ANMCO position paper: guide to the appropriate use of the wearable cardioverter defibrillator in clinical practice for patients at high transient risk of sudden cardiac death.

Extended risk stratification and optimal management of patients with a permanently increased risk of sudden cardiac death (SCD) are becoming increasingly important. There are several clinical conditions where the risk of arrhythmic death is present albeit only transient. As an example, patients with depressed left ventricular function have a high risk of SCD that may be only transient if there will be a significant recovery of function. It is important to protect the patients while receiving and titrating to the optimal dose the recommended drugs that may lead to an improved left ventricular function. In several other conditions, a transient risk of SCD can be observed even if the left ventricular function is not compromised. Examples are patients with acute myocarditis, during the diagnostic work-up of some arrhythmic conditions or after extraction of infected catheters while eradicating the associated infection. In all these conditions, it is important to offer a protection to these patients. The wearable cardioverter defibrillator (WCD) is of particular importance as a temporary non-invasive technology for both arrhythmia monitoring and therapy in patients with increased risk of SCD. Previous studies have shown the WCD to be an effective and safe therapy for the prevention of SCD caused by ventricular tachycardia/fibrillation. The aim of this ANMCO position paper is to provide a recommendation for clinical utilization of the WCD in Italy, based upon current data and international guidelines. In this document, we will review the WCD functionality, indications, clinical evidence, and guideline recommendations. Finally, a recommendation for the utilization of the WCD in routine clinical practice will be presented, in order to provide physicians with a practical guidance for SCD risk stratification in patients who may benefit from this device.

A multidisciplinary consensus document on follow-up strategies for patients treated with percutaneous coronary intervention.

The number of percutaneous coronary interventions (PCI) is increasing worldwide. Follow-up strategies after PCI are extremely heterogeneous and can greatly affect the cost of medical care. Of note, clinical evaluations and non-invasive exams are often performed to low risk patients. In the present consensus document, practical advises are provided with respect to a tailored follow-up strategy on the basis of patients' risk profile. Three strategies follow-up have been defined and types and timing of clinical and instrumental evaluations are reported. Clinical and interventional cardiologists, cardiac rehabilitators, and general practitioners, who are in charge to manage post-PCI patients, equally contributed to the creation of the present document.

[The ETNA-AF Europe registry: 4-year data of edoxaban use in atrial fibrillation in the Italian real world compared to the European cohort]. / Il registro ETNA-AF Europe: dati a 4 anni di utilizzo di edoxaban nella fibrillazione atriale nel mondo reale italiano in confronto alla coorte europea.

BACKGROUND: The prospective, single-arm, observational, phase 4 ETNA-AF Europe study collected real-world data about safety, effectiveness and therapeutic adherence in European patients with non-valvular atrial fibrillation newly prescribed with edoxaban and followed up for 4 years. METHODS: Overall, 13 164 patients were included in the full-analysis set, which means that they had at least one documentation after baseline at 4 years. The current paper reports about the 3329 Italian patients out of the whole European population. RESULTS: In the Italian cohort, median age was 76.0 (69.0-82.0) years, with 57.4% of the patients being ≥75 years old. The CHA2DS2-VASc score was >4 in 586 (18.1%) patients. At baseline, 670 (20.8%) patients were classified as frail by the investigators. Edoxaban 30 mg/day was prescribed to 1013 (31.8%) patients: these were older, with more comorbidities and a lower estimated creatinine clearance compared with those receiving 60 mg/day. All-cause mortality was 4.1%/year and there were very low yearly rates of bleeding and thromboembolic events: major bleeding, 0.9%; intracranial hemorrhage, 0.2%; ischemic stroke, 0.3%; systemic embolism, <0.1%. These events were more frequent in patients ≥75 years or in patients with renal impairment or treated with edoxaban 30 mg/day. Advancing age was not associated with an increased incidence of intracranial bleeding. CONCLUSIONS: These findings confirm the favorable long-term safety and effectiveness profile of edoxaban in non-valvular atrial fibrillation patients treated in routine clinical care in Italy.

Hemodynamic effects of heart rate lowering in patients admitted for acute heart failure: the RedRate-HF Study (Reduction of heart Rate in Heart Failure).

BACKGROUND: In patients admitted for acute heart failure (HF) indication for drugs which reduce the heart rate (HR) is debated. The multicentre prospective study Reduction of heart Rate in Heart Failure (RedRate-HF) was designed to analyse the hemodynamic effects of an early reduction of HR in acute HF. METHODS: Hemodynamic parameters were recorded by using the bioimpedance technique, which was shown to be accurate, highly reproducible and sensitive to intra-observer changes. Lowering HR was obtained by ivabradine 5 mg bd, given 48-72 h after admission on the top of optimized treatment. Patients were followed at 24, 48, 72 h after drug assumption and at hospital discharge. RESULTS: Twenty patients of a mean age of 67 ±â€Š15 years, BNP at entry 1348 ±â€Š1198 pg/ml were enrolled. Despite a clinical stabilization, after 48-72 h from admission, HR was persistently >70 bpm. Ivabradine was well tolerated in all patients with a significant increase in RR interval from 747 ±â€Š69 ms at baseline to 948 ±â€Š121 ms at discharge, P < 0.0001. Change in HR was associated with a significant increase in stroke volume (baseline 73 ±â€Š22 vs. 84 ±â€Š19 ml at discharge, P = 0.03), and reduction in left cardiac work index (baseline 3.6 ±â€Š1.2 vs. 3.1 ±â€Š1.1 kg/m2 at discharge, P = 0.04). Other measures of heart work were also significantly affected while cardiac output remained unchanged. CONCLUSION: The strategy of an early lowering of HR in patients admitted for acute HF on top of usual care is feasible and safe. The HR reduction causes a positive increase in stroke volume and may contribute to saving energy without affecting cardiac output.

Atrial fibrillation and ischemic heart disease: (un)solved therapeutic dilemma?

Concomitant presence of atrial fibrillation and coronary artery disease requiring percutaneous coronary intervention is a frequent occurrence. The choice of optimal antithrombotic therapy, in this context, is still challenging. To offer the best protection both in terms of stroke and stent thrombosis, triple therapy with oral anticoagulation and dual antiplatelet therapy would be required. Several drug combinations have been tested in recent years, including direct oral anticoagulants, with the aim of balancing ischemic and bleeding risk. Both pharmacokinetic aspects of the molecules and patient's characteristics should be analyzed in choosing oral anticoagulation. Then, as suggested by guidelines, triple therapy should start with a seven-day duration and the aim to prolong to thirty days in high thrombotic risk patients. Dual therapy should follow to reach twelve months after coronary intervention. Even not fully discussed by the guidelines, in order to balance ischemic and bleeding risk it should also be considered: 1) integrated assessment of coronary artery disease and procedural complexity of coronary intervention; 2) appropriateness to maintain the anticoagulant drug dosage indicated in technical data sheet; the lack of data on the suspension of antiplatelet drugs one year after percutaneous intervention; 3) the possibility of combination therapy with ticagrelor; and 4) the need to treat the occurrence of paroxysmal atrial fibrillation during acute coronary syndrome. With data provided clinician should pursue a therapy as personalized as possible, both in terms of drug choice and treatment duration, in order to balance ischemic and bleeding risk.

[ANMCO Position paper: Wearable cardioverter defibrillator appropriate use guidance for the management of patients at high transient risk of sudden cardiac death]. / Position paper ANMCO: Guida all'uso appropriato del defibrillatore indossabile nella pratica clinica per i pazienti ad elevato rischio transitorio di morte improvvisa.

Extended risk stratification and optimal management of patients with a permanently increased risk of sudden cardiac death (SCD) is becoming increasingly important. There are several clinical conditions where the risk of arrhythmic death is present albeit only transient. As an example, patients with depressed left ventricular function have a high risk of SCD that may be only transient when there is a significant recovery of function. It is important to protect the patients while receiving the recommended measures and drugs that may either lead or not to an improved left ventricular function. In several other conditions a transient risk of SCD can be observed even if the left ventricular function is not compromised. Examples are patients with acute myocarditis, during the diagnostic work-up of some arrhythmic conditions or after extraction of infected catheters while eradicating the associated infection. In all these conditions it is important to offer a protection to these patients. The wearable cardioverter-defibrillator (WCD) is of particular importance as a temporary non-invasive technology for both arrhythmia monitoring and therapy in patients with increased risk of SCD. Previous studies have shown the WCD to be an effective and safe therapy for the prevention of SCD caused by ventricular tachycardia/fibrillation. The aim of this ANMCO position paper is to provide a recommendation for clinical utilization of the WCD in Italy, based upon current data and international guidelines. In this document we will review the WCD functionality, indications, clinical evidence as well as guideline recommendations. Finally, a recommendation for the utilization of the WCD in routine clinical practice will be presented, in order to provide physicians with a practical guidance for SCD risk stratification in patients who may benefit from this device.

The impact of UEFA Euro 2020 football championship on Takotsubo Syndrome: Results of a multicenter national registry.

Objectives: The UEFA 2020 European Football Championship held in multiple cities across Europe from June 11 to July 11, 2021, was won by Italy, providing an opportunity to examine the relationship between emotional stress and the incidence of acute cardiovascular events (ACE). Methods and results: Cardiovascular hospitalizations in the Cardiac Care Units of 49 hospital networks in Italy were assessed by emergency physicians during the UEFA Euro 2020 Football Championship. We compared the events that occurred during matches involving Italy with events that occurred during the remaining days of the championship as the control period. ACE was assessed in 1,235 patients. ACE during the UEFA Euro 2020 Football Championship semifinal and final, the most stressful matches ended with penalties and victory of the Italian team, were assessed. A significant increase in the incidence of Takotsubo Syndrome (TTS) by a factor of 11.41 (1.6-495.1, P < 0.003), as compared with the control period, was demonstrated during the semifinal and final, whereas no differences were found in the incidence of ACS [IRR 0.93(0.74-1.18), P = 0.57]. No differences in the incidence of ACS [IRR 0.98 (0.87-1.11; P = 0.80)] or TTS [IRR 1.66(0.80-3.4), P = 0.14] were found in the entire period including all matches of the UEFA Euro 2020 compared to the control period. Conclusions: The data of this national registry demonstrated an association between the semifinal and final of UEFA Euro 2020 and TTS suggesting that it can be triggered by also positive emotions such as the victory in the European Football Championship finals.

[Acute myocarditis in a young adult two days after Pfizer vaccination]. / Miocardite acuta in giovane adulto due giorni dopo vaccino Pfizer.

We report the case of a 20-year-old healthy male who developed acute myopericarditis 2 days after receiving the second dose of the mRNA Pfizer-BioNTech COVID-19 vaccine. The course of the disease was mild and the patient was discharged after a few days of hospitalization.Recently, several case reports involving myopericarditis in patients who received an mRNA vaccine against SARS-CoV-2 have been published and the U.S. Centers for Disease Control and Prevention and the European Medicines Agency pharmacovigilance risk assessment committee are currently investigating an overall increased number of cases. They are also assessing whether there is a higher incidence than expected in vaccinated young adults and teenagers, especially males. Although a clear causal link has not been proven at this time, physicians should be aware of such potential adverse event, taking into account the increasing number of young people that will receive mRNA vaccination over the next few months.

Tako-tsubo cardiomyopathy complicated by ventricular septal perforation and septal dissection.

Tako-tsubo cardiomyopathy is a form of reversible left ventricular dysfunction, with a clinical and electrocardiographic picture of acute myocardial infarction in the absence of significant coronary disease. The precise clinical features and etiologic basis of this syndrome remain unclear, although an association with emotional or stressful triggers has been recognized. We describe the first case of this syndrome complicated with a ventricular septal perforation and dissection.

[HCF-ANMCO/AICPR/GIEC/ITAHFA/SICOA/SICP/SIMG/SIT Cardiological Societies Council Consensus document: Anticoagulant therapy in venous thromboembolism and atrial fibrillation of the patient with cancer. Current knowledge and new evidence]. / Documento di consenso della Consulta delle Società Cardiologiche HCF-ANMCO/AICPR/GIEC/ITAHFA/SICOA/SICP/SIMG/SIT: La terapia anticoagulante nel tromboembolismo venoso e nella fibrillazione atriale del paziente con cancro. Le attuali conoscenze e le nuove evidenze.

Venous thromboembolism (VTE), including pulmonary embolism and deep venous thrombosis, either symptomatic or incidental, is a common complication in the history of cancer disease. The risk of VTE is 4-7-fold higher in oncology patients, and it represents the second leading cause of death, after cancer itself. In cancer patients, compared with the general population, VTE therapy is associated with higher rates of recurrent thrombosis and/or major bleeding. The need for treatment of VTE in patients with cancer is a challenge for the clinician because of the multiplicity of types of cancer, the disease stage and the imbricated cancer treatment. Historically, in cancer patients, low molecular weight heparins have been preferred for treatment of VTE. More recently, in large randomized clinical trials, direct oral anticoagulants (DOACs) demonstrated to reduce the risk of VTE. However, in the "real life", uncertainties remain on the use of DOACs, especially for the bleeding risk in patients with gastrointestinal cancers and the potential drug-to-drug interactions with specific anticancer therapies.In cancer patients, atrial fibrillation can arise as a perioperative complication or for the side effect of some chemotherapy agents, as well as a consequence of some associated risk factors, including cancer itself. The current clinical scores for predicting thrombotic events (CHA2DS2-VASc) or for predicting bleeding (HAS-BLED), used to guide antithrombotic therapy in the general population, have not yet been validated in cancer patients. Encouraging data for DOAC prescription in patients with atrial fibrillation and cancer are emerging: recent post-hoc analysis showed safety and efficacy of DOACs for the prevention of embolic events compared to warfarin in cancer patients. Currently, anticoagulant therapy of cancer patients should be individualized with multidisciplinary follow-up and frequent reassessment. This consensus document represents an advanced state of the art on the subject and provides useful notes on clinical practice.

Circulating biomarkers and cardiac function over 3 years after chemotherapy with anthracyclines: the ICOS-ONE trial.

AIMS: A multicentre trial, ICOS-ONE, showed increases above the upper limit of normality of cardiac troponin (cTn) in 27% of patients within 12 months after the end of cancer chemotherapy (CT) with anthracyclines, whether cardiac protection with enalapril was started at study entry in all (prevention arm) or only upon first occurrence on supra-normal cTn (troponin-triggered arm). The aims of the present post hoc analysis were (i) to assess whether anthracycline-based treatment could induce cardiotoxicity over 36 month follow-up and (ii) to describe the time course of three cardiovascular biomarkers (i.e. troponin I cTnI-Ultra, B-type natriuretic peptide BNP, and pentraxin 3 PTX3) and of left ventricular (LV) function up to 36 months. METHODS AND RESULTS: Eligible patients were those prescribed first-in-life CT, without evidence of cardiovascular disease, normal cTn, LV ejection fraction (EF) >50%, not on renin-angiotensin aldosterone system antagonists. Patients underwent echocardiography and blood sampling at 24 and 36 months. No differences were observed in biomarker concentration between the two study arms, 'prevention' vs. 'troponin-triggered'. During additional follow-up 13 more deaths occurred, leading to a total of 23 (9.5%), all due to a non-cardiovascular cause. No new occurrences of LV-dysfunction were reported. Two additional patients were admitted to the hospital for cardiovascular causes, both for acute pulmonary embolism. No first onset of raised cTnI-Ultra was reported in the extended follow-up. BNP remained within normal range: at 36 months was 23.4 ng/L, higher (N.S.) than at baseline, 17.6 ng/L. PTX3 peaked at 5.2 ng/mL 1 month after CT and returned to baseline values thereafter. cTnI-Ultra peaked at 26 ng/L 1 month after CT and returned to 3 ng/L until the last measurement at 36 months. All echocardiographic variables remained stable during follow-up with a median LVEF of 63% and left atrial volume index about 24 mL/m2 . CONCLUSIONS: First-in-life CT with median cumulative dose of anthracyclines of 180 mg/m2 does not seem to cause clinically significant cardiac injury, as assessed by circulating biomarkers and echocardiography, in patients aged 51 years (median), without pre-existing cardiac disease. This may suggest either a 100% efficacy of enalapril (given as preventive or troponin-triggered) or a reassuringly low absolute cardiovascular risk in this cohort of patients, which may not require intensive cardiologic follow-up.

Scheduled intermittent inotropes for Ambulatory Advanced Heart Failure. The RELEVANT-HF multicentre collaboration.

BACKGROUND: Ambulatory Advanced Heart Failure (AAHF) is characterized by recurrent HF hospitalizations, escalating diuretic requirements, intolerance to neurohormonal antagonists, end-organ dysfunction, short-term reduced life expectancy despite optimal medical management (OMM). The role of intermittent inotropes in AAHF is unclear. The RELEVANT-HF registry was designed to obtain insight on the effectiveness and safety of compassionate scheduled repetitive 24-hour levosimendan infusions (LEVO) in AAHF patients. METHODS: 185 AAHF NYHA class III-IV patients, with ≥2 HF hospitalizations/emergency visits in the previous 6 months and systolic dysfunction, were treated with LEVO at tailored doses (0.05-0.2 µg/kg/min) without prior bolus every 3-4 weeks. We compared data on HF hospitalizations (percent days spent in hospital, DIH) in the 6 months before and after treatment start. RESULTS: Infusion-related adverse events occurred in 23 (12.4%) patients the commonest being ventricular arrhythmias (16, 8.6%). During follow-up, 37 patients (20%) required for clinical instability treatment adjustments (decreases in infusion dose, rate of infusion or interval). From the 6 months before to the 6 months after treatment start we found lower DIH (9.4 (8.2) % vs 2.8 (6.6) %, p < 0.0001), cumulative number (1.3 (0.6) vs 1.8 (0.8), p = 0.0001) and length of HF admissions (17.4 (15.6) vs 21.6 (13.4) days, p = 0.0001). One-year survival was 86% overall and 78% free from death/LVAD/urgent transplant. CONCLUSIONS: In AAHF patients, who remain symptomatic despite OMM, LEVO is well tolerated and associated with lower overall length of hospital stay during six months. This multicentre clinical experience underscores the need for a randomized controlled trial of LEVO impact on outcomes in AAHF patients.

Anthracycline-induced cardiotoxicity: A multicenter randomised trial comparing two strategies for guiding prevention with enalapril: The International CardioOncology Society-one trial.

BACKGROUND: Troponin changes over time have been suggested to allow for an early diagnosis of cardiac injury ensuing cancer chemotherapy; cancer patients with troponin elevation may benefit of therapy with enalapril. It is unknown whether a preventive treatment with enalapril may further increase the benefit. METHODS: The International CardioOncology Society-one trial (ICOS-ONE) was a controlled, open-label trial conducted in 21 Italian hospitals. Patients were randomly assigned to two strategies: enalapril in all patients started before chemotherapy (CT; 'prevention' arm), and enalapril started only in patients with an increase in troponin during or after CT ('troponin-triggered' arm). Troponin was assayed locally in 2596 blood samples, before and after each anthracycline-containing CT cycle and at each study visit; electrocardiogram and echocardiogram were done at baseline, and at 1, 3, 6 and 12-month follow-up. Primary outcome was the incidence of troponin elevation above the threshold. FINDINGS: Of the 273 patients, 88% were women, mean age 51 ± 12 years. The majority (76%) had breast cancer, 3% had a history of hypertension and 4% were diabetic. Epirubicin and doxorubicin were most commonly prescribed, with median cumulative doses of 360 [270-360] and 240 [240-240] mg/m2, respectively. The incidence of troponin elevation was 23% in the prevention and 26% in the troponin-triggered group (p = 0.50). Three patients (1.1%) -two in the prevention, one in the troponin-triggered group-developed cardiotoxicity, defined as 10% point reduction of LV ejection fraction, with values lower than 50%. INTERPRETATION: Low cumulative doses of anthracyclines in adult patients with low cardiovascular risk can raise troponins, without differences between the two strategies of giving enalapril. Considering a benefit of enalapril in the prevention of LV dysfunction, a troponin-triggered strategy may be more convenient.

[Management of outpatients with cardiac disease: follow-up timing and modalities]. / Gestione ambulatoriale del paziente di interesse cardiologico: ruolo del medico di medicina generale e del cardiologo, tra sostenibilità ed appropriatezza.

The increasing rate of cardiovascular diseases, the improved survival after the acute phase, the aging of the population and the implementation of primary prevention caused an exponential increase in outpatient cardiac performance, thereby making it difficult to maintain a balance between the citizen-patient request and the economic sustainability of the healthcare system. On the other side, the prescription of many diagnostic tests with a view to defensive medicine and the related growth of patients' expectations, has led several scientific societies to educational campaigns highlighting the concept that "less is more".The present document is aimed at providing the general practitioner with practical information about a prompt diagnosis of signs/symptoms (angina, dyspnea, palpitations, syncope) of the major cardiovascular diseases. It will also provide an overview about appropriate use of diagnostic exams (echocardiogram, stress test), about the appropriate timing of their execution, in order to ensure effectiveness, efficiency, and equity of the health system.

[Tolerability and efficacy of aldosterone inhibition with canrenone in heart failure: the real-world experience of an outpatient heart failure clinic]. / Tollerabilità ed efficacia dell'inibizione aldosteronica con canrenone nello scompenso cardiaco: l'esperienza nel mondo reale di un ambulatorio dedicato.

BACKGROUND: The aim of this study was to evaluate retrospectively the tolerability, safety and efficacy of antialdosterone therapy in patients with heart failure admitted to our ambulatory from June 1995 to September 2003. METHODS: One hundred and fifty-seven consecutive patients (mean age 64 +/- 11.6 years) were enrolled in the study; they were in NYHA class I-IV, on ACE-inhibitor or angiotensin receptor blocker therapy, and were treated with canrenone if they were in NYHA class I-IV having experienced a previous cardiac event and did not show asymptomatic left ventricular dysfunction or creatinine levels at baseline > or = 2.5 mg/dl, hyperkalemia > or = 5.2 mEq/l, and poor compliance. The mean follow-up was 38.7 +/- 21.2 months. Patients were divided into two groups according to either therapy (group 1: 124 patients, 79%, on antialdosterone therapy; group 2: 33 patients, 21%, on no antialdosterone therapy) or ischemic and non-ischemic etiology (group A: 71 patients, 45.2%, and group B: 86 patients, 54.8%, respectively). Serum creatinine and plasma potassium levels, left ventricular ejection fraction, NYHA class, adverse effects, and mortality were evaluated. RESULTS: The mean dose of canrenone was 37 +/- 19.9 mg/day. Creatinine levels did not change significantly whereas potassium levels slightly increased in group 1 vs group 2 (p < 0.01) and in group A vs group B (p < 0.01). Treatment was discontinued by only 12 patients (8.1%) due to hyperkalemia in 8 cases (6.5%), gynecomastia in 2 cases (1.6%), urticaria in 1 case (0.8%), and nausea in 1 case (0.8%). Left ventricular ejection fraction increased in all groups (p < 0.001) with the exception of the subgroup B/group 2 (p = NS). The NYHA class improved significantly in group 1 (p < 0.01). The total mortality rate was 10.8% (17 cases), of which 10.5% (13 cases) in group 1 and 12.1% (4 cases) in group 2 and due to sudden death in 3 group 1 patients (2.4%) and in 2 group 2 patients (6%). CONCLUSIONS: This study shows a good tolerability, safety, and efficacy, and poor adverse effects of canrenone therapy in combination with ACE-inhibitors, angiotensin receptor blockers and beta-blockers in patients with chronic heart failure. Therapy should be monitored by serial clinical and laboratory controls and gradually titrated up to the maximal tolerated dosage.