Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves.

Détails

ID Serval
serval:BIB_FFC9076E392A
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves.
Périodique
Circulation. Cardiovascular Interventions
Auteur⸱e⸱s
Binder R.K., Stortecky S., Heg D., Tueller D., Jeger R., Toggweiler S., Pedrazzini G., Amann F.W., Ferrari E., Noble S., Nietlispach F., Maisano F., Räber L., Roffi M., Grünenfelder J., Jüni P., Huber C., Windecker S., Wenaweser P.
ISSN
1941-7632 (Electronic)
ISSN-L
1941-7640
Statut éditorial
Publié
Date de publication
2015
Peer-reviewed
Oui
Volume
8
Numéro
10
Pages
1-8
Langue
anglais
Notes
Publication types: Clinical Trial ; Journal Article ; Multicenter Study ; Observational Study
Publication Status: ppublish
Résumé
BACKGROUND: New generation transcatheter heart valves (THV) may improve clinical outcomes of transcatheter aortic valve implantation.
METHODS AND RESULTS: In a nationwide, prospective, multicenter cohort study (Swiss Transcatheter Aortic Valve Implantation Registry, NCT01368250), outcomes of consecutive transfemoral transcatheter aortic valve implantation patients treated with the Sapien 3 THV (S3) versus the Sapien XT THV (XT) were investigated. An overall of 153 consecutive S3 patients were compared with 445 consecutive XT patients. Postprocedural mean transprosthetic gradient (6.5±3.0 versus 7.8±6.3 mm Hg, P=0.17) did not differ between S3 and XT patients, respectively. The rate of more than mild paravalvular regurgitation (1.3% versus 5.3%, P=0.04) and of vascular (5.3% versus 16.9%, P<0.01) complications were significantly lower in S3 patients. A higher rate of new permanent pacemaker implantations was observed in patients receiving the S3 valve (17.0% versus 11.0%, P=0.01). There were no significant differences for disabling stroke (S3 1.3% versus XT 3.1%, P=0.29) and all-cause mortality (S3 3.3% versus XT 4.5%, P=0.27).
CONCLUSIONS: The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes.
CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250.
Mots-clé
Aged, Aged, 80 and over, Aortic Valve/surgery, Aortic Valve Stenosis/epidemiology, Aortic Valve Stenosis/surgery, Cohort Studies, Female, Heart Valve Prosthesis/adverse effects, Heart Valve Prosthesis/utilization, Humans, Male, Postoperative Complications/epidemiology, Postoperative Complications/prevention & control, Prospective Studies, Risk, Switzerland, Transcatheter Aortic Valve Replacement, Treatment Outcome
Pubmed
Open Access
Oui
Création de la notice
11/11/2015 9:56
Dernière modification de la notice
20/08/2019 16:30
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