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.

Seat belt-related injuries: A surgical perspective.

INTRODUCTION: Legislation making seatbelt use mandatory is considered to have reduced fatal and serious injuries by 25%, with UK government estimates predicting more than 50,000 lives saved since its introduction. However, whilst the widespread use of seatbelts has reduced the incidence of major traumatic injury and death from road-traffic collisions (RTCs), their use has also heralded a range of different injuries. The first ever seatbelt related injury was described in 1956, and since then clear patterns of seatbelt-related injuries have been recognised. METHODOLOGY AND FINDINGS: This review of the published literature demonstrates that the combination of airbags and three-point seatbelts renders no part of the body free from injury. Serious injuries can, and do, occur even when passengers are properly restrained and attending clinicians should have a high index of suspicion for overt or covert intra-abdominal injuries when patients involved in RTCs attend the Emergency Department. Bruising to the trunk and abdomen in a seatbelt distribution is an obvious sign that suggests an increased risk of abdominal and thoracic injury, but bruising may not be apparent and its absence should not be falsely reassuring. A high index of suspicion should be retained for other subtler signs of injury. Children and pregnant women represent high-risk groups who are particularly vulnerable to injuries. CONCLUSION: In this review we highlight the common patterns of seatbelt-related injuries. A greater awareness of the type of injuries caused by seatbelt use will help clinicians to identify and treat overt and covert injuries earlier, and help reduce the rates of morbidity and mortality following RTCs.

Acute pain management in symptomatic cholelithiasis.

AIM: To review the evidence for the use of different non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of biliary colic. METHODS: The strategies employed included an extensive literature review for articles and studies related to biliary colic from electronic databases including PubMed, Science Direct, Wiley Inter Science, Medline and Cochrane from last 15 years. Keywords: "Biliary colic", "management of biliary colic", "non-steroidal anti-inflammatory drugs", "cholelithiasis" and "biliary colic management". Six randomized control trials, 1 non-randomized trial and 1 meta-analysis were included in this review. The outcomes of these studies and their significance have been reviewed in this paper. RESULTS: Current evidence suggests there are no set protocols for biliary colic pain management. NSAIDs are potent in the management of biliary colic, not only in terms of symptom control but in disease progression as well. Apart from the studies on diclofenac and ketorolac, there are studies which have shown that intravenous tenoxicam and injectable flurbiprofen are equally effective in managing biliary colic. The efficacy of NSAIDs is superior in terms of lower number of doses and longer duration of action in comparison to other analgesic agents. CONCLUSION: This literature review has found that NSAIDs are safe and effective for pain control in biliary colic, and reduce the likelihood of further complications.

Predictors of blood transfusion requirement in elective liver resection.

BACKGROUND: Liver resection remains major surgery frequently requiring intra-operative blood transfusion. Patients are typically over cross-matched, and with blood donor numbers falling, cross-matching and transfusion policies need rationalizing. AIM: To identify predictors of peri-operative blood transfusion. METHODS: A retrospective review of elective hepatic resections over a 4-year period was performed. Twenty-six variables including clinicopathological variables and intra-operative data were collated, together with the number of units of blood cross-matched and transfused in the immediate peri-operative period (48 h). Multivariate regression analysis was performed to identify independent predictors of blood transfusion, and a Risk Score for transfusion constructed. RESULTS: Five hundred and eighty-nine patients were included in the study, and were cross-matched with a median 10 units of blood. Seventeen per cent of patients received a blood transfusion; median transfusion when required was 2 units. Regression analysis identified seven factors predictive of transfusion: haemoglobin <12.5 g/dL, pre-operative biliary drainage, coronary artery disease, largest tumour >3.5 cm, cholangiocarcinoma, redo resection and extended resection (5+ segments). Patients were stratified into high or low risk of transfusion based on Risk Score with a sensitivity of 73% [receiver-operating characteristic (ROC) 0.77]. CONCLUSIONS: Patients undergoing elective liver resection are over-cross-matched. Patients can be classified into high and low risk of transfusion using a Risk Score, and cross-matched accordingly.

Malignant pleural effusion in the presence of trapped lung. Five-year experience of PleurX tunnelled catheters.

Malignant pleural effusions in the presence of trapped lung remain notoriously difficult to treat. Various methods exist ranging from minimally invasive procedures including repeated needle thoracocentesis to the need for a formal surgical procedure such as placement of a pleuroperitoneal shunt and even thoracotomy and decortication. Controversy exists as to what is the optimum treatment for this condition. Any planned treatment should balance the therapeutic benefit provided against convalesce for a disease with a limited life expectancy. Patients should not spend a significant proportion of their remaining life span recovering from palliative procedures. In a series of patients with malignant pleural effusion the medial survival time was 20 weeks, with 30 days and 1 year mortality rates of 12.8% and 83.6%, respectively. We describe our five-year experience with the use of indwelling PleurX catheters in patients with malignant pleural effusions in the presence of confirmed trapped lung on radiological or VATS investigation. Patient health related quality of life was investigated by telephone questionnaire. The parameters analysed were symptomatic relief, mobility and ease of management following insertion. One hundred and sixteen patients underwent PleurX catheter insertion by a single operator, 48 questionnaires were completed. Of the 48 cases analysed, improvement in all three quality of life indices was recorded following catheter insertion. Ease of mobility was recorded as moderately satisfied and very satisfied in 50% and 15% of patients, respectively. Symptomatic improvement was found to have been increased with 42% and 6% of patients responding to moderately satisfied and very satisfied, respectively. Ease of management was recorded as 'slightly satisfied' and moderately satisfied in 50% and 33% of patients, respectively, demonstrating a high satisfaction index in patients with chronic progressively debilitating malignancies. Complications were either transient or readily correctable. Pain was the predominant complication occurring in 35% of patients lasting <3 days. No patient required catheter removal for resolution of discomfort. Our findings support the use of PleurX catheters for palliative patients with malignant pleural effusions in the presence of trapped lung. The catheters are not only easy to insert and discrete but they can be managed effectively by patients and community nurse practitioners and prevent repeated admissions to hospital in palliative patients with compromised life expectancy.