Bonnet Damien, Corno Antonio F, Sidi Daniel, Sekarski Nicole, Beghetti Maurice, Schulze-Neick Ingram, Fasnacht Margrit, Le Bret Emmanuel, Kalangos Afksendyios, Vouhé Pascal R, von Segesser Ludwig K
Pediatric Cardiology, Hôpital Necker Enfants Malades, Paris, France, EU.
Circulation. 2004 Sep 14;110(11 Suppl 1):II158-63. doi: 10.1161/01.CIR.0000138222.43197.1e.
Adjustment of pulmonary artery banding (PAB) may be a challenging procedure in complex congenital heart defects. Whatever the technique used, subsequent re-operations are frequently needed to control the pulmonary blood flow or pressures.
To report the efficacy of a new telemetric adjustable PAB (FloWatch-PAB) operated with the help of an external control unit that transmits to the implant energy and commands to further narrow or release the pulmonary artery using radiofrequency waves.
In a multicenter, prospective, nonrandomized, single-arm clinical investigation, 13 children (median age, 4.5 months; range, 6 days to 11 years; median weight, 4.2 kg; range, 3.1 to 27 kg) underwent implantation of the FloWatch-PAB through median sternotomy in 8 and left thoracotomy in 5. The diagnosis was multiple ventricular septal (VSD) defects with complex anatomy in 3, single ventricle without pulmonary stenosis in 2, VSD with elevated pulmonary vascular resistance (PVR) in 2, atrio-ventricular canal (AVC) with elevated pulmonary vascular resistance in 1, AVC with diminutive right ventricle in 1, complex transposition of the great arteries in 3, and pulmonary atresia with complex pulmonary arteries anatomy in 1. All patients had normosystemic systolic pulmonary artery pressure. Additional procedures were performed in 7: atrial septectomy in 2, double aortic arch division in 1, patent ductus arteriosus ligation in 2, and coarctation repair in 2. There were no early or late deaths or device-related complications in a mean follow-up of 24 weeks (range, 18 to 42 weeks). A mean of 5.8 telemetric regulations per patient using the FloWatch-PAB were required to adjust the tightening of the PAB to the clinical needs (narrowing 74%, releasing 26%). At last follow-up, systolic pulmonary artery pressure was within normal range in all patients but 1. Systemic oxygen saturation demonstrated optimal regulation of the pulmonary blood flow in all according to each specific defect. Four patients were successfully corrected (VSD closure, AVSD repair, and 2 arterial switches with VSD closure). The device was easily removed and the pulmonary artery re-expanded spontaneously.
This new device is safe and allows optimal adjustment of PAB in complex heart defects. In children requiring PAB, the use of this technology can obviate the need for early re-operations and appears to be a valuable option in the panel of surgical alternatives for selected infants.
在复杂先天性心脏病中，调整肺动脉环扎术（PAB）可能是一项具有挑战性的操作。无论采用何种技术，后续通常都需要再次手术来控制肺血流量或压力。
报告一种新型遥测可调式PAB（FloWatch-PAB）的疗效，该装置借助外部控制单元进行操作，通过射频波传输植入能量并发出指令，以进一步缩窄或松开肺动脉。
在一项多中心、前瞻性、非随机、单臂临床研究中，13名儿童（年龄中位数为4.5个月；范围为6天至11岁；体重中位数为4.2 kg；范围为3.1至27 kg）接受了FloWatch-PAB植入术，其中8例通过正中胸骨切开术，5例通过左胸切开术。诊断包括3例解剖结构复杂的多发性室间隔缺损（VSD）、2例无肺动脉狭窄的单心室、2例伴有肺血管阻力（PVR）升高的VSD、1例伴有肺血管阻力升高的房室通道（AVC）、1例右心室较小的AVC、3例大动脉复杂转位以及1例伴有复杂肺动脉解剖结构的肺动脉闭锁。所有患者的体循环收缩期肺动脉压均正常。7例患者还接受了其他手术：2例进行了房间隔切除术、1例进行了双主动脉弓离断术、2例进行了动脉导管未闭结扎术、2例进行了缩窄修复术。平均随访24周（范围为18至42周），未发生早期或晚期死亡或与装置相关的并发症。每位患者平均使用FloWatch-PAB进行5.8次遥测调节，以根据临床需要调整PAB的收紧程度（缩窄74%，松开26%）。在最后一次随访时，除1例患者外，所有患者的收缩期肺动脉压均在正常范围内。根据每个特定缺陷，全身氧饱和度显示所有患者的肺血流量均得到了最佳调节。4例患者成功得到矫正（VSD闭合、房室间隔缺损修复以及2例进行动脉调转术并闭合VSD）。该装置易于取出，肺动脉可自发再扩张。
这种新型装置安全可靠，能够在复杂心脏缺陷中实现PAB的最佳调整。对于需要PAB的儿童，使用该技术可避免早期再次手术，在选定婴儿的一系列手术选择中似乎是一个有价值的选择。
