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January 24, 2023Journal of Comparative Effectiveness Research23 citationsOpen Access

Structural hemodynamic valve deterioration durability of RESILIA-tissue versus contemporary aortic bioprostheses

KBKrzysztof BartuśJBJoseph E. BavariaVTVinod H. Thourani

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).

Key Points

  • This research evaluates the durability of RESILIA tissue aortic bioprostheses compared to contemporary aortic valve replacements.
  • Compared structural valve deterioration and hemodynamic valve deterioration rates between RESILIA and contemporary valves
  • Used echocardiograms to track outcomes over 5 years
  • Involved cohorts of 689 RESILIA valves and 936 contemporary valves, with a propensity-matched analysis of 239 patients.
  • SVD-related HVD in the COMMENCE cohort was 1.8% and 3.5% in the PARTNER 2A cohort (HR 0.92, p=0.07).
  • In propensity-matched cohorts, the rates were 1.0% for RESILIA versus 4.8% for contemporary valves (HR 1.15, 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.

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Cite This Study

Bartuś et al. (2023) conducted a cohort in Aortic valve replacement (n=1,625). RESILIA tissue valves vs. Contemporary aortic bioprostheses was evaluated on Structural valve deterioration (SVD)-related hemodynamic valve deterioration (HVD) of grade ≥2 (HR 0.92, p=0.07). 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).

synapsesocial.com/papers/6a14e3f0253bd9cd3ce627f5https://doi.org/10.2217/cer-2022-0180
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