Long term complications in patients implanted with subcutaneous implantable defibrillators Real-world data from the Extended ELISIR experience

Background

Recently, the Food and Drug administration issued a recall for the subcutaneous implantable cardioverter defibrillator (S-ICD) due to the possibility of lead ruptures and accelerated battery depletion.

Objective

Aim of this study is to evaluate device-related complications over time in a real-world multicentered large S-ICD cohort.

Methods

Patients implanted with S-ICD from January 2015 to June 2020 were enrolled from a 19 institution European registry (ELISIR NCT0473876). Device-related complication rates over follow-up were collected. Last follow-up of patients was performed after the Boston Scientific recall issue.

Results

A total of 1254 patients (52.0 [41.0–62.2] years, 77.6% male, 30.9% ischemic) was enrolled. Over a follow-up of 23.2 [12.8–37.8] months, complications were observed in 117 (9.3%) patients, for a total of 127 device-related complications (23.6% managed conservatively, 76.4%) requiring reintervention). Twenty-seven (2.2%) patients had an unanticipated generator replacement, after 3.6 [3.3–3.9] years, while 4 (0.3%) had a lead rupture. BMI (HR 1.063 [1.028–1.100]; p=0.000), chronic kidney disease (HR 1.960 [1.191–3.225]; p=0.008), and oral anticoagulation (HR 1.437 [1.010–2.045]; p=0.043) were associated with an increase of overall complications whereas older age (HR 0.980 [0.967–0.994]; p=0.007) and procedure performed in high volume centers (HR 0.463 [0.300–0.715]; p=0.001) were protective factors.

Conclusion

The overall complication rate over 23.2 months of follow-up in a multicentered S-ICD cohort was 9.3%. Early unanticipated device battery depletions occurred in 2.2% of patients, while lead fracture was observed in 0.3%, in line with the expected rates reported from Boston Scientific.

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