Magnetic Mini-Mover Procedure for pectus excavatum IV: FDA sponsored multicenter trial.

Abstract

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.

• Authors: Claire E Graves, Shinjiro Hirose, Gary W Raff, Corey W Iqbal, Jill Imamura-Ching, Darrell Christensen, Richard Fechter, Dillon Kwiat, Michael R Harrison
• Journal: Journal of pediatric surgery (J Pediatr Surg) Vol. 52 Issue 6 Pg. 913-919 (Jun 2017) ISSN: 1531-5037 [Electronic] United States
• PMID: 28342579 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: Copyright © 2017 Elsevier Inc. All rights reserved.

Topics

• Adolescent
• Braces
• Child
• Female
• Follow-Up Studies
• Funnel Chest (therapy)
• Humans
• Magnets
• Male
• Orthopedic Procedures (instrumentation, methods)
• Treatment Outcome