Gillespie Matthew J, Benson Lee N, Bergersen Lisa, Bacha Emile A, Cheatham Sharon L, Crean Andrew M, Eicken Andreas, Ewert Peter, Geva Tal, Hellenbrand William E, Hor Kan N, Horlick Eric M, Jones Thomas K, Mayer John, McHenry Brian T, Osten Mark D, Powell Andrew J, Zahn Evan M, Cheatham John P
Division of Cardiology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
The Division of Cardiology, The Labatt Family Heart Center, The Hospital for Sick Children, Toronto, Canada.
Am J Cardiol. 2017 Oct 15;120(8):1387-1392. doi: 10.1016/j.amjcard.2017.07.034. Epub 2017 Jul 26.
This early feasibility study was designed to obtain in vivo data to confirm assumptions on device loading conditions of the Medtronic Harmony transcatheter pulmonary valve (TPV). Secondary objectives included procedural feasibility, safety, and valve performance. The Harmony TPV was developed for nonsurgical pulmonary valve replacement in non-right ventricle-pulmonary artery conduit patients. The Native Outflow Tract TPV Research Clinical Study was the first study approved under the Food and Drug Administration Early Feasibility Study guidance. Enrollment required that patient anatomy be precisely matched to the single-size Harmony TPV implant, necessitating a rigorous selection process. The study was nonrandomized, prospective, and performed at 3 sites. All patients met standard indications for surgical pulmonary valve replacement. The goal of the screening committee was to match the candidate anatomy to predetermined engineering criteria thought to be predictive of secure Harmony TPV implantation for the single-size device under study. A majority of the screening committee was required to recommend a patient as eligible for implant. A total of 270 patients underwent prescreening cardiac magnetic resonance imaging, 66 were enrolled and received a computed tomography scan (24%), 21 met criteria for implant and were catheterized (8%), and 20 underwent implant. Nineteen of 20 met criteria for implant success. In conclusion, the Medtronic Harmony TPV represents an emerging therapeutic option for patients with complex postoperative right ventricular outflow tract failure. The initial clinical evaluation of this technology was unique, and the highly variable anatomy of this population required careful screening to ensure acceptable device fit.
这项早期可行性研究旨在获取体内数据，以证实对美敦力Harmony经导管肺动脉瓣（TPV）装置加载条件的假设。次要目标包括手术可行性、安全性和瓣膜性能。Harmony TPV是为非右心室-肺动脉导管患者的非手术肺动脉瓣置换而开发的。“原生流出道TPV研究临床研究”是根据美国食品药品监督管理局早期可行性研究指南批准的首个研究。入组要求患者解剖结构与单一尺寸的Harmony TPV植入物精确匹配，这需要严格的筛选过程。该研究为非随机、前瞻性研究，在3个地点进行。所有患者均符合手术肺动脉瓣置换的标准适应症。筛选委员会的目标是使候选解剖结构与预定的工程标准相匹配，这些标准被认为可预测所研究的单一尺寸装置的Harmony TPV植入安全。筛选委员会的大多数成员需要推荐患者符合植入条件。共有270例患者接受了预筛选心脏磁共振成像，66例入组并接受了计算机断层扫描（24%），21例符合植入标准并接受了心导管检查（8%），20例接受了植入手术。20例中有19例符合植入成功标准。总之，美敦力Harmony TPV为复杂术后右心室流出道衰竭患者提供了一种新出现的治疗选择。这项技术的初步临床评估具有独特性，并且该人群的解剖结构高度可变，需要仔细筛选以确保装置适配性可接受。
