates, particularly prothrombin complex concentrates (PCCs), for treating nonwarfarin–related perioperative coagulopathy in cardiac surgical patients has increased. Inactive four-factor PCCs contain factors II, VII, IX, and X, along with proteins C and S. Prothrombin complex concentrates have appeal in that the infusion volume is small (often ≤50 mL), lack blood bank compatibility concerns, and have a negligible risk of most transfusion-related complications (eg, infection, transfusion-associated lung injury, and transfusion-associated circulatory overload). Despite early and more routine use in Europe, there remained a relative paucity of data on this topic. Given the fear of thromboembolic complications with PCCs, widespread use and adoption in the United States were appropriately cautious. However, what was seen initially and used as a last-resort salvage therapy in ongoing refractory coagulopathy and bleeding scenarios, has become a more targeted first-line agent in certain settings in recent years. The increase in the use of PCCs in this patient population has been driven largely by small retrospective studies and growing societal guidelines.1Tibi P McClure RS Huang J et al.STS/SCA/AmSECT/SABM Update to the clinical practice guidelines on patient blood management.Ann Thorac Surg. 2021; 35: 2569-2591Google Scholar A 2019 metanalysis by Roman et al., which was the largest to date (861 patients from 4 studies), noted that patients receiving PCCs had a significant reduction in the risk for red blood cell (RBC) transfusion (odds ratio, 2.22; 95% CI 1.45-3.40) and units of RBC received (odds ratio, 1.34; 95% CI 0.78-1.90) without an increased risk for thromboembolic complications.2Roman M Biancari F Ahmed AB et al.Prothrombin complex concentrate in cardiac surgery: A systematic review and meta-analysis.Ann Thorac Surg. 2019; 107: 1275-1283Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar The authors acknowledged the limitations being the small number of studies, lack of prospective randomized controlled trials, and lack of consistent algorithm-guided transfusion practices in all included studies. From 2020 to 2021, 2 randomized pilot studies were published demonstrating the feasibility of recruitment without increased risk for thromboembolic complications.3Green L Roberts N Platton S et al.Impact of prothrombin complex concentrate and fresh frozen plasma on correction of haemostatic abnormalities in bleeding patients undergoing cardiac surgery (PROPHESY trial results).Anaesthesia. 2021; 76: 997-1000Crossref PubMed Scopus (8) Google Scholar,4Karkouti K Bartoszko J Grewal D et al.Comparison of 4-factor prothrombin complex concentrate with frozen plasma for management of hemorrhage during and after cardiac surgery: A randomized pilot trial.JAMA Netw Open. 2021; 4e213936Crossref PubMed Scopus (32) Google Scholar In a post hoc observational substudy of the FIBRES randomized trial, the authors analyzed patients not meeting the criteria to receive fibrinogen concentrate or cryoprecipitate but did receive either PCC (n = 72) or plasma (n =343), and found that PCC use was associated with significantly fewer RBC and platelet transfusions, with similar adverse event rates.5Bartoszko J Callum J Karkouti K et al.The association of prothrombin complex concentrates with postoperative outcomes in cardiac surgery: An observational substudy of the FIBRES randomized controlled trial.Can J Anaesth. 2021; 68: 1789-1801Crossref PubMed Scopus (9) Google Scholar We recently published the article “Prothrombin Complex Concentrate vs Plasma for Post-Cardiopulmonary Bypass Coagulopathy and Bleeding: A Randomized Clinical Trial.”6Smith MM Schroeder DR Nelson JA et al.Prothrombin complex concentrate vs plasma for post-cardiopulmonary bypass coagulopathy and bleeding: A randomized clinical trial.JAMA Surg. 2022; 157: 757-764Crossref PubMed Scopus (19) Google Scholar This study represented the first published prospective randomized controlled trial evaluating the use of PCCs compared with plasma for the treatment of nonwarfarin–associated cardiopulmonary bypass coagulopathy, and bleeding. Patients in this study were randomized to receive either 4-factor PCC 15 IU/kg or plasma 10-to-15 mL/kg if clinically significant microvascular bleeding and laboratory-based evaluation suggested coagulation factor abnormality were present. There was no difference in the primary outcome of bleeding defined as chest tube drainage (median [IQR], 1022 [799-1575] mL v 937 [708-1443] mL). Patients receiving PCC compared with plasma had a greater improvement in prothrombin time (effect estimate, –1.37 seconds [95% CI –1.91 to –0.84]; p < 0.001) and international normalized ratio (effect estimate, –0.12 [95% CI –0.16 to –0.07]; p < 0.001). Also, fewer patients in the PCC group required intraoperative RBC transfusion after treatment (7 of 51 patients [13.7%] v 15 of 49 patients [30.6%]; p = 0.04). Interestingly, 13.7% of patients in the PCC group avoided any allogeneic transfusion exposure compared to all patients receiving plasma. There were no significant differences in adverse events between groups. The results of this trial were important for several reasons. Historic fears of PCCs causing an increased risk for thromboembolic complications were not evident. This was further supported, as previously mentioned, by other recent studies. It should be noted that the exclusion criteria included any patients with a history of hypercoagulable conditions or any recent thromboembolic complications. These factors should go into the decision-making process when considering the administration of PCCs. Additionally, the dosing strategy used in the referenced study was ∼15 units/kg,6Smith MM Schroeder DR Nelson JA et al.Prothrombin complex concentrate vs plasma for post-cardiopulmonary bypass coagulopathy and bleeding: A randomized clinical trial.JAMA Surg. 2022; 157: 757-764Crossref PubMed Scopus (19) Google Scholar similar to dosing seen in other recently published reports,3Green L Roberts N Platton S et al.Impact of prothrombin complex concentrate and fresh frozen plasma on correction of haemostatic abnormalities in bleeding patients undergoing cardiac surgery (PROPHESY trial results).Anaesthesia. 2021; 76: 997-1000Crossref PubMed Scopus (8) Google Scholar,4Karkouti K Bartoszko J Grewal D et al.Comparison of 4-factor prothrombin complex concentrate with frozen plasma for management of hemorrhage during and after cardiac surgery: A randomized pilot trial.JAMA Netw Open. 2021; 4e213936Crossref PubMed Scopus (32) Google Scholar but lower than the ∼25 units/kg dose reported in earlier studies.2Roman M Biancari F Ahmed AB et al.Prothrombin complex concentrate in cardiac surgery: A systematic review and meta-analysis.Ann Thorac Surg. 2019; 107: 1275-1283Abstract Full Text Full Text PDF PubMed Scopus (42) Google Scholar,7Gorlinger K Dirkmann D Hanke AA et al.First-line therapy with coagulation factor concentrates combined with point-of-care coagulation testing is associated with decreased allogeneic blood transfusion in cardiovascular surgery: A retrospective, single-center cohort study.Anesthesiology. 2011; 115: 1179-1191Crossref PubMed Scopus (383) Google Scholar Prior studies have discussed the correlation between reduced coagulation factor levels and thrombin generation potential with excessive postoperative bleeding.5Bartoszko J Callum J Karkouti K et al.The association of prothrombin complex concentrates with postoperative outcomes in cardiac surgery: An observational substudy of the FIBRES randomized controlled trial.Can J Anaesth. 2021; 68: 1789-1801Crossref PubMed Scopus (9) Google Scholar,8Coakley M Hall JE Evans C et al.Assessment of thrombin generation measured before and after cardiopulmonary bypass surgery and its association with postoperative bleeding.J Thromb Haemost. 2011; 9: 282-292Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar In an ex vivo study, 25 units/kg of PCC restored peak thrombin-generation parameters to greater than prebypass levels; however, lower doses were not tested.9Percy CL Hartmann R Jones RM et al.Correcting thrombin generation ex vivo using different haemostatic agents following cardiac surgery requiring the use of cardiopulmonary bypass.Blood Coagul Fibrinolysis. 2015; 26: 357-367Crossref PubMed Scopus (24) Google Scholar It is unclear yet that restoration of “normal” or “supranormal” prebypass coagulation status is necessary to treat postcardiopulmonary bypass microvascular bleeding sufficiently. Regardless, it is important to provide data demonstrating that a lower PCC dose provided important clinical outcome data that was noninferior in some respects and superior in others to that of historic 10-to-15 mL/kg plasma dosing. Data on changes in coagulation factor levels and thrombin generation from our study cohort are forthcoming. These should provide further insight into dosing strategies for future studies. Regarding the off-label use of PCCs in the setting of cardiopulmonary bypass-induced coagulopathy and bleeding, it seems that clinical use has outpaced high-quality research on the topic. Although this has provided some retrospective data, additional prospective studies are needed to support its use further and define best practice initiatives regarding patient selection and dosing. When considering the use of PCCs in cardiac surgery, it is important to discuss the rationale for use in each patient. Factors that go into the decision-making process should include the degree of coagulopathy and intravascular volume physiologic goals. Prothrombin complex concentrates may be a better option in patients with markedly deranged coagulopathy and/or those in whom excessive intravascular volume could be detrimental. However, in patients with mild coagulopathy and/or those needing ongoing aggressive intravascular resuscitation, the benefits of PCCs may not be as evident. Additionally, although we exercised extreme caution in excluding patients at risk for or with recent thromboembolic complications in our study, to what degree is this necessary in clinical practice? This is where further prospective research is needed to better define in whom, when, and how PCCs should be incorporated into perioperative patient blood management algorithms. In conclusion, there are several informative takeaways from this study that clinicians can use to make individualized transfusion decisions for cardiac surgical patients. The use of PCCs in patients undergoing complex cardiac surgery appears similarly safe and effective when compared with plasma transfusion practices. Avoiding the hemodilutional impact of large-volume plasma transfusion with PCCs can potentially reduce intraoperative RBC transfusions. There is insufficient evidence currently to say that PCC administration should replace all plasma transfusions, and there are situations for which the latter may still be preferred, as previously mentioned. Questions remain regarding ideal patient selection and proper administration dosage.
OBJECTIVENo recent prospective studies have analyzed the accuracy of standard coagulation tests and thromboelastography (TEG) to identify patients with excessive microvascular bleeding following cardiopulmonary bypass (CPB). The aim of this study was to assess the value of coagulation profile tests, as well as TEG, for the classification of microvascular bleeding after CPB.DESIGNA prospective observational study.SETTINGAt a single-center academic hospital.PARTICIPANTSPatients ≥18 years of age undergoing elective cardiac surgery.INTERVENTIONSQualitative assessment of microvascular bleeding post-CPB (surgeon and anesthesiologist consensus) and the association with coagulation profile tests and TEG values.MEASUREMENTS AND MAIN RESULTSA total of 816 patients were included in the study-358 (44%) bleeders and 458 (56%) nonbleeders. Accuracy, sensitivity, and specificity for the coagulation profile tests and TEG values ranged from 45% to 72%. The predictive utility was similar across tests, with prothrombin time (PT) (62% accuracy, 51% sensitivity, 70% specificity), international normalized ratio (INR) (62% accuracy, 48% sensitivity, 72% specificity), and platelet count (62% accuracy, 62% sensitivity, 61% specificity) displaying the highest performance. Secondary outcomes were worse in bleeders versus nonbleeders, including higher chest tube drainage, total blood loss, transfusion of red blood cells, reoperation rates (p < 0.001, respectively), readmission within 30 days (p = 0.007), and hospital mortality (p = 0.021).CONCLUSIONSStandard coagulation tests and individual components of TEG in isolation agree poorly with the visual classification of microvascular bleeding after CPB. The PT-INR and platelet count performed best but had low accuracy. Further work is warranted to identify better testing strategies to guide perioperative transfusion decisions in cardiac surgical patients.
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OBJECTIVES This study examined the postoperative analgesic efficacy of single-injection pectoral fascial plane (PECS) II blocks compared to paravertebral blocks for elective robotic mitral valve surgery. DESIGN A single-center retrospective study that reported patient and procedural characteristics, postoperative pain scores, and postoperative opioid use for patients undergoing robotic mitral valve surgery. SETTING This investigation was performed at a large quaternary referral center. PARTICIPANTS Adult patients (age ≥18) admitted to the authors' hospital from January 1, 2016, to August 14, 2020, for elective robotic mitral valve repair who received either a paravertebral or PECS II block for postoperative analgesia. INTERVENTIONS Patients received an ultrasound-guided, unilateral paravertebral or PECS II nerve block. MEASUREMENTS AND MAIN RESULTS One hundred twenty-three patients received a PECS II block, and 190 patients received a paravertebral block during the study period. The primary outcome measures were average postoperative pain scores and cumulative opioid use. Secondary outcomes included hospital and intensive care unit lengths of stay, need for reoperation, need for antiemetics, surgical wound infection, and atrial fibrillation incidence. Patients receiving the PECS II block required significantly fewer opioids in the immediate postoperative period than the paravertebral block group, and had comparable postoperative pain scores. No increase in adverse outcomes was noted for either group. CONCLUSIONS The PECS II block is a safe and highly effective option for regional analgesia for robotic mitral valve surgery, with demonstrated efficacy comparable to the paravertebral block.
Aortic stenosis is one of the most common cardiac valve pathologies in the world and its prevalence increases with age. Although previously associated with increased perioperative mortality, more recent studies suggest that mortality rates may be decreasing. Recent guidelines suggest that major non-cardiac surgery can be performed safely in asymptomatic severe aortic stenosis patients with close hemodynamic monitoring. Among symptomatic patients, the guidelines recommend aortic valve intervention prior to major non-cardiac surgery because of a reduction in the incidence of postoperative heart failure and improved rates of long-term overall survival. This review provides a comprehensive and contemporary review of the perioperative management of patients with severe aortic valve stenosis.
Direct oral anticoagulants (DOACs) have rapidly emerged as popular alternatives to warfarin in the setting of nonvalvular atrial fibrillation, prevention and treatment of venous thromboembolism, and secondary prevention of arterial thrombosis. It is now estimated that more patients in the United States take DOACs than warfarin for approved indications. Studies to date have shown that these drugs are similarly efficacious with perhaps a lower bleeding risk than warfarin. The purpose of this review is to provide insight into the currently available DOACs and discuss the management and reversal strategies for patients in the perioperative period.
OBJECTIVES:This study examined the characteristics, intraoperative, and postoperative course of patients undergoing inferior vena cava tumor thrombectomy for metastatic renal cell carcinoma.DESIGN:A single-center case series that reported demographic data and intraoperative and postoperative outcomes for patients with renal cell carcinoma undergoing inferior vena cava thrombectomy.SETTING:This investigation was performed at a large quaternary referral center.PARTICIPANTS:Adult patients (age ≥18) admitted to the authors' hospital from January 1, 2005, to March 10, 2017, undergoing inferior vena cava thrombectomy for level III and IV renal cell carcinoma.INTERVENTIONS:No interventions were performed.MEASUREMENTS AND MAIN RESULTS:Sixty-five patients who met the inclusion criteria were identified, with 31 patients diagnosed with level III and 34 with level IV renal cell carcinoma. Patients with level IV tumors were significantly more likely to have greater intraoperative blood loss, had longer surgical duration and hospital stays, and had more frequently required blood products, pressors, and cardiopulmonary bypass intraoperatively. Intraoperative transesophageal echo was more frequently used in level IV thrombectomy compared to level III (91.2% v 67.7%). Of patients with level IV thrombus, 41.2% developed postoperative atrial fibrillation compared to only 3.2% with level III thrombus. The 30-day mortality was 4.6% for both groups.CONCLUSIONS:Patients undergoing inferior vena cava tumor thrombectomy for renal cell carcinoma had more complex intraoperative and postoperative courses with level IV compared to level III tumor thrombus.
IMPORTANCE Post-cardiopulmonary bypass (CPB) coagulopathy and bleeding are among the most common reasons for blood product transfusion in surgical practices. Current retrospective data suggest lower transfusion rates and blood loss in patients receiving prothrombin complex concentrate (PCC) compared with plasma after cardiac surgery. OBJECTIVE To analyze perioperative bleeding and transfusion outcomes in patients undergoing cardiac surgery who develop microvascular bleeding and receive treatment with either PCC or plasma. DESIGN, SETTING, AND PARTICIPANTS A single-institution, prospective, randomized clinical trial performed at a high-volume cardiac surgical center. Patients were aged 18 years or older and undergoing cardiac surgery with CPB. Patients undergoing complex cardiac surgical procedures (eg, aortic replacement surgery, multiple procedures, or repeated stemotomy) were preferentially targeted for enrollment. During the study period, 756 patients were approached for enrollment, and 553 patients were randomized. Of the 553 randomized patients, 100 patients met criteria for study intervention. INTERVENTIONS Patients with excessive microvascular bleeding, a prothombin time (PT) greater than 16.6 seconds, and an international normalized ratio (INR) greater than 1.6 were randomized to receive treatment with either PCC or plasma. The PCC dose was 15 Ill/kg or closest standardized dose; the plasma dose was a suggested volume of 10 to 15 mL/kg rounded to the nearest unit. MAIN OUTCOMES AND MEASURES The primary outcome was postoperative bleeding (chest tube output) from the initial postsurgical intensive care unit admission through midnight on postoperative day 1. Secondary outcomes were PT/INR, rates of intraoperative red blood cell (RBC) transfusion after treatment, avoidance of allogeneic transfusion from the intraoperative period to the end of postoperative day 1, postoperative bleeding, and adverse events. RESULTS One hundred patients (mean [SD] age, 66.8 [13.7] years; 61 [61.0%] male; and 1 [1.0%] Black, 1[1.0%] Hispanic, and 98 [98.0%] White) received the study intervention (49 plasma and 51 PCC). There was no significant difference in chest tube output between the plasma and PCC groups (median [IQR], 1022 [799-1575] ml vs 937 [708-1443] mL). After treatment, patients in the PCC arm had a greater improvement in PT (effect estimate, -1.37 seconds [95% CI, -1.91to -0.84]; P < .001) and INR (effect estimate, -0.12 [95% CI, -0.16 to -0.07]; P < .001). Fewer patients in the PCC group required intraoperative RBC transfusion after treatment (7 of 51 patients [13.7%) vs 15 of 49 patients [30.6%]; P = .04); total intraoperative transfusion rates were not significantly different between groups. Seven (13.7%) of 51 patients receiving PCCs avoided allogeneic transfusion from the intraoperative period to the end of postoperative day 1 vs none of those receiving plasma. There were no significant differences in postoperative bleeding, transfusions, or adverse events. CONCLUSIONS AND RELEVANCE The results of this study suggest a similar overall safety and efficacy profile for PCCs compared with plasma in this clinical context, with fewer posttreatment intraoperative RBC transfusions, improved PT/INR correction, and higher likelihood of allogeneic transfusion avoidance in patients receiving PCCs.
The etiologies of thrombocytopenia in patients presenting for cardiac surgery are extensive, but clinically relevant conditions generally can be categorized by those related to decreased platelet production or increased platelet destruction. Many causes require mere acknowledgment and availability of allogeneic platelet transfusion; others have unique considerations for which providers should be familiar. The purpose of this review is to provide an overview of the common causes of thrombocytopenia, summarize the literature, and discuss perioperative considerations for patients undergoing cardiac surgery.
Prothrombin complex concentrate (PCC) administration has increased among cardiac surgery patients in recent years; however, use in LVAD implantation/exchange is not widespread due to the fear of thrombotic complications. The purpose of this study was to compare the clinical outcomes of patients undergoing LVAD implantation/exchange with intraoperative PCC administration versus traditional transfusion practices alone. Adult LVAD implants/exchanges at our institution between 2015 and 2018 were included. Patients were categorized as receiving intraoperative PCC or no-PCC (traditional). The primary outcome was the need for allogenic transfusion and transfusion volume at 48 hours after initial intensive care unit (ICU) admission. Secondary outcomes included metrics of morbidity and mortality. A total of 160 patients (39 PCC, 121 traditional) were analyzed. In unadjusted analysis, patients in the PCC group received lower intraoperative transfusion volumes compared to the traditional group although not statistically significant (1464 mL [IQR 796, 4876] vs. 2568 mL [IQR 1292, 3606]; P value .37). In the fully adjusted analysis, patients in the PCC group had increased odds of transfusion within 48 hours of ICU admission (OR 4.06, 95% CI: 1.35-12.20; P < .01); however, there was no significant difference in transfusion volumes (P = .09). Patients receiving PCCs had higher incidence of deep vein thrombosis (10.3% vs. 0%; P < .01) and 30-day mortality (17.9% vs. 4.1%; P < .01). LVAD pump thrombosis occurred in 2.6% versus 0.8% in the PCC and traditional groups, respectively; P = .98. Patients undergoing LVAD implantation and exchange represent a complex surgical cohort. The results of this study suggest that the intraoperative PCC use during LVAD implant/exchange was associated with reduced intraoperative transfusions. Intraoperative PCC use was, however, associated with higher odds of postoperative transfusion, although transfusion volumes were not significantly different. While the deep vein thrombosis and 30-day mortality rates were higher in the PCC group, these results are likely related to the degree of surgical and patient complexity rather than PCC use itself. Further studies are needed to assess PCC use in this surgical cohort.