Abstract

The extravascular (EV) ICD lead is in the substernal space. The amplitude of the sensed R-wave is less than that of transvenous ICDs. Because the lead does not move with the heart, R-wave amplitude may vary with posture. To characterize postural and temporal R-wave amplitude variability from near-field (Ring1-Ring2) and far-field (Ring1-Can) sensing vectors using data from the EV ICD clinical, pilot study. We studied 17 patients with scheduled follow-up at pre-hospital discharge, 2, 6, and 12 weeks. Unfiltered sinus rhythm R waves for Ring1-Ring2 and Ring1-Can vectors were recorded with each patient in 7 postures: supine, lying on right and left sides, prone, sitting, bending over and standing. R-wave amplitude was measured across time, posture and vector. The mean and standard deviation across patients was calculated for each posture, follow-up time, and vector. The Figure plots R-wave amplitude. The averaged R-wave amplitude was 1.86±0.93mV for Ring1-Ring2, 2.22±1.33mV for Ring1-Can. It was marginally greater for Ring1-Can than Ring1-Ring2 (p=0.076). Neither changed significantly over time (p=0.33). Posture-related changes were significant for sitting versus standing on Ring1-Can (p=0.002) and for bending over versus lying on left for Ring1-Ring2 (p=0.031). In clinical follow-up of 354 patient-months, decreases in R-wave amplitude caused transient oversensing but no inappropriate therapies. For both EV ICD sensing vectors, R-wave amplitude is stable over the first 12 weeks. Despite minor postural changes, R-wave amplitude variability did not cause inappropriate therapy.

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