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1Henry Ford Hospital, New Center Pavilion, Detroit, MI 48202-2691, USA.
Insights
Björk-Shiley Delrin (BSD) heart valves show minimal wear-related issues, with regurgitation not always indicating dysfunction. Prophylactic replacement is not recommended; patients require individualized assessment based on valve function.
Area of Science:
- Biomaterials Science
- Cardiovascular Surgery
- Medical Device Engineering
Background:
- Up to 7,000 patients may have Björk-Shiley Delrin (BSD) heart valves implanted for 15-27 years.
- Clinical uncertainty exists regarding the long-term function and need for prophylactic replacement of BSD valves.
Purpose of the Study:
- To evaluate the long-term performance and safety of Björk-Shiley Delrin (BSD) heart valves.
- To determine if prophylactic replacement of BSD valves is warranted.
Main Methods:
- Review of clinical data and engineering studies related to BSD valve function.
- Analysis of regurgitation patterns and disc wear in implanted BSD valves.
- Assessment of reported cases of valve component failure, including disc fracture and strut fracture.
Main Results:
- Clinically significant regurgitation can occur due to Delrin disc wear in some BSD valves over time.
- Regurgitation in normally functioning BSD valves is higher than in Björk-Shiley Radiopaque Spherical disc valves.
- Only two cases of inlet strut fracture were reported; no catastrophic failures linked to Delrin disc fracture.
- Engineering studies indicate no increased risk of Delrin disc failure from fracture or fatigue.
- Disc wear, when present, occurs at a manageable rate, allowing for timely diagnosis and non-emergency treatment.
Conclusions:
- Björk-Shiley Delrin (BSD) heart valves are expected to provide years of continued service.
- Disc wear does not necessitate prophylactic valve removal; individualized patient management is crucial.
- Treatment decisions should be based on the specific function of each patient's valve.
Abstract:
It has been estimated that up to 7,000 patients with Björk-Shiley Delrin (BSD) heart valves may be alive as of January 1996, the range of implant durations being from 15 to 27 years. The clinical question was whether these BSD valves could be expected to continue to function satisfactorily or if prophylactic replacement might be warranted. The data presented in this supplement suggest that clinically important regurgitation due to wear of the Delrin disc may occur in some BSD valves years after implantation. Normally functioning valves, however, show more regurgitation than Björk-Shiley Radiopaque Spherical disc valves. Some regurgitation does not therefore necessarily indicate dysfunction of BSD valves. There were only two reported cases of inlet strut fracture. However, there are no reports of catastrophic failure associated with fracture of the Delrin disc. Engineering studies showed no reason to suspect an increased rate of failure of the Delrin disc due to fracture or fatigue. All of the data suggested that the BSD valve will continue to provide years of continuing service. Disc wear, if it occurred, was at a rate which allowed adequate time for diagnosis and non-emergency treatment. The data showed no reason to remove BSD valves prophylactically. Patients should be treated on an individual basis, according to the function of their own valve or valves.