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)

TY - JOUR

T1 - 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)

AU - Onorati, Francesco

AU - Gherli, Riccardo

AU - Mariscalco, Giovanni

AU - Girdauskas, Evaldas

AU - Quintana, Eduardo

AU - Santini, Francesco

AU - De Feo, Marisa

AU - Sponga, Sandro

AU - Tozzi, Piergiorgio

AU - Bashir, Mohamad

AU - Perrotti, Andrea

AU - Pappalardo, Aniello

AU - Ruggieri, Vito Giovanni

AU - Santarpino, Giuseppe

AU - Rinaldi, Mauro

AU - Ronaldo, Silva

AU - Nicolini, Francesco

AU - E-AVR Collaborators

N1 - © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

PY - 2018/2/10

Y1 - 2018/2/10

N2 - 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.TRIAL REGISTRATION NUMBER: NCT03143361; Pre-results.

AB - 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.TRIAL REGISTRATION NUMBER: NCT03143361; Pre-results.

KW - Aortic Valve/surgery

KW - Aortic Valve Stenosis/mortality

KW - Cause of Death

KW - Coronary Artery Disease/complications

KW - Europe

KW - Follow-Up Studies

KW - Heart Valve Prosthesis Implantation/methods

KW - Humans

KW - Logistic Models

KW - Minimally Invasive Surgical Procedures

KW - Prospective Studies

KW - Quality of Life

KW - Registries

KW - Research Design

KW - Treatment Outcome

U2 - 10.1136/bmjopen-2017-018036

DO - 10.1136/bmjopen-2017-018036

M3 - SCORING: Journal article

C2 - 29440154

VL - 8

SP - e018036

JO - BMJ OPEN

JF - BMJ OPEN

SN - 2044-6055

IS - 2

ER -