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Ten-year follow-up after valve replacement with the St. Jude Medical prosthesis in children
1Department of Pediatric Cardiovascular Surgery, Heart Institute of Japan, Tokyo Women's Medical College.
Insights
The St. Jude Medical prosthesis demonstrated excellent outcomes in pediatric cardiac valve replacement, with high survival and complication-free rates over 10 years. This study highlights its suitability for children needing valve surgery.
Area of Science:
- Cardiology
- Pediatric Cardiac Surgery
- Biomedical Engineering
Background:
- Pediatric cardiac valve replacement presents unique challenges due to somatic growth and long-term anticoagulation management.
- The St. Jude Medical prosthesis has been utilized in adult cardiac surgery, but its efficacy in pediatric populations required evaluation.
Purpose of the Study:
- To assess the long-term safety and efficacy of the St. Jude Medical prosthesis in pediatric patients undergoing cardiac valve replacement.
- To evaluate valve-related complications, survival rates, and functional outcomes in children receiving this prosthetic valve.
Main Methods:
- A retrospective analysis of 50 pediatric patients (4 months to 15 years) who underwent cardiac valve replacement with the St. Jude Medical prosthesis since 1979.
- Patients received anticoagulation therapy with warfarin or aspirin/dipyridamole.
- Follow-up data over 224 patient-years (1-10 years) were analyzed for valve-related complications, mortality, and functional status.
Main Results:
- The 10-year actuarial rate free from valve-related complications was 84.7%, with low rates of thromboembolism, valve thrombosis, and prosthetic valve endocarditis.
- The 10-year actuarial survival rate was 90.8%, with late deaths primarily due to non-valve-related causes.
- All surviving children achieved functional class I, and no prosthesis replacements were needed due to somatic growth.
Conclusions:
- The St. Jude Medical prosthesis is a safe and effective option for cardiac valve replacement in children.
- The prosthesis demonstrates favorable long-term outcomes, including excellent survival and minimal need for reoperation due to growth.
- This study supports the St. Jude Medical prosthesis as a preferred choice for pediatric valve replacement.
Abstract:
Since 1979, 50 children, 4 months to 15 years of age, have successfully undergone cardiac valve replacement with the St. Jude Medical prosthesis (St. Jude Medical, Inc., St. Paul, Minn.). There were 24 boys and 26 girls. The valve replaced was mitral in 28 children, aortic in 15, mitral and aortic in 1, and mitral and tricuspid in 1. A left-sided tricuspid valve was replaced in 3 children. Anticoagulant therapy was maintained in all children; 40 children were treated with warfarin, whereas 10 children who underwent aortic or mitral valve replacement were on a regimen of aspirin combined with dipyridamole. The follow-up period, comprising 224 patient-years, ranged from 1 to 10 years. There were four valve-related complications: one from thromboembolism, two from valve thrombosis, and the other one from prosthetic valve endocarditis. Actuarial rate free from all valve-related complications at 10 years was 84.7%. There were four late deaths: one from valve thrombosis and the others from non-valve-related complications. Actuarial survival rate at 10 years was 90.8%. All surviving children are in functional class I, and no child so far has needed replacement of a prosthesis because of somatic growth. These results indicate that the St. Jude Medical prosthesis is a cardiac valve substitute of choice for valve replacement in children.