Extracorporeal Research Articles

Venoarterial Extracorporeal Membrane Oxygenation Therapy in Patients with Sickle Cell Disease: Case Series and Review for Intensive Care Physicians.

Sickle cell disease (SCD) is associated with substantial morbidity and early mortality in afflicted adults. Cardiopulmonary complications that occur at increased frequency in SCD such as pulmonary embolism, pulmonary arterial hypertension, and acute chest syndrome can acutely worsen right ventricular function and lead to cardiogenic shock. Mechanical circulatory support including venoarterial extracorporeal membrane oxygenation (VA ECMO) is being increasingly utilized to treat hemodynamic collapse in various patient populations. However, a paucity of literature exists to guide the use of mechanical circulatory support in adults with SCD where disease-related sequela and unique hematologic aspects of this disorder may complicate extracorporeal therapy and must be understood. Here, we review the literature and describe three cases of adult patients with SCD who developed cardiogenic shock from acute decompensated right heart failure and were treated clinically with VA ECMO. Using an in vitro ECMO system, we investigate a potential increased risk of systemic fat emboli in patients with SCD who may be experiencing vaso-occlusive events with bone marrow involvement given the high-volume shunting of blood from venous to arterial systems with VA ECMO. The purpose of this study is to describe available extracorporeal life support experiences, review potential complications, and discuss the special considerations needed to further our understanding of the utility of VA ECMO in those with SCD.

Surgery for the right vertical infra-axillary thoracotomy in treatment of outlet ventricular septal defect in children

BackgroundOutlet ventricular septal defect is often associated with aortic valve regurgitation. Early intervention in these subjects is essential to avoid complications of irreversible aortic valve regurgitation after surgery. ObjectiveThis study aims to evaluate the safety and feasibility of right vertical infra-axillary thoracotomy for the treatment of outlet ventricular septal defect in pediatric patients. MethodsThis report includes data from 39 pediatric patients who underwent right vertical infra-axillary thoracotomy from January 2020 to April 2023. The ventricular septal defect was approached via the pulmonary artery and closed using autologous or bovine pericardium. Intraoperative management of associated lesions included tricuspid valve repair, widening of the right ventricular outflow tract with excision of jet lesions, and ligation of the ductus arteriosus. ResultsThe average weight of the pediatric patients was 8.4 ± 6 kg, with the average age at intervention being 17.1 months. Approximately 50 % of the patients exhibited signs of heart failure preoperatively, and in 38.5 % of cases, the defect was located beneath the two great arteries. The mean durations for extracorporeal circulation and cardioplegia were 113.5 ± 22 min and 70.3 ± 17 min, respectively. There were no postoperative deaths, and no patient required conversion to an alternative surgical approach. The average duration of mechanical ventilation was 17.6 ± 20.7 h, and the postoperative hospital stay averaged 6.8 ± 2.2 days. Follow-up was conducted in all patients, with an average duration of 17.4 months. There was one case of mild residual shunt, one case requiring re-intervention for aortic valve regurgitation, and one case of elevated shoulder blade due to damage to the long thoracic nerve. No instances of mammary asymmetry were observed. ConclusionRight vertical infra-axillary thoracotomy is a safe and feasible alternative for the treatment of outlet ventricular septal defect in children. Further studies across multiple centers are recommended to assess the efficacy of this approach.

Coagulation Risk Predicting in Anticoagulant-Free Continuous Renal Replacement Therapy.

Continuous renal replacement therapy (CRRT) is a prolonged continuous extracorporeal blood purification therapy to replace impaired renal function. Typically, CRRT therapy requires routine anticoagulation, but for patients at risk of bleeding and with contraindications to sodium citrate, anticoagulant-free dialysis therapy is necessary. However, this approach increases the risk of CRRT circuit coagulation, leading to treatment interruption and increased resource consumption. In this study, we utilized artificial intelligence machine learning methods to predict the risk of CRRT circuit coagulation based on pre-CRRT treatment metrics. We retrospectively analyzed 212 patients who underwent anticoagulant-free CRRT from October 2022 to October 2023. Patients were categorized into high-risk and low-risk groups based on CRRT circuit coagulation within 24 h. We employed eight machine learning methods to predict the risk of circuit coagulation. The performance of the model was evaluated using the area under the curve (AUC) of the receiver operating characteristic. 5-fold cross-validation was used to validate the machine learning models. Feature importance and SHAP plots were used to interpret the model's performance and key drivers. We identified 88 patients (41.51%) at high risk of circuit coagulation within 24 h of CRRT. Our machine learning models showed excellent predictive performance, with ensemble learning achieving an AUC of 0.863 (95% CI: 0.860-0.868), outperforming individual algorithms. Random forest was the best single-algorithm model, with an AUC of 0.819 (95% CI: 0.814-0.823). The top three features identified as most important by the SHAP summary plot and feature importance graph are platelet, filtration fraction (FF), and triglycerides. We created a model using machine learning to predict the risk of circuit coagulation during anticoagulant-free CRRT therapy. Our model performs well (AUC 0.863) and identifies key factors like platelets, FF, and triglycerides. This facilitates the development of personalized treatment strategies by clinicians aimed at reducing circuit coagulation risk, thereby enhancing patient outcomes and reducing healthcare expenses.

Protective effects of fructose-1,6-bisphosphate postconditioning on myocardial ischemia-reperfusion injury in patients undergoing valve replacement：a randomized, double-blind, placebo-controlled clinical trial.

Pharmacological postconditioning can protect against myocardial ischaemia-reperfusion injury during cardiac surgery with extracorporeal circulation. The aim of this study was to observe the protective effects of fructose-1, 6-bisphosphate (FDP) postconditioning on myocardial ischaemia-reperfusion injury in patients undergoing cardiac valve replacement with extracorporeal circulation. Patients undergoing elective mitral valve replacement and/or aortic valve replacement were divided into normal saline postconditioning group (NS group) and FDP postconditioning group (FDP group). The primary outcome was the plasma concentration of creatine kinase-MB (CK-MB). The secondary outcomes were the plasma concentrations of lactate dehydrogenase (LDH), creatine kinase (CK), high-sensitivity C-reactive protein (hs-CRP), alpha-hydroxybutyrate dehydrogenase (α-HBDH) and cardiac troponin I (cTnI), the spontaneous cardiac rhythm recovery profile, the extracorporeal circulation time and duration of surgery, ICU and postoperative hospitalization. Forty patients were randomly assigned to receive intervention and included in the analysis. The serum concentrations of CK-MB, LDH, CK, cTnI, α-HBDH and hs-CRP at T1∼4 were lower in the FDP group than in the NS group (P < 0.001). Compared with the NS group, the dosage of dopamine administered 1∼90min after cardiac resuscitation, the spontaneous cardiac rhythm recovery time and the incidence of ventricular fibrillation were lower in the FDP group (P < 0.001, P < 0.001 and P = 0.040, respectively). The values of ST- changes were increased more significantly in the NS group than in the FDP group （median [standard deviation] 1.3 [0.3] mm vs 0.7 [0.2] mm）(P < 0.001). Compared with the NS group, the time of recovery of ST-segment deviations was shorter in the FDP group（50.3 [12.3] min vs 34.6 [6.9] min） (P < 0.001). The fructose-1, 6-bisphosphate postconditioning could improve both myocardial ischaemia-reperfusion injury and the spontaneous cardiac rhythm recovery during cardiac valve surgery with extracorporeal circulation.

A Clinical Study on the Treatment of Adult Atrial Septal Defect Using Thoracoscopic-Assisted Right Vertical Infra-Axillary Thoracotomy, Total Thoracoscopic, and Median Sternotomy Approaches

Background: To compare the clinical outcomes of three surgical approaches for treating adult atrial septal defects (ASD): Thoracoscopic-assisted right vertical infra-axillary thoracotomy (TARVIAT) under central cardiopulmonary bypass (CPB), totally thoracoscopic (TT), and median sternotomy (MS) approaches, and to assess the feasibility and safety of the TARIAVT approach. Methods: This study reviewed 62 cases patients of repairing atrial septal defects via a TARVIAT and central extracorporeal circulation from 2019 to 2023. The patients included 22 males, aged between 18 and 59 years, with a mean age of 33.35 ± 10.97 years. The surgical indications were adult patients with moderate to severe tricuspid regurgitation and who were unsuitable for interventional closure of atrial septal defects. Exclusion criteria included patients diagnosed with severe pulmonary hypertension or Eisenmenger syndrome. Additionally, 67 patients who underwent TT approach repair of ASD and 72 patients who underwent MS approach repair of ASD were selected as the control groups. Operative time, CPB time, aortic clamping time, postoperative Intensive care unit (ICU) stay, postoperative mechanical ventilation time, 24-hour postoperative chest drainage, incision length, postoperative hospital stay, hospital costs, and postoperative complications were compared to assess statistical differences. Results: There were no deaths or major complications observed in any of the three groups. Statistically significant differences were found among the three groups in terms of extracorporeal circulation time, aortic clamping time, surgical time, 24-hour postoperative chest drainage, postoperative mechanical ventilation time, postoperative ICU stay, incision length, and postoperative hospital stay (p &lt; 0.05). The TT group exhibited longer CPB and aortic clamping times compared to the TARVIAT and MS groups, while demonstrating lower 24-hour postoperative chest drainage volumes compared to the TARIAVT and MS groups. Both the TARVIAT and TT groups showed shorter surgical times, postoperative mechanical ventilation times, postoperative ICU stay, incision lengths, and postoperative hospital. However, there were no statistically significant differences among the three groups regarding hospital costs, postoperative left ventricular ejection fraction (LVEF) values, and the incidence of postoperative complications (p &gt; 0.05). Conclusions: TARVIAT under central CPB is feasible and safe for adult patients. This approach presents lower invasiveness, shorter operative duration, and faster recovery compared to other methods. In conclusion, the TARVIAT approach for repairing adult ASD is both safe and effective, offering a viable surgical option for this condition.

Life-Saving Extracorporeal Membrane Oxygenation Combined with Hemoperfusion for a Pregnant Woman with COVID-19 Severe Acute Respiratory Distress Syndrome

The pandemic of the novel coronavirus (COVID-19) affected millions of people worldwide, causing high mortality and morbidity, especially in pregnancy. The management of COVID-19, which progresses to severe acute respiratory distress syndrome during pregnancy, is very challenging. Herein we report a 35-year-old pregnant woman in her second trimester (16 weeks of gestational age) who presented with a productive cough and progressive dyspnea. She was diagnosed with a severe COVID-19 infection, confirmed by PCR testing. During hospitalization, she developed severe acute respiratory distress syndrome (ARDS) and was referred to a tertiary hospital. Despite the use of antiviral therapy, steroids, mechanical ventilators, and muscle relaxants, she still had significant hypoxemia. Thus, she underwent veno-venous extracorporeal membrane oxygenation (VV-ECMO). Due to the limitations of immunomodulatory therapy in pregnancy, our team decided to perform extracorporeal cytokine removal therapy with HA330 adsorbent hemoperfusion to remove circulatory cytokines and proinflammatory mediators and suppress the hyperinflammatory response. After 3 consecutive days of hemoperfusion, her C-reactive protein and interleukin-6 were controlled. On the 13th day of ICU admission, her clinical conditions, including pulmonary function, were improving, and she was successfully weaned off the VV-ECMO. A chest X-ray showed she was completely free of ARDs. The patient left the hospital with good clinical status and a viable fetus. We conclude that pregnant women infected with COVID-19 who develop refractory hypoxemia with cytokine storm syndrome may benefit from combined VV-ECMO and hemoperfusion as a rescue therapy.

Reliable Stenosis Detection Based on Thrill Waveform Analysis Using Non-Contact Arteriovenous Fistula Imaging.

Hemodialysis therapy is an extracorporeal circulation treatment that serves as a substitute for renal function. In Japan, patients receive this efficient four-hour treatment, three times per week, allowing them to maintain a social life nearly equivalent to that of healthy individuals. Before the treatment, two punctures are performed to establish extracorporeal circulation, and a high blood flow rate is essential to ensure efficient therapy. Specialized blood vessels created through arteriovenous fistula (AVF) surgery are utilized to achieve high blood flow rates. Although the AVF allows safe and efficient dialysis treatment, AVF stenosis leads to a serious problem in dialysis. To early detect this abnormal blood flow, auscultation and palpation methods are widely used in hospitals. However, these methods can only provide qualitative judgment of the AVF condition, so the results cannot be shared among other doctors and staff. Additionally, since the conventional methods require contact with the skin, some issues require consideration regarding infection and low reproducibility. In our previous study, we proposed an alternative method for auscultation using non-contact optical imaging technology. This study aims to construct a reliable AVF stenosis detection method using Thrill waveform analysis based on the developed non-contact device to solve the problem with the contact palpation method. This paper demonstrates the performance validation of the non-contact imaging in the normal AVF group (206 total data, 75 patients, mean age: 69.1 years) and in the treatable stenosis group (107 total data, 17 patients, mean age: 70.1 years). The experimental results of the Mann-Whitney U test showed a significant difference (p=0.0002) between the normal and abnormal groups, which indicated the effectiveness of the proposed method as a new possible alternative to palpation.

An endothelium membrane mimetic antithrombotic coating enables safer and longer extracorporeal membrane oxygenation application

Thrombosis and plasma leakage are two of the most frequent dysfunctions of polypropylene (PP) hollow fiber membrane (PPM) used in extracorporeal membrane oxygenation (ECMO) therapy. In this study, a superhydrophilic endothelial membrane mimetic coating (SEMMC) was constructed on polydopamine-polyethyleneimine pre-coated surfaces of the PPM oxygenator and its ECMO circuit to explore safer and more sustainable ECMO strategy. The SEMMC is fabricated by multi-point anchoring of a phosphorylcholine and carboxyl side chained copolymer (PMPCC) and grafting of heparin (Hep) to form PMPCC-Hep interface, which endows the membrane superior hemocompatibility and anticoagulation performances. Furthermore, the modified PPM reduces protein adsorption amount to less than 30 ng/cm2. More significantly, the PMPCC-Hep coated ECMO system extends the anti-leakage and non-clotting oxygenation period to more than 15 h in anticoagulant-free animal extracorporeal circulation, much better than the bare and conventional Hep coated ECMO systems with severe clots and plasma leakage in 4 h and 8 h, respectively. This SEMMC strategy of grafting bioactive heparin onto bioinert zwitterionic copolymer interface has great potential in developing safer and longer anticoagulant-free ECMO systems. Statement of significanceA superhydrophilic endothelial membrane mimetic coating was constructed on surfaces of polypropylene hollow fiber membrane (PPM) oxygenator and its ECMO circuit by multi-point anchoring of a phosphorylcholine and carboxyl side chain copolymer (PMPCC) and grafting of heparin (Hep). The strong antifouling nature of the PMPCC-Hep coating resists the adsorption of plasma bio-molecules, resulting in enhanced hemocompatibility and anti-leakage ability. The grafted heparin on the zwitterionic PMPCC interface exhibits superior anticoagulation property. More significantly, the PMPCC-Hep coating achieves an extracorporeal circulation in a pig model for at least 15 h without any systemic anticoagulant. This endothelial membrane mimetic anticoagulation strategy shows great potential for the development of safer and longer anticoagulant-free ECMO systems.

Estimation of Absolute Blood Volume Using Online Dialysate Dilution: When and How to Measure?

Absolute blood volume can be calculated from the increase in relative blood volume after an infusion of a well-defined volume bolus of ultrapure dialysate into the extracorporeal circulation. Several working groups have applied this method in research and clinical practice. A critical analysis of differing blood volume data between working groups revealed methodologic problems of the measurement procedure and some important technical aspects. This paper presents a statement to standardize the method.

Quo Vadis, ECMO? Multidisciplinary Hybrid Extra Corporeal Membrane Oxygenation Rounds During the COVID-19 Pandemic

The complex care of patients on ECMO requires a high level of collaboration between multiple medical specialties and allied health professionals. Effective and timely communication between team members is imperative in ensuring patient safety. The COVID-19 pandemic posed unique challenges in the care of patients on ECMO. Communication between team members was complicated by social distancing recommendations, increased patient volume, and staff turnover. In this article, we describe a hybrid approach to rounds that allowed team members to attend virtually or in-person to improve team communication. Weekly hybrid ECMO rounds were held to discuss patient cases and work collectively to establish patient centered goals for the following week. Critical care and surgical consultants, RN ECMO specialists, RNs, perfusionists, respiratory therapists, physical and occupational therapists, pharmacists, ethics committee members, and patient family members were invited to attend hybrid ECMO rounds. After eight months of rounds, medical care team members were asked to provide feedback regarding the rounds format, strengths, and weaknesses. The most frequently identified strengths were improved multidisciplinary communication and continuity of care. This article demonstrates that hybrid virtual and in-person patient rounds are a feasible way for ECMO programs to improve team communication and overall patient care.

Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients undergoing cardiac surgery (MiECS): Rationale and design of a multicentre randomised trial.

The ultimate answer to the question whether minimal invasive extracorporeal circulation (MiECC) represents the optimal perfusion technique in contemporary clinical practice remains elusive. The present study is a real-world study that focuses on specific perfusion-related clinical outcomes after cardiac surgery that could potentially be favourably affected by MiECC and thereby influence the future clinical practice. The MiECS study is an international, multi-centre, two-arm randomized controlled trial. Patients undergoing elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or combined procedure (CABG + AVR) using extracorporeal circulation will be randomized to MiECC or contemporary conventional cardiopulmonary bypass (cCPB). Use of optimized conventional circuits as controls is acceptable. The study design includes a range of features to prevent bias and is registered at clinicaltrials.gov (NCT05487612). The primary outcome is a composite of postoperative serious adverse events that could be related to perfusion technique occurring up to 30 days postoperatively. Secondary outcomes include use of blood products, ICU and hospital length of stay (30 days) as well as health-related quality of life (30 and 90 days). The MiECS trial has been designed to overcome perceived limitation of previous trials of MiECC. Results of the proposed study could affect current perfusion practice towards advancement of patient care.

Human Proenkephalin A 119-159 (penKid) in Extracorporeal Therapies: Ex vivo Sieving Coefficient, Diffusive Clearance, and Hemoadsorption Kinetics

Introduction: Enkephalins, endogenous opioid peptides, are involved in the regulation of renal function. One derived molecule, proenkephalin A, also known as penKid, has been demonstrated to be a reliable biomarker for kidney function and its plasma concentration correlates with measured glomerular filtration rate. penKid is used for prediction and diagnosis of AKI and need of renal replacement therapy (RRT). penKid has also been used to predict the successful weaning from RRT in patients with AKI. Whether the concentration of penKid is affected or not by RRT is a controversial point and there are no studies describing the kinetics of the molecule in such conditions. The low molecular weight (4.5 kDa) would imply free removal by the glomerulus and the dialysis membranes. During RRT, this reduction could not be detected in clinical practice due to the complex kinetics involving either low dialytic clearance or increased production in response to impaired kidney function. The aim of this study was to determine the sieving coefficient and the diffusive clearance of the penKid molecule in conditions of in vitro continuous veno-venous hemofiltration (CVVH) and continuous veno-venous hemodialysis (CVVHD), respectively, and also the penKid removal ratio in conditions of in vitro hemoadsorption (HA) using a synthetic microporous resin. Methods: Blood spiked with a lyophilized penKid peptide solved in 20 mm dipotassium phosphate and 6 mm disodium EDTA [pH 8] to reach target concentrations is used as testing solution. In each experiment, the blood batch was adjusted at a volume of 1,000 mL, maintained at 37°, and continuously stirred. Samples were collected from blood, ultrafiltrate, and spent dialysate at different times during the experiments. Sieving, clearance, and removal ratio were calculated. Results: Significant removal of penKid was observed in CVVH (sieving 1.04 ± 0.27), in CVVHD (clearance 23.08 ± 0.89), and in HA (removal ratio 76.1 ± 1% after 120 min). Conclusion: penKid is effectively removed by extracorporeal therapies. In presence of anuria, penKid generation kinetics can be calculated based on extracorporeal removal and volume variation. In steady state conditions, declining values may be the result of an initial renal function recovery and may suggest discontinuation and successful liberation from RRT.

Transapical off-pump implantation of artificial mitral neochords in a patient after Bentall procedure - case report

The NeoChord DS 1000 system offers a minimally invasive alternative for treating degenerative mitral regurgitation (MR), particularly in high-risk patients with previous aortic surgery. A 74-year-old male with a history of Bentall procedure presented with severe MR and dyspnea (NYHA III). Transapical mitral valve repair was performed using the NeoChord DS 1000 system. Three artificial chordae were implanted, significantly reducing MR. The patient had an uneventful recovery and was discharged in good condition after 8 days. This case demonstrates the NeoChord system's potential in high-risk patients where traditional MVR poses high risks. Transapical access avoids sternotomy and extracorporeal circulation, offering a safer alternative. The NeoChord DS 1000 system shows promise for high-risk patients and those with complex surgical histories, though further research is needed to confirm its long-term efficacy and durability.

Differences in outcomes of patients with out-of-hospital cardiac arrest treated with extracorporeal cardiopulmonary resuscitation between day-time and night-time

Although patients who underwent night-time resuscitation for out-of-hospital cardiac arrest (OHCA) had worse clinical outcomes than those who underwent day-time resuscitation, the differences between the outcomes of patients with OHCA who underwent extracorporeal cardiopulmonary resuscitation (ECPR) in the day-time and night-time remain unclear. We analyzed data from the Study of Advanced Life Support for Ventricular Fibrillation with Extracorporeal Circulation in Japan. Patients were categorized according to whether they received treatment during the day-time or night-time. The primary outcomes were survival to hospital discharge and favorable neurological outcome at discharge, and the secondary outcomes were estimated low-flow time, implementation time of ECPR, and complications due to ECPR. A multivariate logistic regression model adjusted for confounders was used for comparison. Among the 1644 patients, the night-time patients had a significantly longer ECMO implementation time and estimated low-flow time than the day-time patients, along with a significantly higher number of complications than the day-time patients. However, the survival and neurologically favorable survival rates did not differ significantly between the groups. Thus, although patients who underwent ECPR at night had an increased risk of longer implementation time and complications, their clinical outcomes did not differ from those who underwent day-time ECPR.

Purified granulocytes in extracorporeal cell therapy: A multifaceted approach to combat sepsis-induced immunoparalysis.

Immune cell dysfunction plays a central role in sepsis-induced immunoparalysis. Targeted treatment using healthy donor immune cell transfusions, particularly granulocyte concentrates (GC) potentially induces tissue damage. Initial trials using GC in an extracorporeal immune cell perfusion system provided evidence for beneficial effects with fewer side effects, by separating patient and donor immune cell compartments. A multicenter clinical trial is exploring feasibility and effects of a 6-h treatment (NCT06143137). This ex vivo study examines technical feasibility and cellular effects of an extended treatment interval up to 24 h. Standard GC were purified to increase the potential storage time and subsequently implemented in the extracorporeal immune cell perfusion system. Parameters assessed included cell viability, phagocytosis activity, oxidative burst, cytokine release, and metabolic parameters of purified. GC during an extended circulation time of up to 24 h. After storage of 72 h granulocytes were viable throughout the study period and exhibited preserved functionality and metabolic activity. The findings highlight a time-dependent nature of cytokine release by neutrophils in the extracorporeal circuit, as cytokine secretion patterns showed IL-8 peaking within 6 h, while MCP-1, IL-6, IL-1β, and TNF-α increased after 24 h of circulation. Purified GC remain functional after 72 h of storage and additional 24 h in the circulating treatment model. Cytokine secretion patterns revealed a significant increase, especially between 10 and 24 h of treatment. Extending treatment time holds promise for enhancing immune response against sepsis-induced immunoparalysis. These findings provide valuable insights for optimizing immune-targeted therapeutic interventions.

EValuating the Effect of periopeRaTIve empaGliflOzin on cardiac surgery associated acute kidney injury: rationale and design of the VERTIGO study.

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a serious complication in patients undergoing cardiac surgery with extracorporeal circulation (ECC) that increases postoperative complications and mortality. CSA-AKI develops due to a combination of patient- and surgery-related risk factors that enhance renal ischemia-reperfusion injury. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) such as empagliflozin reduce renal glucose reabsorption, improving tubulo-glomerular feedback, reducing inflammation and decreasing intraglomerular pressure. Preclinical studies have observed that SGLT2i may provide significant protection against renal ischemia-reperfusion injury due to their effects on inadequate mitochondrial function, reactive oxygen species activity or renal peritubular capillary congestion, all hallmarks of CSA-AKI. The VERTIGO (EValuating the Effect of periopeRaTIve empaGliflOzin) trial is a Phase 3, investigator-initiated, randomized, double-blind, placebo-controlled, multicenter study that aims to explore whether empagliflozin can reduce the incidence of adverse renal outcomes in cardiac surgery patients. The VERTIGO study (EudraCT: 2021-004938-11) will enroll 608 patients that require elective cardiac surgery with ECC. Patients will be randomly assigned in a 1:1 ratio to receive either empagliflozin 10mg orally daily or placebo. Study treatment will start 5days before surgery and will continue during the first 7days postoperatively. All participants will receive standard care according to local practice guidelines. The primary endpoint of the study will be the proportion of patients that develop major adverse kidney events during the first 90days after surgery, defined as ≥25% renal function decline, renal replacement therapy initiation or death. Secondary, tertiary and safety endpoints will include rates of AKI during index hospitalization, postoperative complications and observed adverse events. The VERTIGO trial will describe the efficacy and safety of empagliflozin in preventing CSA-AKI. Patient recruitment is expected to start in May 2024.

A comparative study examining the impact of coronary artery bypass grafting surgery with non-extracorporeal circulation on heart function and structure in patients with various forms of coronary heart diseases.

The aim of this study is to assess alterations in heart function and structure in patients diagnosed with non-ST segment elevation acute myocardial infarction (NSTEAMI), unstable angina (UA), and stable angina (SA) 1 year after undergoing off-pump coronary artery bypass grafting (OPCABG) performed without extracorporeal circulation. A total of 182 patients who underwent OPCABG were included and classified into 3 groups based on their preoperative diagnosis: the NSTEAMI group (n = 68), the UA group (n = 64), and the SA group (n = 50). Cardiac ultrasonography data were collected for all groups both preoperatively and 1 year postoperatively. Clinical data were subjected to statistical analysis. In the NSTEAMI group, postoperative observations revealed increases in left ventricular stroke volume and left ventricular end-systolic diameter, along with reductions in left ventricular end-diastolic volume (LVEDV) and left ventricular end-diastolic diameter (LVEDD) 1-year post-surgery. The UA group demonstrated decreases in LVEDV and LVEDD 1-year post-surgery. Similarly, the SA group exhibited an increase in left ventricular ejection fraction (LVEF) and reductions in LVEDV and LVEDD 1-year post-surgery. Comparative analysis of cardiac ultrasonography data revealed that the NSTEAMI group displayed significantly lower left ventricular stroke volume and notably higher left ventricular end-systolic diameter and volume compared to the UA and SA groups 1-year post-surgery. Furthermore, the SA group exhibited significantly elevated LVEF compared to the UA and NSTEAMI groups 1-year post-surgery. Cardiac ultrasonography findings indicate that all 3 groups exhibited improvements in cardiac function and left ventricular structure 1-year post-surgery. However, the NSTEAMI group demonstrated more substantial improvements in comparison to the UA and SA groups.

Evaluation of Outcomes in Patients with Previous Stroke History following Cardiac Surgery: A Single-Center Study.

Background: The aim of the study to analyze the risk of complications, including neurological sequelae, alongside early and late mortality among patients with antecedent stroke subjected to cardiac surgical interventions with extracorporeal support. Material and methods: A single-center retrospective study was conducted on 10,685 patients who underwent cardiac surgery with extracorporeal circulation at the Department of Cardiac Surgery. The first group comprised all patients eligible for cardiac surgery with extracorporeal circulation. The second group consisted of patients with a preoperative history of stroke. Results: In the study, a statistically significant association was observed between preoperative stroke and the occurrence of postoperative pneumonia (OR = 1.482, p = 0.006), respiratory failure (OR = 1.497, p = 0.006), renal failure (OR = 1.391, p = 0.019), 30-day mortality (OR = 1.528, p = 0.026), 90-day mortality (OR = 1.658, p < 0.001), and one-year mortality (OR = 1.706, p < 0.001). Conclusions: Patients with a history of preoperative stroke more frequently experienced renal failure and respiratory-system complications such as pneumonia and respiratory failure. The survival time of patients with a history of preoperative stroke was shorter compared to that of the control group during the analyzed 30-day, 90-day, and one-year observation periods.

Effects of Fibrinogen Concentrate Supplementation on Postoperative Bleeding in Infants Undergoing Complex Cardiac Surgery.

The use of allogeneic blood products to restore hemostasis during pediatric cardiac surgery is associated with major risks. Consequently, there has been a growing interest in new patient blood management strategies, such as those based on the use of fibrinogen concentrate (FC). Accumulating evidence has shown FC supplementation to be safe and effective. Nevertheless, no guidelines are available on using FC in the pediatric setting, and few objective evaluations have been provided in clinical practice. The endpoint of this monocenterretrospective study was the hemostatic effect of additional FC in infants undergoing complex cardiac surgery with cardiopulmonary bypassto manage persistent clinically relevant bleeding. After weaning from cardiopulmonary bypass and after protamine administration, patients were transfused with conventional allogeneic products such as packed red blood cells, fresh frozen plasma (FFP), and platelets. In the case of redo surgery, according to the institutional protocol, patients also received tranexamic acid. In case of clinically persistent relevant bleeding, according to the anesthesiologist's judgment and thromboelastography, patients received FC supplementation (group with FC) or further FFP transfusions without receiving FC supplementation (group without FC). The primary endpoint was the hemostatic effects of FC. Secondary endpoints were the functional hypofibrinogenemia threshold value (expressed as maximum amplitude fibrinogen, MA-Fib) and postoperative MA-Fib, fibrinogenemia, intraoperative transfusions, and adverse events (AEs). In total, 139 patients who underwent cardiac surgery with CPB and aged less than 2 years were enrolled: 70 patients received allogeneic blood products and FC supplementation (group FC); 69 patients received allogeneic products without FC supplementation (group without FC). Patients that received FC supplementation were characterized by a significantly longer time of extracorporeal circulation (p < 0.001) and aortic cross-clamping (p < 0.001), a significantly lower minimum temperature (p = 0.011), increased use of concentrated prothrombin complex (p = 0.016) and tranexamic acid (p = 0.010), and a significantly higher amount of packed red blood cells, platelets (p < 0.001) and fresh frozen plasma (p = 0.03). Postoperative bleeding and severe bleeding were not statistically different between patients treated with FC and those not treated with FC supplementation (p = 0.786 and p = 0.695, respectively); after adjustment, a trend toward reduced bleeding can be observed with FC (p = 0.064). Overall, 88% of patients with severe bleeding had MA-Fib < 10 mm; a moderate association between severe bleeding and MA-Fib (odds ratio 1.7, 95% CI 0.5-6.5, p = 0.425) was found. Increased MA-Fib and postoperative fibrinogen were higher in the FC group (p = 0.003 and p < 0.001, respectively) than in FFP. AEs in the FC group were comparable to those observed in less complicated surgeries. Our results suggest a potential role of FC in complex surgery in maintaining postoperative bleeding at a level comparable to less complicated surgical procedures and favoring the increase in postoperative MA-Fib and fibrinogen.

Impact of minimal invasive extracorporeal circulation on systemic inflammatory response – a randomized trial

BackgroundExtracorporeal circulation causes a systemic inflammatory response, that may cause postoperative haemodynamic instability and end-organ dysfunction. This study aimed to investigate the impact of minimal invasive extracorporeal circulation (MiECC) on the systemic inflammatory response compared with conventional extracorporeal circulation (CECC).MethodsPatients undergoing coronary artery bypass grafting were randomized to MiECC (n = 30) and CECC (n = 30). Primary endpoint was tumor necrosis factor-α. Secondary endpoints were other biochemical markers of inflammation (IL1β, IL6 and IL8, C-reactive protein, leukocytes), and markers of inadequate tissue perfusion and tissue damage (lactate dehydrogenase, lactate and creatine kinase-MB). In addition, we registered signs of systemic inflammatory response syndrome, haemodynamic instability, atrial fibrillation, respiratory dysfunction, and infection.ResultsPatients treated with MiECC showed significantly lower levels of tumor necrosis factor-α than CECC during and early after extracorporeal circulation (median: MiECC 3.4 pg/mL; CI 2.2–4.5 vs. CECC 4.6 pg/mL; CI 3.4–5.6; p = 0.01). Lower levels of creatine kinase-MB and lactate dehydrogenase suggested less tissue damage. However, we detected no other significant differences in any other markers of inflammation, tissue damage or in any of the clinical outcomes.ConclusionsLower levels of TNF-α after MiECC compared with CECC may reflect reduced inflammatory response, although other biochemical markers of inflammation were comparable. Our results suggest better end-organ protection with MiECC compared with CECC. Clinical parameters related to systemic inflammatory response were comparable in this study.Clinical registration numberNCT03216720.