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Background: Short and rare episodes of atrial fibrillation (AF) are commonly detected using implanted devices (device-detected AF) in patients with prior stroke or transient ischemic attack (TIA). The effectiveness and safety of oral anticoagulation in patients with prior stroke or TIA and device-detected AF but with no ECG-documented AF is unclear., Methods and Results: This prespecified analysis of the NOAH-AFNET 6 (Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes) trial with post hoc elements assessed the effect of oral anticoagulation in patients with device-detected AF with and without a prior stroke or TIA in the randomized, double-blind, double-dummy NOAH-AFNET 6 trial. Outcomes were stroke, systemic embolism, and cardiovascular death (primary outcome) and major bleeding and death (safety outcome). A prior stroke or TIA was found in 253 patients with device-detected AF randomized in the NOAH-AFNET 6 (mean age, 78 years; 36.4% women). There was no treatment interaction with prior stroke or TIA for any of the primary and secondary time-to-event outcomes. In patients with a prior stroke or TIA, 14 out of 122 patients experienced a primary outcome event with anticoagulation (5.7% per patient-year). Without anticoagulation, there were 16 out of 131 patients with an event (6.3% per patient-year). The rate of stroke was lower than expected (anticoagulation: 4 out of 122 [1.6% per patient-year]; no anticoagulation: 6 out of 131 [2.3% per patient-year]). Numerically, there were more major bleeding events with anticoagulation in patients with prior stroke or TIA (8 out of 122 patients) than without anticoagulation (2 out of 131 patients)., Conclusions: Anticoagulation appears to have ambiguous effects in patients with device-detected AF and a prior stroke or TIA in this hypothesis-generating analysis of the NOAH-AFNET 6 in the absence of ECG-documented AF, partially due to a low rate of stroke without anticoagulation.

Background and Aims: The optimal antithrombotic therapy in patients with device-detected atrial fibrillation (DDAF) is unknown. Concomitant vascular disease can modify the benefits and risks of anticoagulation., Methods: These pre-specified analyses of the NOAH-AFNET 6 (n=2534 patients) and ARTESiA (n=4012 patients) trials compared anticoagulation to no anticoagulation in patients with DDAF with or without vascular disease, defined as prior stroke/transient ischemic attack, coronary or peripheral artery disease. Efficacy outcomes were the primary outcomes of both trials, a composite of stroke, systemic arterial embolism (SE), myocardial infarction, pulmonary embolism or cardiovascular death, and stroke or SE. Safety outcomes were major bleeding or major bleeding and death., Results: In patients with vascular disease (NOAH-AFNET 6 56%, ARTESiA 46.0%), stroke, myocardial infarction, systemic or pulmonary embolism, or cardiovascular death occurred at 3.9%/patient-year with and 5.0%/patient-year without anticoagulation (NOAH-AFNET 6), and 3.2%/patient-year with and 4.4%/patient-year without anticoagulation (ARTESiA). Without vascular disease, outcomes were equal with and without anticoagulation (NOAH-AFNET 6 2.7%/patient-year, ARTESiA 2.3%/patient-year in both randomised groups). Meta-analysis found consistent results across both trials (I2heterogeneity=6%) with a trend for interaction with randomised therapy (pinteraction=0.08). Stroke/SE behaved similarly. Anticoagulation increased major bleeding in vascular disease patients (edoxaban 2.1%/patient-year, no anticoagulation 1.3%/patient-year; apixaban 1.7%/patient-year; no anticoagulation 1.1%/patient-year; incidence rate ratio 1.55 [1.10-2.20]) and without vascular disease (edoxaban 2.2%/patient-year; no anticoagulation 0.6%/patient-year; apixaban 1.4%/patient-year; no anticoagulation 1.1%/patient-year, incidence rate ratio 1.93 [0.72-5.20])., Conclusions: Patients with DDAF and vascular disease are at higher risk of stroke and cardiovascular events and may derive a greater benefit from anticoagulation than patients with DDAF without vascular disease., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing., Methods and Results: Patients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72-0.99; P = 0.035]. After adjusting for CHA2DS2-VASc score, the HR remained 0.84 (95% CI, 0.71-0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms., Conclusion: Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing., Competing Interests: Conflict of interest: G.L.B. received speaker’s fee from Abbott, Biotronik, Boston Scientific, Medtronic, and MicroPort. M.D.M., D.G., and A.G. are employees of Biotronik Italia S.p.A., an affiliate of Biotronik SE & Co. KG (study sponsor and manufacturer of investigational devices). All remaining authors have declared no conflicts of interest., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background and Aims: Patients with long atrial high-rate episodes (AHREs) ≥24 h and stroke risk factors are often treated with anticoagulation for stroke prevention. Anticoagulation has never been compared with no anticoagulation in these patients., Methods: This secondary pre-specified analysis of the Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High-rate episodes (NOAH-AFNET 6) trial examined interactions between AHRE duration at baseline and anticoagulation with edoxaban compared with placebo in patients with AHRE and stroke risk factors. The primary efficacy outcome was a composite of stroke, systemic embolism, or cardiovascular death. The safety outcome was a composite of major bleeding and death. Key secondary outcomes were components of these outcomes and electrocardiogram (ECG)-diagnosed atrial fibrillation., Results: Median follow-up of 2389 patients with core lab-verified AHRE was 1.8 years. AHRE ≥24 h were present at baseline in 259/2389 patients (11%, 78 ± 7 years old, 28% women, CHA2DS2-VASc 4). Clinical characteristics were not different from patients with shorter AHRE. The primary outcome occurred in 9/132 patients with AHRE ≥24 h (4.3%/patient-year, 2 strokes) treated with anticoagulation and in 14/127 patients treated with placebo (6.9%/patient-year, 2 strokes). Atrial high-rate episode duration did not interact with the efficacy (P-interaction = .65) or safety (P-interaction = .98) of anticoagulation. Analyses including AHRE as a continuous parameter confirmed this. Patients with AHRE ≥24 h developed more ECG-diagnosed atrial fibrillation (17.0%/patient-year) than patients with shorter AHRE (8.2%/patient-year; P < .001)., Conclusions: This hypothesis-generating analysis does not find an interaction between AHRE duration and anticoagulation therapy in patients with device-detected AHRE and stroke risk factors. Further research is needed to identify patients with long AHRE at high stroke risk., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Unstable and symptomatic complete atrioventricular block represents a potentially fatal condition that requires prompt therapy while waiting for definitive pacemaker implantation. Although transcutaneous pacing is included in acute management, it could be a difficult approach due to its painfulness and the occasional failure of mechanical capture. Drug therapy is a feasible choice, and current guidelines encompass the use of atropine, dopamine, or epinephrine. Isoprenaline has never been investigated in this setting, and no specific indication of its use has been provided despite its potentially more favorable pharmacological profile. The study population included a consecutive series of patients who presented to the emergency department because of unstable third-degree atrioventricular block and were treated with either isoprenaline or dopamine infusion while waiting for definitive pacemaker implantation. Asymptomatic patients or those with reversible causes of complete atrioventricular block were excluded. The clinical response to the drug was deemed poor if, despite achieving a full drug dose, patients remained symptomatic and/or with hemodynamic instability, ventricular rate and rhythm did not improve or worsened, including if ventricular arrhythmias or asystolic pauses and/or irrepressible nausea/vomiting occurred. Isoprenaline infusion has proved to be safe and tolerated with no arrhythmia induction or hypotensive issues. Isoprenaline has also proven to be more satisfactory in achieving an effective clinical response in 84% of patients rather than dopamine (31%, p < 0.001), reducing the need for temporary artificial pacing. Our data point out the efficacy and safety of isoprenaline infusion and its greater tolerability over dopamine in the acute management of unstable third-degree AV block while waiting for definitive pacemaker implantation.

Background: Outcomes of transvenous lead extraction (TLE) are well reported in the general population, However, data on safety, efficacy of TLE in octogenarians with a long lead dwell time, using powered extraction tools are limited. The aim of this multicenter study was to evaluate the safety, effectiveness of TLE in octogenarians using the bidirectional rotational mechanical sheaths and mid-term outcome after TLE., Methods: The study population comprised 83 patients (78.3% male; mean age 85 ± 3 years; [range 80-94 years]) with 181 target leads. All the leads (mean implant duration 112 ± 77 months [range 12-377]) were extracted exclusively using the Evolution RL sheaths (Cook Medical, Bloomington, IN, USA)., Results: The main indication for TLE was infection in 84.3% of cases. Complete procedural success rate, clinical success rate, per lead were 93.9% and 98.3%, respectively. Failure of lead extraction was seen in 1.7% of leads. The additional use of a snare was required in 8.4% of patients. Major complications occurred in one patient (1.2%). Thirty-day mortality after TLE was 6%. During a mean time follow-up of 22 ± 21 months, 24 patients (29%) died. No procedure-related mortality occurred. Predictors of mortality included ischemic cardiomyopathy (HR 4.35; 95% CI 1.87-10.13; p = .001), left ventricularejection fraction ≤35% (HR 7.89; 95% CI 3.20-19.48; p < .001), and TLE for systemic infection (HR 4.24; 95% CI 1.69-10.66; p = .002)., Conclusions: At experienced centers bidirectional rotational mechanical sheaths combined with different mechanical tools and femoral approach allowreasonable success and safety in octogenarian with long lead dwell time. Patient's age should not influence the decision to extract or not the leads, although the 30-day and mid-term mortality are significant, especially in the present of specific comorbidities., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

Post-acute COVID-19 is characterized by the persistence of dyspnea, but the pathophysiology is unclear. We evaluated the prevalence of dyspnea during follow-up and factors at admission and follow-up associated with dyspnea persistence. After five months from discharge, 225 consecutive patients hospitalized for moderate to severe COVID-19 pneumonia were assessed clinically and by laboratory tests, echocardiography, six-minute walking test (6MWT), and pulmonary function tests. Fifty-one patients reported persistent dyspnea. C-reactive protein ( p = 0.025, OR 1.01 (95% CI 1.00-1.02)) at admission, longer duration of hospitalization ( p = 0.005, OR 1.05 (95% CI 1.01-1.10)) and higher body mass index ( p = 0.001, OR 1.15 (95% CI 1.06-1.28)) were independent predictors of dyspnea. Absolute drop in SpO 2 at 6MWT ( p = 0.001, OR 1.37 (95% CI 1.13-1.69)), right ventricular (RV) global longitudinal strain ( p = 0.016, OR 1.12 (95% CI 1.02-1.25)) and RV global longitudinal strain/systolic pulmonary artery pressure ratio ( p = 0.034, OR 0.14 (95% CI 0.02-0.86)) were independently associated with post-acute COVID-19 dyspnea. In conclusion, dyspnea is present in many patients during follow-up after hospitalization for COVID-19 pneumonia. While higher body mass index, C-reactive protein at admission, and duration of hospitalization are predictors of persistent dyspnea, desaturation at 6MWT, and echocardiographic RV dysfunction are associated with this symptom during the follow-up period.

Atrial high-rate episodes (AHRE) are atrial tachyarrhythmias detected by continuous rhythm monitoring by pacemakers, defibrillators, or implantable cardiac monitors. Atrial high-rate episodes occur in 10-30% of elderly patients without atrial fibrillation. However, it remains unclear whether the presence of these arrhythmias has therapeutic consequences. The presence of AHRE increases the risk of stroke compared with patients without AHRE. Oral anticoagulation would have the potential to reduce the risk of stroke in patients with AHRE but is also associated with a rate of major bleeding of ∼2%/year. The stroke rate in patients with AHRE appears to be lower than the stroke rate in patients with atrial fibrillation. Wearables like smart-watches will increase the absolute number of patients in whom atrial arrhythmias are detected. It remains unclear whether anticoagulation is effective and, equally important, safe in patients with AHRE. Two randomized clinical trials, NOAH-AFNET6 and ARTESiA, are expected to report soon. They will provide much-needed information on the efficacy and safety of oral anticoagulation in patients with AHRE., Competing Interests: Conflict of interest: T.T. received speaker fees from Medtronic and honoraria from Boston Scientific. A.B. received honorarium from Boehringer-Ingelheim, Bristol-Myers Squibb and received research grants from Theravance, Zealand Region, Canadian Institutes of Health Research and the Danish Heart Foundation. N.F. received a grant from Biotronik, speaker fees from Abbott, Medtronic, all outside the submitted work. J.R.G. receives consultant or speaker fees from Atricure, Daiichi Sakyo, Bayer, and Novartis. He received research funding through institution from Abbott, Boston Scientific, Medtronic, Atricure, and Owner RhythmCare. E.M. receives consultant fees from Abbott, Bayer, Boston Scientific, Medtronic, and Zoll Carina Blomström Lundqvist received honorarium from Medtronic, Boston Scientific, Abbott, Bayer, Sanofi, Organon, Milestone, Philips, Cathprint outside this work. G.-A.D. receives speaker and consultation fees from Boehringer Ingelheim, Bayer, Novartis, Berlin Chemie, Amgen, Sanofi; nothing linked to the submitted work. B.M. received speaker fees from Abbott, Astra Zeneca, Biotronik, Boehringer Ingelheim, Novartis. Paulus Kirchhof receives research support for basic, translational, and clinical research projects from European Union, British Heart Foundation, Leducq Foundation, Medical Research Council (UK), and German Centre for Cardiovascular Research, from several drug and device companies active in atrial fibrillation and has received honoraria from several such companies in the past, but not in the last 3 years (unrelated to the submitted work). P.K. is listed as inventor on two patents held by University of Birmingham (Atrial Fibrillation Therapy WO 2015140571, Markers for Atrial Fibrillation WO 2016012783). All remaining authors have declared no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

(1) Background: Emerging data regarding patients recovered from COVID-19 are reported in the literature, but cardiac sequelae have not yet been clarified. To quickly detect any cardiac involvement at follow-up, the aims of the research were to identify: elements at admission predisposing subclinical myocardial injury at follow up; the relationship between subclinical myocardial injury and multiparametric evaluation at follow-up; and subclinical myocardial injury longitudinal evolution. (2) Methods and Results: A total of 229 consecutive patients hospitalised for moderate to severe COVID-19 pneumonia were initially enrolled, of which 225 were available for follow-up. All patients underwent a first follow-up visit, which included a clinical evaluation, a laboratory test, echocardiography, a six-minute walking test (6MWT), and a pulmonary functional test. Of the 225 patients, 43 (19%) underwent a second follow-up visit. The median time to the first follow-up after discharge was 5 months, and the median time to the second follow-up after discharge was 12 months. Left ventricular global longitudinal strain (LVGLS) and right ventricular free wall strain (RVFWS) were reduced in 36% (n = 81) and 7.2% (n = 16) of the patients, respectively, at first the follow-up visit. LVGLS impairment showed correlations with patients of male gender ( p 0.008, OR 2.32 (95% CI 1.24-4.42)), the presence of at least one cardiovascular risk factor ( p < 0.001, OR 6.44 (95% CI 3.07-14.9)), and final oxygen saturation ( p 0.002, OR 0.99 (95% CI 0.98-1)) for the 6MWTs. Subclinical myocardial dysfunction had not significantly improved at the 12-month follow-ups. (3) Conclusions: in patients recovered from COVID-19 pneumonia, left ventricular subclinical myocardial injury was related to cardiovascular risk factors and appeared stable during follow-up.

Introduction: Lead dwell time >10 years is a recognized predictor for transvenous lead extraction (TLE) failure and complications. Data on the efficacy and safety of TLE using the bidirectional rotational mechanical sheaths in patients with very old leads are lacking. In this multicenter study, we reported the outcomes of transvenous rotational mechanical lead extraction in patients with leads implanted for ≥10 years., Methods: A total of 441 leads (median: 159 months [135-197]; range: 120-487) in 189 consecutive patients were removed with the Evolution RL sheaths (Cook Medical, Bloomingtom, IN, USA) and mechanical ancillary tools supporting the procedures., Results: The main indication for TLE was infection in 74% of cases. Complete procedural success rate, clinical success rate, per lead were 94.8% and 98.2%, respectively. Failure of lead extraction was seen in 1.8% of leads. The additional use of a snare via the femoral approach was required in 9% of patients. Lead dwell time was the only predictor of incomplete led removal (odds ratio: 1.009; 95% confidence interval [CI]: 1.003-1.014; p = .002). Four major complication (2%) were encountered. During a mean time follow-up of 31 ± 27 months, 21 patients (11%) died. No procedure-related mortality occurred. Predictors of mortality included severe left ventricular systolic dysfunction (hazard ratio [HR]: 8.06; 95% CI: 2.99-21.73; p = .001), TLE for infection (HR: 8.0; 95% CI: 1.04-62.5; p = .045), diabetes (HR: 3.7; 95% CI: 1.48-9.5; p = .005), and previous systemic infection (HR: 3.1; 95% CI: 1.17-8.24; p = .022). Incomplete lead removal or failure lead extraction did not impact on survival during follow-up., Conclusion: Our findings demonstrated that the use of bidirectional rotational TLE mechanical sheaths combined with different mechanical tools and femoral approach allows reasonable success and safety in patients with very old leads at experienced specialized centers., (© 2022 Wiley Periodicals LLC.)

Background: Subclinical atrial fibrillation (SCAF) may represent a cause of embolic stroke of undetermined source (ESUS) and its detection has important implications for secondary prevention with anticoagulation. Indications to implantable cardiac monitors (ICM) include SCAF detection. The aims of this study were to (1) evaluate the frequency of ICM-detected SCAF; (2) determine predictors of SCAF; and (3) identify patients who would benefit most from ICM implantation., Methods: Between February 2017 and November 2020, all consecutive patients referred for ICM implantation after a diagnosis of ESUS and without previous history of atrial fibrillation or atrial flutter were included in this study. SCAF was diagnosed if the ICM electrogram demonstrated an episode of irregularly irregular rhythm without distinct P waves lasting > 2 min., Results: We enrolled 109 patients (age 66, SD = 13 years; 36% females). During a median follow-up of 19.2 (IQR 11.0-27.5) months, SCAF episodes were detected in 36 (33%) patients. Only abnormal P wave terminal force in lead V1, left atrial end-systolic indexed volume > 34 ml/m 2 , and BMI > 25 kg/m 2 were independently associated with an increased risk of SCAF (HR 2.44, 95% CI 1.14-5.21, p = 0.021; HR 2.39, 95% CI 1.11-5.13, p = 0.026; and HR 2.64, 95% CI 1.06-6.49, p = 0.036 respectively). The ROC curve showed that the presence of all three parameters had the best accuracy (74%) to predict SCAF detection (sensitivity 39%, specificity 91%)., Conclusion: A multiparametric evaluation has the best accuracy to predict SCAF in ESUS patients and may help identifying those who would benefit most from ICM., (© 2022. Fondazione Società Italiana di Neurologia.)

Background: Atrial fibrillation (AF) is an uncommon arrhythmia in young adults without structural heart disease, and cryoballoon pulmonary vein isolation (CB-PVI) is an important therapeutic strategy for rhythm control in patients with drug-refractory AF. The aim of this analysis was to evaluate efficacy and safety of CB-PVI in a large cohort of young patients in comparison with middle-aged adults in a real-world setting., Methods: From 2012 to 2020, a total of 3033 patients with AF underwent CB-PVI and were followed prospectively in the framework of the 1STOP Clinical Service project, involving 34 Italian centers. Out of 3033 total 1STOP project subjects, a subgroup of 1318 patients were defined which included a YOUNG group (age ≤ 45 years; n = 368) and a MIDDLE-AGED group (age 60-65 years; n = 950)., Results: The acute success rate of PVI did not differ between the two cohorts (99.9 ± 1.3% vs. 99.8 ± 3.2%, p = 0.415). There was no difference in procedural characteristics, and periprocedural complication rates were similar among the two cohort (1.9% vs. 2.3%, p = 0.646). The 12-month freedom from AF recurrence was 88.9% (95% confidence interval [CI]: 84.7-92.0) in the YOUNG cohort and 85.6% (95% CI: 82.9-88.0) in the MIDDLE-AGED group. At 36-month follow-up, freedom from AF recurrence was 72.4% (65.5%-78.2%) and 71.8% (67.7%-75.6%), respectively with no significant difference among groups (p = 0.550)., Conclusion: CB-PVI had similar efficacy and safety in YOUNG and MIDDLE-AGED patients. Younger age did not affect acute procedural results, complication rate, or AF recurrence after a single procedure., (© 2022 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

Purpose: The aim of the present study was to evaluate the outcome of patients underwent subcutaneous implantable cardioverter defibrillator (S-ICD) implantation with the intermuscular (IM) two-incision technique during 3-year follow-up., Methods: the study population consisted of 105 consecutive patients (79 male; median 50 [13-77] years) underwent S-ICD implantation with the IM two-incision technique. The composite primary end point of the study consisted of device-related complications and inappropriate shocks (IAS). Secondary end points included the individual components of the primary end point, death from any cause, appropriate therapy, major adverse cardiac events, hospitalization for heart failure, and heart transplantation., Results: According to the PRAETORIAN score, the risk of conversion failure was classified as low in 99 patients (94.3%), intermediate in 6 (5.7%).Ventricular fibrillation was successfully converted at ≤65 J in 97.4% of patients. During a median follow-up of 39 (16-53) months, 10 patients (9.5%) experienced device-related complications, and 9 (8.5%) patients reported IAS. Lead-associated complications were the most common (5 patients, 4.7%), including 2 cases of lead failure (1.9%). Pocket complications were reported in 2 patients (1.9%). Extra-cardiac oversensing (3.8%) represented the leading cause of IAS. No T-wave oversensing episodes were recorded. Twelve patients (11.4%) experienced appropriate shocks. Eight patients (7.6%) died during follow-up. IAS or device-related complications did not impact on mortality., Conclusions: The overall device-related complications and IAS rates over 3 years of follow-up were 9.5% and 8.5%, respectively. According to our findings, the IM two-incision technique allows for optimal positioning of the device achieving a low PRAETORIAN score with a high conversion rate. IM two-incision technique allows low incidence of pocket complications, shifting the type of complications towards lead-related complications, which represent the most common complications. The IM two-incision technique would not seem to impact the occurrence of IAS. Management of complications are safe without impact on the outcome., (© 2023. The Author(s).)

When approaching infected lead removal in cardiac device-related infective endocarditis (CDRIE), a surgical consideration for large (>20 mm) vegetations is recommended. We report our experience with the removal of large CDRIE vegetations using the AngioVac system, as an alternative to conventional surgery. We retrospectively reviewed all infected lead extractions performed with a prior debulking using the AngioVac system, between October 2016 and April 2022 at our institution. A total of 13 patients presented a mean of 2(1) infected leads after a mean of 5.7(5.7) years from implantation (seven implantable cardioverter-defibrillators, four cardiac resynchronization therapy-defibrillators, and two pacemakers). The AngioVac system was used as a venous−venous bypass in six cases (46.2%), venous−venous ECMO-like circuit (with an oxygenator) in five (38.5%), and venous−arterial ECMO-like circuit in two cases (15.4%). Successful (>70%) aspiration of the vegetations was achieved in 12 patients (92.3%) and an intraoperative complication (cardiac perforation) only occurred in 1 case (7.7%). Subsequent lead extraction was successful in all cases, either manually (38.5%) or using mechanical tools (61.5%). The AngioVac system is a promising effective and safe option for large vegetation debulking in CDRIE. Planning the extracorporeal circuit design may represent the optimal strategy to enhance the tolerability of the procedure and minimize adverse events.

Background: The 2020 severe acute respiratory syndrome coronavirus 2 outbreak entailed reduced availability of traditional (in-office) cardiology consultations. Remote monitoring is an alternative way of caring that may potentially mitigate the negative effects of the epidemic to the care of cardiovascular diseases. We evaluated the outcome of implantable cardioverter defibrillator (ICD) carriers followed up remotely in 2020 (epidemic period) versus 2019 (control)., Methods: We included all patients with an ICD who remained remotely monitored from the beginning to the end of each year. The combined end point included: new-onset atrial fibrillation; sustained ventricular tachycardia >170 bpm without ICD intervention; appropriate ICD intervention (either shock or antitachycardia pacing); any-cause death. Multiple events in the same patients were counted separately if occurring ≥48 h apart., Results: In 2020, 52 end points occurred in 37 of 366 (10%) ICD carriers [0.14/patient (95% confidence interval [CI] = 0.11-0.19)] versus 43 end points in 32 of 325 (10%) ICD carriers in 2019 [0.13/patient (95% CI = 0.10-0.18) P  = 0.75]. There was no difference between the distribution of any individual end point in 2020 versus 2019 although a nonsignificant mortality increase was observed (from 2.8% to 4.6%, P  = 0.19). The lowest weekly event rate occurred during the national lock down in spring 2020 but a similar trend occurred also in 2019 suggesting that the effect may not be linked to social distancing measures., Conclusions: We did not observe an increase in a combined end point including arrhythmic events and mortality in ICD carriers who were remotely monitored in 2020, compared to 2019, despite the negative impact of the coronavirus disease 2019 outbreak on the healthcare system., (Copyright © 2022 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Introduction: Predictors of late life-threatening arrhythmic events in Brugada syndrome (BrS) patients who received a prophylactic ICD implantation remain to be evaluated. The aim of the present long-term multicenter study was to assess the incidence and clinical-electrocardiographic predictors of late life-threatening arrhythmic events in BrS patients with a prophylactic implantable cardioverter defibrillator (ICD) and undergoing generator replacement (GR)., Methods: The study population included 105 patients (75% males; mean age 45 ± 14years) who received a prophylactic ICD and had no arrhythmic event up to first GR., Results: The median period from first ICD implantation to last follow-up was 155 (128-181) months and from first ICD Implantation to the GR was 84 (61-102) months. During a median follow-up of 57 (38-102) months after GR, 10 patients (9%) received successful appropriate ICD intervention (1.6%/year). ICD interventions included shock on ventricular fibrillation ( n = 8 patients), shock on ventricular tachycardia ( n = 1 patient), and antitachycardia pacing on ventricular tachycardia ( n = 1 patient). At survival analysis, history of atrial fibrillation (log-rank test; P = 0.02), conduction disturbances (log-rank test; P < 0.01), S wave in lead I (log-rank test; P = 0.01) and first-degree atrioventricular block (log-rank test; P = 0.04) were significantly associated with the occurrence of late appropriate ICD intervention. At Cox-regression multivariate analysis, S-wave in lead I was the only independent predictor of late appropriate ICD intervention (HR: 9.17; 95%CI: 1.15-73.07; P = 0.03)., Conclusions: The present study indicates that BrS patient receiving a prophylactic ICD may experience late appropriate intervention after GR in a clinically relevant proportion of cases. S-wave in lead I at the time of first clinical evaluation was the only independent predictor of persistent risk of life-threatening arrhythmic events. These findings support the need for GR at the end of service regardless of previous appropriate intervention, mostly in BrS patients with conduction abnormalities., Competing Interests: VM received an educational grant from the Enrico and Enrica Sovena Fundation, Italy. G-BC received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Boston Scientific, Acutus Medical. CA receives research grants on behalf of the center from Biotronik, Medtronic, Abbott, LivaNova, Boston Scientific, AtriCure, Philips, Acutus, and received compensation for teaching purposes and proctoring from Medtronic, Abbott, Biotronik, Livanova, Boston Scientific, Atricure, Acutus Medical, and Daiichi Sankyo. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 Migliore, Martini, Calo', Martino, Winnicki, Vio, Condello, Rizzo, Zorzi, Pannone, Miraglia, Sieira, Chierchia, Curcio, Allocca, Mantovan, Salghetti, Curnis, Bertaglia, De Lazzari, de Asmundis and Corrado.)

Background: Subcutaneous implantable cardioverter defibrillator (S-ICD) is a suitable alternative for transvenous ICD (TV-ICD) patients who have undergone transvenous lead extraction (TLE). Limited data are available on the outcome of S-ICD patients implanted after TLE. We assessed the safety, efficacy, and outcome of S-ICD implantation after TLE of TV-ICD., Methods: The study population consisted of 36 consecutive patients with a median age of 52 (44-66) years who underwent S-ICD implantation after TLE of TV-ICD., Results: Indications for TLE were infection (63.9%) and lead malfunction (36.1%). During a median follow-up of 31 months, 3 patients (8.3%) experienced appropriate therapy and 7 patients (19.4%) experienced complications including inappropriate therapy (n = 4; 11.1%), isolated pocket erosion (n = 2; 5.5%), and ineffective therapy (n = 1; 2.8%). No lead/hardware dysfunction was reported. Premature device explantation occurred in 4 patients (11%). Eight patients (22.2%) died during follow-up, six of them (75%) because of refractory heart failure (HF). There were no S-ICD-related deaths. Predictors of mortality included NYHA class ≥ 2 (HR 5.05; 95% CI 1.00-26.38; p = 0.04), hypertension (HR 22.72; 95% CI 1.05-26.31; p = 0.02), diabetes (HR 10.64; 95% CI 2.05-55.60; p = 0.001) and ischemic heart disease (HR 5.92; 95% CI 1.17-30.30; p = 0.01)., Conclusion: Our study provides evidences on the use of S-ICD as an alternative after TV-ICD explantation for both infection and lead failure. Mortality of S-ICD patients who underwent TV-ICD explantation does not appear to be correlated with the presence of a prior infection, S-ICD therapy (appropriate or inappropriate), or S-ICD complications but rather to worsening of HF or other comorbidities., (© 2022. The Author(s).)

Background: Recent studies have shown that Evolution RL bidirectional rotational mechanical sheath (Cook Medical, USA) is an effective and safe technique for transvenous lead extraction (TLE). We reported our experience with the bidirectional rotational mechanical tools using a multidisciplinary approach highlighting the value of a joint cardiac surgeon and electrophysiologist collaboration., Methods: The study population comprised 84 patients (77% male; mean age 65 ± 18 years) undergoing TLE. After a multidisciplinary evaluation, a combined procedure was considered., Results: The main indication for TLE was infection in 54 cases (64%). Overall, 152 leads were extracted with a mean implant duration of 94 ± 63 months (range 12-421). Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 91.6% (77/84), 97.6% (82/84), and 98.6% (150/152), respectively. Eighteen combined procedures were performed in 12 patients (14%), such as "hybrid approach" (n = 2) or TLE concomitant to: 1) transcatheter aspiration procedure for large vegetation (n = 8); 2) left ventricular assistance device implantation as bridge to cardiac transplantation (n = 1); 3) permanent pacing with epicardial leads (n = 6); 4) tricuspid valve replacement (n = 1). One major complication (1.2%) and 11 (13%) minor complications were encountered. No injury to the superior vena cava occurred and no procedure-related deaths were reported. During a mean time follow-up of 21 ± 18 months, 17 patients (20%) died. They were more often diabetics (p = .02), and they underwent TLE more often for infection (p = .004)., Conclusions: Our results support the finding that excellent outcomes can be achieved in performing TLE of chronically implanted leads by using the Evolution RL bidirectional rotational mechanical sheath and a multidisciplinary team approach involving both electrophysiologist and cardiac surgeon as first line operators., (© 2021 Wiley Periodicals LLC.)

Background: This report describes the findings of the 2019 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)., Methods: Data collection was retrospective. A standardized questionnaire was completed by each of the participating centers., Results: A total of 15 201 ablation procedures were performed by 91 institutions. Most (78%) of the centers has one electrophysiology laboratory, and 17% of them has a hybrid cardiac surgery laboratory. Almost all (98%) centers have a 3D mapping system. The median number of electrophysiologists and nurses involved in the electrophysiology laboratory was 3 and an electrophysiology technician was involved in 30% of all centers. In 88.4% of cases, ablations were performed for supraventricular arrhythmias, and among these the most frequently treated arrhythmia was atrial fibrillation (32.9%), followed by atrioventricular nodal reentrant tachycardia (23.9%), and common atrial flutter (11.7%). In 10 256 (67.4%) patients catheter ablation was performed by means of a 3D mapping system, with a "near-zero" fluoroscopic approach in 4626 (30.4%) of all patients., Conclusions: The 2019 Italian Catheter Ablation Registry confirmed that atrial fibrillation is the most commonly treated arrhythmia in the ablation centers with an increasing number of procedures performed with a 3D mapping system and a "near-zero" approach.

This study evaluated the potential of alternative treatments against larval stages of Lernaea cyprinacea . For in vitro test, the nanoemulsified oils of Pinus sp. acicule and oleoresin were evaluated, along with Biogermex® (commercial product based on citrus biomass). For this, the motility of five larvae of the same stage (nauplii or copepodite) were evaluated in a 96-well microplate. Using the best results, on the in vivo test, fries of Rhamdia quelen were submitted to a long-term immersion bath (96 h) containing different concentrations of the product diluted directly in the water. It was possible to notice the antiparasitic potential of the oleoresin and the acicule of Pinus sp., as well as the citrus biomass extract against the parasites. The nanoemulsified oils successfully inhibited the development of nauplii (10 mg L -1 in 24 h) and the fries showed to be tolerant to the presence of the compound (LC 50 96 h-16.74 mg L -1 ). The concentration of 30.5 mg L -1 of Biogermex® eliminated the copepodites within 24 h, being more efficient than Pinus sp. when tested at the same stage, at the times analyzed. The results obtained indicate a potential use of these compounds as prophylactic agents against L. cyprinacea ., Competing Interests: Conflict of interestThe authors have no conflicts of interest to declare., (© Indian Society for Parasitology 2021.)

From 2020, many countries have adopted several restrictions to limit the COVID-19 pandemic. The forced containment impacted on healthcare organizations and the everyday life of patients with heart disease. We prospectively analyzed data recorded from implantable defibrillators and/or cardiac resynchronization devices of Italian patients during the lockdown (LDP), post-lockdown period (PLDP) and a control period (CP) of the previous year. We analyzed device data of the period 9 March 2019-31 May 2020 of remotely monitored patients from 34 Italian centers. Patients were also categorized according to areas with high/low infection prevalence. Among 696 patients, we observed a significant drop in median activity in LDP as compared to CP that significantly increased in the PLDP, but well below CP (all p < 0.0001). The median day heart rate and heart rate variability showed a similar trend. This behavior was associated during LDP with a significant increase in the burden of atrial arrhythmias ( p = 0.0150 versus CP) and of ventricular arrhythmias [6.6 vs. 1.5 per 100 patient-weeks in CP; p = 0.0026]; the latter decreased in PLDP [0.3 per 100 patient-weeks; p = 0.0035 vs. LDP]. No modifications were recorded in thoracic fluid levels. The high/low prevalence of COVID-19 infection had no significant impact. We found an increase in the arrhythmic burden in LDP coupled with a decrease in physical activity and heart rate variability, without significant modifications of transthoracic impedance, independent from COVID-19 infection prevalence. These findings suggest a negative impact of the COVID-19 pandemic, probably related to lockdown restrictions.

Permanent His bundle pacing (HBP) has rapidly been adapted into clinical practice in recent years as a physiologic pacing. The 3830 (Medtronic Inc, MN, USA) pacing lead commonly used for HBP is lumenless, and there are limited reports available on extraction of this lead. No data exists on transvenous lead extraction (TLE) of very old HBP lead. Concerns remain about injury to the conduction system during extraction and the lack of lumen for placing a locking stylet for TLE when powered sheaths are required. We reported a unique case of TLE of very old HBP lead (14 years and 3 months) and other two leads, such as passive atrial and passive right ventricular apex backup., (© 2021 Wiley Periodicals LLC.)

Aims: This report describes the findings of the 2018 Italian Catheter Ablation Registry of the Italian Association of Arrhythmology and Cardiac Pacing (AIAC)., Methods: The Italian Catheter Ablation Registry systematically collects data on the ablation procedures performed in Italy. Data collection was retrospective. A standardized questionnaire was completed by participating centres., Results: We collected data on 15 714 catheter ablation procedures performed in Italy during 2018 in 94 electrophysiology centres. In most centres (75/94, 80%), a single electrophysiology laboratory was available, and a hybrid electrophysiology laboratory was available in 15% (14/94) of centres. In most (93%) centres, at least two electrophysiologists were involved in the catheter ablation procedures. In only 13 out of 94 (14%) electrophysiology laboratories, an anaesthesiologist assists every electrophysiology procedure; in most cases (74/94, 79%), an on-demand anaesthesiology service was available. On-site cardiothoracic surgery was reported in 43 out of 94 (46%) centres.Nonfluoroscopic navigation systems were available in most centres (88/94, 93%). Intracardiac echocardiography was used in 59 out of 94 (63%) electrophysiology laboratories. Atrial fibrillation (31%) was the most frequently treated ablation target, followed by atrioventricular nodal re-entrant tachycardia (20%) and cavo-tricuspid isthmus (15%). In 61.7% of all procedures, a 3D mapping system was used. In about one-third of procedures, a near-zero approach was performed., Conclusion: In most Italian electrophysiology centres, a single electrophysiology laboratory was available and at least two electrophysiologists were involved in the ablation procedures. An increasing number of procedures were performed by means of a nonfluoroscopic mapping system with a near-zero approach., (Copyright © 2021 Italian Federation of Cardiology - I.F.C. All rights reserved.)

Background: When an implantable-cardioverter defibrillator (ICD) lead becomes non-functional, a recommendation currently exists for either lead abandonment or removal. Lead abandonment and subcutaneous ICD (S-ICD) implantation may represent an additional option for patients who do not require pacing. The aim of this study was to investigate the outcomes of a strategy of lead abandonment and S-ICD implantation in the setting of lead malfunction. Methods: We analyzed all consecutive patients who underwent S-ICD implantation after abandonment of malfunctioning leads and compared their outcomes with those of patients who underwent extraction and subsequent reimplantation of a single-chamber transvenous ICD (T-ICD). Results: Forty-three patients underwent S-ICD implantation after abandonment of malfunctioning leads, while 62 patients underwent extraction and subsequent reimplantation of a new T-ICD. The two groups were comparable. In the extraction group, no major complications occurred during extraction, while the procedure failed and an S-ICD was implanted in 4 patients. During a median follow-up of 21 months, 3 major complications or deaths occurred in the S-ICD group and 11 in the T-ICD group (HR 1.07; 95% CI 0.29-3.94; P = 0.912). Minor complications were 4 in the S-ICD group and 5 in the T-ICD group (HR 2.13; 95% CI 0.49-9.24; P = 0.238). Conclusions: In the event of ICD lead malfunction, extraction avoids the potential long-term risks of abandoned leads. Nonetheless the strategy of lead abandonment and S-ICD implantation was feasible and safe, with no significant increase in adverse outcomes, and may represent an option in selected clinical settings. Further studies are needed to fully understand the potential risks of lead abandonment. Clinical Trial Registration: URL: ClinicalTrials.gov Identifier: NCT02275637., Competing Interests: ML and SV are employees of Boston Scientific. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Russo, Viani, Migliore, Nigro, Biffi, Tola, Bisignani, Dello Russo, Sartori, Rordorf, Ottaviano, Perego, Checchi, Segreti, Bertaglia, Lovecchio, Valsecchi and Bongiorni.)

Background: More and more heart failure (HF) patients aged ≥ 75 years undergo cardiac resynchronization therapy (CRT) device implantation, however the data regarding the outcomes and their predictors are scant. We investigated the mid- to long-term outcomes and their predictors in CRT patients aged ≥ 75 years., Methods: Patients in the Cardiac Resynchronization Therapy Modular (CRT MORE) Registry were divided into three age-groups: <65 (group A), 65-74 (group B) and ≥75 years (group C). Mortality, hospitalization, and composite event rate were evaluated at 1 year and during long-term follow-up., Results: Patients ( n = 934) were distributed as follows: group A 242; group B 347; group C 345. On 12-month follow-up examination, 63% of patients ≥ 75 years displayed a positive clinical response. Mortality was significantly higher in patients ≥ 75 years than in the other two groups, although the rate of hospitalizations for HF worsening was similar to that of patients aged 65-74 (7 vs. 9.5%, respectively; p = 0.15). Independent predictors of death and of negative clinical response were age >80 years, chronic obstructive pulmonary disease (COPD) and chronic kidney disease (CKD). Over long-term follow-up (1020 days (IQR 680-1362)) mortality was higher in patients ≥ 75 years than in the other two groups. Hospitalization and composite event rates were similar in patients ≥ 75 years and those aged 65-74 (9 vs. 11.8%; p = 0.26, and 26.7 vs. 20.5%; p = 0.06)., Conclusion: Positive clinical response and hospitalization rates do not differ between CRT recipients ≥ 75 years and those aged 65-74. However, age > 80 years, COPD and CKD are predictors of worse outcomes.

Aims: The aims of this study were to determine the rate and the predictors of early recurrences of atrial fibrillation (ERAF) after cryoballoon (CB) ablation and to evaluate whether ERAF correlate with the long-term outcome., Methods and Results: Three thousand, six hundred, and eighty-one consecutive patients (59.9 ± 10.5 years, female 26.5%, and 74.3% paroxysmal AF) were included in the analysis. Atrial fibrillation recurrence, lasting at least 30 s, was collected during and after the 3-month blanking period. Three-hundred and sixteen patients (8.6%) (Group A) had ERAF during the blanking period, and 3365 patients (Group B) had no ERAF. Persistent AF and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of ERAF. After a mean follow-up of 16.8 ± 16.4 months, 923/3681 (25%) patients had at least one AF recurrence. The observed freedom from AF recurrence, at 24-month follow-up from procedure, was 25.7% and 64.8% in Groups A and B, respectively (P < 0.001). ERAF, persistent AF, and number of tested anti-arrhythmic drugs ≥2 resulted as significant predictors of AF. In a propensity score matching, the logistic model showed that ERAF 1 month after ablation are the best predictor of long-term AF recurrence (P = 0.042)., Conclusion: In patients undergoing CB ablation for AF, ERAF are rare and are a strong predictor of AF recurrence in the follow-up, above all when occur >30 days after the ablation., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

Background: Myotonic dystrophy type 1 (DM1) is a multisystemic disorder characterized by progressive cardiac conduction impairment, arrhythmias, and sudden death. Mexiletine is a sodium channel blocker drug used by patients with DM1 for treatment of myotonia, even though definitive proof of its safety over long-term follow-up is lacking., Objective: The purpose of this study was to assess the impact of mexiletine for treatment of neurological symptoms on the composite endpoint of significant electrocardiogram modification (new onset or worsening of atrioventricular [AV] or intraventricular conduction delay) and bradyarrhythmic complications requiring pacemaker (PM) implantation (advanced AV block, symptomatic sinus pause >3 seconds)., Methods: This retrospective longitudinal study included a series of consecutive patients with genetically confirmed DM1 evaluated at our neurology and cardiology clinics from January 1, 2011, to January 1, 2020, who received mexiletine 200 mg twice daily. Patients with a PM, implantable cardioverter-defibrillator, or severe conduction abnormality (PQ interval ≥230 ms, complete bundle branch block, or atrial fibrillation) at enrollment were excluded., Results: The study comprised 18 mexiletine-treated patients and 68 mexiletine-free controls. Over median follow-up of 53 months, the endpoint was reached by 4 (22%) mexiletine-treated patients and 23 (33%) non-mexiletine-treated patients (log-rank P = .45). In 3 non-mexiletine-treated patients, bradyarrhythmic complications requiring PM implantation were observed. At univariable analysis, only the presence of mild conduction delay (first-degree AV block with PQ interval <230 ms or left anterior fascicular block) at baseline predicted the endpoint (hazard ratio 2.22; 95% confidence interval 1.04-4.76)., Conclusion: Mexiletine 200 mg twice daily is safe in patients with DM1 and no severe conduction abnormality., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The burden of premature atrial beats (PABs) at 24-h electrocardiographic (ECG) monitoring correlates with the risk of atrial fibrillation. It is unknown whether prolonged and intense exercise increases the burden of PABs, thus contributing to the higher prevalence of atrial fibrillation observed in middle-aged athletes., Methods: We compared the burden of PABs at 24-h ECG monitoring off therapy in 134 healthy middle-aged (30-60-year-old) competitive athletes who had practised 9 (7-11) h of endurance sports for 8 (4-15) consecutive years, 134 age- and gender-matched healthy sedentary individuals, and 66 middle-aged patients (20 athletes and 46 non-athletes) with 'lone' paroxysmal atrial fibrillation., Results: More than 50 PABs/24 h or ≥1 run of ≥3 PABs were recorded in 23/134 (17%) healthy athletes and in 29/134 (22%) sedentary controls ( p  = 0.61). Healthy athletes with frequent or repetitive PABs were older (median 50 years vs . 43 years, p  < 0.01) and had practised sport for a longer time (median 10 years vs . 6 years, p  = 0.03). At multivariable analysis only age (odds ratio 1.11, 95% confidence interval 1.04-1.20, p  < 0.01) remained an independent predictor of a higher burden of PABs. Also among patients with 'lone' paroxysmal atrial fibrillation, there was no difference in the prevalence of >50 PABs/24 h or ≥1 run of ≥3 PABs between athletes (40%) and controls (48%, p  = 0.74) ., Conclusions: Middle-aged endurance athletes, with or without paroxysmal atrial fibrillation, did not show a higher burden of PABs at 24-h ECG monitoring than sedentary controls. Age, but not intensity and duration of sports activity, predicted a higher burden of PABs among healthy athletes.

Several epidemiological studies found an association between acute exposure to fine particulate matter of less than 2.5 μm and 10 μm in aerodynamic diameter (PM 2.5 and PM 10 ) and cardiovascular diseases, ventricular fibrillation incidence and mortality. The effects of pollution on atrial fibrillation (AF) beyond the first several hours of exposure remain controversial. A total of 145 patients with implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy defibrillators (ICD-CRT), or pacemakers were enrolled in this multicentric prospective study. Daily levels of PM 2.5 and PM 10 were collected from monitoring stations within 20 km of the patient's residence. A Firth Logistic Regression model was used to evaluate the association between AF and daily exposure to PM 2.5 and PM 10 . Exposure levels to PM 2.5 and PM 10 were moderate, being above the World Health Organization (WHO) PM 2.5 and PM 10 thresholds of 25 μg/m 3 and 50 μg/m 3 , respectively, on 26% and 18% of the follow-up days. An association was found between daily levels of PM 2.5 and PM 10 and AF (95% confidence intervals (CIs) of 1.34-2.40 and 1.44-4.28, respectively) for an increase of 50 µg/m 3 above the WHO threshold. Daily exposure to moderate PM 2.5 and PM 10 levels is associated with AF in patients who are not prone to AF.

Objective: To estimate the prevalence of unknown atrial fibrillation (AF) in the elderly population of the Veneto Region, Italy., Methods: 1820 patients aged ≥ 65 years with no history of AF and not anticoagulated were enrolled in primary-care settings. They underwent an opportunistic electrocardiogram screening with a handheld device (MyDiagnostick) designed to specifically detect AF. The electrocardiogram recordings were reviewed by the researchers, who confirmed the presence of AF., Results: The device detected an arrhythmia in 143 patients, which was confirmed as AF in 101/143 (70.6%), with an overall prevalence of AF of 5.5% (101/1820). Prevalence of unknown AF resulted in 3.6% in patients aged 65-74 years, and 7.5% in patients age 75 or older, and increased according to CHA 2 DS 2 -VASc score: 3.5% in patients with a score of 1 or 2, 5.6% in patients with a score of 3, 7.0% in patients with a score of 4, and 7.2% in patients with a score ≥ 5. The detection rate was significantly higher in patients with mild symptoms compared to asymptomatic counterparts (24.1% vs. 4.0%, P < 0.0001). At multivariate analysis, congestive heart failure and age ≥ 75 years-old were independent predictors for screen-detected AF., Conclusions: An opportunistic screening with handheld device revealed an unexpectedly high prevalence of unknown AF in elderly patients with mild symptoms. Prevalence increased with age and CHA 2 DS 2 -VASc score., (Copyright and License information: Journal of Geriatric Cardiology 2020.)

Background: Pulmonary vein isolation (PVI) is the most widely adopted strategy for paroxysmal atrial fibrillation (PAF) ablation. Limited evidence on acute results and late outcomes of cryoballoon (CB)-PVI in patients with structural heart disease (SHD) exist. The aim of this analysis was to compare acute procedural results and the 1-year recurrence rate of a single CB-PVI procedure in a PAF population with and without SHD., Method: From April 2012 to May 2017, a total of 2,031 patients with AF underwent CB-PVI and were followed prospectively in the framework of the One Shot TO Pulmonary vein isolation (1STOP) ClinicalService project, involving 36 Italian cardiology centres. We identified patients with SHD according to criteria proposed by current ESC guidelines: left ventricular (LV) systolic or diastolic dysfunction, long-standing hypertension with LV hypertrophy, and/or other structural heart disease. Data on procedural outcomes and long-term freedom from AF recurrence were evaluated., Results: Our population consisted of 1,452 patients, of whom 282 (19.4%) were classified as having SHD. Compared to non-SHD patients, the SHD cohort was older (mean ± standard deviation, 62.9 ± 9.0 vs 58.2 ± 11.4 years; p < 0.001), was more frequently male (79.1% vs 69.8%; p < 0.002), had a higher thrombo-embolic risk (CHA 2 DS 2 VASc ≥2: 63.4% vs 40.2%; p < 0.001), had a higher body mass index (27.7 ± 3.9 vs 26.4 ± 3.9 kg/m 2 ; p < 0.001), had a larger atrial diameter (43.8 ± 7.0 vs 40.2 ± 5.8 mm; p < 0.001), and had a lower LV ejection fraction (57.2 ± 7.7% vs 60.7 ± 6.0%; p < 0.001). At the time of ablation, 73% of patients were on class Ic or III anti-arrhythmic drugs. Procedure time (106.9 ± 41.5 vs 112.1 ± 46.8 min; p = 0.248), fluoroscopic time (28.7 ± 14.7 vs 28.6 ± 15.2 min; p = 0.819), and complication rate (3.9% vs 4.8%; p = 0.525) were not different between the SHD and non-SHD cohorts. However, the acute success rate (98.9% vs 97.7%; p = 0.016) was higher in patients with SHD. After a follow-up of 13.4 ± 12.8 months, freedom from symptomatic recurrence was 78.0% for SHD and 78.4% for non-SHD (p = 0.895). Recurrence rate was not related to either left atrial size or LVEF. In the SHD cohort, Class Ic or III anti-arrhythmic drugs treatment decreased from 70.7% of patients before ablation to 28.7% of patients after CB-PVI (p = 0.001)., Conclusions: CB-PVI was extensively applied to treat patients with PAF. Unlike previous PVI experiences, the acute success and recurrence rate after a single procedure was not related to the presence of SHD or to the degree of cardiac remodelling. Further studies are required to define whether CB-PVI has a useful role in patients with a significantly reduced ejection fraction as those patients were under-represented in the current population., (Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand. Published by Elsevier B.V. All rights reserved.)

Background: Ablation index (AI) is a new lesion quality marker that has been demonstrated to allow a high single-procedure arrhythmia-free survival in single-center studies. This prospective, multi-center study was designed to evaluate the reproducibility of pulmonary vein (PV) isolation guided by the AI., Methods: A total of 490 consecutive patients with paroxysmal (80.4%) and persistent AF underwent first time PV isolation and were divided in four study groups according to operator's preference in choosing the ablation catheter (a contact force (ST) or contact force surround flow (STSF) catheter) and the AI setting (330-450 or 380-500 at anterior wall or posterior wall, respectively)., Results: At 12 months a high rate of freedom from AF recurrences was observed in patients with both paroxysmal and persistent AF (91% vs 83.3%; P = .039). There was no difference in the rate of AF recurrence among the four study groups (4.5% in group ST330-450, 12.2% in group ST 380-500, 14.9% in group STSF330-450, 9.4% in group STSF380-500; P = .083). Recurrence was also similar between patients treated with a ST (8%) or STSF catheter (12.1%; P = .2), and within patients targeting an AI settings of 330 to 450 (10.9%) or 380 to 500 (10.3%; P = .64). In patients with paroxysmal AF, there was no difference (P = .12) in the 1-year freedom from AF recurrence among 14 operators that performed ≥10 ablation procedure., Conclusions: An ablation protocol respecting strict criteria for contiguity and quality lesion resulted in high rate of 1-year freedom from AF recurrence, irrespective of the ablation catheters, AI settings, and operator., (© 2020 Wiley Periodicals LLC.)

Background: Axillary vein access (AVA) using fluoroscopic landmarks is an effective and safe approach for cardiac implantable electronic devices (CIEDs) implantation. However, it may result in a higher radiation exposure. Ultrasound-guided axillary access (USAA) is an effective alternative technique to conventional subclavian access for CIEDs implantation. Studies comparing USAA and AVA using fluoroscopic landmarks are lacking. The purpose of this study was to compare the safety, efficacy, and radiation exposure data of the USAA approach with the AVA using fluoroscopic landmarks., Methods: The study population included 95 consecutive patients (61% male, median age 78 years [71-85 years]) referred for CIEDs implantation using AVA with fluoroscopic landmark (n = 46) or USAA (n = 49). Baseline characteristics and radiation exposure data (Air-Kerma [mGy], DAP [Gy-cm 2 ], fluoroscopy time [seconds], and X-rays emission time [seconds]) were compared according to the technique used for the AVA., Results: Axillary vein was successfully accessed in 45 of 49 (92%) patients using ultrasound and in 42 of 46 (91%) patients using fluoroscopic landmarks (P = 1.00). Air-Kerma, DAP, fluoroscopy time, and X-rays emission time were shorter for USAA group compared with AVA using fluoroscopic landmarks (11 mGy [8-20] vs 37 mGy [24-81], P < .00001; 3 Gy-cm 2 [2-5] vs 10 Gy-cm 2 [6-16], P < .00001; 97 seconds [62-163] vs 271 seconds [185-365], P < .00001; and 7 seconds [4-10] vs 21 seconds [13-39], P < .00001). There were no significant differences between the two groups in median implant procedure time (P = .55). We did not encounter any acute or long-term complications in both groups., Conclusions: Ultrasound-guided axillary vein cannulation for CIEDs implantation is a feasible and safe alternative approach and offers a significant reduction in fluoroscopy times without increasing procedural time., (© 2020 Wiley Periodicals LLC.)

Introduction: Early evidence suggests that multipoint left ventricular pacing (MPP) may improve response to cardiac resynchronization therapy (CRT). It is unknown whether this benefit is sustained and cost-effective. We used real-world data to evaluate long-term impact of MPP-ON clinical status, heart failure hospitalizations (HFH) and costs., Methods: The Italian registry on multipoint left ventricular pacing is a prospective, multicenter registry of patients implanted with MPP-enabled CRT devices. For this analysis, clinical and echocardiographic data were collected through 24 months and compared between patients with (MPP-ON) or without (MPP-OFF) early MPP activation at implant. The total cost of each HFH was estimated with national Italian reimbursement rates., Results: The study included 190 MPP-OFF and 128 MPP-ON patients with similar baseline characteristics. At 1 and 2 years, the MPP-ON group had lower rates of HFH vs MPP-OFF (1-year hazard ratio [HR]: 0.14, P = .0014; 2-year HR: 0.38, P = .009). The finding persisted in a subgroup of patients with consistent MPP activation through follow-up (1-year HR: 0.19; P = .0061; 2-year HR: 0.39, P = .022). Total HFH per-patient costs were lower in the MPP-ON vs the MPP-OFF group at 1 year (€101 ± 50 vs €698 ± 195, P < .001) and 2 years (€366 ± 149 vs €801 ± 203, P = .038). More MPP-ON patients had ≥5% improvement in ejection fraction (76.8% vs 65.4%, P = .025) and clinical composite score (66.7% vs 47.5%, P = .01)., Conclusions: In this multicenter clinical study, early MPP activation was associated with a significant reduction in cumulative HFH and related costs after 1 and 2 years of follow-up., (© 2020 Wiley Periodicals, Inc.)

Purpose: Operative anaesthetic requirements and perioperative discomfort are barriers to wide adoption of the subcutaneous implantable cardioverter defibrillator (S-ICD) system, especially when the intermuscular technique is used because of the greater amount of tissue dissection. The procedure is most commonly performed under general anaesthesia (GA). There is growing interest in transitioning away from the routine use of GA and towards several alternative anaesthesia modalities for the S-ICD implant procedure without the involvement of an anaesthesiologist. We assessed the feasibility of ultrasound-guided serratus anterior plane block (US-SAPB) in patients undergoing S-ICD implantation with the intermuscular two-incision technique., Methods: The study population included 38 consecutive patients (84% male; median, 53 [46-62] years) who received S-ICD implantation using the intermuscular two-incision technique. All procedures were performed under US-SAPB and conscious sedation without the involvement of an anaesthesiologist., Results: The average procedure time was 67 ± 14 min. No patient experienced significant haemodynamic changes or oxygen desaturation during the period of the US-SAPB procedure and sedation; there was no need for pharmacological interventions. The entire procedure was well tolerated without discomfort or complications and with no need for GA, except in one (2.6%) patient who received GA with a laryngeal mask airway. Patients always remained able to respond appropriately to neurological monitoring during the S-ICD implantation procedure. There were no procedure-related complications., Conclusions: US-SAPB and the intermuscular two-incision technique may be a promising safe and feasible combination for S-ICD implantation, overcoming the potential barrier to wider S-ICD adoption in clinical practice.

For some years now, direct-acting oral anticoagulants (DOACs) have entered the clinical practice for stroke prevention in non-valvular atrial fibrillation (NVAF) or prevention and treatment of venous thromboembolism (VTE). However, there is uncertainty on DOAC use in some clinical scenarios not fully explored by clinical trials, but commonly encountered in the real world. We report a Delphi Consensus on DOAC use in NVAF and VTE patients. The consensus dealt with 16 main topics: (1) clinical superiority of DOACs compared to VKAs; (2) DOACs as a first-line treatment in patients with AF; (3) therapeutic options for patients undergoing electrical cardioversion; (4) selection of patients suitable for switching from VKAs to DOACs; (5) and (7) role of general practitioners in the follow-up of patients receiving a DOAC; (6) duties of Italian oral anticoagulation therapy centers; (8) role of therapy with DOACs in oncological patients with NVAF; (9) role of DOACs in oncological patients with VTE; (10) methods for administration and therapy compliance for DOACs; (11) drug interactions; (12) safety of low doses of DOACs; (13) therapeutic management of frail patients with NVAF; (14) therapeutic management of NVAF patients with glomerular filtration rate <30 ml/min (15); advantages of DOACs for the treatment of frail patients; (16) limitations on therapeutic use of DOACs. Sixty-two cardiologists from Italy expressed their level of agreement on each statement by using a 5-point Likert scale (1: strongly disagree, 2: disagree, 3: somewhat agree, 4: agree, 5: strongly agree). Namely, votes 1-2 were considered as disagreement while votes 3-5 as agreement. Agreement among the respondents of ≥66% for each statement was considered consensus. A brief discussion about the results for each topic is also reported.

Aims: Pocket hematoma is a common complication of cardiac implantable electronic device (CIED) procedures. the aim of the study was to research the clinical factors associated with pocket hematoma formation after CIED implantation or replacement and to identify the best perioperative antithrombotic management., Methods: We retrospectively analyzed 500 consecutive patients who underwent to CIED implantation or replacement at our center from November 2014., Results: Among our population, 206 patients (41.2%) were on anticoagulant therapy at the time of the intervention: 68 (13.6%) on ongoing Warfarin; 111 (22.2%) on low-molecular-weight heparin (LMWH); and 27 (5.4%) on ongoing direct oral anticoagulants. Antiplatelet therapy was present in 262 (52.4%) patients: in particular, 50 (10%) were on dual antiplatelet therapy, 64 (12.8%) were on single antiplatelet therapy and anticoagulant therapy, whereas 12 (2.4%) were on anticoagulant with dual antiplatelet therapy.Incidence of pocket hematoma after CIEDs implantation was of 4.6%. Considering the different perioperative anticoagulant strategies, patients on LMWH presented the higher hematoma rate [11/100 patients (11.0%), P < 0.001]. At the multivariate analysis, anticoagulant with dual antiplatelet therapy (P = 0.021, OR 6.3, IC 1.3-30.8), left ventricular ejection fraction (LVEF) less than 30% (P < 0.001, OR 7.4, IC 2.7-20.4), and use of LMWH (P = 0.008, OR 3.8, IC 1.4-10.6) resulted the strongest predictors of pocket hematoma (Hosmer test = 0.899).Considering replacement procedures, incidence of pocket hematoma was of 4.4%. The incidence was higher after ICD/CRT-D replacement. The majority of pocket hematoma occurred in patients with mechanical valve prosthesis (3/4 cases, 75%, P < 0.001)., Conclusion: The use of LMWH and a low LVEF expose patients to a higher risk of pocket hematoma after CIED procedures. Anticoagulant with dual antiplatelet therapy and LMWH should be avoided.

Background: Multipoint pacing (MPP) may improve clinical outcomes in patients with cardiac resynchronization therapy defibrillators (CRT-D), but its impact on battery longevity in a real-world population has not been investigated in large trials., Objective: Compare projected battery longevity in CRT-D patients with and without MPP during long-term follow-up., Methods: The Italian registry on multipoint left ventricular pacing (IRON-MPP) is a prospective, multicenter registry of patients implanted with MPP-capable CRT-D devices. Projected battery longevity during follow-up was compared for patients with MPP (MPP ON) vs single-site (MPP OFF) left ventricular pacing at CRT-D implantation. A sub-analysis excluded crossover patients with MPP activation or deactivation occurring after implantation. A second sub-analysis excluded patients with a right or left ventricular pacing amplitude >2.5 V., Results: Out of 237 CRT-D patients (71 ± 9 years, 81% male) followed for 1.9 ± 0.8 years, 102 (43%) had MPP ON at implantation. Programmed atrial and ventricular outputs and percentage of pacing were similar between groups. MPP was associated with a 0.44 years reduction in projected battery longevity (P = .03) during long-term follow-up. Results were similar for the first and second sub-analyses, with a 0.57 years (P < .001) and 0.71 years (P < .001) reduction in projected longevity, respectively., Conclusion: In this long-term real-world registry, early MPP activation is associated with less than a 1-year reduction in projected battery life compared to single-site biventricular pacing., (© 2019 Wiley Periodicals, Inc.)

Overcoming lead-related complications, the subcutaneous implantable cardioverter-defibrillator (S-ICD) represents the greatest advancement in the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Due to the absence of leads within the body, the S-ICD requires an innovative approach for sensing of subcutaneous signals and defibrillation. The aim of this review is to analyze the current evidence regarding patient selection, technical aspects such as the implant technique, programming and follow-up, as well as complications and troubleshooting of this innovative technology.