Raymond Yee1, Fredrik Gadler2, Azlan Hussin3, Razali Bin Omar3, Yaariv Khaykin4, Atul Verma4, Mark Lazeroms5, Douglas S Hine6, Kyle R Marquard6. 1. London Health Sciences Center, London, Ontario, Canada. Electronic address: ryee@uwo.ca. 2. Karolinska Hospital, Stockholm, Sweden. 3. Institut Jantung Negara, Kuala Lumpur, Malaysia. 4. Southlake Regional Health Center, Newmarket, Ontario, Canada. 5. Medtronic Bakken Research Center, Maastricht, The Netherlands. 6. Medtronic, Inc, Minneapolis, Minnesota.
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.
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.