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.

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.