January 24, 2023Open Access
Structural hemodynamic valve deterioration durability of RESILIA-tissue versus contemporary aortic bioprostheses
Key Result
RESILIA tissue valves reduced structural valve deterioration-related hemodynamic valve deterioration compared to contemporary aortic bioprostheses at 5 years (1.0% vs 4.8% in matched cohorts; p=0.03).
Study Design
Type
Cohort (n=1,625)
Structured PICO
Does RESILIA tissue-based AVR reduce structural valve deterioration-related hemodynamic valve deterioration compared to contemporary AVR in patients undergoing aortic valve replacement?
P
Population
Patients undergoing aortic valve replacement (AVR) from the COMMENCE trial (n=689) and the PARTNER 2A contemporary AVR arm (n=936), total n=1,625.
I
Intervention
Aortic bioprostheses with RESILIA tissue
C
Comparator
Contemporary aortic valve replacement (AVR) devoid of RESILIA tissue
O
Outcome
Structural valve deterioration (SVD)-related hemodynamic valve deterioration (HVD) of grade ≥2 based upon annual core laboratory echocardiograms through 5 years of follow-upsurrogate
RESILIA tissue-based aortic bioprostheses demonstrated significantly reduced structural valve deterioration-related hemodynamic valve deterioration at 5 years compared to contemporary bioprostheses in a propensity-matched analysis.
Main Result
Effect estimate: HR 0.92
Absolute Event Rate: 1.8% vs 3.5%
p-value: p=0.07
Abstract
Aim: Durability of aortic valve replacement is becoming increasingly important. Aortic bioprostheses with RESILIA tissue have demonstrated outstanding outcomes thus far, but only in single-arm studies. Methods: We compared structural valve deterioration (SVD)-related hemodynamic valve deterioration (HVD) of grade ≥2 of RESILIA tissue valves from the COMMENCE trial (n = 689) to those from the PARTNER 2A contemporary AVR arm (n = 936) based upon annual core laboratory echocardiograms through 5 years of follow-up. Results: SVD-related HVD in the COMMENCE and PARTNER 2A cohorts were 1.8 versus 3.5%, respectively (one-sided 95% lower-bound hazard ratio of 0.92; p = 0.07). In propensity-matched cohorts (n = 239), these outcomes were 1.0 versus 4.8%, respectively (one-sided 95% lower-bound hazard ratio of 1.15; p = 0.03). Conclusion: RESILIA tissue-based AVR exhibited reduced SVD-related HVD compared with a contemporary AVR cohort devoid of RESILIA tissue.