Procedure Time With a Novel Completely Extravascular Temporary Pacing Lead System

Temporary intracardiac pacing is required for emergency pacing and also certain interventional procedures, including the increasingly indicated transcatheter aortic valve implantation. An important condition for the use of temporary pacemakers is a short procedure time. Current temporary pacemakers are implanted through the veins using fluoroscopy, and, when in situ, bedrest is required. As an alternative to this traditional approach, a novel, extravascular temporary pacing lead (EV-TPL) is being studied, which may ultimately be inserted without the use of fluoroscopy outside of the cardiac catheterization laboratory. The objective of this analysis was to characterize effect of implant experience on the time and number of attempts required to place a novel EV-TPL that paces without fixation to the heart. In the STEP III Study (NCT04538287), subjects undergoing a permanent pacemaker or ICD implantation or replacement also received an investigational EV-TPL. The EV-TPL was placed in the anterior mediastinum through a 2-3 cm skin incision made over an intercostal space at the left sternal margin. All leads were placed by one of three collaborating operators. Four sequential cohorts associated with minor device modifications were studied: Cohort 1 (n=8); Cohort 2 (n=8); Cohort 3 (n=7) and Cohort 4 (n=8). The time to achieve pacing capture was measured as the time difference between creation of the incision and demonstrated pacing capture at 10 volts and 1.5 milliseconds. Thirty-one patients were included (52% female, 70±11 years, BMI 26±4 kg/m2). Median times to achieve pacing capture for the successive cohorts were: 13.5 min [IQR 5.3, 45.8] for Cohort 1; 9.0 min [IQR 7.3, 23.5] for Cohort 2; 4.0 min [IQR 3.0, 27.0] for Cohort 3; and 5.5 min [IQR 5.0, 12.3] for Cohort 4, shown in Figure. Experience with the novel EV-TPL placement procedure led to a reduction in duration and variability of time to achieve pacing capture, showing the potential utility of the EV-TPL to provide temporary pacing for emergent situations and lead placement in advance of interventional procedures that require a temporary pacing.