评价Med-Zenith肺动脉瓣膜治疗儿童先天性心脏病（先心病）术后肺动脉瓣反流的短期临床效果。

前瞻性筛查2021年1月至2023年3月上海交通大学医学院附属上海儿童医学中心中度以上肺动脉瓣反流患儿，完善心脏断层扫描血管成像和心脏磁共振（MRI）评估右心室流出道解剖学形态，左、右心室容积和肺动脉瓣反流分数，对符合纳入标准者植入Med-Zenith肺动脉瓣膜。分析和评价手术急性期及随访早期植入瓣膜的功能，患者左、右心室容积指数变化及瓣膜相关并发症。

共13例先心病术后重度肺动脉瓣反流患儿行Med-Zenith肺动脉瓣膜植入，植入时年龄（14.5±2.1）岁，男占61.5%（8/13），体重（50.3±7.9）kg。所有患儿均成功植入Med-Zenith肺动脉瓣膜，中位随访12.0（12.0，24.0）个月，100%患儿临床稳定。超声心动图显示100%患儿肺动脉瓣反流轻度及以下，均未见瓣周漏；多普勒肺动脉峰值血流压力梯度与植入前比较，差异无统计学意义［（15.7±8.3）mmHg对（13.8±5.6）mmHg，P=0.429］。心脏MRI示右心室舒张末期容积指数、右心室收缩末期容积指数及肺动脉瓣反流分数均较术前下降［（129.7±24.1）ml/m²对（197.7±18.9）ml/m²，P<0.001；（79.4±22.1）ml/m²对9（120.9±34.2）ml/m²，P<0.001；（6.4±6.0）%对（54.8±8.3）%，P<0.001］。左心室舒张末期容积指数及左心室收缩末期容积指数分别较术前上升［（94.8±14.2）ml/m²对（88.4±9.6）ml/m²，P=0.046；（49.2±18.5）ml/m²对（39.7±9.2）ml/m²，P=0.025］。胸部X线检查未见支架断裂、移位及形变。

Med-Zenith肺动脉瓣膜治疗儿童先心病外科术后肺动脉瓣反流安全、易行，中位随访1年100%患儿瓣膜轻度及以下反流，未见瓣周漏。患儿心功能好转，左、右心室容积指数均较术前显著改善。

To present the short-term clinical trial outcome of the Med-Zenith pulmonary valve in treating postoperative pulmonary regurgitation in children with congenital heart disease.

Between January 2021 and March 2023, prospective screening of children with moderate to severe pulmonary regurgitation in Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University. The anatomy of right ventricular outflow tract, left and right ventricular volumes and pulmonary regurgitation fraction were evaluated by cardiac tomography angiography and cardiac magnetic resonance imaging (MRI). For patients who met the inclusion criteria, Med-Zenith pulmonary valve was implanted. During acute and short-term follow-up, the function of the Med-Zenith pulmonary valve, ventricular volume and complications were assessed. Inclusion criteria: ①Age ≥ 10 years or weight ≥ 25 kg. ②New York Heart Association (NYHA) functional class Ⅱ or above, accompanied by moderate to severe pulmonary regurgitation measured by echocardiography or a pulmonary regurgitation fraction ≥30% measured by magnetic resonance imaging.

A total of 13 patients with severe pulmonary regurgitation postoperative underwent successful implantation of Med-Zenith pulmonary valve. Among these patients, boys accounted for 61.5% (8/13). Mean age and mean weight at implantation were (14.5±2.1) years and (50.3±7.9) kg, respectively. After a median follow-up of 12.0 (12.0,24.0) months, all patients were clinically stable. All patients showed trivial or mild pulmonary regurgitation by echocardiography, and no paravalvular leakage was observed. Mean peak systolic pulmonary artery gradient was not significantly different from that before operation [(15.7±8.3) mmHg vs. (13.8±5.6) mmHg, P=0.429]. Mean right ventricular end-diastolic volume index, mean right ventricular end-systolic volume index and mean pulmonary artery regurgitation fraction by MRI were significantly decreased [(129.7±24.1) ml/m² vs. (197.7±18.9) ml/m², P<0.001; (129.7±24.1) ml/m² vs.(197.7±18.9) ml/m²,P<0.001;(6.4±6.0) % vs. (54.8±8.3) %, P<0.001]. Mean left ventricular end-diastolic volume index, the left ventricular end-systolic volume index was significantly increased [ (94.8±14.2 ml/m² vs. (88.4±9.6) ml/m², P=0.046; (49.2±18.5) ml/m² vs. (39.7±9.2) ml/m², P=0.025]. X-ray examination showed no fracture, displacement or deformation of the device. There was no serious device-related adverse event.

Med-Zenith pulmonary valve is safe and easy to treat pulmonary artery regurgitation after surgery in children with congenital heart disease. At a median follow-up of 1 year, 100% of the patients had mild or less valvular regurgitation, and no paravalvular leak was observed. The cadiac function of patients improved and the left and right ventricular volume indexes also significantly improved.