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. 2024 Feb 5;11(1):e002517.
doi: 10.1136/openhrt-2023-002517.

Efficacy and safety of novel left ventricular pacing leads: 1-year analysis of the NAVIGATOR trial

Juan Gabriel Martinez  1 , Joao De Sousa  2 , Antoine Dompnier  3 , Mario Martins-Oliveira  4 , Carsten W Israel  5 , Elvis Teijeira  6 , José Manuel Rubin  7 , Frederic Sebag  8 , Maria Martino  9 , Yann Michel  9 , Pedro Marques  2
Affiliations

Efficacy and safety of novel left ventricular pacing leads: 1-year analysis of the NAVIGATOR trial

Juan Gabriel Martinez et al. Open Heart. .

Abstract

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.

Keywords: LV lead; cardiac resynchronization therapy; complication; safety.

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Conflict of interest statement

Competing interests: ET: Honoraria from MicroPort CRM. CI: MicroPort CRM Honoraria for presentations, reimbursement for travel/congress costs, participation in this sponsored research activity. MO: MicroPort CRM Honoraria for presentations.

Figures

Figure 1
Figure 1
NAVIGO 4LV 2D and ARC lead design, and choice of choice of 14 LV pacing vectors. The leads are available as ‘S shaped’ (NAVIGO 4LV 2D) and ‘U shaped’ (NAVIGO 4LV ARC) models for optimised suitability to various venous anatomies and their sizes (figure 1). All models are available in 78 cm and 88 cm versions. LV: left ventricular, CRT-D: Cardiac Resynchronization Therapy Defibrillator.
Figure 2
Figure 2
Study flow chart. LV: left ventricular; FAS: Full Analysis Set.
Figure 3
Figure 3
Phrenic nerve stimulation test and mean pacing threshold per vector at 10 weeks visit. LV, left ventricular; PNS, phrenic nerve stimulation.
See this image and copyright information in PMC

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