OmniaSecure defibrillation lead was successfully implanted in 7 pediatric patients with stable electrical performance and no lead fractures or major complications over 12 months.
Does the OmniaSecure ICD lead provide safe and stable electrical performance in pediatric patients?
The novel 4.7 Fr lumenless OmniaSecure ICD lead demonstrated successful implantation, stable electrical parameters, and no major complications at 12 months in a small pediatric cohort.
Absolute Event Rate: 0% vs 0%
Abstract Background Transvenous (TV) defibrillation leads remain the Achilles heel of Implantable Cardioverter Defibrillators (ICD) with disproportionally higher rates of lead fracture in pediatric patients. Small vasculature may preclude single or multiple TVL implantation. There is a growing need for smaller, reliable TV ICD leads that are designed for targeted right ventricular (RV) placement. The Lead EvaluAtion for Defibrillation and Reliability (LEADR) trial evaluated the novel, lumenless, 4.7 Fr, OmniaSecure (Figure) TVL designed for reliability and targeted placement, based on the SelectSecure 3830 pacing lead in patients ≥ 18 years of age. The trial exceeded primary safety and efficacy objective performance goals with no lead fractures through ~1 year follow-up. Purpose We aimed to assess safety and electrical performance of the OmniaSecure lead in patients ≤ 21 years of age. Methods Local ethics approval using Compassionate Use from the Food and Drug Administration under the Expanded Access Medical Device pathway was used for each case. Indications for OmniaSecure ICD lead were determined by implanting physician. Results Seven patients (3 females (43%), median age 14 years (8-18 years) had an OmniaSecure lead implant attempt, and all (100%) were successfully implanted in targeted RV location with a median follow-up time of 12 months (1-23 months). The median pacing threshold, sensed R wave amplitude, pacing and defibrillation impedance at implant vs. follow up were 0.5 v (0.25-0.75), 11 mv (5-20), 571 ohms (320-1083), 52 (38-124) vs. 0.75 v (0.5-1.5), 15 mv (3-20), 390 mv (266- 494), 64 ohms (54-121), respectively. There were no OmniaSecure lead related major complications at implant or during follow up. One patient had T wave oversensing without inappropriate shock. There were no fractures or lead dislodgements. Conclusion The OmniaSecure ICD lead has the potential to provide significant clinical benefits such as stable electrical parameters, reduced complications, and ability to select a RV target site. This lead may also lower the patient size threshold for TV ICD and avoid sternotomy procedures in some children.OmniaSecure ICD Lead Implant
Shah et al. (Sat,) reported a other. OmniaSecure defibrillation lead was successfully implanted in 7 pediatric patients with stable electrical performance and no lead fractures or major complications over 12 months.