Corno Antonio F, Bonnet Damien, Sekarski Nicole, Sidi Daniel, Vouhé Pascal, von Segesser Ludwig K
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
J Thorac Cardiovasc Surg. 2003 Dec;126(6):1775-80. doi: 10.1016/j.jtcvs.2003.06.011.
After positive experimental results were obtained with the FloWatch-R-PAB (EndoArt S.A., Lausanne, Switzerland), an implantable device for pulmonary artery banding with telemetric control, it was tested in a prospective, multicenter clinical trial.
From June to September 2002, 6 patients with a mean age of 10.6 months (1-31 months) and a mean weight of 6.5 kg (3.5-11 kg) underwent pulmonary artery banding with the implantation of the FloWatch-R-PAB device through median sternotomy (4 patients) or left thoracotomy (2 patients). The diagnoses were the following: univentricular heart (2 patients), complete atrioventricular septal defect (2 patients), ventricular septal defect (1 patient), and multiple ventricular septal defects with double aortic arch (1 patient). The associated procedures were atrioseptostomy with cardiopulmonary bypass (2 patients), closure of patent ductus arteriosus (2 patients), and division of double aortic arch (1 patient).
In a mean follow-up of 7 months (6-9 months), there were no early or late deaths, reoperations, or device-related complications. A mean of 5 regulations per patient (range 2-14) were required to adjust the tightening of the pulmonary artery banding, 50% (15/30) within the first postoperative week, 20% (6/30) during the second week, and 30% (9/30) within 8 months after surgery. In 70% (21/30) of the cases, the regulation was required to further narrow the pulmonary artery, and in 30% (9/30) of the cases, the regulation was required to release the pulmonary artery.
The initial trial confirmed the adequate functioning of the FloWatch-R-PAB device as telemetrically adjustable pulmonary artery banding. Repeated pulmonary artery banding adjustments, dictated by the clinical need in all patients even weeks after surgery, were accomplished without need for reoperation or invasive procedures. In children requiring pulmonary artery banding, the therapeutic strategies can be expanded by this promising technology. This device should be particularly indicated in patients with transposition of the great arteries requiring left ventricular retraining.
在使用FloWatch-R-PAB（瑞士洛桑的EndoArt S.A.公司生产）获得阳性实验结果后，这种带有遥测控制功能的可植入式肺动脉环扎装置在一项前瞻性多中心临床试验中进行了测试。
2002年6月至9月，6例平均年龄10.6个月（1 - 31个月）、平均体重6.5千克（3.5 - 11千克）的患者通过正中胸骨切开术（4例）或左胸切开术（2例）进行了肺动脉环扎并植入FloWatch-R-PAB装置。诊断情况如下：单心室心脏（2例）、完全性房室间隔缺损（2例）、室间隔缺损（1例）以及伴有双主动脉弓的多发性室间隔缺损（1例）。相关手术包括体外循环下房间隔造口术（2例）、动脉导管未闭闭合术（2例）以及双主动脉弓离断术（1例）。
平均随访7个月（6 - 9个月），无早期或晚期死亡、再次手术或与装置相关的并发症。每位患者平均需要进行5次（范围2 - 14次）调节以调整肺动脉环扎的收紧程度，其中50%（15/30）在术后第一周内进行，20%（6/30）在第二周进行，30%（9/30）在术后8个月内进行。70%（21/30）的病例需要调节以进一步缩窄肺动脉，30%（9/30）的病例需要调节以放松肺动脉。
初步试验证实了FloWatch-R-PAB装置作为可遥测调节的肺动脉环扎装置功能良好。根据所有患者术后数周的临床需求进行的反复肺动脉环扎调节无需再次手术或侵入性操作即可完成。在需要肺动脉环扎的儿童中，这项有前景的技术可扩展治疗策略。该装置尤其适用于需要左心室重塑的大动脉转位患者。
