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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)  (2018)

Authors:
Onorati, Francesco; Gherli, Riccardo; Mariscalco, Giovanni; Girdauskas, Evaldas; Quintana, Eduardo; Santini, Francesco; De Feo, Marisa; Sponga, Sandro; Tozzi, Piergiorgio; Bashir, Mohamad; Perrotti, Andrea; Pappalardo, Aniello; Ruggieri, Vito Giovanni; Santarpino, Giuseppe; Rinaldi, Mauro; Ronaldo, Silva; Nicolini, Francesco
Title:
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)
Year:
2018
Type of item:
Articolo in Rivista
Tipologia ANVUR:
Articolo su rivista
Language:
Inglese
Referee:
No
Name of journal:
BMJ OPEN
ISSN of journal:
2044-6055
N° Volume:
8
Number or Folder:
2
Page numbers:
1-16
Keyword:
adult cardiology; cardiac surgery; cardiothoracic surgery; ischaemic heart disease; valvular heart disease; Aortic Valve; Aortic Valve Stenosis; Cause of Death; Coronary Artery Disease; Europe; Follow-Up Studies; Heart Valve Prosthesis Implantation; Humans; Logistic Models; Minimally Invasive Surgical Procedures; Prospective Studies; Quality of Life; Registries; Research Design; Treatment Outcome
Short description of contents:
Introduction 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.Methods and analysis 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.Ethics and dissemination 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.
Note:
The page range is based on PDF file available on the journal website
Product ID:
109426
Handle IRIS:
11562/997838
Last Modified:
September 19, 2022
Bibliographic citation:
Onorati, Francesco; Gherli, Riccardo; Mariscalco, Giovanni; Girdauskas, Evaldas; Quintana, Eduardo; Santini, Francesco; De Feo, Marisa; Sponga, Sandro; Tozzi, Piergiorgio; Bashir, Mohamad; Perrotti, Andrea; Pappalardo, Aniello; Ruggieri, Vito Giovanni; Santarpino, Giuseppe; Rinaldi, Mauro; Ronaldo, Silva; Nicolini, Francesco, 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) «BMJ OPEN» , vol. 8 , n. 22018pp. 1-16

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Title Department Managers
Outcomes comparison of different surgical strategies for the management of severe aortic valve stenosis: a prospective multicentre European registry (E-AVR) Department Scienze Chirurgiche Odontostomatologiche e Materno-Infantili Giuseppe Faggian, Francesco Onorati
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