title: Novel active fixation mechanism permits precise placement of a left ventricular lead: early results from a multicenter clinical study.
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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: London Health Sciences Center, London, Ontario, Canada. Electronic address: ryee@uwo.ca.
authors.forename: Raymond
authors.initials: R
authors.lastname: Yee
authors.affiliation: Karolinska Hospital, Stockholm, Sweden.
authors.forename: Fredrik
authors.initials: F
authors.lastname: Gadler
authors.affiliation: Institut Jantung Negara, Kuala Lumpur, Malaysia.
authors.forename: Azlan
authors.initials: A
authors.lastname: Hussin
authors.affiliation: Institut Jantung Negara, Kuala Lumpur, Malaysia.
authors.forename: Razali
authors.initials: R
authors.lastname: Bin Omar
authors.affiliation: Southlake Regional Health Center, Newmarket, Ontario, Canada.
authors.forename: Yaariv
authors.initials: Y
authors.lastname: Khaykin
authors.affiliation: Southlake Regional Health Center, Newmarket, Ontario, Canada.
authors.forename: Atul
authors.initials: A
authors.lastname: Verma
authors.affiliation: Medtronic Bakken Research Center, Maastricht, The Netherlands.
authors.forename: Mark
authors.initials: M
authors.lastname: Lazeroms
authors.affiliation: Medtronic, Inc, Minneapolis, Minnesota.
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Hine
authors.affiliation: Medtronic, Inc, Minneapolis, Minnesota.
authors.forename: Kyle R
authors.initials: KR
authors.lastname: Marquard
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000379:methods*; D003331:Coronary Vessels / Q000503:physiopathology / Q000601:surgery*; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
keywords: Active fixation; Biventricular pacing; LV lead; Lead dislodgement; Left ventricle