Data on patients with heart failure (HF) receiving the subcutaneous implantable cardioverter defibrillator (S-ICD) device in primary prevention are very scarce. The only trial that focused on inappropriate shocks and procedure-related complications at 30 days was the single prospective UNTOUCHED trial.
Objective:
to assess clinical outcomes of the S-ICD in HF patients, comparing them with a non-HF population, in a real-world analysis from a large, multicenter European retrospective S-ICD registry.
Methods: All consecutive patients who underwent S-ICD implantation at 22 European centers were enrolled in the ELISIR registry. According to European HF Guidelines, the population was classified into two groups: the HF group (further classified as HF with reduced and mildly reduced ejection fraction – HFrEF and HFmrEF) and the non-HF group. The primary outcome of the study was the rate of inappropriate shock (IS) in both groups. Appropriate shocks, cardiovascular mortality and device-related complications during follow-up were assigned as secondary outcomes.
Results:
A total of 1409 patients were included in this analysis; HF patients represented 57.3% of the entire cohort (n=701, 86.9% HFrEF; n=106,13.1% HFmrEF). Patients with heart failure had more cardiovascular risk factors and comorbidities compared to the non-HF cohort. Inappropriate shocks were observed in n=133 of entire cohort over a median follow-up of approximately 2 years. There were no differences between the two groups (9.2% vs 9.8%, p=0.689). The rate of appropriate shocks (9.2% vs 9.8%, p=0.689) was similar in both groups. Inappropriate and effective shocks-free survival is shown in Figure 1, showing Kaplan-Meier estimates comparing HF vs non-HF patients. 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, 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. Sventy-six of 1409 patients experienced device-related complications: 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). The overall rate was higher in the HF cohort (6.2% vs 3.8%, p=0.031).
Conclusion:
The rate of inappropriate shocks seems to be comparable in both HF and non-HF patients. However, the rate of device-related complications was more frequently in HF patients.
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