Imperial College London

Mr Daniel Richard Leff

Faculty of MedicineDepartment of Surgery & Cancer

Reader in Breast Surgery
 
 
 
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Contact

 

+44 (0)20 3312 1947d.leff

 
 
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Location

 

Queen Elizabeth the Queen Mother Wing (QEQM)St Mary's Campus

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Summary

 

Publications

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163 results found

Hall A, Leff D, Wojdecka A, Kinross J, Thompson P, Darzi Aet al., 2019, Beyond the healthcare paradigm: Co-creating a new model for collaborative transdisciplinary healthcare design education

© 2019 Institution of Engineering Designers, The Design Society. All rights reserved. Although healthcare has long been a focus for design research dating from the 1960’s and Bruce Archer’s Industrial Design (Engineering) research unit, there remain very few academic programmes in the field of healthcare design and even fewer that go beyond classic user driven models. This paper reports on a unique collaboration between the Royal College of Art and Imperial College in London to develop an innovative partnership and programme structure between two diverse collaborating institutions. Moreover, the partnership has shown how new design and healthcare research methods have been used for innovative practice-based healthcare design projects. We reflect on the diverse skill sets and approaches that have evolved through collaborative teamwork between healthcare practitioners, designers and diverse disciplinary backgrounds. Our conclusions illustrate how a context driven programme provides evidence of a new ‘post-disciplinary’ mindset and explores implications for research and practice for the future of healthcare design.

Conference paper

Hall A, Leff D, Wojdecka A, Kinross J, Thompson P, Darzi Aet al., 2019, Beyond the healthcare paradigm: Co-creating a new model for collaborative transdisciplinary healthcare design education

© 2019 Institution of Engineering Designers, The Design Society. All rights reserved. Although healthcare has long been a focus for design research dating from the 1960’s and Bruce Archer’s Industrial Design (Engineering) research unit, there remain very few academic programmes in the field of healthcare design and even fewer that go beyond classic user driven models. This paper reports on a unique collaboration between the Royal College of Art and Imperial College in London to develop an innovative partnership and programme structure between two diverse collaborating institutions. Moreover, the partnership has shown how new design and healthcare research methods have been used for innovative practice-based healthcare design projects. We reflect on the diverse skill sets and approaches that have evolved through collaborative teamwork between healthcare practitioners, designers and diverse disciplinary backgrounds. Our conclusions illustrate how a context driven programme provides evidence of a new ‘post-disciplinary’ mindset and explores implications for research and practice for the future of healthcare design.

Conference paper

Ashcroft J, Patel R, Singh H, Darzi A, Leff Det al., 2018, The Impact of Transcranial direct current stimulation (tDCS) on a surgical knot-tying task, Surgery and Cancer Research Afternoon Abstract

Conference paper

Leff DR, Patani N, Finn M, Eshleby S, Omar A, Kaur A, Contractor K, Thiruchelvam P, Curtis S, Main J, Cunningham D, Hogben K, AlMufti R, Hadjiminas DJet al., 2018, A ‘best practice’ care pathway improves management of mastitis and breast abscess, British Journal of Surgery, Vol: 105, Pages: 1615-1622, ISSN: 1365-2168

Background: As a result of surgical sub-specialisation, mastitis and breast abscess may be managed with unnecessary hospitalisation, prolonged admission, variable antibiotic prescribing, incision and drainage rather than aspiration, and loss to follow-up. Objective: To evaluate a ‘best-practice’ algorithm to improve management across a multi-site NHS Trust; focusing on uniformity of antibiotic prescribing, ultrasound assessment, admission rates, length of stay, intervention by aspiration or incision and drainage, and follow-up. Methods: Management was initially evaluated in a retrospective cohort (Phase-I: “PRE-pathway”, n=53) and subsequently compared to two prospective cohorts (Phase II and III = “POST-pathway”, n=141), one immediately following pathway introduction (Phase II n=61), and a further loop-closing audit (Phase-III, n=80) to assess sustainability of quality improvements. Results: The management pathway and referral proforma improved compliance with antibiotic guidelines (Pre=34.0% vs. Post=58.2%, p<0.01), which was maintained (Phase-II=54.1% vs. III=61.3%, p=0.68) and sustainably increased ultrasound assessment (Pre=37.7% vs. Post=77.3%, p<0.001; Phase-II=75.4% vs. III=78.8%, p=0.89). Reductions in rates of incision and drainage (Pre=7.5% vs. Post=0.7%, p<0.01) were maintained (Phase-II=0% vs. III=1.3%, p=0.38), and follow-up consistently improved (Pre=43.4% vs. Post=95.7%, p<0.001; Phase-II=91.8% vs. III=98.8%, p=0.12). Reduced hospital admission (Pre=30.2% vs. Post=20.6%, p=0.25) and median length of stay [Pre=2 days (range=1-5) vs. Post=1 day (range=1-6), p=0.07] were not statistically significant.

Journal article

Modi H, Singh H, Yang G, Darzi A, Leff Det al., 2018, Neural correlates of stress resilience in the operating room, Journal of The American College of Surgeons, Vol: 227, Pages: e208-e208, ISSN: 1072-7515

IntroductionIntraoperative stressors can increase surgeons’ mental demands, precipitating technical performance decline and risking patient safety. However, the neural signatures of stress resilience among surgeons remain unknown. We aimed to compare activation in the prefrontal cortex (PFC)–important for attention and concentration–between residents demonstrating performance stability and those exhibiting performance decline when operating under time pressure.MethodsThirty-three surgical residents [median age (range) = 33 years (29 to 56), 27 males] performed a laparoscopic suturing task under ‘self-paced’ (no time restriction) and ‘time pressure’ (2-minute per knot time restriction) conditions. A composite deterioration score was calculated based on between-condition differences in technical performance, and subjects were divided into quartiles reflecting performance stability (Q1) and decline (Q4). Changes in oxygenated haemoglobin concentration (HbO2) measured at 24 prefrontal locations using functional near-infrared spectroscopy were compared between Q1 and Q4. Subjective workload was quantified using the Surgical Task Load Index (SURG-TLX).ResultsUnder time pressure, Q1 residents demonstrated task-induced increases in HbO2 in the bilateral ventrolateral PFC (VLPFC), whereas Q4 residents demonstrated HbO2 decreases. The amplitude of activation (ΔHbO2) was significantly greater in Q1 than Q4 in the bilateral VLPFC (left VLPFC: Q1=0.44±1.36μM, Q4=-0.03±1.83μM; right VLPFC: Q1=0.49±1.70μM, Q4=-0.32±2.00μM). There were no significant between-group differences in SURG-TLX scores.ConclusionsResilience to intraoperative stress is associated with sustained prefrontal activation indicating preserved attention and concentration. In contrast, sensitivity to stress is marked by prefrontal deactivation suggesting task disengagement. Future work will aim to develop interventions that recr

Journal article

Singh H, Modi HN, Ranjan S, Dilley J, Airantzis D, Yang G, Darzi A, Leff Det al., 2018, Robotic surgery improves technical performance and enhances prefrontal activation during high temporal demand, Annals of Biomedical Engineering, Vol: 46, Pages: 1621-1636, ISSN: 0090-6964

Robotic surgery may improve technical performance and reduce mental demands compared to laparoscopic surgery. However, no studies have directly compared the impact of robotic and laparoscopic techniques on surgeons’ brain function. This study aimed to assess the effect of the operative platform (robotic surgery or conventional laparoscopy) on prefrontal cortical activation during a suturing task performed under temporal demand. Eight surgeons (mean age ± SD = 34.5 ± 2.9 years, male:female ratio = 7:1) performed an intracorporeal suturing task in a self-paced manner and under a 2 min time restriction using conventional laparoscopic and robotic techniques. Prefrontal activation was assessed using near-infrared spectroscopy, subjective workload was captured using SURG-TLX questionnaires, and a continuous heart rate monitor measured systemic stress responses. Task progression scores (au), error scores (au), leak volumes (mL) and knot tensile strengths (N) provided objective assessment of technical performance. Under time pressure, robotic suturing led to improved technical performance (median task progression score: laparoscopic suturing = 4.5 vs. robotic suturing = 5.0; z = − 2.107, p = 0.035; median error score: laparoscopic suturing = 3.0 mm vs. robotic suturing = 2.1 mm; z = − 2.488, p = 0.013). Compared to laparoscopic suturing, greater prefrontal activation was identified in seven channels located primarily in lateral prefrontal regions. These results suggest that robotic surgery improves performance during high workload conditions and is associated with enhanced activation in regions of attention, concentration and task engagement.

Journal article

Cutress RI, McIntosh SA, Potter S, Goyal A, Kirwan CC, Harvey J, Francis A, Carmichael AR, Vidya R, Vaidya JS, Fairbrother P, Benson JR, Reed MWR, Basu NN, Benson JR, Bundred NJ, Carmichael AR, Coombs N, Cutress RI, Dickson J, Dixon JM, Douek M, Fairbrother P, Francis A, Goyal A, Harcourt D, Harvey J, Holcombe C, Horsnell J, Iqbal FM, Khan LR, Kirwan CC, Leff DR, Maxwell AJ, McIntosh SA, Paraskeva N, Potter S, Rattay T, Reed MWR, Sami AS, Singer J, St John ER, Subramanian A, Tobias JS, Touqan N, Vaidya JS, Vidya R, Winters ZEet al., 2018, Opportunities and priorities for breast surgical research, The Lancet Oncology, Vol: 19, Pages: e521-e533, ISSN: 1470-2045

Journal article

Leff DR, de Silva T, Henry F, Thiruchelvam P, Hadjiminas D, Al-Mufti R, Hogben K, Hunter J, Wood S, Jalalli Net al., 2018, Streamlining decision making in contralateral risk-reducing mastectomy: impact of PREDICT and BOADICEA computations, Annals of Surgical Oncology, Vol: 25, Pages: 3057-3063, ISSN: 1068-9265

Introduction.Patients with sporadic breast cancer (BC)have low contralateral breast cancer risk (CLBCR;approximately 0.7% per annum) and contralateral pro-phylactic mastectomy (CPM) offers no survival advantage.CPM with autologous reconstruction (AR) has majormorbidity and resource implications.Objective.The aim of this study was to review the impactof PREDICT survival estimates and lifetime CLBCRscores on decision making for CPM in patients with uni-lateral BC.Methods.Ofn= 272 consecutive patients undergoingmastectomy and AR, 252 were included. Five- and 10-yearsurvival was computed with the PREDICT(V2) onlineprognostication tool, using age and clinicopathologicalfactors. Based on family history (FH) and tumor biology,CLBCR was calculated using validated BODICEA web-based software. Survival scores were correlated againstCLBCR estimates to identify patients receiving CPM with‘low’ CLBCR (\30% lifetime risk) and poor prognosis (5-year survival\80%). Patients with ‘high’ CLBCRreceiving unilateral mastectomy (UM) were similarlyidentified (UK National Institute of Health and CareExcellence [NICE] criteria for CPM,C30% lifetime BCrisk). Justifications motivating CPM were investigated.Results.Of 252 patients, 215 had UM and 37 had bilateralmastectomy and AR. Only 23 (62%) patients receivingCPM fulfilled the NICE criteria. Of 215 patients, 5 (2.3%)failed to undergo CPM despite high CLBCR and goodprognosis. CPMs were performed, at the patient’s request,for no clear justification (n= 8), contralateral non-invasivedisease, and/or FH (n= 5), FH alone (n= 4) and ipsilateralcancer recurrence-related anxiety (n= 3).Conclusion.In the absence of prospective risk estimatesof CLBCR and prognosis, certain patients receive CPMand reconstruction despite modest CLBCR, yet a propor-tion of patients with good prognoses and substantial riskare not undergoing CPM

Journal article

Singh H, Modi H, Yang G, Darzi A, Leff Det al., 2018, Impact of escalating cognitive workload and temporal demands on surgeons cognitive function, 2nd International Neuroergonomics Conference, Publisher: Frontiers Media, ISSN: 1662-5161

Conference paper

Singh H, Modi H, Darzi A, Leff Det al., 2018, Robotic Surgery Improves Technical Performance and Enhances Prefrontal Activation During High Temporal Demand, Ara Darzi

Athanasiou Award Presentation

Conference paper

Osborne-Grinter M, Patel R, Modi H, Singh H, Darzi A, Leff Det al., 2018, Enhancing Surgical Performance Through Mental Rehearsal: An fNIRS Study, society of functional Near Infra-red Spectroscopy, Biennial meeting of society of functional Near Infra-red Spectroscopy (fNIRS-2018)

Background: Mental rehearsal (MR) is the cognitive rehearsal of a skill without movement to produce genuine sensory experiences. Mandates for new approaches to surgical skill acquisition have led to increased interest in MR as a method of practical learning supplementation. However, the neurophysiological mechanisms underpinning the psychomotor benefits of MR are poorly understood.Objective: To delineate the neural mechanisms that underpin mental imagery-related improvements in surgical performance.Methods: Twelve surgical trainees performed a laparoscopic suturing (LS) task (pre-intervention) followed by randomization to either MR (n=6) or textbook reading (TR; n=6). The LS task was repeated (post-intervention). Subjective workload was quantified using the Surgical Task Load Index and Spielberg State-Trait Anxiety Index. Mental imagery ability was assessed using a mental imagery questionnaire. Continuous heart rate (HR) monitoring captured stress responses. Cortical activation was recorded with optical neuroimaging (ETG-4000, Hitachi Medical Corp., Japan). Technical skill was assessed using progression scores (au), performance scores (units) and leak volumes (mL). Results: There were no baseline differences in demographics, mental imagery ability or laparoscopic performance between the two groups. MR significantly improved post-intervention performance scores (53.10 ± 28.00 a.u. vs. -61.32 ± 40.78 a.u., p=0.04) and reduced leak volume (3.48 ±0.44ml vs. 4.81 ± 0.61ml, p=0.04) when compared to TR. MR also led to significant improvement in subjective imagery ability (41.50 ± 4.59 a.u. vs 31.17 ± 9.11 a.u, P=0.009). There were no differences in subjective or objective stress measures between the two groups. Cortical activation was defined by a significant (p < 0.05) rise in oxygenated haemoglobin with a concurrent fall in deoxygenated haemoglobin. During MR, activation was demonstrated in the left supplementary motor area (S

Conference paper

Deligianni F, Singh H, Modi H, Darzi A, Leff D, Yang GUANGet al., 2018, Expertise Related Disparity in Prefrontal-Motor Brain Connectivity, Hamlyn Symposium on Medical Robotics

Conference paper

Fisher R, Muthuswamy K, Petrou F, Mavroveli S, Thiruchelvam P, Fisher C, Leff Det al., 2018, The impact of the American College of Surgeons Oncology Group Z0011 Trial on axillary lymph node dissection cases worldwide: A systematic review, 19th Annual Meeting of the American-Society-of-Breast-Surgeons, Publisher: Springer (part of Springer Nature), Pages: 434-434, ISSN: 1068-9265

Conference paper

Muthuswamy K, Fisher R, Petrou F, Mavroveli S, Leff Det al., 2018, Specialist trainee experiences in axillary lymph node dissection in a post-Z11-era survey indicates declining exposure and confidence, 19th Annual Meeting of the American-Society-of-Breast-Surgeons, Publisher: SPRINGER, Pages: 393-394, ISSN: 1068-9265

Conference paper

Thiruchelvam P, Fisher C, Leff DR, Domcheck Set al., 2018, Pervasive genetic testing, Lancet, Vol: 391, Pages: 2089-2091, ISSN: 0140-6736

Journal article

Erridge S, Chidambaram S, Leff DR, Purkayastha Set al., 2018, Validating touch surgery for training in laparoscopic cholecystectomies: a randomised controlled trial, Annual Meeting of the Society-of-Academic-and-Research-Surgery (SARS), Publisher: Wiley, Pages: 30-30, ISSN: 1365-2168

Background: Surgical training has traditionally involved teaching trainees in the operating theatre. However, this method is associated with longer operating times and complications, which is cost-inefficient and exposes patients to errors. Simulation modalities such as Touch Surgery, which utilises cognitive task analysis (CTA), have been designed to overcome these issues.Methods: Participants performed a laparoscopic cholecystectomy procedure using a box simulator and porcine liver and gall bladder. They were randomly allocated to either the control or the intervention group. Each group received the same preparation prior to intervention, including a 10-minute introduction to laparoscopic equipment and a 15-minute educational tutorial on laparoscopic cholecystectomies. The participants then received CTA training via either Touch Surgery (intervention) or via written information (control).Results: 40 participants were recruited to take part in the study and randomly assigned to either intervention (n=22) or control (n=18). There was no significant difference between age (p=0.320), year of medical school (p=0.322), handedness (p=1.000) or gender (p=0.360) of the groups. The overall mean performance score was higher for intervention (41.9±22.5) than control (24.7±19.6; p=0.016). The intervention group had consistently higher scores throughout all intraoperative segments although this was not statistically significant (p>0.050). Conclusion: This study shows that Touch Surgery is effective for providing cognitive training in laparoscopic cholecystectomies to medical students. It is likely that this effect will be seen across modules and other platforms that utilise CTA alongside high fidelity animation. Further work is necessary to extend this to other surgical procedures for evaluating its longitudinal effectiveness.Take Home Message: CTA training provided via high fidelity simulation is an effective and inexpensive method of providing surgical educat

Conference paper

Modi HN, Singh H, Yang G, Darzi A, Leff DRet al., 2018, Robotic surgery improves attention and concentration during times of intraoperative temporal stress, Association of Surgeons of Great Britain & Ireland International Surgical Congress, Publisher: Wiley, ISSN: 1365-2168

Conference paper

Leiloglou M, Qi J, Rees Whippey D, Curtis A, Price C, Copner N, Martin-Gonzalez P, Hanna G, Darzi A, Leff D, Elson Det al., 2018, Guiding Fluorescence-Augmented Imaging System for Breast Cancer Surgery, BMES Annual Meeting

Conference paper

Leiloglou M, Qi J, Rees Whippey D, Curtis A, Price C, Copner N, Martin-Gonzalez P, Hanna G, Darzi A, Leff D, Elson Det al., 2018, Guiding Fluorescence-Augmented Imaging System for Breast Cancer Surgery, EPSRC Image Guided Therapies Young Investigators

Conference paper

Stebbing J, Baranau Y, Manikhas A, Lee SJ, Thiruchelvam P, Leff D, Esteva FJet al., 2018, Total pathological complete response versus breast pathological complete response in clinical trials of reference and biosimilar trastuzumab in the neoadjuvant treatment of breast cancer, EXPERT REVIEW OF ANTICANCER THERAPY, Vol: 18, Pages: 531-541, ISSN: 1473-7140

Journal article

Modi HN, Singh H, Yang G, Darzi A, Leff Det al., 2017, A decade of imaging surgeons' brain function (Part II): a systematic review of applications for technical and non-technical skills assessment, Surgery, Vol: 162, Pages: 1130-1139, ISSN: 1532-7361

Background: Functional neuroimaging technologies enable assessment of operator brain function, and can deepen our understanding of skills learning, ergonomic optima and cognitive processes in surgeons. Whilst there has been a critical mass of data detailing surgeons’ brain function, this literature has not been systematically reviewed.Methods: A systematic search of original neuroimaging studies assessing surgeons’ brain function, and published up until November 2016, was conducted using Medline, Embase and PsycINFO databases.Results: Twenty-seven studies fulfilled the inclusion criteria, including three feasibility studies, fourteen studies exploring the neural correlates of technical skill acquisition, and the remainder investigating brain function in the context of intraoperative decision-making (n=1), neurofeedback training (n=1), robot-assisted technology (n=5), and surgical teaching (n=3). Early stages of learning open surgical tasks (knot-tying) are characterised by prefrontal cortical (PFC) activation which subsequently attenuates with deliberate practice. However, with complex laparoscopic skills (intra-corporeal suturing), PFC engagement requires substantial training and attenuation occurs over a longer time-course, following years of refinement. Neurofeedback and interventions that improve neural efficiency may enhance technical performance and skills learning. Conclusions: Imaging surgeons’ brain function has identified neural signatures of expertise which might help inform objective assessment and selection processes. Interventions which improve neural efficiency may target skill-specific brain regions and augment surgical performance.

Journal article

Modi HN, Singh H, Yang G, Darzi A, Leff Det al., 2017, Neural markers of sensitivity to intraoperative temporal stress in surgeons, Mexican Symposium on NIRS Neuroimaging, Publisher: MEXNIRS

Conference paper

Orihuela-Espina F, Leff DR, James DRC, Darzi AW, Yang G-Zet al., 2017, Imperial College near infrared spectroscopy neuroimaging analysis framework., Neurophotonics, Vol: 5, ISSN: 2329-4248

This paper describes the Imperial College near infrared spectroscopy neuroimaging analysis (ICNNA) software tool for functional near infrared spectroscopy neuroimaging data. ICNNA is a MATLAB-based object-oriented framework encompassing an application programming interface and a graphical user interface. ICNNA incorporates reconstruction based on the modified Beer-Lambert law and basic processing and data validation capabilities. Emphasis is placed on the full experiment rather than individual neuroimages as the central element of analysis. The software offers three types of analyses including classical statistical methods based on comparison of changes in relative concentrations of hemoglobin between the task and baseline periods, graph theory-based metrics of connectivity and, distinctively, an analysis approach based on manifold embedding. This paper presents the different capabilities of ICNNA in its current version.

Journal article

Ranjan S, Modi HN, Singh H, Darzi A, Leff Det al., 2017, The impact of 3D vision on prefrontal activation and technical performance during a robotic suturing task, 11th London Surgical Symposium

Conference paper

Ranjan S, Modi HN, Singh H, Darzi A, Leff Det al., 2017, The impact of time pressure on prefrontal cortical activation and technical performance during robotic suturing, 11th London Surgical Symposium

Conference paper

Modi HN, Singh H, Yang G, Darzi A, Leff Det al., 2017, A decade of imaging surgeons' brain function (Part I): terminology, techniques and clinical translation, Surgery, Vol: 162, Pages: 1121-1130, ISSN: 1532-7361

Functional neuroimaging has the potential to deepen our understanding of technical and non-technical skill acquisition in surgeons, particularly as established assessment tools leave unanswered questions about inter-operator differences in ability that seem independent of experience. In this first of a two-part article, we aim to utilise our experience in neuroimaging surgeons to orientate the non-specialist reader to the principles of brain imaging. Terminology commonly used in brain imaging research is explained, placing emphasis on the “activation response” to a surgical task and its effect on local cortical haemodynamic parameters (neurovascular coupling). Skills learning and subsequent consolidation and refinement through practice lead to reorganisation of the functional architecture of the brain (known as “neuroplasticity”), evidenced by changes in the strength of regional activation as well as alterations in connectivity between brain regions, culminating in more efficient use of neural resources during task performance. Currently available neuroimaging techniques that either directly (i.e. measure electrical activity) or indirectly (i.e. measure tissue haemodynamics) assess brain function are discussed. Finally, we highlight the important practical considerations when conducting brain imaging research in surgeons.

Journal article

St John ER, Scott AJ, Irvine TE, Pakzad F, Leff DR, Layer GTet al., 2017, Completion of hand-written surgical consent forms is frequently suboptimal and could be improved by using electronically generated, procedure-specific forms, SURGEON-JOURNAL OF THE ROYAL COLLEGES OF SURGEONS OF EDINBURGH AND IRELAND, Vol: 15, Pages: 190-195, ISSN: 1479-666X

Journal article

Qi J, Nabavi E, Hu Y, Whippey DR, Curtis A, Price C, Copner N, Sannassy C, Leiloglou M, Leff D, Hanna G, Elson Det al., 2017, A light-weight near infrared fluorescence endoscope based on a single color camera: a proof-of-concept study, Conference on Lasers and Electro-Optics Pacific Rim (CLEO-PR), Publisher: IEEE

Conference paper

Singh H, Modi HN, Yang GZ, Darzi A, Leff DRet al., 2017, “Losing Your Nerve in the Operating Room” – Prefrontal Attenuation is Associated with Performance Degradation under Temporal Demands, 10th Hamlyn Symposium on Medical Robotics, Pages: 55-56

Conference paper

St John ERC, Leff D, takats Z, Darzi Aet al., 2017, Rapid Evaporative Ionisation Mass Spectrometry of Electrosurgical Vapours for the Identification of Breast Pathology: Towards an Intelligent Knife for Breast Cancer Surgery, Breast Cancer Research, Vol: 19, ISSN: 1465-542X

Background:Re-operation for positive resection margins following breast-conserving surgery occurs frequently (average = 20–25%), is cost-inefficient, and leads to physical and psychological morbidity. Current margin assessment techniques are slow and labour intensive. Rapid evaporative ionisation mass spectrometry (REIMS) rapidly identifies dissected tissues by determination of tissue structural lipid profiles through on-line chemical analysis of electrosurgical aerosol toward real-time margin assessment.Methods:Electrosurgical aerosol produced from ex-vivo and in-vivo breast samples was aspirated into a mass spectrometer (MS) using a monopolar hand-piece. Tissue identification results obtained by multivariate statistical analysis of MS data were validated by histopathology. Ex-vivo classification models were constructed from a mass spectral database of normal and tumour breast samples. Univariate and tandem MS analysis of significant peaks was conducted to identify biochemical differences between normal and cancerous tissues. An ex-vivo classification model was used in combination with bespoke recognition software, as an intelligent knife (iKnife), to predict the diagnosis for an ex-vivo validation set. Intraoperative REIMS data were acquired during breast surgery and time-synchronized to operative videos.Results:A classification model using histologically validated spectral data acquired from 932 sampling points in normal tissue and 226 in tumour tissue provided 93.4% sensitivity and 94.9% specificity. Tandem MS identified 63 phospholipids and 6 triglyceride species responsible for 24 spectral differences between tissue types. iKnife recognition accuracy with 260 newly acquired fresh and frozen breast tissue specimens (normal n = 161, tumour n = 99) provided sensitivity of 90.9% and specificity of 98.8%. The ex-vivo and intra-operative method produced visually comparable high intensity spectra. iKnife interpretation

Journal article

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