Table 2 Clinical evidence of utility the SPY system, by application
Authors | Study design | Applications studied | Key points |
|---|---|---|---|
Free flaps | |||
Pestana et al., 2009 [5] | Case series | Multiple indications: head and neck, breast, lower extremity | 1 partial flap loss |
N = 27 patients, 29 free tissue transfers | |||
Breast recon-struction | |||
Phillips et al., 2012 [12] | Prospective study comparing ICG to fluorescein and clinical judgment | Tissue expander-implant breast reconstruction | ICG and fluorescein had sensitivity of 90% and specificity of 50% and 30%, respectively; negative predictive value for ICG and fluorescein was 88% and 82%, respectively. |
N = 32 patients, 51 breasts | |||
Newman et al., 2011 [6] | Case series | Breast reconstruction: single-pedicle TRAM | ICG perfusion assessment identified perfusion zones; no issues with wound healing or tissue or fat necrosis. |
N = 20 | |||
Komorowska-Timek and Gurtner, 2010 [1] | Case series | Breast reconstruction: tissue expander, latissimus dorsi flaps, DIEP/SIEA | Tissue expander (n = 16), latissimus dorsi (n = 2), DIEP/SIEA (n = 6); complication rate: 4% with ICG vs. 15.1% in 206 previous reconstructions (n = 148; p < 0.01) |
N = 20 patients, 24 breasts | |||
Tamburrino et al., 2010 [17] | Retrospective analysis | Breast reconstruction: tissue expander or unilateral TRAM | 95% correlation between ICG imaging and clinical outcome, 100% sensitivity and 91% specificity. |
Tissue expander (n = 11 patients, 19 breasts) | |||
Unilateral TRAM (n = 1) | |||
Francisco et al., 2010 [52] | Case series N = 5 | Breast reconstruction: DIEP | No flap loss, fat necrosis, or take-backs |
Jones et al., 2009 [14] | Case series | Breast reconstruction: free and pedicle TRAM, DIEP, latissimus dorsi, and expander insertions. | Of 5 patients with poor flap perfusion on ICG imaging, 4 developed necrosis and 1 blistering in a pattern predicted by ICG; necrosis rate of 6.3% vs. published rates of 15-25%. |
N = 43 patients, 64 breasts | |||
Newman & Samson, 2009 [11] | Case series | Breast reconstruction: DIEP or free TRAM | ICG detected marginal or poor perfusion in 4 cases; 3 were revised intraoperatively and the 1 that was not revised required return to OR for venous congestion. Flap survival was 100%. |
N = 8 patients, 10 breasts | |||
NAC evaluation | |||
Murray et al., 2010 [16] | Case series | Breast reduction surgery | ICG used to demonstrate NAC perfusion and venous outflow during surgery. |
|  | N = 12 patients, 22 breasts |  |  |