ANMCO/SIMEU consensus document on the use of reversal agents for antithrombotic therapies in patients with ongoing bleeding or at high risk of haemorrhagic events.

In recent decades, an incredible evolution in antithrombotic therapies used for treating patients with atherosclerosis, atrial fibrillation, and venous thromboembolism has been observed, leading to the availability of increasingly safe drugs. Nonetheless, bleeding complications remain a significant concern, with considerable health, social, and economic implications. To improve the acute management of patients experiencing or at risk for major bleeding events, specific reversal agents for antithrombotic drugs have been recently developed. While these agents demonstrate effectiveness in small-scale pharmacodynamic studies and clinical trials, it is imperative to balance the benefits of reversing antiplatelet or anticoagulant therapy against the risk of prothrombotic effects. These risks include the potential loss of antithrombotic protection and the prothrombotic tendencies associated with bleeding, major surgery, or trauma. This joint document of the Italian Association of Hospital Cardiologists (Associazione Nazionale Medici Cardiologi Ospedalieri) and the Italian Society of Emergency Medicine (Società Italiana di Medicina d'Emergenza-Urgenza) delineates the key features and efficacy of available reversal agents. It also provides practical flowcharts to guide their use in patients with active bleeding or those at elevated risk of major bleeding events.

Italian Association of Hospital Cardiologists position paper-obesity in adults: a clinical primer.

Obesity is a chronic and relapsing disease characterized by the interaction between individual predispositions and an obesogenic environment. Recent advances in understanding the mechanisms of energetic homoeostasis paved the way to more effective therapeutic approaches compared with traditional treatments. Since obesity is a complex disease, it necessitates a multi-disciplinary approach whose implementation remains challenging. Nonetheless, emerging pharmacological interventions appear promising. Currently, therapeutic success is discreet in the short term but often fails to maintain long-term weight loss due to a high likelihood of weight regain. Cardiologists play a key role in managing patients with obesity, yet often lack familiarity with its comprehensive management. The aim of this document is to summarize knowledge to consolidate essential knowledge for clinicians to effectively treat patients living with obesity. The paper emphasizes the pivotal role of a strong patient-clinician relationship in navigating successful treatment. We analyse the criteria commonly used to diagnose obesity and point out the strengths and limitations of different criteria. Furthermore, we discuss the role of obesiologists and the contributions of cardiologists. In addition, we detail key components of effective therapeutic strategies, including educational aspects and pharmacological options.

Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO) scientific statement on the simplification of the drug regimen for secondary cardiovascular prevention.

The issue of suboptimal drug regimen adherence in secondary cardiovascular prevention presents a significant barrier to improving patient outcomes. To address this, the utilization of drug combinations, specifically single pill combinations (SPCs) and polypills, was proposed as a strategy to simplify treatment regimens. This approach aims to enhance treatment accessibility, affordability, and adherence, thereby reducing healthcare costs and improving patient health. The document is an Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO) scientific statement on simplifying drug regimens for secondary cardiovascular prevention. It discusses the underuse of treatments despite available, effective, and accessible options, highlighting a significant gap in secondary prevention across different socio-economic statuses and countries. The statement explores barriers to implementing evidence-based treatments, including patient, healthcare provider, and system-related challenges. The paper also reviews international guidelines, the role of SPCs and polypills in clinical practice, and their economic impact, advocating for their use in secondary prevention to improve patient outcomes and adherence.

Italian Association of Hospital Cardiologists Position Paper 'Gender discrepancy: time to implement gender-based clinical management'.

It has been well assessed that women have been widely under-represented in cardiovascular clinical trials. Moreover, a significant discrepancy in pharmacological and interventional strategies has been reported. Therefore, poor outcomes and more significant mortality have been shown in many diseases. Pharmacokinetic and pharmacodynamic differences in drug metabolism have also been described so that effectiveness could be different according to sex. However, awareness about the gender gap remains too scarce. Consequently, gender-specific guidelines are lacking, and the need for a sex-specific approach has become more evident in the last few years. This paper aims to evaluate different therapeutic approaches to managing the most common women's diseases.

Consensus Document ANMCO/ANCE/ARCA/GICR-IACPR/GISE/SICOA: Long-term Antiplatelet Therapy in Patients with Coronary Artery Disease.

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the cornerstone of pharmacologic management of patients with acute coronary syndrome (ACS) and/or those receiving coronary stents. Long-term (>1 year) DAPT may further reduce the risk of stent thrombosis after a percutaneous coronary intervention (PCI) and may decrease the occurrence of non-stent-related ischaemic events in patients with ACS. Nevertheless, compared with aspirin alone, extended use of aspirin plus a P2Y12 receptor inhibitor may increase the risk of bleeding events that have been strongly linked to adverse outcomes including recurrent ischaemia, repeat hospitalisation and death. In the past years, multiple randomised trials have been published comparing the duration of DAPT after PCI and in ACS patients, investigating either a shorter or prolonged DAPT regimen. Although the current European Society of Cardiology guidelines provide a backup to individualised treatment, it appears to be difficult to identify the ideal patient profile which could safely reduce or prolong the DAPT duration in daily clinical practice. The aim of this consensus document is to review contemporary literature on optimal DAPT duration, and to guide clinicians in tailoring antiplatelet strategies in patients undergoing PCI or presenting with ACS.

ANMCO Position Paper: direct oral anticoagulants for stroke prevention in atrial fibrillation: clinical scenarios and future perspectives.

It is now 4 years since the introduction of the new direct oral anticoagulants into clinical practice. Therefore, the Italian Association of Hospital Cardiologists (ANMCO) has deemed necessary to update the previous position paper on the prevention of thrombo-embolic complications in patients with non-valvular atrial fibrillation, which was published in 2013. All available scientific evidence has been reviewed, focusing on data derived from both clinical trials and observational registries. In addition, all issues relevant to the practical clinical management of oral anticoagulation with the new direct inhibitors have been considered. Specific clinical pathways for optimal use of oral anticoagulation with the new directly acting agents are also developed and proposed for clinical implementation. Special attention is finally paid to the development of clinical algorithms for medium and long-term follow-up of patients treated with new oral direct anticoagulants.

Consensus Document of the Italian Association of Hospital Cardiologists (ANMCO), Italian Society of Cardiology (SIC), Italian Association of Interventional Cardiology (SICI-GISE) and Italian Society of Cardiac Surgery (SICCH): clinical approach to pharmacologic pre-treatment for patients undergoing myocardial revascularization procedures.

The wide availability of effective drugs in reducing cardiovascular events together with the use of myocardial revascularization has greatly improved the prognosis of patients with coronary artery disease. The combination of antithrombotic drugs to be administered before the knowledge of the coronary anatomy and before the consequent therapeutic strategies, can allow to anticipate optimal treatment, but can also expose the patients at risk of bleeding that, especially in acute coronary syndromes, can significantly weigh on their prognosis, even more than the expected theoretical benefit. In non ST-elevation acute coronary syndromes patients in particular, we propose a 'selective pre-treatment' with P2Y12 inhibitors, based on the ischaemic risk, on the bleeding risk and on the time scheduled for the execution of coronary angiography. Much of the problems concerning this issue would be resolved by an early access to coronary angiography, particularly for patients at higher ischaemic and bleeding risk.

ANMCO Position Paper: hospital discharge planning: recommendations and standards.

The hospital discharge is often poorly standardized and affected by discontinuity and fragmentation of care, putting patients at high risk of both post-discharge adverse events and early readmission. The present ANMCO document reviews the modifiable components of the hospital discharge process related to adverse events or re-hospitalizations and suggests the optimal methods for redesigning the whole discharge process. The key principles for proper hospital discharge or transfer of care acknowledge that the hospital discharge: • is not an isolated event, but a process that has to be planned as soon as possible after the admission, ensuring that the patient and the caregiver understand and contribute to the planned decisions, as equal partners; • is facilitated by a comprehensive systemic approach that begins with a multidimensional evaluation process; • must be organized by an operator who is responsible for the coordination of all phases of the hospital patient journey, involving afterward the general practitioner and transferring to them the information and responsibility at discharge; • is the result of an integrated multidisciplinary team approach; • appropriately uses the transitional and intermediate care services; • is carried out in an organized system of care and continuum of services; and • programs the passage of information to after-discharge services.

Consensus Document of the Italian Association of Hospital Cardiologists (ANMCO), Italian Society of Pediatric Cardiology (SICP), and Italian Society of Gynaecologists and Obstetrics (SIGO): pregnancy and congenital heart diseases.

The success of cardiac surgery over the past 50 years has increased numbers and median age of survivors with congenital heart disease (CHD). Adults now represent two-thirds of patients with CHD; in the USA alone the number is estimated to exceed 1 million. In this population, many affected women reach reproductive age and wish to have children. While in many CHD patients pregnancy can be accomplished successfully, some special situations with complex anatomy, iatrogenic or residual pathology are associated with an increased risk of severe maternal and fetal complications. Pre-conception counselling allows women to come to truly informed choices. Risk stratification tools can also help high-risk women to eventually renounce to pregnancy and to adopt safe contraception options. Once pregnant, women identified as intermediate or high risk should receive multidisciplinary care involving a cardiologist, an obstetrician and an anesthesiologist with specific expertise in managing this peculiar medical challenge. This document is intended to provide cardiologists working in hospitals where an Obstetrics and Gynecology Department is available with a streamlined and practical tool, useful for them to select the best management strategies to deal with a woman affected by CHD who desires to plan pregnancy or is already pregnant.

[ANMCO/SIMEU Consensus document on the use of reversal agents of antithrombotic therapies in patients with active bleeding or at high-risk of major bleeding events]. / Documento di consenso ANMCO/SIMEU sull'impiego degli agenti di reversione delle terapie antitrombotiche nei pazienti con sanguinamento in atto o ad alto rischio di eventi emorragici.

In recent decades, an incredible evolution in antithrombotic therapies for the treatment of patients suffering from atherosclerosis, atrial fibrillation and venous thromboembolism occurred, leading to the availability of increasingly safe drugs. However, bleeding complications associated with these drugs still have an important health, social and economic impact. Recently, with the aim of improving the acute management of patients with or at risk of major bleeding events, specific reversal agents of antithrombotic drugs have been developed. Although these agents have demonstrated their effectiveness in small pharmacodynamic studies or clinical trials, it is important to consider that the benefit of reversal of an antiplatelet or anticoagulant drug must always be counterbalanced by the possible prothrombotic effect caused by the removal of antithrombotic protection as well as by prothrombotic mechanisms related to bleeding, major surgery or trauma.In this ANMCO/SIMEU consensus document we summarize the main characteristics and efficacy studies of the currently available reversal agents and present practical flow-charts in which we suggest their possible use in patients with active bleeding or at high risk of major bleeding events.

Exploring the Perioperative Use of DOACs, off the Beaten Track.

A notable increase in direct oral anticoagulant (DOAC) use has been observed in the last decade. This trend has surpassed the prescription of vitamin K antagonists (VKAs) due to the absence of the need for regular laboratory monitoring and the more favorable characteristics in terms of efficacy and safety. However, it is very common that patients on DOACs need an interventional or surgical procedure, requiring a careful evaluation and a challenging approach. Therefore, perioperative anticoagulation management of patients on DOACs represents a growing concern for clinicians. Indeed, while several surgical interventions require temporary discontinuation of DOACs, other procedures that involve a lower risk of bleeding can be conducted, maintaining a minimal or uninterrupted DOAC strategy. Therefore, a comprehensive evaluation of patient characteristics, including age, susceptibility to stroke, previous bleeding complications, concurrent medications, renal and hepatic function, and other factors, in addition to surgical considerations, is mandatory to establish the optimal discontinuation and resumption timing of DOACs. A multidisciplinary approach is required for managing perioperative anticoagulation in order to establish how to face these circumstances. This narrative review aims to provide physicians with a practical guide for DOAC perioperative management, addressing the most controversial issues.

Coagulation Tests and Reversal Agents in Patients Treated with Oral Anticoagulants: The Challenging Scenarios of Life-Threatening Bleeding and Unplanned Invasive Procedures.

In clinical practice, the number of patients treated with direct oral anticoagulants (DOACs) has consistently increased over the years. Since anticoagulant therapy has been associated with an annual incidence of major bleeding (MB) events of approximately 2% to 3.5%, it is of paramount importance to understand how to manage anticoagulated patients with major or life-threatening bleeding. A considerable number of these patients' conditions necessitate hospitalization, and the administration of reversal agents may be imperative to manage and control bleeding episodes effectively. Importantly, effective strategies for reversing the anticoagulant effects of DOACs have been well recognized. Specifically, idarucizumab has obtained regulatory approval for the reversal of dabigatran, and andexanet alfa has recently been approved for reversing the effects of apixaban or rivaroxaban in patients experiencing life-threatening or uncontrolled bleeding events. Moreover, continuous endeavors are being made to develop supplementary reversal agents. In emergency scenarios where specific reversal agents might not be accessible, non-specific hemostatic agents such as prothrombin complex concentrate can be utilized to neutralize the anticoagulant effects of DOACs. However, it is paramount to emphasize that specific reversal agents, characterized by their efficacy and safety, should be the preferred choice when suitable. Moreover, it is worth noting that adherence to the guidelines for the reversal agents is poor, and there is a notable gap between international recommendations and actual clinical practices in this regard. This narrative review aims to provide physicians with a practical approach to managing specific reversal agents.

[ANMCO Position paper: States General 2023 - Role of ANMCO in the setting of clinical research in Cardiology in Italy: current state and future perspectives]. / Position paper ANMCO: Stati Generali 2023 ­ Ruolo dell'ANMCO nella ricerca clinica cardiologica in Italia: attualità e prospettive.

For over 40 years, clinical research has been one of the most important aims of the Italian Association of Hospital Cardiologists (ANMCO), being an essential tool in pursuing promotion and fulfillment of good clinical practices in prevention, treatment and rehabilitation of cardiovascular diseases. Since 1992, with the creation of the Research Center (now part of the Heart Care Foundation), ANMCO is capable of independently and professionally managing all the aspects related to planning, management, and publication of the results of clinical studies. The other strength of ANMCO is the network built in Cardiology Departments on the whole territory of Italy, a human capital that allows ANMCO to deal with the new scientific challenges, in a context of profound changes in the social, economic, technological, and methodological setting. This document is based on the debate about the state of clinical research in Italy and the role of ANMCO in this setting that took place during the 2023 ANMCO States General.

[ANMCO Position paper - 2023 ANMCO States General: The shortage of healthcare personnel in the cardiology field]. / Position paper ANMCO ­ Stati Generali ANMCO 2023: La carenza del personale sanitario in ambito cardiologico.

Over the latest years, a worrying progressive reduction of medical specialists has been observed in Italy and in other European and non-European countries. This trend is assuming alarming proportions, especially considering the continuous population aging and the concomitant increase in the prevalence of chronic cardiovascular disease. The underlying reasons are complex and multifactorial. The purpose of this document, derived from the collegial discussion held during the 2023 ANMCO States General is to highlight the current critical issues regarding the lack of healthcare personnel in the cardiology field, examining the current and future Italian situation and proposing some potential strategies to counteract this alarming phenomenon.

[ANMCO Position paper - 2023 ANMCO States General: Towards a modern Cardiological Community Care]. / Position paper ANMCO ­ Stati Generali ANMCO 2023: Verso una moderna Cardiologia Territoriale.

Over the last two decades, cardiovascular diseases have become the leading cause of chronic disease morbidity and mortality in Italy. Therefore, the chronic cardiovascular care landscape has evolved rapidly in an era of unprecedented demand. Furthermore, the COVID-19 pandemic has highlighted significant deficiencies in existing health and social care systems, especially in the management of chronic cardiovascular disease. In this scenario, the National Reform for Recovery and Resilience (PNRR) may represent a unique opportunity for the development of a new integrated care system between hospital and community. The Italian Association of Hospital Cardiologists (ANMCO) recognizes the need for a statement on the integrated cardiological community care to guide health professionals caring for people with chronic cardiovascular conditions. The aim of the present statement is to outline the evidence for a modern integrated cardiological community care identifying challenges and offering advice for a future transdisciplinary and multi-organizational approach to ensure best practice in the management of chronic cardiovascular disease.

[ANMCO Position paper: States General 2023 - Scientific societies and training: the role of ANMCO]. / Position paper ANMCO: Stati Generali 2023 ­ Società scientifiche e formazione: il ruolo dell'ANMCO.

Scientific societies promote numerous activities, including the training of professionals. With the continuous growing of knowledge and the availability of new evidence in the cardiological field, the achievement and maintenance of knowledge and know-how is difficult. The evolving educational needs of professionals in cardiology have been analyzed during the 2023 ANMCO General States. Furthermore, the initiatives implemented to meet professionals' needs after the university medical training have been discussed. In this document, we report the main and most innovative training activities promoted by ANMCO, from distance training to simulation training, including courses for master's degree, training to and through clinical research and the potential role of teaching hospitals.

[ANMCO Position paper: Obesity in adults - A clinical primer]. / Position paper ANMCO: Obesità nell'adulto ­ Clinical primer.

Obesity is a chronic and relapsing disease due to the coexistence of a patient with predisposing individual characteristics and an obesogenic environment. The recent acquisition of detailed knowledge on the mechanisms underlying the energetic homeostasis paved the way to more effective therapeutic hypotheses as compared to traditional treatments. Since obesity is a complex issue, it requires a multidisciplinary approach which is difficult to implement. However, new drugs appear promising. Currently, therapeutic success is discrete in the short term, but unsatisfying in the long term due to the high probability of body weight gain. Cardiologists play a key role in managing patients with obesity, but they are not used to manage them. The aim of this document is to summarize knowledge that clinicians need to have to appropriately manage these patients. The paper emphasizes the pivotal role of an appropriate relationship with the patient to embark on a successful treatment journey. We analyze the criteria commonly used to diagnose obesity and point out strengths and limitations of different criteria. Furthermore, we discuss the figure of the obesitologist and the role of the cardiologist. In addition, we report the main components of an effective therapeutic strategy, from educational questions to pharmacological options.

[ANMCO Scientific statement on combination therapies and polypill in secondary prevention]. / Scientific statement ANMCO sulla semplificazione del regime terapeutico farmacologico in prevenzione secondaria.

The issue of suboptimal drug regimen adherence in secondary cardiovascular prevention presents a significant barrier to improving patient outcomes. To address this, the utilization of drug combinations, specifically single pill combinations (SPCs) and polypills, was proposed as a strategy to simplify treatment regimens. This approach aims to enhance treatment accessibility, affordability, and adherence, thereby reducing healthcare costs and improving patient health. The document is an ANMCO scientific statement on simplifying drug regimens for secondary cardiovascular prevention. It discusses the underuse of treatments despite available, effective, and accessible options, highlighting a significant gap in secondary prevention across different socioeconomic statuses and countries. The statement explores barriers to implementing evidence-based treatments, including patient, healthcare provider, and system-related challenges. The paper also reviews international guidelines, the role of SPCs and polypills in clinical practice, and their economic impact, advocating for their use in secondary prevention to improve patient outcomes and adherence.

[ANMCO Position paper: States General 2023 - Digital medicine in cardiology: evidence and state of progress in Italy]. / Position paper ANMCO: Stati Generali 2023 ­ La medicina digitale in cardiologia: evidenze e stato di avanzamento in Italia.

Technological innovation provides easily accessible tools capable of simplifying healthcare processes. Notably, digital technology application in the cardiology field can improve prognosis, reduce costs, and lead to an overall improvement in healthcare. The digitization of health data, with the use of electronic health records and of electronic health files in Italy, represents one of the fields of application of digital technologies in medicine. The 2023 States General of the Italian Association of Hospital Cardiologists (ANMCO) provided an opportunity to focus attention on the potential benefits and critical issues associated with the implementation of the aforementioned digital tools, artificial intelligence, and telecardiology. This document summarizes key aspects that emerged during the event.

[Gender discrepancy: time to implement gender-based clinical management]. / Position paper ANMCO: Differenze di genere nell'approccio farmacologico cardiovascolare.

It is well established that gender strongly influences cardiovascular risk factors, playing a crucial role in cardiovascular prevention, clinical pathways, diagnostic approach and treatment. Beyond the sex, which is a biological factor, gender entails a socio-cultural condition that impacts access and quality of care due to structural and institutional barriers. However, despite its great importance, this issue has not been adequately covered. Indeed sex and gender differences scarcely impact the clinical approach, creating a lot of disparities in care and outcomes of patients. Therefore, it becomes essential to increase the awareness of the importance of sex and gender influences on cardiovascular diseases. Moreover, new strategies for reducing disparities should be developed. Importantly, these differences should be taken into account in guideline recommendations. In this regard, it is crucial to include a greater number of women in clinical trials, since they are currently underrepresented. Furthermore, more women should be involved as member of international boards in order to develop recommendations and guidelines with more attention to this important topic.The aim of this ANMCO position paper is to shed light on gender differences concerning many cardiovascular drugs in order to encourage a more personalized therapeutic approach.