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)

Francesco Onorati, Riccardo Gherli, Giovanni Mariscalco, Evaldas Girdauskas, Eduardo Quintana, Francesco Santini, Marisa De Feo, Sandro Sponga, Piergiorgio Tozzi, Mohamad Bashir, Andrea Perrotti, Aniello Pappalardo, Vito Giovanni Ruggieri, Giuseppe Santarpino, Mauro Rinaldi, Silva Ronaldo, Francesco Nicolini, E-AVR Collaborators, Tiziano Gherli, Giuseppe Faggian, Livio San Biagio, Francesco Musumeci, Hermann Reichenspurner, Manuel Castellà, Antonio Salsano, Alessandro Della Corte, Ciro Bancone, Ugolino Livi, Nicola Masala, Gavin J Murphy, Sidney Chocron, Giuseppe Gatti, Luca Maschietto, Stefano Salizzoni, Francesco Pollari, Alessandro Di Cesare, Giulia Bisoffi, Francesco Onorati, Riccardo Gherli, Giovanni Mariscalco, Evaldas Girdauskas, Eduardo Quintana, Francesco Santini, Marisa De Feo, Sandro Sponga, Piergiorgio Tozzi, Mohamad Bashir, Andrea Perrotti, Aniello Pappalardo, Vito Giovanni Ruggieri, Giuseppe Santarpino, Mauro Rinaldi, Silva Ronaldo, Francesco Nicolini, E-AVR Collaborators, Tiziano Gherli, Giuseppe Faggian, Livio San Biagio, Francesco Musumeci, Hermann Reichenspurner, Manuel Castellà, Antonio Salsano, Alessandro Della Corte, Ciro Bancone, Ugolino Livi, Nicola Masala, Gavin J Murphy, Sidney Chocron, Giuseppe Gatti, Luca Maschietto, Stefano Salizzoni, Francesco Pollari, Alessandro Di Cesare, Giulia Bisoffi

Abstract

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.

Keywords: adult cardiology; cardiac surgery; cardiothoracic surgery; ischaemic heart disease; valvular heart disease.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1
Figure 1
Flow chart of enrolment criteria and surgical techniques considered in the registry. CABG, coronary artery bypass grafting; CAD, coronary artery disease; SAVS, severe aortic valve stenosis; TAVR, transcatheter aortic valve replacement.
Figure 2
Figure 2
Flow chart of time-points for data collection.

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