Primary radiotherapy and deep inferior epigastric perforator flap reconstruction for patients with breast cancer (PRADA): a multicentre, prospective, non-randomised, feasibility study.

BACKGROUND: Radiotherapy before mastectomy and autologous free-flap breast reconstruction can avoid adverse radiation effects on healthy donor tissues and delays to adjuvant radiotherapy. However, evidence for this treatment sequence is sparse. We aimed to explore the feasibility of preoperative radiotherapy followed by skin-sparing mastectomy and deep inferior epigastric perforator (DIEP) flap reconstruction in patients with breast cancer requiring mastectomy. METHODS: We conducted a prospective, non-randomised, feasibility study at two National Health Service trusts in the UK. Eligible patients were women aged older than 18 years with a laboratory diagnosis of primary breast cancer requiring mastectomy and post-mastectomy radiotherapy, who were suitable for DIEP flap reconstruction. Preoperative radiotherapy started 3-4 weeks after neoadjuvant chemotherapy and was delivered to the breast, plus regional nodes as required, at 40 Gy in 15 fractions (over 3 weeks) or 42·72 Gy in 16 fractions (over 3·2 weeks). Adverse skin radiation toxicity was assessed preoperatively using the Radiation Therapy Oncology Group toxicity grading system. Skin-sparing mastectomy and DIEP flap reconstruction were planned for 2-6 weeks after completion of preoperative radiotherapy. The primary endpoint was the proportion of open breast wounds greater than 1 cm width requiring a dressing at 4 weeks after surgery, assessed in all participants. This study is registered with ClinicalTrials.gov, NCT02771938, and is closed to recruitment. FINDINGS: Between Jan 25, 2016, and Dec 11, 2017, 33 patients were enrolled. At 4 weeks after surgery, four (12·1%, 95% CI 3·4-28·2) of 33 patients had an open breast wound greater than 1 cm. One (3%) patient had confluent moist desquamation (grade 3). There were no serious treatment-related adverse events and no treatment-related deaths. INTERPRETATION: Preoperative radiotherapy followed by skin-sparing mastectomy and immediate DIEP flap reconstruction is feasible and technically safe, with rates of breast open wounds similar to those reported with post-mastectomy radiotherapy. A randomised trial comparing preoperative radiotherapy with post-mastectomy radiotherapy is required to precisely determine and compare surgical, oncological, and breast reconstruction outcomes, including quality of life. FUNDING: Cancer Research UK, National Institute for Health Research.

Streamlining Decision Making in Contralateral Risk-Reducing Mastectomy: Impact of PREDICT and BOADICEA Computations.

INTRODUCTION: Patients with sporadic breast cancer (BC) have low contralateral breast cancer risk (CLBCR; approximately 0.7% per annum) and contralateral prophylactic mastectomy (CPM) offers no survival advantage. CPM with autologous reconstruction (AR) has major morbidity and resource implications. OBJECTIVE: The aim of this study was to review the impact of PREDICT survival estimates and lifetime CLBCR scores on decision making for CPM in patients with unilateral BC. METHODS: Of n = 272 consecutive patients undergoing mastectomy and AR, 252 were included. Five- and 10-year survival was computed with the PREDICT(V2) online prognostication tool, using age and clinicopathological factors. Based on family history (FH) and tumor biology, CLBCR was calculated using validated BODICEA web-based software. Survival scores were correlated against CLBCR estimates to identify patients receiving CPM with 'low' CLBCR (< 30% lifetime risk) and poor prognosis (5-year survival < 80%). Patients with 'high' CLBCR receiving unilateral mastectomy (UM) were similarly identified (UK National Institute of Health and Care Excellence [NICE] criteria for CPM, ≥ 30% lifetime BC risk). Justifications motivating CPM were investigated. RESULTS: Of 252 patients, 215 had UM and 37 had bilateral mastectomy and AR. Only 23 (62%) patients receiving CPM fulfilled the NICE criteria. Of 215 patients, 5 (2.3%) failed to undergo CPM despite high CLBCR and good prognosis. CPMs were performed, at the patient's request, for no clear justification (n = 8), contralateral non-invasive disease, and/or FH (n = 5), FH alone (n = 4) and ipsilateral cancer recurrence-related anxiety (n = 3). CONCLUSION: In the absence of prospective risk estimates of CLBCR and prognosis, certain patients receive CPM and reconstruction despite modest CLBCR, yet a proportion of patients with good prognoses and substantial risk are not undergoing CPM.

Correction to: 1 Versus 2-cm Excision Margins for pT2-pT4 Primary Cutaneous Melanoma (MelMarT): A Feasibility Study.

In the original article John F. Thompson was inadvertently omitted as an author. The author list is updated as shown in this correction.

1 Versus 2-cm Excision Margins for pT2-pT4 Primary Cutaneous Melanoma (MelMarT): A Feasibility Study.

BACKGROUND: There is a lack of consensus regarding optimal surgical excision margins for primary cutaneous melanoma > 1 mm in Breslow thickness (BT). A narrower surgical margin is expected to be associated with lower morbidity, improved quality of life (QoL), and reduced cost. We report the results of a pilot international study (MelMarT) comparing a 1 versus 2-cm surgical margin for patients with primary melanoma > 1 mm in BT. METHODS: This phase III, multicentre trial [NCT02385214] administered by the Australia & New Zealand Medical Trials Group (ANZMTG 03.12) randomised patients with a primary cutaneous melanoma > 1 mm in BT to a 1 versus 2-cm wide excision margin to be performed with sentinel lymph node biopsy. Surgical closure technique was at the discretion of the treating surgeon. Patients' QoL was measured (FACT-M questionnaire) at baseline, 3, 6, and 12 months after randomisation. RESULTS: Between January 2015 and June 2016, 400 patients were randomised from 17 centres in 5 countries. A total of 377 patients were available for analysis. Primary melanomas were located on the trunk (56.9%), extremities (35.6%), and head and neck (7.4%). More patients in the 2-cm margin group required reconstruction (34.9 vs. 13.6%; p < 0.0001). There was an increased wound necrosis rate in the 2-cm arm (0.5 vs. 3.6%; p = 0.036). After 12 months' follow-up, no differences were noted in QoL between groups. DISCUSSION: This pilot study demonstrates the feasibility of a large international RCT to provide a definitive answer to the optimal excision margin for patients with intermediate- to high-risk primary cutaneous melanoma.

The feasibility and safety of immediate breast reconstruction in the COVID-19 era.

The coronavirus disease-2019 pandemic has had a significant impact on the delivery of surgical services, particularly reconstructive surgery. This article examines the current evidence to assess the feasibility of recommencing immediate breast reconstruction services during the pandemic and highlights considerations required to ensure patient safety.

A Unifying Algorithm in Microvascular Reconstruction of Oral Cavity Defects Using the Trilaminar Concept.

Although many algorithms exist to classify oral cavity defects, they are limited by either considering a single subsite or failing to provide a concise reconstructive algorithm for the breadth of defects. Based upon our experience as a tertiary referral center, a unifying algorithm is presented that guides free flap selection in this heterogenous population. METHODS: All intraoral defects requiring microvascular reconstruction from February 2012 to August 2018 were reviewed. Defects were classified according to their depth as unilaminar (type U = mucosa only), bilaminar (type B = mucosa and bone), or trilaminar (type T = mucosa, bone, and skin) and the number and side of mucosal zones involved (from 1 to 5). Hard palate defects were considered separately and excluded if part of a wider maxillectomy defect. RESULTS: A total of 118 patients were eligible for inclusion in the study. Of type U defects involving 1 mucosal zone, 98% were reconstructed with a radial forearm free flap. Ninety-two percentage of type U defects involving ≥2 mucosal zones were reconstructed with an anterolateral thigh flap. Among type B defects, 86% were reconstructed with a fibula osseocutaneous free flap if less than 4 mucosal zones were involved and 100% reconstructed with an ALT if ≥4 mucosal zones were involved. The algorithm presented was accurate for 93% of the cases. Ninety-eight percentage of patients achieved intelligible speech and 72% returned to a normal diet. Flap success rate was 100%. CONCLUSIONS: The algorithm presented provides a simple system to guide the reconstruction of oral cavity defects.

Secondary free tissue transfer in head and neck reconstruction.

BACKGROUND: The incidence of head and neck cancer (H&N) continues to increase together with the need for reconstructive surgery. Head and Neck microsurgeons are likely to encounter challenging secondary free flap surgery on the background of failed primary flaps, radiotherapy treatment or recurrence. The aim of this study was to review our experience of treating such cases in a tertiary referral centre in the United Kingdom. METHODS: We performed a retrospective analysis of all patients undergoing sequential free flap surgery for head and neck defects in our unit during 2010-2017. Parameters recorded included indication for surgery, type and sequence of reconstruction, recipient vessel use and post-operative complications. RESULTS: We identified 17 patients who underwent 39 free tissue transfers for the reconstruction of head and neck defects (five transfers were performed at other units). The radial forearm and anterolateral thigh flaps were most commonly used. Almost a quarter of patients underwent three or more free flap reconstructive procedures. In over a third, the same vein and artery were used for subsequent anastomoses, and we used five vein grafts over 68 anastomoses. There were no flap failures recorded. CONCLUSIONS: Secondary free flaps in the head and neck are required for a variety of aetiologies and can have success rates similar to those for primary free tissue transfers with minimal morbidity and mortality. Free tissue transfer is the best reconstructive option in H&N patients and should still be considered the first choice option in salvage cases until the patient's donor sites have been depleted.

Pervasive wearable device for free tissue transfer monitoring based on advanced data analysis: clinical study report.

Free tissue transfer (FTT) surgery for breast reconstruction following mastectomy has become a routine operation with high success rates. Although failure is low, it can have a devastating impact on patient recovery, prognosis, and psychological well-being. Continuous and objective monitoring of tissue oxygen saturation (StO2) has been shown to reduce failure rates through rapid detection time of postoperative vascular complications. We have developed a pervasive wearable wireless device that employs near-infrared spectroscopy (NIRS) to continuously monitor FTT via StO2 measurement. Previously tested on different models, the results of a clinical study are introduced. Our goal for the study is to demonstrate that the developed device can reliably detect StO2 variations in a clinical setting: 14 patients were recruited. Advanced data analysis was performed on the StO2 variations, the relative StO2 gradient change, and the classification of the StO2 within different clusters of blood occlusion level (from 0% to 100% at 25% step) based on previous studies made on a vascular phantom and animals. The outcomes of the clinical study concur with previous experimental results and the expected biological responses. This suggests that the device is able to correctly detect perfusion changes and provide real-time assessment on the viability of the FTT in a clinical setting.

Factors that predict deep inferior epigastric perforator flap donor site hernia and bulge.

Deep inferior epigastric artery perforator (DIEP) flap has become the gold standard in autologous breast reconstruction. Attention is now being focused on the impact of DIEP flap harvest technique on abdominal hernia rates. The aim of this study was to evaluate DIEP abdominal wall morbidity in relation to flap harvest and fascial closure technique. A retrospective analysis of patients undergoing DIEP flap breast reconstruction between 2012 and 2016 was performed. Post-operative evaluation of the abdominal wall integrity was performed by an operating consultant. The rectus fascia was closed using one of three techniques. The study included 202 patients, in whom 234 DIEP flaps were performed. Eight patients (3.4%) developed a clinically evident abdominal bulge post-operatively and one (0.5%) had a hernia. Harvesting two or more perforators was more likely to result in post-operative abdominal hernia/bulge than taking a single perforator (p = .032). Using a perforator from the lateral row or both rows was more likely to result in a hernia/bulge than if a single medial perforator was harvested (p = .026). Comparison of the rectus fascia closure technique did not show any statistically significant difference in abdominal wall morbidity. Consideration should be given towards perforator selection when harvesting a DIEP flap. Where appropriate, a suitable single medial row perforator with a favourable suprafascial course should be chosen. This study has not shown mesh-free fascial closure to be inferior to mesh-supported closure. Careful consideration to the role of synthetic mesh within this patient cohort should be given.

Predicting and planning for SIEA flap utilisation in breast reconstruction: An algorithm combining pre-operative computed tomography analysis and intra-operative angiosome assessment.

BACKGROUND: Low flap complication rates and excellent aesthetic outcomes are now commonplace in breast reconstruction. As a result, attention is now being focussed on minimising donor site morbidity. Despite its potential donor site advantages, the superficial inferior epigastric artery (SIEA) flap is often discounted, given concerns about the high flap failure rates. In this study, we present our experience of using the SIEA flap in breast reconstruction and provide an algorithm based on pre-operative computed tomography angiography (CTA) to aid pre-operative planning. METHODS: A retrospective analysis of SIEA flap breast reconstruction cases performed at our unit between 2009 and 2016 was performed and outcomes were assessed. In addition, the patients' pre-operative CTA images were assessed and compared to those of a matched group of patients who underwent deep inferior epigastric artery perforator (DIEP) flap breast reconstruction. RESULTS: Twenty-six patients who underwent SIEA flap breast reconstruction were eligible for inclusion. No flaps were lost. Donor site seroma rate was 20%. The largest SIEA diameter in those who underwent an SIEA flap was significantly larger (p = 0.0001) than in those who underwent DIEP flap breast reconstruction. Significantly more number of patients who underwent SIEA flap breast reconstruction had a SIEA diameter greater than or equal to that of the largest DIEP flap perforator (p = 0.0001) in the group where a DIEP flap was used for breast reconstruction. CONCLUSION: High success rates can be achieved with abdominal flaps based on the superficial vascular system and careful pre- and perioperative assessment of patients.

A prospective randomized trial comparing 2-octyl cyanoacrylate to conventional suturing in closure of laparoscopic cholecystectomy incisions.

OBJECTIVE: To compare 2-octyl cyanoacrylate (Dermabond) with conventional suturing for closure of laparoscopic cholecystectomy (LC) wounds in a prospective randomized controlled trial. SUBJECTS: Twenty-five consecutive patients underwent LC at a teaching hospital in the United Kingdom. Patients were randomly allocated to have skin closed with 2-octyl cyanoacrylate or absorbable suture. METHODS: Fifty-one wounds underwent skin closure with absorbable subcuticular suture (3/0 polydiaxanone) and 48 wounds were closed with tissue adhesive. The time to close the wounds, including the placement of dressings, was recorded. At 6 to 8 weeks, the incisions were evaluated with the Hollander wound evaluation scale (HWES). Using a visual analogue scale (VAS), the wounds were also rated by a plastic surgeon who was blinded to the method of closure. RESULTS: The wounds were closed significantly faster in the Dermabond group (mean 165 seconds versus 356 seconds, P = 0.03). There were no differences in the percentage of wounds achieving optimal scores on the HWES (suture 64.7% versus tissue adhesive 60.4%, P = 0.42) nor on the mean VAS (suture 62 mm versus tissue adhesive 59 mm, P = 0.45). CONCLUSION: The tissue adhesive 2-octyl cyanoacrylate is a safe and fast method for closure of LC wounds, with cosmetic results comparable to suturing.

The use of computed tomography for the estimation of DIEP flap weights in breast reconstruction: a simple mathematical formula.

BACKGROUND: Estimation of the volume of abdominal tissue is desirable when planning autologous abdominal based breast reconstruction. However, this can be difficult clinically. The aim of this study was to develop a simple, yet reliable method of calculating the deep inferior epigastric artery perforator flap weight using the routine preoperative computed tomography angiogram (CTA) scan. METHODS: Our mathematical formula is based on the shape of a DIEP flap resembling that of an isosceles triangular prism. Thus its volume can be calculated with a standard mathematical formula. Using bony landmarks three measurements were acquired from the CTA scan to calculate the flap weight. This was then compared to the actual flap weight harvested in both a retrospective feasibility and prospective study. RESULTS: In the retrospective group 17 DIEP flaps in 17 patients were analyzed. Average predicted flap weight was 667 g (range 293-1254). The average actual flap weight was 657 g (range 300-1290) giving an average percentage error of 6.8% (p-value for weight difference 0.53). In the prospective group 15 DIEP flaps in 15 patients were analyzed. Average predicted flap weight was 618 g (range 320-925). The average actual flap weight was 624 g (range 356-970) giving an average percentage error of 6.38% (p-value for weight difference 0.57). CONCLUSIONS: This formula is a quick, reliable and accurate way of estimating the volume of abdominal tissue using the preoperative CTA scan.

Rhinoplasty and septorhinoplasty outcome evaluation.

Outcome measures are a crucial tool in the analysis and comparison of medical interventions. We review the subjective and objective methods of assessing outcomes of rhinoplasty and septorhinoplasty. Both form and function of the nose are considered.

Surgical management of radiation-induced angiosarcoma after breast conservation therapy.

BACKGROUND: Radiation-induced angiosarcoma (RA) is a well-recognized complication of breast conservation therapy (BCT). METHODS: Over a 12-year period, 14 patients with a median age of 68 years were identified retrospectively. The median latency from BCT to onset of RA was 81 months. The incomplete excision rate (complete histologic margin taken to be > 10 mm) was 46%. There was a significant difference in the size of the cutaneous defect between the complete and incomplete excision groups (412 vs 592 cm(2), respectively; P < .05), indicating more extensive disease in the latter group. RESULTS: The tumor recurred locally in 12 patients (92%). The median time to local recurrence (LR) in patients with incomplete excision was 3 versus 23 months in patients who had a complete excision. The median survival time for patients who underwent complete versus incomplete excision was 42 and 6 months, respectively. CONCLUSIONS: RA is a challenging condition, with a prolonged latency period and variable clinical progression. Incomplete excision of RA is a surrogate marker of aggressive disease and is associated with rapid LR and poor survival.