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)
Background Data on patients with heart failure (HF) with a subcutaneous implantable cardioverter defibrillator (S–ICD) are scarce. Objective Aim of this study was to assess clinical outcomes of the S–ICD in HF patients in a real–world analysis from the largest European retrospective S–ICD registry (ELISIR). Methods All consecutive patients undergoing S–ICD implantation at several European institutions were used for the current analysis. The population was classified into two groups: the HF (classified as HF with reduced and mid–range ejection fraction – HFrEF and HFmrEF) vs the no–HF cohort. 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; HF patients represented 57.3% of the entire cohort (n = 701, 86.9% HFrEF; n = 106,13.1% HFmrEF). 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, with 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 (Kaplan–Meier estimates). At multivariate analysis (Figure 2), age (HR = 0.974 [0.955–0.992], p = 0.005), LVEF (HR = 0.954 [0.926–0.984], p = 0.003), arrhythmogenic right ventricular cardiomyopathy – ARVC (HR = 3.364 [1.206–9.384], p = 0.020) and smart pass + (HR = 0.321 [0.184–0.560], p < 0.001) remained associated with inappropriate shocks. Moreover, 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 use of S–ICD in HF patients did not result in a higher rate of inappropriate shocks when compared to no–HF patients, even when stratifying for LVEF. Only age, LVEF, ARVC e Smart Pass algorithm were predictors of the primary outcome at multivariate analysis. Despite a lower overall rate of complications in the entire cohort, HF patients experienced device–related complications more frequently.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.