2-year complication rate for subcutaneous ICDs nearly 10%
According to real-world data, for patients undergoing subcutaneous implantable cardioverter defibrillator implantation, the overall complication rate was 9.3% during the first 2 years after implantation.
With the recent Boston Scientific recall of subcutaneous ICDs, resulting from the possibility of lead ruptures and accelerated battery depletion and designated by the FDA as a class 1 recall, Alessio Gasperetti, MD, of Luigi Sacco University Hospital, Milan, and colleagues sought to assess device-related complications over time in a large, real-world, multicenter subcutaneous ICD cohort.
The study featured data from the Extended ELISIR experience and included 1,254 patients (median age, 52 years; 78% men; 30.9% ischemic) who received a subcutaneous ICD from 2015 to June 2020.
During follow-up (median, 23.2 months), 9.3% of patients experienced a complication, with pocket hematoma accounting for 25.2% of those complications. In all, 127 device-related complications occurred; of those, 23.6% were managed conservatively and 76.4% required reintervention, Gasperetti and colleagues wrote.
In addition, unanticipated generator replacement after a median of 3.6 years was reported in 2.2% of patients and 0.3% had a lead rupture, figures that were in line with the expected rates reported from Boston Scientific, according to the researchers.
Characteristics that increased the risk for overall complications included BMI (adjusted HR = 1.063; P < .001), chronic kidney disease (aHR = 1.96; P = .008) and oral anticoagulation (aHR = 1.437; P = .043). Conversely, older age (aHR = 0.98; P = .007) and having the procedure performed in a high-volume center (aHR = 0.463; P = .001) served as protective factors.
Regarding the latter finding, Gasperetti and colleagues hypothesized that the importance of a center’s volume extends beyond the number of procedures performed by a single operator, but also accounts for the more experienced scrub teams, the better periprocedural flow and the proactive hospital inward environment. “Our data seem to strongly point towards the centralization of subcutaneous ICD procedures into high-volume centers to reduce overall complications and related downsides,” they wrote.
In other data, 9.4% of patients experienced at least one inappropriate shock. “Despite the efforts made in trying to better set the devices and improve the discrimination algorithms,” the researchers wrote, “inappropriate shocks remain a relevant subcutaneous ICD complication, differently from transvenous ICD, where the programming optimization led to a clear reduction of oversensing-related inappropriate shocks over the years.”
Furthermore, mortality in the registry was 3.4%, with end-stage HF being the leading cause (1.5%). No device-related deaths were reported.
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