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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.

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.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.Twenty patients of a mean age of 67 ± 15 years, BNP at entry 1348 ± 1198 pg/ml were enrolled. Despite a clinical stabilization, after 48-72 h from admission, HR was persistently70 bpm. Ivabradine was well tolerated in all patients with a significant increase in RR interval from 747 ± 69 ms at baseline to 948 ± 121 ms at discharge, P 0.0001. Change in HR was associated with a significant increase in stroke volume (baseline 73 ± 22 vs. 84 ± 19 ml at discharge, P = 0.03), and reduction in left cardiac work index (baseline 3.6 ± 1.2 vs. 3.1 ± 1.1 kg/m2 at discharge, P = 0.04). Other measures of heart work were also significantly affected while cardiac output remained unchanged.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.

Background: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromboembolic events without substantially increasing bleeding. We explored the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). Methods: We randomized 1601 patients with recent acute MI to oral asundexian 10, 20, or 50 mg or placebo once daily for 6 to 12 months in a double-blind, placebo-controlled, phase 2, dose-ranging trial. Patients were randomized within 5 days of their qualifying MI and received dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor. The effect of asundexian on FXIa inhibition was assessed at 4 weeks. The prespecified main safety outcome was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding comparing all pooled asundexian doses with placebo. The prespecified efficacy outcome was a composite of cardiovascular death, MI, stroke, or stent thrombosis comparing pooled asundexian 20 and 50 mg doses with placebo. Results: The median age was 68 years, 23% of participants were women, 51% had ST-segment–elevation MI, 80% were treated with aspirin plus ticagrelor or prasugrel, and 99% underwent percutaneous coronary intervention before randomization. Asundexian caused dose-related inhibition of FXIa activity, with 50 mg resulting in >90% inhibition. Over a median follow-up of 368 days, the main safety outcome occurred in 30 (7.6%), 32 (8.1%), 42 (10.5%), and 36 (9.0%) patients receiving asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian versus placebo: hazard ratio, 0.98 [90% CI, 0.71–1.35]). The efficacy outcome occurred in 27 (6.8%), 24 (6.0%), 22 (5.5%), and 22 (5.5%) patients assigned asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian 20 and 50 mg versus placebo: hazard ratio, 1.05 [90% CI, 0.69–1.61]). Conclusions: In patients with recent acute MI, 3 doses of asundexian, when added to aspirin plus a P2Y12 inhibitor, resulted in dose-dependent, near-complete inhibition of FXIa activity without a significant increase in bleeding and a low rate of ischemic events. These data support the investigation of asundexian at a dose of 50 mg daily in an adequately powered clinical trial of patients who experienced acute MI. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04304534; URL: https://www.clinicaltrialsregister.eu/ctr-search/search ; Unique identifier: 2019-003244-79.

Background MessengerRNA (mRNA) COVID-19 vaccination has been associated with a higher-than-expected occurrence of acute myocarditis. Scarce information is available on mid-term prognosis and changes in cardiac function, volumes, and tissue characterization on cardiac magnetic resonance (CMR). Methods Retrospective, multicenter study including patients with a definite diagnosis of acute myocarditis within 30 days from mRNA COVID-19 vaccination, with a confirmed myocarditis diagnosis based on endomyocardial biopsy (EMB) or autopsy or by the coexistence of positive biomarkers (troponin >99th upper reference limit or elevated creatine kinase myocardial band [CK-MB]) and cardiac MRI findings consistent with AM according to the 2018 updated Lake Louise Criteria. Results 77 patients (median age 25 years [IQR 20-35], 15% female) were included and followed-up for 147 days [IQR 74-215]. Follow-up CMR was available in n=49 patients and showed no changes in biventricular ejection fraction (EF) as compared to CMR at diagnosis (left ventricular EF: 59%[55-65]vs. 60%[57-64], p=0.507, right ventricular EF: 56%[52-62]vs. 57%[52-61], p=0.563, respectively). Late gadolinium enhancement was present in all patients at diagnosis and persisted in only n=39 (79.6%) at follow-up (p=0.001), generally sparing the anterior wall and the septum. N=10 (20.4%) had a persistent edema based on T2-weighted short tau inversion recovery (STIR) sequences, with predominant involvement of inferior or inferior-lateral walls. The proportion of patients with increased T1 and T2 mapping signals significantly decreased at follow-up (n=13 (68%) vs. n=4 (13%),p No differences in morpho-functional CMR parameters based on the type of vaccine administered were found (BNT162b2 Pfizer/BioNTech®, n=36, 73.5%, m-RNA-1273 Moderna®, n=13, 26.5%). Among patients with available follow-up (N=75, 97.4%), no major adverse cardiovascular events nor myocarditis recurrence or death were reported. Conclusions At mid-term follow-up, patients who experienced an acute myocarditis after a mRNA COVID-19 vaccine had preserved biventricular EF. The rate and localization of residual scar or edema on CMR is in line with classic viral myocarditis with a good prognosis. This new piece of information should further reassure patients who experience acute myocarditis after mRNA COVID-19 vaccination.

Background Elderly >80 years represent the most rapidly expanding population segment in Europe. Chronic heart failure (CHF) affects over 10% of this group and generates a major M&M burden. We analyzed the temporal trends in characteristics, therapy and outcomes over two decades in octogenarians enrolled in our nationwide registry. Methods According to the recruitment epoch, among 14.283 CHF patients first enrolled in the registry since 1–1999 through 5–2018, we divided those aged 80+ (2520,17.6%) into 3 cohorts: 1999–2005 (547, 10%); 2006–2011 (659, 16.5%); 2012–2018 (1314, 14.1%). We analyzed trends over time in characteristics, therapy, 1-year all-cause mortality and proportion admitted to hospital. Results From 1999 to 2018 the proportion of 80+ CHF patients (60% men, 84±3 years, LVEF 41±1%, HFrEF 49%) rose from 10% to 24%. Across the 3 epochs (Table 1) we observed a shift towards the HFpEF phenotype with an increase in its driving factors (obesity, diabetes, hypertension, AFib). At the same time, the proportion treated with recommended therapies rose. Cumulative 1-year mortality did not differ across the 3 epochs (Fig.1 top), whereas the proportion of 80+ hospitalized overall, for CV causes and for decompensated HF, declined (Fig. 1 bottom). Conclusions During 20 years, the clinical characteristics of octogenarians enrolled in a nationwide CHF registry have deeply changed, reflecting demographic variations, the evolution of CV risk factors and improved management. There was a consistent implementation of BB, MRA and devices. Survival of 80+ remained stable, but the proportion of those hospitalized for CV causes, and specifically decompensated HF, declined. These data suggest that cardiologists' input may contribute to decrease the socioeconomic burden of CHF in the elderly. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Fondazione per il Tuo cuore – Heart Care Foundation (HCF) ONLUS

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.

Aims: A multicentre trial, ICOS-ONE, showed increases above the upper limit of normality of cardiac troponin (cTn) in 27% of patients within 12months 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 36month 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 36months. 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 36months. 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 36months was 23.4ng/L, higher (N.S.) than at baseline, 17.6ng/L. PTX3 peaked at 5.2ng/mL 1month after CT and returned to baseline values thereafter. cTnI-Ultra peaked at 26ng/L 1month after CT and returned to 3ng/L until the last measurement at 36months. All echocardiographic variables remained stable during follow-up with a median LVEF of 63% and left atrial volume index about 24mL/m2. Conclusions: First-in-life CT with median cumulative dose of anthracyclines of 180mg/m2 does not seem to cause clinically significant cardiac injury, as assessed by circulating biomarkers and echocardiography, in patients aged 51years (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.

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.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.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.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.

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.

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 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.

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.

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.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 baselineor = 2.5 mg/dl, hyperkalemiaor = 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.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 (p0.01) and in group A vs group B (p0.01). 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 (p0.001) with the exception of the subgroup B/group 2 (p = NS). The NYHA class improved significantly in group 1 (p0.01). 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%).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.