Kevin P Jackson1, Svein Faerestrand2, Francois Philippon3, Raymond Yee4, Melissa H Kong5, Axel Kloppe6, Maria Grazia Bongiorni7, Scott F Lee8, Robert C Canby9, Erika Pouliot10, Mireille M E van Ginneken11, George H Crossley12. 1. Division of Cardiology, Duke University Medical Center, Durham, North Carolina. 2. Department of Clinical Science, University of Bergen and Haukeland University Hospital, Bergen, Norway. 3. Department of Medicine, Institut Universitaire De Cardiologie Et De Pneumologie De Quebec, Quebec, Canada. 4. Division of Cardiology, University Hospital, London, Ontario, Canada. 5. Silicon Valley Hospital, Redwood City, California. 6. Medizinische Klinik II, BG Universitätsklinikum Bergmannsheil, Bochum, Germany. 7. Cardiology Department, University Hospital of Pisa, Pisa, Italy. 8. Baptist Heart Specialists, Ponte Vedra Beach, Florida. 9. Texas Cardiac Arrhythmia Research, Austin, Texas. 10. Medtronic Inc., Mounds View, Minnesota. 11. Medtronic Bakken Research Center, Maastricht, The Netherlands. 12. Division of Cardiology, Vanderbilt University Heart and Vascular Institute, Nashville, Tennessee.
Abstract
INTRODUCTION: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. METHODS: Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence. RESULTS: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. CONCLUSIONS: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.
INTRODUCTION: The Medtronic Attain Stability Quad lead is a quadripolar left ventricular (LV) lead with an active fixation helix assembly designed to fixate the lead within the coronary sinus and pace nonapical regions of the LV. The primary objective of this study was to determine the safety and effectiveness of this novel active fixation quadripolar LV lead. METHODS:Patients with standard indications for cardiac resynchronization therapy (CRT) were enrolled. All patients were followed at 3 and 6 months post-implant and every 6 months thereafter until study closure. Pacing capture thresholds (PCTs) were measured at implant and each follow-up and adverse events (AEs) were recorded upon occurrence. RESULTS: Of the 440 patients who underwent implant procedures, placement of the Attain Stability Quad lead was successful in 426 (96.8%). LV lead-related complications occurred in 10 patients (2.3%), including LV lead dislodgement in three patients (0.7%). The percentage of patients with at least one LV pacing vector with a PCT ≤2.5 V at a 6-month follow-up was 96.3%. The LV lead was successfully fixated to the prespecified pacing location in 97.4% of cases. CONCLUSIONS: This large, multinational study of the Attain Stability Quad lead demonstrated a high rate of implant success with a low complication rate. The active fixation mechanism allowed precise placement of the pacing electrodes at the desired target region with good PCTs and a very low dislodgement rate.