Performance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial. (19th August 2016)

• Record Type: Journal Article
• 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
• Is Part Of: Journal of cardiovascular electrophysiology. Volume 27:Number 10(2016)
• Page Start: 1199
• Page End: 1205
• Publication Date: 2016-08-19
• Subjects: biventricular pacing failure -- cardiac resynchronization therapy -- congestive heart -- quadripolar lead; Blood vessels -- Physiology -- Periodicals; Electrophysiology -- Periodicals; Heart -- Physiology -- Periodicals; 612.1
• DOI: 10.1111/jce.13044
• Languages: English
• ISSNs: 1045-3873

Abstract

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)