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 language | English (US) |
|---|---|
| Journal | Journal of Pediatric Surgery |
| DOIs | |
| State | Accepted/In press - Feb 22 2017 |
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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 journal › Article
}
TY - JOUR
T1 - Magnetic Mini-Mover Procedure for pectus excavatum IV
T2 - FDA sponsored multicenter trial
AU - Graves, Claire E.
AU - Hirose, Shinjiro
AU - Raff, Gary W
AU - Iqbal, Corey W.
AU - Imamura-Ching, Jill
AU - Christensen, Darrell
AU - Fechter, Richard
AU - Kwiat, Dillon
AU - Harrison, Michael R.
PY - 2017/2/22
Y1 - 2017/2/22
N2 - 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.
AB - 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.
KW - Brace
KW - Chest wall
KW - Funnel chest
KW - Haller index
KW - Magnet
KW - Sternum
UR - http://www.scopus.com/inward/record.url?scp=85015854691&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85015854691&partnerID=8YFLogxK
U2 - 10.1016/j.jpedsurg.2017.03.009
DO - 10.1016/j.jpedsurg.2017.03.009
M3 - Article
C2 - 28342579
AN - SCOPUS:85015854691
JO - Journal of Pediatric Surgery
JF - Journal of Pediatric Surgery
SN - 0022-3468
ER -