Funding Acknowledgements Type of funding sources: None. Background Young patients often represent the most suitable candidates for an entirely subcutaenous implantable cardioverter defibrillator (S-ICD) system, since they have to face a lifetime of device therapy and they rarely have a pre-existing or concurrent pacing or cardiac resynchronization therapy (CRT) indication. Moreover, S-ICD offers lower rate and a safer management of lead and major procedure-related complications. To date, a few limited case series and experiences with S-ICD in teenagers and young adults have shown that the S-ICD system is safe and feasible in this population, with a rate of inappropriate shocks (IS) comparable to transvenous (TV) ICD, but focused analysis on a large scale are currently lacking in this setting. Purpose The aim of the current study was to compare the age-related differences observed in patient selection, baseline characteristics, and device long-term associated outcomes in a large real world cohort of S-ICD recipients. The primary outcome of the study was defined as the comparisons of the IS rate observed during the entirety of follow up in the teenagers/young adult vs the adult populations. Rate of complications, freedom from sustained ventricular arrhythmic events, overall and cardiovascular mortality were also assessed in the two cohorts and assessed as secondary outcomes. Methods All S-ICD recipients in the ELISIR project were enrolled in the current study. Patients were classified into teenagers + young adults (≤ 30 years old) vs adults (> 30 years old), depending from patient age at device implantation (Figure 1). Rates of device-related complications and IS were compared between the cohorts. Results A total of 1349 patients were extracted from the ELISIR project. Teenagers and young adults represented 12.4% of the registry (n=56 teenagers; n=112 young adults). Patients were followed-up for a median of 23.1 [12.6–37.9] months. Overall, 117 (8.7%) patients experienced inappropriate S-ICD shocks and 100 (7.4%) device related complications were observed, with no age-related differences. IS resulted more frequent in the teenager and young adult cohort (14.3% vs 7.9%; p=0.006). Figure 2 reports Kaplan Meier curves for the occurrence of IS. At univariate analysis, young age was associated with IS, but after correcting for differences in arrhythmic substrate, this association resulted non-significant (aHR: 1.428 [0.883–2.331]; p=0.146). The use of SMART pass algorithm was instead associated to a strong reduction in IS (aHR 0.367 [0.245–0.548]; p<0.001). Conclusion The use of S-ICD in teenagers/young adults resulted safe and effective. Indeed, the rate of complications between teenagers/young adults and adults was not significantly different. Although a higher rate of IS was observed in the teenagers/young adults, when accounting for differences in baseline substrate and comorbidities, young age did not result associated with an increased risk of IS.

Funding Acknowledgements Type of funding sources: None. Background Leadless pacing has evolved as a safe and effective treatment option in selected patients. With the updated generation that allows sensing of atrial contraction, atrioventricular synchronized pacing is now possible in a VDD mode. Previous retrospective analyses have demonstrated that echocardiographic parameters may be helpful in selecting patients with a higher chance of good atrioventricular synchronous pacing behaviour. Purpose Analysis of the early experience with the second generation of leadless pacemaker and the role of ECG parameters to predict a good atrial contraction signal (so-called A4 amplitude) in patients who underwent leadless pacemaker implantation in four tertiary centres. Methods and Results In this retrospective analysis, a total of 136 patients were included. Mean age was 78.0 (64.7 - 84.2 years) years with 48.9 % being male. Coronary artery disease was the leading underlying heart disease with 27.1 % affected patients. 61.7 % of the population suffered from sinus rhythm with complete or intermittent atrioventricular block. The majority of devices were implanted at the mid-septal (61.2 %) or high-septal (25.6 %) right ventricle, respectively. Electrical parameters were optimal at implant (Table 1) and remained stable over time (Table 1). In addition, A4 signal amplitude remained stable too during follow-up compared to the value early after implantation (Table 1). From this entire cohort, patients with an ECG available at implant and those in which the device was working predominantly in the VDD mode were selected for further analyses (62 patients). PR interval measured from the ECG prior to implantation did not correlate with the A4 signal amplitude (Figure 1A; P = NS). Next, P wave amplitudes were measured in all 12 ECG leads. There was a correlation between P wave amplitude from lead V2 with the A4 amplitude (Figure 1B; P = 0.034, R2 = 0.09), whereas the other right-sided ECG leads (V1/aVR), either alone or in combination, did not correlate with the A4 signal amplitude (P = NS). Conclusions In our cohort of patients with the second generation of leadless pacemakers, offering VDD pacing, good electrical parameters can be achieved as it has been observed with the first generation. Also the A4 signal amplitude as a marker for atrial contraction remains stable over time. In regard to ECG parameters measured prior to device implantation, only the P wave amplitude in lead V2 correlated with a amplitude of the A4 signal.

Funding Acknowledgements Type of funding sources: None. Background Data on patients with heart failure (HF) and subcutaneous implantable cardioverter defibrillator (S-ICD) are very scarce and limited to a single prospective analysis from the UNTOUCHED trial. Purpose Aim of this study was to assess clinical outcomes of the S-ICD in HF patients, comparing them with a no-HF population, in a real-world analysis from the largest European retrospective S-ICD registry (ELISIR registry). Methods All consecutive patients undergoing S-ICD implantation at 20 European institutions enrolled in the ELISIR registry were used for the current analysis. According to European Guidelines, the registry population was classified into two groups: the HF cohort (further classified as HF with reduced and mid-range ejection fraction – HFrEF and HFmrEF) vs the no-HF group. The primary outcome of the study was the inappropriate shock (IS) rate across the two cohorts. As secondary outcomes, appropriate shocks, cardiovascular mortality and device-related complications during follow-up were assessed. Results A total of 1409 patients from the ELISIR registry were included in this analysis; HF patients represented 57.3% of the entire cohort (n=701, 86.9% HFrEF; n=106,13.1% HFmrEF). As expected, the HF cohort showed significantly higher rates of cardiovascular risk factors and comorbidities when compared to the no-HF cohort. Over a median follow-up of approximately 2 years, a total of 133 inappropriate shocks were observed in the entire cohort, without significant differences among the two groups (9.2% vs 9.8%, p=0.689). 133 complex ventricular arrhythmias were adequately recognized and treated in the overall cohort, showing similar rates of appropriate shocks (9.2% vs 9.8%, p=0.689). Inappropriate and effective shocks-free survival has been represented in Figure 1, showing Kaplan-Meier estimates comparing HF vs no-HF patients, also stratified by left ventricular ejection fraction (LVEF). The impact of baseline and procedural characteristics on the primary outcome was tested through univariable and multivariable Cox regression analysis in HF patients; at multivariate analysis, only age (HR=0.974 [0.955–0.992], p=0.005), LVEF (HR=0.954 [0.926-0.984], p=0.003), ARVC (HR=3.364 [1.206-9.384], p=0.020) and smart pass algorithm "on" (HR=0.321 [0.184-0.560], p<0.001) remained associated with inappropriate shocks (Figure 2). A low number of patients (n=76) experienced device-related complications, more frequently in the HF cohort (6.2% vs 3.8%, p=0.031) with no significant differences regarding any specific outcome of interest: lead infection (1.1% vs 0.7%, p=0.381), pocket infection (1.9% vs 0.8%, p=0.107), pocket hematoma (3.2% vs 2.8%, p=0.668). Conclusion The rate of inappropriate shocks seems to be comparable in both HF and non-HF patients implanted with S-ICD. However, the rate of device-related complications was slightly more frequent in HF patients.

Funding Acknowledgements Type of funding sources: None. Background The subcutaneous implantable cardioverter defibrillator (S-ICD) has become an alternative to transvenous ICDs (tv-ICD), especially in young patients without a need for pacing. One of the current limitations of the S-ICD is the relatively large size of the generator compared to tv-ICDs. There is little evidence whether the size of the current S-ICD generator is associated with an elevated risk of device-related complications in patients with a low body mass index (BMI). Purpose To compare the device-related complications and long-term outcomes in a large real world cohort of S-ICD recipients in patients with a BMI <18 kg/m2 compared to patients with a BMI >18 kg/m2. Methods The iSuSI registry is a European, multi-center, open-label, independent, and physician-initiated observational registry. A total of twenty-two Public and Private Healthcare Institutions from 4 different countries in Europe were involved in the registry. All consecutive patients meeting current guideline indications for ICD implantation and undergoing implantation of a S-ICD device (Boston Scientific, Marlborough, Massachusetts, USA) at 21 European institutions enrolled in the registry were used for the current analysis. Patients were classified into two cohorts, depending on the BMI at the time of device implantations: BMI < 18 kg/m2 versus > 18 kg/m2. Results Out of a total of 1497 pts, 58 pts (3.9%) had a BMI < 18 kg/m2. Patients with BMI <18 kg/m2 were younger (44.6±2.4 vs 50.8±0.4; p=0.004) and more frequently female (58.6% vs 22.3%, p<0.001). No differences in any of the other baseline characteristic were observed. Implantation techniques resulted comparable between the groups (Rates of 2-incision technique: 87.8% vs 91.9%; p=0.256; inter-muscular placement: 89.7% vs 83.3%; p=0.198). Of note, the mean PRAETORIAN score at implantation of patients with BMI <18 kg/m2 was significantly lower (33.8±9.1 vs 54.1±47.3; p=0.035), although the vast majority of pts in both cohorts qualify as at low risk of conversion failure (100% vs 91.4%; p=0.436). Over a median follow up time of 22.4 [11.6–36.8] months, both overall device-related complications (5.2% vs 7.4%) and rates of inappropriate shocks (12.0% vs 8.8%) resulted comparable between the two groups (p =0.517 and p=0.385, respectively). Figure1 reports Kaplan-Meier curves reporting the combined incidence of device-related complications and inappropriate shocks in the two groups (log-rank p = 0.576). Conclusion No difference in device-related complications and long-term outcomes after S-ICD implantation were observed in patients with BMI <18 kg/m2 compared to the remaining recipients from a large, multi-centered S-ICD registry. Figure 1: Kaplan-Meier-survival curve for the combined endpoint of inappropriate shocks (IAS) and device-related complications (DRC)

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