PMID- 32460798 OWN - NLM STAT- MEDLINE DCOM- 20201023 LR - 20201023 IS - 1749-8090 (Electronic) IS - 1749-8090 (Linking) VI - 15 IP - 1 DP - 2020 May 27 TI - Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. PG - 119 LID - 10.1186/s13019-020-01155-6 [doi] LID - 119 AB - 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). FAU - Meuris, Bart AU - Meuris B AD - Cardiac Surgery, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium. bart.meuris@uzleuven.be. FAU - Borger, Michael A AU - Borger MA AD - Leipzig Heart Center, Leipzig, Germany. FAU - Bourguignon, Thierry AU - Bourguignon T AD - Tours University Hospital, Tours, France. FAU - Siepe, Matthias AU - Siepe M AD - Heart Center University of Freiburg, Freiburg and Bad Krozingen, Germany. FAU - Grabenwoger, Martin AU - Grabenwoger M AD - HZH Heart Center Hietzing, Wien, Austria. FAU - Laufer, Gunther AU - Laufer G AD - Medicine University Wien, Heart Center, Wien, Austria. FAU - Binder, Konrad AU - Binder K AD - Heart Center University St. Polten, St. Polten, Austria. FAU - Polvani, Gianluca AU - Polvani G AD - Cardiology Center Monzino, Milan, MI, Italy. FAU - Stefano, Pierluigi AU - Stefano P AD - Careggi University Hospital, Florence, Italy. FAU - Coscioni, Enrico AU - Coscioni E AD - University Hospital "San Giovanni di Dio e Ruggi d'Aragona", Salerno, Italy. FAU - van Leeuwen, Wouter AU - van Leeuwen W AD - Erasmus University Medical Center, Rotterdam, Netherlands. FAU - Demers, Philippe AU - Demers P AD - Montreal Heart Institute, Montreal, Canada. FAU - Dagenais, Francois AU - Dagenais F AD - Institute University, Cardiology Center, Quebec, Canada. FAU - Canovas, Sergio AU - Canovas S AD - Hospital University Virgen de la Arrixaca, Murcia, Spain. FAU - Theron, Alexis AU - Theron A AD - Hospital de la Timone, Marseille, France. FAU - Langanay, Thierry AU - Langanay T AD - Rennes University Hospital Center, Rennes, France. FAU - Roussel, Jean-Christian AU - Roussel JC AD - CHU Nantes, Nantes, France. FAU - Wendler, Olaf AU - Wendler O AD - King's College Hospital NHS Foundation Trust, London, UK. FAU - Mariscalco, Giovanni AU - Mariscalco G AD - Glenfield Hospital, Leicester, UK. FAU - Pessotto, Renzo AU - Pessotto R AD - Royal Infirmary of Edinburgh, Edinburgh, UK. FAU - Botta, Beate AU - Botta B AD - Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. FAU - Bramlage, Peter AU - Bramlage P AUID- ORCID: 0000-0003-4970-2110 AD - Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. FAU - de Paulis, Ruggero AU - de Paulis R AD - Cardiac Surgery, European Hospital, Rome, Italy. LA - eng SI - ClinicalTrials.gov/NCT03666741 GR - n.a./Edwards Lifesciences/ PT - Journal Article DEP - 20200527 PL - England TA - J Cardiothorac Surg JT - Journal of cardiothoracic surgery JID - 101265113 SB - IM MH - *Aortic Valve MH - Aortic Valve Insufficiency/*surgery MH - *Bioprosthesis MH - Canada MH - Europe MH - Female MH - *Heart Valve Prosthesis MH - *Heart Valve Prosthesis Implantation MH - Humans MH - Male MH - Middle Aged MH - Postoperative Complications MH - Prospective Studies MH - *Registries MH - Reoperation MH - Treatment Outcome PMC - PMC7251702 OTO - NOTNLM OT - Aortic valve disease OT - INSPIRIS RESILIA OT - SAVR OT - Structural valve degeneration OT - Surgical aortic valve replacement OT - Valve durability COIS- 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. EDAT- 2020/05/29 06:00 MHDA- 2020/10/24 06:00 PMCR- 2020/05/27 CRDT- 2020/05/29 06:00 PHST- 2020/04/07 00:00 [received] PHST- 2020/05/10 00:00 [accepted] PHST- 2020/05/29 06:00 [entrez] PHST- 2020/05/29 06:00 [pubmed] PHST- 2020/10/24 06:00 [medline] PHST- 2020/05/27 00:00 [pmc-release] AID - 10.1186/s13019-020-01155-6 [pii] AID - 1155 [pii] AID - 10.1186/s13019-020-01155-6 [doi] PST - epublish SO - J Cardiothorac Surg. 2020 May 27;15(1):119. doi: 10.1186/s13019-020-01155-6.