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The Wind Atlas of Italy, first developed in 2002, was refined by ERSE (former CESI RICERCA S.p.A.) in 2006, when it was also enlarged to offshore areas up to 40 km from the coastline. It displays maps of annual average wind speed (m/s) and specific energy production (MWh/MW) up to 100 m above ground or sea. This Atlas is published in an interactive version (named ATLAEOLICO). The Italian Wind Atlas is based on maps calculated using the WINDS model developed by the Department of Physics of the University of Genoa and has then been fine-tuned by comparison with measuring data from over 400 stations scattered all over Italy. Concerning offshore areas, the calibration of maps resulted more difficult because of the lack of direct measurements. The resulting uncertainty of wind maps over offshore areas has been estimated from a minimum of 2 m/s to a maximum of more than 3 m/s, which results in an uncertainty of no less than 1000 MWh/MW in specific energy production, too high for reliable evaluation of energy production. To reduce this uncertainty, a new wind measuring station has recently been installed at Pianosa, a small uninhabited and flattish island located in the Adriatic Sea off the Gargano promontory, one of the offshore areas with higher discordance of wind speed values among the various maps published so far. This island could also be taken as representative of the transition from the southern zone with better resources to the less promising northern part of the Adriatic Sea. This paper presents the results of the first eight months of measurements at this station. These results have been analyzed by commercial codes for wind resource assessment and then compared with available information on wind resources in the same area, mostly measurements from satellite and coastal stations, and other published wind atlases. [ABSTRACT FROM AUTHOR]

Background: Epicardial access is often crucial for successful ventricular tachycardia (VT) ablation, but it is often burdened by significant procedural risk. Intentional coronary vein exit and intrapericardial CO 2 insufflation (EpiCO 2 ) can facilitate subxiphoid pericardial access., Objective: This prospective study aimed to assess procedural feasibility, safety, and impact of the introduction of intrapericardial CO 2 insufflation for epicardial access in a referral center for VT ablation., Methods: All consecutive patients treated with epicardial VT ablation between November 2022 and January 2024 with the EpiCO 2 technique at Pisa University Hospital were prospectively enrolled and compared in terms of feasibility, efficiency, and safety with a local retrospective cohort of patients treated with subxiphoid dry puncture between July 2018 and October 2022., Results: Twenty-two consecutive patients (90.9% male; mean age, 54.3 years) underwent VT ablation with EpiCO 2 during the study period. Epicardial access was achieved in all patients; median time from coronary sinus (CS) cannulation to epicardial access was 33 minutes. Intentional vein exit was successful in all cases, whereas CO 2 insufflation was not feasible in 1 patient. There were no major complications and no significant bleeding. Since EpiCO 2 introduction, epicardial approach utilization increased from 17.8% to 40% of all VT procedures. Comparison with 20 standard dry approach epicardial ablations showed no significant differences in terms of total procedural duration (322.5 [interquartile range, 296.75-363.75] minutes vs 359 [interquartile range, 323-409] minutes; P = .08)., Conclusion: In our single-center experience, EpiCO 2 was feasible and safe and led to significant increase in procedural volume without affecting total procedural time compared with standard dry puncture., Competing Interests: Disclosures The authors have no conflicts to disclose., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: The legalization of cannabis use and false claims about the plant Cannabis sativa to be considered a pharmaceutical product have been found to increase consumption, lower risk perception, and lead to more health problems, without reducing criminal activity. Brain function, typically assessed by neuropsychological tests, shows abnormalities with acute marijuana use, but inconsistent results have been published after abstinence, with a maximum follow-up of 28 days. Our previous research, using neuropsychological tests and brain perfusion single photon emission computed tomography (neuroSPECT), demonstrated consistent abnormalities in brain function among schoolchildren who consume marijuana compared to their non-consuming peers. The aim of this study is to investigate whether brain function changes in 20 adult marijuana users after 6 months of abstinence., Methodology: Comparison of neuropsychological tests (Rey Complex Figure; Porteus Maze; Four subtests of WAIS-IV Intellectual Tests; STROOP; D2) and perfusion neuroSPECT (functional images), obtained in relation to recent consumption and after 6 months of serial drug-screening test confirmed abstinence., Results: In a one-year period (2020-2021) only five compliant participants were recruited. The COVID-19 pandemic was a limiting factor. Preliminary results of neuropsychological tests, functional brain perfusion images and limited statistical analysis are presented. The results of the neuropsychological tests of the three subjects who completed the abstinence period so far show some improvement in working memory and attention after abstinence. NeuroSPECT shows disorganized hypoperfusion of variable severity in relation to recent consumption, involving areas associated with cognitive function such as the posterior cingulate and temporal lobes, in our five initially enrolled patients, when compared to a normal database. Of these, only two participants have already been re-evaluated with neuroSPECT after 6 months of abstinence, one of whom showed some improvement on the post-abstinence images., Conclusion: We analyze the methodological challenges of this research, including the pandemic, to incorporate the appropriate corrections in the next phase of our investigation. Our final findings may provide clinicians and users with information about the long-term effects of marijuana use on brain function.

Purpose: We evaluated the clinical impact of the high-density (HD) mapping compared with the standard low-density (LD) ablation catheter mapping technique in the treatment of AFLs., Methods: We retrospectively evaluated short and long outcomes of patients approached with an HD and a LD electro-anatomical strategy for atypical AFLs., Results: Eighty-seven patients were included. Patients were almost male (60%), relatively old (65 ± 8 years), with a moderate CHA2DS2Vasc score (2.3 ± 1.3), a preserved ejection fraction (58 ± 6), and moderate atrial dilatation (44 ± 7 mm). Baseline clinical characteristics were comparable between groups (p = NS). Among AFLs, 10 (11%) were located in the right and 78 (89%) in the left atrium, including 22 (28%) roof dependent and 37 (47%) mitral dependent (p = NS). Sinus rhythm restoration during ablation was more frequently observed in the HD group (79% vs 56%, p = 0.037), without differences in mapping time, procedural time, and radiological dose (p = NS). Overall AFL/AT/AF recurrence rate at 1, 2, and 3 years was lower in the HD group (14% vs 37% p = 0.02, 14% vs 48% p = 0.002 and 14% vs 50% p < 0.001, respectively) with a time-dependent trend only in the LD group (37% vs 48% vs 50% at 1, 2, and 3 years respectively, p = 0.059). HD mapping (OR 0.17; 95% CI 0.04-0.66) and younger age (OR 1.09; 95% CI 1.01-1.19) resulted independent predictors of overall arrhythmias at follow-up., Conclusions: Short- and long-term outcomes of atypical AFL ablation were better in the case of HD mapping, which resulted independent predictor of arrhythmia recurrences., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Existing data on the impact of sex differences on transvenous lead extraction (TLE) outcomes in cardiac device patients are limited., Objective: The purpose of this study was to evaluate the safety and efficacy of mechanical TLE in female patients., Methods: A retrospective evaluation was performed on 3051 TLE patients (group 1: female; group 2: male) from a single tertiary referral center. All individuals received treatment using single sheath mechanical dilation and various venous approaches as required., Results: Our analysis included 3051 patients (group 1: 750; group 2: 2301), with a total of 5515 leads handled with removal. Female patients were younger, had a higher left ventricular ejection fraction, and lower prevalences of coronary artery disease and diabetes mellitus. Infection was more common in male patients, whereas lead malfunction or abandonment were more frequent in female patients. Radiologic success was lower in female patients (95.8% vs 97.5%; P = .003), but there was no significant difference in clinical success between groups (97.2% vs 97.5%; P = .872). However, major complications (1.33% vs 0.60%; P <.001) and procedural mortality (0.4% vs 0.1%; P <.001) were higher in females compared to male patients. After multivariate analysis, female sex emerged as the only predictor of major complications, including deaths (odds ratio 3.96; 95% confidence interval 1.39-11.24)., Conclusion: TLE using unpowered simple mechanical sheaths in female patients is safe and effective, but is associated with lower radiologic success and higher complication rates and mortality than in males. This finding underscores the importance of recognizing sex differences in TLE outcomes., (© 2023 Heart Rhythm Society. Published by Elsevier Inc.)

Aims: Patients with cardiomyopathies and channelopathies are usually younger and have a predominantly arrhythmia-related prognosis; they have nearly normal life expectancy thanks to the protection against sudden cardiac death provided by the implantable cardioverter defibrillator (ICD). The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD and has evolved over the years. This study aimed to evaluate the rate of inappropriate shocks (IS), appropriate therapies, and device-related complications in patients with cardiomyopathies and channelopathies who underwent modern S-ICD implantation., Methods and Results: We enrolled consecutive patients with cardiomyopathies and channelopathies who had undergone implantation of a modern S-ICD from January 2016 to December 2020 and who were followed up until December 2022. A total of 1338 S-ICD implantations were performed within the observation period. Of these patients, 628 had cardiomyopathies or channelopathies. The rate of IS at 12 months was 4.6% [95% confidence interval (CI): 2.8-6.9] in patients with cardiomyopathies and 1.1% (95% CI: 0.1-3.8) in patients with channelopathies (P = 0.032). No significant differences were noted over a median follow-up of 43 months [hazard ratio (HR): 0.76; 95% CI: 0.45-1.31; P = 0.351]. The rate of appropriate shocks at 12 months was 2.3% (95% CI: 1.1-4.1) in patients with cardiomyopathies and 2.1% (95% CI: 0.6-5.3) in patients with channelopathies (P = 1.0). The rate of device-related complications was 0.9% (95% CI: 0.3-2.3) and 3.2% (95% CI: 1.2-6.8), respectively (P = 0.074). No significant differences were noted over the entire follow-up. The need for pacing was low, occurring in 0.8% of patients., Conclusion: Modern S-ICDs may be a valuable alternative to transvenous ICDs in patients with cardiomyopathies and channelopathies. Our findings suggest that modern S-ICD therapy carries a low rate of IS., Clinical Trial Registration: URL: http://clinicaltrials.gov/Identifier: NCT02275637., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: The implantable cardioverter-defibrillator (ICD) is a life-saving therapy in patients with hypertrophic cardiomyopathy (HCM) at risk of sudden cardiac death. Implantable cardioverter-defibrillator complications are of concern. The subcutaneous ICD (S-ICD) does not use transvenous leads and is expected to reduce complications. However, it does not provide bradycardia and anti-tachycardia pacing (ATP). The aim of this study was to compare appropriate and inappropriate ICD interventions, complications, disease-related adverse events and mortality between HCM patients implanted with a S- or transvenous (TV)-ICD., Methods and Results: Consecutive HCM patients implanted with a S- (n = 216) or TV-ICD (n = 211) were enrolled. Propensity-adjusted cumulative Kaplan-Meier curves and multivariate Cox proportional hazard ratios were used to compare 5-year event-free survival and the risk of events. The S-ICD patients had lower 5-year risk of appropriate (HR: 0.32; 95%CI: 0.15-0.65; P = 0.002) and inappropriate (HR: 0.44; 95%CI: 0.20-0.95; P = 0.038) ICD interventions, driven by a high incidence of ATP therapy in the TV-ICD group. The S- and TV-ICD patients experienced similar 5-year rate of device-related complications, albeit the risk of major lead-related complications was lower in S-ICD patients (HR: 0.17; 95%CI: 0.038-0.79; P = 0.023). The TV- and S-ICD patients displayed similar risk of disease-related complications (HR: 0.64; 95%CI: 0.27-1.52; P = 0.309) and mortality (HR: 0.74; 95%CI: 0.29-1.87; P = 0.521)., Conclusion: Hypertrophic cardiomyopathy patients implanted with a S-ICD had lower 5-year risk of appropriate and inappropriate ICD therapies as well as of major lead-related complications as compared to those implanted with a TV-ICD. Long-term comparative follow-up studies will clarify whether the lower incidence of major lead-related complications will translate into a morbidity or survival benefit., Competing Interests: Conflict of interest: P.F. received speaker fees from Boston Scientific (BS) and research grants from Abbott and BS. M.Z. received speaker fees from Abbott, Biotronik, and BS. P.D.F. received speaker fees from Abbott, BS, and Medtronic. M.L. is an employee of BS., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: Subcutaneous implantable cardioverter-defibrillator (S-ICD) therapy is expanding rapidly. However, there are few data on the S-ICD extraction procedure and subsequent patient management. The aim of this analysis was to describe the procedure, management, and outcome of S-ICD extractions in clinical practice., Methods and Results: We enrolled consecutive patients who required complete S-ICD extraction at 66 Italian centres. From 2013 to 2022, 2718 patients undergoing de novo implantation of an S-ICD were enrolled. Of these, 71 required complete S-ICD system extraction (17 owing to infection). The S-ICD system was successfully extracted in all patients, and no complications were reported; the median procedure duration was 40 (25th-75th percentile: 20-55) min. Simple manual traction was sufficient to remove the lead in 59 (84%) patients, in whom lead-dwelling time was shorter [20 (9-32) months vs. 30 (22-41) months; P = 0.032]. Hospitalization time was short in the case of both non-infectious [2 (1-2) days] and infectious indications [3 (1-6) days]. In the case of infection, no patients required post-extraction intravenous antibiotics, the median duration of any antibiotic therapy was 10 (10-14) days, and the re-implantation was performed during the same procedure in 29% of cases. No complications arose over a median of 21 months., Conclusion: The S-ICD extraction was safe and easy to perform, with no complications. Simple traction of the lead was successful in most patients, but specific tools could be needed for systems implanted for a longer time. The peri- and post-procedural management of S-ICD extraction was free from complications and not burdensome for patients and healthcare system., Clinical Trial Registration: URL: http://clinicaltrials.gov/Identifier: NCT02275637., Competing Interests: Conflict of interest: R.R. received speaker fees from Abbot and Boston Scientific. L.O. is a consultant for Boston Scientific. P.F. received speaker fees from Boston Scientific and research or educational grants from Abbott and Boston Scientific. G.L.B. reports speaker fees (small amount) from Boston Scientific, Medtronic, Biotronik, Abbot, Microport, and Zoll. M.L. and S.V. are employees of Boston Scientific. The other authors report no conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: In subcutaneous implantable cardioverter defibrillator (S-ICD) recipients, the UNTOUCHED study demonstrated a very low inappropriate shock rate on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice is still unknown, as is its impact on the rates of inappropriate and appropriate therapies., Methods and Results: We assessed ICD programming on implantation and during follow-up in a cohort of 1468 consecutive S-ICD recipients in 56 Italian centres. We also measured the occurrence of inappropriate and appropriate shocks during follow-up. On implantation, the median programmed conditional zone cut-off was set to 200 bpm (IQR: 200-220) and the shock zone cut-off was 230 bpm (IQR: 210-250). During follow-up, the conditional zone cut-off rate was not significantly changed, while the shock zone cut-off was changed in 622 (42%) patients and the median value increased to 250 bpm (IQR: 230-250) (P < 0.001). UNTOUCHED-like programming of detection cut-offs was adopted in 426 (29%) patients immediately after device implantation, and in 714 (49%, P < 0.001) at the last follow-up. UNTOUCHED-like programming was independently associated with fewer inappropriate shocks (hazard ratio 0.50, 95%CI 0.25-0.98, P = 0.044), and had no impact on appropriate and ineffective shocks., Conclusions: In recent years, S-ICD implanting centres have increasingly programmed high arrhythmia detection cut-off rates, at the time of implantation in the case of new S-ICD recipients, and during follow-up in the case of pre-existing implants. This has contributed significantly to reducing the incidence of inappropriate shocks in clinical practice. Rordorf: Programming of the S-ICD., Clinical Trial Registration: URL: http://clinicaltrials.gov/Identifier: NCT02275637., Competing Interests: Conflict of interest: R.R. received speaker fees from Abbot and Boston Scientific. P.F. received speaker fees from Boston Scientific and research or educational grants from Abbott and Boston Scientific. G.L.B. reports speaker fees (small amount) from Boston Scientific, Medtronic, Biotronik, Abbot, Microport, Zoll. M.L. and S.V. are employees of Boston Scientific. The other authors report no conflicts., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Aims: A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket., Methods and Results: We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17-0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30-0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50-1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction., Conclusion: Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks., Clinical Trial Registration: Clinical Trial Registration: ClinicalTrials.gov; NCT02275637., Competing Interests: Conflict of interest: M.L. and S.V. are employees of Boston Scientific. G.L.B. received speaker’s fee from Abbott, Biotronik, Boston Scientific, Medtronic, and Microport; P.F. received speaker’s fees and educational grants from Boston Scientific and research grants from Abbott. R.R. received speaker’s fees from Abbot and Boston Scientific. The other authors report no conflicts of interest., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Introduction: Transcatheter atrial fibrillation (AF) ablation is still carried out with continuous invasive radial arterial blood pressure (IBP) monitoring in many centers. Continuous noninvasive blood pressure (CNBP) measurement using the volume-clamp method is a noninvasive alternative method used in ICU. No data on CNBP reliability are available in the electrophysiology lab during AF ablation, where rhythm variations are common., Background: The objective of the present study was to compare continuous noninvasive arterial pressure measured with the ClearSight device (Edwards Lifesciences, Irvine, CA, USA) with invasive radial artery pressure used as the reference method during AF ablation., Methods: We prospectively enrolled 55 consecutive patients (age 62 ± 11 years, 80% male) undergoing transcatheter AF ablation (62% paroxysmal, 38% persistent) at our center. Standard of care IBP monitoring via a radial cannula and a contralateral noninvasive finger volume-clamp CNBP measurement device were positioned simultaneously in all patients for the entire procedure. Bland-Altman analysis was used to analyze the agreement between the two techniques., Results: A total of 1219 paired measurements for systolic, diastolic, and mean arterial pressure were obtained in 55 subjects, with a mean (SD) of 22 (9) measurements per patient. The mean bias (SD) was -12.97 (13.89) mmHg for systolic pressure (level of agreement -14.24-40.20; correlation coefficient 0.84), -1.85 (8.52) mmHg for diastolic pressure (level of agreement -18.54-14.84; correlation coefficient 0.77) and 2.31 (8.75) mmHg for mean pressure (level of agreement -14.84-19.46; correlation coefficient 0.85)., Conclusion: In patients undergoing AF ablation, CNBP monitoring with the ClearSight device showed acceptable agreement with IBP monitoring. Larger studies are needed to confirm the potential clinical implications of continuous noninvasive BP monitoring during AF ablation.

Background: The study aimed to explore the resolution of left atrial and left atrial appendage (LAA) spontaneous echo-contrast or thrombus in patients with nonvalvular atrial fibrillation/flutter (AF/AFL) under chronic oral anticoagulation (OAC)., Methods: A single-center retrospective analysis of patients who underwent a transesophageal echocardiography (TOE) for an electrical cardioversion was conducted., Results: Among 277 TOE performed, 73 cases (26%) of LAA echo-contrast or thrombus were detected, 53 patients with LAA/LA echo-contrast (19%) and 20 (7%) with a thrombus. All patients were under chronic anticoagulation with a VKA (65%) or with a NOAC (35%). The Echo-contrast Group maintained the same OAC strategy in 49 patients (93%). The Thrombus Group kept the same OAC strategy with a NOAC in 6 cases (30%) and changed the strategy in 14 patients (70%), titrating NOAC dose in 1 (5%) and the VKA dose in 4 (20%) and switching from NOAC to VKA in 5 (25%), from VKA to NOAC in 3 (15%), and from NOAC to NOAC in 1 (5%). Smoke resolution was observed in 4/40 cases (10%) of the smoke group and thrombus resolution in 8/15 (53%) of the thrombus group. Patients with thrombus resolution had a lower CHA2DS2-Vasc score (3.5 ± 2 vs 4 ± 1, p = 0.05), were more often under NOAC (37.5 vs 28%, p = 0.07), and had a longer anticoagulation time (7.5 vs 4 months, p = 0.08)., Conclusion (s): Changing OAC strategy is associated with thrombus resolution in more than 50% of chronically anticoagulated patients., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: The remote device management (RM) is recommended for patients with cardiac implantable electronic devices (CIEDs). RM underutilization is frequently driven by the lack of correct system activation. The MyLATITUDE Patient App (Boston Scientific) has been developed to encourage patient compliance with RM by providing information on communicator setup, troubleshooting, and connection status of the communicator., Methods: At 14 centers, patients with CIEDs were invited to download and install the App on a mobile device. After 3 months, patients were asked to complete an ad hoc questionnaire to evaluate their experience., Results: The App was proposed to 242 consecutive patients: 81 before RM activation, and 161 during follow-up. The App was successfully installed by 177 (73%) patients. The time required for activation of the communicator and the need for additional support were similar between patients who followed the indications provided by the App and those who underwent standard in-clinic training. During follow-up, notifications of lack of connection were received by 20 (11%) patients and missed transmission by 22 (12%). The median time from notification to resolution was 2 days. After 3 months, 175 (99%) communicators of the 177 patients who installed the App were in "Monitored" status versus 113 (94%) of 120 patients without the App installed (p=0.033). The use of the app made 84% of patients feel reassured., Conclusions: The App was well accepted by CIED patients and offered support for communicator management and installation. Its use enabled patients to remain connected with greater continuity during follow-up., (© 2022. The Author(s).)

Background: Defibrillation testing (DT) can be omitted in patients undergoing transvenous implantable cardioverter-defibrillator (T-ICD) implantation, but it is still recommended for patients at risk for a high defibrillation threshold and for ICD generator changes. Moreover, DT is still recommended on implantation of subcutaneous ICD (S-ICD). The aim of the present survey was to analyze the current practice of DT during T-ICD and S-ICD implantations., Methods: In March 2021, an ad hoc questionnaire on the current performance of DT and the standard practice adopted during testing was completed at 72 Italian centers implanting S-ICD and T-ICD., Results: 48 (67%) operators reported never performing DT during de-novo T-ICD implantations, while no operators perform it systematically. The remaining respondents perform it for patients at risk for a high defibrillation threshold. DT is never performed at T-ICD generator change. At the time of de-novo S-ICD implantation, DT is never performed by 9 (13%) operators and performed systematically by 48 (66%). The remaining operators frequently omit DT in patients with more severe systolic dysfunction. DT is not performed at S-ICD generator change by 92% of operators. DT is conducted by delivering a first shock energy of 65 J by 60% of operators, while the remaining 40% test lower energy values., Conclusions: In current clinical practice, most operators omit DT at T-ICD implantation, even when still recommended in the guidelines. DT is also frequently omitted at S-ICD implantation, and a wide variability exists among operators in the procedures followed during DT., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors. Published by Elsevier B.V.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) is an effective alternative to the transvenous ICD. No study has yet compared S-ICD and transvenous ICD by assessing patient acceptance as a patient-centered outcome., Objective: To evaluate the patient acceptance of the S-ICD and to investigate its association with clinical and implantation variables. In patients with symptomatic heart failure and reduced ejection fraction (HFrEF), the acceptance of the S-ICD was compared with a control group of patients who received a transvenous ICD., Methods: Patient acceptance was calculated with the Florida Patient Acceptance Survey (FPAS) which measures four factors: return to function (RTF), device-related distress (DRD), positive appraisal (PA), and body image concerns (BIC). The survey was administered 12 months after implantation., Results: 176 patients underwent S-ICD implantation. The total FPAS and the single factors did not differ according to gender, body habitus, or generator positioning. Patients with HFrEF had lower FPAS and RTF. Younger patients showed better RTF (75 [56-94] vs. 56 [50-81], p = .029). Patients who experienced device complications or device therapies showed higher DRD (40 [35-60] vs. 25 [10-50], p = .019). Patients with HFrEF receiving the S-ICD had comparable FPAS, RTF, DRD, and BIC to HFrEF patients implanted with the transvenous ICD while exhibited significantly better PA (88 [75-100] vs. 81 [63-94], p = .02)., Conclusions: Our analysis revealed positive patient acceptance of the S-ICD, even in groups at risk of more distress such as women or patients with thinner body habitus, and regardless of the generator positioning. Among patients receiving ICDs for HFrEF, S-ICD was associated with better PA versus transvenous ICD., (© 2021 Wiley Periodicals LLC.)

Purpose: The aim of the study was to compare the long-term clinical and electrical performance of Micra leadless pacemaker with transvenous single-chamber pacemaker (TV-VVI PM) in a high-volume centre for transvenous lead extraction (TLE)., Methods: One-hundred patients (group 1) undergoing Micra implant were matched with 100 patients undergoing TV-VVI PM implant (group 2) by age, sex, left ventricular systolic ejection fraction and previous TLE., Results: The implant procedure was successful in all patients. In group 1, the procedure duration was lower than in group 2 (43.86 ± 22.38 vs 58.38 ± 17.85 min, p < 0.001), while the fluoroscopy time was longer (12.25 ± 6.84 vs 5.32 ± 4.42 min, p < 0.001). There was no difference about the rate of septal implant at the right ventricle (76% vs 86%, p = 0.10). Patients were followed-up for a median of 12 months. No acute and chronic procedure-related complication was observed in group 1, while we reported acute complications in seven patients (7%, p = 0.02) and long-term complications in three patients (3%, p = 0.24), needing for a system revision in 6 cases (6%, p = 0.038), in group 2. One systemic infection occurred in TV-VVI PM group. Electrical measurements were stable during follow-up in both groups, with a longer estimated battery life in group 1 (mean delivered energy at threshold at discharge: 0.14 ± 0.21 vs 0.26 ± 0.22 μJ, p < 0.001)., Conclusion: Micra pacemaker implant is a safe and effective procedure, with a lower rate of acute complications and system revisions compared with TV-VVI PM, even in a real-life setting including patients who underwent TLE., (© 2020. Springer Science+Business Media, LLC, part of Springer Nature.)

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: The traditional technique for subcutaneous implantable cardioverter defibrillator (S-ICD) implantation involves three incisions and a subcutaneous (SC) pocket. An intermuscular (IM) 2-incision technique has been recently adopted., Aims: We assessed acute defibrillation efficacy (DE) of S-ICD (DE ≤65 J) according to the implantation technique., Methods: We analyzed consecutive patients who underwent S-ICD implantation and DE testing at 53 Italian centers. Regression analysis was used to determine the association between DFT and implantation technique., Results: A total of 805 patients were enrolled. Four groups were assessed: IM + 2 incisions (n = 546), SC + 2 incisions (n = 133), SC + 3 incisions (n = 111), and IM + 3 incisions (n = 15). DE was ≤65 J in 782 (97.1%) patients. Patients with DE ≤65 J showed a trend towards lower body mass index (25.1 vs. 26.5; p = .12), were less frequently on antiarrhythmic drugs (13% vs. 26%; p = .06) and more commonly underwent implantation with the 2-incision technique (85% vs. 70%; p = .04). The IM + 2-incision technique showed the lowest defibrillation failure rate (2.2%) and shock impedance (66 Ohm, interquartile range: 57-77). On multivariate analysis, the 2-incision technique was associated with a lower incidence of shock failure (hazard ratio: 0.305; 95% confidence interval: 0.102-0.907; p = .033). Shock impedance was lower with the IM than with the SC approach (66 vs. 70 Ohm p = .002) and with the 2-incision than the 3-incision technique (67 vs. 72 Ohm; p = .006)., Conclusions: In a large population of S-ICD patients, we observed a high defibrillation success rate. The IM + 2-incision technique provides lower shock impedance and a higher likelihood of successful defibrillation., (© 2021 The Authors. Journal of Cardiovascular Electrophysiology Published by Wiley Periodicals LLC.)

Objectives: This study evaluated the efficacy of conversion test performed at 40 J (defibrillation margin ≥40 J), and factors potentially associated with test failure were identified., Background: Current subcutaneous implantable cardioverter-defibrillator (S-ICD) devices deliver a maximum of 80 J. Functional defibrillation testing is recommended at S-ICD implantation, and it is usually conducted by delivering a shock energy of 65 J to ensure a safety defibrillation margin ≥15 J. Although high rates of successful conversion were reported at 65 J, limited data exist on the defibrillation margin extent., Methods: Ventricular fibrillation was induced and conversion test was performed by delivering a 40-J shock in 308 patients. Success was defined as termination of ventricular fibrillation by the first shock delivered in standard polarity. The S-ICD system positioning was evaluated with the PRAETORIAN score using bidirectional chest X-rays., Results: The generator was positioned in an intermuscular pocket in 301 patients (98%) and the lead was implanted by means of a 2-incision technique. The PRAETORIAN score was <90 (low risk of conversion failure) in 293 (95%) patients. Overall, ventricular fibrillation termination occurred in 259 (84%) patients with 40 J. Male gender (odds ratio [OR]: 3.79; 95% confidence interval [CI]: 1.09 to 13.14; p = 0.036), body mass index (OR: 1.09; 95% CI: 1.01 to 1.19; p = 0.036), dilated cardiomyopathy with reduced ejection fraction (OR: 0.42; 95% CI: 0.20 to 0.87; p = 0.019), and PRAETORIAN score >50 (OR: 2.93; 95% CI: 1.26 to 6.83; p = 0.013) were independently associated with conversion failure., Conclusions: The authors showed a high rate of defibrillation success with 40-J shocks in S-ICD systems implanted by means of modern surgical techniques. The variables associated with shock failure were male gender, higher body mass index, and suboptimal device position according to the PRAETORIAN score., Competing Interests: Funding Support And Author Disclosures Ms. Lovecchio and Mr. Valsecchi are employees of Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Cardiac computed tomography (CT) is commonly used to study left atrial (LA) and pulmonary veins (PVs) anatomy before atrial fibrillation (AF) ablation. The aim of the study was to determine the impact of pre-procedural cardiac CT with 3D reconstruction on procedural outcomes and radiological exposure in patients who underwent radiofrequency catheter ablation (RFA) of AF., Methods: In this registry, 493 consecutive patients (age 62 ± 8 years, 70% male) with paroxysmal (316) or persistent (177) AF who underwent first procedure of RFA were included. A pre-procedural CT scan was obtained in 324 patients (CT group). Antral pulmonary vein isolation was performed in all patients using an open-irrigation-tip catheter with a 3D electroanatomical navigation system. Procedural outcome, including radiological exposure, and clinical outcomes were compared among patients who underwent RFA with (CT group) and without (no CT group) pre-procedural cardiac CT., Results: Acute PV isolation was obtained in all patients, with a comparable overall complication rate between CT and no CT group (4.3% vs 3%, p = 0.7). No differences were observed about mean duration of the procedure (231 ± 60 vs 233 ± 58 min, p = 0.7) and fluoroscopy time (13 ± 10 vs 13 ± 8 min, p = 0.6) among groups. Cumulative radiation dose resulted significantly higher in the CT group compared with no CT group (8.9 ± 24 vs 4.8 ± 15 mSv, P = 0.02). At 1 year, freedom from AF/atrial tachycardia were comparable among groups (CT group, 227/324 (70%), vs no CT group,119/169 (70%), p = ns)., Conclusions: Pre-procedural CT does not improve safety and efficacy of AF ablation, increasing significantly the cumulative radiological exposure.

Aims: The traditional technique for subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation involves three incisions and a subcutaneous pocket. Recently, a two-incision and intermuscular (IM) technique has been adopted. The PRAETORIAN score is a chest radiograph-based tool that predicts S-ICD conversion testing. We assessed whether the S-ICD implantation technique affects optimal position of the defibrillation system according to the PRAETORIAN score., Methods and Results: We analysed consecutive patients undergoing S-ICD implantation. The χ2 test and regression analysis were used to determine the association between the PRAETORIAN score and implantation technique. Two hundred and thirteen patients were enrolled. The S-ICD generator was positioned in an IM pocket in 174 patients (81.7%) and the two-incision approach was adopted in 199 (93.4%). According to the PRAETORIAN score, the risk of conversion failure was classified as low in 198 patients (93.0%), intermediate in 13 (6.1%), and high in 2 (0.9%). Patients undergoing the two-incision and IM technique were more likely to have a low (<90) PRAETORIAN score than those undergoing the three-incision and subcutaneous technique (two-incision: 94.0% vs. three-incision: 78.6%; P = 0.004 and IM: 96.0% vs. subcutaneous: 79.5%; P = 0.001). Intermuscular plus two-incision technique was associated with a low-risk PRAETORIAN score (hazard ratio 3.76; 95% confidence interval 1.01-14.02; P = 0.04). Shock impedance was lower in PRAETORIAN low-risk patients than in intermediate-/high-risk categories (66 vs. 96 Ohm; P = 0.001). The PRAETORIAN score did not predict shock failure at 65 J., Conclusion: In this cohort of S-ICD recipients, combining the two-incision technique and IM generator implantation yielded the lowest PRAETORIAN score values, indicating optimal defibrillation system position., Clinical Trial Registration: http://clinicaltrials.gov/ Identifier: NCT02275637., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.)

To evaluate predictors of zero-X ray procedures for supraventricular arrhythmias (SVT) using minimally fluoroscopic approach (MFA). Patients referred for RF catheter ablation of SVT were admitted for a MFA with an electro-anatomical navigation system or a conventional fluoroscopic approach (ConvA). Exclusion criterion was the need to perform a transseptal puncture. 206 patients (98 men, age 53 ± 19 years) underwent an EP study, 93 (45%) with an MFA and 113 (55%) with a ConvA. Fifty-five had no inducible arrhythmias (EPS). Fifty-four had AV nodal reentrant tachycardia (AVNRT), 49 patients had typical atrial flutter (AFL), 37 had AV reciprocating tachycardia (AVRT/WPW), 11 had focal atrial tachycardia (AT), and underwent a RF ablation. X-ray was not used at all in 51/93 (58%) procedures (zero X ray). MFA was associated with a significant reduction in total fluoroscopy time (5.5 ± 10 vs 13 ± 18 min, P = 0.01) and operator radiation dose (0.8 ± 2.5 vs 3 ± 8.2 mSV, P < 0.05). The greatest absolute dose reduction was observed in AVNRT (0.1 ± 0.3 vs 5.1 ± 10 mSV, P = 0.01, 98% relative dose reduction) and in AFL (1.3 ± 3.6 vs 11 ± 16 mSV, P = 0.003, 88% relative dose reduction) groups. Both AVNRT or AFL resulted the only statistically significant predictors of zero x ray at multivariate analysis (OR 4.5, 95% CI 1.5-13 and OR 5, 95% CI 1.7-15, P < 0.001, respectively). Success and complication rate was comparable between groups (P = NS). Using MFA for SVT ablation, radiological exposure is significantly reduced. Type of arrhythmia is the strongest predictor of zero X ray procedure.

Aims: Optimal management of redundant or malfunctioning leads is controversial. We aimed to assess safety and efficacy of mechanical transvenous lead extraction (TLE) in patients with abandoned leads., Methods and Results: Consecutive TLE procedures performed in our centre from January 2009 to December 2017 were considered. We evaluated the safety and efficacy of mechanical TLE in patients with abandoned (Group 1) compared to non-abandoned (Group 2) leads. We analysed 1210 consecutive patients that required transvenous removal of 2343 leads. Group 1 accounted for 250 patients (21%) with a total of 617 abandoned leads (26%). Group 2 comprised 960 patients (79%) with 1726 leads (74%). The total number of leads (3.0 vs. 2.0), dwelling time of the oldest lead (108.00 months vs. 60.00 months) and infectious indications for TLE were higher in Group 1. Clinical success was achieved in 1168 patients (96.5%) with a lower rate in Group 1 (90.4% vs. 98.1%; P < 0.001). Major complications occurred in only 9 patients (0.7%), without significant differences among the two groups. The presence of one or more abandoned leads [odds ratio (OR) 3.47; 95% confidence interval (CI) 1.07-11.19; P = 0.037] and dwelling time of the oldest lead (OR 1.01 for a month; 95% CI 1.01-1.02; P < 0.001) were associated with a higher risk of clinical failure., Conclusion: Transvenous mechanical lead extraction is a safe procedure also in high-risk settings, as patients with abandoned leads. Success rate resulted a bit lower, especially in the presence of abandoned leads with long implantation time., (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: At the time of subcutaneous implantable cardioverter-defibrillator (S-ICD) implantation, successful termination of ventricular fibrillation (VF) is confirmed. A previous study reported cases of prolonged time to therapy during defibrillation testing., Objectives: We sought to evaluate the time to therapy, identify possible predictors of delay, and investigate the impact of delayed therapy on VF conversion., Methods: We analyzed consecutive patients with S-ICDs who underwent initial conversion testing at a shock energy of 65 J in 53 Italian centers., Results: We analyzed 570 patients (467 [82%] male; mean age 48 ± 15 years; mean body mass index 25 ± 6 kg/m 2 ; mean ejection fraction 47% ± 17%). General anesthesia was used in 165 (29%) of patients, with sub- or intermuscular positioning of the generator in (422; 74%). Cardioversion was successful at 65 J in 557 (97.7%) of patients. In 12 patients (2.1%) the shock did not convert VF, and in 1 patient the shock was not delivered because of noise from entrapped subcutaneous air. All failures were successfully managed by reprogramming or repositioning the device. The mean time to therapy was 15 ± 3 seconds, and it exceeded 18 seconds in 51 patients (9%). Independent predictors of delayed therapy (18 seconds) were ejection fraction (odds ratio [OR] 0.98; 95% confidence interval [CI] 0.96-0.99; P = .016) and a 2× gain programmed (OR 3.66; 95% CI 1.44-9.30; P = .006). Effectiveness at 65 J was not associated with time to therapy (OR 1.13; 95% CI 0.97-1.32; P = .122)., Conclusion: In this analysis of a large population of patients with S-ICDs, delayed therapy during defibrillation testing occurred less frequently than previously reported and had no effect on VF conversion success. Delayed therapies seemed more common when a vector with a 2× gain was programmed., (Copyright © 2019 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: We aimed at investigating the feasibility and outcome of Micra implant in patients who have previously undergone transvenous lead extraction (TLE), in comparison to naïve patients implanted with the same device., Methods and Results: Eighty-three patients (65 males, 78.31%; 77.27 ± 9.96 years) underwent Micra implant at our centre. The entire cohort was divided between 'post-extraction' (Group 1) and naïve patients (Group 2). In 23 of 83 patients (20 males, 86.96%; 73.83 ± 10.29 years), Micra was implanted after TLE. Indication to TLE was an infection in 15 patients (65.21%), leads malfunction in four (17.39%), superior vena cava syndrome in three (13.05%), and severe tricuspid regurgitation in one case (4.35%). The implant procedure was successful in all patients and no device-related events occurred at follow-up (median: 18 months; interquartile range: 1-24). No differences were observed between groups in fluoroscopy time (13.88 ± 10.98 min vs. 13.15 ± 6.64 min, P = 0.45), single device delivery (Group 1 vs. Group 2: 69.56% vs. 55%, P = 0.22), electrical performance at implant and at 12-month follow-up (Group 1 vs. Group 2: pacing threshold 0.48 ± 0.05 V/0.24 ms vs. 0.56 ± 0.25 V/0.24 ms, P = 0.70; impedance 640 ± 148.83 Ohm vs. 583.43 ± 99.7 Ohm, P = 0.27; and R wave amplitude 10.33 ± 2.88 mV vs. 12.62 ± 5.31 mV, P = 0.40). A non-apical site of implant was achievable in the majority of cases (72.3%) without differences among groups (78.26% vs. 70%; P = 0.42)., Conclusion: Micra implant is an effective and safe procedure in patients still requiring a ventricular pacing after TLE, with similar electrical performance and outcome compared with naïve patients at long-term follow-up., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) does not require the insertion of any leads into the cardiovascular system., Objective: The aims of the study were to describe current practice and to measure outcomes associated with S-ICD or standard single-chamber transvenous ICD (TV-ICD) use after TV-ICD explantation., Methods: We analyzed all consecutive patients who underwent transvenous extraction of an ICD and subsequent implantation of an S-ICD or a single-chamber TV-ICD at 12 Italian centers from 2011 to 2017., Results: A total of 229 patients were extracted and subsequently reimplanted with an S-ICD (90; 39%) or a single-chamber TV-ICD (139; 61%). S-ICD implantation increased from 9% in 2011 to 85% in 2017 (P < .001). Patients reimplanted with an S-ICD were younger (53 ± 13 years vs 60 ± 18 years; P = .011) and more frequently had undergone extraction owing to infection (73% vs 52%; P < .001). The rates of complications at follow-up were comparable between groups (hazard ratio 0.97; 95% confidence interval 0.49-1.92; P = .940). No lead failures, systemic infections, or system-related deaths occurred in the S-ICD group. In the TV-ICD group, 1 lead fracture occurred and 2 systemic infections were reported, resulting in death in 1 case. In the S-ICD group, the rate of complications was lower when the generator was positioned in a sub- or intermuscular pocket (hazard ratio 0.21; 95% confidence interval 0.05-0.87; P = .048)., Conclusion: Our results show an increasing use of S-ICD over the years in patients undergoing TV-ICD explantation. An S-ICD is preferably adopted in young patients, mostly in the case of infection. The complication rate was comparable between groups and decreased when a sub- or intermuscular S-ICD generator position was adopted., (Copyright © 2018 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Despite expanding indication of the subcutaneous implantable cardioverter defibrillator (S-ICD) in clinical practice, limited data exists on safety and efficacy of S-ICD in arrhythmogenic right ventricular cardiomyopathy (ARVC) patients. The aim of this multicenter study was to evaluate the safety and efficacy of S-ICD in ARVC patients., Methods: The study population included 44 consecutive patients with definite ARVC diagnosis according to the 2010 ITF criteria (57% male, mean age 37 ± 17 years [range 10-75 years]) who received an S-ICD. Eighteen (41%) patients were implanted for secondary prevention., Results: At implant, all inducible patients (34/44) had conversion of ventricular fibrillation at 65 J. No early complications occurred. During a median follow-up of 12 months (7-19), 3 (6.8%) patients experienced complications requiring surgical revision. No local or systemic device-related infections were observed. Six patients (14%) received a total of 61 appropriate and successful shocks on ventricular arrhythmias. Six (14%) patients experienced 8 inappropriate shocks for oversensing of cardiac signal (4 cases) and non-cardiac signal (4 cases) with one patient requiring device explantation. No patients had the device explanted due to the need for antitachycardia pacing., Conclusions: The study shows that S-ICD provides safe and effective therapy for termination of both induced and spontaneous malignant ventricular tachyarrhythmias with high energy shocks in ARVC patients, but the risk of inappropriate shocks and complications needing surgical revision should be considered., (Copyright © 2019. Published by Elsevier B.V.)

Aims: To demonstrate the feasibility and long-term performances of a non-apical Micra pacemaker implantation., Methods and Results: Fifty-two consecutive patients underwent Micra implantation, targeting a non-apical site of delivery when feasible. Each patient received a regular follow-up (mean 13 ± 9 months). The first 17 patients were also enrolled in the Micra transcatheter pacing system trial (Group 1); the remaining ones presented broader indications and included post-extraction subjects (Group 2). In 19 of 52 patients (Group 1: 6%, Group 2: 51%; P = 0.002) Micra was implanted because of high-risk characteristics that discouraged the implantation of a traditional pacemaker. In 31 of 52 patients (60%) Micra was implanted in a non-apical location, with a lower rate of single delivery compared with apical sites (48% vs. 81%, P = 0.035), but without any impact on electrical performance. Pacing threshold remained optimal in the majority of patients (94%), regardless of the site of implantation (apical vs. non-apical location: 0.50 vs. 0.52 V/0.24 ms; P = 0.856) and group membership, with only 6% of the subjects showing elevated values (mean 1.92 ± 0.92 V/0.24 ms) at the last follow-up. No device-related adverse events were registered., Conclusion: Micra pacemaker implant is a safe and effective procedure even in a real life cohort of high-risk patients. A non-apical site of implantation is feasible in the majority of patients allowing stable electrical performance at long-term follow-up.