Complex Cardiac Surgery Research Articles

Impact of CytoSorb® on interleukin-6 in cardiac surgery.

Cardiac surgery is known to activate a cascade of inflammatory mediators leading to a systemic inflammatory response. Hemadsorption (HA) devices such as CytoSorb® have been postulated to mitigate an overshooting immune response, which is associated with increased morbidity and mortality, and thus improve outcome. We aimed to investigate the effect of CytoSorb® on interleukin (IL)-6 levels in patients undergoing complex cardiac surgery in comparison to a control group. A total of 56 patients (28 CytoSorb®, 28 control) undergoing acute and elective cardiac surgery between January 2020 and February 2021 at the Department of Cardiac and Vascular Surgery, Clinic Floridsdorf, Vienna, were retrospectively analyzed. The primary endpoint was the difference in IL-6 levels between the CytoSorb® and control group. Secondary endpoint was periprocedural mortality. CytoSorb®, installed in the bypass circuit, had no significant effect on IL-6 levels. IL-6 peaked on the first postoperative day (HA: 775.3 ± 838.4 vs. control: 855.5 ± 1,052.9 pg/ml, p = 0.856). In total, three patients died in the HA group, none in the control (logistic regression model, p = 0.996). Patients with an increased Euroscore II of 7 or more showed a reduced IL-6 response compared to patients with an Euroscore II below 7 (178.3 ± 63.1 pg/ml vs. 908.6 ± 972.6 pg/ml, p-value = 0.00306). No significant reduction of IL-6 levels or periprocedural mortality through intraoperative HA with CytoSorb® in patients undergoing cardiac surgery was observed. However, this study was able to show a reduced immunologic response in patients with a high Euroscore II. The routine application of CytoSorb® in cardiac surgery to reduce inflammatory mediators has to be scrutinized in future prospective randomized studies.

1226 The Role of Extracorporeal Membrane Oxygenation in William’s Syndrome Following Cardiac Surgery: A Case Report

Abstract Williams-Beuren Syndrome (WS) is a genetic syndrome seen in childhood, characterised by intellectual disabilities, outgoing personalities, elfin-like faces and cardiovascular complications. We report the story of a girl with WS who underwent complex cardiac surgery requiring extracorporeal membrane oxygenation (ECMO), to raise awareness of the perioperative challenges with WS. At 2 years old, a cardiac murmur was incidentally discovered. Further investigations revealed WS with cardiac manifestations including peripheral pulmonary artery stenosis (PPAS) and supravalvular aortic stenosis (SVAS). Isolated SVAS repair was feasible, however the severity of pulmonary artery hypoplasia deemed her inoperable. Her care was redirected to palliation. 18 months later, she remained in good clinical condition which prompted the multidisciplinary team (MDT) to change their decision and proceed with complex SVAS repair surgery (Brom technique) at the age of 5. Postoperatively, 3 failed attempts to wean from cardiopulmonary bypass preceded veno-arterial ECMO, which lasted 7 days. She stayed in intensive care for 17 days, and in hospital for 28 days. Frequent MDT decision making was crucial during her complex care. The patient is currently 15 years old, in good clinical condition, albeit exercise restrictions. WS patients have a known increased risk of perioperative sudden cardiac death and increasing use of paediatric ECMO, hence great attention and thorough preparation is required. Clear perioperative care guidelines for WS are essential to secure good outcomes in this patient population. This case demonstrated that MDT involvement and regular communication with the patient were key to deliver the appropriate care throughout her life.

Infective Endocarditis among Pediatric Patients with Prosthetic Valves and Cardiac Devices: A Review and Update of Recent Emerging Diagnostic and Management Strategies.

Infective endocarditis (IE) is a disease of the endocardium, which leads to the appearance of vegetation on the valves, cardiac structures, or, potentially, vascular endothelium of the heart. The risk of IE can be increased more than 140 times by congenital heart disease (50-59% of all IE), particularly if cyanotic. An increase in mortality may result from IE in patients with a complex cardiac pathology or patients with an implanted prosthetic material, most frequently conduits in a pulmonary position. Cardiac implantable electronic devices (CIED) infective endocarditis is a life-threatening complication representing 10% of all cases of endocarditis. Common signs of presentation are often fever and chills; redness and swelling at the pocket of the pacemaker, including the erosion and exteriorization of the device; and life-threatening sepsis. The use of intracardiac echocardiography for the diagnosis of IE is an innovative method. This may be needed, especially in older children undergoing complex cardiac surgery, when transthoracic echocardiography (TTE) and transesophageal echocardiography (TOE) failed to provide a reliable diagnosis. The 2018 European Heart Rhythm Association (EHRA) experts' consensus statement on transvenous lead extraction recommends complete device removal and antimicrobial therapy for any device-related infection, including CIED-IE. The most detected microorganism was Staphylococcus Aureus. In addition, cardiac surgery and interventional cardiology associated with the placement of prostheses or conduits may increase the risk of IE up to 1.6% for Melody valve implantation. Our manuscript presents a comprehensive review of infective endocarditis associated with cardiac devices and prostheses in the pediatric population, including recent advances in diagnosis and management.

Relative Survival After Adult Cardiac Surgery: Analysis of the Italian Nationwide Registry Data

The authors aimed to investigate life expectancy after adult cardiac surgery. Nationwide study including University and non-University hospitals. Consecutive adult patients who underwent heart valve and coronary artery surgery from a nationwide administrative registry. Surgical procedures on the heart valves and coronary arteries. The authors estimated the 10-year relative survival of adult patients who underwent surgery for heart valve diseases and coronary artery disease taken from a nationwide administrative registry. Overall, data on 415,472 patients were available for this study. Among them, 394,445 (94.9%) survived 90 days after surgery, and their 10-year survival was 58.0% (95% CI 57.8-58.3); the expected survival was 70.1%, and the relative survival was 0.83 (95% CI 0.82-0.83). Patients who underwent surgical repair of the mitral valve and aortic valve had relative survival of 0.96 and 0.92, respectively. Isolated coronary artery bypass grafting had a relative survival of 0.88. Surgical replacement of the heart valves had a relative survival below 0.80. Poor results with relative survival <0.70 were observed after complex cardiac surgery. Relative survival was <0.60 in patients who underwent double- or triple-valve surgery combined with coronary artery surgery. The authors observed markedly lower relative survival among women (0.77, 95% CI 0.77-0.78) compared with men (0.86, 95% CI 0.85-0.86) at 10 years. Such a difference was observed after almost all different procedures. The present findings provided a picture of the real expectation in terms of the late survival of patients after having undergone adult cardiac surgery. This information should be communicated to patients and their relatives before surgery, and it may be relevant in the decision-making process and in planning tertiary prevention.

Impact of ketamine versus propofol for anesthetic induction on cognitive dysfunction, delirium, and acute kidney injury following cardiac surgery in elderly, high-risk patients.

Evaluate the effects of ketamine versus propofol when used for induction of anesthesia in elderly, high-risk cardiac surgical patients on postoperative complications including cognitive dysfunction, delirium, and acute kidney injury. Prospective, randomized study performed at a tertiary medical center. A total of 52 patients aged ≥70 and older presenting for complex cardiac surgery were randomized to receive either ketamine or propofol for induction of anesthesia. Patients underwent a battery of cognitive testing preoperatively and postoperatively and the incidence of delirium and acute kidney injury were measured. Norepinephrine (NEE) equivalents following induction were assessed for each group. A total of 49 patients were included, 25 in the ketamine group and 24 in the propofol group with 3 patients excluded from the analysis. No difference was found between groups in either postoperative cognitive dysfunction or delirium incidence. Acute kidney injury occurred in 6 (24%) patients in the ketamine group in 12 (50%) patients in the propofol group, but the difference did not meet statistical significance (P = 0.08; Relative Risk = 2.1, 95% CI 0.9-4.7). NEE equivalents were lower in the ketamine group, 9.6 ± 22.2 versus 32.7 ± 46.0, P < 0.03. The use of ketamine versus propofol for induction of anesthesia did not impact the incidence of postoperative cognitive dysfunction or delirium. Twice as many patients in the propofol group developed acute kidney injury, although not reaching statistical significance and warranting further investigation. In elderly, high-risk patients, ketamine was associated with a significantly reduced need for vasopressor support following induction.

Blood versus crystalloid cardioplegia during triple valve surgery: A single center experience.

The efficacy of different cardioplegia solutions on outcomes of complex cardiac operations such as triple valve surgery (TVS) is scarce. Here we compared the outcomes in TVS patients receiving either crystalloid (Bretschneider) or blood (Calafiore) cardioplegia. Screening of our institutional database with prospectively entered data identified 471 consecutive patients (mean age 70.3 ± 9.2 years; 50.9% male), who underwent TVS (replacement or repair of aortic, mitral and tricuspid valve) between December 1994 and January 2013. In 277 patients, cardiac arrest was induced with HTK-Bretschneider solution (HTK, n = 277, 58.8%), whereas 194 received cold blood cardioplegia (BCP) according to Calafiore (n = 194, 41.2%). Comparisons of perioperative and follow up outcomes were made between cardioplegia groups. Preoperative patient characteristics and comorbidities were equally balanced between groups. 30-days mortality was similar between groups (HTK: 16.2%; BCP: 18.2%; p = 0.619). Incidence of the cumulative endpoint (30days mortality, myocardial infarction (MI), arrhythmia, low cardiac output syndrome or need for permanent pacemaker implantation) was also comparable (HTK: 47.6%; BCP: 54.8%, p = 0.149). In patients with reduced left ventricular ejection fraction (LVEF <40%), 30days mortality was higher in the HTK group (HTK 18/71 22.5%; BCP 5/50 10%; p = 0.037). Five-year survival was similar between groups (52 ± 6% for HTK and 55 ± 5% for BCP patients). In-Hospital mortality was best predicted by length of surgery and reperfusion ratio. Decreased age, shorter bypass time, preserved LVEF and concomitant surgical procedures have been found to be protective from long-term mortality. Myocardial protection with HTK shows equivalent outcomes compared to BCP during TVS. Patients with reduced left ventricular function may benefit from BCP during TVS.

Abstract Number ‐ 54: First Fully Automated Robotic Transcranial Doppler Optimization of Cerebral Blood Flow During Cardiac Revascularization Surgery

Introduction Current technologies including EEG and near infrared pulse oximetry for non‐invasive monitoring of cerebral blood flow during cardiac surgery have proven inadequate for perioperative stroke risk mitigation. Cerebral arterial flow velocity is an excellent indicator of cerebral blood flow making transcranial doppler ultrasound (TCD) an excellent alternative technology for operating room continuous cerebral monitoring. To date, TCD utilization in the operating room has been limited due to frequent movement‐related loss of signal requiring nearly continuous manual probe readjustment. The recent development of fully autonomous robotic TCD (aTCD) has overcome these technical limitations, opening the door for real‐time continuous noninvasive cerebral blood flow monitoring with simultaneous emboli detection. Methods A 47‐year‐old female patient was found to have preoperative complete occlusion of the proximal brachiocephalic artery producing a double cerebral steal phenomenon with retrograde flow in the right internal carotid and vertebral arteries into the subclavian. A preoperative aTCD study disclosed baseline markedly diminished blood flow in the right middle cerebral artery (MCA) fed exclusively by small‐diameter collaterals via the circle of Willis.Intraoperatively, robotic aTCD was used to continuously monitor blood flow in the bilateral MCAs and perform emboli detection. In response to movement‐related signal loss, the robotic aTCD autonomously adjusted the probe position to maintain continuous MCA insonation. Results Shortly after intubation, a small drop in mean arterial pressure led to a near‐total loss of cerebral perfusion to the entire right hemisphere. This perfusion decrease was detected by aTCD, triggering the anesthesiologist to rapidly correct blood pressure to ensure adequate cerebral perfusion as confirmed by the robotic system. The patient was then placed on bypass pump with deployment of a temporary Y‐graft from the pump to the subclavian artery distal to the vertebral branch point and to the aorta to temporarily reverse the double cerebral steal. Coronary bypass was then performed, throughout which cerebral flow velocities were monitored continuously with aTCD and maintained in the safe cerebral perfusion range by adjusting pump pressures. Following a three‐vessel coronary bypass graft, permanent brachiocephalic artery bypass grafts were placed from the proximal aorta to the right subclavian and the proximal common carotid artery.Postoperative aTCD disclosed correction of the previously diminished blood flow detected in the right MCA preoperatively. Brain MRI postoperatively confirmed the absence of acute stroke. Conclusions This case represents the first use of robotic aTCD for real time continuous cerebral blood flow monitoring and optimization during complex cardiac surgery. Our experience suggests that aTCD may improve patient outcomes, particularly during high‐risk cardiac surgical and interventional procedures. Further studies of this promising technology are now needed.

Myocardial Protection in High-Risk Cardiopulmonary Bypass Support

The development of cardioplegia has facilitated complex cardiac surgery and allowed high-risk patients to safely tolerate life-saving procedures. By following the principles of electromechanical arrest, inducing hypothermia, and using adjunctive agents to help mitigate the effects of hypothermia and ischemia reperfusion injury, cardioplegia can be safely induced with various commercially available compositions, which can be delivered by several different surgical techniques. Although many studies have compared these methods, there is little consensus on whether any one method is superior to another. Just as a surgeon may need to modify technique according to individual patient factors, so too must a surgeon be flexible and be prepared to use different cardioplegia strategies according to the clinical circumstances. Increasing evidence shows the advantage of coronary artery bypass grafting (CABG) over percutaneous interventions in patients with low ejection fractions. Thus, optimal myocardial protection will continue to be necessary in this higher-risk cohort. Moreover, while patients in cardiogenic shock rarely present for CABG, the high mortality in this cohort demonstrates the need for ongoing efforts to improve myocardial protection. Lastly, there may be circumstances in which alternative approaches involving fibrillatory arrest or keeping the heart beating are more effective than conventional cardioplegia. These techniques should all be part of the surgeon’s armamentarium, enabling the surgeon to tailor the operation to the individual patient.

Design and logistical considerations for the randomized adaptive non-inferiority storage-duration-ranging CHIlled Platelet Study.

Platelet transfusion is a potentially life-saving therapy for actively bleeding patients, ranging from those undergoing planned surgical procedures to those suffering unexpected traumatic injuries. Platelets are currently stored at room temperature (20°C-24°C) with a maximum storage duration of 7 days after donation. The CHIlled Platelet Study trial will compare the efficacy and safety of standard room temperature-stored platelets with platelets that are cold-stored (1°C-6°C), that is, chilled, with a maximum of storage up to 21 days in adult and pediatric patients undergoing complex cardiac surgical procedures. CHIlled Platelet Study will use a Bayesian adaptive design to identify the range of cold storage durations for platelets that are non-inferior to standard room temperature-stored platelets. If cold-stored platelets are non-inferior at durations greater than 7 days, a gated superiority analysis will identify durations for which cold-stored platelets may be superior to standard platelets. We present example simulations of the CHIlled Platelet Study design and discuss unique challenges in trial implementation. The CHIlled Platelet Study trial has been funded and will be implemented in approximately 20 clinical centers. Early randomization to enable procurement of cold-stored platelets with different storage durations will be required, as well as a platelet tracking system to eliminate platelet wastage and maximize trial efficiency and economy. The CHIlled Platelet Study trial will determine whether cold-stored platelets are non-inferior to platelets stored at room temperature, and if so, will determine the maximum duration (up to 21 days) of storage that maintains non-inferiority. ClinicalTrials.gov, NCT04834414.

Cold-stored Platelets for Bleeding Patients: Comment.

Cold-stored Platelets for Bleeding Patients: Comment.

PREOPERATIVE RISK ASSESSMENT IN CARDIAC SURGERY. EUROSCORE I AND EUROSCORE II IN A MODERN COHORT.

<h3>Introduction</h3> EuroSCORE I was used to predicting mortality among patients undergoing cardiac surgery. Nonetheless, it overestimated the risk. Since its introduction in 2011, the EuroSCORE II has been used instead of Euroscore I. Nowadays EuroSCORE II is a worldwide useful tool to assess the preoperatory risk of mortality in cardiac surgery. <h3>Objective</h3> This paper aims to assess the EuroSCORE II and EuroSCORE I in a contemporary cardiac surgery cohort in Spain. Moreover, we wanted to evaluate its performance in different types of surgeries. <h3>Methods</h3> The original logistic EuroSCORE was compared to EuroSCORE II and with the observed mortality in our center. We studied patients that underwent surgery from 2017 to 2021. Analysis was performed amongst patients that underwent: coronary artery bypass grafts alone (CABG) n=406, aortic valve replacement alone (AVR) n=489 (we excluded patients undergoing transcatheter aortic valve implantation) and the last group of patients were those undergoing a complex cardiac surgery (2 or more procedures) n=455. Total of patients n=1350 <h3>Results</h3> Logistic EuroSCORE of our overall population was 11,69 % whereas EuroSCORE II was 4,05 %. Our observed mortality was 3,92%. For the population of CABG, Logistic EuroSCORE was 8,91 %, EuroSCORE II was 2,5% and the mortality was 2,21%. In the group of AVR Logistic EuroSCORE was 12,05%, EuroSCORE II was 3,2% and the observed mortality was 2,04%. Finally, in those patients that underwent a complex cardiac surgery, their Logistic EuroSCORE was 14,53%, EuroSCORE II was 6,34% and the mortality in this group was 7,47%. <h3>Conclusion</h3> EuroSCORE II is more accurate than logistic EuroSCORE for the assessment of preoperatory risk in patients undergoing cardiac surgery. Its use for AVR isolation may be controversial as it overestimates the risk.

Hemoadsorption in Complex Cardiac Surgery—A Single Center Experience

(1) Background: Cardiac surgery may evoke a generalized inflammatory response, typically magnified in complex, combined, redo, and emergency procedures with long aortic cross-clamp times. Various treatment options have been introduced to help regain control over post-cardiac surgery hyper-inflammation, including hemoadsorptive immunomodulation with CytoSorb®. (2) Methods: We conducted a single-center retrospective observational study of patients undergoing complex cardiac surgery. Patients intra-operatively treated with CytoSorb® were compared to a control group. The primary outcome was the change in the vasoactive-inotropic score (VIS) from pre-operatively to post-operatively. (3) Results: A total of 52 patients were included in the analysis, where 23 were treated with CytoSorb® (CS) and 29 without (controls). The mean VIS increase from pre-operative to post-operative values was significantly lower in the CS group compared to the control group (3.5 vs. 5.5, respectively, p = 0.05). In-hospital mortality in the control group was 20.7% (6 patients) and 9.1% (2 patients) in the CS group (p = 0.26). Lactate level changes were comparable, and the median intensive care unit and hospital lengths of stay were similar between groups. (4) Conclusions: Despite notable imbalances between the groups, the signals revealed point toward better hemodynamic stability with CytoSorb® hemoadsorption in complex cardiac surgery and a trend of lower mortality.

Science, Medicine, and the Anesthesiologist

Science, Medicine, and the Anesthesiologist

Aortic root replacement in severe left ventricular dysfunction: The added value of beating-heart surgery.

There are limits to the use of cardioplegic arrest during complex cardiac surgical procedures, especially in patients with severe left ventricular dysfunction. In the current report, we graphically present the detailed surgical strategy and technique for beating-heart aortic root replacement with concomitant coronary bypass grafting, for patients otherwise deemed inoperable. With support of cardiopulmonary bypass (CPB), beating-heart bypass surgery is realized, after which the bypass grafts can selectively be connected to the CPB, preserving coronary flow. Then, on the beating and perfused heart, a complex procedure such as aortic root replacement can be performed, without jeopardizing postoperative cardiac function. However, several important caveats and remarks regarding the use of beating-heart surgery should be considered, including: coronary perfusion verification and maintenance, temperature management, and prevention of air embolisms. By use of this strategy, risks associated with cardioplegic arrest are minimized, while it circumvents the potential need for long-term postoperative extracorporeal membrane oxygenation.

Mortality and adverse events of hemoadsorption with CytoSorb® in critically ill patients: A systematic review and meta-analysis of randomized controlled trials.

BackgroundThe effects and safety of extracorporeal hemoadsorption with CytoSorb® in critically ill patients with inflammatory conditions are controversial.MethodsWe performed a systematic review with meta‐analysis and trial sequential analysis (TSA) of randomized‐controlled trials to assess the mortality and safety of CytoSorb® therapy in critically ill patients with inflammatory conditions. Electronic databases were searched up to April 2022. The primary outcome was mortality at longest follow‐up and secondary outcomes included various adverse event (AE) outcomes. Conflict of interest and funding of each trial were assessed. We calculated relative risk (RR) and 95% confidence interval (CI).ResultsFourteen published (n = 764) and 4 unpublished (n = 111) trials were included. Eight trials were performed in medical ICU patients and 10 in complex cardiac surgery. Ten trials had significant industrial funding or an author conflict of interest. Hemoadsorption with CytoSorb® was associated with higher mortality at latest follow‐up (16 trials, n = 807, 120 of 402 [29.85%] patients in the CytoSorb® group vs. 98 of 405 [24.20%] patients in the control group, RR = 1.24 [95% CI, 1.04–1.49], p = .02, [TSA‐adjusted CI, 0.92–1.68]) and at 30‐days or in‐hospital (11 trials, n = 727; RR = 1.41 [95% CI, 1.06–1.88], p = .02, [TSA‐adjusted CI, 0.44–4.62]). Only one trial reported the definition of adverse event, while detailed results were reported in 3 trials; the risk of adverse events was not higher with CytoSorb®. Certainty of evidence ranged from low to very low.ConclusionLow certainty of evidence showed that the use of CytoSorb® might increase mortality in critically ill patients with inflammatory conditions. Adverse events were frequent but underreported and not systematically evaluated. Industrial funding and conflict of interest were common. Considerable uncertainty about the findings does not allow firm conclusions and suggests a need for high‐quality randomized trials to clarify mortality and adverse events related to CytoSorb®.Editorial CommentHemoadsorption with CytoSorb® have been used in critically ill patients despite lack of high quality data from RCTs suggesting any patient‐important benefits. The findings from this systematic review and meta‐analysis suggests an increased risk of adverse events including mortality. With no apparent benefits and at the same time risk of harm, use of hemoadsorption with CytoSorb® in daily clinical practice cannot be recommended at this time.

Use of CytoSorb® hemoadsorption column during prolonged cardiopulmonary bypass in complex cardiac surgery patient

BackgroundComplex cardiac surgery and prolonged cardiopulmonary bypass are associated with significant activation of the systemic inflammatory response system. Pro-inflammatory cytokines, oxygen free radicals and complement activation products contribute to postoperative complications and multiorgan injury. CytoSorb® hemoadsorption therapy has been suggested to alleviate the hyperinflammatory response triggered by cardiopulmonary bypass during cardiac surgery.Case presentationWe describe the use of CytoSorb® hemoadsorption therapy in a 61-year-old male presenting for aortic valve replacement, mitral valve replacement, tricuspid valve repair, coronary artery bypass grafting and left atrial appendage clip.ConclusionWe were able to demonstrate that CytoSorb® use during cardiopulmonary bypass may be a safe and feasible adjunct therapy that may contribute to improved postoperative outcomes in a patient with complex cardiac disease.

Effect of perioperative use of oral triidothyronine for infants undergoing complex congenital cardiac surgeries under cardiopulmonary bypass: A double-blinded randomised controlled study.

ABSTRACTBackground:Thyroid hormone metabolism disrupts after cardiopulmonary bypass both in adults and pediatric patients. This is known as Euthyroid sick syndrome, and it is more evident in pediatric patients who were undergoing complex cardiac surgeries compared to adults. This decrease in serum T3 levels increases the incidence of low cardiac output, requirement of inotropes, prolonged mechanical ventilation, and prolonged intensive care unit (ICU) stay.Aims and Objectives:The primary objective was to compare the mean Vasoactive-inotropic score (VIS) at 72 hours postoperatively between T3 and Placebo groups.Materials and Methods:One hundred patients were screened, and 88 patients were included in the study. Triidothyronine 1 mic/kg 10 doses 8th hourly was given orally postoperatively to cases and sugar sachets to controls. The blood samples for analysis of FT3, FT4, and TSH were taken every 24 hours postoperatively, and baseline values were taken after induction. Mean VIS scores, ejection Fraction (EF), Left ventricular outflow tract velocity time integral (LVOT VTi), hemodynamics and partial pressure of oxygen/ fraction of inspired oxygen(PaO2/FiO2) were recorded daily.Results:The Mean VIS scores at 72 Hours postoperatively were significantly less in the T3 group (5.49 ± 6.2) compared to the Placebo group (13.6 ± 11.7). The PaO2/FiO2 ratios were comparatively more in the T3 group than the Placebo group. The serum levels of FT3 FT4 were significantly higher in the T3-supplemented group than the Placebo group. The VIS scores were significantly lower from 48 hours postoperatively in children < 6 months of age.Conclusion:In this study, we observed that supplementing T3 postoperatively decreases the ionotropic requirement from 72 hours postoperatively. This is more useful in children <6 months of age undergoing complex cardiac surgeries.

Prothrombin Complex Concentrate vs Plasma for Post–Cardiopulmonary Bypass Coagulopathy and Bleeding

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. To analyze perioperative bleeding and transfusion outcomes in patients undergoing cardiac surgery who develop microvascular bleeding and receive treatment with either PCC or plasma. 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 sternotomy) 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. 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 IU/kg or closest standardized dose; the plasma dose was a suggested volume of 10 to 15 mL/kg rounded to the nearest unit. 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. 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, -1.91 to -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. 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. ClinicalTrials.gov Identifier: NCT02557672.

Use and safety of aprotinin in routine clinical practice: A European postauthorisation safety study conducted in patients undergoing cardiac surgery.

BACKGROUNDAprotinin has been used to reduce blood loss and blood product transfusions in patients at high risk of major blood loss during cardiac surgery. Approval by the European Medicines Agency (EMA) for its current indication is limited to patients at high risk of major blood loss undergoing isolated coronary artery bypass graft surgery (iCABG).OBJECTIVETo report current real-world data on the use and certain endpoints related to the safety of aprotinin in adult patients.DESIGNThe Nordic aprotinin patient registry (NAPaR) received data from 83 European centres in a noninterventional, postauthorisation safety study (PASS) performed at the request of the EMA.SETTINGCardiac surgical centres committed to enrolling patients in the NAPaR.PATIENTSPatients receiving aprotinin agreeing to participate.INTERVENTIONThe decision to administer aprotinin was made by the treating physicians.MAIN OUTCOME MEASURESAprotinin safety endpoints were in-hospital death, thrombo-embolic events (TEEs), specifically stroke, renal impairment, re-exploration for bleeding/tamponade.RESULTSFrom 2016 to 2020, 5309 patients (male 71.5%; >75 years 18.9%) were treated with aprotinin; 1363 (25.7%) underwent iCABG and 3946 (74.3%) another procedure, including a surgical treatment for aortic dissection (n = 660, 16.7%); 54.5% of patients received the full-dose regimen. In-hospital mortality in iCABG patients was 1.3% (95% CI, 0.66 to 1.84%) vs. 8.3% (7.21 to 8.91%) in non-iCABG patients; incidence of TEEs and postoperative rise in creatinine level greater than 44 μmol l−1 2.3% (1.48 to 3.07%) and 2.7% (1.79 to 3.49%) vs. 7.2% (6.20 to 7.79%) and 15.5% (13.84 to 16.06%); patients undergoing re-exploration for bleeding 1.4% (0.71 to 1.93%) vs. 3.0% (2.39 to 3.44%). Twelve cases of hypersensitivity/anaphylactic reaction (0.2%) were reported as Adverse Drug Reactions.CONCLUSIONThe data in the NApaR indicated that in this patient population, at high risk of death or blood loss undergoing cardiac surgery, including complex cardiac surgeries other than iCABG, the incidence of adverse events is in line with data from current literature, where aprotinin was not used.TRIAL REGISTRATIONEU PAS register number: EUPAS11384.

Bilateral chylothorax: A late complication of Kawashima procedure despite normal pulmonary pressures.

IntroductionChylothorax, a relatively rare congenital heart disease early postoperative complication, is occurring more frequently due to complexity of cardiac surgeries.Presentation of caseWe present a 9-month-old boy who had hypoplastic left heart (HLH) syndrome with interrupted inferior vena cava (IVC) and bilateral superior vena cava (SVC) palliated with left sided modified Blalock-Taussig (MBT) shunt during neonatal period and second stage palliation with left sided bidirectional glen (BDG) procedure and right sided Kawashima procedure develop bilateral chylothorax two weeks after discharge.DiscussionThis is the first reported case in the literature of a patient who developed chylothorax with relatively low Fontan systemic venous pressures after a Kawashima procedure. Clinically important chylothorax may be a marker of poor long-term outcomes, demonstrating an inability to handle overwhelming lymphatic congestion.ConclusionEarly diagnosis of chylothorax in complex cardiac surgeries may permit successful conservative management.