PDF(Pubmed)
Abstract：
UNASSIGNED: To determine the effectiveness and safety of different patch materials in the treatment of pediatric patients with congenital supravalvular aortic stenosis (SVAS).
UNASSIGNED: 218 consecutive SVAS patients (age < 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).
UNASSIGNED: The median age at operation was 43.5 months (IQR 24.0-73.0). Only three patients had patch-related adverse complications, and no difference existed among the three groups (p = 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.
UNASSIGNED: In pediatric patients, the safety of autologous pericardium patch is acceptable, along with lower rates of middle-term re-operation or restenosis.
UNASSIGNED: http://www.chictr.org.cn, number: ChiCTR2300067851.
UNASSIGNED: 218 consecutive SVAS patients (age < 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).
UNASSIGNED: The median age at operation was 43.5 months (IQR 24.0-73.0). Only three patients had patch-related adverse complications, and no difference existed among the three groups (p = 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.
UNASSIGNED: In pediatric patients, the safety of autologous pericardium patch is acceptable, along with lower rates of middle-term re-operation or restenosis.
UNASSIGNED: http://www.chictr.org.cn, number: ChiCTR2300067851.
摘要：
■确定不同贴片材料在治疗先天性瓣上主动脉瓣狭窄（SVAS）的儿科患者中的有效性和安全性。
■在2002年至2020年期间在北京阜外和云南阜外医院接受手术的218例连续SVAS患者（年龄<14岁）。患者分为心包补片组（133例（61.0%）），改良贴剂组(43(19.7%))和人工贴剂组(42(19.3%))。主要安全终点是贴片相关的不良并发症（术后2年随访时贴片出血或主动脉窦瘤）。主要有效性结果是2年随访时的再手术或再狭窄。使用多变量cox回归获得风险比（HR）。
■手术年龄中位数为43.5个月（IQR24.0-73.0）。只有3例患者出现贴片相关的不良并发症,三组间差异无统计学意义(p=0.763)。在中位随访24.0个月(IQR6.0-48.0)后，与其他两组相比，心包补片的患者再次手术或再狭窄率较低(心包补片与改良补片，HR=0.30，95%CI0.12-0.77；心包补片与人工补片，HR=0.33，95%CI0.13-0.82），甚至在主亚组和敏感性分析中。
■在儿科患者中，自体心包补片的安全性是可以接受的，以及较低的中期再手术或再狭窄率。
■http://www.chictr.org.cn,货号:ChiCTR2300067851.
■在2002年至2020年期间在北京阜外和云南阜外医院接受手术的218例连续SVAS患者（年龄<14岁）。患者分为心包补片组（133例（61.0%）），改良贴剂组(43(19.7%))和人工贴剂组(42(19.3%))。主要安全终点是贴片相关的不良并发症（术后2年随访时贴片出血或主动脉窦瘤）。主要有效性结果是2年随访时的再手术或再狭窄。使用多变量cox回归获得风险比（HR）。
■手术年龄中位数为43.5个月（IQR24.0-73.0）。只有3例患者出现贴片相关的不良并发症,三组间差异无统计学意义(p=0.763)。在中位随访24.0个月(IQR6.0-48.0)后，与其他两组相比，心包补片的患者再次手术或再狭窄率较低(心包补片与改良补片，HR=0.30，95%CI0.12-0.77；心包补片与人工补片，HR=0.33，95%CI0.13-0.82），甚至在主亚组和敏感性分析中。
■在儿科患者中，自体心包补片的安全性是可以接受的，以及较低的中期再手术或再狭窄率。
■http://www.chictr.org.cn,货号:ChiCTR2300067851.
