Does anxiety influence outcome measurements in ankle replacement patients?

BACKGROUND: Total ankle arthroplasty (TAA) is increasingly used to treat end-stage ankle arthritis to restore ankle functional outcomes and alleviate pain. This treatment outcome may be influenced by pre-morbid patient anxiety. METHODS: Twenty-five Infinity TAA implants were prospectively followed post-operatively with a mean follow-up time of 34.18 months. Demographic, clinical, and functional outcomes were assessed. Analysis was performed on the effect of anxiety, reported by the HADS, on patient-perceived postoperative pain, functioning, and quality of life. RESULTS: Postoperative the PROMs and Range of Motion (ROM) improved significantly. Linear regression analysis and Pearson correlation showed a significant negative effect of anxiety on the postoperative patient-reported outcome measurements (EQ-5D-5L, VAS, and MOxFQ) at the end of follow-up. CONCLUSION: Good functional, clinical, and radiographic results were observed in this prospective cohort study. Anxiety had a negative influence on the outcome of the patient-reported outcome measurements (EQ-5D-5L and MOxFQ) postoperatively. LEVEL OF EVIDENCE: Level III, prospective cohort study.

Quality assurance of radiation therapy after breast-conserving surgery among patients in the BOOG 2013-08 trial.

BACKGROUND AND PURPOSE: In the BOOG 2013-08 trial (NCT02271828), cT1-2N0 breast cancer patients were randomized between breast conserving surgery with or without sentinel lymph node biopsy (SLNB) followed by whole breast radiotherapy (WBRT). While awaiting primary endpoint results (axillary recurrence rate), this study aims to perform a quality assurance analysis on protocol adherence and (incidental) axillary radiation therapy (RT) dose. MATERIALS AND METHODS: Patients were enrolled between 2015 and 2022. Data on prescribed RT and (in 25% of included patients) planning target volumes (PTV) parameters were recorded for axillary levels I-IV and compared between treatment arms. Multivariable linear regression analysis was performed to determine prognostic variables for incidental axillary RT dose. RESULTS: 1,439/1,461 included patients (98.5%) were treated according to protocol and 87 patients (5.9%) received regional RT (SLNB 10.9%, no-SLNB 1.5 %). In 326 patients included in the subgroup analysis, the mean incidental PTV dose at axilla level I was 59.5% of the prescribed breast RT dose. In 5 patients (1.5%) the mean PTV dose at level I was ≥95% of the prescribed breast dose. No statistically or clinically significant differences regarding incidental axillary RT dose were found between treatment arms. Tumour bed boost (yes/no) was associated with a higher incidental mean dose in level I (R2 = 0.035, F(6, 263) = 1.532, p 0.168). CONCLUSION: The results indicate that RT-protocol adherence was high, and that incidental axillary RT dose was low in the BOOG 2013-08 trial. Potential differences between treatmentarms regarding the primary endpoint can thus not be attributed to different axillary radiation doses.

Societal costs and quality of life analysis in patients undergoing resective epilepsy surgery: A one-year follow-up.

Although effectiveness of Resective Epilepsy Surgery (RES) for patients with drug-resistant epilepsy (DRE) is widely proven, research on the impact of societal costs (SC) is lacking. The aim of this study is to provide both clinical and economic outcomes of RES by offering an overview of treatment effectiveness as well as SC of RES in a cohort of 30 Dutch DRE patients. This project serves as a pilot project to offer an up-to-date model for larger cost-effectiveness studies. Medical consumption, productivity losses, disease-specific and generic health-related quality of life (QoL), and seizure frequency were assessed before and 3-, 6-, and 12-months post-surgery with validated questionnaires. Linear mixed models, ANOVAs, and logistic regressions were performed. SC for the first year after RES entailed €54,376 and decreased over time. Moreover, 50% of patients experienced a clinically important increase in disease-specific QoL and 53% of patients in generic health-related QoL. Lastly, 73% of patients reached seizure freedom 12 months postoperative. Seizure reduction was correlated with increase in disease-specific QoL. Within one year after surgery, RES leads to reduction in SC and improvements in QoL over time. Future research should encompass longer follow-up periods, larger sample size, and a cost-effectiveness analysis with a comparator.

Economic evaluation of flap fixation techniques after mastectomy: Results of a double-blind randomized controlled trial (SAM-trial).

BACKGROUND: An economic evaluation was performed alongside an RCT investigating flap fixation in reducing seroma formation after mastectomy. The evaluation focused on the first year following mastectomy and assessed cost-effectiveness from a health care and societal perspective. METHODS: The economic evaluation was conducted between 2014 and 2018 in four Dutch breast clinics. Patients with an indication for mastectomy or modified radical mastectomy were randomly assigned to: conventional closure (CON), flap fixation with sutures (FFS) or flap fixation with tissue glue (FFG). Health care costs, patient and family costs and costs due to productivity losses were assessed. Outcomes were expressed in incremental cost-effectiveness ratios (ICERs): the incremental cost per quality-adjusted life year (QALY). Bootstrapping techniques, sensitivity and secondary analyses were employed to address uncertainty. RESULTS: The FFS-group yielded most QALYs (0.810; 95%-CI 0.755-0.856), but also incurred the highest mean costs at twelve months (€10.416; 95%-CI 8.231-12.930). CON was the next best alternative with 0.794 QALYs (95%-CI 0.733-0.841) and mean annual costs of €10.051 (95%-CI 8.255-12.044). FFG incurred fewer QALYs and higher costs, when compared to the CON group. The ICER of FFS compared to CON was €22.813/QALY. Applying a willingness to pay threshold in the Netherlands of €20.000/QALY, the probability that FFS was cost-effective was 42%, compared to 37% and 21% for CON and FFG, respectively. CONCLUSION: The cost-effectiveness of FFS following mastectomy, versus CON and FFG, is uncertain from a societal perspective. Yet, from a health care and hospital perspective FFS is likely to be the most cost-effective intervention.

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.

Prediction model for hypertension in first decade after pre-eclampsia in initially normotensive women.

OBJECTIVE: To develop a prediction model for the development of hypertension in the decade following pre-eclampsia in women who were normotensive shortly after pregnancy. METHODS: This was a longitudinal cohort study of formerly pre-eclamptic women attending a university hospital in The Netherlands between 1996 and 2019. We developed a prediction model for incident hypertension using multivariable logistic regression analysis. The model was validated internally using bootstrapping techniques. RESULTS: Of 259 women, 185 (71%) were normotensive at the first cardiovascular assessment, at a median of 10 (interquartile range (IQR), 6-24) months after a pre-eclamptic pregnancy, of whom 49 (26%) had developed hypertension by the second visit, at a median of 11 (IQR, 6-14) years postpartum. The prediction model, based on birth-weight centile, mean arterial pressure, total cholesterol, left ventricular mass index and left ventricular ejection fraction, had good-to-excellent discriminative ability, with an area under the receiver-operating-characteristics curve (AUC) of 0.82 (95% CI, 0.75-0.89) and an optimism-corrected AUC of 0.80. The sensitivity and specificity of our model to predict hypertension were 98% and 34%, respectively, and positive and negative predictive values were 35% and 98%, respectively. CONCLUSIONS: Based on five variables, we developed a good-to-excellent predictive tool to identify incident hypertension following pre-eclampsia in women who were normotensive shortly after pregnancy. After external validation, this model could have considerable clinical utility in tackling the cardiovascular legacy of pre-eclampsia. © 2023 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy (FALCON): an international multicentre randomized controlled trial.

AIM: To assess the added value of Near InfraRed Fluorescence (NIRF) imaging during laparoscopic cholecystectomy. METHODS: This international multicentre randomized controlled trial included participants with an indication for elective laparoscopic cholecystectomy. Participants were randomised into a NIRF imaging assisted laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. Primary end point was time to 'Critical View of Safety' (CVS). The follow-up period of this study was 90 postoperative days. An expert panel analysed the video recordings after surgery to confirm designated surgical time points. RESULTS: A total of 294 patients were included, of which 143 were randomized in the NIRF-LC and 151 in the CLC group. Baseline characteristics were equally distributed. Time to CVS was on average 19 min and 14 s for the NIRF-LC group and 23 min and 9 s for the CLC group (p 0.032). Time to identification of the CD was 6 min and 47 s and 13 min for NIRF-LC and CLC respectively (p < 0.001). Transition of the CD in the gallbladder was identified after an average of 9 min and 39 s with NIRF-LC, compared to 18 min and 7 s with CLC (p < 0.001). No difference in postoperative length of hospital stay nor occurrence of postoperative complications was found. ICG related complications were limited to one patient who developed a rash after injection of ICG. CONCLUSION: Use of NIRF imaging in laparoscopic cholecystectomy provides earlier identification of relevant extrahepatic biliary anatomy: earlier achievement of CVS, cystic duct visualisation and visualisation of both cystic duct and cystic artery transition into the gallbladder.

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.

Major adverse cardiovascular events in older emergency department patients presenting with non-cardiac medical complaints.

OBJECTIVE: The risk of major adverse cardiovascular events (MACE) for older emergency department (ED) patients presenting with non-cardiac medical complaints is unknown. To apply preventive measures timely, early identification of high-risk patients is incredibly important. We aimed at investigating the incidence of MACE within one year after their ED visit and the predictive value of high-sensitivity cardiac troponin T (hs-cTnT) and N­terminal pro-B-type natriuretic peptide (NT-proBNP) for subsequent MACE. METHODS: This is a substudy of a Dutch prospective cohort study (RISE UP study) in older (≥ 65 years) medical ED patients who presented with non-cardiac complaints. Biomarkers were measured upon ED arrival. Cox-regression analysis was used to determine the predictive value of the biomarkers, when corrected for other possible predictors of MACE, and area under the curves (AUCs) were calculated. RESULTS: Of 431 patients with a median age of 79 years, 86 (20.0%) developed MACE within 1 year. Both hs-cTnT and NT-proBNP were predictive of MACE with an AUC of 0.74 (95% CI 0.68-0.80) for both, and a hazard ratio (HR) of 2.00 (95% CI 1.68-2.39) and 1.82 (95% CI 1.57-2.11) respectively. Multivariate analysis correcting for other possible predictors of MACE revealed NT-proBNP as an independent predictor of MACE. CONCLUSION: Older medical ED patients are at high risk of subsequent MACE within 1 year after their ED visit. While both hs-cTnT and NT-proBNP are predictive, only NT-proBNP is an independent predictor of MACE. It is likely that early identification of those at risk offers a window of opportunity for prevention.

Radiomics biopsy signature for predicting survival in patients with spinal bone metastases (SBMs).

STUDY DESIGN: Retrospective analysis of a registered cohort of patients treated and irradiated for metastases in the spinal column in a single institute. OBJECTIVE: This is the first study to develop and internally validate radiomics features for predicting six-month survival probability for patients with spinal bone metastases (SBM). BACKGROUND DATA: Extracted radiomics features from routine clinical CT images can be used to identify textural and intensity-based features unperceivable to human observers and associate them with a patient survival probability or disease progression. METHODS: A study was conducted on 250 patients treated for metastases in the spinal column irradiated for the first time between 2014 and 2016, at the MAASTRO clinic in Maastricht, the Netherlands. The first 150 available patients were used to develop the model and the subsequent 100 patient were considered as a test set for the model. A bootstrap (B = 400) stepwise model selection, which combines both the forward and backward variable elimination procedure, was used to select the most useful predictive features from the training data based on the Akaike information criterion (AIC). The stepwise selection procedure was applied to the 400 bootstrap samples, and the results were plotted as a histogram to visualize how often each variable was selected. Only variables selected more than 90 % of the time over the bootstrap runs were used to build the final model.A prognostic index (PI) called radiomics score (radscore) and clinical score (clinscore) was calculated for each patient. The prognostic index was not scaled, the original values were used which can be extracted from the model directly or calculated as a linear combination of the variables in the model multiplied by the respective beta value for each patient. RESULTS: The clinical model had a good discrimination power. The radiomics model, on the other hand, had an inferior performance with no added predictive power to the clinical model. The internal imaging characteristics do not seem to have a value in the prediction of survival. However, the Shape features were excluded from further analyses in our study since all biopsies had a standard shape hence no variability.

Value of ultra-high field MRI in patients with suspected focal epilepsy and negative 3 T MRI (EpiUltraStudy): protocol for a prospective, longitudinal therapeutic study.

PURPOSE: Resective epilepsy surgery is a well-established, evidence-based treatment option in patients with drug-resistant focal epilepsy. A major predictive factor of good surgical outcome is visualization and delineation of a potential epileptogenic lesion by MRI. However, frequently, these lesions are subtle and may escape detection by conventional MRI (≤ 3 T). METHODS: We present the EpiUltraStudy protocol to address the hypothesis that application of ultra-high field (UHF) MRI increases the rate of detection of structural lesions and functional brain aberrances in patients with drug-resistant focal epilepsy who are candidates for resective epilepsy surgery. Additionally, therapeutic gain will be addressed, testing whether increased lesion detection and tailored resections result in higher rates of seizure freedom 1 year after epilepsy surgery. Sixty patients enroll the study according to the following inclusion criteria: aged ≥ 12 years, diagnosed with drug-resistant focal epilepsy with a suspected epileptogenic focus, negative conventional 3 T MRI during pre-surgical work-up. RESULTS: All patients will be evaluated by 7 T MRI; ten patients will undergo an additional 9.4 T MRI exam. Images will be evaluated independently by two neuroradiologists and a neurologist or neurosurgeon. Clinical and UHF MRI will be discussed in the multidisciplinary epilepsy surgery conference. Demographic and epilepsy characteristics, along with postoperative seizure outcome and histopathological evaluation, will be recorded. CONCLUSION: This protocol was reviewed and approved by the local Institutional Review Board and complies with the Declaration of Helsinki and principles of Good Clinical Practice. Results will be submitted to international peer-reviewed journals and presented at international conferences. TRIAL REGISTRATION NUMBER: www.trialregister.nl : NTR7536.

Health-related quality of life of patients with a recent fracture attending a fracture liaison service: a 3-year follow-up study.

This study explored the course of health state utility value over 3 years in patients with a recent fracture attending a Fracture Liaison Service and suggested that the overall change in health-related quality of life was not significant, although significant improvements were observed at 6 and 12 months compared to baseline. INTRODUCTION: To estimate the 3-year health-related quality of life (HRQoL) of patients with a recent fracture presenting at a Fracture Liaison Service (FLS) and to explore factors associated with health state utility value (HSUV). METHODS: Patients' HSUVs were derived from the EQ-5D-5L and SF-6D and calculated at six time points. Multiple imputation was applied for missing data. Linear mixed-effects regression analysis with random intercept and slope was applied to explore the course of HSUV over 3 years. The impact of subsequent fracture and the length of time between FLS visit and patients' index fracture on HSUV were also investigated. A backward stepwise elimination was applied to identify factors associated with HSUV. RESULTS: A total of 499 patients were included. The change of EQ-5D HSUV was not significant over 3-year follow-up (P = 0.52), although slightly but significantly higher HSUV was captured at 6 months (mean difference (MD): 0.015, P = 0.02) and 12 months (MD: 0.018, P = 0.01). There was no significant difference in the course of EQ-5D HSUV between fracture locations (P = 0.86). A significant increase in HSUV was only captured for patients had shorter time period (< 107 days) between FLS visit and their index fracture. Suffering a subsequent fracture was associated with significant QoL loss (MD: - 0.078, P < 0.001). Subsequent fracture, previous treatment with anti-osteoporosis medication, a prevalent vertebral fracture (grade 2 or 3), use of a walking aid, previous falls, and higher BMI were negatively associated with mean EQ-5D HSUV over 3 years. Comparable results were found using SF-6D HSUV. The lack of HRQoL data immediately after fracture and selection bias were two main limitations. CONCLUSION: The 3-year change in HSUV was not statistically significant, although significant improvements were observed at 6 and 12 months in comparison with baseline. Six factors were negatively associated with EQ-5D HSUV.

The percentage of residual DCIS in patients diagnosed with primary invasive breast cancer treated with neoadjuvant systemic therapy: A nationwide retrospective study.

INTRODUCTION: Neoadjuvant systemic therapy (NST) is increasingly applied in breast cancer to improve surgical and oncological outcome. Approximately 21% of patients receiving NST achieve pathological complete response (pCR) of the breast. There is disagreement on the definition of pCR with respect to residual DCIS (ypT0 versus ypT0/is). The aim of this retrospective study was to determine the percentage of breast pCR (ypT0) and residual DCIS (ypTis), and its association with clinicopathological variables, in patients treated with NST and surgery. MATERIALS AND METHODS: Patients with invasive breast cancer treated with neoadjuvant chemotherapy, with or without targeted therapy, in the period of 2010-2019 were selected from the Netherlands Cancer Registry (NCR). Descriptive statistics and multivariable logistic regression analyses were used to analyse the percentage of ypT0 and ypTis and its association with clinicopathological variables. RESULTS: From the NCR database, 20495 patients were included, of whom 5847 (28.5%) achieved breast pCR (ypT0) and 881 (4.3%) showed residual DCIS (ypTis). The percentage of ypTis was highest in HER2+ tumour subtypes (ER+HER2+ 7.9%, ER-HER2+ 9.8%, ER+HER2- 2.1%, triple negative 3.3%, p < 0.001). Multivariable logistic regression analyses demonstrated high tumour grade (OR 2.00, p = 0.003) and HER2+ tumour subtype (ER+HER2+ OR 3.58, ER-HER2+ OR 4.37, p < 0.001) as independent predictors for ypTis. CONCLUSION: pCR (ypT0) was achieved in 5847 (28.5%) patients receiving NST and residual DCIS (ypTis) was found in 881 (4.3%) patients. Consequently, the rate of pCR may be affected by ypTis when not excluded from the definition. The percentage of ypTis is highest in HER2+ subtypes.

Outcome of revised metal-on-metal hip arthroplasties: a Dutch arthroplasty register study.

BACKGROUND: Preliminary results of metal-on-metal (MoM) hip arthroplasty were satisfactory, but since 2004 data showed high failure rates. National joint replacement registries are multi-centre databases comprised of thousands of subjects and implants which allow for identifying variables predictive of implant failure. The aim of the current study was to estimate re-revision rates after revision of a primary MoM hip arthroplasty in the Dutch Arthroplasty Register (LROI) and to assess potential predictor variables of re-revision of these MoM hip arthroplasties. METHODS: Eligible procedures were those with a revision for any reason except infection, after an initial primary surgery with a hip resurfacing (HRA) or large-head MoM (LH-MoM) total hip arthroplasty (THA). The probability of re-revision for both types of MoM hip arthroplasty over time was estimated using the cumulative incidence function taking mortality as a competing risk into account. A proportional sub-distribution hazards regression model was used to assess potential predictor variables of re-revision of these MoM hip arthroplasties. RESULTS: A total of 3476 records of revised implants were included, of which 873 (25.2%) were MoM implants. Over the course of follow-up, 101 (11.5%) MoM implants were re-revised. During follow-up 36 (4.3%) patients who received a MoM-implant at primary arthroplasty and a revision afterwards had died. The regression model showed that for primary MoM implants a MoM articulation after revision (HR 2.48; 95% CI 1.53-4.03, p < 0.001), femoral-only revisions (HR 3.20; 95% CI 2.06-4.99, p < 0.001) and periprosthetic fractures (HR 1.98; 95% CI 1.03-3.82, p = 0.042) as reason for the first revision were statistically significant risk factors for re-revision. CONCLUSION: Both types of large-head MoM hip arthroplasties have shown high revision and re-revision rates; risk factors were identified. The outcome of this study can be helpful in managing expectations of patients and orthopaedic surgeons.

Risk factors for total ankle arthroplasty failure: A Dutch Arthroplasty Register study.

BACKGROUND: Studies concerning total ankle arthroplasty could be influenced by several forms of bias. Independent national arthroplasty registries represent objective data on survival and patient reported outcomes. The aim of this study was to determine survival and identify risk factors for early failure in a nationwide series of total ankle arthroplasties from the Dutch Arthroplasty Register (LROI). PATIENTS AND METHODS: Data of 810 patients, who received 836 total ankle arthroplasties between 2014 and 2020 were obtained from the Dutch Arthroplasty Register (LROI) with a median follow-up of 38 months (range 1-84 months). Survival was expressed in Kaplan-Meier analysis and associated hazard ratios for implant failure were determined. Implant failure was defined as the need for revision surgery for any reason or (pan)arthrodesis. RESULTS: During follow-up, we recorded 39 failures (4.7%) resulting in a implant survival of 95.3% with a median follow-up of 38 months (range 1-84 months). Medial malleolus osteotomy (HR = 2.27), previous surgery (HR = 1.83), previous osteotomy (HR = 2.82) and previous ligament reconstruction (HR = 2.83) all showed potentially clinically meaningful associations with a higher incidence of implant failure, yet only previous OCD treatment (HR = 6.21), BMI (HR = 1.09) and age (HR = 0.71) were statistically significant. INTERPRETATION: Excellent short-term survival (95.3%) with a median follow-up of 38 months was reported for TAA patients from the Dutch Arthroplasty Register. Patients with a lower age, a higher BMI or who had a prior surgical OCD treatment before TAA surgery appear to have a higher risk for revision after short-term clinical follow-up. Thorough patient selection with emphasis on risk factors associated with early implant failure might be essential to improve TAA survivorship.

Assessment of the healing of conservatively-treated scaphoid fractures using HR-pQCT.

Improving the clinical outcome of scaphoid fractures may benefit from adequate monitoring of their healing in order to for example identify complications such as scaphoid nonunion at an early stage and to adjust the treatment strategy accordingly. However, quantitative assessment of the healing process is limited with current imaging modalities. In this study, high-resolution peripheral quantitative computed tomography (HR-pQCT) was used for the first time to assess the changes in bone density, microarchitecture, and strength during the healing of conservatively-treated scaphoid fractures. Thirteen patients with a scaphoid fracture (all confirmed on HR-pQCT and eleven on CT) received an HR-pQCT scan at baseline and three, six, twelve, and 26 weeks after first presentation at the emergency department. Bone mineral density (BMD) and trabecular microarchitecture of the scaphoid bone were quantified, and failure load (FL) was estimated using micro-finite element analysis. Longitudinal changes were evaluated with linear mixed-effects models. Data of two patients were excluded due to surgical intervention after the twelve-week follow-up visit. In the eleven fully evaluable patients, the fracture line became more apparent at 3 weeks. At 6 weeks, individual trabeculae at the fracture region became more difficult to identify and distinguish from neighboring trabeculae, and this phenomenon concerned a larger region around the fracture line at 12 weeks. Quantitative assessment showed that BMD and FL were significantly lower than baseline at all follow-up visits with the largest change from baseline at 6 weeks (-13.6% and - 23.7%, respectively). BMD remained unchanged thereafter, while FL increased. Trabecular thickness decreased significantly from baseline at three (-3.9%), six (-6.7%), and twelve (-4.4%) weeks and trabecular number at six (-4.5%), twelve (-7.3%), and 26 (-7.9%) weeks. Trabecular separation was significantly higher than baseline at six (+13.3%), twelve (+19.7%), and 26 (+16.3%) weeks. To conclude, this explorative HR-pQCT study showed a substantial decrease in scaphoid BMD, Tb.Th, and FL during the first 6 weeks of healing of conservatively-treated scaphoid fractures, followed by stabilization or increase in these parameters. At 26 weeks, BMD, trabecular microarchitecture, and FL were not returned to baseline values.

Negative pressure wound therapy does not decrease postoperative wound complications in patients undergoing mastectomy and flap fixation.

Patients and breast cancer surgeons are frequently confronted with wound complications after mastectomy. Negative pressure wound therapy (NPWT) is a promising technique for preventing wound complications after skin closure in elective surgery. However, a clinical study evaluating postoperative complications following the use of NPWT, focusing solely on closed incisions in patients undergoing mastectomy, has yet to be performed. Between June 2019 and February 2020, 50 consecutive patients underwent mastectomy with NPWT during the first seven postoperative days. This group was compared to a cohort of patients taking part in a randomized controlled trial between June 2014 and July 2018. Primary outcome was the rate of postoperative wound complications, i.e. surgical site infections, wound necrosis or wound dehiscence during the first three postoperative months. Secondary outcomes were the number of patients requiring unplanned visits to the hospital and developing clinically significant seroma (CSS). In total, 161 patients were analyzed, of whom 111 patients in the control group (CON) and 50 patients in the NPWT group (NPWT). Twenty-eight percent of the patients in the NPWT group developed postoperative wound complications, compared to 18.9% in the control group (OR = 1.67 (95% CI 0.77-3.63), p = 0.199). The number of patients requiring unplanned visits or developing CSS was not statistically significant between the groups. This study suggests that Avelle negative pressure wound therapy in mastectomy wounds does not lead to fewer postoperative wound complications. Additionally, it does not lead to fewer patients requiring unplanned visits or fewer patients developing clinically significant seromas.Trial registration: ClinicalTrials.gov number, NCT03942575. Date of registration: 08/05/2019.

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.

A systematic review of seroma formation following drain-free mastectomy.

BACKGROUND: Seroma is a common complication after mastectomy. The aim of this review is to elucidate whether closed suction drainage can safely be omitted in patients undergoing mastectomy when assessing seroma formation and its complications. The second aim is to assess the influence of flap fixation on seroma related complications, as there is existing evidence showing that combining mastectomy with flap fixation may make the use of drainage systems obsolete. SEARCH & SELECTION: A review of the literature was performed and articles that compared mastectomy with drainage and mastectomy without drainage were selected. Due to the small number of eligible studies, no selection based on whether flap fixation was performed was possible. If outcome was described in terms of seroma formation or seroma related complications, papers were eligible for inclusion. Studies older than 20 years, animal studies, studies not written in English and studies with male patients were excluded. RESULTS: A total of eight articles were eligible for inclusion. Four prospective studies and four retrospective studies were included. In four studies, flap fixation was performed. Frequency of seroma formation as well as seroma that required intervention was reported. The included studies demonstrated that omitting closed suction drainage does not lead to a higher incidence of seroma formation in patients undergoing mastectomy. CONCLUSION: Despite substantial heterogeneity, there is evidence that drainage can safely be omitted without exacerbating seroma formation and its complications. A well-powered, randomized controlled trial evaluating the effect of drainage omission on seroma formation, with or without flap fixation, is needed.

Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial).

BACKGROUND: Seroma is a common complication after mastectomy, with an incidence of 3% to 85%. Seroma is associated with pain, delayed wound healing, and additional outpatient clinic visits, leading potentially to repeated seroma aspiration or even surgical interventions. This study aimed to assess the effect of flap fixation using sutures or tissue glue in preventing seroma formation and its sequelae. METHODS: Between June 2014 and July 2018, 339 patients with an indication for mastectomy or modified radical mastectomy were enrolled in this randomized controlled trial in the Netherlands. Patients were randomly allocated to one of the three following arms: conventional wound closure (CON, n = 115), flap fixation using sutures (FFS, n = 111) or flap fixation using tissue glue (FFG, n = 113). The primary outcome was the need for seroma aspiration. The secondary outcomes were additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores. RESULTS: Flap fixation after mastectomy leads to fewer seroma aspirations than conventional wound closure (CON 17.5% vs FFS 7.3% vs FFG 10.8%; p = 0.057), with a significant difference between flap fixation with sutures and conventional wound closure (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.89; p = 0.025). Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain. CONCLUSION: Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly advise surgeons to use sutures for flap fixation in patients undergoing mastectomy. (ClinicalTrials.gov no. NCT03305757). PREREGISTRATION: The trial was registered after enrollment of the first participant. However, no specific explanation exists for this except that through the years more importance has been given to central trial registration. Our research team can ensure that after enrollment of the first participant, no changes were made to the trial, analysis plan, and/or study design.