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

Claire E. Graves, Shinjiro Hirose, Gary W Raff, Corey W. Iqbal, Jill Imamura-Ching, Darrell Christensen, Richard Fechter, Dillon Kwiat, Michael R. Harrison

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
JournalJournal of Pediatric Surgery
DOIs
StateAccepted/In press - Feb 22 2017

Fingerprint

Funnel Chest
Multicenter Studies
Titanium
Thorax
Therapeutics
Safety
Equipment and Supplies
Braces
Stress Fractures
Sternum
Magnets
Outpatients

Keywords

  • Brace
  • Chest wall
  • Funnel chest
  • Haller index
  • Magnet
  • Sternum

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Surgery

Cite this

Magnetic Mini-Mover Procedure for pectus excavatum IV : FDA sponsored multicenter trial. / Graves, Claire E.; Hirose, Shinjiro; Raff, Gary W; Iqbal, Corey W.; Imamura-Ching, Jill; Christensen, Darrell; Fechter, Richard; Kwiat, Dillon; Harrison, Michael R.

In: Journal of Pediatric Surgery, 22.02.2017.

Research output: Contribution to journalArticle

Graves, Claire E. ; Hirose, Shinjiro ; Raff, Gary W ; Iqbal, Corey W. ; Imamura-Ching, Jill ; Christensen, Darrell ; Fechter, Richard ; Kwiat, Dillon ; Harrison, Michael R. / Magnetic Mini-Mover Procedure for pectus excavatum IV : FDA sponsored multicenter trial. In: Journal of Pediatric Surgery. 2017.
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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.",
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