A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves

Abstract

Background This randomized controlled trial was designed to compare 1-year hemodynamic performances and clinical outcomes after aortic valve replacement (AVR) using a recently introduced (the AVALUS group) and worldwide used (the CEPME group) bovine pericardial bioprostheses.

Methods Patients were screened to enroll 70 patients in each group based on a noninferiority design. The primary endpoint of the trial was the mean pressure gradient across the aortic valve (AVMPG) at 1 year after surgery. One-year echocardiographic data were obtained from 92.1% (129 of 140 patients) of the study patients.

Results There were no differences in baseline characteristics, including sex and body surface area (1.64 ± 0.18 vs. 1.65 ± 0.15 m²) between the groups. The AVMPG on 1-year echocardiography was 14.0 ± 4.3 and 13.9 ± 5.1 mmHg in the AVALUS and CEPME groups, respectively (the p-value for noninferiority was 0.0004). In the subgroup analyses for the respective size of the prostheses, AVMPG of the 19-mm prostheses was significantly lower in the AVALUS group than in the CEPME group (14.0 ± 4.3 vs. 20.0 ± 4.7 mmHg, p = 0.012), whereas those of the other sizes were not significantly different between the two groups. There were no significant differences in the effective orifice area (1.49 ± 0.40 vs. 1.53 ± 0.38 cm², p = 0.500) or effective orifice area index (0.91 ± 0.22 vs 0.93 ± 0.23 cm²/m², p = 0.570) in all the patients, or in the subgroup analysis for the 19-mm prosthesis. There were no differences in the 1-year clinical outcomes between the two groups.

Conclusion The 1-year hemodynamic and clinical outcomes of the AVALUS group were noninferior to those of the CEPME group (NCT03796442).

Keywords

aortic valve replacement - bioprosthesis - outcome - hemodynamics

Note

This study was simultaneously conducted at two institutions, and H.Y.H and C.L took equal responsibility for completing this study as principal investigators at each institution. Thus, H.Y.H and L.C were presented with equal contribution to this study.

Authors' Contribution

Conceptualization was done by S.H.S., C.L., and H.Y.H. Data curation was done by S.H.S., Y.K., J.S.K., J.W.C., J.H.L., J.S.K., C.L., and H.Y.H. Statistical analysis was done by S.H.S. and H.Y.H. Methodology was developed by C.H. and H.Y.H. Validation was done by C.L. and H.Y.H. Writing of the original draft was done by S.H.S., while H.Y.H. was responsible for reviewing and editing the manuscript.

^* These authors contributed equally to the study.

Publikationsverlauf

Eingereicht: 11. April 2023

Angenommen: 25. Oktober 2023

Accepted Manuscript online:
26. Oktober 2023

Artikel online veröffentlicht:
05. Dezember 2023

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