Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
Clinical and Echocardiographic Outcomes After Implantation of the ALLEGRA Transcatheter Valve Using the Fully Repositionable IMPERIA Delivery System: One-Year Results of the EMPIRE I Study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Baz José Antonio, Ren Claire B, Burgdorf Christof, Frerker Christian, Cruz-González Ignacio, Gómez Joan Antoni, Hernândez José Maria, Jimenez Pilar, Spitzer Ernest, Tonino Pim, Vriesendorp Pieter, van Mieghem Nicolas, Copt Samuel, Jönsson Anders, Oldroyd Keith G, Doll Nicolas
Аннотация
BACKGROUND: The EMPIRE I study assessed the early (30 days) safety and efficacy of a new fully repositionable delivery system (IMPERIA) for the commercially available ALLEGRA transcatheter aortic valve in patients with either severe native aortic stenosis or a degenerated surgical bioprosthesis.
AIM: To report the final 1-year results of the EMPIRE I study.
METHODS: EMPIRE I is a pre-market, prospective, multi-center, single-arm study conducted at 11 centers in 3 European countries. There were independent data safety and clinical events committees and an independent echocardiographic core laboratory. In this analysis, VARC-3 definitions of all clinical endpoints and echocardiographic parameters were employed.
RESULTS: The study recruited 121 patients with severe native aortic stenosis and 16 with degenerated surgical bioprosthesis. At 1 year, the incidence of bioprosthetic valve dysfunction in the native population was 5.9%. No patients developed structural valve deterioration or endocarditis, and there were no patients with haemodynamic valve deterioration or bioprosthetic valve failure. In the valve-in-valve sub-group, 2/14 (14.3%) patients had moderate patient prosthesis mismatch at 30 days with no evidence of new bioprosthetic valve dysfunction at 1 year. In the native population, new permanent pacemaker implantation was 14.3% at 30 days and remained unchanged at 1 year. Cardiovascular mortality was 6.8% in the native population and 0% in the valve-in-valve patients. At 1-year, all-cause mortality was 10.8% (95% CI 6.4%-17.8%) in the native aortic stenosis population and 0% in the valve-in-valve patients.
CONCLUSION: After 1 year of follow-up, the results of the EMPIRE 1 study show excellent haemodynamic performance, a low rate of bioprosthetic valve dysfunction, and no bioprosthetic valve failure in patients treated with the ALLEGRATM trans-catheter aortic valve implanted using the new IMPERIATM fully repositionable delivery system.
AIM: To report the final 1-year results of the EMPIRE I study.
METHODS: EMPIRE I is a pre-market, prospective, multi-center, single-arm study conducted at 11 centers in 3 European countries. There were independent data safety and clinical events committees and an independent echocardiographic core laboratory. In this analysis, VARC-3 definitions of all clinical endpoints and echocardiographic parameters were employed.
RESULTS: The study recruited 121 patients with severe native aortic stenosis and 16 with degenerated surgical bioprosthesis. At 1 year, the incidence of bioprosthetic valve dysfunction in the native population was 5.9%. No patients developed structural valve deterioration or endocarditis, and there were no patients with haemodynamic valve deterioration or bioprosthetic valve failure. In the valve-in-valve sub-group, 2/14 (14.3%) patients had moderate patient prosthesis mismatch at 30 days with no evidence of new bioprosthetic valve dysfunction at 1 year. In the native population, new permanent pacemaker implantation was 14.3% at 30 days and remained unchanged at 1 year. Cardiovascular mortality was 6.8% in the native population and 0% in the valve-in-valve patients. At 1-year, all-cause mortality was 10.8% (95% CI 6.4%-17.8%) in the native aortic stenosis population and 0% in the valve-in-valve patients.
CONCLUSION: After 1 year of follow-up, the results of the EMPIRE 1 study show excellent haemodynamic performance, a low rate of bioprosthetic valve dysfunction, and no bioprosthetic valve failure in patients treated with the ALLEGRATM trans-catheter aortic valve implanted using the new IMPERIATM fully repositionable delivery system.
Предметные рубрики MeSH
HumansHeart Valve ProsthesisFemaleTreatment OutcomeAortic Valve StenosisProsthesis DesignBioprosthesisMaleProspective StudiesTime FactorsEuropeAged, 80 and overAortic ValveAgedProsthesis FailureCardiac CatheterizationHemodynamicsSeverity of Illness IndexHeart Valve Prosthesis ImplantationRisk FactorsTranscatheter Aortic Valve Replacement