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Protocol for Relative Hydrodynamic Assessment of Tri-leaflet Polymer Valves
Published on: October 18, 2013
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Leaflet escape in a new bileaflet mechanical valve: TRI technologies
Tomaso Bottio1, Dino Casarotto, Gaetano Thiene
1Department of Cardiovascular Surgery, University of Padua Medical School, Via A. Gabelli, 61, 35121 Padova, Italy.
Circulation
|May 7, 2003
Summary
Mechanical heart valve failure due to leaflet escape occurred in two patients receiving TRI Technologies prostheses. This structural valve failure, caused by leaflet fracture, led to a halt in the implantation program.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Materials Science
Background:
- Leaflet escape is a critical mode of structural failure in mechanical heart valves.
- Previous reports documented this complication in various mechanical valve designs.
- This study details two cases of leaflet escape with TRI Technologies valve prostheses.
Purpose of the Study:
- To report and analyze two occurrences of leaflet escape in patients with TRI Technologies valve prostheses.
- To investigate the cause of structural valve failure in these specific devices.
- To assess the implications for the continued use of TRI Technologies valve prostheses.
Main Methods:
- Retrospective analysis of patients who received TRI Technologies valve prostheses.
- Clinical data review including patient demographics, surgical procedures, and outcomes.
- Examination of explanted prostheses to determine the mechanism of failure.
Main Results:
- 36 TRI Technologies valve prostheses were implanted in 34 patients between November 2000 and February 2002.
- Two patients experienced catastrophic prosthetic leaflet escape due to leaflet pivoting system fracture.
- One patient died postoperatively, while the other required emergency reoperation.
Conclusions:
- The observed structural valve failures raise significant concerns about the durability of TRI Technologies valve prostheses.
- The high risk of failure prompted an interruption of the implantation program.
- Further investigation into the design and manufacturing of these prostheses is warranted.
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