Durability of bioprosthetic aortic valves in patients under the age of 60\u2009years \u2013 rationale and design of the international INDURE registry

Bart Meuris,Günther Laufer,Martin Grabenwöger,Matthias Siepe,Enrico Coscioni,François Dagenais ,Giovanni Mariscalco,Thierry Bourguignon,Alexis Théron ,Sergio Cánovas ,Renzo Pessotto,Beate Botta,Philippe Demers,Michael A Borger,Gianluca Polvani,Thierry Langanay,Wessel Van Leeuwen ,Pierluigi Stefàno ,Konrad Binder,Jean‐Christian Roussel ,Peter Bramlage,Olaf Wendler,Ruggero De Paulis

doi:10.1186/s13019-020-01155-6

Abstract

BackgroundThere is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR.MethodsThe INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20–22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery.The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5 years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life.DiscussionINDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60 years.Trial registrationClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018).

Highlights

There is an ever-growing number of patients requiring aortic valve replacement (AVR)
While some studies have shown a survival benefit of mechanical valves in younger patients [3,4,5,6,7], large retrospective observational studies [8,9,10,11,12] and one randomized controlled trial [13] have shown similar long-term survival in patients 50 to 69 years of age undergoing mechanical versus bioprosthetic valve replacement
The primary objectives (Table 1) are to 1) determine the time-related valve safety at 1-year depicted as freedom from events [23] and 2) determine freedom from stage 3 structural valve deterioration (SVD) following the Salaun definition at 5 years [23, 24]

Summary

Introduction

There is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR. Homografts are possible but less popular due to inferior longevity. The Ross procedure gains in popularity in selected expert centres. Mechanical valves have been preferred over bioprosthetic valves in younger patients, but this is not equivocal. While some studies have shown a survival benefit of mechanical valves in younger patients [3,4,5,6,7], large retrospective observational studies [8,9,10,11,12] and one randomized controlled trial [13] have shown similar long-term survival in patients 50 to 69 years of age undergoing mechanical versus bioprosthetic valve replacement

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Conclusion