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Durability Testing With Calcification of Surgical Aortic Valves and Transcatheter Heart Valves: An In Vitro Study
Najla Sadat1,2, Antonia Osterloh1, Michael Scharfschwerdt2
1University Luebeck, Campus-Luebeck, Luebeck, 23562, Germany.
Interdisciplinary Cardiovascular and Thoracic Surgery
|August 19, 2025
Summary
Structural valve deterioration in bioprosthetic heart valves is a major concern. This study found transcatheter heart valves (THVs) showed less calcification than surgical aortic valves (SAVs), with the Evolut PRO THV maintaining function after simulated wear.
Area of Science:
- Biomaterials Science
- Cardiovascular Engineering
- Medical Device Research
Background:
- Structural valve deterioration (SVD), primarily due to calcification, limits bioprosthetic heart valve longevity.
- While surgical aortic valve (SAV) bioprostheses have extensive clinical data, transcatheter heart valve (THV) degeneration requires further investigation.
- Understanding calcification patterns is crucial for improving bioprosthetic valve design and durability.
Purpose of the Study:
- To analyze and compare the calcification patterns of different SAV and THV models under standardized in vitro conditions.
- To evaluate the impact of simulated calcification on the hydrodynamic performance of these valves.
- To identify potential differences in calcification susceptibility between SAVs and THVs.
Main Methods:
- SAVs and THVs were subjected to simulated physiological stress using a calcification buffer in a Hi-Cycle-tester for 5 patient-years.
- Hydrodynamic performance (mean pressure gradient and effective orifice area) was assessed before and after calcification.
- Macroscopic, microscopic (SEM, histology), and biochemical analyses (calcium titration) were performed on calcified and control valve tissues.
Main Results:
- All tested valves, except Evolut PRO THV, showed significant changes in hydrodynamic performance after durability testing.
- Calcification predominantly occurred in regions of high mechanical stress (commissures, nadirs, ventricle side) and involved hydroxyapatite crystal formation.
- THVs demonstrated superior resistance to calcification compared to SAVs, with significant variations observed among different valve models.
Conclusions:
- The Evolut PRO THV maintained functional performance post-durability testing, suggesting lower susceptibility to calcification.
- Significant differences in calcification susceptibility exist between various bioprosthetic heart valve models.
- Further clinical studies are necessary to validate these in vitro findings and confirm the long-term calcification behavior of THVs.
