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Plast Reconstr Surg. 2010 Nov;126(5):1472-81. doi: 10.1097/PRS.0b013e3181f059c7.

The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in perforator flap breast reconstruction.

Author information

1
Division of Plastic and Reconstructive Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.

Abstract

BACKGROUND:

The ability to determine flap perfusion in reconstructive surgery is still primarily based on clinical examination. In this study, the authors demonstrate the use of an intraoperative, near-infrared fluorescence imaging system for evaluation of perforator location and flap perfusion.

METHODS:

Indocyanine green was injected intravenously in six breast cancer patients undergoing a deep inferior epigastric perforator flap breast reconstruction after mastectomy. Three dose levels of indocyanine green were assessed using the fluorescence-assisted resection and exploration (FLARE) imaging system. This system uses light-emitting diodes for fluorescence excitation, which is different from current commercially available systems. In this pilot study, the operating surgeons were blinded to the imaging results.

RESULTS:

Use of the FLARE system was successful in all six study subjects, with no complications or sequelae. Among the three dose levels, 4 mg per injection resulted in the highest observed contrast-to-background ratio, signal-to-background ratio, and signal-to-noise ratio. However, because of small sample size, the authors did not have sufficient power to detect statistical significance for these pairwise comparisons at the multiple-comparison adjusted type I error of 0.017. Six milligrams per injection provided a similar contrast-to-background ratio but also a higher residual background signal.

CONCLUSION:

Based on this pilot study, the authors conclude that near-infrared assessment of perforator flap breast reconstruction is feasible with a light-emitting diode-based system, and that a dose of 4 mg of indocyanine green per injection yields the best observed contrast-to-background ratio compared with a dose of 2 or 6 mg for assessment of flap perfusion.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00952107.

PMID:
21042103
PMCID:
PMC2974179
DOI:
10.1097/PRS.0b013e3181f059c7
[Indexed for MEDLINE]
Free PMC Article
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