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A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves
Suk Ho Sohn1, Yoonjin Kang1, Ji Seong Kim1
1Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Insights
The AVALUS bovine pericardial bioprosthesis demonstrated noninferior 1-year hemodynamic performance and clinical outcomes compared to the widely used CEPME bioprosthesis in aortic valve replacement surgery.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Clinical Trials
Background:
- Aortic valve replacement (AVR) is a critical procedure for managing aortic valve disease.
- Bovine pericardial bioprostheses are commonly used for AVR, with ongoing development of new devices.
- Comparing the performance of novel versus established bioprostheses is essential for clinical decision-making.
Purpose of the Study:
- To compare the 1-year hemodynamic performance and clinical outcomes of a new bioprosthesis (AVALUS) against a widely used one (CEPME).
- To assess the noninferiority of the AVALUS bioprosthesis in terms of aortic valve mean pressure gradient (AVMPG).
Main Methods:
- A randomized controlled trial enrolled 140 patients (70 per group) undergoing AVR.
- The primary endpoint was the AVMPG at 1 year post-surgery, assessed via echocardiography.
- Noninferiority design was used to compare the two bovine pericardial bioprostheses.
Main Results:
- No significant differences in baseline characteristics were observed between the AVALUS and CEPME groups.
- The 1-year AVMPG was similar between groups (14.0 ± 4.3 mmHg vs. 14.0 ± 5.1 mmHg), confirming noninferiority (p=0.0004).
- A subgroup analysis showed a significantly lower AVMPG for the 19-mm AVALUS prosthesis compared to CEPME (p=0.012).
Conclusions:
- The AVALUS bioprosthesis demonstrated noninferior 1-year hemodynamic and clinical outcomes compared to the CEPME bioprosthesis.
- These findings support the use of the AVALUS bioprosthesis in aortic valve replacement.
- The study provides valuable data for clinicians selecting bioprosthetic valves.
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).
