自膨式介入肺动脉瓣经胸植入术早期疗效的前瞻性临床研究

Early outcomes of self-expanding interventional pulmonary valve in transthoracic implantation:A prospective clinical study

目的评估使用国产自膨式瓣膜(Salus^(TM))行经胸肺动脉瓣植入术治疗中重度肺动脉瓣反流的早期结果。方法前瞻性纳入2021年9月2日—2022年11月25日在广东省人民医院行经胸肺动脉瓣植入术患者,对术后早期并发症发生情况、瓣膜及心脏功能改善情况等进行总结分析。结果共纳入患者25例,其中男16例、女9例,平均年龄(24.5±1.5)岁,平均体重(57.0±3.0)kg。经CT血管成像测得25例患者术前近主肺动脉分叉处、主动脉中段较狭窄处、近右心室流出道瓣膜处收缩期平均直径分别为(31.8±7.4)mm、(30.6±5.9)mm、(38.4±8.0)mm。所有患者均成功植入瓣膜,术后早期未出现死亡、冠状动脉压迫、支架断裂、瓣膜移位、感染性心内膜炎等严重并发症。与术前相比,术后左心房和右心房上下径指数、右心室流出道前后径指数均明显降低;三尖瓣和肺动脉瓣反流程度均明显减轻,反流面积指数明显降低,以上差异均有统计学意义(P<0.05)。结论使用国产自膨式肺动脉瓣(SalusTM)行经胸肺动脉植入术,治疗严重肺动脉瓣反流的早期效果良好,长期效果还需大样本长期随访结果验证。

Objective To evaluate early outcomes of transthoracic pulmonary valve implantation for the treatment of moderate and severe pulmonary regurgitation by using homemade self-expanding valve(Salus^(TM)).Methods Patients with severe pulmonary regurgitation who underwent transthoracic pulmonary valve implantation in Guangdong Provincial People’s Hospital from September 2,2021 to November 25,2022 were prospectively enrolled.The early postoperative complications and improvement of valve and heart function were summarized and analyzed.Results A total of 25 patients were enrolled,including 16 males and 9 females,with an average age of 24.5±1.5 years and an average weight of 57.0±3.0 kg.The mean systolic diameters of the bifurcation near the main pulmonary artery,the stenosis of the middle segment of the aorta and near the valve of the right ventricular outflow tract of the patients were 31.8±7.4 mm,30.6±5.9 mm and 38.4±8.0 mm,respectively.All patients were successfully implanted with valves,and there were no serious complications such as death,coronary compression,stent fracture,valve displacement and infective endocarditis in the early postoperative period.The indexed left atrial longitudinal diameter,indexed right atrial longitudinal diameter,and indexed right ventricular outflow tract anteroposterior diameter decreased significantly after the operation.The degree of tricuspid and pulmonary valve regurgitation and the indexed regurgitation area decreased significantly.The above differences were statistically significant(P<0.05).Conclusion The early outcomes of transthoracic pulmonary valve implantation with homemade self-expanding pulmonary valve(SalusTM)in the treatment of severe pulmonary regurgitation is relatively good,and the long-term outcomes need to be verified by the long-term follow-up studies with large samples.