Left Bundle Branch Area Pacing using a Stylet-Driven, Retractable-Helix Lead: Short Term Results from a Prospective, Multicenter IDE Trial (The BIO-CONDUCT Study).
Academic Article
Overview
abstract
BACKGROUND: Left bundle branch area pacing (LBBAP) has swiftly emerged as a safe and effective alternative to right ventricular (RV) pacing. Limited data exists on the use of retractable-helix, stylet-driven leads (SDL) for LBBAP. OBJECTIVE: The objective is to prospectively evaluate performance and safety of the Solia S stylet-driven pacing lead in a rigorously controlled multi-center trial to support U.S. market application. METHODS: A multi-center, prospective, non-randomized trial enrolled patients with standard pacing indications. Implant procedural and lead data, including threshold, sensing, impedance, and capture type were collected through 3-months. Primary endpoints were freedom from LBBAP lead-related serious complications through 3-months and LBBAP implant success according to pre-specified criteria. A blinded Clinical Events Committee (CEC) adjudicated all potential endpoint complications. RESULTS: A total of 186 patients were included from 14 US sites. LBBAP implants were successful in 95.7% (178/186; 95% CI: 91.7%, 98.1%; p< 0.0001 for comparison to performance goal of 88%). Through the 3-month follow-up, 3 patients experienced a serious LBBAP complication, all lead dislodgements, resulting in a LBBAP lead-related complication-free rate of 98.3%. A total of 13 patients (7.8%) experienced any system-related or procedure-related complication. Mean threshold was 0.89V at 0.4ms, sensing was 10.8mV, and impedance was 608 ohms. CONCLUSION: The short-term results from this prospective trial demonstrate both high implant success and freedom from LBBAP lead-related complications utilizing this stylet driven retractable helix lead. This trial supports the safety, use, and effectiveness of SDL for performing contemporary physiologic pacing.
