The objective is to report the safety and efficacy of TPNS in patients with concomitant CIEDs.
In the remedē System Pivotal Trial, 151 patients underwent TPNS device implant. This analysis compared patients with concomitant CIEDs to those without with respect to safety, implant metrics and efficacy of TPNS. Safety was assessed using incidence of adverse events and device-device interactions. A detailed interaction protocol was followed. Implant metrics included overall TPNS implantation success. Efficacy endpoints included changes in the apnea-hypopnea index (AHI) and quality of life.
Of 151 patients, 64 (42%) had a concomitant CIED. There were no significant differences between the groups with respect to safety. There were 4 CIED oversensing events in 3 patients leading to one inappropriate defibrillator shock and delivery of anti-tachycardia pacing. There was no difference in efficacy between the CIED and non-CIED subgroups receiving TPNS, with both having similar percentages of patients who achieved ≥ 50% reduction in AHI and quality of life improvement.
Concomitant CIED and TPNS therapy is safe. The presence of a concomitant CIED did not appear to impact implant metrics, implantation success and TPNS efficacy. A detailed interaction protocol should be followed to minimize the incidence of device-device interaction.
Copyright © 2020. Published by Elsevier Inc.