Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry).
Détails
Etat: Public
Version: Final published version
Licence: CC BY-NC 4.0
ID Serval
serval:BIB_DFFE29FEE0AC
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Institution
Titre
Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: study protocol of a prospective multicentre European registry (E-AVR registry).
Périodique
BMJ open
Collaborateur⸱rice⸱s
E-AVR Collaborators
Contributeur⸱rice⸱s
Gherli T., Faggian G., Biagio L.S., Musumeci F., Reichenspurner H., Castellà M., Salsano A., Corte A.D., Bancone C., Livi U., Masala N., Murphy G.J., Chocron S., Gatti G., Maschietto L., Salizzoni S., Pollari F., Cesare A.D., Bisoffi G.
ISSN
2044-6055 (Electronic)
ISSN-L
2044-6055
Statut éditorial
Publié
Date de publication
10/02/2018
Peer-reviewed
Oui
Volume
8
Numéro
2
Pages
e018036
Langue
anglais
Notes
Publication types: Journal Article
Publication Status: epublish
Publication Status: epublish
Résumé
Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life expectancy. Recent randomised controlled trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared with traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the 'real clinical world'. Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full sternotomy; minimally invasive; or transcatheter; with both 'sutured' and 'sutureless' valves) will provide a 'real-world' picture of available results of current surgical options and will help to clarify the 'grey zones' of current guidelines.
European Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing 'early' 30-day all-cause and cardiovascular mortality, as well as major morbidity, and 'late' cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results.
The study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship.
NCT03143361; Pre-results.
European Aortic Valve Registry is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery centres located in six countries (France, Germany, Italy, Spain, Switzerland and UK). Patients will be enrolled over a 2-year period and followed up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with Valve Academic Research Consortium-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing 'early' 30-day all-cause and cardiovascular mortality, as well as major morbidity, and 'late' cardiovascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results.
The study protocol is approved by local ethics committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors for authorship.
NCT03143361; Pre-results.
Mots-clé
adult cardiology, cardiac surgery, cardiothoracic surgery, ischaemic heart disease, valvular heart disease
Pubmed
Web of science
Open Access
Oui
Création de la notice
15/02/2018 19:39
Dernière modification de la notice
20/08/2019 17:04