Efficacy and safety of novel left ventricular pacing leads : 1-year analysis of the NAVIGATOR trial
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
Open heart - 11(2024), 1 vom: 05. Feb. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Martinez, Juan Gabriel [VerfasserIn] |
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| Links: |
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| Themen: |
Cardiac resynchronization therapy |
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| Anmerkungen: |
Date Completed 07.02.2024 Date Revised 14.02.2024 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1136/openhrt-2023-002517 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368057577 |
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| 100 | 1 | |a Martinez, Juan Gabriel |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of novel left ventricular pacing leads |b 1-year analysis of the NAVIGATOR trial |
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| 500 | |a Date Revised 14.02.2024 | ||
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| 520 | |a © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a OBJECTIVES: Assess safety and performance of novel quadripolar preshaped left ventricular (LV) leads: NAVIGO 4LV 2D ('S shaped') and NAVIGO 4LV ARC ('U shaped') | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a safety | |
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| 700 | 1 | |a Dompnier, Antoine |e verfasserin |4 aut | |
| 700 | 1 | |a Martins-Oliveira, Mario |e verfasserin |4 aut | |
| 700 | 1 | |a Israel, Carsten W |e verfasserin |4 aut | |
| 700 | 1 | |a Teijeira, Elvis |e verfasserin |4 aut | |
| 700 | 1 | |a Rubin, José Manuel |e verfasserin |4 aut | |
| 700 | 1 | |a Sebag, Frederic |e verfasserin |4 aut | |
| 700 | 1 | |a Martino, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Michel, Yann |e verfasserin |4 aut | |
| 700 | 1 | |a Marques, Pedro |e verfasserin |4 aut | |
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