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.

Recommendations on scuba diving in Birt-Hogg-Dubé syndrome.

INTRODUCTION: Although very uncommon, severe injury and death can occur during scuba diving. One of the main causes of scuba diving fatalities is pulmonary barotrauma due to significant changes in ambient pressure. Pathology of the lung parenchyma, such as cystic lesions, might increase the risk of pulmonary barotrauma. AREAS COVERED: Birt-Hogg-Dubé syndrome (BHD), caused by pathogenic variants in the FLCN gene, is characterized by skin fibrofolliculomas, an increased risk of renal cell carcinoma, multiple lung cysts and spontaneous pneumothorax. Given the pulmonary involvement, in some countries patients with BHD are generally recommended to avoid scuba diving, although evidence-based guidelines are lacking. We aim to provide recommendations on scuba diving for patients with BHD, based on a survey of literature on pulmonary cysts and pulmonary barotrauma in scuba diving. EXPERT OPINION: In our opinion, although the absolute risks are likely to be low, caution is warranted. Given the relative paucity of literature and the potential fatal outcome, patients with BHD with a strong desire for scuba diving should be informed of the potential risks in a personal assessment. If available a diving physician should be consulted, and a low radiation dose chest computed tomography (CT)-scan to assess pulmonary lesions could be considered.

Frostbite: a treatment guideline for prehospital treatment in a military environment.

Frostbite remains a severe medical condition that causes long-lasting sequelae and can threaten military operations. Information on prehospital treatment of frostbite is scarce and existing guidelines are aimed at the general population.This paper provides a guideline on prehospital emergency care of frostbite in the (Netherlands) Armed Forces. The insights gained from studies reporting on frostbite treatment in the prehospital setting were combined with the expert opinions of the authors and applied to the military context. The resulting guideline consists of two stages: (prolonged) field care and care at a Medical Treatment Facility. The cornerstones are rewarming in warm water and evacuation to a medical facility. Additional aspects of prehospital treatment are rehydration, proper analgesia, non-steroidal anti-inflammatory drugs and wound care.We suggest further collaboration among North Atlantic Treaty Organization partners and other affiliated nations, focusing on the full spectrum of military injury management including state-of-the-art aftercare, long-lasting sequelae and return to duty after frostbite.

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.

Frostbite: a systematic review on freezing cold injuries in a military environment.

BACKGROUND: Military practice or deployment in extreme conditions includes risks, dangers and rare disorders. One of the challenges is frostbite; however, current literature does not provide an overview of this condition in a military context. This review aims to map the incidence, risk factors and outcome of frostbite in military casualties in the armed forces. METHODS: A systematic literature search on frostbite (freezing cold injuries) in military settings from 1995 to the present was performed. A critical appraisal of the included articles was conducted. Data on incidence, risk factors, treatment and outcome were extracted. RESULTS: Fourteen studies were included in our systematic review. Most studies of frostbite in a military setting were published nearly half a century ago. Frostbite incidence has declined from 7% to around 1% in armed forces in arctic regions but could be as high as 20% in small-scale arctic manoeuvres. Overall and military-specific risk factors for contracting frostbite were identified. CONCLUSION: During inevitable arctic manoeuvres, frostbite is a frequently diagnosed injury in service members. Postfreezing symptoms often persist after severe frostbite injury, which decreases employability within the service. Over time, military practice has changed considerably, and modern protective materials have been introduced; therefore, re-evaluation and future study in the military field are appropriate, preferably with other North Atlantic Treaty Organization partners.

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.

It's all about timing, early treatment with hyperbaric oxygen therapy and corticosteroids is essential in acute acoustic trauma.

BACKGROUND: Acute acoustic trauma (AAT) is an acute hearing impairment caused by intense noise-impact. The current management strategy for AAT with substantial hearing loss in the Dutch military is the combination therapy with corticosteroids and hyperbaric oxygen therapy (HBOT). In a previous study, early initiation of the combination therapy was associated with better outcomes. Therefore, we performed a new analysis to assess the difference in hearing outcome between patients in whom combination therapy was started within two days, versus after more than two days. METHODS: A retrospective analysis was performed on military patients diagnosed with AAT with substantial hearing loss who presented between February 2018 and March 2020. Absolute and relative hearing improvement between first and last audiograms were calculated for all affected frequencies (defined as loss of ≥20 dB on initial audiogram). We also determined the amount of patients who recovered to the level of Dutch military requirement, and performed speech discrimination tests. RESULTS: In this analysis, 30 male patients (49 ears) with AAT were included. The median age was 24.5 years (IQR 23-29). The median time to initiation of therapy with corticosteroids and HBOT were one and two days, respectively. HBOT was started within two days in 31 ears, and after more than two days in 18 ears. The mean absolute and relative hearing gains were 18.8 dB (SD 14.6) and 46.8% (SD 31.3) on all affected frequencies. The 100% discrimination/speech perception level improved from 64.0 dB to 51.7 dB (gain 12.3 dB ± 14.1). There was significantly more improvement in absolute and relative hearing improvement when HBOT was started in ≤2 days, compared to >2 days. CONCLUSION: Our analysis shows results in favor of early initiation (≤2 days) of the combination treatment of HBOT and corticosteroids in patients with AAT.

Hyperbaric oxygen therapy for the treatment of rectovaginal fistulas in patients with Crohn's disease: results of the HOT-REVA pilot study.

BACKGROUND: Positive effects of hyperbaric oxygen (HBO) on perianal fistulas in Crohn's disease (CD) have been described, but the effect on rectovaginal fistulas (RVFs) has not yet been studied. The aim was to investigate the efficacy, safety and feasibility of HBO in patients with RVF in CD. METHODS: In this prospective study, consecutive CD patients between November 2018 and February 2020 presenting with RVF at the outpatient fistula clinic of the Amsterdam University Medical Centre were included and selected to receive treatment with 30 daily HBO sessions, if fistulas were actively draining and any concomitant treatment regimen was stable at least 6 weeks prior to start of HBO. Patients with a stoma were excluded. The primary endpoint was clinical closure at 3-month follow-up, defined as cessation of complaints and/or closure of the external orifice if visible at baseline. Secondary outcomes were improvement of concomitant perianal fistulas as measured by the perianal disease activity index (PDAI) and fistula drainage assessment (FDA), as well as improvement in patient-reported outcomes (visual analogue scale (VAS), inflammatory bowel disease questionnaire (IBDQ), faecal incontinence quality of life scale (FIQL) and female sexual functioning index (FSFI)) at 3-month follow-up. RESULTS: Out of 14 eligible patients, nine patients (median age 50 years) were treated, all of whom had previously had one or more unsuccessful medical and/or surgical treatments for their RVF. Clinical closure occurred in none of the patients at 3-month follow-up. There was no improvement in PDAI and patient-reported outcomes (VAS, IBDQ, FIQL and FSFI). Two patients had concomitant perianal fistulas; using FDA, one patient had a clinical response and one patient was in clinical remission 3 months after HBO. There were two treatment-related adverse events during HBO concerning claustrophobia and fatigue. Furthermore, two patients had a surgical intervention due to RVF and two patients were treated with antibiotics for a urinary tract infection during follow-up. One patient had a dose reduction of ustekinumab because of decreased luminal complaints. CONCLUSION: Treatment with HBO was feasible, but in this therapy-refractory cohort without deviating ostomy no clinical closure of RVF or improvement in quality of life was seen 3 months after HBO. Treatment with HBO alone in this specific group of patients therefore appears to be ineffective.

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.

The AirSeal® insufflation device can entrain room air during routine operation.

BACKGROUND: Surgical procedures that use insufflation carry a risk of gas embolism, which is considered relatively harmless because of the high solubility of carbon dioxide. However, an in vitro study suggested that valveless insufflation devices may entrain non-medical room air into the surgical cavity. Our aim was to verify if this occurs in actual surgical procedures. METHODS: The oxygen percentage in the pneumoperitoneum or pneumorectum/pneumopelvis of eight patients operated with use of the AirSeal® was continuously measured, to determine the percentage of air in the total volume of the surgical cavity. RESULTS: Basal air percentage in the surgical cavity was 0-5%. During suctioning from the operative field air percentage increased to 45-65%. CONCLUSIONS: The AirSeal® valveless insufflation device maintains optimal distension of the surgical cavity not only by insufflating carbon dioxide, but also by entraining room air, especially during suctioning from the operative field. This may theoretically lead to air embolism in patients operated on with this device.

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.

Arrhythmogenicity of scuba diving: Holter monitoring in a hyperbaric environment.

INTRODUCTION: About 26% of diving-related fatalities are caused by cardiac disease, part of which might be associated with fatal arrhythmias. This raises the question as to whether fatal arrhythmias are being provoked by hyperbaric conditions themselves or if exercise or stress provokes the fatal arrhythmias in cases of underlying (ischemic) cardiac disease. OBJECTIVE: To measure the influence of hyperbaric conditions (50 msw) on cardiac conduction and arrhythmias in professional divers by means of ECG. METHODS: This is a prospective study on military divers in a hyperbaric chamber with continuous ECG monitoring using Holter registrations. Supraventricular and ventricular ectopy was registered during hyperbaric conditions. RR, PR, QRS, QT and QTc intervals were calculated at 50 msw and compared with ECGs at rest. RESULTS: Included were 17 male military divers who made 20 dives. A total of 10 PVCs, 45 PACs, four atrial runs and four atrial pairs were seen. Significant prolongation of the PR interval was seen and a decrease of in QRS duration at 50 msw. There was no significant change in the RR, QT and QTc intervals. CONCLUSION: In these divers, no clinically relevant arrhythmias were observed during wet dives in a recompression chamber at 50 msw. We observed a small prolongation of PR interval that is probably not clinically relevant in divers without any known conduction disorders.