Initial experience of a large, self-expanding, and fully recapturable transcatheter aortic valve: The UK & Ireland Implanters' registry.
Aged
Aged, 80 and over
Aortic Valve
/ diagnostic imaging
Aortic Valve Stenosis
/ diagnostic imaging
Female
Heart Valve Prosthesis
Hemodynamics
Humans
Ireland
Male
Postoperative Complications
/ mortality
Prosthesis Design
Registries
Risk Assessment
Risk Factors
Time Factors
Transcatheter Aortic Valve Replacement
/ adverse effects
Treatment Outcome
United Kingdom
aortic stenosis
self-expanding transcatheter aortic valve
transcatheter aortic valve replacement
Journal
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
ISSN: 1522-726X
Titre abrégé: Catheter Cardiovasc Interv
Pays: United States
ID NLM: 100884139
Informations de publication
Date de publication:
01 03 2019
01 03 2019
Historique:
received:
18
07
2018
revised:
04
09
2018
accepted:
23
09
2018
pubmed:
6
11
2018
medline:
15
4
2020
entrez:
6
11
2018
Statut:
ppublish
Résumé
The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves. The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus. Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days. A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.
Sections du résumé
OBJECTIVES
The UK & Ireland Implanters' registry is a multicenter registry which reports on real-world experience with novel transcatheter heart valves.
BACKGROUND
The 34 mm Evolut R transcatheter aortic valve is a self-expanding and fully recapturable transcatheter aortic valve, designed to treat patients with a large aortic annulus.
METHODS
Between January 2017 and April 2018, clinical, procedural and 30-day outcome data were prospectively collected from all patients receiving the 34 mm Evolut R valve across 17 participating centers in the United Kingdom and Ireland. The primary efficacy outcome was the Valve Academic Research Consortium-2(VARC-2)-defined endpoint of device success. The primary safety outcome was the VARC-2-defined composite endpoint of early safety at 30 days.
RESULTS
A total of 217 patients underwent attempted implant. Mean age was 79.5 ± 8.8 years and Society of Thoracic Surgeons Predicted Risk of Mortality Score 5.2% ± 3.4%. Iliofemoral access was used in 91.2% of patients. Device success was 79.7%. Mean gradient was 7.0 ± 4.6 mmHg and effective orifice area 2.0 ± 0.6 cm
CONCLUSIONS
Real-world experience of the 34 mm Evolut R transcatheter aortic valve demonstrated acceptable procedural success, safety, valve function, and incidence of new permanent pacemaker implantation.
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
751-757Informations de copyright
© 2018 Wiley Periodicals, Inc.