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Aims Myotonic dystrophy type 1 (DM1) predisposes to the development of life-threatening arrhythmias and sudden cardiac death. Our study aimed to evaluate the prognostic value of programmed ventricular stimulation (PVS) in DM1 patients with conduction system disease. Methods and results Arrhythmic CArdiac DEath in MYotonic dystrophy type 1 patients (ACADEMY 1) is a double-arm non-randomized interventional prospective study. Myotonic dystrophy type 1 patients with permanent cardiac pacing indication were eligible for the inclusion. The study population underwent to pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation according to the inducibility of ventricular tachyarrhythmias at PVS. Primary endpoint of the study was a composite of appropriate ICD therapy and cardiac arrhythmic death. The secondary study endpoint was all-cause mortality. Seventy-two adult-onset DM1 patients (51 ± 12 years; 39 male) were enrolled in the study. A ventricular tachyarrhythmia was induced in 25 patients (34.7%) at PVS (PVS+) who underwent dual chambers ICD implantation. The remaining 47 patients (65.3%) without inducible ventricular tachyarrhythmia (PVS−) were treated with dual-chamber PM. During an average observation period of 44.7 ± 10.2 months, nine patients (12.5%) met the primary endpoint, four in the ICD group (16%) and five (10.6%) in the PM group. Thirteen patients died (18.5%), 2 in the ICD group (8%) and 11 in PM group (23.4%). The Kaplan–Meier analysis did not show a significantly different risk of both primary and secondary endpoint event rates between the two groups. Conclusions The inducibility of ventricular tachyarrhythmias has shown a limited value in the arrhythmic risk stratification among DM1 patients.

Standard therapy for venous thromboembolism (VTE) includes the use of heparins and vitamin K antagonists. Randomized clinical trials have shown that non-vitamin K oral anticoagulants are as effective and safe as standard therapy in VTE treatment, with an improved pharmacological profile. Edoxaban, a direct inhibitor of factor Xa, has demonstrated noninferiority to standard therapy for the treatment of VTE, preserving a high safety profile even in long-term therapy, in frail patients and in severe clinical presentations. The present paper focuses on the role of edoxaban in VTE treatment, from general population to cancer patients, presenting the available data from randomized clinical trials and real world, to discuss edoxaban use in clinical practice.Lay abstractAnticoagulants are the main treatment for venous thromboembolism (VTE), a condition in which a blood clot forms in the deep veins of the body, in areas such as the leg. Currently, direct oral anticoagulants are available as an alternative to warfarin, a drug that is sensitive to changes in the diet and requires constant monitoring. Direct-oral anticoagulants have been shown in large-scale studies to be as effective and safe as warfarin in the treatment of this disease, with the advantage of not being affected by the food the patient eats. Among these, edoxaban only needs to be taken once a day and has obtained many favorable results in high-risk populations (such as the elderly, patients with cancer, those receiving prolonged treatment or those with severe VTE). In this review we discuss the role of edoxaban for the treatment of VTE in several scenarios and review its role in clinical practice.Tweetable abstractEdoxaban is effective and safe for the treatment of venous thromboembolism (VTE) even in special population. Caution is needed in some patients to avoid major bleeding events. Favorable results are also shown in the ETNA VTE study, a real-world data prospective registry. #edoxaban #VTE #efficacy #safety

Purpose The purpose of the present study was to compare the long-term effectiveness and safety of newly initiated anticoagulation with edoxaban (EDO) versus uninterrupted vitamin K antagonist (VKA) therapy in patients with atrial fibrillation (AF) scheduled for transesophageal echocardiogram (TEE)-guided direct electrical current cardioversion (DCC). Methods A propensity score-matched cohort observational study was performed comparing the safety and effectiveness of edoxaban versus well-controlled VKA therapy among a cohort of consecutive non-valvular AF patients scheduled for DCC. The primary safety outcome was major bleeding. The primary efficacy outcome was the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). Findings A total of 130 AF patients receiving edoxaban 60-mg (EDO) treatment were compared with the same number of VKA recipients. The cumulative incidence of major bleedings was 1.54% in the EDO group and 3.08% in the VKA group (P = 0.4). The cumulative incidence of thromboembolic events was 1.54% in the EDO group and 2.31% in the VKA group (P = 0.9). A non-significant trend in improved adherence was observed between the EDO and VKA groups with a total anticoagulant therapy discontinuation rate of 4.62% (6/130) vs 6.15% (8/130), respectively (P = 0.06). Implications Our study provides the evidence of a safe and effective use of edoxaban in this clinical setting, justified by no significant difference in major bleedings and thromboembolic events between edoxaban and well-controlled VKA treatments.

Although radiofrequency (RF) catheter ablation of cavo-tricuspid isthmus (CTI) is an established treatment for typical right atrial flutter (RAFL), it remains to be established whether local tissue impedance (LI) is able to predict effective CTI ablation and what LI drop values during ablation should be used to judge a lesion as effective. We aimed to investigate the ability of LI to predict ablation efficacy in patients with RAFL.RF delivery was guided by the DirectSense™ algorithm. Successful single RF application was defined according to a defragmentation of atrial potentials (DAP), reduction of voltage (RedV) by at least 80% or changes on unipolar electrogram (UPC). The ablation endpoint was the creation of bidirectional conduction block (BDB) across the isthmus.392 point-by-point RF applications were analyzed in 48 consecutive RAFL patients. The mean baseline LI was 105.4 ± 12Ω prior to ablation and 92.0 ± 11Ω after ablation (p 0.0001). According to validation criteria, absolute drops in impedance were larger at successful ablation sites than at ineffective ablation sites (DAP: 17.8 ± 6Ω vs. 8.7 ± 4Ω; RedV: 17.2 ± 6Ω vs. 7.8 ± 5Ω; UPC: 19.6 ± 6Ω vs. 10.1 ± 5Ω, all p 0.0001). LI drop values significantly increased according to the number of criteria satisfied (ranging from 7.5Ω to 19.9). BDB was obtained in all cases. No procedure-related adverse events were reported.A LI-guided approach to CTI ablation was safe and effective in treating RAFL. The magnitude of LI drop was associated with effective lesion formation and BDB and could be used as a marker of ablation efficacy.Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/ Identifier: NCT03793998.

Aims The aim of our study was to evaluate the prevalence and clinical predictors of cardioinhibitory (CI) responses with asystole at the nitroglycerin (NTG)-potentiated head-up tilt test (HUTT) in patients with a history of syncope admitted to a tertiary referral syncope unit. Methods We retrospectively evaluated all consecutive patients who underwent NTG-potentiated HUTT for suspected reflex syncope at our institution from March 1 2017 to May 1 2020. The prevalence of HUTT-induced CI syncope was assessed. Univariate and multivariate analyses were performed to test the association of asystolic response to HUTT with a set of clinical covariates. Results We enrolled 1285 patients (45 ± 19.1 years; 49.6% male); 368 (28.6%) showed HUTT-induced CI response with asystole. A multivariate analysis revealed that the following factors were independently associated with HUTT-induced CI syncope: male sex (OR 1.48; ConInt 1.14–1.92; P = 0.003), smoking (OR 2.22; ConInt 1.56–3.115; P P P = 0.002), and the use of diuretics (OR 9.94; ConInt 3.83–25.76; P Conclusions The cardioinhibitory syncope with asystole induced by NTG-potentiated HUTT is more frequent than previously reported. The male gender, smoking habit, history of traumatic syncope, and use of diuretics were independent predictors of HUTT-induced CI responses. Conversely, the history of situational syncope seems to reduce this probability.

Background Air entrapment has been recently described as a cause of inappropriate shock (IAS) among patients who underwent subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation. Data about this complication are lacking in the literature. Methods In this meta-summary 14 case reports describing IAS due to air entrapment were included. Patients' characteristics, S-ICD implant technique and air entrapment properties were collected. Results All patients experienced IAS within 4 days following S-ICD implant. The subcutaneous air was demonstrated by chest x-ray in 11 cases (73.3%). The sensing vector was reprogrammed in 11 cases (73.3%), and ICD was switched off in 2 cases (1.3%). Conclusions IAS due to air entrapment is an early complication of S-ICD implant. No association was observed between the implant technique and air retention. Diagnosis is confirmed by chest x-ray and device interrogation. Management includes switching off the device or, preferably, changing the sensing vector.

Purpose The use of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) and bioprosthetic heart valve is still controversial. The aim of this study was to compare the tolerability and effectiveness of treatment with DOACs versus vitamin K antagonists (VKAs) in patients with AF and a bioprosthetic heart valve in clinical practice. Methods Data for this study were sourced from the multicenter, prospectively maintained AF Research Database (NCT03760874), which includes all patients with AF undergoing follow-up at participating centers through outpatient visits every 3–6 months. The rates of occurrence of thromboembolic events (ischemic stroke, transient ischemic attack, systemic embolism), major bleed, and intracranial hemorrhage (ICH) were assessed. These data were used for quantifying the net clinical benefit (NCB) of DOACs versus VKAs, in accordance with the following formula: (Thromboembolic events incidence rate with VKAs – Thromboembolic events incidence rate with DOACs) – Weighting factor × (ICH rate with DOACs – ICH incidence rate with VKAs). The database was retrospectively queried for patients with AF who were prescribed a DOAC or VKA and had a history of bioprosthetic heart valve replacement. Findings A total of 434 patients with AF (DOACs, n = 211; VKAs, n = 223) were identified. Propensity score matching identified 130 patients prescribed DOACs (apixaban, 55.4%; rivaroxaban, 30.0%; dabigatran, 13.1%; edoxaban, 1.4%) and the same number of VKA recipients (warfarin, 89.2%; acenocoumarol, 10.8%). The mean (SD) duration of follow-up was 26.8 (2.3) months. The incidence rates of thromboembolic events were 1.3 per 100 person-years in the DOAC group versus 2.0 per 100 person-years in the VKA group (P = 0.14). The incidence rates of major bleed events were 2.6 per 100 person-years in the DOAC group versus 4.9 per 100 person-years in the VKA group (P = 0.47). The incidence rates of ICH were 0.38 per 100 person-years in the DOAC group versus 1.16 in the VKA group (hazard ratio = 0.33; 95% CI, 0.05–2.34; P = 0.3). A positive NCB of DOACs over VKAs of +1.87 was found. Implications According to these data from clinical practice, DOACs seem to be associated with a greater NCB versus VKAs in patients with AF with a bioprosthetic heart valve, primarily due to lower rates of both major bleeds and thromboembolic events.

Introduction:Little is known about the clinical performance of single-chamber leadless pacemaker (LLPM) in patients without atrial fibrillation (AF) as pacing indication. The aim of this study was to describe the clinical characteristics of patients who underwent single chamber LLPM implantation at three tertiary referral centers and to compare the safety and effectiveness of the single-chamber LLPM among patients with or without AF.Materials and Methods:All the consecutive patients who underwent LLPM implantation at three referral centers were analyzed. The indications to LLPM in a real-world setting were described. The study population was divided into two groups according to AF as pacing indication. We assessed the procedure-related complications; moreover, we compared syncope, cardiac hospitalization, pacemaker syndrome, and all-cause death recurrence during the follow-up between patients with and without AF as pacing indication.Results:A total of 140 consecutive patients (mean age, 76.7 ± 11.24 years, men 64.3%) were included in the study. The indication to implantation of LLPM was permanent AF with slow ventricular response (n: 67; 47.8%), sinus node dysfunction (n: 25; 17.8%), third atrioventricular block (AVB) (n: 20; 14.2%), second-degree AVB (n: 18; 12.8%), and first degree AVB (n: 10; 7.1%). A total of 7 patients (5%) experienced perioperative complications with no differences between the AF vs. non-AF groups. During a mean follow-up of 606.5 ± 265.9 days, 10 patients (7.7%) died and 7 patients (5.4%) were reported for cardiac hospitalization; 5 patients (3.8%) experienced syncope; no patients showed pacemaker syndrome. No significant differences in the clinical events between the groups were shown. The Kaplan–Meier analysis for the combined endpoints did not show significant differences between the AF and non-AF groups [hazard ratio (HR): 0.94, 95% CI: 0.41–2.16; p = 0.88].Conclusion:Our real-world data suggest that LLPM may be considered a safe and reasonable treatment in patients without AF in need of pacing. Further studies are needed to confirm these preliminary results.

BACKGROUND: Aim of our study was to assess the association between COVID-19 lockdown and cardiac pacing (CP) procedures rates in Campania Region, the third-most-populous region of Italy with about 5.8 million residents. METHODS: Data about type of CP procedures and unit admissions were obtained from 14 CP centers throughout Campania region from March 10th and May 4Th 2020 and compared with the same time frame in 2019. RESULTS: A remarkable reduction in both temporary (reduction rate: -62.5%), definitive pace maker (reduction rate: -30.2%), ICD (reduction rate: -48.3%) and CRT (reduction rate: -48.4%) implantation and in CRT replacement (reduction rate: -88.8%) procedures has been shown between the two observation periods among 951 hospitalized patients. Planned hospitalizations showed a reduction rate of 69.3%. Conversely, urgent intra-hospital admissions (increase rate +430%; P 

Anna Rago,1 Enrica Pezzullo,1 Marco Malvezzi Caracciolo d’Aquino,1 Gabriella Scognamiglio,1 Valentina Maria Caso,2 Francesco Martone,3 Emilio Attena,4 Valentina Parisi,5 Antonio D’Onofrio,4 Paolo Golino,1 Gerardo Nigro,1 Vincenzo Russo1 1Department of Cardiology, Monaldi Hospital, Naples, Italy; 2Department of Medical Translational Sciences, University of the Study of Campania “Luigi Vanvitelli”, Naples, Italy; 3Clinical Biochemistry Unit, Monaldi Hospital, Naples, Italy; 4Departmental Unit of Electrophysiology, Monaldi Hospital, Naples, Italy; 5Department of Translational Medical Sciences, University of Naples Federico II, Naples, ItalyCorrespondence: Vincenzo RussoDepartment of Medical Transalational Sciences, University of Campania - Monaldi Hospital, Via Leonardo Bianchi, Naples, 80131, ItalyFax +39-0817587482Email v.p.russo@libero.itAim: The aim of the present study was to assess the safety and effectiveness of non-vitamin K antagonist oral anticoagulants (NOACs) versus vitamin K antagonists (VKAs) in atrial fibrillation (AF) patients undergoing electrical cardioversion (EC).Methods: A propensity score-matched analysis was performed in order to identify two homogeneous groups including AF patients on NOACs and VKAs treatment scheduled for EC. The primary safety endpoint was major bleeding. The composite of stroke, transient ischemic attack (TIA) and systemic embolism (SE) was the primary effectiveness endpoint. The discontinuation rate of anticoagulant therapy was assessed.Results: A total of 495 AF patients on NOACs therapy and scheduled for EC were compared to 495 VKAs recipients. No statistically significant differences in the incidence of both major bleeding (1.01% versus 1.4%; P= 0.5) and thromboembolic events (0.6% versus 0.8%; P= 0.7) were observed during a mean follow-up of 15 ± 3 months. The discontinuation rate of NOACs was significantly lower compared to VKAs (1.6% versus 3.6%, P=0.04).Conclusion: We showed a safe and effective clinical profile of NOACs among AF patients scheduled for electrical cardioversion in real-life setting. Patients on NOACs therapy showed a lower discontinuation rate compared to those on VKAs.Keywords: atrial fibrillation, electrical cardioversion, transesophageal echocardiogram, non-vitamin K antagonist oral anticoagulants, discontinuation rate, vitamin K antagonists

Beta-thalassemias are a group of inherited, autosomal recessive diseases, characterized by reduced or absent synthesis of beta-globin chains of the hemoglobin tetramer, resulting in variable phenotypes, ranging from clinically asymptomatic individuals to severe anemia. Three main forms have been described: heterozygotes, homozygotes β+, and homozygotes β°. Beta-thalassemia major (β-TM), the most serious form, is characterized by an absent synthesis of globin chains that are essential for hemoglobin formation, causing chronic hemolytic anemia. Cardiac complications represent a leading cause of mortality in β-TM patients, although an important and progressive increase of life expectancy has been demonstrated after the introduction of chelating therapies. Iron overload is the primary factor of cardiac damage resulting in thalassemic cardiomyopathy, in which diastolic dysfunction usually happens before systolic impairment and overt heart failure (HF). Although iron-induced cardiomyopathy is slowly progressive and it usually takes several decades for clinical and laboratory features of cardiac dysfunction to manifest, arrhythmias or sudden death may be present without signs of cardiac disease and only if myocardial siderosis is present. Careful analysis of electrocardiograms and other diagnostic tools may help in early identification of high-risk β-TM patients for arrhythmias and sudden cardiac death.

Introduction: Atrial fibrillation (AF) is associated with an increased risk of thromboembolic events. Objectives: This study compared the long-term efficacy and safety of apixaban with that of uninterrupted vitamin K antagonist (VKA) therapy in patients with AF scheduled for transesophageal echocardiogram (TEE)-guided direct current cardioversion (DCC) from June 2014 to September 2016. Methods: We enrolled consecutive patients with persistent nonvalvular AF scheduled to undergo DCC. Patients received apixaban 5 mg or 2.5 mg twice daily (bid) or VKA at therapeutic doses for at least 3 weeks before and 4 weeks after DCC. All patients underwent anamnestic, clinical, electrocardiographic, and echocardiographic evaluation at each follow-up visit and were followed-up for 12 months. The primary efficacy endpoint was the composite of stroke/transient ischemic attack and systemic embolism. The primary safety endpoint was major bleeding. Results: After propensity score matching, comparative treatment groups comprised 182 (75.8%) patients receiving apixaban 5 mg bid and 182 receiving VKA. A low incidence of atrial thrombus (0.5%) at TEE was found in both groups. The acute cardioversion success rate was 86.1% in the apixaban group (156/181) and 83.9% in the VKA group (152/181). During the follow-up period, a similarly low incidence of thromboembolic events (1.1%) was reported in both groups; the bleeding safety profile tended to favor apixaban over VKA (1.1 vs. 1.6%; p = 0.3). Conclusions: Newly initiated anticoagulation with apixaban in patients with nonvalvular AF scheduled for TEE-guided DCC seems to be as effective and safe as uninterrupted VKA therapy during 12 months of follow-up.

INTRODUCTION Implantable cardioverter-defibrillator (ICD) alarm systems are an important means of monitoring device functioning. The aim of this study was to compare the ability of patients with sense two types of device alert systems: an audible alert and a vibratory alarm. METHODS The ability to recognize the alarms was assessed in three alarm tests performed in a series of consecutive ICD patients enrolled during routine outpatient device follow-up. To avoid overestimating the rate of patients able to sense the alarm, the first test was performed without forewarning. Subsequently, the second test was performed after the patients had been forewarned. Finally, to assess the learning effect of a demonstration test, a third test was performed, again without forewarning. RESULTS A total of 528 patients (65.4 ± 14.4 years, 74.6% male) were enrolled: 347 (65.7%) with an audible alert-endowed device and 181 (34.3%) with a vibratory alarm-endowed device. When emitted without warning, the alarms were sensed by 72.4% of patients. When patients were forewarned, the probability of sensing the alarms rose to 92.5% (P

Aims Following coronavirus disease (COVID-19) outbreak, the Italian government adopted strict rules of lockdown and social distancing. The aim of our study was to assess the admission rate for cardiac implantable electronic devices (CIEDs) replacement procedures in Campania, the 3rd-most-populous region of Italy, during COVID-19 lockdown. Methods and results Data were sourced from 16 referral hospitals in Campania from 10 March to 4 May 2020 (lockdown period) and during the same period in 2019. We retrospectively evaluated consecutive patients hospitalized for CIEDs replacement procedures during the two observational periods. The number and type of CIEDs replacement procedures among patients followed by remote monitoring (RM), the admission rate, and the type of hospital admission between the two observational periods were compared. In total, 270 consecutive patients were hospitalized for CIEDs replacement procedures over the two observation periods. Overall CIEDs replacement procedures showed a reduction rate of 41.2% during COVID-19 lockdown. Patients were equally distributed for sex (P = 0.581), and both age [median 76 years (IQR: 68–83) vs. 79 years (IQR: 68–83); P = 0.497]. Cardiac implantable electronic devices replacement procedures in patients followed by RM significantly increased (IR: +211%; P Conclusions We showed a significant increase trend rate of replacement procedures among CIEDs patients followed by RM, suggesting the hypothesis of its increased use to closely monitoring and to optimize the hospital admission time during COVID-19 lockdown.

Cardiac involvement is recorded in about 80% of patients affected by myotonic dystrophy type 1 (DM1). The prevalence of cardiac conduction abnormalities is well described. Data regarding the prevalence of atrial fibrillation (AF) are still conflicting. The primary objective of this review was to assess the prevalence of AF in DM1. The secondary aim was to examine the association of clinical features with AF, to detect predisposing and/or influencing prognosis factors. A systematic search was developed in MEDLINE, EMBASE, Cochrane Register of Controlled Trials and Web of Science databases, to identify original reports between January 1, 2002 and January 30, 2020, assessing the prevalence of AF in DM1 population. Retrospective/prospective cohort studies and case series describing the prevalence of atrial fibrillation evaluated by periodic electrocardiogram (ECG) and/or ECG Holter 24 h, external loop recording (ELR) and implantable devices interrogation in DM1 patients were included. Case reports, simple reviews, commentaries and editorials were excluded. Thirteen reports fulfilled eligibility criteria and were included in our systematic review. According to the results from all the evaluated studies, the mean prevalence of AF in DM1 patients was 10.9% (n = 404) in 3677 DM1 patients. Male sex, conduction defects, echocardiographic findings of prolonged atrial electromechanical delay seem to be strongly associated with atrial fibrillation, representing factors favoring its onset. DM1 patients who develop AF seem to have a higher risk of cardiovascular and non-cardiovascular death. Further studies are needed to assess the prevalence of AF in DM1 patients and to investigate ECG abnormalities and other clinical features associated with this condition.

Standard therapy for venous thromboembolism (VTE) includes the use of heparins and vitamin K antagonists. Randomized clinical trials have shown that non-vitamin K oral anticoagulants are as effective and safe as standard therapy in VTE treatment, with an improved pharmacological profile. Edoxaban, a direct inhibitor of factor Xa, has demonstrated noninferiority to standard therapy for the treatment of VTE, preserving a high safety profile even in long-term therapy, in frail patients and in severe clinical presentations. The present paper focuses on the role of edoxaban in VTE treatment, from general population to cancer patients, presenting the available data from randomized clinical trials and real world, to discuss edoxaban use in clinical practice.

Background: Atrial fibrillation (AF) is the most common cardiac arrhythmia and is frequently present in patients with mitral regurgitation (MR). Currently, there is a lack of real-world evidence specifically addressing the clinical performance of direct oral anticoagulants (DOACs) in patients with AF and concomitant MR. Therefore, the aim of the present study was to assess the efficacy and safety profile of DOACs therapy in patients with AF and MR. Methods: Data for this study were sourced from the Atrial Fibrillation Research Database in the Department of Cardiology at Monaldi Hospital. The database was queried for AF patients with MR who were prescribed DOACs therapy. The primary safety outcome was defined as the annual incidence rate of major bleeding events and the primary effectiveness outcome as the annual incidence rate of all events classified as ischemic stroke, transient ischemic attacks, and systemic embolisms. Results: Consecutive AF patients with concomitant mild to severe MR who received DOACs therapy (n = 259) were included. Patients were dichotomized in 2 groups according to MR severity: a mild-to-moderate group (MR 1-2+; n = 151) and a moderate-to-severe group (MR 3-4+; n = 108). The incidence rate of major bleedings was significantly higher in MR 3-4+ group (3.92%) compared with the MR 1-2+ group (1.18%; hazard ratio [HR]: 3.2; 95% CI: 1.4-7.3; P = .0059). The incidence rate of thromboembolic events between MR 3-4+ group (0.66%) and MR 1-2+ group (0.62%) was not significantly different (HR: 0.75; P = .823). Conclusions: In the present study, there was no difference in the efficacy profile of DOACs between AF patients with mild-to-moderate and moderate-to-severe MR. Considering the increased bleeding risk, a close and careful follow-up should be warranted for patients with moderate-to-severe MR.

Funding Acknowledgements NO FUNDING OnBehalf RHYTHM DETECT Registry Background The class of recommendation for S-ICD implantation in patients who have inadequate vascular access is I according to AHA-ACC-HRS Guidelines and IIb according to ESC Guidelines. Data are lacking about the use of S-ICD for patients in which a transvenous ICD is not a viable option because of the inability to deploy a transvenous lead. Purpose To describe current practice and to measure outcomes associated with S-ICD use in patients in which a transvenous ICD is not a viable option. Methods 942 consecutive patients underwent S-ICD implantation at 22 Italian centers from 2014 to 2019. We identified 101 (11%) patients who received S-ICD because of the reported impossibility of deploying a transvenous lead. Results 21 patients presented with inadequate vascular access but no previous device in place. One patient had a mechanical prosthesis in tricuspid position. The remaining 79 patients received the S-ICD after removal of a prior system implanted, and venous occlusion was diagnosed after lead extraction, or partially or completely failed lead removal. In 24 of these patients a functional transvenous pacing system was left in place for persisting pacing needs. Patients were 60 ± 15 years old, 85% were male, 77% had ischemic or non-ischemic dilated cardiomyopathy, ejection fraction was 36 ± 13%. At implantation, acute conversion test was performed in 64 patients and shock energy of ≤65J was successful in 62 (96.9%) patients. During a median follow-up of 18 months, 6 patients died for non-device related reasons and 1 patient underwent heart transplantation. One patient underwent device replacement for battery depletion and one patient underwent leadless pacemaker implantation. Minor complications (hematomas not requiring system revision) were reported in 2 patients. Appropriate therapies were delivered in 4 patients and 8 patients experienced inappropriate therapies (in 3 patients due to double counting during pacing); all resolved with device reprogramming. Conclusions: In current clinical practice, a minority of S-ICD patients receive the device because of inadequate vascular access. The profile of these patients is similar to that of the typical ICD population in the context of primary sudden death prevention, but many of them present with pacing indications. Acute and mid-term efficacy of S-ICD seemed high. Few complications occurred during follow-up. Particular attention must be paid to device programming for those patients with concomitant pacing systems, in order to prevent inappropriate therapies.

Coronavirus disease 2019 (COVID-19) outbreak is a public health emergency of international concern due to a highly pathogenic human coronavirus (HCoV), actually named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Despite much emerging data about the epidemiological association between cardiovascular diseases and COVID-19, little is still known atrial fibrillation (AF) and its optimal management in this clinical contest. The aim of our review is to describe the pharmacological interactions between cardiovascular drugs more commonly used in AF management and experimental COVID-19 therapies, based on European (EU) and Unites States (US) summaries of product characteristics.

Diabetes mellitus (DM) is a chronic metabolic disease which is independently associated with unfavorable clinical outcomes in patients with atrial fibrillation (AF). Few real-world data are available about the clinical performance of non-vitamin K oral anticoagulants (NOACs) among patients with atrial fibrillation and diabetes. The aim of our propensity score-matched cohort study was to compare the safety and effectiveness of Edoxaban versus well-controlled vitamin K antagonists (VKAs) therapy among this population. In this study, we considered patients with AF and diabetes on Edoxaban or VKAs therapy included in the multicenter Atrial Fibrillation Research Database (NCT03760874). The occurrence of major bleedings (MB) and thromboembolic events (a composite of ischemic stroke, transient ischemic attack, systemic embolism) was respectively considered primary safety and effectiveness outcome. We identified 557 AF patients with diabetes who received Edoxaban (n: 230) or VKAs (n: 327) treatment. After propensity score matching analysis, 135 Edoxaban and 135 VKA recipients with similar clinical characteristics were evaluated. The mean follow-up was 27 &plusmn, 3 months. The incidence rate of thromboembolic events (TE) was 3.0 per 100 person-years (1.11 in Edoxaban vs. 1.9 in the VKA group, hazard ratio (HR): 0.59, 95% confidence interval (CI), 0.14 to 2.52, p = 0.48). The incidence rate of major bleedings (MB) was 3.7 per 100 person-years (1.2 in Edoxaban vs. 2.7 in the VKA group, HR: 0.43, 95% CI, 0.10 to 1.40, p = 0.14). The incidence rate of intracranial hemorrhage was 0.35 per 100 person-years in Edoxaban vs. 0.74 in the VKA group (HR: 0.49, 95% CI: 0.05 to 5.54, p = 0.56). A positive net clinical benefit (NCB) of Edoxaban over VKAs was found (+1.39). Insulin therapy (HR: 1.76, p = 0.004) and glycated hemoglobin (HR: 1.17, p = 0.002) were found to be independent predictors of TE, moreover, the concomitant use of antiplatelet drugs (HR: 2.41, p = 0.001) was an independent predictor of MB. Conclusions: Our data support the hypothesis of the safety and efficacy of Edoxaban for use in patients with AF and diabetes, justified by a favorable NCB over VKAs.

We present the case of a 80-year-old man with atrial fibrillation, morbid obesity (weight 123 kg, height 167 cm, BMI 44.1), high clearance of creatinine and pharmacological polytherapy, in which the serial determinations of edoxaban plasma levels help us to choose the appropriate dose.

Sacubitril/valsartan therapy reduces sudden cardiac death (SCD) among patients with reduced ejection fraction (HFrEF) when compared to guidelines recommended doses of enalapril, however the mechanism is still not clear. There are few, contrasting results about the effect of sacubitril/valsartan on arrhythmias in the clinical context of dilated cardiomyopathy (DCM) and there are no clinical data about its effect on measured implantable cardioverter defibrillator (ICD) electrical parameters, such as atrial/ventricular electrograms sensing and pacing threshold. We conducted a 12 month follow-up observational study in 167 ischemic and nonischemic DCM patients (mean age 68.1 &plusmn, 11.6 years, 85% male), with dual-chamber ICD on sacubitril/valsartan treatment, to evaluate the incidence of device detected tachyarrhythmia events, both atrial and ventricular, and the change in measured ICD electrical parameters. We collected data on clinical, electrocardiographic and echocardiographic parameters to find a possible electro-mechanical correlation within results. Our results show that DCM patients with reduced ejection fraction and ICD on sacubitril/valsartan treatment experienced a reduction in both atrial and ventricular arrhythmias incidence and an improvement in ICD electrical atrial parameters. The findings might be explained by the electro-mechanical cardiac reverse remodeling induced by sacubitril/valsartan therapy.

Background Cardiac resynchronization therapy (CRT) is an established treatment in patients with heart failure and prolonged QRS duration. A biventricular device is implanted to achieve faster activation and more synchronous contraction of the ventricles. Despite the convincing effect of CRT, 30-40% of patients do not respond. We decided to investigate the role of multipoint pacing (MPP) in a selected group of patients with right ventricle (RV)-to-left ventricle (LV) intervals less than 80 ms that do not respond to traditional CRT. Methods We will enrol 248 patients in this patient-blinded, observational, clinical study aiming to investigate if MPP could decrease LV end-systolic volume (ESV) in patients with RV-to-LV interval less than 80 ms. MPP will be activated ON at implant in patients with RV-to-LV delay less than 80 ms and OFF in RV-to-LV at least 80 ms. At follow-up the activation of MPP will be related to CRT response. The primary study endpoint will be the responder rate at 6 months, defined as a decrease in LV ejection fraction, LV end-diastolic volume, LV end-systolic volume (LVESV) at least 15% from baseline. Secondary outcomes include 12 months relative percentage reduction in LVESV and a combined clinical outcome measure of response to CRT defined as the patient being alive, no hospitalization due to heart failure, and experiencing an improvement in New York Heart Association functional class (Composite-Score). Conclusion Reducing the nonresponder rate continues to be an important goal for CRT.If an increase in reverse remodelling can be achieved by MPP, this study supports the conduct of larger trials investigating the role of MPP on clinical outcomes in selected patients treated, right now, only with traditional CRT. Trial registration ClinicalTrials.gov, NCT02713308. Registered on 18 March 2016.

Background: Octogenarian patients are at high risk of both ischaemic and bleeding events, and the low body weight is considered a risk factor for major bleeding in atrial fibrillation (AF) patients on anticoagulation therapy. The aim of our study was to compare the safety and effectiveness of NOACs versus well-controlled VKA therapy among patients aged>80year with AF and low body weight in real-life setting. Methods: Data for this study were sourced from the multicenter prospectively maintained Atrial Fibrillation Research Database (NCT03760874). From this, we selected AF patients aged≥80years and weighted≤60kg who received NOACs or VKAs treatment (only those with a time in therapeutic range>70%). 279 patients (136 in NOAC group and 143 in VKA group) were selected. Results: A total of 71 patients (17 in NOAC vs 54 in VKA group) died during the follow-up. The incidence rate of all-cause mortality was 27.70 per 100 person-years (14.91 in NOAC vs 37.94 in VKA group, adjusted hazard ratio 0.43; 95% CI 0.25 to 0.975; P=.003). 22 patients (9 in NOAC vs 13 in VKA group, P=.6) had major bleeding events. Diabetes mellitus, COPD and age resulted positively associated with death, whereas NOACs, parossistic AF and weight negatively associated with mortality. Conclusions: Our real-world data might suggest the safe and efficacy use of NOACs in this setting of population, justified by a reduction in overall mortality over VKAs. Further studies are needed to confirm these data.

A highly pathogenic human coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been recently recognized in Wuhan, China, as the cause of the coronavirus disease 2019 (COVID-19) outbreak which has spread rapidly from China to other countries in the world, causing a pandemic with alarming morbidity and mortality. The emerging epidemiological data about COVID-19 patients suggest an association between cardiovascular diseases (CVD) and SARS-CoV-2 infection, in term of clinical features at hospital admission and prognosis for disease severity. The aim of our review is to describe the cardiological features of COVID-19 patients at admission, the acute cardiac presentation, the clinical outcome for patients with underlying CVD and the pharmacological implications for disease management.

Direct oral anticoagulants (DOACs) are considered a first-line therapy for long-term stroke prevention in patients with nonvalvular atrial fibrillation (AF) and high thromboembolic risk. The potential role of DOACs in cardiac interventional procedures is a pressing clinical question, considering the increasing number of procedures and the growing prevalence of patients in DOAC therapy. The aim of this review is to provide an update on available evidence about the clinical performance of DOACs in AF patients undergoing different interventional procedures (AF cardioversion and ablation, and percutaneous coronary and structural heart disease interventions) and to explore the possible role of DOACs as an alternative therapeutic strategy in cardiac interventional procedures among non-AF patients.

This is an observational study to investigate the efficacy and safety of nonvitamin K antagonist oral anticoagulants (NOACs) in atrial fibrillation (AF) patients with bioprosthetic valves or prior surgical valve repair in clinical practice. A total of 122 patients (mean age: 74.1 ± 13.2; 54 females) with bioprosthetic heart valve or surgical valve repair and AF treated with NOACs were included in the analysis. The mean CHA2DS2-VASc (Congestive heart failure, Hypertension, Age >75 years, Diabetes mellitus, prior Stroke or transient ischemic attack, Vascular disease) and HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile INR [international normalized ratio], Elderly, Drugs or alcohol) score values were 3.6 ± 1.2 and 2.6 ± 1.4, respectively. Of the total study population, 28.6% was taking apixaban 5 mg twice daily (BID), 24.5% apixaban 2.5 mg BID, 18% dabigatran 150 mg BID, 13% dabigatran 110 mg BID, 9.8% rivaroxaban 20 mg daily (QD), and 5.7% rivaroxaban 15 mg QD. Also, 92% of the study population previously had warfarin replaced with NOACs due to lack compliance and labile INR control (time in therapeutic range

Recently, several cases of symptomatic, sometimes fatal bradycardia during the first days of direct-acting antiviral (DAA) (eg, sofosbuvir [SOF]) administration have been reported. We analyzed in detail electrocardiographic (ECG) changes during SOF- or non-SOF-based chronic hepatitis C (CHC) treatment, specifically focusing on bradyarrhythmias. All 39 consecutive patients treated at our center with any interferon-free regimen between June and December 2015 were included in this study (26 SOF-based therapy vs 13 no-SOF interferon-free regimens). ECG tracings were obtained from all patients the first day of treatment and after 7, 14, and 28 days. ECG parameters (P-wave, QRS, QT interval, JT interval, Tapex -Tend interval duration) were compared between the 2 groups at baseline and at the 3 different time points during antiviral therapy. There were no cases of symptomatic bradycardia/syncope. In the SOF group, QTc duration rose after 1 week (from 424.3 to 431.2 milliseconds; P = .013) and returned to baseline during therapy. QT dispersion dropped since week 1 (from 85.6 to 67.2 milliseconds) and remained significantly reduced until the end of the observation period (72.9 msec) (P = .003). JT dispersion reduced up to week 2 (P = .010) and returned to baseline at week 4; in the no-SOF group, QRS dispersion transiently reduced (from 41 to 34.5 milliseconds, day 7). No other significant changes were observed in the remaining parameters. In CHC patients treated with SOF and other DAAs, ECG parameter changes were mild and/or transient and did not translate into clinically significant electrophysiological effects in the absence of amiodarone coadministration.

Background Ablation technique targeting high-amplitude signals (maximum voltage guided - MVG -) on the cavotricuspid isthmus (CTI) has emerged as viable alternative option compared to standard anatomical approach (ST) for the creation of bidirectional conduction block (BDB) across the isthmus but limited data are available to date. Purpose To evaluate the effectiveness of acute and long-term outcome of CTI ablation through MVG technique for AFL compared to standard linear (SL) lesion ablation. Methods Atrial Flutter Ablation in a Real World Population (LEONARDO) is a prospective, multicenter cohort study aimed at providing an estimate of acute to long-term outcome in a large population of patients (pts) indicated for AFL ablation. Recurrence of AFL were retrieved at 12-month follow-up. Complete BDB was defined by agreement with the presence of widely split double potentials (DP) along the ablation line and assessment of the atrial activation sequence (AAS). For MVG technique the ablation catheter was positioned at the site of maximum local electrogram voltage. Results Two-hundred fifteen consecutive pts were included (mean age 68 years, 73% male). A median of 4 [2–6] ablation lesions were required. Median follow up was 359 [192–443] days. Complete BDB was achieved in 175 (81.4%) pts (9 pts had DP only criterion, 30 pts had AAS only criterion whereas in 1 pt we failed to reach a BDB). In the 106 pts with complete data at 1-year follow-up, 10 (9.4%) had a recurrence of AFL. 171 pts (79%) underwent a SL ablation whereas 44 pts (21%) were treated by MVG approach. The median number of lesions/pt was significantly lower in the group of pts targeted with MVG compared to the SL approach (3 [2–4] vs 4 [2–8], p Conclusion Ablation of a targeted site through MGV approach seems to be safe and effective as standard anatomical ablation technique. This strategy may avoid unnecessary ablation of the entire anatomic isthmus. Acknowledgement/Funding None

Introduction: The aim of the present study was to evaluate the role of high-sensitivity cardiac troponin I, N terminal pro-B-type natriuretic peptide (NT-proBNP), creatine kinase-MB mass concentration (CK-MB mass) and copeptin (CP) in predicting incident atrial fibrillation (AF) in myotonic dystrophy type 1 (DM1) patients. Materials and methods: The study enrolled 60 consecutive DM1 patients (age 50.3 ± 7.3 years, 34 male) who underwent pacemaker (PM) implantation for cardiac rhythm abnormalities and 60 PM recipients whose age and sex matched served as control group. All DM1 patients underwent a 12-lead electrocardiogram, 2D color Doppler echocardiogram, biomarkers measurements and device interrogation at implantation, 1 month after and every 6 months thereafter for a minimum of 2-year follow-up. Results: The study population was divided into two groups according to the presence of AF (AF group vs non-AF group). The AF group was older (47.3 ± 8 vs 38.6 ± 7 years, P =.03) and showed higher serum levels of NT-proBNP (151 ± 38.4 vs 107.3 ± 24.2 pg/mL, P

Atrial fibrillation is the most common arrhythmia in clinical practice, and age is one of the strongest predictors/risk factors for ischemic stroke in patients with atrial fibrillation. Elderly patients, in particular patients aged 80 years and older, are at higher risk of both ischemic and bleeding events compared with younger patients. Vitamin K antagonists (VKAs) reduce the risk of ischemic stroke, especially in the elderly, but increase the bleeding risk. In addition, frequent international normalized ratio monitoring is needed to ensure the optimal level of anticoagulation. Furthermore, VKAs have multiple drug and food interactions. Direct oral anticoagulants (DOACs) have recently emerged as alternatives to VKAs and are gradually increasing their popularity mainly because of their fewer drug and food interactions and ease of use. Their effectiveness and safety have been well-established in the general population, but the benefit in the very elderly (≥80 years old) is still unclear. Data about the safety and the effectiveness of DOACs in patients older than 75 years are available in literature, but the evidences of the use of DOACs in patients aged 80 years and older are lacking. This review aims to give light to the differences, in terms of benefits and safety, of the DOACs in this subset of patients.

Cardiac involvement is recorded in about 80% of patients affected by myotonic dystrophy type 1 (DM1). The prevalence of cardiac conduction abnormalities and arrhythmias has been well described. Data regarding the prevalence of left ventricle systolic dysfunction (LVSD) and heart failure (HF) are still conflicting. The primary objective of this review was to assess the prevalence of LVSD and HF in DM1. The secondary aim was to examine the association of clinical features with LVSD and to detect predisposing and influencing prognosis factors. A systematic search was developed in MEDLINE, EMBASE, Cochrane Register of Controlled Trials, and Web of Science databases to identify original reports between January 1, 2009, and September 30, 2017, assessing the prevalence of LVSD and HF in populations with DM1. Retrospective and prospective cohort studies and case series describing the prevalence of LVSD, as evaluated by echocardiography, and HF in patients with DM1 were included. Case reports, simple reviews, commentaries and editorials were excluded. Seven studies were identified as eligible, of which 1 was a retrospective population-based cohort study, and 6 were retrospective single-center-based cohort studies. Echocardiographic data concerning LV function were available for 647 of the 876 patients with DM1 who were included in the analysis. The prevalence of LVSD in patients with DM1, defined as LVEF < 55%, was 13.8%, 4.5-fold higher than in general population. Patients with DM1 and LVSD were older, were more likely to be male, had longer baseline atrioventricular and intraventricular conduction-time durations, had higher incidences of atrial arrhythmias, and were more likely to have undergone device implantation. Also, symptomatic HF is more prevalent in patients with DM1 despite their limited levels of physical activity. Further studies are needed to evaluate the prevalence of LVSD and HF in patients with DM1 and to investigate electrocardiographic abnormalities and other clinical features associated with this condition.

Background. Combination of dual antiplatelet (DAPT) and oral anticoagulation therapy is required to decrease cardioembolic stroke and stent thrombosis risk in patients with atrial fibrillation (AF) and acute coronary syndrome (ACS). We compared the safety and efficacy of dabigatran etexilate with vitamin K antagonist (VKA), in combination with DAPT (aspirin plus clopidogrel) treatment in AF patients who underwent percutaneous coronary intervention (PCI) with stenting for ACS. Methods. Consecutive nonvalvular AF patients who received twice-daily dabigatran 110 mg (n = 389) or VKA (n = 510) and DAPT were included. Primary endpoints were major bleeding (safety) and the composite of ischemic stroke, systemic embolism, and myocardial infarction (efficacy). The secondary efficacy endpoint was hospitalization for cardiovascular disease. Results. After propensity score matching, comparative treatment groups comprised 175 dabigatran recipients and 175 VKA recipients. The cumulative incidence of major bleeding was lower in the dabigatran group (2.3%) compared with the VKA group (10.3%) with a hazard ratio (HR) of 4.81 [95% confidence interval (CI) 1.6–14.2, p < 0.005]. The cumulative incidence of thromboembolic events with dabigatran was slightly higher (8.0%) than with VKA (6.85%), but not statistically significantly so (0.8, 0.39–1.8; p = 0.6). Cumulative incidence of hospitalization for cardiovascular disease was lower with dabigatran (10.3%) compared with VKA (20.6%) treatment (2.2, 1.25–3.8; p < 0.006). Conclusion. Dabigatran at the dose used for stroke prevention appears safer than VKA and maintains a similar efficacy profile, when used with DAPT, in AF patients who have undergone PCI with stenting for ACS.

Catheter ablation of cardiac arrhythmias has conventionally been performed with the aid of fluoroscopy to direct catheter placement. Unfortunately, the use of fluoroscopy comes with radiation risks to the patient as well as to the electrophysiology lab staff. Newly navigation methods are used to help in mapping and ablation, reducing X-ray exposure to zero or near zero. The aim of the present review is to evaluate the safety and efficacy of radiofrequency ablation (RFA) for atrial flutter performed in a fluoroless manner compared with the traditional method using fluoroscopy.

Introduction Implantable cardioverter-defibrillator (ICD) alarm systems are an important means of monitoring device functioning. The aim of this study was to compare the ability of patients with sense two types of device alert systems: an audible alert and a vibratory alarm. Methods The ability to recognize the alarms was assessed in three alarm tests performed in a series of consecutive ICD patients enrolled during routine outpatient device follow-up. To avoid overestimating the rate of patients able to sense the alarm, the first test was performed without forewarning. Subsequently, the second test was performed after the patients had been forewarned. Finally, to assess the learning effect of a demonstration test, a third test was performed, again without forewarning. Results A total of 528 patients (65.4 ± 14.4 years, 74.6% male) were enrolled: 347 (65.7%) with an audible alert-endowed device and 181 (34.3%) with a vibratory alarm-endowed device. When emitted without warning, the alarms were sensed by 72.4% of patients. When patients were forewarned, the probability of sensing the alarms rose to 92.5% (P < 0.001). In both cases, the vibratory alarm was more likely to be sensed than the audible alert (77.3 vs. 67.7% in the first case; 96.1 vs. 87.9% in the second case; all P < 0.05). Conclusion ICD alarms emitted in an outpatient setting are sensed by a large proportion of patients, but not by all. Training patients by means of demonstration tests significantly increases the rate of patients who recognize the alarm. Vibratory alarm seems to be more effective than audible alert.