Department of Congenital Heart Disease-Pediatric Cardiology, German Heart Institute Berlin, Augustenburger Platz 1, Berlin, Germany.
Department of Pediatric Cardiology and Congenital Heart Disease, German Heart Center Munich, Lazarettstraße 36, Munich, Germany.
Eur Heart J. 2019 Jul 14;40(27):2255-2264. doi: 10.1093/eurheartj/ehz201.
The post-approval MELODY Registry aimed to obtain multicentre registry data after transcatheter pulmonary valve implantation (TPVI) with the Melody™ valve (Medtronic plc.) in a large-scale cohort of patients with congenital heart disease (CHD).
Retrospective analysis of multicentre registry data after TPVI with the Melody™ valve. Eight hundred and forty-five patients (mean age: 21.0 ± 11.1 years) underwent TPVI in 42 centres between December 2006 and September 2013 and were followed-up for a median of 5.9 years (range: 0-11.0 years). The composite endpoint of TPVI-related events during follow-up (i.e. death, reoperation, or reintervention >48 h after TPVI) showed an incidence rate of 4.2% per person per year [95% confidence interval (CI) 3.7-4.9]. Transcatheter pulmonary valve implantation infective endocarditis (I.E.) showed an incidence rate of 2.3% per person per year (95% CI 1.9-2.8) and resulted in significant morbidity and in nine deaths. In multivariable Cox proportional hazard models, the invasively measured residual right ventricle (RV)-to-pulmonary artery (PA) pressure gradient (per 5 mmHg) was associated with the risk of the composite endpoint (adjusted hazard ratio: 1.21, 95% CI 1.12-1.30; P < 0.0001) and the risk of TPVI I.E. (adjusted hazard ratio: 1.19, 95% CI 1.07-1.32; P = 0.002). Major procedural complications (death, surgical, or interventional treatment requirement) occurred in 0.5%, 1.2%, and 2.0%, respectively. Acutely, the RV-to-PA pressure gradient and the percentage of patients with pulmonary regurgitation grade >2 improved significantly from 36 [interquartile range (IQR) 24-47] to 12 (IQR 7-17) mmHg and 47 to 1%, respectively (P < 0.001 for each).
The post-approval MELODY Registry confirms the efficacy of TPVI with the Melody™ valve in a large-scale cohort of CHD patients. The residual invasively measured RV-to-PA pressure gradient may serve as a target for further improvement in the composite endpoint and TPVI I.E. However, TPVI I.E. remains a significant concern causing significant morbidity and mortality.
经导管肺动脉瓣植入（TPVI）后 MELODY 注册研究旨在对大量患有先天性心脏病（CHD）的患者进行经导管肺动脉瓣植入（TPVI）后多中心注册数据的回顾性分析。
TPVI 后 Melody™瓣膜多中心注册数据的回顾性分析。2006 年 12 月至 2013 年 9 月，42 个中心对 845 例（平均年龄：21.0±11.1 岁）患者进行了 TPVI 治疗，并进行了中位数为 5.9 年（范围：0-11.0 年）的随访。随访期间（即 TPVI 后 48 小时以上死亡、再次手术或再次介入治疗）与 TPVI 相关的复合终点发生率为 4.2%/人/年[95%可信区间（CI）为 3.7-4.9]。经导管肺动脉瓣植入感染性心内膜炎（IE）的发生率为 2.3%/人/年（95%CI 为 1.9-2.8），导致显著的发病率和 9 例死亡。多变量 Cox 比例风险模型显示，经侵入性测量的右心室（RV）至肺动脉（PA）压力梯度（每 5mmHg）与复合终点的风险相关（校正后的危险比：1.21，95%CI 为 1.12-1.30；P<0.0001）和 TPVI IE 的风险（校正后的危险比：1.19，95%CI 为 1.07-1.32；P=0.002）。主要手术并发症（死亡、手术或介入治疗需要）的发生率分别为 0.5%、1.2%和 2.0%。急性时，RV 至 PA 压力梯度和肺动脉瓣反流程度>2 的患者百分比分别从 36mmHg（四分位间距[IQR] 24-47）显著改善至 12mmHg（IQR 7-17）和 47%至 1%（P<0.001）。
TPVI 后 MELODY 注册研究在 CHD 患者的大型队列中证实了经导管肺动脉瓣植入术的疗效。经侵入性测量的残余 RV 至 PA 压力梯度可能是进一步改善复合终点和 TPVI IE 的目标。然而，TPVI IE 仍然是一个显著的关注点，导致显著的发病率和死亡率。
