Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population.

Abstract

The extravascular (EV) implantable cardioverter-defibrillator (ICD) includes features to address sensing and arrhythmia detection challenges presented by its substernal lead location. In this study, the authors sought to evaluate sensing and detection performance in 299 patients discharged with an EV-ICD in the global pivotal study. We reviewed and adjudicated all induced ventricular fibrillation (VF) episodes and spontaneous device-stored episodes that satisfied rate and duration criteria in a programmed ventricular tachycardia (VT)/VF therapy zone. At implantation, all EV-ICDs detected induced VF at the programmed sensitivity; 95.9% detected VF with a 3× safety margin. In follow-up, EV-ICDs detected all 59 VT/VF episodes that sustained until therapy. Of 1,034 non-VT/VF episodes, oversensing caused 87.9% and supraventricular tachycardia caused 12.1%. Therapy was withheld in 80.9%, aborted in 10.6%, and delivered in 8.5%. The most common causes of oversensing were myopotentials (61.2%) and P-wave oversensing (PWOS) (19.9%). Inappropriate shocks occurred in only 3.2% of myopotential episodes, but in 21.8% of PWOS episodes. Myopotential oversensing was more common with Ring-Can sensing (P< 0.0001) and correlated with low R-wave amplitude (P< 0.0001). PWOS occurred almost exclusively with Ring1-Ring2 sensing (P=0.0001) and began with transient decrease in R-wave or increase in P-wave amplitude (P< 0.0001). In software emulation, a new PWOS discriminator significantly reduced total inappropriate detections. In a global population, EV-ICD detected induced and spontaneous VT/VF accurately. Although discriminators withheld detection from most non-VT/VF episodes, inappropriate shocks were common. The most common cause was PWOS, which may be reduced by optimizing sensing at implantation and incorporation of the PWOS discriminator, which is now in the current device. (Extravascular ICD Pivotal Study [EV ICD]; NCT04060680).