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


CONCLUSIONS
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.
Boston, Mass.; and Leiden, The Netherlands From the Division of Plastic and Reconstructive Surgery, Department of Surgery, the Divisions of General Medicine and Primary Care and Hematology/Oncology, Department of Medicine, and the Department of Radiology, Beth Israel Deaconess Medical Center, Harvard Medical School, and the Department of Surgery, Leiden University Medical Center.
Bernard T
BT
Lee
Merlijn
M
Hutteman
Sylvain
S
Gioux
Alan
A
Stockdale
Samuel J
SJ
Lin
Long H
LH
Ngo
John V
JV
Frangioni
D000328:Adult; D004396:Coloring Agents; D005260:Female; D005470:Fluorometry; D006801:Humans; D007208:Indocyanine Green; D007259:Infrared Rays; D007432:Intraoperative Period; D016462:Mammaplasty; D008408:Mastectomy; D008875:Middle Aged; D013524:Surgical Flaps / Q000098:blood supply*
D004396:Coloring Agents; D007208:Indocyanine Green