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Published on: September 21, 2021
St. Jude Medical cardiac valve prosthesis in infants and children: early and intermediate experience
Insights
The St. Jude Medical valve prosthesis showed promising results in pediatric heart valve replacement surgeries. This study found no complications or adverse events in children, indicating its initial safety and efficacy.
Area of Science:
- Pediatric Cardiology
- Cardiovascular Surgery
- Biomaterials and Medical Devices
Background:
- Pediatric heart valve disease necessitates effective and durable prosthetic solutions.
- The St. Jude Medical valve prosthesis is a mechanical device used for heart valve replacement.
- Assessing the safety and efficacy of prosthetic valves in pediatric populations is crucial.
Purpose of the Study:
- To evaluate the initial clinical performance of the St. Jude Medical valve prosthesis in pediatric patients.
- To assess the safety, efficacy, and complication rates associated with this valve in children undergoing valve replacement.
Main Methods:
- Retrospective review of 14 pediatric patients who received St. Jude Medical valve prostheses.
- Patients' ages ranged from 14 months to 17 years.
- Follow-up included clinical assessment, anticoagulation management (warfarin or aspirin), and postoperative cardiac catheterization in select cases.
Main Results:
- All 14 pediatric patients survived the operation, with no late deaths reported.
- The follow-up period (2 months to 3 years) revealed no valve-related complications, thromboemboli, or hemolysis.
- Postoperative cardiac catheterization in three patients demonstrated satisfactory hemodynamic and angiographic results.
Conclusions:
- The St. Jude Medical valve prosthesis demonstrates initial satisfactory performance in pediatric heart valve replacement.
- The device appears safe and effective in this pediatric cohort, with a notable absence of early complications.
- Further long-term studies are warranted to confirm durability and outcomes in pediatric patients.
Abstract:
The St. Jude Medical valve prosthesis has been used for valve replacement in 14 children. Ages ranged from 14 months to 17 years (average 8.5 years). Preoperative diagnosis included mitral regurgitation in five patients, aortic stenosis in one patient, aortic regurgitation in one, mitral stenosis in one, combined aortic stenosis and aortic regurgitation in five patients, and other in one patient. Seven patients required mitral valve replacement and seven aortic valve replacement. All patients survived operation and there have been no late deaths. Ten patients have been maintained on warfarin anticoagulation and four on aspirin alone. During a follow-up period of two months to three years (average 20.5 months) there have been no complications related to the valve, no thromboemboli, and no incidence of hemolysis. Three patients have had postoperative cardiac catheterization, and satisfactory pressure and angiographic studies have been recorded. The St. Jude Medical valve prosthesis initially appears to be a satisfactory device for valve replacement in children.
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