Lang Xinyue, Lv Lizhi, Zhang Simeng, Zhi Aihua, Wang Cheng, Wang Qiang
Medical Research & Biometrics Center, National Center for Cardiovascular Diseases, The National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, 102300 Beijing, China.
Department of Pediatric Cardiac Center, Beijing Anzhen Hospital, Capital Medical University, 100029 Beijing, China.
Rev Cardiovasc Med. 2024 Jan 9;25(1):14. doi: 10.31083/j.rcm2501014. eCollection 2024 Jan.
To determine the effectiveness and safety of different patch materials in the treatment of pediatric patients with congenital supravalvular aortic stenosis (SVAS).
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).
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 ( = 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.
In pediatric patients, the safety of autologous pericardium patch is acceptable, along with lower rates of middle-term re-operation or restenosis.
http://www.chictr.org.cn, number: ChiCTR2300067851.
确定不同补片材料治疗小儿先天性主动脉瓣上狭窄（SVAS）患者的有效性和安全性。
纳入2002年至2020年间在北京阜外医院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%））、改良补片组（43例（19.7%））和人工补片组（42例（19.3%））。主要安全终点是补片相关不良并发症（术后2年随访时补片出血或主动脉窦瘤）。主要有效性结局是术后2年随访时再次手术或再狭窄。采用多变量cox回归获得风险比（HR）。
手术时的中位年龄为43.5个月（IQR 24.0 - 73.0）。只有3例患者出现补片相关不良并发症，三组之间无差异（P = 0.763）。中位随访24.0个月（IQR 6.0 - 48.0）后，心包补片患者的再次手术或再狭窄率低于其他两组（心包补片组与改良补片组相比，HR = 0.30，95%CI 0.12 - 0.77；心包补片组与人工补片组相比，HR = 0.33，95%CI 0.13 - 0.82），即使在主要亚组和敏感性分析中也是如此。
在小儿患者中，自体心包补片的安全性是可以接受的，中期再次手术或再狭窄率较低。
