Division of Pediatric Surgery, University of California, San Francisco, CA 94143-0570, USA.
J Pediatr Surg. 2010 Jan;45(1):185-91; discussion 191-2. doi: 10.1016/j.jpedsurg.2009.10.032.
The Magnetic Mini-Mover Procedure (3MP) uses a magnetic implant coupled with an external magnet to generate force sufficient to gradually remodel pectus excavatum deformities. This is an interim report of the evolution of the 3MP during a Food and Drug Administration-approved clinical trial.
After obtaining Institutional Review Board approval, we performed the 3MP on 10 otherwise healthy patients with moderate to severe pectus excavatum deformities (age, 8-14 years; Haller index >3.5). Operative techniques evolved to improve ease of implantation. Patients were evaluated monthly by a pediatric surgeon and orthotist. Electrocardiograms were performed pre- and postoperatively. Sternal position was documented by pre- and postprocedure computed tomographic scan, interval chest x-ray, depth gauge, and interval photographs.
There was no detectable effect of the static magnetic field on wound healing or cardiopulmonary function. No detectable injuries and minimal skin changes resulted from brace wear. Operative techniques evolved to include a custom sternal punch and a flexible guide wire to guide the posterior plate into position behind the sternum, reducing outpatient operating time to one-half hour. In 9 patients, the procedure was performed as an outpatient basis; and 1 patient was observed overnight. Three patients required evacuation of retained pleural air postoperatively, and 2 required an outpatient revision. A custom-fitted orthotic brace (Magnatract) was extensively modified to increase user friendliness and functionality while incorporating several novel functions: a screw displacement mechanism so patients can easily self-adjust magnetic force, a miniature data logger to measure force and temperature data every 10 minutes, and an interactive online Web portal for remote patient evaluation. All attempts to quantitate sternal position (radiographic, fluid volume, and depth gauge) were inadequate. Visual assessment remains the best indicator.
In this interim report, the 3MP appears to be a safe, minimally invasive, outpatient, cost-effective alternative treatment of pectus excavatum. Outcomes will be reported upon the completion of this phase II clinical trial.
磁微型移动术（3MP）使用带有外部磁铁的磁性植入物来产生足以逐渐重塑漏斗胸畸形的力。这是在食品和药物管理局批准的临床试验中 3MP 演变的中期报告。
在获得机构审查委员会批准后，我们对 10 名其他健康的中重度漏斗胸畸形患者（年龄 8-14 岁；Haller 指数>3.5）进行了 3MP 手术。手术技术不断发展，以提高植入的便利性。每月由儿科外科医生和矫形师对患者进行评估。在术前和术后进行心电图检查。胸骨位置通过术前和术后计算机断层扫描、间隔胸部 X 光、深度计和间隔照片记录。
静磁场对伤口愈合或心肺功能没有可检测到的影响。由于佩戴支具，没有可检测到的损伤和最小的皮肤变化。手术技术不断发展，包括定制胸骨冲头和柔性引导线，以将后板引导到胸骨后面，将门诊手术时间缩短至半小时。在 9 名患者中，该手术在门诊基础上进行；1 名患者观察过夜。3 名患者术后需要清除胸腔残留空气，2 名患者需要门诊修正。定制矫形支具（Magnatract）经过广泛修改，以提高用户友好性和功能性，同时增加了几个新功能：螺钉位移机构，使患者可以轻松地自行调整磁力，微型数据记录器，每 10 分钟测量一次力和温度数据，以及用于远程患者评估的交互式在线网络门户。所有试图定量胸骨位置（放射照相、液体体积和深度计）的尝试都不充分。视觉评估仍然是最佳指标。
在本中期报告中，3MP 似乎是一种安全、微创、门诊、具有成本效益的漏斗胸替代治疗方法。在完成该 II 期临床试验后，将报告结果。
