Delphi survey of intercontinental experts to identify areas of consensus on the use of indocyanine green angiography for tissue perfusion assessment during plastic and reconstructive surgery.

BACKGROUND: In recent years, indocyanine green angiography (ICG-A) has been used increasingly to assist tissue perfusion assessments during plastic and reconstructive surgery procedures, but no guidelines exist regarding its use. We sought to identify areas of consensus and non-consensus among international experts on the use of ICG-A for tissue-perfusion assessments during plastic and reconstructive surgery. METHODS: A two-round, online Delphi survey was conducted of 22 international experts from four continents asking them to vote on 79 statements divided into five modules: module 1 = patient preparation and contraindications (n = 11 statements); module 2 = ICG administration and camera settings (n = 17); module 3 = other factors impacting perfusion assessments (n = 10); module 4 = specific indications, including trauma debridement (n = 9), mastectomy skin flaps (n = 6), and free flap reconstruction (n = 8); and module 5 = general advantages and disadvantages, training, insurance coverage issues, and future directions (n = 18). Consensus was defined as ≥70% inter-voter agreement. RESULTS: Consensus was reached on 73/79 statements, including the overall value, advantages, and limitations of ICG-A in numerous surgical settings; also, on the dose (0.05 mg/kg) and timing of ICG administration (∼20-60 seconds preassessment) and best camera angle (61-90o) and target-to-tissue distance (20-30 cm). However, consensus also was reached that camera angle and distance can vary, depending on the make of camera, and that further research is necessary to technically optimize this imaging tool. The experts also agreed that ambient light, patient body temperature, and vasopressor use impact perfusion assessments. CONCLUSION: ICG-A aids perfusion assessments during plastic and reconstructive surgery and should no longer be considered experimental. It has become an important surgical tool.

Perioperative Hyperspectral Imaging to Assess Mastectomy Skin Flap and DIEP Flap Perfusion in Immediate Autologous Breast Reconstruction: A Pilot Study.

Mastectomy skin flap necrosis (MSFN) and partial DIEP (deep inferior epigastric artery perforator) flap loss represent two frequently reported complications in immediate autologous breast reconstruction. These complications could be prevented when areas of insufficient tissue perfusion are detected intraoperatively. Hyperspectral imaging (HSI) is a relatively novel, non-invasive imaging technique, which could be used to objectively assess tissue perfusion through analysis of tissue oxygenation patterns (StO2%), near-infrared (NIR%), tissue hemoglobin (THI%), and tissue water (TWI%) perfusion indices. This prospective clinical pilot study aimed to evaluate the efficacy of HSI for tissue perfusion assessment and to identify a cut-off value for flap necrosis. Ten patients with a mean age of 55.4 years underwent immediate unilateral autologous breast reconstruction. Prior, during and up to 72 h after surgery, a total of 19 hyperspectral images per patient were acquired. MSFN was observed in 3 out of 10 patients. No DIEP flap necrosis was observed. In all MSFN cases, an increased THI% and decreased StO2%, NIR%, and TWI% were observed when compared to the vital group. StO2% was found to be the most sensitive parameter to detect MSFN with a statistically significant lower mean StO2% (51% in the vital group versus 32% in the necrosis group, p < 0.0001) and a cut-off value of 36.29% for flap necrosis. HSI has the potential to accurately assess mastectomy skin flap perfusion and discriminate between vital and necrotic skin flap during the early postoperative period prior to clinical observation. Although the results should be confirmed in future studies, including DIEP flap necrosis specifically, these findings suggest that HSI can aid clinicians in postoperative mastectomy skin flap and DIEP flap monitoring.

Influence of intraoperative vasopressor use on indocyanine green fluorescence angiography: first evaluation in an experimental model.

Intraoperative indocyanine green (ICG) fluorescence angiography has gained popularity and acceptance in many surgical fields for the real-time assessment of tissue perfusion. Although vasopressors have the potential to preclude an accurate assessment of tissue perfusion, there is a lack of literature with regards to its effect on ICG fluorescence angiography. An experimental porcine model was used to expose the small bowel for quantitative tissue perfusion assessment. Three increasing doses of norepinephrine infusion (0.1, 0.5, and 1.0 µg/kg/min) were administered intravenously over a 25-min interval. Time-to-peak fluorescence intensity (TTP) was the primary outcome. Secondary outcomes included absolute fluorescence intensity and local capillary lactate (LCL) levels. Five large pigs (mean weight: 40.3 ± 4.24 kg) were included. There was no significant difference in mean TTP (in seconds) at baseline (4.23) as compared to the second (3.90), third (4.41), fourth (4.60), and fifth ICG assessment (5.99). As a result of ICG accumulation, the mean and the maximum absolute fluorescence intensity were significantly different as compared to the baseline assessment. There was no significant difference in LCL levels (in mmol/L) at baseline (0.74) as compared to the second (0.82), third (0.64), fourth (0.60), and fifth assessment (0.62). Increasing doses of norepinephrine infusion have no significant influence on bowel perfusion using ICG fluorescence angiography.

Assessing the development status of intraoperative fluorescence imaging for perfusion assessments, using the IDEAL framework.

OBJECTIVES: Intraoperative fluorescence imaging is currently used in a variety of surgical fields for four main purposes: assessing tissue perfusion; identifying/localizing cancer; mapping lymphatic systems; and visualizing anatomy. To establish evidence-based guidance for research and practice, understanding the state of research on fluorescence imaging in different surgical fields is needed. We evaluated the evidence on fluorescence imaging for perfusion assessments using the Idea, Development, Exploration, Assessment, Long Term Study (IDEAL) framework, which was designed for describing the stages of innovation in surgery and other interventional procedures. DESIGN: Narrative literature review with analysis of IDEAL stage of each field of study. SETTING: All publications on intraoperative fluorescence imaging for perfusion assessments reported in PubMed through 2019 were identified for six surgical procedures: coronary artery bypass grafting (CABG), upper gastrointestinal (GI) surgery, colorectal surgery, solid organ transplantation, reconstructive surgery, and cerebral aneurysm surgery. MAIN OUTCOME MEASURES: The IDEAL stage of research evidence was determined for each specialty field using a previously described approach. RESULTS: 196 articles (15 003 cases) were selected for analysis. Current status of research evidence was determined to be IDEAL Stage 2a for upper GI and transplantation surgery, IDEAL 2b for CABG, colorectal and cerebral aneurysm surgery, and IDEAL Stage 3 for reconstructive surgery. Using the technique resulted in a high (up to 50%) rate of revisions among surgical procedures, but its efficacy improving postoperative outcomes has not yet been demonstrated by randomized controlled trials in any discipline. Only one possible adverse reaction to intravenous indocyanine green was reported. CONCLUSIONS: Using fluorescence imaging intraoperatively to assess perfusion is feasible and appears useful for surgical decision making across a range of disciplines. Identifying the IDEAL stage of current research knowledge aids in planning further studies to establish the potential for patient benefit.

Outcomes following lymphaticovenous anastomosis (LVA) for 100 cases of lymphedema: results over 24-months follow-up.

PURPOSE: Lymphedema is a debilitating condition that significantly affects patient's quality of life (QoL). The aim of this study was to assess the long-term outcomes after lymphaticovenous anastomosis (LVA) for extremity lymphedema. METHODS: A single-center prospective study on upper and lower extremity lymphedema patients was performed. All LVA procedures were preceded by outpatient Indocyanine Green (ICG) lymphography. Quality of life measured by the Lymph-ICF was the primary outcome. Limb circumference, use of compression garments, and frequency of cellulitis episodes and manual lymphatic drainage (MLD) sessions were secondary outcomes. RESULTS: One hundred consecutive patients, predominantly experiencing upper extremity lymphedema following breast cancer (n = 85), underwent a total of 132 LVAs. During a mean follow-up of 25 months, mean Lymph-ICF score significantly decreased from 43.9 preoperative to 30.6 postoperative, representing significant QoL improvement. Decrease in upper and lower limb circumference was observed in 52% of patients with a mean decrease of 6%. Overall mean circumference was not significantly different. Percentage of patients that could reduce compression garments in the upper and lower extremity group was 65% and 40%, respectively. Number of cellulitis episodes per year and MLD sessions per week showed a mean decrease of respectively 0.6 and 0.8 in the upper extremity and 0.4 and 1.0 in the lower extremity group. CONCLUSIONS: LVA resulted in significant QoL improvement in upper and lower extremity lymphedema patients. Limb circumference did not significantly improve but good results concerning compression garments, cellulitis episodes, and MLD sessions were obtained. Additionally, a simple and patient-friendly method for outpatient ICG lymphography is presented.

Indocyanine green angiography for preventing postoperative mastectomy skin flap necrosis in immediate breast reconstruction.

BACKGROUND: Breast cancer will affect one in eight women during their lifetime. The opportunity to restore the removed tissue and cosmetic appearance is provided by reconstructive breast surgery following skin-sparing mastectomy (SSM). Mastectomy skin flap necrosis (MSFN) is a common complication following SSM breast reconstruction. This postoperative complication can be prevented by intraoperative assessment of mastectomy skin flap viability and intervention when tissue perfusion is compromised. Indocyanine green fluorescence angiography is presumed to be a better predictor of MSFN compared to clinical evaluation alone. OBJECTIVES: To assess the effects of indocyanine green fluorescence angiography (ICGA) for preventing mastectomy skin flap necrosis in women undergoing immediate breast reconstruction following skin-sparing mastectomy. To summarise the different ICGA protocols available for assessment of mastectomy skin flap perfusion in women undergoing immediate breast reconstructions following skin-sparing mastectomy. SEARCH METHODS: We searched the Cochrane Breast Cancer Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL; Issue 3, 2019), MEDLINE, Embase, the World Health Organization's International Clinical Trials Registry Platform (ICTRP) and Clinicaltrials.gov in April 2019. In addition, we searched reference lists of published studies. SELECTION CRITERIA: We included studies that compared the use of ICGA to clinical evaluation to assess mastectomy skin vascularisation and recruited women undergoing immediate autologous or prosthetic reconstructive surgery following SSM for confirmed breast malignancy or high risk of developing breast cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the risk of bias of the included nonrandomised studies and extracted data on postoperative outcomes, including postoperative MSFN, reoperation, autologous flap necrosis, dehiscence, infection, haematoma and seroma, and patient-related outcomes. The quality of the evidence was assessed using the GRADE approach and we constructed two 'Summary of finding's tables: one for the comparison of ICGA to clinical evaluation on a per patient basis and one on a per breast basis. MAIN RESULTS: Nine nonrandomised cohort studies met the inclusion criteria and involved a total of 1589 women with 2199 breast reconstructions. We included seven retrospective and two prospective cohort studies. Six studies reported the number of MSFN on a per breast basis for a total of 1435 breasts and three studies reported the number of MSFN on a per patient basis for a total of 573 women. Five studies reported the number of other complications on a per breast basis for a total of 1370 breasts and four studies reported the number on a per patient basis for a total of 613 patients. Therefore, we decided to pool data separately. Risk of bias for each included nonrandomised study was assessed using the Newcastle-Ottawa Scale for cohort studies. There was serious concern with risk of bias due to the nonrandomised study design of all included studies and the low comparability of cohorts in most studies. The quality of the evidence was found to be very low, after downgrading the quality of evidence twice for imprecision based on the small sample sizes and low number of events in the included studies. Postoperative complications on a per patient basis We are uncertain about the effect of ICGA on MSFN (RR 0.79, 95% CI 0.40 to 1.56; three studies, 573 participants: very low quality of evidence), infection rates (RR 0.91, 95% CI 0.60 to 1.40; four studies, 613 participants: very low quality of evidence), haematoma rates (RR 0.87, 95% CI 0.30 to 2.53; two studies, 459 participants: very low quality of evidence) and seroma rates (RR 1.68, 95% CI 0.41 to 6.80; two studies, 408 participants: very low quality of evidence) compared to the clinical group. We found evidence that ICGA may reduce reoperation rates (RR 0.50, 95% CI 0.35 to 0.72; four studies, 613 participants: very low quality of evidence). One study considered dehiscence as an outcome. In this single study, dehiscence was observed in 2.2% of participants (4/184) in the ICGA group compared to 0.5% of participants (1/184) in the clinical group (P = 0.372). The RR was 4.00 (95% CI 0.45 to 35.45; one study; 368 participants; very low quality of evidence). Postoperative complications on a per breast basis We found evidence that ICGA may reduce MSFN (RR 0.62, 95% CI 0.48 to 0.82; six studies, 1435 breasts: very low quality of evidence), may reduce reoperation rates (RR 0.65, 95% CI 0.47 to 0.92; five studies, 1370 breasts: very low quality of evidence) and may reduce infection rates (RR 0.65, 95% CI 0.44 to 0.97; five studies, 1370 breasts: very low quality of evidence) compared to the clinical group. We are uncertain about the effect of ICGA on haematoma rates (RR 1.53, CI 95% 0.47 to 4.95; four studies, 1042 breasts: very low quality of evidence) and seroma rates (RR 0.71, 95% CI 0.37 to 1.35; two studies, 528 breasts: very low quality of evidence). None of the studies reported patient-related outcomes. ICGA protocols: eight studies used the SPY System and one study used the Photodynamic Eye imaging system (PDE) to assess MSFN. ICGA protocols in the included studies were not extensively described in most studies. AUTHORS' CONCLUSIONS: Although mastectomy skin flap perfusion is performed more frequently using ICGA as a helpful tool, there is a lack of high-quality evidence in the context of randomised controlled trials. The quality of evidence in this review is very low, since only nonrandomised cohort studies have been included. With the results from this review, no conclusions can be drawn about what method of assessment is best to use during breast reconstructive surgery. High-quality randomised controlled studies that compare the use of ICGA to assess MSFN compared to clinical evaluation are needed.

Optimizing Indocyanine Green Fluorescence Angiography in Reconstructive Flap Surgery: A Systematic Review and Ex Vivo Experiments.

Background. Indocyanine green angiography (ICGA) offers the potential to provide objective data for evaluating tissue perfusion of flaps and reduce the incidence of postoperative necrosis. Consensus on ICGA protocols and information on factors that have an influence on fluorescence intensity is lacking. The aim of this article is to provide a comprehensive insight of in vivo and ex vivo evaluation of factors influencing the fluorescence intensity when using ICGA during reconstructive flap surgery. Methods. A systematic literature search was conducted to provide a comprehensive overview of currently used ICGA protocols in reconstructive flap surgery. Additionally, ex vivo experiments were performed to further investigate the practical influence of potentially relevant factors. Results. Factors that are considered important in ICGA protocols, as well as factors that might influence fluorescence intensity are scarcely reported. The ex vivo experiments demonstrated that fluorescence intensity was significantly related to dose, working distance, angle, penetration depth, and ambient light. Conclusions. This study identified factors that significantly influence the fluorescence intensity of ICGA. Applying a weight-adjusted ICG dose seems preferable over a fixed dose, recommended working distances are advocated, and the imaging head during ICGA should be positioned in an angle of 60° to 90° without significantly influencing the fluorescence intensity. All of these factors should be considered and reported when using ICGA for tissue perfusion assessment during reconstructive flap surgery.

Potential of near-infrared fluorescence image-guided debridement in trauma surgery.

This case report presents the use of near-infrared fluorescence (NIRF) imaging using indocyanine green (ICG) and its potential for the evaluation of soft tissue viability in a traumatic case. Standard implementation of this novel imaging modality might decrease the number of surgical debridement procedures in complex traumatic wounds.

Keloid Formation due to Repetitive Mammographies.

A keloid is the result of an abnormal wound healing response to a variety of skin injuries, characterized by a well-circumscribed, firm, irregular, mildly tender, and pink to purple hyperpigmented lump with a glossy surface. The present case reports on excessive formation of keloid due to repetitive mammographies causing symptomatic, cosmetically disturbing symptoms.