A rare case of bilateral malignant glaucoma after cataract surgery with capsular tension ring implantation: a case report.

BACKGROUND: Bilateral malignant glaucoma induced by a capsular tension ring associated with ring-shaped cysts of the ciliary body post-cataract surgery is rare. Herein, we present a case to highlight the possibility of capsular tension ring-induced malignant glaucoma. CASE PRESENTATION: A 59-year-old woman underwent phacoemulsification combined with capsular tension ring implantation for cataracts and zonular fibre laxity in both eyes. Upon admission, annular ciliary masses were detected in both eyes using ultrasound biomicroscopy. Two months post-surgery, the patient experienced vision deterioration, high intraocular pressure, and an axial shallowing anterior chamber in the right eye, and responded poorly to traditional anti-glaucoma medication. Ten days later, similar symptoms appeared in the left eye. Ultrasound biomicroscopy detected contact between the ciliary body and the capsular tension ring. Subsequently, malignant glaucoma was diagnosed. Anterior and posterior capsulotomies performed peripheral to intraocular lens optics using neodymium: YAG laser restored communication and alleviated the symptoms. A one-year follow-up revealed stable intraocular pressure and anterior chamber in both eyes. CONCLUSIONS: This is the first case report of bilateral malignant glaucoma after cataract surgery induced by capsular tension ring, which is associated with bilateral ring-shaped cysts of the ciliary body. Blockage between the ciliary body and capsular tension ring was confirmed using ultrasound biomicroscopy.

Efficacy of Foldable Capsular Vitreous Body Implants Filled With Light or Heavy Silicone Oil in the Treatment of Silicone Oil-dependent Eyes.

Purpose: The purpose of this study was to compare the clinical efficacy of foldable capsular vitreous body (FCVB) filled with either light or heavy silicone oil and the incidence of complications after their implantation for the treatment of severe ocular trauma and silicone oil-dependent eyes. Methods: FCVB filled with either light (n = 16) or heavy (n = 8) silicone oil was implanted in 24 patients. During the 12-month follow-up period, the intraocular pressure, final best-corrected visual acuity, retinal reattachment condition, position of the FCVB, and complications were assessed. Results: All surgeries were performed without issue. There was no significant difference in preoperative and postoperative best-corrected visual acuity between the two groups. A significant improvement in the intraocular pressure was observed after surgery in both the light silicone oil (P = 0.029) and heavy silicone oil (P = 0.035) groups. None of the patients developed displacement or prolapse of the FCVB. The most common early and late postoperative complications were postoperative hemorrhage (33.3%) and corneal opacification (50%), respectively. Conclusions: FCVB filled with heavy silicone oil can be used as a supplemental therapy for patients who have lost the anterior segment of their eye, have lesions of the inferior retina, or cannot maintain the prone position for various reasons. Translational Relevance: Implantation of FCVB combined with heavy silicone oil compensates for the shortcomings of this with light silicone oil, providing patients with more personalized treatment.

Treating acid reflux without compressing the food passageway: 4-year safety and clinical outcomes with the RefluxStop device in a prospective multicenter study.

INTRODUCTION: RefluxStop is an implantable device for laparoscopic surgical treatment of gastroesophageal reflux disease (GERD) to restore and maintain lower esophageal sphincter and angle of His anatomy without encircling and putting pressure on the food passageway, thereby avoiding side effects such as dysphagia and bloating seen with traditional fundoplication. This study reports the clinical outcomes with RefluxStop at 4 years following implantation of the device. METHODS: A prospective, single arm, multicenter clinical investigation analyzing safety and effectiveness of the RefluxStop device in 50 patients with chronic GERD. RESULTS: Available data are presented for 44 patients at 4 years with the addition of three patients at 3 years carried forward. At 4 years, median GERD-HRQL score was 90% reduced compared to baseline. Two patients (2/44) used regular daily proton pump inhibitors (PPIs) despite subsequent 24-h pH monitoring off PPI therapy yielding normal results. There were no device-related adverse events (AEs), esophageal dilations, migrations, or explants during the entire study period. AEs reported between 1 and 4 years were as follows: one subject with heartburn and a pathologic pH result with device positioned too low at surgery; one subject with dysphagia, thus, 46/47 patients reported no dysphagia-related AEs between years 1 and 4. Two patients (2/47) were dissatisfied with treatment despite normal 24-h pH monitoring, of whom one had manometry-verified dysmotility at 6 months, indicating dissatisfaction for reasons other than acid reflux. CONCLUSION: These results confirm the excellent and already published 1-year results as stable in the long-term, supporting the safety and effectiveness of the RefluxStop device in treating GERD for over 4 years. GERD-HRQL score, pH testing, and PPI usage indicate treatment success without dysphagia or gas-bloating and only minimal incidence of other AEs. This favorably low rate of AEs is likely attributable to RefluxStop's dynamic physiologic interaction and non-encircling nature.

Foregut Erosion Related to Biomedical Implants: A Scoping Review.

Introduction: Biomedical devices implanted transabdominally have gained popularity over the past 50 years in the treatment of gastroesophageal reflux disease, paraesophageal hiatal hernia, and morbid obesity. Device-related foregut erosions (FEs) represent a challenging event that demands special attention owing to the potential of severe postoperative complications and death. Purpose: The aim was to provide an overview of full-thickness foregut injury leading to erosion associated with four types of biomedical devices. Methods: The study was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). PubMed, EMBASE, and Web of Science databases were queried until December 31, 2023. Eligible studies included all articles reporting data, management, and outcomes on device-related FE. Results: Overall, 132 articless were included for a total of 1292 patients suffering from device-related FE. Four different devices were included: the Angelchik antireflux prosthesis (AAP) (n = 25), nonabsorbable mesh for crural repair (n = 60), adjustable gastric banding (n = 1156), and magnetic sphincter augmentation device (n = 51). The elapsed time from device implant to erosion ranged from 1 to 480 months. Most commonly reported symptoms were dysphagia and epigastric pain, while acute presentation was reported rarely and mainly for gastric banding. The technique for device removal evolved from more invasive open approaches toward minimally invasive and endoscopic techniques. Esophagectomy and gastrectomy were mostly reported for nonabsorbable mesh FE. Overall mortality was .17%. Conclusions: Device-related FE is rare but may occur many years after AAP, nonabsorbable mesh, adjustable gastric banding, and magnetic sphincter augmentation implant. FE-related mortality is infrequent, however, increased postoperative morbidity and the need for esophagogastric resection were observed for nonabsorbable mesh-reinforced cruroplasty.

Contact Dermatitis From Biomedical Devices, Implants, and Metals-Trouble From Within.

Allergic contact dermatitis is characterized by its appearance of red, raised and infiltrated, scaling or scabbed skin and intense pruritus, and distinguished from irritant contact dermatitis by its specific immune process and histopathology. Many contact allergens are low-molecular- weight chemicals including metals such as nickel, cobalt, and chromium, preservatives, and adhesives. When such materials are used internally in biomedical devices, they are similarly capable of causing sensitization and an inflammatory response. Sometimes, the reaction remains internal, and presents as swelling, pain, stiffness, decreased range of motion, and internal itching around the implant. Such reactions may, in some cases, also extend to include a localized or, rarely, systemic contact dermatitis indicative of the same process. This review will present an overview of reported skin and local internal reactions to orthopedic implants, which are the largest category of implanted internal metal devices. Immune reactions to smaller categories of medical appliances include cardiac devices and vascular stents, neuromodulation devices, diabetic appliances, Nuss bar surgery for pectus excavatum, and dental and spinal implants. We will review the available diagnostic tools, the consensus on interpretation, and reported strategies for treatment.

Wear and corrosion of titanium alloy spinal implants in vivo.

To investigate the wear and corrosion of titanium alloy spinal implants in vivo, we evaluated removed implants and their surrounding scar tissues from 27 patients between May 2019 and April 2021. We performed scanning electron microscopy, energy-dispersive X-ray spectroscopy, and histological analysis. The results revealed metal-like particles in the soft tissues of seven patients, without any considerable increase in inflammatory cell infiltration. Patients with fractures showed lower percentages of wear and corrosion compared with other patients (42% and 17% vs. 59% and 26%). Polyaxial screws exhibited higher wear and corrosion percentages (53% and 23%) compared with uniaxial screws (39% and 3%), although in patients with fracture, the reverse was observed (20% and 0% vs. 39% and 3%). We found that titanium alloy spinal implants experience some degree of wear and corrosion in vivo. The titanium alloy particles formed by wear exhibited good histocompatibility, not causing inflammation, foreign body reactions, or osteolysis. Therefore, spinal implants should be removed cautiously when treating titanium alloy spinal metallosis. The wear and corrosion of the implants increase with the increase in implantation time, although the screw structure does not significantly affect these changes.

Biomechanical and biological advantages of retaining the silicone-induced capsule for cartilage graft survival in revision rhinoplasty.

To answer the increased demand for augmentation rhinoplasty, particularly in Asian demographics, a shift from autogenous materials to synthetic implants like silicone and expanded polytetrafluoroethylene has been witnessed. These materials present an increased risk of complications like infection, extrusion, capsular contracture, and dissatisfaction. This study focuses on a case of revision rhinoplasty in a 48-year-old patient with a previous silicone implant and propose an innovative approach in managing the implant capsule. The use of the existing capsule as a mechanical and biological support structure for the diced cartilage graft in dorsal reconstruction showcases a promising method to mitigate risks and improve outcomes in revision surgeries. The capsule around the silicone is biologically active and provides a good environment for the cartilage graft to survive and improve the healing process. This approach tends to minimize the dissection to avoid potential revision complications like skin necrosis, fibrotic tissue, and infections.

Optimal ultrasonic treatment frequency and duration parameters were used to detect the pathogenic bacteria of orthopedic implant-associated infection by ultrasonic oscillation.

INTRUDUCTON: The most accurate method for detecting the pathogen of orthopedic implant-associated infections (OIAIs) is sonication fluid (SF). However, the frequency and duration of ultrasound significantly influence the number and activity of microorganisms. Currently, there is no consensus on the selection of these two parameters. Through this study, the choice of these two parameters is clarified. METHODS: We established five ultrasonic groups (40kHz/10min, 40kHz/5min, 40 kHz/1min, 20kHz/5min, and 10kHz/5min) based on previous literature. OIAIs models were then developed and applied to ultrasound group treatment. Subsequently, we evaluated the efficiency of bacteria removal by conducting SEM and crystal violet staining. The number of live bacteria in the SF was determined using plate colony count and live/dead bacteria staining. RESULTS: The results of crystal violet staining revealed that both the 40kHz/5min group and the 40kHz/10min group exhibited a significantly higher bacterial clearance rate compared to the other groups. However, there was no significant difference between the two groups. Additionally, the results of plate colony count and fluorescence staining of live and dead bacteria indicated that the number of live bacteria in the 40kHz/5min SF group was significantly higher than in the other groups. CONCLUSION: 40kHz/5min ultrasound is the most beneficial for the detection of pathogenic bacteria on the surface of orthopedic implants.

Celastrol alleviates subconjunctival fibrosis induced by silicone implants mimicking glaucoma surgery.

Subconjunctival fibrosis is critical to the outcomes of several ophthalmic conditions or procedures, such as glaucoma filtering surgery. This study aimed to investigate the anti-fibrotic effect of celastrol on subconjunctival fibrosis and to further reveal the underlying mechanisms. We used celastrol-loaded nanomicelles hydrogel hybrid as a sustained-release drug. A rabbit model of subconjunctival fibrosis following silicone implantation was used for in vivo study, and TGF-ß1-induced human pterygium fibroblast (HPF) activation as an in vitro model. The effects of celastrol on inhibiting TGF-ß1-induced migration and proliferation of HPFs were evaluated by scratch wound assay and CCK-8, respectively. Immunofluorescence and western blotting were used to examine the effect of celastrol on the expression of α-SMA, collagen I, fibronectin, and the targets of the Hippo signaling pathway. We found that in vivo celastrol treatment reduced the expression of YAP and TAZ in subconjunctival tissue. Moreover, celastrol alleviated collagen deposition and subconjunctival fibrosis at 8 weeks. No obvious tissue toxicity was observed in the rabbit models. Mechanistically, celastrol significantly inhibited TGF-ß1-induced proliferation and migration of HPFs. Pretreatment of HPFs with celastrol also suppressed the TGF-ß1-induced protein expression of α-SMA, collagen I, fibronectin, TGF-ßRII, phosphorylated Smad2/3, YAP, TAZ, and TEAD1. In conclusion, celastrol effectively prevented subconjunctival fibrosis through inhibiting TGF-ß1/Smad2/3-YAP/TAZ pathway. Celastrol could serve as a promising therapy for subconjunctival fibrosis.

New materials and complications of prostheses in humans: situation in Spain.

Prostheses or implantable medical devices (IMDs) are parts made of natural or artificial materials intended to replace a body structure and therefore must be well tolerated by living tissues. The types of IMDs currently available and usable are very varied and capable of replacing almost any human organ. A high but imprecise percentage of Spaniards are carriers of one or more IMDs to which they often owe their quality of life or survival. IMDs are constructed with different types of materials that are often combined in the same prosthesis. These materials must combine harmlessness to human tissues with high wear resistance. Their durability depends on many factors both on the host and the type of prosthesis, but the vast majority last for more than 10-15 years or remain in function for the lifetime of the patient. The most frequently implanted IMDs are placed in the heart or great vessels, joints, dental arches or breast and their most frequent complications are classified as non-infectious, particularly loosening or intolerance, and infectious. Complications, when they occur, lead to a significant increase in morbidity, their repair or replacement multiplies the health care cost and, on occasions, can cause the death of the patient. The fight against IMD complications is currently focused on the design of new materials that are more resistant to wear and infection and the use of antimicrobial substances that are released from these materials. Their production requires multidisciplinary technical teams, but also a willingness on the part of industry and health authorities that is not often found in Spain or in most European nations. Scientific production on prostheses and IMD in Spain is estimated to be less than 2% of the world total, and probably below what corresponds to our level of socio-economic development. The future of IMDs involves, among other factors, examining the potential role of Artificial Intelligence in their design, knowledge of tissue regeneration, greater efficiency in preventing infections and taking alternative treatments beyond antimicrobials, such as phage therapy. For these and other reasons, the Ramón Areces Foundation convened a series of experts in different fields related to prostheses and IMDs who answered and discussed a series of questions previously formulated by the Scientific Council. The following lines are the written testimony of these questions and the answers to them.

Intrastromal Corneal Ring Implants Associated Bacterial Infections.

PURPOSE: This study examines the incidence of infection and resistance associated with Intracorneal Ring Segment (ICRS) implantation, a common outpatient surgical treatment for correcting refractive errors and corneal ectatic diseases. Although ICRS procedures are typically safe and reversible, there is a low but notable risk of microbial infections, which require prompt and sometimes invasive treatment. METHODS: Three electronic databases, PubMed, Web of Science (WoS), and Scopus, were utilised to search for literature according to PRISMA guidelines to identify infections related to the implantation of ICRS in the cornea between January 2000 and December 2022. RESULTS: Gram-positive organisms were involved in 86% of cases: 35.7% S. aureus, 25% coagulase-negative staphylococci species, 17.8% streptococci and 7.1% Nocardia species. Less commonly recorded were Gram-negative bacteria (14%), with Pseudomonas aeruginosa (circa 10%) and Klebsiella pneumonia (4%) being the most common Gram-negative bacteria. In rare cases, fungi have also been reported. ICRS-related bacterial infections can be categorised into early or late onset. Early onset infection typically manifests within the first few weeks after implantation and is often associated with contamination during surgery, unhygienic practices, or inadequate sterilisation techniques. On the other hand, late-onset infection may develop months or even years after the initial procedures and may be associated with persistent bacterial colonisation, secondary infections, or prolonged use of prophylactic antibiotics. S aureus is encountered in both early and late-onset infections, while Nocardia species and K. pneumoniae have generally been reported to occur in late-onset infections. In addition, vision recovery from S. aureus infections tends to be poor compared to other bacterial infections. CONCLUSION: S. aureus is a predominant pathogen that often requires surgical intervention with poor outcomes. Early infections result from incision gaps and ring segment rubbing, while late infections are linked to prolonged antibiotic use. Further research is needed on novel antimicrobial ICRS to procure the vision.

B-Cell Lymphoma Arising From a Nasal Implant: A Brief Clinical Study.

Continuous exposure to foreign substances initiates a sustained inflammatory reaction in the body, and subsequent chronic inflammation is recognized as one of the causes of lymphoma. Most lymphomas caused by foreign bodies are composed of 2 major phenotypes. Diffuse large B-cell lymphoma arising from metallic prosthesis, also called metallic implant-associated lymphoma and T-cell phenotype anaplastic large cell lymphoma, commonly associated with breast implants. Augmentation rhinoplasty is often performed to improve the esthetics of the nasal dorsum and various synthetic materials have been used as implants. The occurrence of lymphoma originating from a nasal implant is scarcely documented, and even more uncommon is its manifestation as epstein-barr virus (EBV)-negative extranodal marginal zone lymphoma. Here, the authors describe a rare case of B-cell lymphoma of the nose and nasolacrimal duct in a 49-year-old woman who underwent rhinoplasty with a silicone implant 20 years ago.

Metal implant allergy: A retrospective cohort analysis at a university allergy practice.

Background: Concern of metal sensitization in pre- and postsurgical evaluation is growing, with the recent guidelines remaining the criterion standard for consideration of patch testing. Information remains scarce on surgical screening in the groups of patients who reported a history of metal sensitivity versus those with no reported history. Objective: The objective of this study was to assess the utility of patch testing in surgical candidates based on reported metal allergy history. The secondary objective was to evaluate the utility and outcomes in postsurgical patch testing. Methods: Nine hundred and thirty-one patient charts of patients with the diagnosis of "contact dermatitis" who underwent an evaluation at a single allergy clinic site between January 2013 and December 2022 were identified and reviewed as part of a retrospective chart review study. Patients were included in subgroups based on the time of patch testing and history of reported metal allergy. Results: In all, 67 patients underwent patch testing, 10 (14.9%) of whom were surgical candidates without a history of metal sensitivity, 31 (46.2%) of whom were surgical candidates with a history of metal sensitivity, and 26 (38.8%) of whom were postsurgical patients. Twenty-nine (43.3%) of patients had positive patch testing results, with only one (10%) in the presurgical group, 17 (54.8%) in the presurgical with a history of metal sensitivity, and 11 (42.3%) in the postsurgical group. Zero patients in our cohort without metal sensitivity who were undergoing the Nuss procedure had positive reactions on patch testing, whereas two of four (50%) with reported metal sensitivity who were undergoing the Nuss procedure had positive relevant metal reactions. Conclusion: Ambiguity in the utility of patch testing for surgical decision making remains, despite common utilization. Recent guidelines along with coordination of care among the surgeon, allergist, and patient remains the criterion standard of care.

Etiology, pathogenesis, and management of angiosarcoma associated with implants and foreign body: Clinical cases and research updates.

Angiosarcomas are rare and highly malignant soft tissue sarcomas originating from endothelial cells lining the lymphatic or vascular system. While they predominantly emerge from (sub)cutaneous regions, occurrences have been reported throughout the body. The etiology of angiosarcoma remains elusive in most clinical cases. Nevertheless, several prognosis risk factors play a pivotal role, including chronic lymphedema, therapeutic irradiation, environmental carcinogens, familial syndromes, and the presence of foreign materials like metallic objects and biomedical implants. Despite evidence implicating retained foreign material in angiosarcoma development, understanding its prognosis and pathogenesis remains limited. The pathogenesis of angiosarcoma appears to involve a complex interplay of chronic inflammation, tissue remodeling, and genetic factors that create a conducive microenvironment for malignant transformation. Management of these sarcomas remains challenging due to their infiltrative nature owing to the high chance of metastasis and local recurrence. The primary treatment modalities currently include surgery, radiotherapy, and chemotherapy, but recent advances in targeted immunotherapy and gene therapy hold promise for more effective approaches. This comprehensive review delves into the potential etiological and pathogenic roles of foreign materials, such as metallic objects, biomedical implants, and biomaterials, in the development of angiosarcoma. Further research into the underlying molecular mechanisms could provide valuable insights for tailored management and developing novel targeted therapeutic strategies.

Bronchial Valves for Persistent Air Leak: A Systematic Review and Meta-analysis.

BACKGROUND: Patients with persistent air leak (PAL) pose a therapeutic challenge to physicians, with prolonged hospital stays and high morbidity. There is little evidence on the efficacy and safety of bronchial valves (BV) for PAL. METHODS: We systematically searched the PubMed and Embase databases to identify studies evaluating the efficacy and safety of BV for PAL. We calculated the success rate (complete resolution of air leak or removal of intercostal chest drain after bronchial valve placement and requiring no further procedures) of BV for PAL in individual studies. We pooled the data using a random-effects model and examined the factors influencing the success rate using multivariable meta-regression. RESULTS: We analyzed 28 observational studies (2472 participants). The pooled success rate of bronchial valves in PAL was 82% (95% confidence intervals, 75 to 88; 95% prediction intervals, 64 to 92). We found a higher success rate in studies using intrabronchial valves versus endobronchial valves (84% vs. 72%) and in studies with more than 50 subjects (93% vs. 77%). However, none of the factors influenced the success rate of multivariable meta-regression. The overall complication rate was 9.1% (48/527). Granulation tissue was the most common complication reported followed by valve migration or expectoration and hypoxemia. CONCLUSION: Bronchial valves are an effective and safe option for treating PAL. However, the analysis is limited by the availability of only observational data.