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J. Cardiovasc. Electrophysiol. · Oct 2016
Multicenter Study Clinical TrialPerformance of Anatomically Designed Quadripolar Left Ventricular Leads: Results from the NAVIGATE X4 Clinical Trial.
- Suneet Mittal, Devi Nair, Benzy J Padanilam, Allen Ciuffo, Nigel Gupta, Peter Gallagher, Bruce Goldner, Eric F Hammill, Nicolas Wold, Kenneth Stein, and Martin Burke.
- Valley Health System, Ridgewood, NJ, USA. mittsu@valleyhealth.com.
- J. Cardiovasc. Electrophysiol. 2016 Oct 1; 27 (10): 1199-1205.
IntroductionThe 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 ResultsPatients 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.ConclusionThe 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).© 2016 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals, Inc.
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