Safety and efficacy of up to 60 h of iv istaroxime in pre-cardiogenic shock patients: Design of the SEISMiC trial.

AIMS: Cardiogenic shock (CS) is linked to high morbidity and mortality rates, posing a challenge for clinicians. Interventions to improve tissue perfusion and blood pressure are crucial to prevent further deterioration. Unfortunately, current inotropes, which act through adrenergic receptor stimulation, are associated with malignant arrhythmias and poorer outcomes. Due to its unique mechanism of action, istaroxime should improve haemodynamics without adrenergic overactivation. The SEISMiC study is designed to examine the safety and efficacy (haemodynamic effect) of istaroxime administrated in pre-CS patients. METHODS AND RESULTS: The SEISMiC study is a multinational, multicentre, randomized, double-blind, placebo-controlled safety and efficacy study with two parts (A and B). The study enrols patients hospitalized for decompensated heart failure (pre-CS, not related to myocardial ischaemia) with persistent hypotension [systolic blood pressure (SBP) 70-100 mmHg for at least 2 h] and clinically confirmed congestion, NT-proBNP ≥1400 pg/mL, and LVEF≤40%. Subjects must not have taken intravenous (iv) vasopressors, inotropes or digoxin in the past 6 h. Eligible patients are randomized to receive IV infusion of istaroxime (different doses and regimens in Parts A and B) or placebo for up to 60 h. Central haemodynamics, ECG Holter monitoring, cardiac ultrasound and biomarkers are recorded at predefined time points during the trial. The study's primary efficacy endpoint is the SBP area under the curve from baseline curve from baseline to 6 and 24 h in the combined SEISMiC Parts A and B population. Key secondary efficacy endpoints include haemodynamic, laboratory and clinical measures in SEISMiC B alone in the combined SEISMiC A and B studies. CONCLUSIONS: The study results will contribute to our understanding of the role of istaroxime in pre-CS patients and potentially provide insight into the drug's haemodynamic effects and safety in this population.

Hemocompatibility-related Adverse Events in Patients With Temporary Mechanical Circulatory Support: The Scoring Haemostasis Events and Assessment for Risk (SHEAR) Score.

Evaluation of treatment outcomes in patients supported by temporary mechanical circulatory support (tMCS) currently relies mainly on mortality, which may not sufficiently address other patient benefits or harms. Bleeding and thrombosis are major contributors to mortality. Still, current bleeding scores are not designed for critically ill patients undergoing tMCS, only consider selected populations, and do not account for the high heterogeneity among bleeding and thrombotic adverse events. To improve clinical management, a group of European experts has proposed a revised scoring system based on the MOMENTUM 3 Hemocompatibility Score and the Society of Cardiac Angiography and Interventions (SCAI)classification of cardiogenic shock. The new system termed the Scoring Haemostasis Events and Assessment for Risk (SHEAR) score, is divided into a baseline characterization stage and four escalating scoring stages encompassing all aspects of clinical relevance. This report summarizes the literature on hemocompatibility-related adverse events associated with tMCS, including bleeding, stroke, vascular access complications, hemolysis, thrombosis, and device failure. The SHEAR score provides a simple and rapid bedside scoring system aiming to provide a univocal tool to increase physician awareness of hemocompatibility complications at baseline and beyond, improve clinical research, and enable the capture of device-related complications that will inform relevant outcomes beyond mortality.

Value of APACHE II, SOFA and CardShock scoring as predictive tools for cardiogenic shock: A single-centre pilot study.

AIMS: The aim of this study was to determine the value of the Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA) and CardShock scoring systems in predicting the risk of in-hospital, 30 day and 3 year mortality in patients with cardiogenic shock (CS). METHODS: This was a single-centre observational study conducted between May 2016 and December 2017. Data from consecutive patients with CS admitted to the intensive cardiac care unit (ICCU) were included in the analysis. RESULTS: The study group comprised 63 patients with CS {median age 71.0 [interquartile range (IQR), 59-82]; 42 men}: 32 patients with ischaemic and 31 with non-ischaemic aetiology. The median APACHE II, SOFA and CardShock scores were 13 (IQR, 9.9-19.0) points, 8.0 (IQR, 6.0-10.0) points and 3.0 (IQR, 2.0-5.0) points, respectively. The in-hospital, 30 day and 3 year mortality rates were 39.7%, 41.3% and 77.8%, respectively. APACHE II and SOFA scores were significantly higher in the group of patients who died at 30 days (P = 0.043 and P = 0.045, respectively). The CardShock score was higher in patients with CS who died in hospital (P = 0.007) and within 30 days (P = 0.004). No score was statistically significant for 3 year mortality. Area under the curve (AUC) analysis showed that the CardShock score had the highest value in predicting in-hospital and 30 day mortality relative to APACHE II and SOFA, with a cut-off score of 5 points [AUC: 0.70; 95% confidence interval (CI): 0.59-0.81; P = 0.001] and 4 points (AUC: 0.71; 95% CI: 0.60-0.82; P < 0.001), respectively. The Bayesian Weibull model demonstrated the utility of all scales in estimating short-term risk in patients with CS, with the impact of APACHE II and SOFA on patient life expectancy decreasing to a non-significant level at approximately 32 days and CardShock at 33 days. The forest plots derived from the Bayesian logistic regression analysis show significant estimated coefficients with 94% highest density interval (HDI) for in-hospital and 30 day mortality. The use of invasive or non-invasive ventilation, a higher heart rate and a less negative fluid balance showed an unfavourable prognosis. Survival was associated with being in the pre-CS class, with a higher glomerular filtration rate and a higher platelet count. CONCLUSIONS: APACHE II and SOFA could be used for the risk stratification of patients with CS admitted to the ICCU. CardShock proved to be a more appropriate tool for assessing short-term prognosis in patients with CS of all aetiologies, suggesting that there is potential for its promotion for use in daily clinical practice.

The use of andexanet alpha in the Polish setting: An interdisciplinary protocol. Expert consensus statement of the Polish Cardiac Society.

Andexanet alfa (AA) is a recombinant inactive analog of human activated factor X (FXa), effectively reversing the effects of its inhibitors - rivaroxaban and apixaban, which are available in Poland. The drug was approved for clinical use registration after the publication of the results of the ANNEXA-4 trial (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXa Inhibitors 4), in which its efficacy in restoring hemostasis in life-threatening hemorrhages in patients receiving using the aforementioned anticoagulants was demonstrated. Hence, AA is now recommended for patients on apixaban or rivaroxaban therapy with massive and uncontrollable hemorrhages, including hemorrhagic strokes (HS) and gastrointestinal bleeding. Drug-specific chromogenic anti-Xa assays are generally best suited for estimating rivaroxaban and apixaban plasma levels, aside from direct assessment of their concentrations. The absence of anti-Xa activity, determined using these assays, allows us to rule out the presence of clinically relevant plasma concentrations of any FXa inhibitor. On the other hand, the dose of AA should not be modified based on the results of coagulation tests, as it depends solely on the time that elapsed since the last dose of FXa inhibitor and oon the dose and type of FXa inhibitor. AA is administered as an intravenous (i.v.) bolus, followed by an i.v. infusion of the drug. The maximum reversal of anti-Xa activity occurs within two minutes of the end of the bolus treatment, with the continuation of the continuous i.v. infusion allowing the effect to be maintained for up to two hours afterwards. Because anticoagulant activity can reappear after the infusion is completed, it is currently unclear at what point after AA administration FXa inhibitors or heparin should be re-administered. In Poland AA is starting to become available and its urgent need to administer it to patients with severe bleeding on apixaban or rivaroxaban.

Cangrelor - Expanding therapeutic options in patients with acute coronary syndrome.

Cangrelor is the only intravenous P2Y12 receptor antagonist. It is an adenosine triphosphate analog that selectively, directly, and reversibly binds to the platelet P2Y12 receptors exerting its antiaggregatory effect. Cangrelor is characterized by linear, dose-dependent pharmacokinetics and rapid onset of action providing potent platelet inhibition exceeding 90%. Cangrelor is rapidly metabolized by endothelial endonucleotidase; thus, its half-life is 2.9 to 5.5 min, and its antiplatelet effect subsides within 60 to 90 min. Data originating from three pivotal cangrelor trials (CHAMPION PLATFORM, CHAMPION PCI, and CHAMPION PHOENIX) indicate that cangrelor reduces the risk of periprocedural thrombotic complications during percutaneous coronary intervention at the expense of mild bleedings. Its unique pharmacological properties allow it to overcome the limitations of oral P2Y12 receptor inhibitors, mainly related to the delayed and decreased bioavailability and antiplatelet effect of these agents, which are often observed in the setting of acute coronary syndrome. Subgroups of patients who could theoretically benefit the most from cangrelor include those in whom pharmacokinetics and pharmacodynamics of oral P2Y12 receptor antagonists are most disturbed, namely patients with ST-segment elevation myocardial infarction, those treated with opioids, with mild therapeutic hypothermia, or in cardiogenic shock. Cangrelor could also be useful if bridging is required in patients undergoing surgery. According to the current guidelines cangrelor may be considered in P2Y12 receptor inhibitor-naïve patients undergoing percutaneous coronary intervention in both acute and stable settings.

Management of myocardial infarction complicated by cardiogenic shock: Expert opinion of the Association of Intensive Cardiac Care and Association of Cardiovascular Interventions of the Polish Society of Cardiology.

Despite significant advances in interventional cardiology and mechanical circulatory support (MCS) techniques, outcomes for patients with myocardial infarction (MI) complicated by cardiogenic shock (CS) remain suboptimal. This expert consensus aims to provide information on the current management of patients with MI complicated by CS in Poland and to propose solutions, including systemic ones, for all stages of care. The document uses data from the Polish PL-ACS Registry of Acute Coronary Syndromes, which includes records of more than 820 000 hospital admissions. We describe the role of medical rescue teams, highlighting the necessity to expand their range of competencies at the level of prehospital care. We emphasize the importance of treating the underlying cause of CS and direct patient transfer to centers capable of performing percutaneous coronary interventions. We present current recommendations of scientific societies on MCS use. We underline the role of the Cardiac Shock Team in the management of patients with MI complicated by CS. Such teams should comprise an interventional cardiologist, a cardiothoracic surgeon, and an intensive care physician. Patients should be transferred to highly specialized CS centers, following the example of so-called Cardiac Shock Care Centers described in some other countries. We propose criteria for the operation of such centers Other important aspects discussed in the document include the role of rehabilitation, multidisciplinary care, and long-term follow-up of treatment outcomes. The document was developed in cooperation with experts from different scientific societies in Poland, which illustrates the importance of interdisciplinary care in this patient population.

Telemedicine in Heart Failure in the COVID-19 and Post-Pandemic Era: What Have We Learned?

Numerous studies showed that patients with heart failure (HF) and COVID-19 are at high risk of in-hospital complications and long-term mortality. Changes in the organisation of the medical system during the pandemic also worsened access to standard procedures, increasing the general mortality in HF and forcing the systems to be reorganised with the implementation and development of telemedical technologies. The main challenges for HF patients during the pandemic could be solved with new technologies aimed to limit the risk of SARS-CoV-2 transmission, optimise and titrate the therapy, prevent the progression and worsening of HF, and monitor patients with acute HF events in the course of and after COVID-19. Dedicated platforms, phone calls or video conferencing and consultation, and remote non-invasive and invasive cardiac monitoring became potential tools used to meet the aforementioned challenges. These solutions showed to be effective in the model of care for patients with HF and undoubtedly will be developed after the experience of the pandemic. However, the multitude of possibilities requires central coordination and collaboration between institutes with data protection and cost reimbursement to create effective mechanisms in HF management. It is crucial that lessons be learned from the pandemic experience to improve the quality of care for HF patients.

Position of the Polish Cardiac Society on therapeutic targets for LDL cholesterol concentrations in secondary prevention of myocardial infarctions.

Cardiovascular diseases account for 43% of deaths in Poland. The COVID-19 pandemic increased the number of cardiovascular deaths by as much as 16.7%. Lipid metabolism disorders are observed in about 20 million Poles. Lipid disorders are usually asymptomatic, they cause a significant increase in the risk of cardiovascular diseases. Up to 20% of patients who experience an acute coronary syndrome (ACS) may experience a recurrence of a cardiovascular event within a year, and up to 40% of these patients may be re-hospitalized. Within 5 years after a myocardial infarction, 18% of patients suffer a second ACS and 13% have got a stroke. Lipid-lowering therapy is an extremely important element of comprehensive management, both in primary and secondary prevention, and its main goal is to prevent or extend the time to the onset of heart or vascular disease and reduce the risk of cardiovascular events. A patient with a history of ACS belongs to the group of a very high risk of a cardiovascular event due to atherosclerosis. In this group of patients, low-density lipoprotein cholesterol levels should be aimed below 55 mg/dl (1.4 mmol/l). Many scientific guidelines define the extreme risk group, which includes not only patients with two cardiovascular events within two years, but also patients with a history of ACS and additional clinical factors: peripheral vascular disease, multivessel disease (multilevel atherosclerosis), or multivessel coronary disease, or familial hypercholesterolemia, or diabetes with at least one additional risk factor: elevated Lp(a) >50 mg/dl or hsCRP >3 mg/l, or chronic kidney disease (eGFR <60 ml/min/1.73 m²). In this group of patients, the LDL-C level should be aimed at below 40 mg/dl (1.0 mmol/l). Achieving therapeutic goals in patients after ACS should occur as soon as possible. For this purpose, a high-dose potent statin should be added to the therapy at the time of diagnosis, and ezetimibe should be added if the goal is not achieved after 4-6 weeks. Combination therapy may be considered in selected patients from the beginning. After 4-6 weeks of combination therapy, if the goal is still not achieved, adding a proprotein convertase subtilisin/kexin type 9 protein inhibitor or inclisiran should be considered. In order to increase compliance with the recommendations, Polish Cardiac Society and Polish Lipid Society propose to attach in the patient's discharge letter a statement clearly specifying what drugs should be used and what LDL-C values should be achieved. It is necessary to cooperate between the patient and the doctor, to follow the recommendations and take medicines regularly, to achieve and maintain therapeutic goals.

The GLVC scoring system: a single-center model for predicting survival and hospitalization in patients with heart failure.

BACKGROUND: Heart failure (HF) is the only cardiovascular disease with an ever-increasing incidence. AIMS: The aim of this study was to assess the predictors of adverse clinical events (CE) and the creation and evaluation of the prognostic value of a novel personalized scoring system in patients with HF. METHODS: The study included 113 HF patients (median age 64 years (IQR 58-69); 57.52% male). The new novel prognostic score named GLVC (G, global longitudinal peak strain (GLPS); L, left ventricular diastolic diameter (LVDD); V, oxygen pulse (VO2/HR); and C, high sensitivity C-reactive protein (hs-CRP)) was created. The Kaplan-Meier method and log-rank test were used to compare the CE. RESULTS: Results from final analyses showed that low GLPS (< 13.9%, OR = 2.66, 95% CI = 1.01-4.30, p = 0.002), high LVDD (> 56 mm, OR = 2.37, 95% CI = 1.01-5.55, p = 0.045), low oxygen pulse (< 10, OR = 2.8, 95% CI = 1.17-6.70, p = 0.019), and high hs-CRP (> 2.38 µg/ml, OR = 2.93, 95% CI = 1.31-6.54, p = 0.007) were independent prognostic factors for adverse CE in HF population. All the patients were stratified into a low-risk or high-risk group according to a novel "GLVC" scoring system. The Kaplan-Meier analyses demonstrated that patients in the high-risk group were more predisposed to having higher adverse clinical events compared to patients in the low-risk group. CONCLUSIONS: A novel and comprehensive personalized "GLVC" scoring system is an easily available and effective tool for predicting the adverse outcomes in HF.

Role of catheter-directed therapies in the treatment of acute pulmonary embolism. Expert opinion of the Polish PERT Initiative, Working Group on Pulmonary Circulation, Association of Cardiovascular Interventions, and Association of Intensive Cardiac Care of the Polish Cardiac Society.

Thanks to advances in interventional cardiology technologies, catheter-directed treatment has become recently a viable therapeutic option in the treatment of patients with acute pulmonary embolism at high risk of early mortality. Current transcatheter techniques allow for local fibrinolysis or embolectomy with minimal risk of complications. Therefore, these procedures can be considered in high-risk patients as an alternative to surgical pulmonary embolectomy when systemic thrombolysis is contraindicated or ineffective. They are also considered in patients with intermediate-high-risk pulmonary embolism who do not improve or deteriorate clinically despite anticoagulation. The purpose of this article is to present the role of transcatheter techniques in the treatment of patients with acute pulmonary embolism. We describe current knowledge and expert opinions in this field. Interventional treatment is described in the broader context of patient care organization and therapeutic modalities. We present the organization and responsibilities of pulmonary embolism response team, role of pre-procedural imaging, periprocedural anticoagulation, patient selection, timing of intervention, and intensive care support. Currently available catheter-directed therapies are discussed in detail including standardized protocols and definitions of procedural success and failure. This expert opinion has been developed in collaboration with experts from various Polish scientific societies, which highlights the role of teamwork in caring for patients with acute pulmonary embolism.

Comparison of reorganized versus unaltered cardiology departments during the COVID-19 era: A subanalysis of the COV-HF-SIRIO 6 study.

BACKGROUND: Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic, numerous cardiology departments were reorganized to provide care for COVID-19 patients. We aimed to compare the impact of the COVID-19 pandemic on hospital admissions and in-hospital mortality in reorganized vs. unaltered cardiology departments. METHODS: The present research is a subanalysis of a multicenter retrospective COV-HF-SIRIO 6 study that includes all patients (n = 101,433) hospitalized in 24 cardiology departments in Poland between January 1, 2019 and December 31, 2020, with a focus on patients with acute heart failure (AHF). RESULTS: Reduction of all-cause hospitalizations was 50.6% vs. 21.3% for reorganized vs. unaltered cardiology departments in 2020 vs. 2019, respectively (p < 0.0001). Considering AHF alone respective reductions by 46.5% and 15.2% were registered (p < 0.0001). A higher percentage of patients was brought in by ambulance to reorganized vs. unaltered cardiology departments (51.7% vs. 34.6%; p < 0.0001) alongside with a lower rate of self-referrals (45.7% vs. 58.4%; p < 0.0001). The rate of all-cause in-hospital mortality in AHF patients was higher in reorganized than unaltered cardiology departments (10.9% vs. 6.4%; p < 0.0001). After the exclusion of patients with concomitant COVID-19, the mortality rates did not differ significantly (6.9% vs. 6.4%; p = 0.55). CONCLUSIONS: A greater reduction in hospital admissions in 2020 vs. 2019, higher rates of patients brought by ambulance together with lower rates of self-referrals and higher all-cause in-hospital mortality for AHF due to COVID-19 related deaths were observed in cardiology departments reorganized to provide care for COVID-19 patients vs. unaltered ones.

Handling high-risk patients in the catheterization laboratory.

Protected percutaneous coronary intervention is considered a life-saving procedure for high-risk patients. Therefore it is important that the interventional cardiology team is prepared, the procedure is planned, and potential complications, as well as bail out strategies are considered. Throughout the procedure, it is critical to monitor the patient to identify any early signs of deterioration or changes in patient well-being to avoid any potential complications.

COVID-19 Related Myocarditis in Adults: A Systematic Review of Case Reports.

Despite the progress of its management, COVID-19 maintains an ominous condition which constitutes a threat, especially for the susceptible population. The cardiac injury occurs in approximately 30% of COVID-19 infections and is associated with a worse prognosis. The clinical presentation of cardiac involvement can be COVID-19-related myocarditis. Our review aims to summarise current evidence about that complication. The research was registered at PROSPERO (CRD42022338397). We performed a systematic analysis using five different databases, including i.a. MEDLINE. Further, the backward snowballing technique was applied to identify additional papers. Inclusion criteria were: full-text articles in English presenting cases of COVID-19-related myocarditis diagnosed by the ESC criteria and patients over 18 years old. The myocarditis had to occur after the COVID-19 infection, not vaccination. Initially, 1588 papers were screened from the database search, and 1037 papers were revealed in the backward snowballing process. Eventually, 59 articles were included. Data about patients' sex, age, ethnicity, COVID-19 confirmation technique and vaccination status, reported symptoms, physical condition, laboratory and radiological findings, applied treatment and patient outcome were investigated and summarised. COVID-19-related myocarditis is associated with the risk of sudden worsening of patients' clinical status, thus, knowledge about its clinical presentation is essential for healthcare workers.

Elevated intra-abdominal pressure: A review of current knowledge.

Elevated intra-abdominal pressure (IAP) is a known cause of increased morbidity and mortality among critically ill patients. Intra-abdominal hypertension (IAH) and abdominal compartment syndrome can lead to rapid deterioration of organ function and the development of multiple organ failure. Raised IAP affects every system and main organ in the human body. Even marginally sustained IAH results in malperfusion and may disrupt the process of recovery. Yet, despite being so common, this potentially lethal condition often goes unnoticed. In 2004, the World Society of the Abdominal Compartment Syndrome, an international multidisciplinary consensus group, was formed to provide unified definitions, improve understanding and promote research in this field. Simple, reliable and nearly costless standardized methods of non-invasive measurement and monitoring of bladder pressure allow early recognition of IAH and timely optimized management. The correct, structured approach to treatment can have a striking effect and fully restore homeostasis. In recent years, significant progress has been made in this area with the contribution of surgeons, internal medicine specialists and anesthesiologists. Our review focuses on recent advances in order to present the complex underlying pathophysiology and guidelines concerning diagnosis, monitoring and treatment of this life-threatening condition.