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Efficacy and Safety of Novel Left Ventricular Pacing Leads: 1-Year Analysis of the NAVIGATOR Trial

2024Journal article Open access
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dc.contributor.authorMartinez, JG
dc.contributor.authorDe Sousa, J
dc.contributor.authorDompnier, A
dc.contributor.authorOliveira, M
dc.contributor.authorIsrael, C
dc.contributor.authorTeijeira, E
dc.contributor.authorRubin, JM
dc.contributor.authorSebag, F
dc.contributor.authorMartino, M
dc.contributor.authorMichel, Y
dc.contributor.authorMarques, P
dc.date.accessioned2024-05-15T15:02:07Z
dc.date.available2024-05-15T15:02:07Z
dc.date.issued2024
dc.description.abstractObjectives: 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationOpen Heart . 2024 Feb 5;11(1):e002517.pt_PT
dc.identifier.doi10.1136/openhrt-2023-002517pt_PT
dc.identifier.urihttp://hdl.handle.net/10400.17/4900
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherBMJpt_PT
dc.subjectHSM CARpt_PT
dc.subjectCardiac Resynchronization Therapy Devices / adverse effectspt_PT
dc.subjectCardiac Resynchronization Therapy* / adverse effectspt_PT
dc.subjectHumanspt_PT
dc.subjectElectrodes, Implanted / adverse effectspt_PT
dc.subjectHeart Failure* / diagnosispt_PT
dc.subjectHeart Failure* / etiologypt_PT
dc.subjectHeart Failure* / therapypt_PT
dc.subjectProspective Studiespt_PT
dc.titleEfficacy and Safety of Novel Left Ventricular Pacing Leads: 1-Year Analysis of the NAVIGATOR Trialpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue1pt_PT
oaire.citation.startPagee002517pt_PT
oaire.citation.titleOpen Heartpt_PT
oaire.citation.volume11pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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