Infection experience and management in the extravascular implantable cardioverter- defibrillator: Retrospective analysis from the Pivotal Trial

Background The extravascular implantable cardioverter-defibrillator (EV ICD) is a commercially available device for patients at risk of sudden cardiac death. Results from pre-market studies have demonstrated a low complication rate and effective therapy through chronic follow-up. Lead placement outside the vasculature has the potential to reduce the severity of infections compared to other ICD options. Objective To report on details of infection occurrence and management from the EV ICD Pivotal study. Methods The EV ICD Pivotal study was an international, prospective, single-arm, premarket clinical study. Patients with any system- or procedure-related infection noted were included in our analysis. Results In the EV ICD Pivotal study, 316 patients had an implant attempt, of which 15 had a system- or procedure-related infection (4.7%, 9-737 days post-implant) through an average 29.0±10.6 months follow-up. Of these infections, eight (2.5% of Pivotal patients) were classified as major complications, three as minor, and four as observations. Most (n=9, 60%) infections were addressed through medication with or without wound care while 6 (40%) resulted in system removal. The infectious organism was reported for six. There were no reports of mediastinitis, sepsis, or endocarditis. Conclusions The results from this study support that EV ICD-related infections are treatable with antibiotic therapy or system removal and major infections are rare. Importantly, no system- or procedure-related systemic infections such as mediastinitis, sepsis, or endocarditis were reported.