漏斗胸畸形IV的磁性微型移动器手术：美国食品药品监督管理局资助的多中心试验。
Magnetic Mini-Mover Procedure for pectus excavatum IV: FDA sponsored multicenter trial.
作者信息
Graves Claire E, Hirose Shinjiro, Raff Gary W, Iqbal Corey W, Imamura-Ching Jill, Christensen Darrell, Fechter Richard, Kwiat Dillon, Harrison Michael R
机构信息
Division of Pediatric Surgery, UCSF Benioff Children's Hospital, 550 16th Street, 5th Floor, Box 0570, San Francisco, CA 94143, United States.
Davis Health System, Department of Surgery, University of California, 2315 Stockton Blvd., OP512, Sacramento, CA 95817, United States; Department of Surgery, Shriners Hospital for Children-Northern California, 2425 Stockton Blvd., Sacramento, CA 95817, United States.
出版信息
J Pediatr Surg. 2017 Jun;52(6):913-919. doi: 10.1016/j.jpedsurg.2017.03.009. Epub 2017 Mar 15.
PURPOSE
The Magnetic Mini-Mover Procedure (3MP) is a minimally invasive treatment for prepubertal patients with pectus excavatum. This multicenter trial sought to supplement safety and efficacy data from an earlier pilot trial.
METHODS
Fifteen patients with pectus excavatum had a titanium-enclosed magnet implanted on the sternum. Externally, patients wore a custom-fitted magnetic brace. Patients were monitored closely for safety. Efficacy was determined by the Haller Index (HI) and satisfaction surveys. After 2 years, the implant was removed.
RESULTS
Mean patient age was 12 years (range 8-14), and mean pretreatment HI was 4.7 (range 3.6-7.4). The device was successfully implanted in all patients. Mean treatment duration was 25 months (range 18-33). Posttreatment chest imaging in 13 patients indicated that HI decreased in 5, remained stable in 2, and increased in 6. Seven out of 15 patients had breakage of the implant's titanium cables because of fatigue fracture. Eight out of 13 patients were satisfied with their chest after treatment.
CONCLUSION
The 3MP is a safe, minimally invasive, outpatient treatment for prepubertal patients with pectus excavatum. However, the magnetic implant design led to frequent device breakage, confounding analysis. The HI indicated mixed efficacy, although surveys indicated most patients perceived a benefit.
STUDY TYPE/LEVEL OF EVIDENCE: Case series, treatment study. Level IV.
目的
磁性微型移动器手术（3MP）是一种针对青春期前漏斗胸患者的微创治疗方法。这项多中心试验旨在补充早期试点试验的安全性和有效性数据。
方法
15名漏斗胸患者在胸骨上植入了钛包裹的磁体。在体外，患者佩戴定制的磁性支架。密切监测患者的安全性。通过哈勒指数（HI）和满意度调查来确定疗效。2年后，取出植入物。
结果
患者平均年龄为12岁（范围8 - 14岁），治疗前平均HI为4.7（范围3.6 - 7.4）。该装置在所有患者中均成功植入。平均治疗持续时间为25个月（范围18 - 33个月）。13名患者的治疗后胸部成像显示，HI下降的有5例，保持稳定的有2例，上升的有6例。15名患者中有7例因疲劳骨折导致植入物的钛缆断裂。13名患者中有8名对治疗后的胸部情况感到满意。
结论
3MP是一种针对青春期前漏斗胸患者的安全、微创的门诊治疗方法。然而，磁性植入物的设计导致装置频繁断裂，干扰了分析。HI显示出混合疗效，尽管调查表明大多数患者认为有获益。
研究类型/证据水平：病例系列，治疗研究。IV级。
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