Impact of Sapien 3 Balloon-Expandable Versus Evolut R Self-Expandable Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis: Data From a Nationwide Analysis.


Journal

Circulation
ISSN: 1524-4539
Titre abrégé: Circulation
Pays: United States
ID NLM: 0147763

Informations de publication

Date de publication:
28 01 2020
Historique:
pubmed: 19 11 2019
medline: 1 7 2020
entrez: 19 11 2019
Statut: ppublish

Résumé

Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10-599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.

Sections du résumé

BACKGROUND
Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices.
METHODS
Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France.
RESULTS
A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10-599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected
CONCLUSIONS
On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.

Identifiants

pubmed: 31736332
doi: 10.1161/CIRCULATIONAHA.119.043971
doi:

Types de publication

Clinical Trial Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

260-268

Commentaires et corrections

Type : CommentIn
Type : CommentIn
Type : CommentIn

Auteurs

Pierre Deharo (P)

Département de Cardiologie (P.D., T.C.), CHU Timone, Marseille, France.
INSERM, INRA (P.D., F.C., T.C.), Aix Marseille Université, France.
Faculté de Médecine (P.D., F.C., T.C.), Aix Marseille Université, France.

Arnaud Bisson (A)

Service de Cardiologie, Centre Hospitalier Universitaire Trousseau et Faculté de Médecine (A.B., J.H., T.L., C.S.E., L.F.), France.

Julien Herbert (J)

Service de Cardiologie, Centre Hospitalier Universitaire Trousseau et Faculté de Médecine (A.B., J.H., T.L., C.S.E., L.F.), France.
Service d'information médicale, d'épidémiologie et d'économie de la santé, Unité d'épidémiologie hospitalière régionale (J.H., T.L., L.G.-G.), France.

Thibaud Lacour (T)

Service de Cardiologie, Centre Hospitalier Universitaire Trousseau et Faculté de Médecine (A.B., J.H., T.L., C.S.E., L.F.), France.
Service d'information médicale, d'épidémiologie et d'économie de la santé, Unité d'épidémiologie hospitalière régionale (J.H., T.L., L.G.-G.), France.

Christophe Saint Etienne (C)

Service de Cardiologie, Centre Hospitalier Universitaire Trousseau et Faculté de Médecine (A.B., J.H., T.L., C.S.E., L.F.), France.

Leslie Grammatico-Guillon (L)

Service de Cardiologie, Centre Hospitalier Universitaire Trousseau et Faculté de Médecine (A.B., J.H., T.L., C.S.E., L.F.), France.

Frederic Collart (F)

Département de Chirurgie Cardiaque (F.C.), CHU Timone, Marseille, France.
INSERM, INRA (P.D., F.C., T.C.), Aix Marseille Université, France.
Faculté de Médecine (P.D., F.C., T.C.), Aix Marseille Université, France.

Thierry Bourguignon (T)

Service de Chirurgie Cardiaque (T.B.), France.

Thomas Cuisset (T)

Département de Cardiologie (P.D., T.C.), CHU Timone, Marseille, France.
INSERM, INRA (P.D., F.C., T.C.), Aix Marseille Université, France.
Faculté de Médecine (P.D., F.C., T.C.), Aix Marseille Université, France.

Laurent Fauchier (L)

Service d'information médicale, d'épidémiologie et d'économie de la santé, Unité d'épidémiologie hospitalière régionale (J.H., T.L., L.G.-G.), France.

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Classifications MeSH