From the Division of Cardiology, UCSF Benioff Children's Hospital, University of California, San Francisco (J.J.M., P.M.M.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., S.L.C.); Department of Cardiology, Children's Hospital Boston, MA (D.P.); Division of Cardiology, The Children's Hospital of Philadelphia, PA (M.J.G., J.J.R.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); and Division of Cardiology, New York University Medical Center (D.B.M.).
Circ Cardiovasc Interv. 2014 Jun;7(3):374-80. doi: 10.1161/CIRCINTERVENTIONS.114.001225. Epub 2014 May 27.
Melody Transcatheter Pulmonary Valve (TPV) replacement therapy represents an important advance in congenital cardiovascular interventions. The off-label extension of the Melody TPV to patients with nonconduit outflow tracts (right ventricular outflow tract [RVOT]) has the potential to vastly expand the population of patients eligible to benefit from nonsurgical restoration of RVOT function. However, knowledge on the performance of the Melody TPV in this setting is limited.
This is a multicenter, retrospective review of the Melody TPV when placed in nonconduit RVOTs, in which at least a portion of the circumference was composed of native tissue. Five centers contributed data on 31 patients. The median age at implantation was 24 years (range, 7-66). At a median follow-up of 15 months, all patients were alive. No patient had greater than mild TPV insufficiency, and the median maximum instantaneous gradients across the RVOT was 23 mm Hg. Stent fracture occurred in 32%. Eight patients developed more than mild TPV obstruction, of whom 6 were associated with identified stent fracture. Three patients developed blood stream infections. There were 5 reinterventions in 3 patients, including 3 repeat TPV implantations and 2 TPV explantations.
Melody TPV implantation is feasible in selected patients with RVOTs comprised solely or predominantly native tissue and has the potential to expand the population of patients eligible to benefit from nonsurgical restoration of RVOT function. In early follow-up, valve competency seems preserved. The dominant mechanism of valve dysfunction seems to be related to stent fracture with recurrent obstruction. Additional data are necessary to better understand how to safely expand TPV therapy to this population.
Melody 经导管肺动脉瓣（TPV）置换疗法代表了先天性心血管介入治疗的重要进展。将 Melody TPV 超适应证应用于无管道流出道（右心室流出道 [RVOT]）的患者，有可能极大地扩大有资格从 RVOT 功能非手术恢复中获益的患者群体。然而，关于这种情况下 Melody TPV 的性能的知识是有限的。
这是一项多中心、回顾性研究，研究了将 Melody TPV 置于非管道 RVOT 中的情况，其中至少一部分周长由原生组织组成。五个中心提供了 31 名患者的数据。植入时的中位年龄为 24 岁（范围 7-66 岁）。中位随访 15 个月时，所有患者均存活。没有患者出现大于轻度 TPV 功能不全，中位 RVOT 最大瞬时梯度为 23mmHg。支架断裂发生在 32%的患者中。8 名患者出现大于轻度 TPV 梗阻，其中 6 例与支架断裂有关。3 名患者发生血流感染。3 名患者中有 5 例进行了 5 次再介入治疗，包括 3 例重复 TPV 植入和 2 例 TPV 取出。
在完全或主要由原生组织组成的 RVOT 的选定患者中，Melody TPV 植入是可行的，有可能扩大有资格从 RVOT 功能非手术恢复中获益的患者群体。在早期随访中，瓣膜功能似乎保持完好。瓣膜功能障碍的主要机制似乎与支架断裂和反复梗阻有关。需要更多的数据来更好地了解如何安全地将 TPV 治疗扩展到这一人群。
