The 6 month interim analysis of a randomized controlled trial assessing the quality of life in patients with breast cancer related lymphedema undergoing lymphaticovenous anastomosis vs. conservative therapy.

Breast cancer related lymphedema (BCRL) is a chronic condition with a detrimental impact on psychosocial and physical well-being. Lymphaticovenous anastomosis has shown promising results in alleviating physical symptoms and increasing quality of life in patients with BCRL. The aim of the study is to evaluate the effect on health related quality of life (HrQol) after LVA surgery versus conservative treatment in patients with BCRL. The study is a prospective, multicenter randomized controlled trial. Adult women with unilateral BCRL, with early stage lymphedema and viable lymphatic vessels were included. The primary outcome measure was HrQol measured by the lymphedema functioning disability and health (Lymph-ICF) questionnaire. The secondary outcomes were volume difference measured by the water displacement method; the Upper Extremity Lymphedema (UEL) index; and daily use of the compression garments after 3 and 6 months. For this interim analysis 46 patients per group were included. There was a significant improvement in the domains in physical and mental function in the Lymph-ICF questionnaire in the LVA group after 6 months, (- 16.46 ± 18.5, p < 0.05, - 10.12 ± 29.5, p < 0.05 respectively). However, there was no statistical difference in the total score of the Lymph-ICF after 6 months in both groups (LVA-group; - 8.57 ± 22.6, p > 0.05, CDT-group; - 2.65 ± 18.2, p < 0.05). Furthermore, there was no significant volume reduction in both groups (LVA-group: 20.04 ± 196.40, p = 0.497, CDT: 33.98 ± 189.87, p = 0.236). In the LVA group, 41% partially of completely stopped wearing the compression garments after six months whereas in the CDT group 0% discontinued to use of compression garments. LVA resulted in improvement of the domains physical and mental function of the Lymph-ICF. Limb volume did not significantly improve after 6 months. However, around 42% could completely or partially stopped with the use of compression garments in the LVA group. The current results are promising, however longer follow up is required to assess long term effect of LVA for secondary lymphedema. Clinical Trial Registration: NCT02790021 registered on 03/06/2016.

A Dutch randomized controlled study shows autologous fat transfer with pre-expansion is more cost-effective in the long term than implants.

BACKGROUND: One in seven women will develop breast cancer, making it the most common female cancer worldwide. Consequently, breast cancer-related treatment, including breast reconstruction, impacts societal costs. Autologous fat transfer (AFT) is a relatively new breast reconstruction technique; however, several surgeries are necessary. This study investigates if AFT with pre-expansion is more cost-effective than implant-based reconstruction (IBR). METHODS: Seven centers assigned patients randomly from 2015 to 2021 to evaluate costs and EQ-5D-5L quality-adjusted life years (QALY) of AFT vs. IBR at 12 months postoperative. Costs were calculated, including direct costs related to treatment and PROductivity and DISease Questionnaire, to estimate productivity loss (indirect costs). Sensitivity analyses were performed for 10- and 30 years to estimate costs for patients replacing or explanting their breast implants over time. RESULTS: A total of 152 women, of which 91 received AFT (mean age 49.3) and 80 IBR (mean age 49.1). The mean EQ-5D-5L QALY in the AFT group was 0.83, compared with the IBR group of 0.79. Total costs for AFT at 12 months postoperative were higher than IBR (incremental cost: €6763.59). Sensitivity analyses for 10- and 30-year scenarios showed mean incremental costs of respectively €2586.56 and €680.22. CONCLUSION: Mean EQ-5D-5L QALY and costs were higher for AFT over the first year after reconstruction. However, these costs were low; therefore, AFT was estimated to be more cost-effective over the 10- and 30-year period since no additional surgeries are necessary for this group. Larger cohorts are required to confirm AFT is more cost-effective in the long term.

COVID-associated complications after reconstructive breast surgery: a retrospective cohort study.

PURPOSE: The COVID pandemic significantly influenced reconstructive breast surgery regimens. Many surgeries were cancelled or postponed. COVID entails not only respiratory, but also coagulative symptoms. It, therefore, potentially increases the risk of postoperative complications. The incidence of perioperative COVID infection and its influence on postoperative recovery after reconstructive breast surgery is still unknown. METHODS: This dual center retrospective cohort study included patients that underwent reconstructive breast surgery between March 2020 and July 2021. Post-mastectomy autologous or implant-based breast reconstruction (ABR; IBR), as well as post-lumpectomy oncoplastic partial breast reconstruction (PBR) were eligible. Patient data were extracted from electronic medical records. Data regarding COVID-19 infection was collected through a questionnaire. The primary outcome was complication rate. RESULTS: The ABR, IBR and PBR groups consisted of 113 (12 COVID-positive), 41 (2 COVID-positive) and 113 (10 COVID-positive) patients. In the ABR and PBR groups, postoperative complications occurred significantly more often in patients with perioperative COVID-infection. Especially impaired wound healing occurred significantly more often in the ABR and PBR breasts, but also at the donor site of ABR patients with perioperative COVID. CONCLUSION: Perioperative COVID-infection increases susceptibility to complicated wound healing after reconstructive breast surgery. A possible explanation lies in the dysregulation of haemostasis by the virus, and its direct effects on microvasculature. A hypercoagulable state results. We recommend to postpone elective breast surgery for 4-6 weeks after COVID-19 infection. Also, precautionary measures remain important to minimize the risk of perioperative COVID-19 infection.

The impact of using the internal mammary artery as a recipient vessel on medial mastectomy skin flap perfusion in autologous breast reconstruction: An observational study using indocyanine green.

BACKGROUND: The internal mammary artery (IMA) is the preferred recipient vessel for microvascular anastomosis in immediate autologous breast reconstruction following skin-sparing mastectomy (SSM). Although the IMA accounts for approximately 60% of the blood supply to the breast, the exact contribution to the mastectomy skin flap perfusion is unclear. The aim of this observational study was to investigate the impact of using the IMA as a recipient vessel on medial mastectomy skin flap perfusion assessed with indocyanine green angiography (ICGA). METHODS: This observational study included ten consecutive women who underwent immediate autologous breast reconstructions following SSM. Two intraoperative indocyanine green (ICG) assessments were performed to assess tissue perfusion of the upper and lower part of the medial mastectomy skin flap: the first following the SSM and the second after clamping the IMA. During a 120-second angiography, three additional images were made after 60, 90, and 120 s. The ICG inflow time and mean, minimum, and maximum fluorescence intensities (FIs) were obtained. RESULTS: Four unilateral and six bilateral autologous breast reconstructions were included. There was no difference in tissue perfusion when comparing the inflow time (24.1 s vs. 23.0 s, P = 0.348), the mean FI (131.4 vs. 124.0, P = 0.126), minimum FI (28.6 vs. 33.4, P = 0.086), and maximum FI (253.1 vs. 247.6, P = 0.166) before and after clamping the IMA. CONCLUSION: According to this study, the use of the IMA as a recipient vessel does not reduce medial mastectomy skin flap perfusion in patients undergoing immediate autologous breast reconstructions following SSM.

Risk of major postoperative complications in breast reconstructive surgery with and without an acellular dermal matrix: A development of a prognostic prediction model.

Introduction: Acellular dermal matrices (ADM) have been suggested to allow for different approaches and reduce the risk of postoperative complications in implant-based breast surgery. Surgeons seem to embrace ADMs around the world, although a lack of consistent evidence regarding the factors that increase the risk of major postoperative complications remains. Purpose: To develop and internally validate a model to predict the risk of a major postoperative complication in breast reconstructive surgery with and without an ADM. Methodology: The DBIR is an opt-out registry that holds characteristics of all breast implant surgeries in the Netherlands since 2015. Using a literature-driven preselection of predictors, multivariable mixed-effects logistic regression modelling was used to develop the prediction model. Results: A total of 2939 breasts were eligible, of which 11% underwent an ADM-assisted procedure (single-stage or two-stage). However, 31% underwent a two-stage procedure (with or without the use of ADM). Of all breasts, 10.2% developed a major postoperative complication. Age (OR 1.01), delayed timing (OR 0.71), and two-stage technique (OR 4.46) were associated with the outcome. Conclusion: The data suggest that ADM use was not associated with a major postoperative complication, while two-stage reconstructions were strongly associated with an increased risk of major complications. Despite these findings, ADMs are not as popular in the Netherlands as in the USA. The predictive capabilities of the developed model are mediocre to poor, but because of the above findings, we believe that the role of the two-stage technique as a golden standard should be put up for debate.

Sun Protection Behavior Following Skin Cancer Resection and Reconstruction.

Increased exposure to ultraviolet radiation (UVR) is associated with an increased risk of nonmelanoma skin cancer. Cutaneous surgery can be negatively influenced by UVR, causing delayed wound healing, hyperpigmentation of the scar, and an increased incidence of additional skin cancers. By changing sun protection behavior, these risks can be limited. Therefore, this study evaluates changes in patients' sun protective behavior after Mohs micrographic surgery (MMS). Patients undergoing MMS between December 2017 and November 2019 were included. Patients were asked to complete the FACE-Q Skin Cancer - Sun Protection Behavior checklist before and 3 months and 1 year post-surgery. A total of 125 patients completed the pre-operative and 3-months post-operative checklists, and 89 (71.2%) completed the 1-year post-operative checklist. Reported sun protective behaviors increased post-surgery at all time points (p < 0.001). Patients with a prior history of facial skin cancer demonstrated a larger increase in sun protection behaviors after surgery than patients without a history of facial skin cancer (p = 0.04). Patients with defects located on the ear or scalp demonstrated a lesser increase in sun protection behaviors than patients with defects located in more conspicuous areas as the face (p = 0.02). Our study demonstrates a change in sun protection behavior, with an increase in sun protection behavior over time in patients after MMS. However, more improvement is possible. Targeted counseling can increase sun protection behavior in patients without a history of facial skin cancer and patients with skin cancer located on the ears or scalp.

The difference in local, regional and distant breast cancer recurrence between the immediate and delayed DIEP flap procedure; a retrospective cohort study.

PURPOSE: It has been hypothesized that autologous breast reconstruction can cause reactivation of dormant micro metastases by its extensive tissue trauma, influencing the risk of breast cancer recurrence. However, about the specific effect of timing on breast cancer recurrence in the deep inferior epigastric perforator (DIEP) flap reconstruction is not much known. In this study the rate of local, regional and distant recurrence between patients undergoing an immediate and delayed autologous DIEP flap breast reconstruction were evaluated. METHODS: In this retrospective cohort study, breast cancer patients undergoing a DIEP flap breast reconstruction between 2010 and 2018 in three hospitals in the Netherlands were evaluated. Cox proportional hazards regression analyses were performed to assess the impact of different factors on breast cancer recurrence. The primary endpoint was local breast cancer recurrence. Secondary endpoints were regional and distant recurrence. RESULTS: A total of 919 DIEP-flap reconstructions were done in 862 women of which 347 were immediate- and 572 were delayed DIEP flap reconstructions. After a median follow-up of 46 months and 86 months respectively (p < 0.001), local breast cancer recurrence occurred in 1.5% and in 1.7% of the patients resulting in an adjusted hazard ratio of 2.890 (p = 0.001, 95% CI 1.536, 5437). CONCLUSION: This study suggests an increased risk for breast cancer recurrence in women receiving a delayed DIEP flap reconstruction as compared to women receiving an immediate DIEP flap reconstruction. However, these data should be interpreted carefully as a result of selection bias.

Fasciocutaneous anterolateral thigh flaps for complex abdominal wall reconstruction after resection of enterocutaneous fistulas and the role of indocyanine green angiography: a pilot study.

PURPOSE: No previous study reported the use of a fasciocutaneous anterolateral thigh (ALT) flap combined with a biological mesh for abdominal wall reconstruction (AWR) after enterocutaneous fistula (ECF) in a single-staged procedure and the use of Indocyanine Green Angiography (ICGA) intraoperatively. The purpose of this study was to determine the feasibility and safety of this procedure and to examine the added value of ICGA in minimizing postoperative complications. METHODS: A single-institution review of a prospectively maintained database was conducted at Maastricht University Medical Center. To evaluate the feasibility and safety of this procedure, early (≤ 30 days) and late (> 30 days) postoperative complications were assessed. ECF recurrence was considered the primary outcome. To examine the added value of ICGA, complications in the ICGA group and the non-ICGA group were compared descriptively. RESULTS: Ten consecutive patients, with a mean age of 66.7 years, underwent a single-staged AWR with fasciocutaneous ALT flaps. Mean follow-up was 17.4 months (4.3-28.2). Two early ECF recurrences were observed. Both restored without the need for reoperation. A lower rate of early complications was observed in the ICGA group compared to the non-ICGA group. CONCLUSION: The combination of a biological mesh and fasciocutaneous ALT flap is feasible and safe in AWR after ECF repair in a single-staged approach, with an acceptable complication rate in a cohort of complex patients operated in a dedicated center. ECF closure was achieved in all patients. ICGA seems to be of great added value in minimizing postoperative complications during AWR.

Quality of life after autologous fat transfer additional to prosthetic breast reconstruction in women after breast surgery: A systematic review.

BACKGROUND: Breast cancer is the most frequent form of cancer among women worldwide. Reconstructive surgery may improve the quality of life (QoL), after mastectomy. Various techniques are used to reconstruct the female breast; however, few is known about its specific post-surgery influence represented in patient-reported outcomes. OBJECTIVE: This systematic review assesses the difference in patient-reported QoL between prosthetic reconstruction alone, and prosthetic reconstruction with additional autologous fat transfer (AFT). DATA SOURCES: A literature search was performed in PubMed, Embase, Cochrane and CINAHL online databases from inception to February 11th, 2020. STUDY SELECTION: Inclusion and exclusion criteria were used to assess the eligibility of the retrieved articles. The only eligible studies were cohort studies. DATA COLLECTION AND ANALYSIS: Relevant data for the research question was extracted from the articles and systematically documented. Results not contributing to answering the objective were intentionally left out. No meta-analysis was realized. RESULTS: This systematic review resulted in the inclusion of only six relevant studies, all cohort studies, consisting of 1437 unique patients. These studies evaluated the quality of life of patients by means of the validated BREAST-Q questionnaire. Outcomes varied for which reason no definite answer could be provided to whether additional AFT results in a higher QoL. CONCLUSIONS: It is unclear whether additional AFT after prosthetic surgery leads to a higher QoL when compared to sole prosthetic reconstruction or not. Additional studies, assessing the QoL of patients who received additional AFT, are required to draw solid conclusions. LEVEL OF EVIDENCE: Level III; systematic literature review of cohort studies.

Early detection and follow-up of colorectal neoplasia based on faecal volatile organic compounds.

AIM: Early detection and removal of colorectal cancer (CRC) and advanced adenomas (AAs) decreases the incidence of and mortality from the disease. We aimed to evaluate the potential of faecal volatile organic compounds (VOCs) for detection and follow-up of colorectal adenoma using advanced electronic nose technology. METHOD: This was a prospective multi-centre case-control cohort including two district hospitals and one tertiary referral hospital. Patients undergoing colonoscopy were instructed to collect a faecal sample prior to bowel cleansing and were included in the study when CRC, AAs, large adenomas (LAs; 0.5-1.0 cm), small adenomas (SAs; 0.1-0.5 cm) or no endoscopic abnormalities (controls) were observed. Patients undergoing polypectomy and controls were asked for a second sample after 3 months. Faecal VOCs were measured with gas chromatography-ion mobility spectrometry. Random forest, support vector machine, Gaussian process and neural net classification were used to evaluate accuracy. RESULTS: In total, 14 patients with CRC, 64 with AAs, 69 with LAs, 127 with SAs and 227 controls were included. A second sample was collected from 32 polypectomy patients and 32 controls. Faecal VOCs discriminated CRC and adenomas from control [AUC (95% CI): CRC vs control 0.96 (0.89-1); AA vs control 0.96 (0.93-1); LA vs control 0.96 (0.92-0.99); SA vs control 0.96 (0.94-0.99)]. There were no significant differences between CRC and adenoma groups. Patients with adenomas and controls were discriminated prior to polypectomy, whereas 3 months after polypectomy VOC profiles were similar [T0 adenoma vs control 0.98 (0.95-1); T1 adenoma vs control 0.55 (0.40-0.69)]. CONCLUSIONS: Faecal VOC profiles may be useful for early detection of CRC and adenomas and the timing of polyp surveillance as polypectomy led to a normalization of the VOC profile.

Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial.

INTRODUCTION: Early breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective. METHODS AND ANALYSIS: A multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media. TRIAL REGISTRATION NUMBER: NCT02790021; Pre-results.

Risk of Positive Sentinel Lymph Node After Neoadjuvant Systemic Therapy in Clinically Node-Negative Breast Cancer: Implications for Postmastectomy Radiation Therapy and Immediate Breast Reconstruction.

BACKGROUND: Residual axillary lymph node involvement after neoadjuvant systemic therapy (NST) is the determining factor for postmastectomy radiation therapy (PMRT). Preoperative identification of patients needing PMRT is essential to enable shared decision-making when choosing the optimal timing of breast reconstruction. We determined the risk of positive sentinel lymph node (SLN) after NST in clinically node-negative (cN0) breast cancer. METHODS: All cT1-3N0 patients treated with NST followed by mastectomy and SLNB between 2010 and 2016 were identified from the Netherlands Cancer Registry. Rate of positive SLN for different breast cancer subtypes was determined. Logistic regression analysis was performed to determine correlated clinicopathological variables with positive SLN. RESULTS: In total 788 patients were included, of whom 25.0% (197/788) had positive SLN. cT1-3N0 ER+HER2+, cT1-3N0 ER-HER2+ , and cT1-2N0 triple-negative patients had the lowest rate of positive SLN: 7.2-11.5%, 0-6.3%, and 2.9-6.2%, respectively. cT1-3N0 ER+HER2- and cT3N0 triple-negative patients had the highest rate of positive SLN: 23.8-41.7% and 30.4%, respectively. Multivariable regression analysis showed that cT2 (odds ratio [OR] 1.93; 95% confidence interval [CI] 1.01-3.96), cT3 (OR 2.56; 95% CI 1.30-5.38), grade 3 (OR 0.44; 95% CI 0.21-0.91), and ER+HER2- subtype (OR 3.94; 95% CI 1.77-8.74) were correlated with positive SLN. CONCLUSIONS: In cT1-3N0 ER+HER2+, cT1-3N0 ER-HER2+, and cT1-2N0 triple-negative patients treated with NST, immediate reconstruction can be considered an acceptable option due to low risk of positive SLN. In cT1-3N0 ER+HER2- and cT3N0 triple-negative patients treated with NST, risks and benefits of immediate reconstruction should be discussed with patients due to the relatively high risk of positive SLN.

The Effect of Smoking on Sternal Scar Healing: A Prospective Cohort Study.

INTRODUCTION: Cardiothoracic surgery with a median sternotomy is an electing factor for the development of a hypertrophic scar. Hypertrophic scars, characterized by an increased vascularity, often result in aesthetic and functional problems. Smoking, due to its negative effects on vascularization, could therefore have an effect on scar healing. OBJECTIVE: A prospective cohort study was conducted to evaluate the effect of smoking on scar healing after cardiothoracic surgery with a median sternotomy incision. MATERIALS AND METHODS: One hundred patients who underwent cardiac surgery with a median sternotomy were divided into 3 groups: smokers, ex-smokers, and nonsmokers. Erythema values of the scar were measured with a colorimeter on 3 standardized parts of the scar. Scar evaluation was performed at 6 weeks, 3 months, 6 months, and 12 months after surgery. RESULTS: During 1 year, a total of 90 patients were followed after a median sternotomy; 10 patients were lost to follow-up. There were 23 smokers, 52 ex-smokers, and 15 nonsmokers with an overall mean age of 61.5 ± 8.83 years. No significant difference in redness as a parameter for hypertrophic scarring was observed between the 3 groups. Nevertheless, a trend in favor of the smokers was seen, as they developed less hyperemic scars. The caudal part of the scar showed a significantly higher incidence of hypertrophy compared with the middle and cranial part of the scar at all time points. CONCLUSIONS: It is presumed that a large sample size with younger patients is needed to confirm the results herein. Furthermore, more caudally located skin, especially the subxiphoidal part, is prone to hypertrophic scarring and should, for that reason, be avoided in the incision.

The influence of neoadjuvant chemotherapy on complications of immediate DIEP flap breast reconstructions.

PURPOSE: The impact of neoadjuvant chemotherapy on the surgical outcomes of immediate breast reconstruction remains controversial. The aim of this study was to analyze the incidence of complications of immediate deep inferior epigastric artery perforator (DIEP) flap breast reconstructions in patients who received neoadjuvant chemotherapy compared to patients without neoadjuvant chemotherapy prior to surgery. METHODS: A multicenter, retrospective cohort study was conducted of all patients who underwent immediate DIEP flap breast reconstruction between January 2010 and June 2017. Patients were divided in two groups as breast reconstructions with or without neoadjuvant chemotherapy, respectively. The primary outcome was the incidence of postoperative flap re-explorations, recipient-site complications and donor-site complications. RESULTS: In total 432 immediate DIEP flap breast reconstructions in 326 patients were included. Forty-eight patients (n = 67 flaps) received neoadjuvant chemotherapy prior to immediate breast reconstruction and 278 patients (n = 365 flaps) did not. No statistically significant differences for any major (4.5% vs. 10.4%; p = 0.175) or minor (16.4% vs. 24.7%; p = 0.191) recipient-site complication were observed. Donor-site complications were recorded in 9 (18.8%) and 62 (22.2%) patients, respectively (p = 0.587). There was no difference in need for flap re-exploration between groups (3.0% vs. 8.5%; p = 0.139). Correction for potential confounding variables did not result in significant differences. CONCLUSIONS: This study demonstrated similar complication rates for patients with and without neoadjuvant chemotherapy prior to immediate breast reconstruction, indicating that it is safe to perform an immediate DIEP flap breast reconstruction after neoadjuvant chemotherapy.

Short-term cost-effectiveness of one-stage implant-based breast reconstruction with an acellular dermal matrix versus two-stage expander-implant reconstruction from a multicentre randomized clinical trial.

BACKGROUND: Implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure and its economic impact is significant. This study aimed to analyse whether a direct one-stage IBBR with use of an acellular dermal matrix (ADM) is more cost-effective than two-stage (expander-implant) breast reconstruction. METHODS: The BRIOS (Breast Reconstruction In One Stage) study was an open-label multicentre RCT in which women scheduled for skin-sparing mastectomy and immediate IBBR were randomized between one-stage IBBR with ADM or two-stage IBBR. Duration of surgery and hospital stay, and visits for the primary surgery, unplanned and cosmetic procedures were recorded. Costs were estimated at an institutional level. Health status was assessed by means of the EuroQol Five Dimensions 5L questionnaire. RESULTS: Fifty-nine patients (91 breasts) underwent one-stage IBBR with ADM and 62 patients (92 breasts) two-stage IBBR. The mean(s.d.) duration of surgery in the one-stage group was significantly longer than that for two-stage IBBR for unilateral (2·52(0·55) versus 2·02(0·35) h; P < 0·001) and bilateral (4·03(1·00) versus 3·25(0·58) h; P = 0·017) reconstructions. Costs were higher for one-stage compared with two-stage IBBR for both unilateral (€12 448 (95 per cent c.i. 10 722 to 14 387) versus €9871 (9373 to 10 445) respectively; P = 0·025) and bilateral (€16 939 (14 887 to 19 360) versus €13 383 (12 414 to 14 669); P = 0·002) reconstructions. This was partly related to the use of relatively expensive ADM. There was no difference in postoperative health status between the groups. CONCLUSION: One-stage IBBR with ADM was associated with higher costs, but similar health status, compared with conventional two-stage IBBR. Registration number: NTR5446 ( http://www.trialregister.nl).

Breast sensibility after mastectomy and implant-based breast reconstruction.

PURPOSE: The aim of the study is to evaluate the level of sensible impairment after mastectomy or implant-based breast reconstruction (IBBR). In addition, factors influencing breast sensibility were evaluated. METHODS: A cross-sectional study was performed in Maastricht University Medical Center between July 2016 and August 2018. Women with unilateral mastectomy with or without IBBR were included. Objective sensory measurements were performed using Semmes-Weinstein monofilaments. Their healthy breast served as control, using a paired t test. Differences between mastectomy with and without IBBR were evaluated using the independent t test. Linear regression was performed to evaluate the association between patient characteristics on breast sensibility. The paired t test was used to evaluate in which part of the breast the sensibility is best preserved. RESULTS: Fifty-one patients were eligible for inclusion. Sixteen patients underwent IBBR after mastectomy. Twenty-three patients received radiotherapy and 35 patients received chemotherapy. Monofilament values were significantly higher in the operated group compared to the reference group (p < 0.001). Linear regression showed a statistically significant association between IBBR and objectively measured impaired sensation (p = 0.008). After mastectomy, the cutaneous protective sensation is only diminished. After IBBR, it is lost in the majority of the breast. The medial part of the breast was significantly more sensitive than the lateral part in all operated breasts (p < 0.001). CONCLUSION: IBBR has a significantly negative impact on the breast sensibility compared to mastectomy alone. This study shows that the protective sensation of the skin in the breast is lost after IBBR. To our knowledge, this is the first study to evaluate the level of sensible impairment after mastectomy or IBBR. More research is necessary to confirm these results.

Satisfaction with Facial Appearance and Quality of Life after Treatment of Face Scars with a Transparent Facial Pressure Mask.

Treatment of facial hypertrophic scars and deformities has developed from the use of elastic fabric hoods to transparent facemasks. The clinical effects of these masks have been described. However, the psychological impact of wearing such a mask is not well documented. The aim of this study was to assess patients' satisfaction with their current facial appearance, to assess the end result of facemask therapy, and to assess the decision to have undergone facemask therapy by means of four different FACE-Q questionnaires. Out of the eligible 87 patients who completed the facemask therapy between January 2012 and November 2017, 42 filled out the questionnaires. These patients wore a custom-fabricated facemask because of facial hypertrophic scars and severe postsurgical facial irregularities. Patients who wore the mask 12 to 16 hours per day were significantly more satisfied with the end result compared with those who wore it 4 to 8 hours daily. Also, patients who wore the mask 8 to 12 and 12 to 16 hours each day were more satisfied to have undergone therapy compared with those who wore it 4 to 8 hours daily. Furthermore, patients who finished therapy 3 to 4 years and 4 to 5 years ago reported a significant higher satisfaction with facial appearance compared with those who completed therapy in a time period shorter than 1 year ago. Patients who finished therapy 3 to 4 years ago reported higher satisfaction with their facial appearance compared with those who finished therapy 2 to 3 years ago. Additionally, the Patient and Observer Scar Assessments Score (POSAS) showed a significant reduction between start and end of therapy. This study shows facemask therapy to result in long-lasting stable results. It also shows a longer daily wearing of the facemask to result in the highest satisfaction according to patients.

Predictors of complications after direct-to-implant breast reconstruction with an acellular dermal matrix from a multicentre randomized clinical trial.

BACKGROUND: In the multicentre randomized trial BRIOS (Breast Reconstruction In One Stage), direct-to-implant (DTI) breast reconstruction with an acellular dermal matrix (ADM) was associated with a markedly higher postoperative complication rate compared with two-stage tissue expander/implant breast reconstruction. This study aimed to identify factors that contribute to the occurrence of complications after DTI ADM-assisted breast reconstruction. METHODS: Data were obtained from the BRIOS study, including all patients treated with DTI ADM-assisted breast reconstruction. Logistic regression analyses were performed to identify factors predictive of postoperative complications. RESULTS: Fifty-nine patients (91 breasts) were included, of whom 27 (35 breasts) developed a surgical complication. Reoperations were performed in 29 breasts (32 per cent), with prosthesis removal in 22 (24 per cent). In multivariable analyses, mastectomy weight was associated with complications (odds ratio (OR) 1·94, 95 per cent c.i. 1·33 to 2·83), reoperations (OR 1·70, 1·12 to 2·59) and removal of the implant (OR 1·55, 1·11 to 2·17). Younger patients (OR 1·07, 1·01 to 1·13) and those who received adjuvant chemotherapy (OR 4·83, 1·15 to 20·24) more frequently required reoperation. In univariable analyses, adjuvant radiotherapy showed a trend towards more complications (OR 7·23, 0·75 to 69·95) and removal of the implant (OR 5·12, 0·76 to 34·44), without reaching statistical significance. CONCLUSION: Breast size appeared to be the most significant predictor of complications in DTI ADM-assisted breast reconstruction. The technique should preferably be performed in patients with small to moderate sized breasts. Registration number: NTR5446 ( http://www.trialregister.nl).

Correction to: Randomized Controlled Study Comparing Disposable Negative-Pressure Wound Therapy with Standard Care in Bilateral Breast Reduction Mammoplasty Evaluating Surgical Site Complications and Scar Quality.

The second to last sentence in the Results section of the Abstract should be corrected to, "At 180-days follow-up, there was a significant improvement in total VAS scores."