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1.
Surg Innov ; 30(5): 607-614, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37490999

ABSTRACT

BACKGROUND: Surgical robots have innovated the microsurgical field by providing advantages that improve surgical performance. These robots have been adopted by certain specialties more than others. This study discusses the potential advantages of robotics in plastic and reconstructive surgery. METHOD: This study is a literature review of articles investigating "robotic microsurgery in plastic and reconstructive surgery" using the PubMed database and the Cochrane Library. RESULT: A total of nineteen relevant articles were found and 5 articles performed a direct comparison between the robotic and manual approaches. Longer operating times were reported in the robotic groups featuring higher learning curves. Reported advantages to robotic use included higher accuracy, precision and flexibility, elimination of tremor and improvement of ergonomic factors. CONCLUSION: While the results provide an outlook into the outcome of robotic platforms in this field, current research is limited and further studies are required to provide a fundamental analysis.


Subject(s)
Plastic Surgery Procedures , Robotic Surgical Procedures , Robotics , Surgery, Plastic , Microsurgery/methods
2.
Life (Basel) ; 13(5)2023 May 11.
Article in English | MEDLINE | ID: mdl-37240803

ABSTRACT

Background: Lower extremity free flap dangling protocols are still widely practiced, despite a paucity of evidence for their use. This pilot study investigates the use of tissue oximetry to provide further insight into the physiological effect of postoperative dangling in lower limb free flap transfer. Methods: Ten patients undergoing lower extremity free flap reconstruction were included in this study. Free flap tissue oxygen saturation (StO2) was continuously measured using non-invasive near-infrared spectroscopy. Measurements were performed on the free flap and contralateral limb during dangling from postoperative day (POD) 7 until 11, according to the local dangling protocol. Results: StO2 values measured in the free flap diminished to 70 ± 13.7% during dangling. This minimum StO2 was reached significantly later, and correspondingly the area under the curve (AUC) was significantly larger on POD 11 compared to the start of the dangling protocol on POD 7, reflecting an improving free flap microvascular reactivity. The dangling slope was equal between the free flap and contralateral leg. The reperfusion slope was significantly flatter on POD 7 compared to the other PODs (p < 0.001). Thereafter, no significant differences between PODs were observed. Patients with a history of smoking had significantly lower tissue oximetry values compared to non-smokers. Conclusions: The application of tissue oximetry during dangling provides further insight into the physiological effect (i.e., changes in microcirculatory function) of the free flap of the reconstructed lower extremity. This information could potentially be useful to either revise or disrupt the use of such dangling protocols.

3.
Life (Basel) ; 13(3)2023 Mar 03.
Article in English | MEDLINE | ID: mdl-36983847

ABSTRACT

Innovative techniques can help overcome the limitations of the human body. Operating on very small structures requires adequate vision of the surgical field and precise movements of sophisticated instruments. Both the human eye and hand are limited when performing microsurgery. Conventional microsurgery uses operation microscopes to enhance the visualization of very small structures. Evolving technology of high-definition 3D cameras provides the opportunity to replace conventional operation microscopes, thereby improving ergonomics for surgeons. This leaves the human hand as a limiting factor in microsurgery. A dedicated robot for microsurgery has been developed to overcome this limitation and enhance the precision and stability of the surgeons' hands. We present the first-in-human case in reconstructive microsurgery where both technologies are integrated using a dedicated microsurgical robot in combination with a 4K 3D exoscope.

4.
Life (Basel) ; 13(2)2023 Jan 28.
Article in English | MEDLINE | ID: mdl-36836713

ABSTRACT

BACKGROUND: In vivo diffuse reflectance spectroscopy provides additional contrast in discriminating nerves embedded in adipose tissue during surgery. However, large datasets are required to achieve clinically acceptable classification levels. This study assesses the spectral similarity between ex vivo porcine and in vivo human spectral data of nerve and adipose tissue, as porcine tissue could contribute to generate large datasets. METHODS: Porcine diffuse reflectance spectra were measured at 124 nerve and 151 adipose locations. A previously recorded dataset of 32 in vivo human nerve and 23 adipose tissue locations was used for comparison. In total, 36 features were extracted from the raw porcine to generate binary logistic regression models for all combinations of two, three, four and five features. Feature selection was performed by assessing similar means between normalized features of nerve and of adipose tissue (Kruskal-Wallis test, p < 0.05) and for models performing best on the porcine cross validation set. The human test set was used to assess classification performance. RESULTS: The binary logistic regression models with selected features showed an accuracy of 60% on the test set. CONCLUSIONS: Spectral similarity between ex vivo porcine and in vivo human adipose and nerve tissue was present, but further research is required.

5.
Surgery ; 172(6S): S21-S28, 2022 12.
Article in English | MEDLINE | ID: mdl-36427926

ABSTRACT

BACKGROUND: Published empirical data have increasingly suggested that using near-infrared fluorescence cholangiography during laparoscopic cholecystectomy markedly increases biliary anatomy visualization. The technology is rapidly evolving, and different equipment and doses may be used. We aimed to identify areas of consensus and nonconsensus in the use of incisionless near-infrared fluorescent cholangiography during laparoscopic cholecystectomy. METHODS: A 2-round Delphi survey was conducted among 28 international experts in minimally invasive surgery and near-infrared fluorescent cholangiography in 2020, during which respondents voted on 62 statements on patient preparation and contraindications (n = 12); on indocyanine green administration (n = 14); on potential advantages and uses of near-infrared fluorescent cholangiography (n = 18); comparing near-infrared fluorescent cholangiography with intraoperative x-ray cholangiography (n = 7); and on potential disadvantages of and required training for near-infrared fluorescent cholangiography (n = 11). RESULTS: Expert consensus strongly supports near-infrared fluorescent cholangiography superiority over white light for the visualization of biliary structures and reduction of laparoscopic cholecystectomy risks. It also offers other advantages like enhancing anatomic visualization in obese patients and those with moderate to severe inflammation. Regarding indocyanine green administration, consensus was reached that dosing should be on a milligrams/kilogram basis, rather than as an absolute dose, and that doses >0.05 mg/kg are necessary. Although there is no consensus on the optimum preoperative timing of indocyanine green injections, the majority of participants consider it important to administer indocyanine green at least 45 minutes before the procedure to decrease the light intensity of the liver. CONCLUSION: Near-infrared fluorescent cholangiography experts strongly agree on its effectiveness and safety during laparoscopic cholecystectomy and that it should be used routinely, but further research is necessary to establish optimum timing and doses for indocyanine green.


Subject(s)
Cholecystectomy, Laparoscopic , Indocyanine Green , Humans , Cholecystectomy, Laparoscopic/methods , Cholangiography/methods , Optical Imaging , Coloring Agents
7.
Surgery ; 172(6S): S46-S53, 2022 12.
Article in English | MEDLINE | ID: mdl-36427930

ABSTRACT

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.


Subject(s)
Breast Neoplasms , Plastic Surgery Procedures , Humans , Female , Indocyanine Green , Mastectomy , Plastic Surgery Procedures/methods , Angiography/methods , Perfusion
8.
Surgery ; 172(6S): S54-S59, 2022 12.
Article in English | MEDLINE | ID: mdl-36427931

ABSTRACT

BACKGROUND: Despite exponentially growing evidence supporting the use of intraoperative fluorescence imaging + indocyanine green dye, considerable variability exists in how and when it is used, and no published consensus guidelines exist. We have conducted Delphi surveys of international experts in the use of intraoperative fluorescence imaging covering 6 distinct surgical scenarios: laparoscopic cholecystectomy; colorectal, lymphedema, gastric cancer, and plastic surgery; and thyroid and parathyroid resections. Although each survey asked experts to vote on field-specific consensus statements, they also had 29 shared statements to permit some analysis spanning the 6 specialties. This article summarizes these results. METHODS: Data on the 29 shared statements from 6 two-round Delphi consensus surveys were compiled to identify areas of overall consensus and compare the different specialties. As with the individual surveys, consensus was defined as ≥70% intervoter agreement. RESULTS: Among 140 participating experts, overall consensus was achieved on 16 statements, including strong agreement that using indocyanine green is extremely safe, that it can be used even when informed written consent cannot be provided, that it significantly enhances anatomical visualization and impacts how procedures are performed, and that it significantly reduces overall procedural risk. However, indocyanine green dosing and timing are procedure-specific, with considerable variability persisting for some applications, and the overall consensus is that further research is necessary to optimize this facet of intraoperative fluorescence imaging. CONCLUSION: Fluorescence imaging is gaining traction across multiple surgical specialties as an invaluable intraoperative tool. Its use in clinical practice and research seems destined to increase.


Subject(s)
Indocyanine Green , Surgery, Plastic , Humans , Optical Imaging , Consensus , Ethnicity
9.
Diagnostics (Basel) ; 12(1)2022 Jan 13.
Article in English | MEDLINE | ID: mdl-35054352

ABSTRACT

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.

10.
Life (Basel) ; 12(1)2022 Jan 03.
Article in English | MEDLINE | ID: mdl-35054458

ABSTRACT

Rapid identification of possible vascular compromise in free flap reconstruction to minimize time to reoperation improves achieving free flap salvage. Subjective clinical assessment, often complemented with handheld Doppler, is the golden standard for flap monitoring; but this lacks consistency and may be variable. Non-invasive optical methods such as near-infrared spectroscopy (NIRS) and hyperspectral imaging (HSI) could facilitate objective flap monitoring. A systematic review was conducted to compare NIRS with HSI in detecting vascular compromise in reconstructive flap surgery as compared to standard monitoring. A literature search was performed using PubMed and Embase scientific database in August 2021. Studies were selected by two independent reviewers. Sixteen NIRS and five HSI studies were included. In total, 3662 flap procedures were carried out in 1970 patients using NIRS. Simultaneously; 90 flaps were performed in 90 patients using HSI. HSI and NIRS flap survival were 92.5% (95% CI: 83.3-96.8) and 99.2% (95% CI: 97.8-99.7). Statistically significant differences were observed in flap survival (p = 0.02); flaps returned to OR (p = 0.04); salvage rate (p < 0.01) and partial flap loss rate (p < 0.01). However, no statistically significant difference was observed concerning flaps with vascular crisis (p = 0.39). NIRS and HSI have proven to be reliable; accurate and user-friendly monitoring methods. However, based on the currently available literature, no firm conclusions can be drawn concerning non-invasive monitoring technique superiority.

11.
Plast Reconstr Surg ; 149(1): 151-161, 2022 Jan 01.
Article in English | MEDLINE | ID: mdl-34936615

ABSTRACT

BACKGROUND: Lymphaticovenous anastomosis, a supermicrosurgical technique, creates bypasses between the lymphatic and venous systems. The quality of lymphaticovenous anastomosis depends on the surgeon's dexterity and precision, and is subject to imperfections caused by the physiologic tremor of the human hand. A dedicated robot for microsurgery has been created to overcome these limitations (MUSA, MicroSure, Eindhoven, The Netherlands). This study describes 1-year clinical outcomes of the first-in-human trial of robot-assisted and manual lymphaticovenous anastomosis in patients with breast cancer-related lymphedema. METHODS: In this prospective pilot study, women with breast cancer-related lymphedema were randomized into the robot-assisted or manual lymphaticovenous anastomosis group. Outcomes were quality of life, arm circumference, conservative treatment frequency, arm dermal backflow stage, and anastomosis patency. RESULTS: Twenty women were included, of whom eight underwent robot-assisted lymphaticovenous anastomosis surgery and 12 underwent manual surgery. In both groups, quality of life significantly improved at 12 months (robot-assisted surgery, p = 0.045; manual surgery, p = 0.001). Arm circumference did not decrease (robot-assisted surgery, p = 0.094; manual surgery, p = 0.240). Daily use of compression garments decreased by 61.9 percent (robot-assisted surgery) and 70.2 percent (manual surgery). The frequency of manual lymphatic drainage remained similar compared with baseline. Arm dermal backflow stage was reduced in one patient in the robot-assisted group and in five cases in the manual group. Overall, 76.5 percent of the anastomoses were patent (robot-assisted surgery, 66.6 percent; manual surgery, 81.8 percent). CONCLUSIONS: After evaluating 1-year follow-up data, this study confirms the feasibility of robot-assisted lymphaticovenous anastomosis surgery. Clinical outcomes were comparable between robot-assisted and manual lymphaticovenous anastomosis. This encourages further research using the new microsurgical robot MUSA for lymphaticovenous anastomosis and other (super)microsurgical procedures. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.


Subject(s)
Breast Cancer Lymphedema/surgery , Lower Extremity/blood supply , Lymphatic Vessels/surgery , Microsurgery/methods , Quality of Life , Robotic Surgical Procedures/methods , Upper Extremity/blood supply , Aged , Anastomosis, Surgical/methods , Breast Neoplasms/surgery , Female , Humans , Middle Aged , Pilot Projects , Prospective Studies
13.
Sci Rep ; 11(1): 9650, 2021 05 06.
Article in English | MEDLINE | ID: mdl-33958693

ABSTRACT

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.


Subject(s)
Fluorescein Angiography/methods , Indocyanine Green , Norepinephrine/pharmacology , Vasoconstrictor Agents/pharmacology , Animals , Disease Models, Animal , Female , Infusions, Intravenous , Injections, Intravenous , Intestines/blood supply , Intraoperative Period , Laparotomy , Norepinephrine/administration & dosage , Swine , Vasoconstrictor Agents/administration & dosage
14.
BMJ Surg Interv Health Technol ; 3(1): e000088, 2021.
Article in English | MEDLINE | ID: mdl-35047805

ABSTRACT

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.

15.
Breast Cancer Res Treat ; 184(1): 173-183, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32767202

ABSTRACT

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.


Subject(s)
Breast Neoplasms , Lymphatic Vessels , Lymphedema , Anastomosis, Surgical/adverse effects , Female , Follow-Up Studies , Humans , Indocyanine Green , Lymphatic Vessels/diagnostic imaging , Lymphatic Vessels/surgery , Lymphedema/epidemiology , Lymphedema/etiology , Lymphedema/surgery , Prospective Studies , Quality of Life , Treatment Outcome
16.
Surg Innov ; 27(5): 534-542, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32701027

ABSTRACT

Background. Postoperative monitoring of deep inferior epigastric perforator (DIEP) flaps for breast reconstruction using noninvasive tissue oximetry enables timely recognition of vascular compromise. This may limit ischemic tissue damage, minimizing postoperative morbidity and healthcare costs. The aim of this review was to provide an economic analysis of tissue oximetry for postoperative monitoring of DIEP flap breast reconstruction. Methods. A systematic literature search was conducted utilizing PubMed and Embase. Articles reporting costs related to tissue oximetry following DIEP flap breast reconstruction, costs directly related to DIEP flap surgical procedure, and costs associated with postoperative complications were included. Risk of bias was assessed using different tools depending on study type. Results. Six articles were included. Four studies provided an overview of total costs associated with DIEP flap breast reconstruction; two studies focused on whether tissue oximetry could facilitate a decrease in hospital costs. Average overall costs for DIEP flap procedure were estimated at $28 000, with additional costs up to $37 530 in case of total flap failure. Tissue oximetry to monitor DIEP flaps could potentially save up to $1667 per procedure. Moreover, it might eliminate the need for specialized postoperative care. Conclusion. Tissue oximetry following DIEP flap breast reconstruction can potentially facilitate a decrease in hospital costs since its readings enable physicians to intervene in an early stage of tissue malperfusion, contributing to minimizing complications. Tissue oximetry may eliminate the need for specialized postoperative care. However, based on the current literature, no firm conclusions can yet be drawn regarding cost-effectiveness of standard implementation.


Subject(s)
Mammaplasty , Perforator Flap , Cost-Benefit Analysis , Epigastric Arteries/surgery , Humans , Mammaplasty/adverse effects , Oximetry , Postoperative Complications , Retrospective Studies
17.
Cochrane Database Syst Rev ; 4: CD013280, 2020 04 22.
Article in English | MEDLINE | ID: mdl-32320056

ABSTRACT

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.


Subject(s)
Angiography/methods , Coloring Agents , Indocyanine Green , Mammaplasty/adverse effects , Postoperative Complications/prevention & control , Surgical Flaps/pathology , Bias , Breast Neoplasms/surgery , Female , Hematoma/epidemiology , Humans , Mammaplasty/methods , Mastectomy/adverse effects , Mastectomy/methods , Necrosis/epidemiology , Necrosis/prevention & control , Postoperative Complications/epidemiology , Prospective Studies , Reoperation/statistics & numerical data , Retrospective Studies , Seroma/epidemiology , Surgical Flaps/blood supply , Surgical Wound Dehiscence/epidemiology , Surgical Wound Infection/epidemiology
18.
Nat Commun ; 11(1): 757, 2020 02 11.
Article in English | MEDLINE | ID: mdl-32047155

ABSTRACT

Advancements in reconstructive microsurgery have evolved into supermicrosurgery; connecting vessels with diameter between 0.3 and 0.8 mm for reconstruction of lymphatic flow and vascularized tissue transplantation. Supermicrosurgery is limited by the precision and dexterity of the surgeon's hands. Robot assistance can help overcome these human limitations, thereby enabling a breakthrough in supermicrosurgery. We report the first-in-human study of robot-assisted supermicrosurgery using a dedicated microsurgical robotic platform. A prospective randomized pilot study is conducted comparing robot-assisted and manual supermicrosurgical lymphatico-venous anastomosis (LVA) in treating breast cancer-related lymphedema. We evaluate patient outcome at 1 and 3 months post surgery, duration of the surgery, and quality of the anastomosis. At 3 months, patient outcome improves. Furthermore, a steep decline in duration of time required to complete the anastomosis is observed in the robot-assisted group (33-16 min). Here, we report the feasibility of robot-assisted supermicrosurgical anastomosis in LVA, indicating promising results for the future of reconstructive supermicrosurgery.


Subject(s)
Breast Neoplasms/surgery , Lymphedema/complications , Microsurgery/methods , Robotic Surgical Procedures/methods , Aged , Anastomosis, Surgical/methods , Female , Humans , Middle Aged , Netherlands , Pilot Projects , Prospective Studies , Plastic Surgery Procedures , Robotic Surgical Procedures/instrumentation
19.
Surg Innov ; 27(1): 103-119, 2020 Feb.
Article in English | MEDLINE | ID: mdl-31347468

ABSTRACT

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.


Subject(s)
Fluorescein Angiography , Indocyanine Green/therapeutic use , Plastic Surgery Procedures , Surgery, Computer-Assisted , Surgical Flaps/surgery , Evidence-Based Medicine , Humans
20.
J Laparoendosc Adv Surg Tech A ; 29(12): 1549-1555, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31259650

ABSTRACT

Aims: To investigate whether different calculation methods to express fluorescence intensity (FI) as target-to-background (BG) ratio are comparable and which method(s) match with human perception. Materials and Methods: Comparison of three calculation methods from current literature (OsiriX®, ImageJ®, and Photoshop®) to objectify FI during laparoscopic cholecystectomy measured at the exact same locations within recorded images of two categories: ex vivo and in vivo. Currently applied formulas to present FI in relation to the BG signal are compared with the subjective assessment by the human observers. These three formulas are Signal contrast = (FI in fluorescence regions-FI in BG)/255; Target-to-background ratio = (FI of target-FI of BG)/FI of BG; Signal-to-background ratio = FI of cystic duct/FI of liver and Target-to-background ratio = (FI of target-noise)/(FI of BG-noise). Results: In our evaluation OsiriX and ImageJ provided similar results, whereas OsiriX values were structurally slightly lower compared with ImageJ. Values obtained through Photoshop were less evidently related to those obtained with OsiriX and ImageJ. The formula Target-to-background ratio = (FI of target-noise)/(FI of BG-noise) was less corresponding with human perception compared with the other used formulas. Conclusions: FI results based on measurements using the programs OsiriX and ImageJ are similar, allowing for comparison of results between these programs. Results using Photoshop differ significantly, making direct comparison impossible. This is an important finding when interpreting study results. We propose to report both target and BG FI in articles, so that proper interpretation between articles can be made.


Subject(s)
Cholecystectomy, Laparoscopic/methods , Fluorescence , Optical Imaging/methods , Cystic Duct/diagnostic imaging , Humans , Indocyanine Green , Liver/diagnostic imaging
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