Browsing by Subject "Valve durability"

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    Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years — 1-year follow-up from the prospective INDURE registry
    (Oxford University Press, 2023-07-18) Meuris, Bart; Roussel, Jean-Christian; Borger, Michael A.; Siepe, Matthias; Stefano, Pierluigi; Laufer, Günther; Langanay, Thierry; Theron, Alexis; Grabenwöger, Martin; Binder, Konrad; Demers, Philippe; Pesotto, Renzo; Leeuwen, Wouter van; Bourguignon, Thierry; Cánovas López, Sergio; Mariscalco, Giovanni; Coscioni, Enrico; Dagenais, Francois; Wendler, Olaf; Polvani, Gianluca; Eden, Matthias; Botta, Beate; Bramlage, Peter; De Paulis, Ruggero; Cirugía, Pediatría y Obstetricia y Ginecología
    OBJECTIVES: We report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention. METHODS: The INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed. RESULTS: A total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2. CONCLUSIONS: The 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement.
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    Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry
    (BMC, 2020-05-27) Meuris, Bart; Borger, Michael A.; Bourguignon, Thierry; Siepe, Matthias; Grabenwöger, Martin; Laufer, Günther; Binder, Konrad; Polvani, Gianluca; Stefano, Pierluigi; Coscioni, Enrico; Leeuwen, Wouter van; Demers, Philippe; Dagenasis, Francois; Cánovas López, Sergio; Theron, Alexis; Langanay, Thierry; Roussel, Jean Christian; Wendler, Olaf; Mariscalco, Giovanni; Pesotto, Renzo; Botta, Beate; Bramlage, Peter; Paulis, Ruggero de; Cirugía, Pediatría y Obstetricia y Ginecología
    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.