Biotronik has initiated the second phase of its BIO-CONDUCT study, enrolling the first patient to assess the safety and efficacy of its next-generation Solia CSP S pacing lead specifically designed for left bundle branch area pacing (LBBAP). This FDA investigational device exemption (IDE) trial at NYU Langone Health marks a significant step in refining LBBAP techniques and tools, potentially improving outcomes for patients requiring ventricular pacing support.
Advancing LBBAP Technology
The Solia CSP S lead builds upon the earlier Solia S model, incorporating enhancements such as a fixed helix for simplified preparation, a lengthened helix for easier access to the left bundle branch area, and an optimized distal end to enhance durability. According to Larry Chinitz, MD, director of cardiac electrophysiology at NYU Langone Heart Rhythm Center, these refinements aim to provide physicians with more effective tools for successful LBBAP procedures.
The second arm of the BIO-CONDUCT trial plans to enroll up to 110 patients across 14 sites in the United States. The study will evaluate the investigational pacing lead's safety and effectiveness in the left bundle branch area over a 12-month period, focusing on successful lead implant rates, complication rates, lead performance, and patient quality of life.
Industry-Wide Movement Toward LBBAP
Interest in LBBAP has surged in recent years as a method to achieve more physiological activation of cardiac tissue compared to conventional pacing locations. Several electrophysiology (EP) device vendors are actively involved in LBBAP trials and working toward new device approvals or expanded FDA indications. Medtronic was the first to secure an LBBAP indication for its SelectSecure MRI SureScan Model 3830 cardiac lead in October 2022.
In September 2024, the FDA cleared LBBAP indications for Boston Scientific's Ingevity+ pacing leads, Biotronik's Solia S lead and Selectra 3D catheter, and Abbott's UltiPace stylet-driven pacing lead. Furthermore, Abbott announced the world's first in-human leadless LBBAP procedures in December 2024 using its investigational Aveir Conduction System Pacing (CSP) leadless pacemaker system, which has received FDA Breakthrough Device Designation.
Clinical Advantages of LBBAP
LBBAP, also known as conduction system pacing, has been a prominent topic at major cardiology conferences, including the Heart Rhythm Society meetings. This technique involves placing a single lead in the left bundle branch, located in the septum after the area of block, which can simplify pacemaker procedures compared to using two leads to pace each ventricle in left bundle branch block (LBBB) patients.
While LBBAP presents anatomical and placement challenges, experts suggest it can be particularly beneficial for heart failure patients. Kenneth Ellenbogen, MD, director of clinical cardiac electrophysiology and pacing for Virginia Commonwealth University, noted that LBB pacing might not significantly impact patients with relatively good heart muscle function but can make a substantial difference in heart failure cases. Pugazhendhi Vijayaraman, MD, director of electrophysiology at the Geisinger Heart Institute, added that conduction system pacing simulates natural activation and can yield positive outcomes.
Juan C. Diaz, MD, a specialist with Clinica Las Vegas, presented results from the SYNCHRONY Collaborative Group trial at HRS 2023, comparing LBBAP versus standard biventricular pacing (BiVp) for cardiac resynchronization therapy (CRT). The study demonstrated a significant 38% decrease in the composite outcome of heart failure hospitalization and all-cause mortality with LBBAP, along with improvements in heart failure symptoms.
