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.

In-Hospital and One-Year Outcomes of Patients after Early and Late Resuscitated Cardiac Arrest Complicating Acute Myocardial Infarction-Data from a Nationwide Database.

The prognostic role of early (less than 48 h) resuscitated cardiac arrest (ErCA) complicating acute myocardial infarction (AMI) is still controversial. The present study aimed to analyse the short-term and one-year outcomes of patients after ErCA and late resuscitated cardiac arrest (LrCA) compared to patients without cardiac arrest (CA) complicating AMI. Data from the prospective nationwide Polish Registry of Acute Coronary Syndromes (PL-ACS) were used to assess patients with resuscitated cardiac arrest (rCA) after AMI. Baseline clinical characteristics and the predictors of all-cause death were assessed. The all-cause mortality rate, complications, performed procedures, and re-hospitalisations were assessed for the in-hospital period, 30 days after discharge, and 6- and 12-month follow-ups. Among 167,621 cases of AMI, CA occurred in 3564 (2.1%) patients, that is, 3100 (87%) and 464 (13%) patients with ErCA and LrCA, respectively. The mortality rates in the ErCA vs. LrCA and CA vs. non-CA groups were as follows: in-hospital: 32.1% vs. 59.1% (p < 0.0001) and 35.6% vs. 6.0% (p < 0.0001); 30-day: 2.2% vs. 3.2% (p = 0.42) and 9.9% vs. 5.2% (p < 0.0001); 6-month: 9.2% vs. 17.9% (p = 0.0001) and 12.3% vs. 21.1% (p < 0.0001); and 12-month: 12.3% vs. 21.1% (p = 0.001) and 13% vs. 7.7% (p < 0.0001), respectively. ErCA (hazard ratio (HR): 1.54, confidence interval (CI):1.28-1.89; p < 0.0001) and LrCA (HR: 2.34, CI: 1.39-3.93; p = 0.001) increased the risk of 12-month mortality. During the 12-month follow-up, patients after LrCA more frequently required hospitalisation due to heart failure compared to patients after ErCA. ErCA was related to a higher hospitalisation rate due to coronary-related causes and a higher rate of percutaneous coronary intervention. An episode of LrCA was associated with higher in-hospital and long-term mortality compared to ErCA. ErCA and LrCA were independent risk factors for one-year mortality.

Impact of COVID-19 pandemic on acute heart failure admissions and mortality: a multicentre study (COV-HF-SIRIO 6 study).

AIMS: The coronavirus disease-2019 (COVID-19) pandemic has changed the landscape of medical care delivery worldwide. We aimed to assess the influence of COVID-19 pandemic on hospital admissions and in-hospital mortality rate in patients with acute heart failure (AHF) in a retrospective, multicentre study. METHODS AND RESULTS: From 1 January 2019 to 31 December 2020, a total of 101 433 patients were hospitalized in 24 Cardiology Departments in Poland. The number of patients admitted due to AHF decreased by 23.4% from 9853 in 2019 to 7546 in 2020 (P < 0.001). We noted a significant reduction of self-referrals in the times of COVID-19 pandemic accounting 27.8% (P < 0.001), with increased number of AHF patients brought by an ambulance by 15.9% (P < 0.001). The length of hospital stay was overall similar (7.7 ± 2.8 vs. 8.2 ± 3.7 days; P = not significant). The in-hospital all-cause mortality in AHF patients was 444 (5.2%) in 2019 vs. 406 (6.5%) in 2020 (P < 0.001). A total number of AHF patients with concomitant COVID-19 was 239 (3.2% of AHF patients hospitalized in 2020). The rate of in-hospital deaths in AHF patients with COVID-19 was extremely high accounting 31.4%, reaching up to 44.1% in the peak of the pandemic in November 2020. CONCLUSIONS: Our study indicates that the COVID-19 pandemic led to (i) reduced hospital admissions for AHF; (ii) decreased number of self-referred AHF patients and increased number of AHF patients brought by an ambulance; and (iii) increased in-hospital mortality for AHF with very high mortality rate for concomitant AHF and COVID-19.

Repetitive use of LEvosimendan in Ambulatory Heart Failure patients (LEIA-HF) - The rationale and study design.

PURPOSE: Clinical practice forces the necessity to conduct a clinical trial concerning the group of outpatients with chronically advanced heart failure in III or IV NYHA functional class, frequently requiring hospitalizations due to HF exacerbation, and often left without any additional therapeutic option. The current trial aims to determine the efficacy and safety of repeated levosimendan infusions in the group of severe outpatients with reduced ejection fraction (HFrEF). MATERIAL AND METHODS: LEIA-HF (LEvosimendan In Ambulatory Heart Failure Patients) is a multicentre, randomized, double-blind, placebo-controlled, phase 4 clinical trial to determine whether the repetitive use of levosimendan reduces the incidence of adverse cardiovascular events in ambulatory patients with chronic, advanced HFrEF. A total of 350 patients will be randomized in a 1:1 ratio to receive either levosimendan or placebo, which will be administered as continuous 24 â€‹h infusions, every 4 weeks for 48 weeks (12 infusions in total - phase I), and followed by double-blind 6 visits, every 4 weeks (phase II of the trial including the option of restarting levosimendan or placebo, based on the fulfillment of additional criteria). The primary endpoint for efficacy assessment will be death from any cause or unplanned hospitalization for HF assessed together, whichever occurs first, in a 12-month follow-up period. CONCLUSIONS: A well-designed study with a consistent protocol, including the drug side effects, comprehensive clinical assessment, appropriate definition of endpoints, and monitoring therapy, may provide a complete overview of the effectiveness and safety profile of the repetitive levosimendan administration in ambulatory severe HFrEF patients.

Mechanical circulatory support. An expert opinion of the Association of Intensive Cardiac Care and the Association of Cardiovascular Interventions of the Polish Cardiac Society.

Mechanical circulatory support (MCS) methods are used in patients with both acute and chronic heart failure, who have exhausted other options for pharmacological or surgical treatments. The purpose of their use is to support, partially or completely, the failed ventricles and ensure adequate organ perfusion, which allows patients to restore full cardiovascular capacity, prolonging their life and effectively improving its quality. The three most popular devices include an intra-aortic balloon pump (IABP), percutaneous assist devices (including Impella, TandemHeart), and venoarterial extracorporeal membrane oxygenation (VA-ECMO). A multidisciplinary approach with the special participation of the Heart Team is required to determine the proper MCS strategy, the choice of the supporting method, and the time of its use. The studies published so far do not allow us to determine which MCS method is the safest and the most effective. Thus, the site experience and accessibility of the method seem to matter most today. MCS finds particular application in patients with acute coronary syndromes complicated by refractory cardiogenic shock, as well as in patients with acute heart failure of the high potential for reversibility. It can also serve as a backup for percutaneous coronary interventions of high risk (complex and high-risk indicated percutaneous coronary intervention [PCI], complex and high-risk indicated PCI [CHIP]). The use of appropriate supportive drugs, precise hemodynamic and echocardiographic monitoring, as well as optimal non-invasive or mechanical ventilation, are extremely important in the management of a patient with MCS. The most serious complications of MCS include bleeding, thromboembolic events, as well as infections, and hemolysis.