From the Division of Cardiology, Miami Children's Hospital, FL (D.P.B., E.M.Z.); Department of Cardiology, Children's Hospital Boston, MA (D.B.M.); Departments of Pediatrics, Medicine, and Cardiothoracic Surgery, New York University, NY (D.B.M.); Division of Cardiology, Morgan Stanley Children's Hospital, New York, NY (J.A.V., W.E.H.); Division of Pediatric Cardiology, Yale University, New Haven, CT (W.E.H.); and Congenital Heart Program, Cedars-Sinai Medical Center, Los Angeles, CA (E.M.Z.).
Circ Cardiovasc Interv. 2014 Apr;7(2):142-8. doi: 10.1161/CIRCINTERVENTIONS.113.000881. Epub 2014 Feb 25.
In 2010, the Melody transcatheter pulmonary valve (TPV) received Food and Drug Administration approval for treatment of dysfunctional right ventricular outflow tract conduits in patients ≥30 kg. Limited data are available regarding use of this device in smaller patients.
We evaluated technical and short-term clinical outcomes of 25 patients <30 kg (10 patients <20 kg) who underwent TPV replacement for treatment of conduit dysfunction at 3 centers. Median age and weight were 8.0 years (3.4-14.4) and 21.4 kg (13.8-29.0). The median conduit diameter at the time of surgical implant was 17 mm (12-23). Two patients did not undergo TPV implant (risk of coronary compression in 1; inability to advance the delivery sheath beyond the common femoral vein in 1). After successful TPV implant, the peak conduit gradient fell from 29±16 to 9±6 mm Hg (P<0.001), and all but 2 patients had no/trivial regurgitation (down from moderate or severe preimplant in 20). TPV implant was via the femoral vein in 17 patients, the right internal jugular vein in 4, and the left subclavian vein in 2 patients. At a median follow-up of 16 months, 1 patient underwent conduit replacement for recurrent conduit stenosis, 2 developed stent fracture requiring a second TPV, and 2 developed bacterial endocarditis treated with antibiotics, 1 of whom then underwent conduit replacement. The average Melody valve mean Doppler gradient and conduit regurgitation were unchanged from early postimplant.
Percutaneous TPV replacement can be performed in small children with good procedural and early hemodynamic results in the majority of patients.
2010 年，Melody 经导管肺动脉瓣（TPV）获得美国食品和药物管理局批准，用于治疗体重≥30kg 的患者功能性右心室流出道（RVOT）导管功能障碍。目前，关于该设备在较小患者中的应用数据有限。
我们评估了 3 个中心的 25 名体重<30kg（10 名体重<20kg）患者接受 TPV 置换术治疗导管功能障碍的技术和短期临床结果。患者的中位年龄和体重分别为 8.0 岁（3.4-14.4）和 21.4kg（13.8-29.0）。手术植入时的中位导管直径为 17mm（12-23）。2 名患者未进行 TPV 植入（1 例存在冠状动脉受压风险；1 例无法将输送鞘管推进至股总静脉以外）。成功植入 TPV 后，峰值导管梯度从 29±16mmHg 降至 9±6mmHg（P<0.001），除 2 例患者外，所有患者均无/轻度反流（20 例患者为中度或重度反流）。17 例患者经股静脉、4 例经右颈内静脉、2 例经左锁骨下静脉植入 TPV。中位随访 16 个月，1 例患者因导管再狭窄行导管置换，2 例患者因支架断裂需行第二次 TPV，2 例患者发生细菌性心内膜炎，经抗生素治疗，其中 1 例患者随后行导管置换。大多数患者的经皮 TPV 置换术可在小患儿中安全进行，操作过程和早期血流动力学结果良好。
在大多数患者中，经皮 TPV 置换术可在小患儿中安全进行，大多数患者的操作过程和早期血流动力学结果良好。
