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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.)

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: 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.)

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.)

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.)

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.)

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.

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.)

Background: Remote monitoring (RM) of implantable cardioverter defibrillators (ICD) has been shown to improve patient safety and reduce in-office visits. The subcutaneous ICD (S-ICD) is an effective alternative to transvenous ICD and has recently been endowed with the RM function. However, the RM communicator for S-ICD requires patient interaction to activate data transmission. We assessed patient compliance and acceptance., Methods: Patients with S-ICD received the communicator and were followed up for 15 months. Weekly remote transmissions were programmed. Compliance with checks was measured as the number of checks performed by the patient divided by the number of automatic notifications by the communicator. A questionnaire on acceptance of the system was administered to patients., Results: A total of 106 patients were analyzed. The proportion of weekly checks properly executed by the patients was 94% during the first 3 months and 93% from months 12 to 15. Of the checks performed, 93% were on the same day as the automatic notification. On a patient basis, compliance with weekly checks was > 85% (less than one check missed per month) in 88% of patients during the first 3 months and in 82% from months 12 to 15 (p = 0.615). No variables emerged as predictors of lower (≤ 85%) long-term compliance with weekly checks. During follow-up, 49 alerts were transmitted and the mean delay between the detected event and the patient transmission was 2 ± 2 days. The majority of patients found the system easy to use and felt confident about being remotely monitored., Conclusions: The level of patient compliance with remote checks is high with current technology for RM of S-ICD. The vast majority of data transmissions are consistently performed on a weekly basis on the day scheduled.

Introduction: Increasing device implantations, patient comorbidities, and longer life expectancy contribute to an increased need for lead extraction. Even if transvenous lead extraction (TLE) is a highly successful procedure, some serious procedural complications are reported. In order to identify those patients who are at higher risk, risk stratification scores were proposed. Areas covered: The major obstacles to lead extractions are represented by the body's response to the foreign implanted material and by the following development of fibrotic reaction between the lead and the vascular system. Several clinical factors and device features are associated with major complications and worse outcomes. Although different multiparametric scores predicting the safety and the efficacy of TLE procedures were reported, none of these scores were prospective evaluated. Expert commentary: A correct risk stratification is needed in order to refer complex patients to centers with proven experience and avoid futile procedures. Furthermore, the identification of high-risk patients allows to perform the extraction procedure in the operating room instead of electrophysiology lab. Albeit some risk scores able to predict adverse event in cardiac lead extraction were described, there are still several limitations to their use and reproducibility.

Purpose: Since subcutaneous implantable cardioverter defibrillator (S-ICD) introduction, the pre-implant screening based on a dedicated manual ECG tool (MST) was required to assure adequate sensing by the S-ICD. A novel automated screening tool (AST) has been recently developed. We assessed and compared the pass rate with AST and MST, and we measured the agreement between screening tools., Methods: Three electrodes were positioned at locations mimicking the placement of the S-ICD, and ECG recordings were collected in the supine and standing postures at rest. The three sensing vectors were analyzed with the MST and the AST. Eligibility was defined by the presence of at least one or two appropriate vectors in both postures., Results: A total of 235 patients with an indication to ICD and no need for permanent pacing were enrolled. At least one suitable vector was identified in 214 (91%) patients with MST and 221 (94%) patients with AST (p = 0.219). At least two vectors were appropriate in 162 (69%) patients with MST and 187 (80%) patients with AST (p = 0.008). Overall, out of 1587 ECG analyzed, 1035 (65%) qualifying leads were identified with MST and 1111 (70%) with AST (p = 0.004). The agreement between the results of MST and AST ECG analysis was moderate (Kappa = 0.570; standard error = 0.022; CI = 0.526-0.613). The results were consistent regardless of the underlying cardiomyopathy. The most frequent reason for screening failure with MST was a high-amplitude T-wave (31% of failures). With AST, 23% of recordings that failed with MST for high-amplitude T-wave were classified as acceptable., Conclusion: The AST is associated with higher pass rate than the standard MST. It seems more tolerant of high-amplitude T-waves. Consequently, the agreement between MST and AST findings was only moderate.

The implantable cardioverter defibrillator (ICD) is today an indisputable evidence-based treatment for cardiac sudden death both in primary and secondary prevention. However many clinical conditions that would represent an indication to ICD implantation, according to guidelines, may be potentially reversible or may be accompanied by temporary contraindications to the implant. Moreover transvenous cardioverter defibrillator implantation still carries a not negligible risk of complications both acutely and at follow-up. The Wearable Cardioverter Defibrillator and the Subcutaneous Defibrillator are two recently developed technologies that can potentially overcome the aforementioned limitations of traditional transvenous ICDs. This review will discuss the main aspects of these 2 technologies, the data coming from clinical experiences and future perspectives.

Aims: To investigate the different strategies adopted for the management of antithrombotic therapy and the related hemorrhagic and infective complication rates in patients undergoing cardiac implantable electronic devices (CIEDs) surgery in a real-world setting., Methods: THE Management of AntiThrOMbotic therApy in patients undergoing electrophysiological device surgery: Italian NatiOnal Multicenter Observational REgistry (HEMATOMA NO MORE) is an observational, prospective, multicenter, national cohort study (with a retrospective, multicenter, regional pilot phase) designed to enroll patients with standard indications to CIED implantations/replacements receiving concomitant antithrombotic therapy. The primary outcome is clinically significant pocket hematoma defined as a postprocedural hematoma, resulting in prolonged hospitalization and/or requiring interruption of antithrombotic therapy and/or requiring further surgery and/or requiring transfusion., Results: The pilot phase included 569 patients from 11 centers in Tuscany enrolled between September 2014 and May 2015 and followed up for 1 month. Patients were categorized according to the strategy of management of antithrombotic therapy, with heparin bridging being associated with the highest incidence of clinically significant pocket hematoma (12.3%). Overall nonpocket hemorrhagic events rate was quite low (0.52%) and thromboembolic complications were negligible (0.17%)., Conclusion: Occurrence of pocket hematoma in patients undergoing CIED surgery is largely influenced by the strategy of management of antithrombotic therapy. The HEMATOMA NO MORE will assess the impact of different strategies on the risk of developing pocket hematoma and of subsequent CIED-related infections.

Introduction: The implantation rate of cardiac implantable electronic devices has consistently increased in the last 20 years, as have the related complication rates. The most relevant issue is the removal of pacing and implantable cardioverter defibrillator (ICD) leads, which a few months after implantation tend to develop intravascular fibrosis, often making extraction a challenging and risky procedure. Areas covered: The transvenous lead extraction (TLE) scenario is constantly evolving. TLE is a key procedure in lead management strategies. Many efforts have been made to develop new TLE approaches and techniques allowing a safe and effective procedure for patients. The increasing rate of cardiac implantable electronic device (CIED) implantations and of CIED related complications highlight the importance of TLE. Lead related- and patient-related factors may change the future of extractions. We review the current status of TLE, focusing on the strategies available to perform the optimal procedure in the right patient and reducing procedure related complications. Expert commentary: Understanding the importance of an accurate TLE risk stratification is mandatory to optimize the procedural risk-to-benefits ratio. The use of adequate tools, techniques and approaches, and appropriate training are cornerstones for the achievement of safer procedures.

Background: Subcutaneous ICD (S-ICD) is a promising option for Hypertrophic Cardiomyopathy (HCM) patients at risk of Sudden Cardiac Death (SCD). However, its effectiveness in terminating ventricular arrhythmias in HCM is yet unresolved., Methods: Consecutive HCM patients referred for S-ICD implantation were prospectively enrolled. Patients underwent one or two attempts of VF induction by the programmer. Successful conversion was defined as any 65J shock that terminated VF (not requiring rescue shocks). Clinical and instrumental parameters were analyzed to study predictors of conversion failure., Results: Fifty HCM patients (34 males, 40±16years) with a mean BMI of 25.2±4.4kg/m2 were evaluated. Mean ESC SCD risk of was 6.5±3.9% and maximal LV wall thickness (LVMWT) was 26±6mm. In 2/50 patients no arrhythmias were inducible, while in 7 (14%) only sustained ventricular tachycardia was induced and cardioverted. In the remaining 41 (82%) patients, 73 VF episodes were induced (1 episode in 14 and >1 in 27 patients). Of these, 4 (6%) spontaneously converted. In 68/69 (98%) the S-ICD successfully cardioverted, but failed in 1 (2%) patient, who needed rescue defibrillation. This patient was severely obese (BMI 36) and LVMWT of 25mm. VF was re-induced and successfully converted by the 80J reversed polarity S-ICD., Conclusions: Acute DT at 65J at the implant showed the effectiveness of S-ICD in the recognition and termination of VT/VF in all HCM patients except one. Extreme LVH did not affect the performance of the device, whereas severe obesity was likely responsible for the single 65J failure., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Riata (RT) and Sprint Fidelis (SF) leads were recalled by the United States Food and Drug Administration because of an increased rate of failure mainly due to conductor fracture or insulation abrasion. According to lead design and type of failure, extraction complexity may be different, potentially affecting procedural outcomes and indications., Objective: The purpose of this study was to assess the extraction profile of RT leads with and without cable externalization in comparison to SF leads., Methods: From January 1997 to April 2014, all consecutive RT and SF leads extracted transvenously were analyzed. Among 661 consecutive patients with 705 ventricular implantable cardioverter-defibrillator (ICD) leads extracted, 194 patients with 134 RT leads (RT group) and 61 SF leads (SF group) were identified. Removal indications often were infective (64%), and extracted leads had a prevalence of dual-coil design (89%). Baseline patients and lead characteristics were comparable between groups., Results: Success rate was high in both groups (97.8% RT vs 100% SF) without major complications. Mechanical dilation was comparable between groups, but RT leads often required larger sheaths (11.7 ± 1.4 vs 11.3 ± 1.4), a more frequent crossover to the internal transjugular approach (14% vs 3%), and a longer procedural time (23 ± 33 minutes vs 12 ± 16 minutes). Implantation time (odds ratio 4.84, 95% confidence interval 1.05-22.2, P = .042) and RT leads (odds ratio 1.04, 95% confidence interval 1.02-1.06, P <.001) were independent predictors of the internal transjugular approach., Conclusion: Extraction of RT leads is feasible and effective. However, extraction of RT leads is more complex than that of SF leads. Lack of coil backfilling and cable externalization in RT group may account for these differences., (Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

The implantable cardioverter defibrillator is today an indisputable evidence-based treatment for cardiac sudden death both in primary and secondary prevention. However, trans-venous cardioverter defibrillator implantation still carries a not negligible risk of complications both acutely and during follow-up. Trans-venous endocardial lead is the weak link of implantable cardioverter defibrillator (ICD) technology being the source of most mechanical complications on vessels and heart structures and exposed to infection, malfunction and recalls. A totally subcutaneous defibrillation lead has recently been introduced in clinical practice. With the subcutaneous pulse generator forms a defibrillation system that leaves the vessels and the heart completely "untouched." Subcutaneous ICD has proven to be safe and effective in many clinical trials. Patients without pacing indications and at higher risk of complications from trans-venous lead implantation represent the perfect candidates to S-ICD technology. However, with technical improvement, it is reasonable to expect a further expansion of indications.

Background: Percutaneous removal of implantable cardioverter-defibrillator (ICD) leads is a difficult procedure because of the consequence of massive fibrous tissue growth along the lead., Objective: The purpose of this study was to describe the occurrence and location of fibrous adherences in ICD lead extraction and to identify potential predictors among patient and lead characteristics., Methods: We studied 637 consecutive patients who underwent transvenous extraction of 678 ICD leads from 1997 to 2013., Results: Procedural success rate was 99%, without major complications. Areas of adherence were found in the subclavian vein (78%), innominate vein (65%), superior vena cava (66%), and heart (73%). Dwell-time, passive fixation, and dual-coil lead design were independently associated with adherences. Dual-coil lead design was associated with adherences in the innominate vein and superior vena cava, whereas coil treatment (eg, expandable polytetrafluoroethylene-coated or medical adhesive back-filled strategies) prevented adherences. Passive fixation mechanism was associated with adherences in the heart., Conclusion: ICD leads, after long dwell-time, are affected by fibrous adherences uniformly distributed along the lead course. Lead features represent major predictors of the phenomenon. Careful lead selection is recommended at the time of implantation to prevent adherences. In addition, lead-related risk stratification is mandatory before a transvenous extraction procedure., (Copyright © 2014 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Aims: We report our 15 years experience of a mechanical single-sheath technique with a multiple venous entry-site approach. We evaluated the effectiveness and safety of this technique in implantable defibrillator (ICD) lead extraction and investigated the potential association between clinical and lead-related factors and procedural complexity., Methods and Results: The proposed technique consists of an initial attempt at manual traction, followed by mechanical dilatation performed through the venous entry-site and, if necessary, by crossover to the internal transjugular approach. The study cohort comprised 545 consecutive patients referred to our institution for transvenous lead extraction from January 1997 to December 2012. Initial manual traction resulted in the effective removal of 6% of leads. Mechanical dilatation increased the success rate to 89% when performed through the venous entry-site, and to 99% when subsequently attempted via the internal jugular vein. No major complications were associated with lead extraction. Dwell-time, a passive fixation mechanism and dual-coil lead design were independently associated with the need for mechanical dilatation. However, dwell-time was the only variable associated with crossover to the internal transjugular approach. Specifically, a dwell-time of 20 months best predicted the need for venous entry-site mechanical dilatation, while a value of 55 months predicted crossover to the internal transjugular approach., Conclusion: Mechanical transvenous extraction of ICD leads is a complex but safe and effective procedure. A longer lead dwell-time is associated with the need for mechanical dilatation and for crossover to the internal transjugular approach; this should be considered when planning the removal procedure. Moreover, passive lead fixation and dual-coil lead design predict a more challenging extraction procedure., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Background: In the Endotak Reliance G defibrillating leads (Guidant Corporation, St. Paul, MN, USA), coils are covered with expanded polytetrafluoroethylene (ePTFE) to prevent tissue ingrowth. The aim of the study was to evaluate transvenous extraction performance, outcomes, and fibrotic adherences rate of ePTFE defibrillating leads in comparison to traditional non-ePTFE cardiac defibrillator (ICD) leads., Methods: Seventeen consecutive ICD recipients (ePTFE Group A, 16 men, mean age 66 ± 12 years) with 17 Endotak Reliance G dual-coil ICD leads (mean implantation time 23 ± 26 months) underwent a transvenous removal procedure. They were compared with two control groups, including 20 Sprint Quattro 6944 (non-ePTFE Group B; Medtronic Inc., Minneapolis, MN, USA) and 36 Riata 1570 ICD leads (non-ePTFE Group C; St. Jude Medical, St. Paul, USA). The indication for lead extraction was local infection in 35 patients (48%), sepsis in 24 patients (33%), and lead malfunction in 14 patients (19%)., Results: In all groups, all leads were successfully and completely removed without major complications. Overall manual traction was effective in six patients (8%) and more effective in the ePTFE Group (29%) compared to Group B (0%) and Group C (3%) (P = 0.001). Sixty-seven leads (92%) required mechanical dilatation by the venous entry site approach, with a shorter extraction time in the ePTFE Group (5 ± 11 min) compared to Group B (21 ± 22 min) and Group C (16 ± 22 min) (P = 0.003). ePTFE leads showed a lower rate of fibrotic adherences at the superior vena cava level (P = 0.01) without statistically significant differences in the other sites., Conclusions: ePTFE-covered leads may be removed more easily and quickly than non-ePTFE leads, requiring less frequently mechanical dilatation., (©2010, The Authors. Journal compilation ©2010 Wiley Periodicals, Inc.)

Heart failure is one of the most important public health problems in western countries because of its frequent association with cardiac death and with rehospitalization. Patients with heart failure generally die of sudden arrhythmic death (SD) and progressive pump failure with a SD incidence inversely related to the severity of the underlying heart disease. SD occurs approximately in one half of the patients in New York Heart Association (NYHA) functional classes II-II/III and in one third of those in NYHA classes III/IV-IV, respectively. In the last decade, numerous studies have shown that the automatic implantable cardioverter-defibrillator (ICD) significantly reduces the incidence of SD in those patients who are identified as being at risk. Unfortunately, little is known on whether the ICD actually prolongs the survival of the subgroup of patients with most severe heart failure. The main reasons for such a paucity of information are the small number of available studies, the unavailability of randomized and controlled investigations and the difficulty in comparing the results of such studies owing to the lack of homogeneity. In patients with severe heart failure, both the perioperative mortality and morbidity related to transvenous ICD implantation are similar to those of patient subgroups with moderate or slight heart failure. The defibrillation threshold at implantation and the frequency of intractable ventricular arrhythmias during follow-up (2% of all ICD implantations) are slightly higher than in the patient subgroup with moderate or no heart failure. In the patient subgroup with severe heart failure or with a very poor left ventricular function, ICD implantation is unable to prolong the 1- and 2-year survival despite a clear reduction in the incidence of SD. On the other hand, in the patient subgroup with moderate left ventricular dysfunction, ICD implantation prolongs survival and reduces the incidence of SD. No information is available regarding the primary prevention of SD in patients with heart failure.