Venus-P自膨式肺动脉瓣经皮植入术的中期随访

Medium-term follow-up of percutaneous pulmonary valve implantation using the Venus-P self-expanding valve

目的评估经皮植入国产自膨式瓣膜Venus-P在治疗法洛四联症(TOF)术后肺动脉瓣重度返流中的中期临床结果。方法回顾性研究。2017年12月至2020年12月郑州大学人民医院儿童心脏中心应用Venus-P成功为13例患者实施经皮肺动脉瓣植入术(PPVI), 瓣膜型号为(31.9±3.1) mm。13例均为TOF术后合并肺动脉瓣重度返流患者, 先前均采用跨环补片重建右心室流出道, 其中男7例, 女6例, 年龄为(17.8±4.7)岁, 体质量为(50.2±12.3) kg。13例患者均完成术后12个月的随访, 对术后随访信息, 如并发症发生情况, 瓣膜及心脏功能改善情况和瓣膜相关的再干预情况等进行总结分析。术前和术后右心室舒张末期容积指数(RVEDVi)比较采用配对t检验, 纽约心脏病协会(NYHA)分级比较采用配对Wilcoxon符号秩和检验。结果 13例患者均成功实施PPVI, 无死亡病例。术后6个月心脏磁共振检查示患者RVEDVi由术前(145.7±9.6) mL/m^(2)降至(100.2±12.2) mL/m^(2), 差异有统计学意义(P<0.05)。术后6个月NYHA心功能分级较术前明显改善, 差异有统计学意义(P<0.05)。1例患者术后12个月出现肺动脉瓣中度返流, 超声心动图未见赘生物, 血培养亦为阴性, 6例患者术后肺动脉瓣无返流, 其余6例肺动脉瓣均为轻度以下返流。1例患者术后第6天突发室性心动过速, 给予同步电复律后转为窦性心律。除1例术后7个月因急性阑尾炎行阑尾切除术外, 无瓣膜相关再干预病例。随访时间(22.8±8.0)个月, 瓣膜支架结构完整, 无移位、瓣周漏和支架断裂等, 无血栓和冠脉受压等并发症。结论自膨式Venus-P PPVI对于TOF术后肺动脉瓣重度返流患者安全、有效, 中期临床结果满意, 但尚需更大样本量和更长时间的临床研究。

Objective To evaluate the medium-term clinical and hemodynamic outcomes of percutaneous pulmonary valve implantation(PPVI)using a domestic Venus-P self-expanding valve in the treatment of severe pulmonary regurgitation after Tetralogy of Fallot(TOF).Methods Retrospective study.From December 2017 to December 2020,13 TOF patients with(17.8±4.7)years old and(50.2±12.3)kg underwent PPVI using the Venus-P self-expanding valve in the Department of Children′s Heart Center,Zhengzhou University People′s Hospital were recruited.The mean valve size was(31.9±3.1)mm.All patients received the transannular patch surgery and developed severe pulmonary regurgitation.After PPVI,13 patients were followed up for at least 12 months.The operation-related complications,improvement of valve and heart function and the durability and reintervention of the Venus-P self-expanding valve were analyzed.The right ventricular end-diastolic volume index(RVEDVi)before and after operation was compared by the paired t-test,and the New York Heart Association(NYHA)class was compared by the paired Wilcoxon signed rank sum test.Results PPVI was successfully performed in all 13 patients without death.At 6 months post-PPVI,cardiac magnetic resonance imaging findings showed that RVEDVi was significantly reduced[(145.7±9.6)mL/m^(2)vs.(100.2±12.2)mL/m^(2),P<0.05],and the NYHA class was significantly improved(P<0.05).One patient presented moderate pulmonary valve regurgitation at 12 months postoperatively.No vegetation was found on echocardiography,and blood culture was negative in this case.Six patients did not have postoperative pulmonary valve regurgitation,and the remaining presented mild or less pulmonary regurgitation.One patient had sudden ventricular tachycardia on the 6th day postoperatively,which was converted to sinus rhythm after synchronous electrocardiography.Only one case underwent appendectomy 7 months after operation due to acute appendicitis,and the remaining did not require valve-related reintervention after implantation.During the follow-up for(22.8±8.0)months,no patients had perivalve leakage,stent migration and rupture.Complications like embolization and coronary artery compression were not reported.Conclusions PPVI using the Venus-P self-expanding valve is safe and effective in patients with severe pulmonary valve regurgitation after TOF surgery,showing an acceptable medium-term follow-up outcome.Studies with a large sample size and long follow-up period are still needed to validate our findings.