Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry

Bart Meuris, Michael A Borger, Thierry Bourguignon, Matthias Siepe, Martin Grabenwöger, Günther Laufer, Konrad Binder, Gianluca Polvani, Pierluigi Stefano, Enrico Coscioni, Wouter van Leeuwen, Philippe Demers, Francois Dagenais, Sergio Canovas, Alexis Theron, Thierry Langanay, Jean-Christian Roussel, Olaf Wendler, Giovanni Mariscalco, Renzo Pessotto, Beate Botta, Peter Bramlage, Ruggero de Paulis, Bart Meuris, Michael A Borger, Thierry Bourguignon, Matthias Siepe, Martin Grabenwöger, Günther Laufer, Konrad Binder, Gianluca Polvani, Pierluigi Stefano, Enrico Coscioni, Wouter van Leeuwen, Philippe Demers, Francois Dagenais, Sergio Canovas, Alexis Theron, Thierry Langanay, Jean-Christian Roussel, Olaf Wendler, Giovanni Mariscalco, Renzo Pessotto, Beate Botta, Peter Bramlage, Ruggero de Paulis

Abstract

Background: 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.

Methods: The 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.

Discussion: INDURE 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 registration: ClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018).

Keywords: Aortic valve disease; INSPIRIS RESILIA; SAVR; Structural valve degeneration; Surgical aortic valve replacement; Valve durability.

Conflict of interest statement

BM, RdP, TB, PB and MB have received lecture fees and/or research support from Edwards Lifesciences. The institutions of these and those of the remaining authors representing study centres have received patient inclusion-based funding. VG is an employee of Edwards Lifesciences. BB has no conflict of interest to disclose.

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