美国 melody 瓣膜研究性器械豁免试验中经导管肺动脉瓣置换术后 7 年的临床和血液动力学结果。
Clinical and hemodynamic outcomes up to 7 years after transcatheter pulmonary valve replacement in the US melody valve investigational device exemption trial.
机构信息
From Division of Cardiology, Nationwide Children's Hospital, Ohio State University School of Medicine, Columbus (J.P.C., D.P.B.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.); Division of Cardiology, Seattle Children's Hospital, University of Washington School of Medicine (T.K.J.); Division of Cardiology, Miami Children's Hospital, FL (D.P.B.); Division of Pediatric Cardiology, Columbia University Medical Center, New York, NY (J.A.V.); and Department of Cardiothoracic Surgery, Stanford University School of Medicine, Palo Alto, CA (D.B.M.).
出版信息
Circulation. 2015 Jun 2;131(22):1960-70. doi: 10.1161/CIRCULATIONAHA.114.013588. Epub 2015 May 5.
BACKGROUND
Studies of transcatheter pulmonary valve (TPV) replacement with the Melody valve have demonstrated good short-term outcomes, but there are no published long-term follow-up data.
METHODS AND RESULTS
The US Investigational Device Exemption trial prospectively enrolled 171 pediatric and adult patients (median age, 19 years) with right ventricular outflow tract conduit obstruction or regurgitation. The 148 patients who received and were discharged with a TPV were followed up annually according to a standardized protocol. During a median follow-up of 4.5 years (range, 0.4-7 years), 32 patients underwent right ventricular outflow tract reintervention for obstruction (n=27, with stent fracture in 22), endocarditis (n=3, 2 with stenosis and 1 with pulmonary regurgitation), or right ventricular dysfunction (n=2). Eleven patients had the TPV explanted as an initial or second reintervention. Five-year freedom from reintervention and explantation was 76±4% and 92±3%, respectively. A conduit prestent and lower discharge right ventricular outflow tract gradient were associated with longer freedom from reintervention. In the 113 patients who were alive and reintervention free, the follow-up gradient (median, 4.5 years after implantation) was unchanged from early post-TPV replacement, and all but 1 patient had mild or less pulmonary regurgitation. Almost all patients were in New York Heart Association class I or II. More severely impaired baseline spirometry was associated with a lower likelihood of improvement in exercise function after TPV replacement.
CONCLUSIONS
TPV replacement with the Melody valve provided good hemodynamic and clinical outcomes up to 7 years after implantation. Primary valve failure was rare. The main cause of TPV dysfunction was stenosis related to stent fracture, which was uncommon once prestenting became more widely adopted.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870.
背景
经导管肺动脉瓣（TPV）置换术的研究使用 Melody 瓣膜已显示出良好的短期结果，但尚无长期随访数据。
方法和结果
美国研究性器械豁免试验前瞻性纳入了 171 例患有右心室流出道导管梗阻或反流的儿科和成年患者（中位年龄 19 岁）。148 例接受并出院时带有 TPV 的患者按照标准化方案每年进行随访。在中位随访 4.5 年（范围 0.4-7 年）期间，32 例患者因梗阻（27 例，其中 22 例为支架断裂）、心内膜炎（3 例，2 例狭窄，1 例肺动脉瓣反流）或右心室功能障碍而进行了右心室流出道再次干预。11 例患者将 TPV 作为初始或第二次再干预进行了置换。5 年无再干预和无 TPV 置换的生存率分别为 76±4%和 92±3%。支架前预扩张和较低的出院右心室流出道梯度与较长的无再干预时间相关。在 113 例存活且无再干预的患者中，随访梯度（植入后中位时间 4.5 年）与 TPV 置换后早期相比无变化，除 1 例患者外，所有患者均为轻度或更轻的肺动脉瓣反流。几乎所有患者都处于纽约心脏协会心功能分级 I 或 II 级。基线肺功能检查受损更严重与 TPV 置换后运动功能改善的可能性降低相关。
结论
使用 Melody 瓣膜进行 TPV 置换术在植入后 7 年内提供了良好的血液动力学和临床结果。原发性瓣膜失功罕见。TPV 功能障碍的主要原因是与支架断裂相关的狭窄，一旦支架前预扩张术得到更广泛的应用，这种情况就不常见了。
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