TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE NAVITOR SYSTEM: REAL-WORLD UNITED KINGDOM EXPERIENCE.
Efficacy
Navitor
Safety
TAVR
Journal
The American journal of cardiology
ISSN: 1879-1913
Titre abrégé: Am J Cardiol
Pays: United States
ID NLM: 0207277
Informations de publication
Date de publication:
29 Apr 2024
29 Apr 2024
Historique:
received:
04
02
2024
revised:
05
04
2024
accepted:
19
04
2024
medline:
2
5
2024
pubmed:
2
5
2024
entrez:
1
5
2024
Statut:
aheadofprint
Résumé
The Navitor (THV) is the latest iteration of the Portico self-expanding valve system. Early prospective studies have shown promising outcomes, however there is a lack of complementary 'real-world' data. To assess early safety and efficacy outcomes of the Navitor Transcatheter Heart Valve (THV) using registry data from six high-volume UK TAVR centers. Demographic, procedural and in-hospital outcome data were retrieved from six UK centers. The primary safety end-point was 30-day mortality. Primary efficacy end-points were procedural success, mean aortic gradient, and ≥moderate paravalvular leak (PVL). Secondary endpoints included rates of new pacemaker implantation (PPM), stroke and vascular injury. 574 patients (Mean age 83.4 years; 54.5% female) underwent Navitor TAVR between January 2020 and May 2023. The 30-day mortality in this patient cohort was 1.6%. Procedural success was 98.1%, mean echo-derived gradient post-TAVR was 7.7±4.8mmHg (95% CI [7.2, 8.3], p<0.001) and 5.1% of patients had ≥moderate PVL (p̂=0.051, 95% CI [0.035, 0.073, p<0.001). New PPM to discharge was required in 11% (p̂ =0.119, 95% CI [0.088, 0.158], p<0.001), stroke occurred in 1.2% of patients (p̂= 0.017, 95% CI [0.006, 0.036], p<0.001) and significant vascular injury in 1.6% (p̂= 0.014, 95% CI [0.005, 0.032], p<0.001). Early procedural outcomes with Navitor TAVR compare favorably to new generation THVs. Procedural success was high with a low incidence of complications.
Sections du résumé
BACKGROUND
BACKGROUND
The Navitor (THV) is the latest iteration of the Portico self-expanding valve system. Early prospective studies have shown promising outcomes, however there is a lack of complementary 'real-world' data.
AIMS
OBJECTIVE
To assess early safety and efficacy outcomes of the Navitor Transcatheter Heart Valve (THV) using registry data from six high-volume UK TAVR centers.
METHODS
METHODS
Demographic, procedural and in-hospital outcome data were retrieved from six UK centers. The primary safety end-point was 30-day mortality. Primary efficacy end-points were procedural success, mean aortic gradient, and ≥moderate paravalvular leak (PVL). Secondary endpoints included rates of new pacemaker implantation (PPM), stroke and vascular injury.
RESULTS
RESULTS
574 patients (Mean age 83.4 years; 54.5% female) underwent Navitor TAVR between January 2020 and May 2023. The 30-day mortality in this patient cohort was 1.6%. Procedural success was 98.1%, mean echo-derived gradient post-TAVR was 7.7±4.8mmHg (95% CI [7.2, 8.3], p<0.001) and 5.1% of patients had ≥moderate PVL (p̂=0.051, 95% CI [0.035, 0.073, p<0.001). New PPM to discharge was required in 11% (p̂ =0.119, 95% CI [0.088, 0.158], p<0.001), stroke occurred in 1.2% of patients (p̂= 0.017, 95% CI [0.006, 0.036], p<0.001) and significant vascular injury in 1.6% (p̂= 0.014, 95% CI [0.005, 0.032], p<0.001).
CONCLUSION
CONCLUSIONS
Early procedural outcomes with Navitor TAVR compare favorably to new generation THVs. Procedural success was high with a low incidence of complications.
Identifiants
pubmed: 38692400
pii: S0002-9149(24)00321-7
doi: 10.1016/j.amjcard.2024.04.036
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2024. Published by Elsevier Inc.