Comment to "An unusual "linitis plastica" like breast cancer bladder metastasis".

Dear Editor, We read with interest the recently published article by Farci et al., titled "An unusual 'linitis plastica' like breast cancer bladder metastasis" and we congratulate the authors for the very interesting topic and case presented...

Porto-sinusoidal vascular liver disorder with portal hypertension: Natural history and long-term outcome.

BACKGROUND & AIMS: Current knowledge of the natural history of patients with porto-sinusoidal vascular disorder (PSVD) is derived from small studies. The aim of the present study was to determine the natural history of PSVD and prognostic factors in a large multicenter cohort of patients. METHODS: We performed a retrospective study on patients with PSVD and signs of portal hypertension (PH) prospectively registered in 27 centers. RESULTS: A total of 587 patients were included, median age of 47 years and 38% were women. Four-hundred and one patients had an associated condition, which was graded as severe in 157. Median follow-up was 68 months. At diagnosis, 64% of patients were asymptomatic while 36% had a PH-related complication: PH-related bleeding in 112 patients, ascites in 117, and hepatic encephalopathy in 11. In those not presenting with bleeding, the incidence of first bleeding was 15% at 5 years, with a 5-year rebleeding rate of 18%. The 5-year cumulative incidence of new or worsening ascites was 18% and of developing PVT was 16%. Fifty (8.5%) patients received a liver transplantation and 109 (19%) died, including 55 non-liver-related deaths. Transplant-free survival was 97% and 83% at 1 and 5 years, respectively. Variables independently associated with transplant-free survival were age, ascites, serum bilirubin, albumin and creatinine levels at diagnosis and severe associated conditions. This allowed for the creation of a nomogram that accurately predicted prognosis. CONCLUSIONS: The prognosis of PSVD is strongly determined by the severity of the associated underlying conditions and parameters of liver and renal function. IMPACT AND IMPLICATIONS: Porto-sinusoidal vascular liver disorder (PSVD) is a rare entity that usually affects young people, frequently causes severe complications of portal hypertension, and may reduce life expectancy. To date, there is scarce information regarding its clinical manifestations, natural history and prognostic factors. The present study, including the largest number of patients with PSVD reported so far, shows that overall, when managed at centers of expertise, the prognosis of patients with PSVD is good, with LT-free survival rates of 83% and 72% at 5 and 10 years, respectively. Presence and severity of an underlying associated condition, presence of ascites, age and bilirubin, albumin and creatinine levels were associated with poor prognosis. These results are important to know for hepatologists. A final model combining these parameters enabled development of a nomogram that predicts prognosis with good discrimination and calibration capacity and can be easily applied in clinical practice.

The senescence-associated secretome of Hedgehog-deficient hepatocytes drives MASLD progression.

The burden of senescent hepatocytes correlates with the severity of metabolic dysfunction-associated steatotic liver disease (MASLD), but the mechanisms driving senescence and how it exacerbates MASLD are poorly understood. Hepatocytes experience lipotoxicity and become senescent when Smoothened (Smo) is deleted to disrupt Hedgehog signaling. We aimed to determine whether the secretomes of Smo-deficient hepatocytes perpetuate senescence to drive MASLD progression. RNA-Seq analysis of liver samples from human and murine cohorts with MASLD confirmed that hepatocyte populations in MASLD livers were depleted of Smo+ cells and enriched with senescent cells. When fed a choline-deficient, amino acid-restricted high-fat diet (CDA-HFD) to induce MASLD, Smo- mice had lower antioxidant markers and developed worse DNA damage, senescence, steatohepatitis, and fibrosis than did Smo+ mice. Sera and hepatocyte-conditioned medium from Smo- mice were depleted of thymidine phosphorylase (TP), a protein that maintains mitochondrial fitness. Treating Smo- hepatocytes with TP reduced senescence and lipotoxicity, whereas inhibiting TP in Smo+ hepatocytes had the opposite effect and exacerbated hepatocyte senescence, steatohepatitis, and fibrosis in CDA-HFD-fed mice. We conclude that inhibition of Hedgehog signaling in hepatocytes promoted MASLD by suppressing hepatocyte production of proteins that prevent lipotoxicity and senescence.

Flavan-3-ols and Vascular Health: Clinical Evidence and Mechanisms of Action.

Cardiovascular diseases (CVDs) are one of the main causes of mortality and morbidity worldwide. A healthy diet rich in plant-derived compounds such as (poly)phenols appears to have a key role in improving cardiovascular health. Flavan-3-ols represent a subclass of (poly)phenols of great interest for their possible health benefits. In this review, we summarized the results of clinical studies on vascular outcomes of flavan-3-ol supplementation and we focused on the role of the microbiota in CVD. Clinical trials included in this review showed that supplementation with flavan-3-ols mostly derived from cocoa products significantly reduces blood pressure and improves endothelial function. Studies on catechins from green tea demonstrated better results when involving healthy individuals. From a mechanistic point of view, emerging evidence suggests that microbial metabolites may play a role in the observed effects. Their function extends beyond the previous belief of ROS scavenging activity and encompasses a direct impact on gene expression and protein function. Although flavan-3-ols appear to have effects on cardiovascular health, further studies are needed to clarify and confirm these potential benefits and the rising evidence of the potential involvement of the microbiota.

A Rare Case of Breast Metastasis from a Primary Lung Tumor: Case Report.

Breast metastasis originating from a primary lung tumor is exceedingly rare and can present challenges in distinguishing it from primary breast cancer. This case report discusses the management of a 64-year-old woman who initially presented with a nodule in her left breast. A biopsy revealed an infiltrating ductal carcinoma. Despite negative BRCA genetic testing, her significant family history of cancer and the presence of a newly detected right breast lesion led to a bilateral mastectomy. Post-operative imaging identified multiple hypodense nodules and a spiculated pulmonary nodule, necessitating further investigation. An endoscopic lung biopsy confirmed a primary pulmonary carcinoma with histological features similar to the breast carcinoma, suggesting the lung as the primary source. This case highlights the complexity of differentiating breast metastasis originating from a lung tumor and primary breast cancer. It underscores the importance of comprehensive diagnostic evaluations and the consideration of extramammary origins in metastatic cases. The findings emphasize the role of multidisciplinary teams in managing such rare and challenging cases and highlight the necessity for thorough and repeated assessments in atypical breast cancer presentations.

A Non-Interventional, Multicenter Study to Characterize the Socio-Demographics, Clinical Characteristics, and Management of Generalized Pustular Psoriasis Patients in Spain: IMPULSE Study.

INTRODUCTION: Generalized pustular psoriasis (GPP) is a chronic, rare, and potentially life-threatening skin condition characterized by flares comprising widespread sterile pustules and systemic inflammation. Both the rarity and heterogeneity of the disease have made GPP classification and standardization of clinical criteria challenging. Before the approval of spesolimab (IL-36R antibody) in 2022, there were no approved treatments in the USA or Europe for GPP flares. Treatment for GPP has amounted to off-label use of medicines approved to treat plaque psoriasis. Our aim was to describe the sociodemographics, clinical characteristics, and treatment patterns of patients with GPP in Spain. METHODS: Non-interventional, descriptive, multi-center, retrospective chart review of patients diagnosed with GPP in Spain. RESULTS: 56 patients (50% women) were included, with a mean (standard deviation, SD) age at diagnosis of 53.7 (20.5) and a mean (SD) time of follow-up of 3.7 (3.1) years. In 80% of patients, GPP diagnosis was associated with a flare and 67.3% had known risk factors for GPP (such as previous diagnosis or family history of plaque psoriasis, comorbidities, smoking or stress). Hypertension and plaque psoriasis were the most frequent comorbidities (44.6% each). The number of GPP flares per patient-year was 0.55 with (range 0-4) a mean (SD) body surface area involvement of 21.3% (19.1). The most frequent manifestations of GPP flares were pustules (88.5%), erythema (76.9%), and scaling (76.9%). Additionally, 65.4% of patients had plaque psoriasis, 53.8% had unspecified skin lesions, and 30.8% experienced pain. The treatments used for GPP flares were off-label conventional systemic drugs (75%), mostly corticosteroids, cyclosporine, and acitretin. In the periods between flares, off-label biologics were used in 56.5% of patients. During the study period, 9 patients (16.1%) had at least one complication and 5 of them required hospitalization. CONCLUSION: This is the first multicenter study in Spanish GPP patients. Most patients were in their fifties, with personal or family history of plaque psoriasis, stress, smoking and a wide range of comorbidities and complications. Even though the number of flares per patient/year was 0.55, there was variability between patients. Both off-label conventional systemics and off-label biologics were used for flare management without a clear treatment pattern.

Aging promotes metabolic dysfunction-associated steatotic liver disease by inducing ferroptotic stress.

Susceptibility to the biological consequences of aging varies among organs and individuals. We analyzed hepatocyte transcriptomes of healthy young and aged male mice to generate an aging hepatocyte gene signature, used it to deconvolute transcriptomic data from humans and mice with metabolic dysfunction-associated liver disease, validated findings with functional studies in mice and applied the signature to transcriptomic data from other organs to determine whether aging-sensitive degenerative mechanisms are conserved. We discovered that the signature enriches in diseased livers in parallel with degeneration. It is also enriched in failing human hearts, diseased kidneys and pancreatic islets from individuals with diabetes. The signature includes genes that control ferroptosis. Aged mice develop more hepatocyte ferroptosis and liver degeneration than young mice when fed diets that induce metabolic stress. Inhibiting ferroptosis shifts the liver transcriptome of old mice toward that of young mice and reverses aging-exacerbated liver damage, identifying ferroptosis as a tractable, conserved mechanism for aging-related tissue degeneration.

A Comparison of the Clinical Characteristics of Short-, Mid-, and Long-Term Mortality in Patients Attended by the Emergency Medical Services: An Observational Study.

AIM: The development of predictive models for patients treated by emergency medical services (EMS) is on the rise in the emergency field. However, how these models evolve over time has not been studied. The objective of the present work is to compare the characteristics of patients who present mortality in the short, medium and long term, and to derive and validate a predictive model for each mortality time. METHODS: A prospective multicenter study was conducted, which included adult patients with unselected acute illness who were treated by EMS. The primary outcome was noncumulative mortality from all causes by time windows including 30-day mortality, 31- to 180-day mortality, and 181- to 365-day mortality. Prehospital predictors included demographic variables, standard vital signs, prehospital laboratory tests, and comorbidities. RESULTS: A total of 4830 patients were enrolled. The noncumulative mortalities at 30, 180, and 365 days were 10.8%, 6.6%, and 3.5%, respectively. The best predictive value was shown for 30-day mortality (AUC = 0.930; 95% CI: 0.919-0.940), followed by 180-day (AUC = 0.852; 95% CI: 0.832-0.871) and 365-day (AUC = 0.806; 95% CI: 0.778-0.833) mortality. DISCUSSION: Rapid characterization of patients at risk of short-, medium-, or long-term mortality could help EMS to improve the treatment of patients suffering from acute illnesses.

Effects of a Pharmacist-Designed Clinical Decision Support System on Antimicrobial Stewardship.

BACKGROUND: Clinical decision support systems (CDSSs) are computer applications, which can be applied to give guidance to practitioners in antimicrobial stewardship (AS) activities; however, further information is needed for their optimal use. OBJECTIVES: Our objective was to analyze the implementation of a CDSS program in a second-level hospital, describing alerts, recommendations, and the effects on consumption and clinical outcomes. METHODS: In October 2020, a pharmacist-driven CDSS designed for AS was implemented in a second-level hospital. The program provides a list of alerts related to antimicrobial treatment and microbiology, which were automatized for revision by the AS professionals. To analyze the implementation of the CDSS, a pre-post-intervention, retrospective study was designed. AS-triggered alerts and recommendations (total number and rate of acceptance) were compiled. The effect of the CDSS was measured using antimicrobial consumption, duration of antimicrobial treatments, in-hospital mortality, and length of stay (LOS) for patients admitted for infectious causes. RESULTS: The AS team revised a total of 7,543 alerts and 772 patients had at least one recommendation, with an acceptance rate of 79.3%. Antimicrobial consumption decreased from 691.1 to 656.8 defined daily doses (DDD)/1,000 beds-month (p = 0.04) and the duration of antimicrobial treatment from 3.6 to 3.3 days (p < 0.01). In-hospital mortality decreased from 6.6 to 6.2% (p = 0.46) and mean LOS from 7.2 to 6.2 days (p < 0.01). CONCLUSION: The implementation of a CDSS resulted in a significant reduction of antimicrobial DDD, duration of antimicrobial treatments, and hospital LOS. There was no significant difference in mortality.

Multidisciplinary and Tailored Treatment of Locally Advanced Breast Cancer in Progression during Neoadjuvant Chemotherapy: Case Report.

Locally advanced breast cancer (LABC) is a complex disease that requires a multidisciplinary approach. Neoadjuvant chemotherapy (NAC) is usually performed in order to achieve loco-regional radical resection; although its importance in the multidisciplinary approach to LABC is well recognized, a small number of patients show Progressive Disease (PD). No standard salvage treatment (ST) has been defined and different strategies can be adopted, such as second-line systemic therapies, radiation therapy, and surgery. Herein, a case of LABC in PD during NAC is reported with a literature review, with the aim of highlighting the importance of a tailored multidisciplinary treatment for each patient.

Risk Factors for Eating Disorders in University Students: The RUNEAT Study.

The purpose of the study is to assess the risk of developing general eating disorders (ED), anorexia nervosa (AN), and bulimia nervosa (BN), as well as to examine the effects of gender, academic year, place of residence, faculty, and diet quality on that risk. Over two academic years, 129 first- and fourth-year Uneatlántico students were included in an observational descriptive study. The self-administered tests SCOFF, EAT-26, and BITE were used to determine the participants' risk of developing ED. The degree of adherence to the Mediterranean diet (MD) was used to evaluate the quality of the diet. Data were collected at the beginning (T1) and at the end (T2) of the academic year. The main results were that at T1, 34.9% of participants were at risk of developing general ED, AN 3.9%, and BN 16.3%. At T2, these percentages were 37.2%, 14.7%, and 8.5%, respectively. At T2, the frequency of general ED in the female group was 2.5 times higher (OR: 2.55, 95% CI: 1.22-5.32, p = 0.012). The low-moderate adherence to the MD students' group was 0.92 times less frequent than general ED at T2 (OR: 0.921, 95%CI: 0.385-2.20, p < 0.001). The most significant risk factor for developing ED is being a female in the first year of university. Moreover, it appears that the likelihood of developing ED generally increases during the academic year.

Intraoperative image-guidance during robotic surgery: is there clinical evidence of enhanced patient outcomes?

BACKGROUND: To date, the benefit of image guidance during robot-assisted surgery (IGS) is an object of debate. The current study aims to address the quality of the contemporary body of literature concerning IGS in robotic surgery throughout different surgical specialties. METHODS: A systematic review of all English-language articles on IGS, from January 2013 to March 2023, was conducted using PubMed, Cochrane library's Central, EMBASE, MEDLINE, and Scopus databases. Comparative studies that tested performance of IGS vs control were included for the quantitative synthesis, which addressed outcomes analyzed in at least three studies: operative time, length of stay, blood loss, surgical margins, complications, number of nodal retrievals, metastatic nodes, ischemia time, and renal function loss. Bias-corrected ratio of means (ROM) and bias-corrected odds ratio (OR) compared continuous and dichotomous variables, respectively. Subgroup analyses according to guidance type (i.e., 3D virtual reality vs ultrasound vs near-infrared fluoresce) were performed. RESULTS: Twenty-nine studies, based on 11 surgical procedures of three specialties (general surgery, gynecology, urology), were included in the quantitative synthesis. IGS was associated with 12% reduction in length of stay (ROM 0.88; p = 0.03) and 13% reduction in blood loss (ROM 0.87; p = 0.03) but did not affect operative time (ROM 1.00; p = 0.9), or complications (OR 0.93; p = 0.4). IGS was associated with an estimated 44% increase in mean number of removed nodes (ROM 1.44; p < 0.001), and a significantly higher rate of metastatic nodal disease (OR 1.82; p < 0.001), as well as a significantly lower rate of positive surgical margins (OR 0.62; p < 0.001). In nephron sparing surgery, IGS significantly decreased renal function loss (ROM 0.37; p = 0.002). CONCLUSIONS: Robot-assisted surgery benefits from image guidance, especially in terms of pathologic outcomes, namely higher detection of metastatic nodes and lower surgical margins. Moreover, IGS enhances renal function preservation and lowers surgical blood loss.

Decadal changes in biomass and distribution of key fisheries species on Newfoundland's Grand Banks.

Canadian fisheries management has embraced the precautionary approach and the incorporation of ecosystem information into decision-making processes. Accurate estimation of fish stock biomass is crucial for ensuring sustainable exploitation of marine resources. Spatio-temporal models can provide improved indices of biomass as they capture spatial and temporal correlations in data and can account for environmental factors influencing biomass distributions. In this study, we developed a spatio-temporal generalized additive model (st-GAM) to investigate the relationships between bottom temperature, depth, and the biomass of three key fished species on The Grand Banks: snow crab (Chionoecetes opilio), yellowtail flounder (Limanda ferruginea), and Atlantic cod (Gadus morhua). Our findings revealed changes in the centre of gravity of Atlantic cod that could be related to a northern shift of the species within the Grand Banks or to a faster recovery of the 2J3KL stock. Atlantic cod also displayed hyperaggregation behaviour with the species showing a continuous distribution over the Grand Banks when biomass is high. These findings suggest a joint stock assessment between the 2J3KL and 3NO stocks would be advisable. However, barriers may need to be addressed to achieve collaboration between the two distinct regulatory bodies (i.e., DFO and NAFO) in charge of managing the stocks. Snow crab and yellowtail flounder centres of gravity have remained relatively constant over time. We also estimated novel indices of biomass, informed by environmental factors. Our study represents a step towards ecosystem-based fisheries management for the highly dynamic Grand Banks.

Quantification and Influence of IL-1ß on Pain and Inflammatory Response after Placement of a Cement-Screw-Retained Restoration.

Background: The objective of this study was to evaluate the pain and inflammatory response in soft tissues using healing and prosthetic abutments of different diameters and lengths. Methods: The study population was rehabilitated with Astra Tech EV single implants (Dentsply Sirona, Atlantis, Dentsply Sirona S.A., Barcelona, Spain) of 4.2 and 4.8 millimetres in diameter in the upper and lower maxilla and loaded with custom abutments digitally designed using Dentsply Sirona's Virtual Atlantis Design software (Atlantis WebOrder, Dentsply Sirona S.A., Barcelona, Spain), version 4.6.5. The custom abutments had a larger diameter than the healing abutments to evaluate for biomarkers through ELISA. Results: Rehabilitations in the mandible and with healing abutments with diameters less than 4.29 mm and rehabilitators with diameters less than 2.18 mm elicited a higher pain and inflammatory response and, in turn, higher interleukin-1ß values. Conclusions: Greater inflammation was evident in cases in which healing abutments with reduced diameter were used compared to the same subsequent rehabilitation with prosthetic abutments with larger diameters.

Isoflavones Effects on Vascular and Endothelial Outcomes: How Is the Gut Microbiota Involved?

Isoflavones are a group of (poly)phenols, also defined as phytoestrogens, with chemical structures comparable with estrogen, that exert weak estrogenic effects. These phytochemical compounds have been targeted for their proven antioxidant and protective effects. Recognizing the increasing prevalence of cardiovascular diseases (CVD), there is a growing interest in understanding the potential cardiovascular benefits associated with these phytochemical compounds. Gut microbiota may play a key role in mediating the effects of isoflavones on vascular and endothelial functions, as it is directly implicated in isoflavones metabolism. The findings from randomized clinical trials indicate that isoflavone supplementation may exert putative effects on vascular biomarkers among healthy individuals, but not among patients affected by cardiometabolic disorders. These results might be explained by the enzymatic transformation to which isoflavones are subjected by the gut microbiota, suggesting that a diverse composition of the microbiota may determine the diverse bioavailability of these compounds. Specifically, the conversion of isoflavones in equol-a microbiota-derived metabolite-seems to differ between individuals. Further studies are needed to clarify the intricate molecular mechanisms behind these contrasting results.

Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry.

BACKGROUND: Safety is an important consideration in decisions on treatment for patients with moderate-to-severe psoriasis and the study of drug safety is the main purpose of the BIOBADADERM registry. The combination of a biologic agent and a conventional systemic drug [generally methotrexate (MTX)] is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in the treatment of psoriasis. OBJECTIVES: The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate-to-severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy using tumour necrosis factor (TNF), interleukin (IL)-17 and IL-23 inhibitors with the use of the same drugs in combination with MTX. METHODS: Using data from the BIOBADADERM registry, we compared biologic monotherapies with therapies that were combined with MTX. We estimated adjusted incidence rate ratios (aIRR) using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections and other AEs by system organ class. RESULTS: We analysed data from 2829 patients and 5441 treatment cycles, a total of 12 853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a TNF inhibitor combined with MTX was associated with an increase in the incidence of gastrointestinal AEs (aIRR 2.50, 95% CI 1.57-3.98; P < 0.002). CONCLUSIONS: The risk of AEs and SAEs was not significantly increased in patients with moderate-to-severe psoriasis receiving different classes of biologic drugs combined with MTX compared with those on biologic monotherapy.

Update on the role of T cells in cognitive impairment.

The central nervous system (CNS) has long been considered an immune-privileged site, with minimal interaction between immune cells, particularly of the adaptive immune system. Previously, the presence of immune cells in this organ was primarily linked to events involving disruption of the blood-brain barrier (BBB) or inflammation. However, current research has shown that immune cells are found patrolling CNS under homeostatic conditions. Specifically, T cells of the adaptive immune system are able to cross the BBB and are associated with ageing and cognitive impairment. In addition, T-cell infiltration has been observed in pathological conditions, where inflammation correlates with poor prognosis. Despite ongoing research, the role of this population in the ageing brain under both physiological and pathological conditions is not yet fully understood. In this review, we provide an overview of the interactions between T cells and other immune and CNS parenchymal cells, and examine the molecular mechanisms by which these interactions may contribute to normal brain function and the scenarios in which disruption of these connections lead to cognitive impairment. A comprehensive understanding of the role of T cells in the ageing brain and the underlying molecular pathways under normal conditions could pave the way for new research to better understand brain disorders. LINKED ARTICLES: This article is part of a themed issue From Alzheimer's Disease to Vascular Dementia: Different Roads Leading to Cognitive Decline. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v181.6/issuetoc.

Augmentation of a Transosseous-Equivalent Repair in Posterosuperior Nonacute Rotator Cuff Tears With a Bioinductive Collagen Implant Decreases the Retear Rate at 1 Year: A Randomized Controlled Trial.

PURPOSE: To determine whether the addition of a bioinductive collagen implant (BCI) over a transosseous equivalent (TOE) repair of medium-to-large posterosuperior rotator cuff tears improves the healing rate determined by magnetic resonance imaging (MRI) at 12-month follow-up. METHODS: A Level I randomized controlled trial was performed in 124 subjects with isolated, symptomatic, reparable, full-thickness, medium-to-large posterosuperior nonacute rotator cuff tears, with fatty infiltration ≤2. These were randomized to 2 groups in which an arthroscopic posterosuperior rotator cuff tear TOE repair was performed alone (Control group) or with BCI applied over the TOE repair (BCI group). The primary outcome was the retear rate (defined as Sugaya 4-5) determined by MRI at 12 months of follow-up. Secondary outcomes were characteristics of the tendon (Sugaya grade and thickness of the healed tendon) and clinical outcomes (pain levels, EQ-5D-5L, American Shoulder and Elbow Surgeons, and Constant-Murley scores) at 12 months of follow-up. RESULTS: Of the 124 randomized patients, 122 (60 in the BCI group and 62 in the Control group) were available for MRI evaluation 12.2 ± 1.02 months after the intervention. There were no relevant differences in preoperative characteristics. Adding the BCI reduced the retear rate (8.3% [5/60] in the BCI group vs 25.8% [16/62] in the Control group, P = .010; relative risk of retear of 0.32 [95% confidence interval 0.13-0.83]). Sugaya grade was also better in the BCI group (P = .030). There were no differences between groups in the percentage of subjects who reached the MCID for CMS (76.7% vs 81.7%, P = .654) or American Shoulder and Elbow Surgeons (75% vs 80%, P = .829), in other clinical outcomes or in complication rates at 12.4 ± 0.73 (range 11.5-17) months of follow-up. CONCLUSIONS: Augmentation with a BCI of a TOE repair in a medium-to-large posterosuperior rotator cuff tear reduces the retear rate at 12-month follow-up by two-thirds, yielding similar improvements in clinical outcomes and without increased complication rates. LEVEL OF EVIDENCE: Level I, randomized controlled trial.