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Learn more about 
fluorescence imaging
What is fluorescence imaging? Near-infrared (NIR) Fluorescence Imaging is an imaging technique that uses near-infrared light to excite an optical imaging agent that emits a light which is detected and visualized by a digital camera in real-time. It is used by scientists to study tissue perfusion, anatomical features, internal organs, and lymphatic vasculatures; as well as by clinicians to visualize tumor perfusion and assist surgical procedures.
Stryker's fluorescence imaging systems

SPY-PHI
SPY Portable Handheld Imaging System

Indications for use

The SPY Portable Handheld Imaging System (SPY-PHI System) is an active device used to visualize circulation, including lymphatics and blood vessels, as well as related tissue perfusion with near infrared fluorescence imaging during a variety of surgical procedures.

 

1688 AIM
4K Camera System

Indications for use

The 1688 Advanced Imaging Modalities (AIM) 4K platform enables surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels and microvessels, blood flow and related tissue and organ perfusion, lymphatics, perfusion associated with tumors and tumor margins, and at least one of the extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) using near-infrared imaging.

Is fluorescence guided surgery as effective as other tracers in sentinel lymph node (SLN) detection in breast cancer patients?

Fluorescence guided SLN biopsy in breast cancer patients is not inferior to the RI+BD technique or to RI alone.

  • Ballardini et al. (2013) included n = 134 woman in a prospective study and assessed concordance between the ICG method and the 99mTc method. Authors concluded that the ICG method is not inferior to that of RI and can be used alone to reliably identify SLNs.
  • In a prospective study, Samorani et al. (2015) aimed to validate the ICG method of detecting SLN in breast cancer patients. Authors enrolled n = 301 patients who underwent SLN detection using both the 99mTc – and the ICG method. 99% of the nodes were identified with ICG, and 76.7 % were identified with 99mTc.
  • Somashekbar et al. (2020) conducted a prospective, comparative study to assess the detection and accuracy of SLN detection with ICG in comparison to the dual-dye technique (RI+BD). SLN detection was performed in n   = 100 patients, the identification rate with the dual dye technique was 94%, whereas with ICG alone, it was 96%.
  • In a meta-analysis, Kedrzycki et al. (2021) demonstrated the ICG is equivalent to RI in node identification. This finding was based on n = 944 patients out of 10 studies.

Fluorescence guided SLN biopsy in breast cancer patients is not inferior to the RI+BD technique or to RI alone.

  • Ballardiniet al. (2013) included n = 134 woman in a prospective study and assessed concordance between the ICG method and the 99mTc method. Authors concluded that the ICG method is not inferior to that of RI and can be used alone to reliably identify SLNs.
  • In a prospective study, Samoraniet al. (2015) aimed to validate the ICG method of detecting SLN in breast cancer patients. Authors enrolled n = 301 patients who underwent SLN detection using both the 99mTc –and the ICG method. 99% of the nodes were identified with ICG, and 76.7 % were identified with 99mTc.
  • Somashekbaret al. (2020) conducted a prospective, comparative study to assess the detection and accuracy of SLN detection with ICG in comparison to the dual-dye technique (RI+BD). SLN detection was performed in n = 100 patients, the identification rate with the dual dye technique was 94%, whereas with ICG alone, it was 96%.
  • In a meta-analysis, Kedrzyckiet al. (2021) demonstrated the ICG is equivalent to RI in node identification. This finding was based on n = 944 patients out of 10 studies.

Note - 1688 AIM is not indicated for lymphatic mapping in breast surgery

Is fluorescence guided surgery as effective as other tracers in sentinel lymph node detection in cervical cancer patients?

ICG FA has a higher SLN bilateral detection rates than 99mTc + BD.

  • Beaten et al. (2021) included a meta-analysis on 589 patients out of 7 studies and concluded that ICG appears to result in higher bilateral SLN detection compared to the combination of 99mTc + BD.
  • Buda et al. (2016) included 114 women with cervical cancer into a retrospective study, comparing SLN detection rates of ICG vs RI+BD. Bilateral mapping was achieved in 98.5% for ICG and 76.3% for 99mTc + BD. 
  • Buda et al. (2018) performed another retrospective study and included 65 women with early-stage cervical cancer. The authors compared bilateral SLN detection rates of ICG vs 99mTc + BD (95.2% vs 69.6%).
  • Di Martino et al. (2017) conducted a retrospective multi-center study and assessed 95 women with stage IB1 cervical cancer. 47 patients underwent SLN mapping with 99mTc +/-BD and 48 with ICG. A 91.7% bilateral SLN detection rate was achieved with ICG, compared to 66% obtained with 99mTc.

Is fluorescence guided surgery a useful tool to reduce post-operative complications after colorectal cancer surgery?

ICG-FA can reduce the risk for anastomotic leaks after colorectal cancer surgery.

  • Alekseev et al. (2020) demonstrated in a single-center RCT (n=380 pts) a significant reduction of AL rates in LAR from 25.7% in the non-ICG-FA group to 14.4% in the ICG-FA group.
  • In a retrospective comparative study, Ishii et al. (2020) found that the AL rate was significantly lower in the ICG group (1.8%) compared to the non-ICG group (5.3%) for rectal cancer patients.
  • Kim et al. (2016) performed a cohort study of 436 rectal cancer patients, demonstrating a significant reduction of AL in the ICG group (0.8 % vs 5.4%).
  • In a series of 50 patients, Skrovinaet al. (2020) found a significant reduction of AL in the ICG-FA group (10%) when compared to a historical control without ICG-FA (18%).
  • Wada et al (2019) performed a retrospective PSM study of 149 patients and detected a reduction in symptomatic AL rate from 14.7% (no ICG) to 8.8% (ICG-FA)
  • In a retrospective study, Mizrahi et al. (2018) compared AL rates of patients who underwent LAR and observed a reduction of AL rate from 6.7% (no-ICG group) to 0% (ICG-FA group).
  • Wanatabeet al. (2019) found a significantly reduced AL rate in a retrospective PSM cohort study (OR 0.427, CI 0.197 –0.926)

ICG-FA can reduce the risk for re-operation after rectal cancer surgery.

  • Wanatabe et al. (2019) performed a multi-center, retrospective PSM study and found a significantly lower rate of re-operations in the ICG-FA group (OR 0.19, CI 0.042 – 0.889). 
  • In a retrospective case-control analysis, Jafari et al (2013) found a reduction of the re-operation rate from 9% to 6% for non-ICG and ICG, respectively. 

ICG-FA can reduce length of hospital stay.

  • In a retrospective PSM study, Wanatabe et al. (2019) found a significantly shorter post-operative hospital stay in the ICG-FA group: x (mean) = 2.62 days, (CI 0.96 – 4.28). 

ICG-FA can reduce operative time.

  • In a retrospective study of n=657 rectal cancer patients Kim et al. (2017) found significant difference in OR time from between ICG-FA (177 ± 43 min) and no-ICG-FA group (197 ± 47 min)

Stryker´s fluorescence imaging system requires the imaging agent Indocyanine Green (ICG). Indocyanine green (ICG) is a drug and is not provided by Stryker but is independently sourced by the customer. The approval status of the drug may vary. Customers shall determine the status applicable at their hospital in their country and consult the manufacturer’s instructions of the drug for specifications and use.

SPY Moments

Associate Prof. Dr. med. Mustafa Muallem
Germany

Deputy Director of the Department of Gynecology with Center for Oncological Surgery, Charité Medical University of Berlin

Mr. John Butler
United Kingdom

Consultant Gynaecologist and Gynaecological Oncology Surgeon
Royal Marsden Hospital

Professor Dawid Murawa
Poland

Surgical Oncology Specialist
Head of the Oncological Surgery Clinic, Zielona Góra University Hospital

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