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Valve prostheses in children: a reassessment of anticoagulation
R M Sade1, F A Crawford, D A Fyfe
1Division of Cardiothoracic Surgery, Medical University of South Carolina, Charleston.
Insights
Pediatric patients with St. Jude Medical heart valves may not need anticoagulation. However, children without anticoagulation had more thrombotic events than anticoagulated adults.
Area of Science:
- Cardiology
- Pediatric Cardiology
- Biomaterials Science
Background:
- Previous studies suggested St. Jude Medical prostheses in pediatric patients might not require anticoagulation.
- Anticoagulation is standard for mechanical heart valves to prevent thrombosis and thromboembolism.
Purpose of the Study:
- To evaluate the safety and efficacy of omitting anticoagulation in children with St. Jude Medical heart valves.
- To compare thrombotic and thromboembolic event rates in pediatric patients without anticoagulation versus adult patients with anticoagulation.
Main Methods:
- Follow-up of 48 pediatric patients (5 months to 21 years) with St. Jude Medical prostheses, without anticoagulant therapy for up to 7 years.
- Concurrent follow-up of 340 adult patients with St. Jude Medical prostheses receiving warfarin sodium (Coumadin) anticoagulation.
- Analysis of thrombotic and thromboembolic events, mortality, and prosthesis-related complications.
Main Results:
- Seven thrombotic or thromboembolic events occurred in the pediatric cohort (5.7 events per 100 patient-years).
- No early deaths were associated with prosthesis thrombosis; one late death was linked to a thrombosed prosthesis.
- Pediatric patients without anticoagulation experienced significantly more thrombotic/thromboembolic events than anticoagulated adults (p < 0.01).
Conclusions:
- Omitting anticoagulation in children with St. Jude Medical heart valves resulted in a higher rate of thrombotic and thromboembolic events compared to anticoagulated adults.
- Further investigation is warranted to determine optimal anticoagulation strategies for pediatric patients with mechanical heart valves.
Abstract:
We have previously published evidence that children with St. Jude Medical prostheses on the left side of the heart may not require anticoagulation. Between March 1979 and September 1986, we followed up 48 patients who had no anticoagulant therapy for up to 7 years after valve replacement, an aggregate of 122 patient-years. The 25 male and 23 female patients ranged in age at implantation from 5 months to 21 years (12 +/- 6 years, mean +/- standard deviation). Five patients (all with complex associated malformation) died in the hospital (10%), and nine died late (22%). None of the early and one of the late deaths was associated with a thrombosed prosthesis. During follow-up, seven thrombotic (one mitral, one aortic) or thromboembolic (two mitral, three aortic) events occurred (5.7 +/- 2.1 per 100 patient-years). Of these seven events, five occurred within the last 14 months of the study. There was no relation of these events to age of patient at implantation, age at the time of even, gender, or site of implantation. Concurrently, we have followed up 340 adult patients with St. Jude Medical prostheses who had warfarin sodium (Coumadin) anticoagulation for 875 patient-years. By the end of this study, the children who did not receive anticoagulants were significantly less free of thrombotic and thromboembolic events than the adults who did receive anticoagulants (p less than 0.01).