Evaluation of the Fusion Rate and Safety of Escherichia coli-Derived rhBMP-2 in Transforaminal Lumbar Interbody Fusion for Patients with Degenerative Lumbar Disease: A Prospective, Multicenter, Single-Arm Trial.

Background: Few studies have documented the viability of E. coli-derived recombinant human bone morphogenetic protein-2 (rhBMP-2) in transforaminal lumbar interbody fusion (TLIF). This study aimed to assess the safety and fusion rate of rhBMP-2 in TLIF. Methods: The study was conducted as a prospective, multicenter, single-arm trial, and 30 patients needing one- or two-level TLIF were enrolled. Fusion rate was assessed using the 12-month interbody fusion rate on CT. Postoperative problems, including seroma, radiculitis, and ectopic bone formation, which have been documented as risks associated with rhBMP-2 in prior studies, were recorded. Results: The study demonstrated fusion outcomes in all instances at 52 and 104 weeks post-surgery. Significant improvements were observed in clinical outcomes, with ODI, SF-36, and VAS scores, all achieving statistical significance (p < 0.0001). No perioperative adverse events requiring reoperation were reported, and there were no incidences of seroma, radiculitis, cage migration, grafted bone extrusion, postoperative neurologic deficit, or deep wound infection. Conclusions: The study demonstrates the high safety and efficacy in inducing bone fusion of E. coli-derived rhBMP-2 in TLIF, with a notable absence of adverse postoperative complications. Trial registration: This study protocol was registered at Korea Clinical Research Information Service (number identifier: KCT0004738) on July 2020.

Exploration of Point-of-Care Ultrasonography for Silicone Breast Implant Rupture Detection and Classification.

Background and Objectives: The surge in breast-related surgeries in Korea underscores the critical need for an accurate early diagnosis of silicone breast implant-related issues. Complications such as BIA-ALCL and BIA-SCC add complexity to breast health concerns, necessitating vigilant monitoring. Despite advancements, discrepancies persist between ultrasonographic and pathologic classifications of silicone implant ruptures, highlighting a need for enhanced diagnostic tools. This study explores the reliability of ultrasonography in diagnosing silicone breast implant ruptures and determining the extent of silicone migration, specifically with a focus on guiding potential capsulectomy based on pathology. Materials and Methods: A comprehensive review of medical records encompassing 5557 breast implants across 2790 patients who underwent ultrasound-assisted examinations was conducted. Among the screened implants, 8.9% (249 cases) were diagnosed with silicone breast implant rupture through ultrasonography. Subsequently, 89 women underwent revisional surgery, involving capsulectomy. The pathological analysis of 111 periprosthetic capsules from these cases aimed to assess the extent of silicone migration, and the findings were juxtaposed with the existing ultrasonographic rupture classification. Results: The diagnostic agreement between preoperative sonography and postoperative findings reached 100% for silicone breast implant ruptures. All eighty prosthetic capsules exhibiting a snowstorm sign in ultrasonography demonstrated silicone migration to capsules upon pathologic findings. Conclusions: High-resolution ultrasonography emerged as a valuable and reliable imaging modality for diagnosing silicone breast implant ruptures, with a notable ability to ascertain the extent of free silicone migration to capsules. This diagnostic precision is pivotal in informing decisions about potential capsulectomy during revisional surgery. The study advocates for an update to the current binary ultrasonographic classification, suggesting a more nuanced categorization into three types (subcapsular, intracapsular, and extracapsular) based on pathology.

Effect of Solitary Osteochondroma on Alignment and Length in the Lower Extremities.

BACKGROUND: There is a lack of information about the effects of untreated solitary osteochondroma (SO) on longitudinal growth of the lower extremities in children and adolescents. This study aimed to assess the coronal alignment and length of the lower extremity in patients with SO around the knee and to identify the factors related to the development of deformities. METHODS: We retrospectively reviewed 111 patients diagnosed with SO around the knee. The patients were classified into 2 groups depending on the location of the SO: 51 in the distal femur and 60 in the proximal tibia. Characteristics of the lesions, such as type, location, size, and distance from the joint line, were determined. Radiographic analysis of the lower limbs included mechanical lateral distal femoral angle, mechanical medial proximal tibial angle, whole-leg length, femoral length, and tibial length. RESULTS: The mean age at the time of diagnosis was 12.3±3.4 years. No statistically significant differences were found between the affected and contralateral sides for mechanical lateral distal femoral angle and mechanical medial proximal tibial angle in either the distal femur or the proximal tibia groups. In patients with femoral lesions, the femoral and whole-leg lengths were significantly shorter on the affected side than on the unaffected side ( P <0.001 and 0.002, respectively), and the mean differences were 2.1±3.6 and 2.1±4.4 mm, respectively. Univariate logistic regression analysis did not reveal any factors associated with limb length discrepancy (LLD). In patients with tibial lesions, no statistically significant differences were found in LLD. CONCLUSIONS: SOs around the knee did not cause clinically significant deformity of the lower extremity. However, in contrast to proximal tibia lesions, SO in the distal femur was associated with the shortening of the affected limb. Consideration should be given to the development of LLD in skeletally immature children with SO in the distal femur. LEVEL OF EVIDENCE: Level III-retrospective comparative study.

Lipocalin-2 as a mediator of neuroimmune communication.

Lipocalin-2 (LCN2), a neutrophil gelatinase-associated lipocalin (NGAL), is a 25 kDa secreted protein implicated in a broad range of inflammatory diseases affecting the brain and periphery. It is a pleotropic protein expressed by various immune and non-immune cells throughout the body. Importantly, the surge in LCN2 levels in disease states has been associated with a myriad of undesirable effects, further exacerbating the ongoing pathological processes. In the brain, glial cells are the principal source of LCN2, which plays a definitive role in determining their functional phenotypes. In different central nervous system (CNS) pathologies, an increased expression of glial LCN2 has been linked to neurotoxicity. LCN2 mediates a crosstalk between central and peripheral immune cells under neuroinflammatory conditions. One intriguing aspect is that elevated LCN2 levels in peripheral disorders, such as cancer, metabolic conditions, and liver diseases, potentially incite an inflammatory activation of glial cells while disrupting neuronal functions. This review comprehensively summarizes the influence of LCN2 on the exacerbation of neuroinflammation by regulating various cellular processes. Additionally, this review explores LCN2 as a mediator of neuroimmune crosstalk in various CNS pathologies and highlights the role of LCN2 in carrying inflammatory signals along the neuroimmune axis.

EBP50 is a key molecule for the Schwann cell-axon interaction in peripheral nerves.

Peripheral nerve injury disrupts the Schwann cell-axon interaction and the cellular communication between them. The peripheral nervous system has immense potential for regeneration extensively due to the innate plastic potential of Schwann cells (SCs) that allows SCs to interact with the injured axons and exert specific repair functions essential for peripheral nerve regeneration. In this study, we show that EBP50 is essential for the repair function of SCs and regeneration following nerve injury. The increased expression of EBP50 in the injured sciatic nerve of control mice suggested a significant role in regeneration. The ablation of EBP50 in mice resulted in delayed nerve repair, recovery of behavioral function, and remyelination following nerve injury. EBP50 deficiency led to deficits in SC functions, including proliferation, migration, cytoskeleton dynamics, and axon interactions. The adeno-associated virus (AAV)-mediated local expression of EBP50 improved SCs migration, functional recovery, and remyelination. ErbB2-related proteins were not differentially expressed in EBP50-deficient sciatic nerves following injury. EBP50 binds and stabilizes ErbB2 and activates the repair functions to promote regeneration. Thus, we identified EBP50 as a potent SC protein that can enhance the regeneration and functional recovery driven by NRG1-ErbB2 signaling, as well as a novel regeneration modulator capable of potential therapeutic effects.

Two distinct forms of human BLT2: long-form and short-form BLT2.

BLT2 is a low-affinity leukotriene B4 receptor that plays an essential role in the pathogenesis of various inflammatory diseases, including asthma and cancer. BLT2 is minimally expressed in a normal internal environment but is overexpressed in a stress-induced inflammatory environment. Recent research indicated that human BLT2 has two distinct forms. Although their functions are likely to be different, very few studies investigated these differences. Therefore, this paper will discuss about the two distinct forms of human BLT2; the short-form of BLT2 and the long-form of BLT2.

Use of High-Resolution Ultrasound in Characterizing the Surface Topography of a Breast Implant.

Background and Objectives: With the emergence of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), it has become necessary to identify the implant shell type patients have received. Therefore, an immediate, reliable method for identifying a breast implant shell type is essential. Evidence-based research and applying a real-world technique that identifies the surface topographic information of the inserted breast implants, without surgery, has become of paramount importance for breast implant physicians. Methods and Materials: A review of the medical records of 1901 patients who received 3802 breast implants and subsequently received an ultrasound-assisted examination was performed. All patients received not only a breast cancer examination but also a high-resolution ultrasonography (HRUS) assisted examination of the device at a single center between 31 August 2017 and 31 December 2022. Results: Most patients had breast implants within 10 years (77.7%) of the examination. Of the 3802 implants screened, 2034 (53.5%) were identified with macro-textured shell topography in ultrasonography. A macrotextured shell type implant was used in 53.5% of cases and a smooth type in 42.7% of cases. Seventy-three (1.9%) breast implant shell types could not be identified due to ruptures. However, 250 breast implant shell types could be identified despite rupture cases (6.5%). Conclusions: HRUS was found to be a useful and reliable image modality for identifying various surface shell types of breast implants. The shell type information would be helpful to patients who lack information about their breast implants and are concerned about BIA-ALCL.

Rapid Screening and Comparison of Chimeric Lysins for Antibacterial Activity against Staphylococcus aureus Strains.

Chimeric lysins composed of various combinations of cell wall-lysing (enzymatic) and cell-wall-binding (CWB) domains of endolysins, autolysins, and bacteriocins have been developed as alternatives to or adjuvants of conventional antibiotics. The screening of multiple chimeric lysin candidates for activity via E. coli expression is not cost effective, and we previously reported on a simple cell-free expression system as an alternative. In this study, we sufficiently improved upon this cell-free expression system for use in screening activity via a turbidity reduction test, which is more appropriate than a colony reduction test when applied in multiple screening. Using the improved protocol, we screened and compared the antibacterial activity of chimeric lysin candidates and verified the relatively strong activity associated with the CHAP (cysteine, histidine-dependent amidohydrolase/peptidase) domain of secretory antigen SsaA-like protein (ALS2). ALS2 expressed in E. coli showed two major bands, and the smaller one (subprotein) was shown to be expressed by an innate downstream promoter and start codon (ATG). The introduction of synonymous mutations in the promoter resulted in clearly reduced expression of the subprotein, whereas missense mutations in the start codon abolished antibacterial activity as well as subprotein production. Interestingly, most of the S. aureus strains responsible for bovine mastitis were susceptible to ALS2, but those from human and chicken were less susceptible. Thus, the simple and rapid screening method can be applied to select functional chimeric lysins and define mutations affecting antibacterial activity, and ALS2 may be useful in itself and as a lead molecule to control bovine mastitis.

A multiplexed siRNA screen identifies key kinase signaling networks of brain glia.

The dynamic behaviors of brain glial cells in various neuroinflammatory conditions and neurological disorders have been reported; however, little is known about the underlying intracellular signaling pathways. Here, we developed a multiplexed kinome-wide siRNA screen to identify the kinases regulating several inflammatory phenotypes of mouse glial cells in culture, including inflammatory activation, migration, and phagocytosis of glia. Subsequent proof-of-concept experiments involving genetic and pharmacological inhibitions indicated the importance of T-cell receptor signaling components in microglial activation and a metabolic shift from glycolysis to oxidative phosphorylation in astrocyte migration. This time- and cost-effective multiplexed kinome siRNA screen efficiently provides exploitable drug targets and novel insight into the mechanisms underlying the phenotypic regulation of glial cells and neuroinflammation. Moreover, the kinases identified in this screen may be relevant in other inflammatory diseases and cancer, wherein kinases play a critical role in disease signaling pathways.

A non-manufacturer-sponsored, retrospective study to assess 2-year safety outcomes of the BellaGel® SmoothFine as compared with its competitors in the context of the first Korean case of a medical device fraud.

BACKGROUND: We conducted this study to assess preliminary 2-year safety outcomes of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine in the context of the first Korean case of a medical device fraud. METHODS: Our clinical series of the patients (n = 579; 1,158 breasts) received augmentation using the BellaGel® SmoothFine, Naturgel™, Motiva Ergonomix™, Eurosilicone Round Collection™, Natrelle® INSPIRA™, Natrelle® 410, Mentor® MemoryGel Xtra or Microthane®. The patients were evaluated for incidences of postoperative complications and Kaplan-Meier survival and hazards. RESULTS: Overall, there were a total of 101 cases (17.4%) of postoperative complications; these include 31 cases (5.4%) of shape deformity, 21 cases (3.6%) of CC, 18 cases (3.1%) of early seroma, 8 cases (1.4%) of infection, 5 cases (0.9%) of early hematoma, 1 case (0.2%) of delayed hematoma, 1 case (0.2%) of rupture and 1 case (0.2%) of ripping. Moreover, there were also 15 cases (2.6%) of other complications. There were significant differences in incidences of postoperative complications between the breast implants from different manufacturers (P = 0.034). The Natrelle® 410 showed the longest survival (333.3±268.2 [141.5-525.1] days). A subgroup analysis showed that there were no significant differences in incidences of postoperative complications between the breast implants (P = 0.831). Moreover, the Natrelle® INSPIRA™ showed the longest survival (223.7±107.1 [-42.3-489.6] days). CONCLUSIONS: Here, we describe preliminary 2-year safety outcomes of an implant-based augmentation mammaplasty using the BellaGel® SmoothFine in the context of the first Korean case of a medical device fraud.

Use of High-Resolution Ultrasound in Characterizing a Breast Implant and Detecting a Rupture of the Device.

SUMMARY: With the emergence of state-of-the art implant technology and advanced surgical techniques, plastic surgeons face challenging problems, such as identification of a specific type of a device and diagnosis of postoperative complications, in managing patients undergoing implant-based augmentation mammaplasty. In this article, the authors introduce a novel method for characterizing a breast implant based on diverse factors (eg, filler properties, type of pocket, surface topography, shape type, and manufacturer of the device) and detecting the presence and scope of rupture using high-resolution ultrasound.

Lipocalin-2 Is a Key Regulator of Neuroinflammation in Secondary Traumatic and Ischemic Brain Injury.

Reactive glial cells are hallmarks of brain injury. However, whether these cells contribute to secondary inflammatory pathology and neurological deficits remains poorly understood. Lipocalin-2 (LCN2) has inflammatory and neurotoxic effects in various disease models; however, its pathogenic role in traumatic brain injury remains unknown. The aim of the present study was to investigate the expression of LCN2 and its role in neuroinflammation following brain injury. LCN2 expression was high in the mouse brain after controlled cortical impact (CCI) and photothrombotic stroke (PTS) injury. Brain levels of LCN2 mRNA and protein were also significantly higher in patients with chronic traumatic encephalopathy (CTE) than in normal subjects. RT-PCR and immunofluorescence analyses revealed that astrocytes were the major cellular source of LCN2 in the injured brain. Lcn2 deficiency or intracisternal injection of an LCN2 neutralizing antibody reduced CCI- and PTS-induced brain lesions, behavioral deficits, and neuroinflammation. Mechanistically, in cultured glial cells, recombinant LCN2 protein enhanced scratch injury-induced proinflammatory cytokine gene expression and inhibited Gdnf gene expression, whereas Lcn2 deficiency exerted opposite effects. Together, our results from CTE patients, rodent brain injury models, and cultured glial cells suggest that LCN2 mediates secondary damage response to traumatic and ischemic brain injury by promoting neuroinflammation and suppressing the expression of neurotropic factors.

Associations between local acidosis induced by renal LDHA and renal fibrosis and mitochondrial abnormalities in patients with diabetic kidney disease.

During the progression of diabetic kidney disease (DKD), renal lactate metabolism is rewired. The relationship between alterations in renal lactate metabolism and renal fibrosis in patients with diabetes has only been partially established due to a lack of biopsy tissues from patients with DKD and the intricate mechanism of lactate homeostasis. The role of lactate dehydrogenase A (LDHA)-mediated lactate generation in renal fibrosis and dysfunction in human and animal models of DKD was explored in this study. Measures of lactate metabolism (urinary lactate levels and LDHA expression) and measures of DKD progression (estimated glomerular filtration rate and Wilms' tumor-1 expression) were strongly negatively correlated in patients with DKD. Experiments with streptozotocin-induced DKD rat models and the rat renal mesangial cell model confirmed our findings. We found that the pathogenesis of DKD is linked to hypoxia-mediated lactic acidosis, which leads to fibrosis and mitochondrial abnormalities. The pathogenic characteristics of DKD were significantly reduced when aerobic glycolysis or LDHA expression was inhibited. Further studies will aim to investigate whether local acidosis caused by renal LDHA might be exploited as a therapeutic target in patients with DKD.

Astrocyte-derived adenosine excites sleep-promoting neurons in the ventrolateral preoptic nucleus: Astrocyte-neuron interactions in the regulation of sleep.

Although ATP and/or adenosine derived from astrocytes are known to regulate sleep, the precise mechanisms underlying the somnogenic effects of ATP and adenosine remain unclear. We selectively expressed channelrhodopsin-2 (ChR2), a light-sensitive ion channel, in astrocytes within the ventrolateral preoptic nucleus (VLPO), which is an essential brain nucleus involved in sleep promotion. We then examined the effects of photostimulation of astrocytic ChR2 on neuronal excitability using whole-cell patch-clamp recordings in two functionally distinct types of VLPO neurons: sleep-promoting GABAergic projection neurons and non-sleep-promoting local GABAergic neurons. Optogenetic stimulation of VLPO astrocytes demonstrated opposite outcomes in the two types of VLPO neurons. It led to the inhibition of non-sleep-promoting neurons and excitation of sleep-promoting neurons. These responses were attenuated by blocking of either adenosine A1 receptors or tissue-nonspecific alkaline phosphatase (TNAP). In contrast, exogenous adenosine decreased the excitability of both VLPO neuron populations. Moreover, TNAP was expressed in galanin-negative VLPO neurons, but not in galanin-positive sleep-promoting projection neurons. Taken together, these results suggest that astrocyte-derived ATP is converted into adenosine by TNAP in non-sleep-promoting neurons. In turn, adenosine decreases the excitability of local GABAergic neurons, thereby increasing the excitability of sleep-promoting GABAergic projection neurons. We propose a novel mechanism involving astrocyte-neuron interactions in sleep regulation, wherein endogenous adenosine derived from astrocytes excites sleep-promoting VLPO neurons, and thus decreases neuronal excitability in arousal-related areas of the brain.

Neuroinflammation Induced by Transgenic Expression of Lipocalin-2 in Astrocytes.

Transgenic mice are a useful tool for exploring various aspects of gene function. A key element of this approach is the targeted overexpression of specific genes in cells or tissues. Herein, we report for the first time, the generation and characterization of conditional transgenic (cTg) mice for lipocalin-2 (LCN2) expression. We generated the R26-LCN2-transgenic (LCN2-cTg) mice that carried a loxP-flanked STOP (neo) cassette, Lcn2 cDNA, and a GFP sequence. When bred with Tg mice expressing Cre recombinase under the control of various tissues or cell-specific promoters, Cre-mediated recombination deletes the STOP cassette and allows the expression of LCN2 and GFP. In this study, we achieved the recombination of loxP-flanked LCN2 in hippocampal astrocytes of cTg mouse brain, using a targeted delivery of adeno-associated virus (AAVs) bearing Cre recombinase under the control of a GFAP promoter (AAVs-GFAP-mCherry-Cre). These mice with localized LCN2 overexpression in astrocytes of the hippocampus developed neuroinflammation with enhanced glial activation and increased mRNA and protein levels of proinflammatory cytokines. Furthermore, mice showed impairment in cognitive functions as a typical symptom of hippocampal inflammation. Taken together, our study demonstrates the usefulness of LCN2-cTg mice in targeting specific cells at various organs for conditional LCN2 expression and for subsequent investigation of the functional role of cell-type-specific LCN2 within these sites. Moreover, the LCN2-cTg mice with targeted expression of LCN2 in hippocampal astrocytes are a new in vivo model of neuroinflammation.

Additional Excision Biopsy in Patients With Atypical Ductal Hyperplasia at Ultrasound-guided Vacuum-assisted Breast Biopsy.

BACKGROUND/AIM: We conducted this single-center, retrospective study to identify predictors of upgrading to malignancy and to discuss the necessity of additional excision biopsy in patients who were diagnosed with atypical ductal hyperplasia (ADH) at ultrasound (US)-guided vacuum-assisted breast biopsy (VABB) based on our 18-year, single-center experience. PATIENTS AND METHODS: The current study was conducted in a total of 12,160 patients who were evaluated at our medical institution during an 18-year period between January of 2003 and December of 2020. We included the patients who were diagnosed with ADH at US-guided VABB using the Mammotome® (Devicor Medical Products, Inc., Cincinnati, OH, USA). We therefore included a total of 114 patients (n=114) with ADH in the current study. RESULTS: Of 114 eligible patients, 36 underwent additional excision biopsy and the remaining 78 did not. Of these 36 patients, 15 were found to have an upgrading to malignancy at a rate of upgrading of 41.7%. These include 7 cases (46.6%) of low-grade ductal carcinoma in situ (DCIS), 3 cases (20.0%) of intermediate grade DCIS, 1 case (6.7%) of microinvasive DCIS, 3 cases (20.0%) of multifocal lobular carcinoma in situ, and 1 case (6.7%) of mucinous carcinoma. Finally, only suspicious microcalcification on mammography was a significant predictor of upgrading to malignancy (p=0.023). CONCLUSION: An additional excision biopsy is recommended to reduce the rate of upgrading to malignancy in patients who were diagnosed with ADH through a US-guided VABB.

A Surgeon's Empirical Perspectives on Use of High-resolution Ultrasound in Preoperatively Detecting a Rupture in the Context of Breast Implant Crisis in Korea.

BACKGROUND: We previously proposed a novel method for detecting a rupture of a breast implant using high-resolution ultrasound (HRUS). We therefore conducted this retrospective, observational study to describe its feasibility in making a preoperative diagnosis of rupture of the device in patients receiving an implant-based augmentation mammaplasty. METHODS: We initially evaluated the medical records of the patients who had received primary or secondary augmentation mammaplasty using a breast implant at other hospitals for aesthetic or reconstructive purposes between August 31, 2017, and August 31, 2020. The patients underwent breast US using the Aplio i600 (Canon Medical System, Otawara, Tochigi, Japan) system with a 7-18 MHz linear transducer. Through a retrospective review of the patients' medical records, we analyzed their baseline and clinical characteristics. Then, we compared an agreement between preoperative diagnosis of rupture on HRUS and findings at reoperation. RESULTS: A total of 29 patients with rupture (55 breasts) were evaluated for the performance of ultrasound in making a diagnosis of rupture. This showed that they were unaware of rupture but they were diagnosed with it on ultrasound. Preoperatively, there were no cases of rupture in 110 left breasts (80.9%) and 107 right breasts (78.7%), which exactly matched to the number of breasts without rupture on HRUS. Moreover, preoperatively, there were 26 (19.1%) and 29 cases (21.3%) of rupture in the left and right breast, respectively, which exactly matched to the number of breasts with rupture on HRUS. CONCLUSIONS: In conclusion, patients who are suspected of having rupture of a breast implant should be stringently evaluated for presence of rupture and, if any, its scope using HRUS. Moreover, we propose that surgeons consider using HRUS in making a preoperative diagnosis of rupture of a breast implant. 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 .

The Role of High Resolution Ultrasonography in Elucidating Features of the Breast Implants in Asymptomatic Patients After Implant-based Augmentation Mammaplasty.

BACKGROUND: We conducted this study to describe the feasibility of high-resolution ultrasound (HRUS) in characterizing a breast implant in patients receiving an implant-based augmentation mammaplasty. METHODS: The current study was conducted in a total of 612 patients (n =6 12) receiving an implant-based augmentation mammaplasty at other hospitals between August 31, 2017 and August 31, 2020. Of these, 136 patients (n = 136; 272 breasts) receiving reoperation were included in the current study. We compared between the patients' subjective awareness of a breast implant and its HRUS findings and an agreement between HRUS findings of a breast implant and its findings at reoperation. RESULTS: The proportion of the patients receiving a silicone gel-filled breast implant was increased from 65.44% (89/136) to 81.61% (111/136) on HRUS. Moreover, HRUS was effective in identifying a manufacturer of the device. CONCLUSIONS: In conclusion, our results indicate that HRUS is feasible in characterizing a breast implant in patients receiving an implant-based augmentation mammaplasty. But further prospective, large-scale studies are warranted to corroborate our results. LEVEL OF EVIDENCE V: 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 .

High-Resolution Ultrasound-Assisted Assessment of Preliminary Short-term Safety Outcomes of an Implant-Based Augmentation Mammaplasty Using a Bioengineered, Cell-Friendly, Smooth-Surface Device in Korean Females.

BACKGROUND: The Motiva Ergonomix Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) is one of the representative brands of the fifth generation of a silicone gel-filled breast implant with a microtextured surface. OBJECTIVES: In this study, the authors describe preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface in Korean females. METHODS: The authors performed a retrospective analysis of medical records in a total of 69 females (n = 69) receiving an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface between September 26, 2017, and December 31, 2020. The authors analyzed incidences of postoperative complications. RESULTS: A total of 6 cases (8.7%) of postoperative complications occurred; these include 2 cases (2.9%) of early seroma, 1 case (1.4%) of capsular contracture, 2 cases (2.9%) of alterations in the shape, and 1 case (1.4%) of foreign body sensation. Time-to-events were estimated at 266.81 ± 273.17 days. CONCLUSIONS: The authors describe our preliminary short-term safety outcomes of an implant-based augmentation mammaplasty using the Motiva Ergonomix Round SilkSurface in Korean females. But this deserves further large-scale studies with long periods of follow-up.

The Value of Capsule Thickness on Breast Ultrasound as an Indicator of the Severity of Capsular Contracture and Its Correlation with the Baker Classification.

BACKGROUND: We conducted this study to explore the value of the capsule thickness as an indicator of the severity of capsular contracture (CC) alternatively to the Baker classification system in patients who were treated with an implant-based augmentation mammaplasty. METHODS: A total of 117 eligible patients (202 breasts) were included in the current study. We measured the capsule thickness using ultrasound and histologic examination in association with the Baker grades I, II, III and IV. Then, we analysed agreement of the capsule thickness between the two methods using an intra-correlation coefficient (ICC 2,1) with 95% confidence intervals (CIs). The CC of Baker grades II, III and IV (105 breasts), for which the capsule thickness could be measured using US, served as Model 1. Moreover, Model 1 including the CC of Baker grades I (97 breasts) served as Model 2. RESULTS: The capsule thickness was measured as 0.58 ± 0.11 (0.4-0.8) mm, 1.07 ± 0.16 (0.8-1.31) mm and 1.89 ± 0.55 (1-4.1) mm on ultrasound in association with Baker grades II, III and IV, respectively. In addition, it was also measured as 0.28 ± 0.07 (0.09-0.41) mm, 0.58 ± 0.08 (0.42-0.75) mm, 1.06 ± 0.14 (0.79-1.34) mm and 2.13 ± 1.14 (1.38-6.98) mm on histologic examination in association with Baker grades I, II, III and IV, respectively. In Model 1 and 2, the ICC was calculated as 0.942 (95%CI 0.914-0.961) and 0.955 (95%CI 0.940-0.966), respectively. The cut-off values between the Baker grades I-II, II-III and III-IV were calculated as 0. mm, 0.8 mm and 1.2 mm, respectively. CONCLUSIONS: In conclusion, the capsule thickness might be used as an indicator of the severity of CC alternatively to the Baker classification system. But further studies are warranted to establish our results. LEVEL OF EVIDENCE IV: 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 .