Could fluorescence-guided surgery be an efficient and sustainable option? A SICE (Italian Society of Endoscopic Surgery) health technology assessment summary

Vettoretto, Nereo; Foglia, Emanuela; Ferrario, Lucrezia; Gerardi, Chiara; Molteni, Beatrice; Nocco, Umberto; Lettieri, Emanuele; Molfino, Sarah; Baiocchi, Gian Luca; Elmore, Ugo; Rosati, Riccardo; Currò, Giuseppe; Cassinotti, Elisa; Boni, Luigi; Cirocchi, Roberto; Marano, Alessandra; Petz, Wanda; Arezzo, Alberto; Bonino, Marco Augusto; Davini, Federico; Biondi, Alberto; Anania, Gabriele; Agresta, Ferdinando; Silecchia, Gianfranço

doi:10.1007/s00464-020-07542-3

Cited by 16 publications

(8 citation statements)

References 71 publications

(86 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In general, surgical procedures guided by uorescence with ICG have demonstrated advantages in the patient's length of stay (LOS) in hospital, especially for colorectal surgery, with a reduction in anastomotic leakage rates and redo anastomosis, at the expense of a slight increase in operating time. This study as well as multiple studies completed to date, con rms that this imaging technology is safe, effective and sustainable [19].…”

Section: Resultssupporting

confidence: 58%

The Use of IndoCyanine Green Fluorescence in the Assessment of Bowel Perfusion in Emergency and Elective Colorectal Surgery

Picardi¹,

Rossi²,

Monte³

et al. 2021

Preprint

View full text Add to dashboard Cite

Background The use of Indocyanine Green (ICG) fluorescence is a well-established technique in colorectal surgery for the evaluation of bowel stump perfusion. However there is still no definitive acceptance, except intraoperative macroscopic evidence, with reference to the incidence of anastomotic leakage (AL). The objective of this study is to confirm the same efficacy and reliability of ICG in elective colorectal surgery, and emergency cases, which would be more exposed to complications related to inadequate vascularization.Methods From January 2019 to June 2020, we used ICG to evaluate the perfusion of colonicstumps before and after packaging the anastomosis in right and left hemicolectomy, rectal resection and Hartmann’s reversals.Results A total of 40 patients underwent surgery, 21 (52.50%) had benign pathology and 19 (47.50%) exhibited malignant neoplasia. 13 (32.50%) were emergency surgeries and 27 (67.50%) were planned elective surgeries. In almost all cases, the postoperative course was regular, in only 1 (2.5%) case of TaTME there was an AL. Other complications were not related to the anastomosis, but some validated the excellent perfusion despite episodes of prolonged acute ischemia due to postoperative hemorrhage. Data were finally compared to a control group of 39 patients where the ICG fluorescence was not used.Conclusions The study confirms the validity of the use of ICG fluorescence as a method for intraoperative assessment of bowel perfusion even in emergency conditions and in acute postoperative hemorrhage, detecting an incidence of 2.5% (1 case out of 40) of AL. It’s evident that to validate our results, further randomized studies on a larger data set are required. It would also be beneficial to evaluate quantitatively the fluorescence between the mucous and serous layer, to confirm the reduction of AL rate, the better evaluation of bowel perfusion and, especially in emergency surgeries, the potential reduction of further operations.

show abstract

Section: Resultssupporting

confidence: 58%

The Use of IndoCyanine Green Fluorescence in the Assessment of Bowel Perfusion in Emergency and Elective Colorectal Surgery

Picardi¹,

Rossi²,

Monte³

et al. 2021

Preprint

View full text Add to dashboard Cite

show abstract

“…Application of the EUnetHTA Core Model in HTA research is not new. [44][45][46] Although technologies, jurisdictions, and purposes differ among studies, the use of similar terminology and definitions increases transferability and dissemination of HTA practices. In a previous research, Radaelli et al 45 described that issues identified based on the EUnetHTA workflow resembled questions that needed to be addressed in the assessment.…”

Section: Discussionmentioning

confidence: 99%

Key Considerations in the Health Technology Assessment of Advanced Therapy Medicinal Products in Scotland, The Netherlands, and England

Ham

Frederix

et al. 2022

Value in Health

View full text Add to dashboard Cite

Objectives: Advanced therapy medicinal products (ATMPs) are highly innovative therapies. Their costs and uncertain value claims have raised concerns among health technology assessment (HTA) bodies and payers. Little is known about how underlying considerations in HTA of ATMPs shape assessment and reimbursement recommendations. We aim to identify and assess key considerations that played a role in HTA of ATMPs underlying reimbursement recommendations.Methods: A review of HTA reports was conducted of all authorized ATMPs in Scotland, The Netherlands, and England. Considerations were extracted and categorized into EUnetHTA Core Model domains. Per jurisdiction, considerations were aggregated and key considerations identified (defined as occurring in .1/assessment per jurisdiction). A narrative analysis was conducted comparing key considerations between jurisdictions and different reimbursement recommendations.Results: We identified 15 ATMPs and 18 HTA reports. In The Netherlands and England most key considerations were identified in clinical effectiveness (EFF) and cost-and economic effectiveness (ECO) domains. In Scotland, the social aspects domain yielded most key considerations, followed by ECO and EFF. More uncertainty in evidence and assessment outcomes was accepted when orphan or end-of-life criteria were applied. A higher percentage of considerations supporting recommendations were identified for products with positive recommendations compared with restricted and negative recommendations.Conclusions: This is the first empirical review of HTA's using the EUnetHTA Core Model to identify and structure key considerations retrospectively. It provides insights in supporting and opposing considerations for reimbursement of individual products and differences between jurisdictions. Besides the EFF and ECO domain, the social, ethical, and legal domains seem to bear considerable weight in assessment of ATMPs.

show abstract

“…It is safe since adverse events are reported in less than 1 in 40.000 patients and mostly including hypersensitivity reactions ( 25 , 26 ). It is used in surgery for various purposes: evaluation of the anastomotic blood supply, visualization of the biliary tract during cholecystectomy, identification of the sentinel lymph node in breast cancer, melanoma and gastric carcinoma ( 27 – 32 ), but its use in bariatric surgery is still debated ( 22 – 24 ).…”

Section: Introductionmentioning

confidence: 99%

Indocyanine Green Fluorescence Angiography During Laparoscopic Bariatric Surgery: A Pilot Study

et al. 2022

View full text Add to dashboard Cite

AimsIndocyanine green (ICG) fluorescence angiography (FA) is used for several purposes in general surgery, but its use in bariatric surgery is still debated. The objective of the present pilot study is to evaluate the intraoperative utility of ICG-FA during bariatric surgery in order to focus future research on a reliable tool to reduce the postoperative leak rate.MethodsThirteen patients (4 men, 30.8%, 9 women, 69.2%) with median age of 52 years (confidence interval, CI, 95% 46.2–58.7 years) and preoperative median body mass index of 42.6 kg/m2 (CI, 95% 36 to 49.3 kg/m2) underwent bariatric surgery with ICG-FA in our center. Three mL of ICG diluted with 10 cc sterile water were intravenously injected after gastric tube creation during laparoscopic sleeve gastrectomy (LSG) and after the gastric pouch and gastro-jejunal anastomosis creation during laparoscopic gastric by-pass (LGB). For the ICG-FA, Karl Storz Image 1S D-Light system (Karl Storz Endoscope GmbH & C. K., Tuttlingen, Germany) placed at a fixed distance of 5 cm from the structures of interest and zoomed vision modality were used to identify the vascular supply. The perfusion pattern was assessed by the surgical team according to a score. The score ranged from 1 (poor vascularization) to 5 (excellent vascularization) based on the intensity and timing of fluorescence of the vascularized structures.ResultsFom January 2021 to February 2022, six patients underwent LSG (46.2%), three patients underwent LGB (23.1%), and four patients underwent re-do LGB after LSG (30.8%). No adverse effects to ICG were observed. In 11 patients (84.6%) ICG-FA score was 5. During two laparoscopic re-do LGB, the vascular supply was not satisfactory (score 2/5) and the surgical strategy was changed based on ICG-FA (15.4%). At a median follow-up of five months postoperatively, leaks did not occur in any case.ConclusionsICG-FA during bariatric surgery is a safe, feasible and promising procedure. It could help to reduce the ischemic leak rate, even if standardization of the procedure and objective fluorescence quantification are still missing. Further prospective studies with a larger sample of patients are required to draw definitive conclusions.

show abstract

Could fluorescence-guided surgery be an efficient and sustainable option? A SICE (Italian Society of Endoscopic Surgery) health technology assessment summary

Cited by 16 publications

References 71 publications

The Use of IndoCyanine Green Fluorescence in the Assessment of Bowel Perfusion in Emergency and Elective Colorectal Surgery

The Use of IndoCyanine Green Fluorescence in the Assessment of Bowel Perfusion in Emergency and Elective Colorectal Surgery

Key Considerations in the Health Technology Assessment of Advanced Therapy Medicinal Products in Scotland, The Netherlands, and England

Indocyanine Green Fluorescence Angiography During Laparoscopic Bariatric Surgery: A Pilot Study

Contact Info

Product

Resources

About