title: Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial.
abstract: The safety and efficacy of a novel family of quadripolar left ventricular (LV) pacing leads designed to pace from nonapical regions of the LV with low pacing capture thresholds was studied in patients undergoing implantation of a cardiac resynchronization therapy defibrillator (CRT-D).
  
  
  
  Patients receiving a CRT-D were implanted with 1 of 3 ACUITY X4 leads (Spiral Long, Spiral Short, or Straight), designed to address coronary venous anatomical variability. Electrical performance and LV lead related complications were evaluated 3 and 6 months post implantation, respectively. 764 patients (68 ± 11 years, 66% male) were enrolled; 738 (97%) successfully implanted with an ACUITY X4 lead (Spiral L, n = 239, 31%; Spiral S, n = 281, 37%; Straight, n = 218, 29%). A targeted threshold ≤2.5 V was achieved in 644 (94%) patients. The median threshold from the best proximal electrode was lower than the tip electrode (0.9 V [IQR 0.7, 1.3] vs. 1.3 V [IQR 0.7, 2.5], p< 0.001) on Spiral leads. Irrespective of lead implanted, one of the proximal electrodes was the programmed cathode in most patients. The overall LV complication-free rate was 98%. LV lead dislodgment occurred in 8 (1%) patients. PNS occurred in 58 (8%) patients, but only 3 (0.4%) patients required surgical intervention.
  
  
  
  The ACUITY X4 LV leads had low pacing thresholds particularly from proximal electrodes, a high incidence of pacing from the nondistal electrode, and low likelihood of dislodgment or PNS requiring surgical intervention. (ClinicalTrials.gov Identifier: NCT02071173).
authors.affiliation: Valley Health System, Ridgewood, NJ, USA. mittsu@valleyhealth.com.
authors.forename: Suneet
authors.initials: S
authors.lastname: Mittal
authors.affiliation: Division of Cardiac Electrophysiology, Department of Medicine, St. Bernard's Heart & Vascular Center, Jonesboro, AR, USA.
authors.forename: Devi
authors.initials: D
authors.lastname: Nair
authors.affiliation: Department of Medicine, St. Vincent Hospital, Indianapolis, IN, USA.
authors.forename: Benzy J
authors.initials: BJ
authors.lastname: Padanilam
authors.affiliation: Department of Medicine, Sentara Heart Hospital, Norfolk, VA, USA.
authors.forename: Allen
authors.initials: A
authors.lastname: Ciuffo
authors.affiliation: Department of Medicine, Kaiser Permanente, Los Angeles Medical Center, Los Angeles, CA, USA.
authors.forename: Nigel
authors.initials: N
authors.lastname: Gupta
authors.affiliation: Department of Medicine, Nebraska Heart Institute, Lincoln, NE, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Gallagher
authors.affiliation: Department of Medicine, Northwell Health System, New Hyde Park, NY, USA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Goldner
authors.affiliation: Boston Scientific, St. Paul, MN, USA.
authors.forename: Eric F
authors.initials: EF
authors.lastname: Hammill
authors.affiliation: Boston Scientific, St. Paul, MN, USA.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Wold
authors.affiliation: Boston Scientific, St. Paul, MN, USA.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Stein
authors.affiliation: Section of Cardiology, Department of Medicine, Heart Rhythm Center, University of Chicago, USA.
authors.forename: Martin
authors.initials: M
authors.lastname: Burke
mesh_terms: D000368:Aged; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects; D058409:Cardiac Resynchronization Therapy Devices; D017023:Coronary Angiography; D017147:Defibrillators, Implantable; D018572:Disease-Free Survival; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D018487:Ventricular Dysfunction, Left / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D016277:Ventricular Function, Left
keywords: biventricular pacing failure; cardiac resynchronization therapy; congestive heart; quadripolar lead