ABSTRACT
BACKGROUND: Left ventricular (LV) lead implantation for cardiac resynchronization therapy (CRT) is associated with lead dislodgement rates ranging from 3% to 10%, and some implant approaches to prevent dislodgement may contribute to suboptimal CRT response. We report our early human experience with an LV lead with a side helix for active fixation to the coronary vein wall. OBJECTIVES: To assess the feasibility and safety of the Model 20066 LV lead and to evaluate the implant procedure. METHODS: The Model 20066 is a 4-F bipolar steroid eluting lead that has a small exposed side helix and can be delivered using a guidewire or stylet. At the desired vein location, the lead body is rotated clockwise until the helix is fixated. This study was a single-arm, prospective, nonrandomized trial that enrolled 40 patients from 4 centers who met standard indications for CRT. RESULTS: The lead was successfully implanted in 39 of 40 (98%) patients. In 38 of 40 (95%) patients, the implanters were successful at implanting at a predetermined target site. There were no Model 20066 LV lead dislodgements reported within 12 months of follow-up. The electrical performance of the tip and ring electrodes was stable through the 12-month follow-up visit and similar to other LV leads. Overall lead handling was rated as acceptable for all implants. CONCLUSION: This new LV lead specifically designed with an active fixation mechanism for stability and precise placement was successfully and safely deployed in the coronary vasculature.
