Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial

• Published in: Journal of cardiovascular electrophysiology 2016-10, Vol.27 (10), p.1199-1205
• Main Authors: MITTAL, SUNEET, NAIR, DEVI, PADANILAM, BENZY J., CIUFFO, ALLEN, GUPTA, NIGEL, GALLAGHER, PETER, GOLDNER, BRUCE, HAMMILL, ERIC F., WOLD, NICOLAS, STEIN, KENNETH, BURKE, MARTIN
• Format: Article
• Language: English
• Subjects: Aged; biventricular pacing failure; cardiac resynchronization therapy; Cardiac Resynchronization Therapy - adverse effects; Cardiac Resynchronization Therapy Devices; congestive heart; Coronary Angiography; Defibrillators, Implantable; Disease-Free Survival; Electric Countershock - adverse effects; Electric Countershock - instrumentation; Electrodes; Female; Heart Failure - diagnosis; Heart Failure - physiopathology; Heart Failure - therapy; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Prospective Studies; Prosthesis Design; Prosthesis Failure; quadripolar lead; Risk Factors; Time Factors; Treatment Outcome; United States; Ventricular Dysfunction, Left - diagnosis; Ventricular Dysfunction, Left - physiopathology; Ventricular Dysfunction, Left - therapy; Ventricular Function, Left
• ISSN: 1045-3873; 1540-8167
• DOI: 10.1111/jce.13044

Anatomically Designed Quadripolar LV Leads Introduction 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). Methods and Results 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. Conclusion 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)