Mechanical Support Devices Research Articles

Cardioprotective shock management: monitoring and supportive therapies.

Cardiogenic shock is a highly lethal syndrome, leading to rapid death or secondary multiorgan damage, but current shock therapies, including mechanical support devices, also have a significant side effect profile. The overarching goal of shock therapy is ensuring long-term survival with good quality of life. This implies averting death, modifying the disease course by promoting heart recovery and avoiding additional cardiac damage, protecting other organs, and circumventing complications. Monitoring and supportive therapies are subordinate to these goals. Rather than merely following preconceived notions, the rapid evolution in mechanical support technology requires iterative and critical review of the benefits of current procedures, protocols and drugs in view of their overall contribution to the therapeutic goals. This article discusses various monitoring and supportive pharmaceutical modalities typically used in patients with cardiogenic shock requiring mechanical support.

Elevated Plasma Big Endothelin-1 at Admission Is Associated With Poor Short-Term Outcomes in Patients With Acute Decompensated Heart Failure.

Objective: We aimed to evaluate the association between plasma big endothelin-1 (ET-1) at admission and short-term outcomes in acute decompensated heart failure (ADHF) patients.Methods: In this single-center, retrospective study, a total of 746 ADHF patients were enrolled and divided into three groups according to baseline plasma big ET-1 levels: tertile 1 (<0.43 pmol/L, n = 250), tertile 2 (between 0.43 and 0.97 pmol/L, n = 252), and tertile 3 (>0.97 pmol/L, n = 244). The primary outcomes were all-cause death, cardiac arrest, or utilization of mechanical support devices during hospitalization. Logistic regression analysis and net reclassification improvement approach were applied to assess the predictive power of big ET-1 on short-term outcomes.Results: During hospitalization, 92 (12.3%) adverse events occurred. Etiology, arterial pH, lactic acid, total bilirubin, serum creatine, serum uric acid, presence of atrial fibrillation and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels were positively correlated with plasma big ET-1 level, whereas systolic blood pressure, serum sodium, hemoglobin, albumin, and estimated glomerular filtration rate were negatively correlated. In multivariate logistic regression, tertile 3 compared with tertile 1 had a 3.68-fold increased risk of adverse outcomes [odds ratio (OR) = 3.681, 95% confidence interval (CI) 1.410–9.606, p = 0.008]. However, such adverse effect did not exist between tertile 2 and tertile 1 (OR = 0.953, 95% CI 0.314–2.986, p = 0.932). As a continuous variable, big ET-1 level was significantly associated with primary outcome (OR = 1.756, 95% CI 1.413–2.183, p < 0.001). The C statistic of baseline big ET-1 was 0.66 (95% CI 0.601–0.720, p < 0.001). Net reclassification index (NRI) analysis showed that big ET-1 provided additional predictive power when combining it to NT-proBNP (NRI = 0.593, p < 0.001).Conclusion: Elevated baseline big ET-1 is an independent predictor of short-term adverse events in ADHF patients and may provide valuable information for risk stratification.

New Strategy to Prevent Acute Myocardial Infarction by Public Education - A Position Statement of the Committee on Public Education About Emergency Medical Care of the Japanese Circulation Society.

Although many efforts have been made to prevent death from acute myocardial infarction (MI) by quick revascularization therapy and use of mechanical circulation support devices, and to prevent the occurrence of acute MI by optimal medical therapy, acute MI is still a leading cause of death worldwide. Because the majority of fatal MI cases occur outside hospital and death occurs so rapidly after MI onset, it is difficult to effectively prevent deaths from acute MI by improving the in-hospital treatment strategy of acute MI or by reducing the prehospital delay in the treatment. Therefore, we need a new strategy to prevent death from acute MI, mainly by preventing the occurrence of acute MI itself. In this review, we summarize the present status and propose a new strategy, the "STOP MI Campaign", to prevent acute MI by public education.

The Intra-Aortic Balloon Pump.

Cardiogenic shock remains one of the most challenging clinical syndromes in modern medicine. Mechanical support is being increasingly used in the management of cardiogenic shock. Intra-aortic balloon pump (IABP) is one of the earliest and most widely used types of mechanical circulatory support. The device acts by external counterpulsation and uses systolic unloading and diastolic augmentation of aortic pressure to improve hemodynamics. Although IABP provides less hemodynamic support when compared with newer mechanical circulatory support devices, it can still be the mechanical support device of choice in appropriate situations because of its relative simplicity of insertion and removal, need for smaller size vascular access and better safety profile. In this review, we discuss the equipment, procedural and technical aspects, hemodynamic effects, indications, evidence, current status and recent advances in the use of IABP in cardiogenic shock.

Galectin-3 and sST2 as Prognosticators for Heart Failure Requiring Extracorporeal Life Support: Jack n' Jill.

Extracorporeal life support provides perfusion for patients with heart failure to allow time for recovery, function as a bridge for patients to heart transplantation, or serve as destination therapy for long term mechanical device support. Several biomarkers have been employed in attempt to predict these outcomes, but it remains to be determined which are suitable to guide clinical practice relevant to extracorporeal life support. Galectin-3 and soluble suppression of tumorigenicity-2 (sST2) are two of the more promising candidates with the greatest supporting evidence. In this review, we address the similarities and differences between galectin-3 and sST2 for prognostic prediction in adults and children with heart failure requiring extracorporeal life support and highlight the significant lack of progress in pediatric biomarker discovery and utilization.

Predictive Ability of Academic Research Consortium for High Bleeding Risk Criteria in ST-Elevation Myocardial Infarction Patients Undergoing Primary Coronary Intervention.

This observational study validated Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and the Predicting Bleeding Complication in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score in patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention.Methods and Results:Risk clusters of 939 STEMI patients with traceable 1-year outcomes were assessed according to ARC-HBR criteria and PRECISE-DAPT score. The diagnostic accuracy and first-year probability of bleeding events, defined as Bleeding Academic Research Consortium (BARC) 3 or 5, according to risk cluster were assessed. Of all patients, 42.9% and 46.8% were classified as HBR (ARC-HBR criteria) and at high risk (PRECISE-DAPT score), respectively, and bleeding events were observed in 13.7% and 16.2% of these patients. The C-statistic for ARC-HBR criteria and the PRECISEDAPT score was 0.60 and 0.69, respectively (P<0.01). Patients with mechanical hemodynamic support devices had high bleeding rates, even in the non-HBR group (22.6%), and excluding these patients improved the C-statistics, making them equivalent between the 2 models (0.72 vs. 0.74; P=0.53). Bleeding event probabilities (95% confidence intervals) were equivalent in high-risk patients in the 2 models (0.12 [0.09-0.16] vs. 0.12 [0.08-0.16]). After exclusion of patients with mechanical devices, who had high bleeding event rates regardless of risk cluster, both ARC-HBR criteria and the PRECISE-DAPT score had high predictive ability.

The Society of Thoracic Surgeons Intermacs 2020 Annual Report

The Society of Thoracic Surgeons (STS)-Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) 2020 Annual Report reviews outcomes on 25,551 patients undergoing primary isolated continuous-flow left ventricular assist device (LVAD) implantation between 2010 and 2019. In 2019, 3198 primary LVADs were implanted, which is the highest annual volume in Intermacs history. Compared with the previous era (2010-2014), patients who received an LVAD in the most recent era (2015-2019) were more likely to be African American (26.8% vs 22.9%, P < .0001) and more likely to be bridged to durable LVAD with temporary mechanical support devices (36.8% vs 26.0%, P < .0001). In 2019, 50% of patients were INTERMACS Profile 1 or 2 before durable LVAD, and 73% received an LVAD as destination therapy. Magnetic levitation technology has become the predominant design, accounting for 77% of devices in 2019. The 1- and 2-year survival in the most recent era has improved compared with 2010 to 2014 (82.3% and 73.1% vs 80.5% and 69.1%, respectively; P < .0001). Major bleeding and infection continue to be the leading adverse events. Incident stroke has declined in the current era to 12.7% at 1 year. STS-Intermacs research publications are highlighted, and the new quality initiatives are introduced.

Comparison of Outcomes Among Patients With Cardiogenic Shock Admitted on Weekends Versus Weekdays

Cardiogenic shock (CS) is associated with high mortality and often requires involvement of a multidisciplinary provider team to deliver timely care. Care coordination is more difficult on weekends, which may lead to a delay in care. We sought to assess the effect of weekend admissions on outcomes in patients admitted with CS. Patients admitted with CS were identified from 2005 to 2014 in the National Inpatient Sample using ICD9 code 785.51. Baseline demographics, in-hospital procedures, and outcomes were obtained and compared by day of admission. A multivariable model was used to assess the impact of weekend admission on in-hospital mortality. A total of 875,054 CS admissions were identified (age 67.4 ± 15.1 years, 40.2% female, 72.1% Caucasian), with 23% of patients being admitted on weekends. Baseline co-morbidities were similar between groups. Weekend admissions were associated with higher in-hospital mortality (40.6% vs 37.5%) and cardiac arrest (20.3% vs 18.1%, p < 0.001 for both) consistently over the study period. Use of temporary and permanent mechanical support devices and heart transplantation were slightly less common for weekend admissions. In a multivariable model adjusting for relevant confounders, weekend admission was associated with a 10% increased mortality in patients with CS. In conclusion, patients with CS admitted on weekends had higher in-hospital mortality and were slightly less likely to receive mechanical support and advanced therapies compared with those admitted on weekdays. Future studies and health system initiatives should focus on rectifying these disparities with around-the-clock multidisciplinary coordinated care for CS.

Single centre 12 year experience with durable mechanical circulatory support: comparison with the EUROMACS registry.

Mechanical circulatory support is an established therapy in end-stage heart failure. The EUROMACS registry was created to promote research in these patients. The aim of this report was to present our 12 year experience with the durable mechanical circulatory support devices and compare it with the EUROMACS registry. Data from the entire EUROMACS registry from January 2011 to April 2019 were included (4704 implantations in 4410 patients). During the 12 years of our experience, until April 2019,125 mechanical support devices were implanted, in 122 patients. We compare patients´ characteristics, operative data and results with the EUROMACS registry and we report the major complications during the observational period. Primary end-point (death) occurred in 40 (32.8 %) patients in our cohort during the follow-up period, representing the survival rate 75 %, 68 %, and 58 % for 6, 12, 24 months respectively, which compares favourably with the data, reported by the EUROMACS registry, the survival 66 % and 53 % after 1 and 2 years respectively. Cerebrovascular accident occurred in 7 %, a bleeding event in 32 %, significant infection (driveline) in 78 % and a device malfunction in 13 % of the patients. Forty- three patients underwent a heart transplant with hospital and long-term mortality of 11.6 % and 14 % respectively. Mechanical circulatory support is a valuable therapeutic option with excellent survival rates, nevertheless it is associated with clinically significant complications rates. The direct comparison between our cohort and the EUROMACS registry showed that early implantation strategy and mini invasive approach may improve survival rates and decrease postoperative complications (Tab. 3, Fig. 3, Ref. 16).

Accuracy of Acetabular Cup Implantation, as a Function of Body Mass Index and Soft-tissue Thickness, with a Mechanical Intraoperative Support Device: A Retrospective Observational Study.

HipCOMPASS, a mechanical intraoperative support device used in total hip arthroplasty (THA), improves the cup-alignment accuracy. However, the alignment accuracy achieved by HipCOMPASS has not been specifically examined in obese patients. In this study, we retrospectively evaluated the relation between alignment accuracy and several obesity-related parameters in 448 consecutive patients who underwent primary THA using HipCOMPASS. We used computed tomography (CT) to measure the preoperative soft-tissue thickness of the anterior-superior iliac spine (ASIS) and pubic symphysis and the differences between preoperative and postoperative cup angle based on the cup-alignment error. We found significant correlations between the absolute value of radiographic anteversion difference and body mass index (r = 0.205), ASIS thickness (r = 0.419), and pubic symphysis thickness (r = 0.434). The absolute value of radiographic inclination difference was significantly correlated with ASIS (r = 0.257) and pubic symphysis thickness (r = 0.202). The receiver operating characteristic curve showed a pubic symphysis thickness of 37.2 mm for a ≥ 5° implantation error in both radiographic inclination and anteversion simultaneously. The cup-alignment error for HipCOMPASS was large in patients whose pubic symphysis thickness was ≥ 37.2 mm on preoperative CT. Our results indicate that methods other than HipCOMPASS, including computed tomography-based navigation systems, might be preferable in obese patients.

Mediastinitis after cardiac surgery: risk factors and our vacuum-assisted closure results.

IntroductionMediastinitis after cardiac surgery is a rare complication, but with high morbidity and mortality.AimTo determine its risk factors and to investigate the efficacy of vacuum-assisted closure (VAC).Material and methodsNine thousand one hundred sixty cases of patients who underwent cardiac surgery during 2010–2017 were reviewed retrospectively. One hundred and twenty-seven patients, the case group, were treated by VAC. Three hundred cases with no diagnosis of mediastinitis were selected as the control group. Both groups’ clinical and demographic characteristics, preoperative variables, and postoperative follow-up parameters were compared. Factors affecting treatment were analyzed.ResultsWe found that the presence of diabetes mellitus, bilateral internal thoracic artery and intra-aortic balloon pump usage are independent risk factors for the development of mediastinitis (p < 0.05). It was found that 74% of tissue cultures were positive and the most common detected organism was Staphylococcus. It was found that many perioperative parameters had a significant effect on the duration of treatment (p < 0.05). However, regression analysis revealed that bacterial growth was the only independent variable in prolonging the treatment period.ConclusionsWe believe that the establishment of perioperative blood glucose regulation, patient selection to use bilateral internal thoracic artery grafts, and maximum attention to sepsis and antisepsis rules in patients who need mechanical support devices such as intra-aortic balloon pump, will significantly reduce the development of mediastinitis. Since we could not find an independent risk factor for the duration of VAC treatment other than culture growth, we think that VAC therapy is successful and safe in the treatment of mediastinitis and should be used more widely.

The role of mechanical support devices during percutaneous coronary intervention.

The practice of interventional cardiology has changed dramatically over the last four decades since Andreas Gruentzig carried out the first balloon angioplasty. The obvious technological improvements in stent design and interventional techniques have facilitated the routine treatment of a higher risk cohort of patients, including those with complex coronary artery disease and poor left ventricular function, and more often in the setting of cardiogenic shock (CS) complicating acute myocardial infarction (AMI). The use of mechanical cardiac support (MCS) in these settings has been the subject of intense interest, particularly over the past decade . A number of commercially available devices now add to the interventional cardiologist’s armamentarium when faced with the critically unwell or high-risk patient in the cardiac catheter laboratory. The theoretical advantage of such devices in these settings is clear- an increase in cardiac output and hence mean arterial pressure, with variable effects on coronary blood flow. In doing so, they have the potential to prevent the downward cascade of ischaemia and hypoperfusion, but there is a paucity of evidence to support their routine use in any patient subset, even those presenting with cardiogenic shock. This review will discuss the use and haemodynamic effect of MCS devices during percutaneous coronary intervention (PCI), and also examine the clinical evidence for their use in patients with cardiogenic shock, and those undergoing ‘high risk’ PCI

The German-Austrian S3 Guideline "Cardiogenic Shock Due to Myocardial Infarction: Diagnosis, Monitoring, and Treatment".

Despite advances in the treatment of acute myocardial infarction with subsequent mortality reduction, which are mainly caused by the early timing of revascularization, cardiogenic shock still remains the leading cause of death with mortality rates still approaching 40 to 50%. Cardiogenic shock is characterized by a multiorgan dysfunction syndrome, often complicated by a systemic inflammatory response syndrome that affects the outcome more than the reduction of the cardiac contractile function. However, both European and American guidelines on myocardial infarction focus on interventional or surgical aspects only. Therefore, experts from eight German and Austrian specialty societies including the German Society for Thoracic and Cardiovascular Surgery published the German-Austrian S3 guideline "cardiogenic shock due to myocardial infarction: diagnosis, monitoring, and treatment" to provide evidence-based recommendations for the diagnosis and treatment of infarction-related cardiogenic shock in 2010 covering the topics of early revascularization, revascularization techniques, intensive care unit treatment including ventilation, transfusion regimens, adjunctive medical therapy, and mechanical support devices. Within the last 3 years, this guideline was updated as some major recommendations were outdated, or new evidence had been found. This review will therefore outline the management of patients with cardiogenic shock complicating acute myocardial infarction according to the updated guideline with a major focus on evidence-based recommendations which have been found relevant for cardiac surgery.

Left Pulmonary Artery Ligation and Chronic Pulmonary Artery Banding Model for Inducing Right Ventricular-Pulmonary Hypertension in Sheep.

Pulmonary hypertension (PH) is a progressive disease that leads to cardiopulmonary dysfunction and right heart failure from pressure and volume overloading of the right ventricle (RV). Mechanical cardiopulmonary support has theoretical promise as a bridge to organ transplant or destination therapy for these patients. Solving the challenges of mechanical cardiopulmonary support for PH and RV failure requires its testing in a physiologically relevant animal model. Previous PH models in large animals have used pulmonary bead embolization, which elicits unpredictable inflammatory responses and has a high mortality rate. We describe a step-by-step guide for inducing pulmonary hypertension and right ventricular hypertrophy (PH-RVH) in sheep by left pulmonary artery (LPA) ligation combined with progressive main pulmonary artery (MPA) banding. This approach provides a controlled method to regulate RV afterload as tolerated by the animal to achieve PH-RVH, while reducing acute mortality. This animal model can facilitate evaluation of mechanical support devices for PH and RV failure.

Right axillary artery cannulation for venoarterial extracorporeal membrane oxygenation: a retrospective single centre observational study.

Our goal was to assess the safety, outcomes and complication rate of axillary artery cannulation for venoarterial extracorporeal membrane oxygenation (VA-ECMO). A retrospective analysis was conducted on data obtained from the review of medical charts of all consecutive patients undergoing VA-ECMO implantation between January 2013 and December 2017 at a teaching hospital. Only patients with right axillary VA-ECMO implantation in a non-emergency setting were included. Post-procedural outcomes and local and systemic complications were analysed. One hundred and seventy-four [131 male (75.3%), 43 female (24.7%); mean age 56.8 ± 15.1 years] patients underwent femoral-axillary VA-ECMO. Indications were cardiogenic shock from any cause (n = 78, 44.8%) or post-cardiotomy syndrome (n = 96, 55.2%). Fifty-three (30.5%) patients died while on VA-ECMO support. At the time of VA-ECMO ablation, 89 (51.1%) patients had recovered; 13 (7.5%) patients were bridged to a long-term mechanical support device and 19 (10.9%) patients underwent heart transplants. Thirty-day and 1-year mortality was 36.2% (n = 63) and 49.4% (n = 86), respectively. The 1-year survival rate of patients who were weaned from VA-ECMO support was 72.7% (n = 88). The complications of axillary cannulation were bleeding (n = 7, 4%), local infection (n = 3, 1.7%), upper limb ischaemia (n = 2, 1.1%) and brachial plexus injury (n = 1, 0.6%). Left ventricle unloading was required for 9 (5.2%) patients. The median duration of VA-ECMO support was 7 (range 1-26) days. Right axillary artery cannulation is a safe and reliable method for VA-ECMO support with a low rate of local complications. In the absence of a control group with femoro-femoral cannulation, no definitive conclusion about the superiority of axillary over femoral cannulation can be drawn.

Abstract 16945: Total Artificial Heart Implantation in Patients With Intractable Ventricular Arrhythmias

Ventricular arrhythmias (VAs) are pathological rhythms that are often incompatible with life and require decisive intervention. If the rhythm is refractory to treatment or causes hemodynamic compromise, mechanical support devices may be required. Oftentimes, patients with underlying heart failure do very poorly with VAs, requiring a higher level of support than can be achieved by most devices, with the exception of LVADs and TAHs. Mechanistically, a TAH is an orthotopic pneumatic biventricular mechanical support device that requires removal of the native cardiac ventricles and replacement with two artificial ventricles. Due to the nature of the procedure, the ventricular substrate, which causes VAs, is removed and the patient receives biventricular mechanical support. This case series retrospectively follows eight patients requiring implantation of a TAH due to intractable VAs between 06/2008 and 03/2017 at VCU Health. On arrival, all patients were in multiorgan failure and requiring hemodynamic support, including a varied combination of support devices, inotropes, and/or pressors. The median time of admission to implantation was 12.6 days. Major adverse events included cerebral vascular attack (CVA), significant bleeding requiring surgical intervention, and surgical site infection. Three patients had ischemic CVAs, three had significant mediastinal hematoma resulting in tamponade requiring intervention, and two had significant operative site infections requiring antibiotics and surgery. Of the original eight patients, six went on to undergo an orthotopic heart transplant, all were alive at one year follow-up. While adverse events can be serious and should be considered when evaluating for implantation, the use of a TAH can be beneficial in patients with intractable VAs and can be used to successfully stabilize patients who would otherwise perish.

Abstract 116: Impella Device Success: Walking Home After Cardiogenic Shock From Ventricular Fibrillation

Ventricular fibrillation is a fatal arrhythmia due to its detrimental impact on cardiac output. Managing patients in V-Fib arrest is often challenging, but newer mechanical support devices such as Impella CP 5.0 (Abiomed, Danvers, MD) are proving to be an excellent adjunct to inotrope and vasopressor therapy. We present a 75-year-old female with a medical history of atrial fibrillation and obstructive sleep apnea that presented to the ER unresponsive. On arrival, the patient was pulseless and initial rhythm on telemetry revealed ventricular fibrillation. The patient demonstrated minimally reactive pupils to light, negative corneal reflex, and lower extremity clonus. ROSC was achieved with electric defibrillation and two rounds of CPR. Chest radiograph revealed mild bilateral pulmonary congestion. Head CT revealed no acute intracranial pathology. The patient was placed on targeted temperature management protocol for the next 48 hours. Emergent left heart catheterization revealed no signs of occlusive coronary disease. TTE revealed left ventricular ejection fraction 5-10%, likely from stunned myocardium. The patient continued to clinically decline and decision was made to place an Impella device for further hemodynamic support. Unlike ECMO, the Impella fully unloaded the LV and allowed diastolic coronary filling. The patient ultimately demonstrated significant improvement and repeat TTE revealed an improved EF of 45-50%. Prior to hospital discharge, an AICD was placed for primary SCD prevention. The patient maintained close outpatient follow-up with her cardiologist and PCP. This case illustrates the importance life-saving mechanical support devices such as Impella in the setting of cardiogenic shock, even from non-ischemic ventricular fibrillation.

Abstract 17018: Left Ventricular Assist Device Failure With Total Artificial Heart Bridge to Heart Transplant

Mechanical support devices are used in cardiogenic shock as a bridge to heart transplantation (OHT) or as a destination treatment. The two long term variants are left ventricular assist devices (LVADs) and total artificial hearts (TAHs). Developed in tandem, LVADs have gained favor, but are not without limitations. Adverse events include thrombosis, bleeding, mechanical failures, ventricular arrhythmias (VAs), and right ventricular failure (RVF). When LVADs fail, often the only options becomes OHT or TAH implantation. This case series retrospectively follows ten patients requiring TAH implantation due to LVAD failure between 12/2009-09/2018 at VCU Health. On admission, all were in multiorgan failure with four requiring hemodialysis and two requiring intubation. Eight patients required extra support including pressors, inotropes, and additional mechanical support. The causes of failure included refractory infection, outflow graft mechanical compromise, right ventricular failure, VAs, and pump thrombosis. The mean time from admission to TAH was 13.5 days. Major adverse events included mediastinal hematoma with tamponade in three patients requiring surgical intervention and one patient with an acute cerebral vascular attack who died. One patient died from ongoing respiratory failure. Another patient died from multiorgan failure and hemorrhage. Of the seven surviving patients, all underwent successful OHT and were alive at one year follow-up. The patients who experience LVAD failure are extremely sick and have limited options. TAH implantation, while not without risk, can be a useful tool to bridge patients to transplant with favorable outcomes.

Heparin is more effective than apixaban in inhibiting in vitro contact activated coagulation

Abstract Introduction Contact of blood with artificial surfaces such as mechanical support devices, catheters, and mechanical heart valves activates the contact activation (CA) pathway of coagulation. Furthermore, recent animal data and clinical studies suggest a more important contribution of CA in pathological thrombus formation in other cardiovascular diseases. Direct oral anticoagulants (DOACs) are recommended as first-line treatment in most patients who require long-term anticoagulation. However, because DOACs directly inhibit a single downstream coagulation factor (thrombin (fXIIa) or factor Xa (fXa)), it has been suggested that their efficacy could be reduced in the presence of strong activation of the CA pathway as compared to anticoagulants that target multiple, more upstream located coagulation factors. Purpose To compare the efficacy of a DOAC (apixaban) and heparin to suppress thrombin generation in the presence of strong CA pathway activation. Methods Pooled platelet-poor plasma was spiked with either apixaban (dissolved in DMSO and PBS) or unfractionated heparin to achieve therapeutic plasma levels. SynthASil, a commercially available mixture of phospholipids and silica, was used to stimulate the CA pathway in two different dilutions (1–80 and 5–80). Downstream coagulation was accessed by Thrombin Generation Test using Thrombinoscope by Stago and associated Thrombin Calibrator (activity 640 nM). The endogenous thrombin potential (area under the thrombin generation curve; ETP), peak thrombin generation (PTG), time to peak (ttPeak) and time to start (ttStart) were accessed. Results With decreasing concentrations of apixaban, stimulation with the lower dose SynthASil reveals an increasing ETP and PTG. As expected, ttPeak and ttStart decreased. Even supratherapeutic levels of apixaban (i.e. 1120 ng/mL) could not inhibit thrombin from being generated, in striking contrast with UFH where no thrombin was formed. Using a five times higher dose of SynthASil showed comparable ETP for all concentrations of apixaban, allocated around the control value. PTG, however, slightly increased with decreasing concentrations of apixaban. ttPeak and ttStart slightly decreased. Except for the subtherapeutic UFH concentration of 0,114 IU/mL, no thrombin was generated with UFH. Conclusion UFH is more effective in inhibiting downstream thrombin generation compared to apixaban as a response to activation of the CA pathway in vitro. These findings could help explain why direct inhibitors were not able to show non-inferiority in patients with mechanical heart valves and support the development of specific CA pathway inhibitors for patients with conditions that activate the CA pathway. Thrombin generation curves Funding Acknowledgement Type of funding source: None

Temporary assist devices in France 2014–2018: intra-aortic balloon pump: is the technique really outdated?

Abstract Aims Intra-aortic balloon pump (IABP) utilization was expected to be quickly abandoned following the IABP-shock trial and its class III, level B of recommendation in the 2016 ESC guidelines. The aim of this study was to evaluate the use of IABP compared to other mechanical support devices in a nationwide approach. Methods We conducted a retrospective study based on the French national hospital discharge database. All patients implanted by an assist device either by IABP, extracorporeal membrane oxygenation (ECMO) or IMPELLA® from 2014 to 2018 (2 years before/2 years after the 2016 guidelines) were included. The primary endpoint was the incidence of IABP implantation over the years. Secondary endpoints were incidence of total assist devices implantations, ECMO and IMPELLA® implantation. Results From 2014 to 2018, a total of 18,872 patients benefited from mechanical support by IABP (n=6,637, 35.2%), ECMO (n=11,833, 62.7%) or IMPELLA® (n=402, 2.1%) in France. The incidence of total mechanical support implantations (ECMO and IABP) was constant over the years. IABP implantation decreased progressively from 1,725 implantations in 2014 to 976 in 2018 (−44%). By contrast, ECMO implantation increased progressively from 1,919 implantations in 2014 to 2,715 implantations in 2018 (+42%). IMPELLA® implantations remained stable over the years from 63 (1.7%) implantations in 2014 to 83 (2.1%) in 2018. Conclusion In this nationwide real-life study, despite a significant decline in IABP implantations over the years since the ESC guidelines, this device remained used in clinical practice with around 1,000 implantations in 2018. The size of the centers is not strictly correlated with this use, suggesting differential uses depending of the local background. Funding Acknowledgement Type of funding source: None