Five-year outcomes of rapid-deployment aortic valve replacement with the Edwards Intuity valve.
5-year
aortic valve replacement
outcomes
overall mortality
prospective
rapid-aortic valve deployment
single-center
Journal
Journal of cardiac surgery
ISSN: 1540-8191
Titre abrégé: J Card Surg
Pays: United States
ID NLM: 8908809
Informations de publication
Date de publication:
Aug 2021
Aug 2021
Historique:
revised:
28
04
2021
received:
09
03
2021
accepted:
02
05
2021
pubmed:
27
5
2021
medline:
14
7
2021
entrez:
26
5
2021
Statut:
ppublish
Résumé
This report presents 5-year outcomes of the rapid-deployment Edwards Intuity valve in a prospective, single-center study. All patients who underwent an aortic valve replacement (AVR) with an Edwards Intuity bioprosthesis at La Timone Hospital, Marseille, France, from July 2012 to June 2015 were assessed over a 5-year follow-up period. The primary outcome was overall mortality at 5 years. Secondary outcomes were reoperation, overall mortality and stroke, cardiovascular mortality, composite endpoints defined by the updated Valve Academic Research Consortium-2 (VARC-2), periprosthetic regurgitation, prosthesis-patient mismatch, and the need for new pacemaker implantation. In total, 170 consecutive patients were assessed, of which 67.1% were males. The mean age was 76 years, mean EuroSCORE II was 3.5% and 5-year overall mortality was 12.4%. At 5 years, reoperation was 2.9%, overall mortality and stroke was 4.1% per patient-year, and cardiovascular mortality was 4.7%. VARC clinical efficacy and VARC time-related valve safety were achieved in 46.0% and 59.9% of patients, respectively. At one month VARC device success was 71.2% and VARC early safety was 87.1%. At one year, mild and moderate periprosthetic regurgitation were 2.4% and 0.6%, respectively, and moderate and severe prosthesis-patient mismatch were 18.8% and 4.8%, respectively. Conduction disturbances needing new PPI occurred in 3.5% patients. The 5-year outcomes of AVR with the Edwards Intuity valve system demonstrate satisfactory midterm safety and excellent haemodynamic performance.
Sections du résumé
BACKGROUND
BACKGROUND
This report presents 5-year outcomes of the rapid-deployment Edwards Intuity valve in a prospective, single-center study.
METHODS
METHODS
All patients who underwent an aortic valve replacement (AVR) with an Edwards Intuity bioprosthesis at La Timone Hospital, Marseille, France, from July 2012 to June 2015 were assessed over a 5-year follow-up period. The primary outcome was overall mortality at 5 years. Secondary outcomes were reoperation, overall mortality and stroke, cardiovascular mortality, composite endpoints defined by the updated Valve Academic Research Consortium-2 (VARC-2), periprosthetic regurgitation, prosthesis-patient mismatch, and the need for new pacemaker implantation.
RESULTS
RESULTS
In total, 170 consecutive patients were assessed, of which 67.1% were males. The mean age was 76 years, mean EuroSCORE II was 3.5% and 5-year overall mortality was 12.4%. At 5 years, reoperation was 2.9%, overall mortality and stroke was 4.1% per patient-year, and cardiovascular mortality was 4.7%. VARC clinical efficacy and VARC time-related valve safety were achieved in 46.0% and 59.9% of patients, respectively. At one month VARC device success was 71.2% and VARC early safety was 87.1%. At one year, mild and moderate periprosthetic regurgitation were 2.4% and 0.6%, respectively, and moderate and severe prosthesis-patient mismatch were 18.8% and 4.8%, respectively. Conduction disturbances needing new PPI occurred in 3.5% patients.
CONCLUSION
CONCLUSIONS
The 5-year outcomes of AVR with the Edwards Intuity valve system demonstrate satisfactory midterm safety and excellent haemodynamic performance.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2826-2833Subventions
Organisme : Edwards Lifesciences
ID : HVT-I19-032
Informations de copyright
© 2021 Wiley Periodicals LLC.
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