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Browsing by Author "Israel, C"

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  • Efficacy and Safety of Novel Left Ventricular Pacing Leads: 1-Year Analysis of the NAVIGATOR Trial
    Publication . Martinez, JG; De Sousa, J; Dompnier, A; Oliveira, M; Israel, C; Teijeira, E; Rubin, JM; Sebag, F; Martino, M; Michel, Y; Marques, P
    Objectives: Assess safety and performance of novel quadripolar preshaped left ventricular (LV) leads: NAVIGO 4LV 2D ('S shaped') and NAVIGO 4LV ARC ('U shaped'). Methods: Patients indicated for cardiac resynchronisation therapy were enrolled in a multicentre, prospective, controlled study (NAVIGATOR, NCT03279484). Patients were implanted with either a NAVIGO 4LV 2D or ARC lead, and assessed at 10 weeks, 6, 12 and 24 months post-implant. Co-primary safety and performance endpoints were assessed at 10 weeks. Safety endpoint was the patients' rate free from lead-related complications. Performance endpoint was the rate of patients with successful lead performance, defined as LV pacing threshold ≤2.5 V at 0.5 ms on at least one pacing vector, and the absence of phrenic nerve stimulation at the final programmed configuration. Lead-related complications and electrical parameters were monitored throughout study. Results: A NAVIGO 4LV lead was successfully implanted in 211 out of 217 patients (97.2%). The safety endpoint was met, with 100% and 96.1% of patients free from complications for NAVIGO 4LV 2D and ARC, respectively. The performance endpoint was met with 98.1% and 98.9% of patients with a successful lead performance for NAVIGO 4LV 2D and ARC, respectively. Over 12 months, the global complication-free rate for both leads was 97.1% (95% CI: 93.71% to 98.70%), with a mean pacing capture threshold of 1.23 V±0.73 V and a mean impedance of 951 Ω±300.1 Ω. Conclusion: A high implantation success rate and low complication rate was reported for the novel NAVIGO 4LV 2D and ARC leads, along with successful performance up to 12 months.
    2024Journal article Open access Show more
  • EHRA Expert Consensus Statement and Practical Guide on Optimal Implantation Technique for Conventional Pacemakers and implantable cardioverter-defibrillators: endorsed by the Heart Rhythm Society (HRS), the Asia Pacific Heart Rhythm Society (APHRS), and the Latin-American Heart Rhythm Society (LAHRS)
    Publication . Burri, H; Starck, C; Auricchio, A; Biffi, M; Burri, M; D’Avila, A; Deharo, JC; Glikson, M; Israel, C; Lau, CP; Leclercq, C; Love, C; Nielsen, J; Vernooy, K; Dagres, N; Boveda, S; Butter, C; Marijon, E; Braunschweig, F; Mairesse, G; Gleva, M; Defaye, P; Zanon, F; Lopez-Cabanillas, N; Guerra, J; Vassilikos, V; Oliveira, M
    With the global increase in device implantations, there is a growing need to train physicians to implant pacemakers and implantable cardioverter-defibrillators. Although there are international recommendations for device indications and programming, there is no consensus to date regarding implantation technique. This document is founded on a systematic literature search and review, and on consensus from an international task force. It aims to fill the gap by setting standards for device implantation.
    2021-07Journal article Open access Show more