| Autor: |
Juan Gabriel Martinez, Joao De Sousa, Antoine Dompnier, Mario Martins -Oliveira, Carsten W Israel, Elvis Teijeira, José Manuel Rubin, Frederic Sebag, Maria Martino, Yann Michel, Pedro Marques |
| Jazyk: |
angličtina |
| Rok vydání: |
2024 |
| Předmět: |
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| Zdroj: |
Open Heart, Vol 11, Iss 1 (2024) |
| Druh dokumentu: |
article |
| ISSN: |
2053-3624 |
| DOI: |
10.1136/openhrt-2023-002517 |
| Popis: |
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. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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