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In an international trial involving 450 patients with acute subdural hematoma, craniotomy (bone flap replaced) and decompressive craniectomy (bone flap left out) yielded similar disability-related outcomes at 12 months.

PurposeIndications for nipple-sparing mastectomy (NSM) have broadened to include the risk reducing setting and locally advanced tumors, which resulted in a dramatic increase in the use of NSM. The Oncoplastic Breast Consortium consensus conference on NSM and immediate reconstruction was held to address a variety of questions in clinical practice and research based on published evidence and expert panel opinion.MethodsThe panel consisted of 44 breast surgeons from 14 countries across four continents with a background in gynecology, general or reconstructive surgery and a practice dedicated to breast cancer, as well as a patient advocate. Panelists presented evidence summaries relating to each topic for debate during the in-person consensus conference. The iterative process in question development, voting, and wording of the recommendations followed the modified Delphi methodology.ResultsConsensus recommendations were reached in 35, majority recommendations in 24, and no recommendations in the remaining 12 questions. The panel acknowledged the need for standardization of various aspects of NSM and immediate reconstruction. It endorsed several oncological contraindications to the preservation of the skin and nipple. Furthermore, it recommended inclusion of patients in prospective registries and routine assessment of patient-reported outcomes. Considerable heterogeneity in breast reconstruction practice became obvious during the conference.ConclusionsIn case of conflicting or missing evidence to guide treatment, the consensus conference revealed substantial disagreement in expert panel opinion, which, among others, supports the need for a randomized trial to evaluate the safest and most efficacious reconstruction techniques.

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

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.

Large full thickness abdominal wall defects following malignancies can be a reconstructive challenge. The purpose of this study was to analyze long-term outcomes and complications following abdominal wall reconstruction using composite antero-lateral thigh (ALT) flaps. The study retrospectively investigated 16 consecutive patients who underwent abdominal wall reconstruction with autologous flap between May 2003 and March 2018. Volumetric flap analysis was used to assess flap atrophy over time, evaluating the role of denervation and reinnervation. The long-term outcome was assessed to compare the two groups (free vs. pedicled ALT flap reconstructions). All flaps successfully covered the defects. We found a significant increase in flap resorption in free flaps when compared to pedicled ones. Abdominal bulging was seen in 3 out of 16 (19%) patients after more than 12 months follow-up, in close correlation with mesh absence. Free flaps were shown to be equally effective as their pedicled counterparts, without significant increase in complication rate.

To report closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure. Twenty-eight patients were randomized (1:1) to receive a vitrectomy with either Cover or Fill ILM flap technique. All patients underwent BCVA, RS and FS assessment at baseline, 1-month and 3-months after surgery. MH closed in all patients. BCVA rose from 20/100 (baseline) to 20/33 (1-month) in both groups, to 20/28 in CG versus 20/33 in FG (3-months) ( p  < 0.05). The central 4° RS rose from 11.5 and 12 dB to 19 and 19.5 dB (1-month) and to 22 and 20 dB (3-months), respectively, in CG and FG ( p  < 0.001). The central 10° RS rose from 11 and 15 dB to 22 and 20 dB (1-month) and to 23 and 20 dB (3-months), respectively, in CG and FG ( p  < 0.001). FS increased significantly more in CG. CG improved significantly more than FG in terms of BCVA, RS and FS. The average MH diameter was relatively small (397 µm); larger MHs may behave differently. Trial registration: Trial Registry: https://www.clinicaltrials.gov ; Identifier: NCT04135638. Registration date 22/10/2019.

BackgroundDespite high success rates, flap failure remains an inherent risk in microvascular breast reconstruction. Identifying patients who are at high risk for flap failure would enable us to recommend alternative reconstructive techniques. However, as flap failure is a rare event, identification of risk factors is statistically challenging. Machine learning is a form of artificial intelligence that automates analytical model building. It has been proposed that machine learning can build superior prediction models when the outcome of interest is rare.MethodsIn this study we evaluate machine learning resampling and decision-tree classification models for the prediction of flap failure in a large retrospective cohort of microvascular breast reconstructions.ResultsA total of 1012 patients were included in the study. Twelve patients (1.1%) experienced flap failure. The ROSE informed oversampling technique and decision-tree classification resulted in a strong prediction model (AUC 0.95) with high sensitivity and specificity. In the testing cohort, the model maintained acceptable specificity and predictive power (AUC 0.67), but sensitivity was reduced. The model identified four high-risk patient groups. Obesity, comorbidities and smoking were found to contribute to flap loss. The flap failure rate in high-risk patients was 7.8% compared with 0.44% in the low-risk cohort (p = 0.001).ConclusionsThis machine-learning risk prediction model suggests that flap failure may not be a random event. The algorithm indicates that flap failure is multifactorial and identifies a number of potential contributing factors that warrant further investigation.

We investigated the postoperative visual outcomes and morphological changes of the internal limiting membrane (ILM) flap, in patients who underwent the temporal inverted ILM flap technique for macular hole (MH). Between August 2018 and February 2020, 22 eyes of 22 patients with idiopathic or myopic MH who underwent vitrectomy with ILM flap were included in this study and followed-up for more than 6 months. Postoperative MH status, comparison of best-corrected visual acuity (BCVA) before and 6 months after surgery, changes in the ILM flap area at 1 and 6 months postoperatively, and the factors related to changes in ILM flap size, were analyzed. MH closure was achieved in all of the patients. The BCVA at 6 months postoperatively (0.18 ± 0.15) was significantly better than the preoperative BCVA of 0.63 ± 0.37 ( P  < 0.001, paired t test). The area of the ILM flap decreased significantly from 3.25 ± 1.27 mm 2 at 1 month to 3.13 ± 1.23 mm 2 at 6 months ( P  = 0.024, Wilcoxon signed-rank test). Two eyes showed an ILM flap contraction of more than 20%, and one eye required reoperation due to an increase in metamorphopsia and decreased visual acuity. Among age, sex, ILM flap area at 1 month, preoperative BCVA, and axial length, ILM flap contraction was correlated with patient age and ILM flap area. Although vitrectomy with the inverted ILM flap technique confers a good visual outcome, the ILM flap may contract in younger patients.

Background Rates of mastectomy with immediate reconstruction are rising. Skin flap necrosis after this procedure is a recognized complication that can have an impact on cosmetic outcomes and patient satisfaction, and in worst cases can potentially delay adjuvant therapies. Many retrospective studies of this complication have identified variable event rates and inconsistent associated factors. Methods A prospective study was designed to capture the rate of skin flap necrosis as well as pre-, intra-, and postoperative variables, with follow-up assessment to 8 weeks postoperatively. Uni- and multivariate analyses were performed for factors associated with skin flap necrosis. Results Of 606 consecutive procedures, 85 (14 %) had some level of skin flap necrosis: 46 mild (8 %), 6 moderate (1 %), 31 severe (5 %), and 2 uncategorized (0.3 %). Univariate analysis for any necrosis showed smoking, history of breast augmentation, nipple-sparing mastectomy, and time from incision to specimen removal to be significant. In multivariate models, nipple-sparing, time from incision to specimen removal, sharp dissection, and previous breast reduction were significant for any necrosis. Univariate analysis of only moderate or severe necrosis showed body mass index, diabetes, nipple-sparing mastectomy, specimen size, and expander size to be significant. Multivariate analysis showed nipple-sparing mastectomy and specimen size to be significant. Nipple-sparing mastectomy was associated with higher rates of necrosis at every level of severity. Conclusions Rates of skin flap necrosis are likely higher than reported in retrospective series. Modifiable technical variables have limited the impact on rates of necrosis. Patients with multiple risk factors should be counseled about the risks, especially if they are contemplating nipple-sparing mastectomy.

Background Indocyanine green angiography (ICG-A) is a useful tool for evaluating mastectomy skin flap (MSF) perfusion during breast reconstruction. However, a standardized protocol for interpreting and applying MSF perfusion after mastectomy has not been established yet. The purpose of this study is to establish criteria for assessing MSF perfusion in immediate implant-based prepectoral breast reconstruction while correlating ICG-A findings with postoperative outcomes Methods This prospective observational study was conducted at a single institution and involved patients with breast cancer who underwent mastectomy and immediate implant-based prepectoral breast reconstruction between August 2021 and August 2023. The terms “hypoperfused flap” and “hypoperfused area” were defined according to ICG-A perfusion. MSF exhibited < 30% perfusion, excluding the nipple and the corresponding region, respectively. Data on the hypoperfused flap, hypoperfused area, and MSF necrosis were collected. Results Fifty-three breast cases were analyzed. Eight patients developed MSF necrosis (15.1%, 8/53). Of these, two patients underwent surgical debridement and revision within 3 months (3.8%, 2/53). There were nine cases of a hypoperfused flap, eight of which developed MSF necrosis. The hypoperfused flap was a significant predictor of the occurrence of MSF necrosis ( p  < 0.001). There was a tendency for increased full-thickness necrosis with a wider hypoperfused area. Conclusions The hypoperfused flap enabled the prediction of MSF necrosis with high sensitivity, specificity, positive predictive value, and negative predictive value. Considering the presumed correlation between the extent of the hypoperfused area and the need for revision surgery, caution should be exercised when making intraoperative decisions regarding the reconstruction method. Level of Evidence III This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .