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Updated: Jun 27, 2025
Author Spotlight: Development of a Minimally Invasive Large-Animal Model for Reliable and Reproducible Cardiovascular Research
Published on: October 20, 2023
Examining the typical hemodynamic performance of nearly 3000 modern surgical aortic bioprostheses
Robert J M Klautz1, Vivek Rao2, Michael J Reardon3
1Department of Cardiothoracic Surgery, Leiden University Medical Center, Leiden, Netherlands.
Insights
Surgical aortic valve replacement shows good to excellent hemodynamic performance at one year. This analysis of contemporary tissue valves provides a benchmark for future bioprosthetic valve studies.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Clinical Echocardiography
Background:
- Pooled data from 4 multicenter studies (NCT02088554, NCT02701283, NCT01586910, NCT01531374).
- Analysis focused on contemporary surgical aortic valves.
- Included patients with significant valvular dysfunction.
Purpose of the Study:
- Assess the 1-year hemodynamic performance of modern surgical aortic valves.
- Provide data to inform valve selection and patient management.
- Establish a benchmark for evaluating bioprosthetic surgical valves.
Main Methods:
- Echocardiograms analyzed by a single core laboratory.
- Evaluated effective orifice area, dimensionless velocity index, mean aortic gradient, peak aortic velocity, and stroke volume.
- Included 2938 patients with 10 tissue valve models.
Main Results:
- At 1 year, effective orifice area ranged from 1.46–2.12 cm².
- Dimensionless velocity index ranged from 0.39–0.56.
- Mean gradient ranged from 8.6–16.1 mmHg; peak velocity 1.96–2.65 m/s; stroke volume 75.3–89.8 ml.
Conclusions:
- The pooled cohort represents the largest analysis of contemporary surgical aortic valves with single core lab echocardiogram assessment.
- Overall hemodynamic performance at 1 year was good to excellent.
- Data can serve as a benchmark for evaluating bioprosthetic surgical valve performance.
Objectives:
The objective of this analysis was to assess the normal haemodynamic performance of contemporary surgical aortic valves at 1 year postimplant in patients undergoing surgical aortic valve replacement for significant valvular dysfunction. By pooling data from 4 multicentre studies, this study will contribute to a better understanding of the effectiveness of surgical aortic valve replacement procedures, aiding clinicians and researchers in making informed decisions regarding valve selection and patient management.
Methods:
Echocardiograms were assessed by a single core laboratory. Effective orifice area, dimensionless velocity index, mean aortic gradient, peak aortic velocity and stroke volume were evaluated.
Results:
The cohort included 2958 patients. Baseline age in the studies ranged from 70.1 ± 9.0 to 83.3 ± 6.4 years, and Society of Thoracic Surgeons risk of mortality was 1.9 ± 0.7 to 7.5 ± 3.4%. Twenty patients who had received a valve model implanted in fewer than 10 cases were excluded. Ten valve models (all tissue valves; n = 2938 patients) were analysed. At 1 year, population mean effective orifice area ranged from 1.46 ± 0.34 to 2.12 ± 0.59 cm2, and dimensionless velocity index, from 0.39 ± 0.07 to 0.56 ± 0.15. The mean gradient ranged from 8.6 ± 3.4 to 16.1 ± 6.2 mmHg with peak aortic velocity of 1.96 ± 0.39 to 2.65 ± 0.47 m/s. Stroke volume was 75.3 ± 19.6 to 89.8 ± 24.3 ml.
Conclusions:
This pooled cohort is the largest to date of contemporary surgical aortic valves with echocardiograms analysed by a single core lab. Overall haemodynamic performance at 1 year ranged from good to excellent. These data can serve as a benchmark for other studies and may be useful to evaluate the performance of bioprosthetic surgical valves over time.
Clinical Trial Registration Number:
NCT02088554, NCT02701283, NCT01586910 and NCT01531374.
