Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system
Early outcomes of percutaneous pulmonary valve implantation using the Edwards SAPIEN XT transcatheter heart valve system
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DOI：
10.1016/j.ijcard.2017.10.015
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发表时间：
2018-01-01
影响因子：
3.5
通讯作者：
Ewert, Peter
中科院分区：
文献类型：
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作者：
Haas, Nikolaus A.;Carere, Ronald Giacomo;Ewert, Peter
背景：影响肺动脉瓣和右心室流出道（RVOT）的先天性或获得性心脏缺损患者通常需要多次手术干预，其发病率很高。另一种侵入性较小的方法是经皮肺动脉瓣植入术（PPVI）。虽然先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，但最近的设备数据严重缺乏。方法和结果：我们对使用Edwards SAPIEN XT THV进行PPVI的患者进行了多国、多中心、回顾性、观察性登记分析。在纳入的46例患者中，大多数诊断为法洛四联症（58.7%），无支架异种移植物是最常见的RVOT解剖结构（34.8%）。手术成功率高（93.5%），术中并发症和不良事件发生率低（分别为6.5%和10.9%）。术后30天，NYHA分级明显改善（90.6%为NYHA I级或II级）。中度/重度肺返流率从基线时的76.1%下降到30天时的5.0%，计算的峰值收缩梯度从45.2 (SD +/- 21.3) mm Hg下降到16.4 (SD +/- 8.0) mm Hg，这些值一直保持在低水平直到2年。结论：这些数据表明SAPIEN XT THV在普通解剖结构的有导管的PPVI患者中，以及那些有天然肺瓣膜或经环补片的患者中是有效和安全的。继续收集数据是验证长期发现的必要条件。(C) 2017 Elsevier b.v.版权所有
Background: 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.Methods and results: 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 30 days 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 30 days, and the calculated peak systolic gradient had decreased from 45.2 (SD +/- 21.3) mm Hg to 16.4 (SD +/- 8.0) mm Hg, with these values remaining low up to 2 years.Conclusions: 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. (C) 2017 Elsevier B. V. All rights reserved.