应用国产封堵器治疗室间隔缺损对心脏瓣膜功能的影响

Function of the valves after transcatheter closure of ventricular septal defect with Xianjian^(TM) occluders

目的探讨应用国产封堵器进行室间隔缺损(VSD)封堵术对心脏瓣膜功能的影响,并与Amplatzer封堵器、外科手术治疗VSD对心脏瓣膜功能的影响进行对比。方法将VSD患儿分为三组,国产封堵器组76例,Amplatzer封堵器组34例,外科手术组56例;国产封堵器组分别与Amplatzer封堵器组、外科手术组在术后1周及3个月对三尖瓣关闭不全、三尖瓣狭窄及主动脉瓣关闭不全的发生率进行对比研究。两组间率的比较采用卡方检验。结果在术后1周,国产封堵器组主动脉瓣关闭不全的发生率较外科手术组高(P<0.05),与Amplatzer封堵器组比较差异无统计学意义(P>0.05)。术后3个月,国产封堵器组与外科手术组、Amplatzer封堵器组比较,主动脉瓣关闭不全的发生率差异无统计学意义(P>0.05)。术后1周及3个月,国产封堵器组与外科手术组、Amplatzer封堵器组分别比较,三尖瓣关闭不全、三尖瓣狭窄的发生率差异无统计学意义(P>0.05)。结论国产封堵器作为封堵VSD的新器械,在术后及近期对心脏瓣膜功能的影响轻。为避免瓣膜功能受影响,应严格掌握介入术的指征,术中应用心脏超声监测,避免操作动作粗暴,选用合适大小的封堵器。

Objective To assess the function of valves after transcatheter closure of congenital ventricular septal defect （VSD） with local made XianjianTM occluder and compare with AmplatzerTM occluder and operations. Methods The rate of tricuspid valve regurgitation, tricuspid valve stenosis and aortic valve regurgitation at 1 week and 3 months after interventions were analyzed using Chi square test in XianjianTM occluder group （n = 76）, AmplatzerTM occluder group （n = 34） and operation group （n = 56）. Results The rate of aortic valve regurgitation of the XianjianTM occluder group at 1 week follow-up was higher than that of the operation group （P 〈 0.05 ）, but no significant differences in comparison with AmplatzerTM occluder group. Neither statistical differences between the XianjianTM occluder group and the Amplatzer^TM occluder group, nor differences between the Xianjian^TM oceluder group and the operation group were found in the rate of aortic valve regurgitation at 3 months follow-up （both P 〉 0.05）. There were no significant differences either between the Xianjian^TM occluder group and the AmplatzcrTM occluder group, or between the XianjianTM occluder group and the operation group in the rate of tricuspid valve regurgitation, the rate of tricuspid valve stenosis at 1 week and 3 months follow-up （both P 〉 0.05 ）. Conclusions The Xianjian^TM VSD occluder is a new instrument of the transcatheter closure of VSD. The function of the valves are mildly impacted after the interventions but are improved during the short-term follow-up. To prevent its impact on the valves, it is important to strictly observe the indications for occluder implantation and closely monitor the implanting process by echocardiography, avoid violent manipulations and choose suitable devices.