Suneet Mittal1, Devi Nair2, Benzy J Padanilam3, Allen Ciuffo4, Nigel Gupta5, Peter Gallagher6, Bruce Goldner7, Eric F Hammill8, Nicolas Wold8, Kenneth Stein8, Martin Burke9. 1. Valley Health System, Ridgewood, NJ, USA. mittsu@valleyhealth.com. 2. Division of Cardiac Electrophysiology, Department of Medicine, St. Bernard's Heart & Vascular Center, Jonesboro, AR, USA. 3. Department of Medicine, St. Vincent Hospital, Indianapolis, IN, USA. 4. Department of Medicine, Sentara Heart Hospital, Norfolk, VA, USA. 5. Department of Medicine, Kaiser Permanente, Los Angeles Medical Center, Los Angeles, CA, USA. 6. Department of Medicine, Nebraska Heart Institute, Lincoln, NE, USA. 7. Department of Medicine, Northwell Health System, New Hyde Park, NY, USA. 8. Boston Scientific, St. Paul, MN, USA. 9. Section of Cardiology, Department of Medicine, Heart Rhythm Center, University of Chicago, USA.
Abstract
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).
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).
Authors: Giuseppe Stabile; Valter Bianchi; Francesco Solimene; Assunta Iuliano; Quintino Parisi; Patrizia Pepi; Mario Bocchiardo; Francesco Urraro; Antonio De Simone; Roberto Ospizio; Antonio D'Onofrio Journal: J Interv Card Electrophysiol Date: 2017-08-10 Impact factor: 1.900