State of the art medical devices for fluorescence-guided surgery (FGS): technical review and future developments.

BACKGROUND: Medical devices for fluorescence-guided surgery (FGS) are becoming available at a fast pace. The main challenge for surgeons lies in the lack of in-depth knowledge of optical imaging, different technical specifications and poor standardisation, and the selection of the best device based on clinical application. METHODS: This manuscript aims to provide an up-to-date description of the commercially available fluorescence imaging platforms by comparing their mode of use, required settings, image types, compatible fluorophores, regulatory approval, and cost. We obtained this information by performing a broad literature search on PubMed and by contacting medical companies directly. The data for this review were collected up to November 2023. RESULTS: Thirty-two devices made by 19 medical companies were identified. Ten systems are surgical microscopes, 5 can be used for both open and minimally invasive surgery (MIS), 6 can only be used for open surgery, and 10 only for MIS. One is a fluorescence system available for the Da Vinci robot. Nineteen devices can provide an overlay between fluorescence and white light image. All devices are compatible with Indocyanine Green, the most common fluorescence dye used intraoperatively. There is significant variability in the hardware and software of each device, which resulted in different sensitivity, fluorescence intensity, and image quality. All devices are CE-mark regulated, and 30 were FDA-approved. CONCLUSION: There is a prolific market of devices for FGS and healthcare professionals should have basic knowledge of their technical specifications to use it at best for each clinical indication. Standardisation across devices must be a priority in the field of FGS, and it will enhance external validity for future clinical trials in the field.

Evaluating the Development Status of Fluorescence-Guided Surgery (FGS) in Pediatric Surgery Using the Idea, Development, Exploration, Assessment, and Long-Term Study (IDEAL) Framework.

Fluorescence-guided surgery (FGS) is used in many pediatric subspecialties but there are currently no standard guidelines or outcome data. We aimed to assess the current status of FGS in pediatrics using the Idea, Development, Exploration, Assessment, and Long-term study (IDEAL) framework. Clinical papers on FGS in children published from January 2000 to December 2022 were systematically reviewed. The stage of research development was measured considering seven fields of application: biliary tree imaging, vascular perfusion for gastrointestinal procedures, lymphatic flow imaging, tumor resection, urogenital surgery, plastic surgery, and miscellaneous procedures. Fifty-nine articles were selected. For each field of application, the overall IDEAL stage was determined to be 2a for biliary tree imaging (10 publications, 102 cases), 1 for vascular perfusion for gastrointestinal procedures (8 publications, 28 cases), 1 for lymphatic flow imaging (12 publications, 33 cases), 2a for tumor resection (20 publications, 238 cases), 2a for urogenital surgery (9 publications, 197 cases), and 1-2a for plastic surgery (4 publications, 26 cases). One report did not belong to any categories. FGS in children is still in an early phase of adoption and development. We recommend using the IDEAL framework as a guide and suggest developing multicenter studies to define the standard guidelines, effectiveness, and outcomes.

Shortwave Infrared Imaging Enables High-Contrast Fluorescence-Guided Surgery in Neuroblastoma.

Fluorescence-guided surgery is set to play a pivotal role in the intraoperative management of pediatric tumors. Shortwave infrared imaging (SWIR) has advantages over conventional near-infrared I (NIR-I) imaging with reduced tissue scattering and autofluorescence. Here, two NIR-I dyes (IRDye800CW and IR12), with long tails emitting in the SWIR range, were conjugated with a clinical-grade anti-GD2 monoclonal antibody (dinutuximab-beta) to compare NIR-I and SWIR imaging for neuroblastoma surgery. A first-of-its-kind multispectral NIR-I/SWIR fluorescence imaging device was constructed to allow an objective comparison between the two imaging windows. Conjugates were first characterized in vitro. Tissue-mimicking phantoms, imaging specimens of known geometric and material composition, were used to assess the sensitivity and depth penetration of the NIR-I/SWIR device, showing a minimum detectable volume of ∼0.9 mm3 and depth penetration up to 3 mm. In vivo, fluorescence imaging using the NIR-I/SWIR device showed a high tumor-to-background ratio (TBR) for both dyes, with anti-GD2-IR800 being significantly brighter than anti-GD2-IR12. Crucially, the system enabled higher TBR at SWIR wavelengths than at NIR-I wavelengths, verifying SWIR imaging enables high-contrast delineation of tumor margins. This work demonstrates that by combining the high specificity of anti-GD2 antibodies with the availability and translatability of existing NIR-I dyes, along with the advantages of SWIR in terms of depth and tumor signal-to-background ratio, GD2-targeted NIR-I/SWIR-guided surgery could improve the treatment of patients with neuroblastoma, warranting investigation in future clinical trials. SIGNIFICANCE: Multispectral near-infrared I/shortwave infrared fluorescence imaging is a versatile system enabling high tumor-to-background signal for safer and more complete resection of pediatric tumors during surgery.

The clinical effectiveness of an integrated multidisciplinary evidence-based program to prevent intraoperative pressure injuries in high-risk children undergoing long-duration surgical procedures: A quality improvement study.

The prevention of hospital-acquired pressure injuries (HAPIs) in children undergoing long-duration surgical procedures is of critical importance due to the potential for catastrophic sequelae of these generally preventable injuries for the child and their family. Long-duration surgical procedures in children have the potential to result in high rates of HAPI due to physiological factors and the difficulty or impossibility of repositioning these patients intraoperatively. We developed and implemented a multi-modal, multi-disciplinary translational HAPI prevention quality improvement program at a large European Paediatric University Teaching Hospital. The intervention comprised the establishment of wound prevention teams, modified HAPI risk assessment tools, specific education, and the use of prophylactic dressings and fluidized positioners during long-duration surgical procedures. As part of the evaluation of the effectiveness of the program in reducing intraoperative HAPI, we conducted a prospective cohort study of 200 children undergoing long-duration surgical procedures and compared their outcomes with a matched historical cohort of 200 children who had undergone similar surgery the previous year. The findings demonstrated a reduction in HAPI in the intervention cohort of 80% (p < 0.01) compared to the comparator group when controlling for age, pathology, comorbidity, and surgical duration. We believe that the findings demonstrate that it is possible to significantly decrease HAPI incidence in these highly vulnerable children by using an evidence-based, multi-modal, multidisciplinary HAPI prevention strategy.