Mp-453087-7 procedure time for a novel intercostal extravascular icd lead and comparison to the substernal extravascular icd lead

The procedure for intercostal placement of a novel extravascular (EV) ICD lead (AtaCor Medical, San Clemente, CA) differs substantially from other well-studied extravascular ICD leads. The AtaCor EV ICD lead is placed through an incision on the anterior chest wall at the sternal margin and into the mediastinum through an intercostal space. The objective of this analysis was to characterize implant success and the time required to place the novel EV ICD lead. In the non-randomized, single-center SECURE EV Study (NCT05099289), subjects (n=18) were implanted with the novel EV ICD lead, which was fixated (sutured) at the fascial plane and tunneled subcutaneously to the lateral ICD pocket for testing. Procedure times were collected from the time of the initial parasternal incision to: 1) removal of the delivery tool following lead deployment in the final position, and 2) complete fixation (suturing) at this insertion site. All insertion procedures were performed by 1 of 2 operators. All implanted subjects underwent defibrillation testing and retained the EV ICD system in monitor only mode (therapy off) for up to 90 days. The study cohort (n=18) averaged 59±18 years old, 29±5 kg/m2 BMI and was 22% female. Lead deployment was attempted in 17 of 18 subjects. In one subject, ossified costal cartilage obstructed the intercostal space and lead deployment was not attempted. Of the 17 attempted lead deployments, 16 (94%) deployments were successful. In one subject, an adhesion prevented adequate deployment of the lead and it was removed without testing. In the 16 successful implant procedures, the median time from making the parasternal incision to lead placement was 7.9 minutes [IQR 5.4, 16.3]. The median time from the parasternal incision to fixation (suturing) at the lead incision site was 21.5 minutes [IQR 18.2, 28.6]. This early experience with a novel intercostal EV ICD lead demonstrates that the insertion procedure is fast and predictable. Although more data are needed from multiple operators, the data compare favorably with other published EV ICD approaches.