Clinical Outcomes of a New-Generation Surgical Aortic Bioprosthesis: A Noninferiority Study

The Inspiris Resilia valve features novel anticalcification technology and based on the Magna Ease design (Edwards Lifesciences) has shown promising preclinical durability. However, its clinical benefit remains uncertain. This study presents the first noninferiority analysis comparing Inspiris Resilia and Magna Ease valves in a real-world cohort. Our aim is to evaluate clinical outcomes of the Inspiris Resilia compared with the Magna Ease valve, regarding noninferiority in all-cause mortality at up to 7 years follow-up.

A retrospective noninferiority study was conducted at a single center in Vienna, including 1704 consecutive patients who underwent surgical aortic valve replacement between October 2008 and January 2024. After propensity score matching for age, sex, European System for Cardiac Operative Risk Evaluation II, valve size, isolated versus combined surgery, and periprocedural mortality, 554 patients were included in each group.

In the Cox proportional hazard model, the Inspiris Resilia valve demonstrated noninferiority in overall survival (hazard ratio, 0.791; 95% CI, 0.546-1.146). Cumulative survival at 1, 3, 5, and 7 years was 94.6%, 93.1%, 91.1%, and 86.8% for the Inspiris Resilia, and 94.8%, 91.9%, 87.7%, and 84.2% for the Magna Ease, respectively. Both groups displayed low rates of bioprosthetic valve failure. Mean age was 67.0 ± 8.6 years (Inspiris Resilia) and 67.7 ± 8.9 years (Magna Ease), with comparable European System for Cardiac Operative Risk Evaluation II values (3.2 ± 3.4 vs 3.3 ± 3.2).

This study establishes the Inspiris Resilia valve as at least equivalent to the Magna Ease in mid-term outcomes, while offering the potential to guide future surgical valve selection.