Department of Pediatric Cardiology, Pediatric Intensive Care, LMU, München, Germany; Centre for Congenital Heart Defects, Heart and Diabetes Centre Bad Oeynhausen, Ruhr University Bochum, Bad Oeynhausen, Germany.
St. Paul's Hospital, Vancouver, Canada.
Int J Cardiol. 2018 Jan 1;250:86-91. doi: 10.1016/j.ijcard.2017.10.015. Epub 2017 Oct 6.
Patients with congenital or acquired heart defects affecting the pulmonary valve and right ventricular outflow tract (RVOT) commonly require multiple surgical interventions, resulting in significant morbidity. A less invasive alternative is percutaneous pulmonary valve implantation (PPVI). Though studies have previously reported the safety and efficacy of the early generation transcatheter heart valves (THVs), data on more recent devices are severely lacking.
We performed a multinational, multicentre, retrospective, observational registry analysis of patients who underwent PPVI using the Edwards SAPIEN XT THV. Of the 46 patients that were enrolled, the majority had tetralogy of Fallot as the underlying diagnosis (58.7%), and stentless xenograft as the most common RVOT anatomy (34.8%). Procedural success rate was high (93.5%), with a low frequency of periprocedural complications and adverse events (6.5% and 10.9%, respectively). At 30days post-procedure, NYHA class had improved significantly (90.6% were at NYHA I or II). The rate of moderate/severe pulmonary regurgitation had decreased from 76.1% at baseline to 5.0% at 30days, and the calculated peak systolic gradient had decreased from 45.2 (SD±21.3) mmHg to 16.4 (SD±8.0) mmHg, with these values remaining low up to 2years.
The data suggest the efficacy and safety of the SAPIEN XT THV in PPVI in common anatomies in patients with conduits, as well as those with native pulmonary valves or transannular patches. Continued data collection is necessary to verify long-term findings. CLINICALTRIALS.
NCT02302131.
患有先天性或后天性心脏缺陷影响肺动脉瓣和右心室流出道（RVOT）的患者通常需要多次手术干预，导致发病率显著增加。一种侵入性较小的替代方法是经皮肺动脉瓣植入术（PPVI）。虽然之前的研究报告了早期经导管心脏瓣膜（THV）的安全性和有效性，但关于最近设备的数据却严重缺乏。
我们对使用 Edwards SAPIEN XT THV 进行 PPVI 的患者进行了一项多中心、回顾性、观察性多国注册分析。在纳入的 46 名患者中，大多数患者的基础诊断为法洛四联症（58.7%），最常见的 RVOT 解剖结构为无支架异种移植物（34.8%）。手术成功率高（93.5%），围手术期并发症和不良事件的发生率低（分别为 6.5%和 10.9%）。在术后 30 天，NYHA 分级显著改善（90.6%为 NYHA I 或 II 级）。中重度肺动脉瓣反流的发生率从基线时的 76.1%降至 30 天时的 5.0%，计算得出的收缩期峰值梯度从 45.2（SD±21.3）mmHg 降至 16.4（SD±8.0）mmHg，这些值在 2 年内仍保持较低水平。
数据表明，SAPIEN XT THV 在经导管心脏瓣膜植入术（PPVI）中用于常见解剖结构的疗效和安全性，无论是在带瓣管道的患者中，还是在具有原生肺动脉瓣或跨瓣环补片的患者中。需要继续收集数据以验证长期发现。临床试验。
NCT02302131。
