Background:The Harmony transcatheter pulmonary valve (TPV) was designed for treatment of postoperative pulmonary valve regurgitation in patients with repaired right ventricular outflow tracts.Methods:The Native TPV EFS (Early Feasibility Study) is a prospective, multicenter, nonrandomized feasibility study. Three-year outcomes are reported.Results:Of 20 implanted patients, 17 completed 3-year follow-up (maximum: 4.1 years). There were no deaths and 2 early explants. One patient did not complete the 3-year visit. In patients with available 3-year echocardiographic data, 1 had a mild paravalvular leak and the rest had none/trace; 1 patient had mild pulmonary valve regurgitation and the remainder had none/trace. The 3-year mean right ventricular outflow tract echocardiographic gradient was 15.7±5.5 mm Hg. Radiographically, no late frame fractures or erosions were identified. At 2 years, 2 patients presented with an increased echocardiographic outflow gradient (1 mixed lesion with moderate/severe pulmonary valve regurgitation). Computed tomography scans identified neointimal tissue ingrowth within the stent frame in both patients, and they were treated successfully with a transcatheter valve-in-valve procedure (Melody TPV). Additional follow-up computed tomography scans performed at 3.2±0.5 years after implant were obtained in 16 patients and revealed luminal tissue thickening at the inflow and outflow portion of the frame with no significant alteration of the valve housing.Conclusions:Three-year results from the Native TPV EFS revealed stable Harmony TPV device position, good valve function in most, and the absence of moderate/severe paravalvular leak and significant late frame fractures. Two patients developed significant neointimal proliferation requiring valve-in-valve treatment, while all others had no clinically significant right ventricular outflow tract obstruction.Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01762124.

中文翻译：

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和谐本地流出域的三年成果早期可行性研究。

背景：和谐经导管肺动脉瓣（TPV）设计用于治疗右心室流出道修复的患者术后肺动脉瓣关闭不全。方法：天然TPV EFS（早期可行性研究）是一项前瞻性，多中心，非随机的可行性研究。报告了三年结局。结果：在20名植入患者中，有17名完成了3年的随访（最长4.1年）。没有死亡和2个早期外植体。一名患者未完成3年随访。有3年超声心动图数据的患者中，1例有轻度瓣周漏，其余均无/痕迹。1例患者出现轻度肺动脉瓣关闭不全，其余患者均无/无痕迹。右室流出道的3年平均超声心动图梯度为15.7±5.5 mm Hg。射线照相 未发现晚期框架骨折或糜烂。在2岁时，有2例患者的超声心动图流出梯度增加（1例混合病变，伴有中度/重度肺动脉瓣关闭不全）。计算机断层扫描可以确定两名患者在支架框架内的新内膜组织向内生长，并且已成功通过经导管瓣膜瓣膜手术（Melody TPV）对其进行了治疗。16例患者在植入后3.2±0.5年进行了其他后续计算机体层摄影扫描，结果显示在框架的流入和流出部分腔腔组织增厚，而瓣膜壳体未发生明显改变。 Native TPV EFS显示了稳定的Harmony TPV设备位置，大多数阀门功能良好，并且没有中度/重度瓣周漏和明显的晚期框架骨折。两名患者出现了明显的新内膜增生，需要进行瓣膜治疗，而其他所有患者均没有临床上显着的右心室流出道梗阻。临床试验注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT01762124。