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).

BACKGROUND

Left bundle branch area pacing (LBBAP) has swiftly emerged as a safe and effective alternative to right ventricular pacing. Limited data exist on the use of retractable-helix, stylet-driven leads for LBBAP.

OBJECTIVE

The objective of this study was to prospectively evaluate the performance and safety of a stylet-driven pacing lead in a rigorously controlled multicenter trial to support US market application.

METHODS

A multicenter, prospective, nonrandomized trial enrolled patients with standard pacing indications. Implant procedure and lead data, including threshold, sensing, impedance, and capture type, were collected through 3 months. Primary end points were freedom from LBBAP lead-related serious complications through 3 months and LBBAP implant success according to prespecified criteria. A blinded clinical events committee adjudicated all potential end point complications.

RESULTS

A total of 186 patients were included from 14 US sites. LBBAP implants were successful in 95.7% (178 of 186; 95% confidence interval 91.7%-98.1%; P < .0001 for comparison to the performance goal of 88%). Through the 3-month follow-up visit, 3 patients (1.7%) experienced a serious LBBAP complication (all lead dislodgments), resulting in a LBBAP lead-related complication-free rate of 98.3%. A total of 13 patients (7.8%) experienced any system- or procedure-related complication. The mean threshold was 0.89 V at 0.4 ms, the sensing value was 10.8 mV, and impedance was 608 Ω.

CONCLUSION

The short-term results from this prospective trial demonstrate both high implant success and freedom from LBBAP lead-related complications using this stylet-driven retractable helix lead. This trial supports the safety, use, and effectiveness of stylet-driven leads for performing contemporary physiologic pacing.