Results of shared learning of a new magnetic seed localisation device - A UK iBRA-NET breast cancer localisation study.

INTRODUCTION: Shared learning is imperative in the assessment and safe implementation of new healthcare interventions. Magnetic seeds (Magseed®) potentially offer logistical benefit over wire localisation for non-palpable breast lesions but few data exist on outcomes comparing these techniques. A national registration study (iBRA-NET) was conducted to collate device outcomes. In order to share learning, thematic analysis was conducted to ascertain early clinical experiences of Magseed® and wire guided localisation and explore how learning events may be applied to improve clinical outcomes. METHODS: A qualitative study of 27 oncoplastic surgeons, radiologists and physicians was conducted in January 2020 to ascertain the feasibility and challenges associated with Magseed® versus wire breast localisation surgery. Four focus groups were asked to discuss experiences, concerns and shared learning outcomes which were tabulated and analysed thematically. RESULTS: Three key themes were identified comparing Magseed® and wire localisation of breast lesions relating to preoperative, intraoperative and postoperative learning outcomes. Percutaneous Magseed® detection, instrument interference and potential seed or wire dislodgement were the most common issues identified. Clinician experience suggested Magseed® index lesion identification was non-inferior to wire placement and improved the patient pathway in terms of scheduling and multi-site insertion. CONCLUSIONS: Prospective shared learning suggested Magseed® offered additional non-clinical benefits over wire localisation, improving the efficiency of the patient pathway. Recommendations for improving breast localisation technique, appropriate patient selection and clinical practice through shared learning are discussed that may aid other surgeons in the adoption of this relatively new technique.

Wire- and magnetic-seed-guided localization of impalpable breast lesions: iBRA-NET localisation study.

BACKGROUND: Wire localization is historically the most common method for guiding excision of non-palpable breast lesions, but there are limitations to the technique. Newer technologies such as magnetic seeds may allow some of these challenges to be overcome. The aim was to compare safety and effectiveness of wire and magnetic seed localization techniques. METHODS: Women undergoing standard wire or magnetic seed localization for non-palpable lesions between August 2018 and August 2020 were recruited prospectively to this IDEAL stage 2a/2b platform cohort study. The primary outcome was effectiveness defined as accurate localization and removal of the index lesion. Secondary endpoints included safety, specimen weight and reoperation rate for positive margins. RESULTS: Data were accrued from 2300 patients in 35 units; 2116 having unifocal, unilateral breast lesion localization. Identification of the index lesion in magnetic-seed-guided (946 patients) and wire-guided excisions (1170 patients) was 99.8 versus 99.1 per cent (P = 0.048). There was no difference in overall complication rate. For a subset of patients having a single lumpectomy only for lesions less than 50 mm (1746 patients), there was no difference in median closest margin (2 mm versus 2 mm, P = 0.342), re-excision rate (12 versus 13 per cent, P = 0.574) and specimen weight in relation to lesion size (0.15 g/mm2versus 0.138 g/mm2, P = 0.453). CONCLUSION: Magnetic seed localization demonstrated similar safety and effectiveness to those of wire localization. This study has established a robust platform for the comparative evaluation of new localization devices.

A Novel Mixed-Methods Platform Study Protocol for Investigating New Surgical Devices, with Embedded Shared Learning: Ibra-net Breast Lesion Localisation Study.

INTRODUCTION: New medical devices must have adequate research, such that outcomes are known, enabling patients to be consented with knowledge of the safety and efficacy of the device to be implanted. Device trials are challenging due to the learning curve and iterative assessment of best practice. This study is designed to pilot a national collaborative approach to medical device introduction by breast surgeons in the UK, using breast localisation devices as an exemplar. The aim is to develop an effective and transferable surgical device platform protocol design, with embedded shared learning. METHODS AND ANALYSIS: The iBRA-net localisation study is a UK based prospective, multi-centre platform study, comparing the safety and efficacy of novel localisation devices with wire-guided breast lesion localisation for wide local excision, using Magseed® as the pilot intervention group. Centres performing breast lesion localisation for wide local excision or excision biopsy will be eligible to participate if using one of the included devices. Further intervention arms will be added as new devices are CE marked. Outcomes will be collected via an online database. The primary outcome measure will be identification of the index lesion. Participating surgeons will be asked to record shared learning events via online questionnaires and focus group interviews to inform future study arms. ETHICS AND DISSEMINATION: The study will aim to collect data on 950 procedures for each intervention (Magseed® and wire localisation) from UK breast centres over an 18-month period. Shared learning will be prospectively evaluated via thematic analysis to refine breast localisation technique and to promote early identification of potential pitfalls and problems. Results will be presented at national and international conferences and published in peer reviewed journals. REGISTRATION: This is a UK national audit registered with Manchester University NHS Foundation Trust. HIGHLIGHTS: This protocol outlines a novel methodology for a collaborative national platform study to collate safety and efficacy data on new medical devices. Improved registration and audit of new medical devices is a major theme of the Cumberlege report of the Independent Medicines and Medical Devices Safety Review.We outline a protocol for a UK based multi-centre prospective audit to investigate the safety and efficacy of new surgical devices for breast lesion localisation. The study will run as a platform study using wire localisation as a control group and Magseed® as the first intervention arm.The protocol is designed for additional bolt-on intervention arms for other localisation devices, such as Hologic Localizer™ and Savi Scout®, when they become available to the European market. This will enable comparison of these devices to datasets already collected on wire and Magseed® localisation.The study includes a novel shared learning methodology using iterative online database reporting and surgical interviews to centrally distribute information on learning events, critical governance issues and recommended protocols for future use.

Impalpable breast lesion localisation, a logistical challenge: results of the UK iBRA-NET national practice questionnaire.

INTRODUCTION: Breast conserving surgery of impalpable breast lesions requires safe and effective localisation techniques. Wire localisation has traditionally been used, but has limitations. Newer techniques are now being introduced to mitigate this. The iBRA-NET group aims to robustly evaluate these new techniques in well-designed prospective studies. We report the first phase of this evaluation, a survey to establish current practice and service provision of breast localisation techniques in the UK. METHODS: A national practice questionnaire was designed using 'SurveyMonkey®' and was circulated to UK breast surgeons via the Association of Breast Surgery and the Mammary Fold. The questionnaire was live from 6th October 2018 to 6th April 2019. Only one response per unit was requested to reflect the unit's practice. RESULTS: Complete responses were received from 98 breast units across the UK. Wires were the mostly commonly used localisation technique (n = 82) with fewer units using Magseed® (n = 9), Radioguided Occult Lesion Localisation (n = 5) and Radioiodine Seed Localisation (n = 2). There was significant variation in practice and logistics involved. Frequent delays and theatre overruns were reported in 39 and 16 units, respectively. The median satisfaction score of the current technique was 7 out of 10. The main perceived limitation of existing localisation methods was logistics affecting theatre scheduling and the main barrier to introducing a new technique was cost. CONCLUSION: Wires are currently the most commonly used localisation technique but are associated with significant logistical issues. Newer techniques may offer a better solution but will need robust evaluation before they are adopted to ensure safety and efficacy.

Is the future magnetic? Magseed localisation for non palpable breast cancer. A multi-centre non randomised control study.

INTRODUCTION: Magseed is an alternative method of localising non-palpable breast lesions that has addressed many of the limitations of wire guided localisation (WGL). It consists of a paramagnetic seed that can be visualised on mammography and ultrasound. Intraoperative localisation of the seed is achieved with the use of the Sentimag probe. The aim of this study was to prospectively compare localisation in patients undergoing wide local excision (WLE) for non-palpable lesions between Magseed and WGL. METHODS: We prospectively collected data on all patients undergoing image-guided WLE between October 2017 and September 2018 in two academic breast units with a planned accrual of 100 consecutive patients undergoing Magseed localisation. Data was also collected on a cohort of 100 consecutive patients undergoing WGL in the same time period. RESULTS: Demographic and disease characteristics were well balanced between the two groups. 4/104 patients were converted preoperatively from Magseed to WGL (2 misplaced Magseeds; 2 undetected Magseeds). Intraoperative identification and excision of the localised lesion was successful in all patients as confirmed with specimen radiography. Overall no significant differences were observed in the proportion of patients requiring re-excision between the two groups (Magseed 16% vs. WGL 14% p = 0.692). Specimens size by weight and volume was similar for both groups (Magseed 39.6 g vs. WGL 44.5 g p = 0.206 and 90.1 cm3 for Magseed vs. 95.6 cm3 for WGL p = 0.579). CONCLUSIONS: In our series Magseed localisation proved to be as reliable and effective as WGL in terms of lesion identification, excision with tumour free margins and specimen weight.

Effect of PREDICT on chemotherapy/trastuzumab recommendations in HER2-positive patients with early-stage breast cancer.

PREDICT is an online prognostication tool for early-stage breast cancer, which incorporates human epidermal growth factor 2 (HER2) status and stratifies absolute treatment benefits for hormone therapy, chemotherapy and trastuzumab. The present study compared historical multidisciplinary team (MDT) decisions regarding adjuvant treatment with PREDICT estimates, to determine whether certain patients are being over- or undertreated, particularly when stratified by age and oestrogen-receptor (ER) status. HER2-positive early-stage breast cancer cases over a five-year period at the Cambridge Breast Unit (Addenbrooke's Hospital, Cambridge, UK) were retrospectively reviewed. Patients receiving neo-adjuvant therapy were excluded. Adjuvant chemotherapy/trastuzumab recommendations based on PREDICT (<3%, no benefit; 3-5%, discuss treatment; and >5%, recommend treatment) were compared with actual MDT decisions. In total, 109 eligible patients were identified. The average age at diagnosis was 59.6 years, with 21 patients older than 70 years (19%). Four patients were predicted to gain an absolute benefit of >5% from chemotherapy/ trastuzumab, but were not offered treatment (all >70 years). Amongst the 19 patients aged >70 years predicted to benefit >3%, six were not offered treatment (32%). In the patients aged <69 years, there was evidence of overtreatment with adjuvant chemotherapy/trastuzumab in 8 out of 12 cases with <3% benefit using PREDICT. For all 20 patients with ER-negative tumours, the MDT and PREDICT decisions correlated, whilst for ER-positive cases, more than half (8 out of 14) were offered treatment despite a <3% predicted benefit. PREDICT can aid decision-making in HER2-positive early-stage breast cancer by identifying older patients at risk of undertreatment with chemotherapy/trastuzumab, and by reducing the overtreatment of patients with little predicted benefit, particularly in ER-positive disease.

Oncological advantages of oncoplastic breast-conserving surgery in treatment of early breast cancer.

The standard approach to breast-conserving surgery is wide local excision of the tumor and radiotherapy. However, a significant number of patients require further surgery to obtain oncologically clear margins, and may obtain a poor cosmetic result following adjuvant radiotherapy. Oncoplastic techniques may result in improved cosmesis, but few studies have investigated the oncological advantage of this approach. The aim of this retrospective study was to compare tumor clearance and the need for further margin excision following standard wide local excision (group A, 121 patients), and oncoplastic breast-conserving surgery (group B, 37 patients). These techniques included therapeutic mammoplasty, sub-axillary fat pad rotation mammoplasty, thoraco-epigastric flap, and central flap. Compared to standard surgery (group A), oncoplastic techniques (group B) can be employed for significantly larger tumors (17.6 mm versus 23.9 mm, p = 0.002). Oncoplastic breast-conserving surgery results in higher mean specimen weights (58.1 g versus 231.1 g, p < 0.0001), higher specimen volumes (112.3 cm(3) versus 484.5 cm(3) , p < 0.0001), and wider clear margins (6.1 mm versus 14.3 mm, p < 0.0001), resulting in lower rates of further surgery (28.9% versus 5.4%, p = 0.002). There was no statistical increase in complication rates following oncoplastic surgery. Oncoplastic breast-conserving surgery is more successful than standard wide local excision in treating larger tumors and obtaining wider radial margins, thus reducing the need for further margin excision, which delays adjuvant therapy. There was no increase in postoperative complication rate using an oncoplastic approach.

Avoiding back wound dehiscence in extended latissimus dorsi flap reconstruction.

BACKGROUND: The latissimus dorsi breast reconstruction flap has a number of advantages, but despite the advances in surgical techniques, it has remained vulnerable to skin dehiscence or necrosis at the donor site. We describe a novel surgical technique to prevent this. METHODS: Patients treated with extended latissimus dorsi flap reconstruction between January 2005 and January 2010 were studied prospectively. RESULTS: Eighteen patients were reviewed (12 immediate and 6 delayed). Two patients were smokers. The mean age was 54.4 (range: 42-64) years and the mean body mass index was 31.6 (range: 22.3-38). The mean weight of the mastectomy specimen was 551 g (range: 280-980 g). Six patients developed back seroma which required aspiration, and one patient developed a haematoma of the reconstructed breast. All wounds healed primarily. CONCLUSION: The new technique is safe, simple and effective in avoiding wound dehiscence at the donor site after extended latissimus dorsi flap reconstruction.

Training the oncoplastic breast surgeon-current and future perspectives.

Oncoplastic breast surgery has evolved to become a distinct subspecialty within the field of general surgery. The oncoplastic breast surgeon requires comprehensive knowledge and understanding of all aspects of breast oncology, in addition to technical proficiency in operative procedures to remodel and reconstruct the breast. This article describes current educational resources available for the training of oncoplastic breast surgeons both within the UK and internationally. A recent development is the online Master of Surgery degree in Oncoplastic Breast Surgery, based at the University of East Anglia in the UK. This innovative course combines delivery of clinical knowledge using interactive problem-based forum discussions with assessment of operative and decision making skills. The degree is facilitated and assessed by an expert specialist breast faculty, and requires students to achieve standards expected of a first year practising UK oncoplastic breast consultant. Future international developments using this blended educational model are discussed.

Low ninety-day re-admission rates after emergency and elective laparoscopic cholecystectomy in a district general hospital.

INTRODUCTION: Re-admission rate following laparoscopic cholecystectomy is currently defined as within 30 days of the initial operation. This may underestimate the true incidence and financial cost of postoperative morbidity. This study aimed to analyse re-admissions within 90 days of elective and emergency laparoscopic cholecystectomy at a district general hospital, and to compare outcomes to larger teaching centres. PATIENTS AND METHODS: We undertook a retrospective analysis of all patients re-admitted within 90 days of laparoscopic cholecystectomy during an 18-month period (June 2006 to December 2007). Patient characteristics, details of the primary operation, and reasons for re-admission were identified, and a comparison of re-admissions following elective versus emergency procedures was performed. RESULTS: A total of 326 laparoscopic cholecystectomies were performed during the 18-month period (246 elective, 80 emergency). No operations required conversion to an open procedure. Twenty-five patients were re-admitted within 90 days of their operation, of whom only 14 had complications directly related to their surgery (overall re-admission rate 4.3%). There was no statistical difference in re-admission rate or cause of re-admission between elective and emergency procedures. However, the mean time to re-admission following elective procedures was significantly longer (36 days; P = 0.0003). CONCLUSIONS: Re-admission rates at our district general hospital are comparable to those reported by larger teaching centres. Current 30-day re-admission data may significantly underestimate morbidity rates and socio-economic cost following elective laparoscopic cholecystectomy.

Nintendo Wii video-gaming ability predicts laparoscopic skill.

BACKGROUND: Studies using conventional consoles have suggested a possible link between video-gaming and laparoscopic skill. The authors hypothesized that the Nintendo Wii, with its motion-sensing interface, would provide a better model for laparoscopic tasks. This study investigated the relationship between Nintendo Wii skill, prior gaming experience, and laparoscopic skill. METHODS: In this study, 20 participants who had minimal experience with either laparoscopic surgery or Nintendo Wii performed three tasks on a Webcam-based laparoscopic simulator and were assessed on three games on the Wii. The participants completed a questionnaire assessing prior gaming experience. RESULTS: The score for each of the three Wii games correlated positively with the laparoscopic score (r = 0.78, 0.63, 0.77; P < 0.001), as did the combined Wii score (r = 0.82; P < 0.001). The participants in the top tertile of Wii performance scored 60.3% higher on the laparoscopic tasks than those in the bottom tertile (P < 0.01). Partial correlation analysis with control for the effect of prior gaming experience showed a significant positive correlation between the Wii score and the laparoscopic score (r = 0.713; P < 0.001). Prior gaming experience also correlated positively with the laparoscopic score (r = 0.578; P < 0.01), but no significant difference in the laparoscopic score was observed when the participants in the top tertile of experience were compared with those in the bottom tertile (P = 0.26). CONCLUSIONS: The study findings suggest a skill overlap between the Nintendo Wii and basic laparoscopic tasks. Surgical candidates with advanced Nintendo Wii ability may possess higher baseline laparoscopic ability.