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Clinical experience with the Björk-Shiley Delrin tilting disc heart valve
K C Dellsperger1, G L Grunkemeier, P D Stein
1University of Iowa, Department of Internal Medicine, Iowa City, USA.
Insights
Clinically important regurgitation from Björk-Shiley Delrin (BSD) disc heart valve wear is rare but possible. Larger BSD valves showed more wear, though disc fracture was not reported.
Area of Science:
- Biomaterials Science
- Cardiovascular Surgery
- Medical Device Engineering
Background:
- The Björk-Shiley Delrin (BSD) disc heart valve was introduced clinically in 1969.
- An estimated 7,000 patients were alive with a BSD valve as of January 1996.
Purpose of the Study:
- To assess the long-term performance and potential complications of the Björk-Shiley Delrin disc heart valve.
- To evaluate disc wear, regurgitation, and structural integrity of explanted BSD valves.
Main Methods:
- Review of published clinical experience with BSD valves.
- Analysis of explanted BSD valve records from Shiley Incorporated.
- Measurement of disc wear, including radial gap and static leak flow rate.
Main Results:
- Clinically significant regurgitation due to disc wear was infrequent.
- Larger valve sizes exhibited more pronounced disc wear compared to smaller ones.
- No Delrin disc fractures were reported; however, two cases of inlet strut fracture occurred.
Conclusions:
- Disc wear in BSD valves rarely leads to clinically important regurgitation.
- While disc fracture is absent, inlet strut fractures and late disc embolization are potential risks.
- Disc wear does not typically impede normal valve function but can increase regurgitation.
Background And Aims Of The Study:
The Björk-Shiley Delrin (BSD) disc heart valve was first used clinically in 1969. We estimate that as of January 1996, no more than 7,000 patients may be alive with the BSD valve.
Methods:
We reviewed the published reports of clinical experience with the BSD valve in addition to the records regarding BSD valves returned to Shiley Incorporated. Measurements of the maximum radial gap, static leak flow rate and inspection of the Delrin disc for wear were obtained.
Results And Conclusions:
We concluded that clinically important regurgitation, due to disc wear, was rare but may occur. Larger prostheses, in general, showed greater disc wear than smaller sized valves. There were no reports of fracture of the Delrin disc. Two cases of inlet strut fracture were reported. Late disc embolization, in the absence of inlet strut fracture, occurred in two patients following surgical manipulation. Disc wear did not cause abnormal valve opening or closing although increased regurgitation may occur.