Left Bundle Branch Area Stylet-Driven Lead: Performance, Safety and Quality of Life at 12 Months Post Implant (The BIO-CONDUCT IDE Study).
Academic Article
Overview
abstract
BACKGROUND: Prospective studies with a focus on the safety and effectiveness profile of stylet-driven left bundle branch area pacing (LBBAP) leads at both implant and chronic stages significantly contribute to a comprehensive perspective of utilizing SDL in this pacing modality. OBJECTIVE: Prospectively evaluate the performance and safety of LBBA-placed Solia S leads and the related impact on the patient's quality of life (QOL) through 12 months. METHODS: A multi-center, prospective, non-randomized trial enrolled patients with standard pacing indications in whom a Solia S lead was implanted in the left bundle branch area (LBBA). Adverse events and quality-of-life metrics were collected out to 12 months post implant along with threshold, sensing, and lead impedance data. RESULTS: For the 161 patients who experienced an SADE event or had at least 335 days of follow-up, the associated 12-month serious adverse device effect (SADE) rate was 0.02 events per subject-year [SADE-free rate of 98.1% (95% CI: 94.7%, 99.6%)]. The mean threshold was 0.98V at 0.4ms (vs. 0.84V at implant), mean sensing was 12.76mV (vs. 9.15mV at implant), and mean impedance was 521.8 ohms (vs. 670.5 ohms at implant). The mean change for the QOL physical function scale was +11.4 ± 24.0 (95% CI: 7.4, 15.4; t-value = 4.23; p < 0.001). CONCLUSION: These 12-month results utilizing the Solia S SDL demonstrate freedom from LBBAP lead-related complications, acceptable lead performance characteristics along with a significant coincident improvement in a patient's physical function.
