Early Outcomes of Real-World Aortic Valve Replacement With RESILIA Tissue in the Chinese Population

Aortic valve replacement (AVR) with the INSPIRIS RESILIA aortic valve (Edwards Lifesciences, Irvine, CA) has established durability and promising outcomes. However, real-world safety and functional performance data remain limited. This study reported early outcomes in the Chinese population.

This prospective, multicenter, single-arm, post-market, real-world study enrolled patients scheduled for elective AVR using the study valve. Safety outcomes included all-cause death, study valve-related death, structural valve deterioration (SVD), non SVD, reoperation on the study valve, major bleeding, and thromboembolic events. Effectiveness outcomes included valve hemodynamic performance and New York Heart Association (NYHA) class.

A total of 250 patients underwent study valve implantation, with 238 completing 1-year follow-up (mean follow-up duration: 448.2 ± 162.50 days). The mean age was 58.5 ± 9.17 years, with 11.4% undergoing concomitant aortic root/annular enlargement. The 1-year freedom from all-cause death and freedom from reoperation on the study valve were 98.0% and 99.2%, respectively. All deaths were assessed as unrelated to the study device. Incidence of complications included thromboembolic events (2.4%), major bleeding (4.4%), endocarditis (0.4%), and new permanent pacemaker implantation (0.4%) at 1 year. Two patients (0.8%) required reoperation on the study valve. No SVD was observed. At 1-year post-operation, no severe aortic regurgitation (AR) occurred, while 1 patient (0.4%) developed moderate AR. Three patients (1.3%) had mild paravalvular leakage. Functional status improved with 100% of patients having a NYHA Class I/II at 1 year.

INSPIRIS RESILIA aortic valve shows favorable 1-year safety profiles and stable hemodynamics in Chinese patients.