Key result
Autologous pericardium patches significantly reduced the rate of middle-term re-operation or restenosis compared to modified patches (HR 0.30) and artificial patches (HR 0.33) in pediatric patients with supravalvular aortic stenosis.
Why the study?
The study was conducted to determine the effectiveness and safety of different patch materials in treating pediatric patients with congenital supravalvular aortic stenosis.
Does an autologous pericardium patch reduce re-operation or restenosis compared to modified or artificial patches in pediatric patients undergoing surgical repair of congenital supravalvular aortic stenosis?
Cohort (n=218)
Yes
Does an autologous pericardium patch reduce re-operation or restenosis compared to modified or artificial patches in pediatric patients undergoing surgical repair of congenital supravalvular aortic stenosis?
Hazard Ratio: 0.3 (95% CI 0.12–0.77)
Absolute Event Rate: 9.3% vs 26.3%
p-value: p=<0.012
In pediatric patients with congenital supravalvular aortic stenosis, the use of an autologous pericardium patch is associated with lower rates of mid-term re-operation or restenosis compared to modified or artificial patches, with comparable safety.
Background: To determine the effectiveness and safety of different patch materials in the treatment of pediatric patients with congenital supravalvular aortic stenosis (SVAS). Methods: 14 years) who underwent surgery from Beijing Fuwai and Yunnan Fuwai hospital between 2002 and 2020 were included. Patients were divided into the pericardium patch group (133 (61.0%)), modified patch group (43 (19.7%)) and artificial patch group (42 (19.3%)). The primary safety endpoint was patch-related adverse complications (post-operation patch hemorrhage or aortic sinus aneurysm at 2-year follow-up). The primary effectiveness outcome was the re-operation or restenosis at 2-year follow-up. Multivariable cox regression was used to obtain the hazard ratio (HR). Results: = 0.763). After a median follow-up of 24.0 months (IQR 6.0-48.0), patients with a pericardium patch had a lower re-operation or restenosis rate compared with the other two groups (pericardium patch vs modified patch, HR = 0.30, 95% CI 0.12-0.77; pericardium patch vs artificial patch, HR = 0.33, 95% CI 0.13-0.82), even in the main subgroup and sensitivity analysis. Conclusions: In pediatric patients, the safety of autologous pericardium patch is acceptable, along with lower rates of middle-term re-operation or restenosis. Clinical Trial Registration: http://www.chictr.org.cn, number: ChiCTR2300067851.
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Lang et al. (2024) conducted a cohort in Congenital supravalvular aortic stenosis (SVAS) (n=218). Autologous pericardium patch vs. Modified patch or artificial patch was evaluated on Re-operation or restenosis at 2-year follow-up (HR 0.30, 95% CI 0.12-0.77, p=<0.012). Autologous pericardium patches significantly reduced the rate of middle-term re-operation or restenosis compared to modified patches (HR 0.30) and artificial patches (HR 0.33) in pediatric patients with supravalvular aortic stenosis.
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