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Acta Ophthalmologica May 2022Minimally invasive glaucoma surgery (MIGS) has grown in popularity over the past decade. This systematic review explores the peri-operative and intraoperative... (Review)
Review
Minimally invasive glaucoma surgery (MIGS) has grown in popularity over the past decade. This systematic review explores the peri-operative and intraoperative application of anterior segment imaging to maximize the efficacy and safety of MIGS. A review of the PubMed, EMBASE and CINAHL databases was conducted, with inclusion criteria restricted to MIGS that had received United States Food and Drug Administration (FDA) premarket approval, FDA 510(K) premarket notification, or were listed as a class 1 device exempt from FDA approval or notification. 21 manuscripts from 21 unique studies were identified pertaining to MIGS devices including the XEN Gel Stent, Trabectome, iStent Inject, 1st-generation iStent and the Kahook Dual Blade (KDB). Anterior segment imaging modalities included anterior segment optical coherence tomography (AS-OCT), ultrasound biomicroscopy (UBM), aqueous angiography, OCT volumetric scans and in vivo confocal microscopy. Identification and evaluation of aqueous outflow pathways before and after MIGS have potential for improving patient preoperative patient selection and postoperative outcomes. Intraoperative imaging potentially provides the resolution needed for good visualization of angle anatomy and accurate evaluation of surgical endpoints in angle-based MIGS. Anterior segment imaging has been used to identify procedural complications, provide objective information on implant location in relation to surrounding anatomy, assess the post-implantation structural impact of MIGS devices and manage bleb failure and scarring. Technical difficulties in incorporating imaging modalities into the surgical microscope, variable quality of images and optical interference from ocular structures or surgical instruments are remaining barriers, which discourage the widespread clinical use of this technology.
Topics: Glaucoma; Humans; Intraocular Pressure; Minimally Invasive Surgical Procedures; Stents; Tomography, Optical Coherence
PubMed: 34250742
DOI: 10.1111/aos.14962 -
Journal of Taibah University Medical... Feb 2023Dental implants are prosthetic devices that are surgically placed in direct contact with the jawbone to support intra-oral functions and esthetics. Diabetes mellitus may... (Review)
Review
Dental implants are prosthetic devices that are surgically placed in direct contact with the jawbone to support intra-oral functions and esthetics. Diabetes mellitus may contribute to peri-implant bone loss. During the last few years, there have been attempts to reduce this bone loss and improve the survival rate of implants. Metformin, an anti-diabetic drug known for its osteogenic properties, is thought to prevent peri-implant bone loss in diabetic patients. Although several studies have been conducted to study metformin's effect on diabetic and non-diabetic study models, no systematic review has analyzed and summarized these studies critically. Therefore, the objectives of this systematic review were to summarize the outcomes of these studies and critically appraise them. Seven studies were included in this systematic review. Four studies used only animal models, two used both animal and cell culture models, and one used only cell culture studies. The general characteristics and outcomes of the included studies were summarized, and Animal Research: Reporting of In Vivo Experiments (ARRIVE) guidelines were used to assess the quality of the animal studies. In vitro studies indicate that metformin may induce stem cells to undergo osteoblastic differentiation to produce a higher amount of bone and may also improve osseointegration. Nevertheless, several studies had potential sources of bias. Therefore, it is recommended that emphasis be placed on increasing the quality of future animal studies and human trials to determine the effects of metformin on the osseointegration of dental implants. Future studies are needed with adequate follow-up to evaluate the efficacy of metformin in improving the osseointegration of dental implants.
PubMed: 36398019
DOI: 10.1016/j.jtumed.2022.07.003 -
European Cells & Materials Oct 2021Osteomyelitis is an inflammatory bone disease caused by an infecting microorganism leading to a gradual bone loss. Due to the difficulty in studying osteomyelitis...
Osteomyelitis is an inflammatory bone disease caused by an infecting microorganism leading to a gradual bone loss. Due to the difficulty in studying osteomyelitis directly in patients, animal models allow researchers to investigate the pathogenesis of the infection and the development of novel prophylactic, anti-inflammatory and antimicrobial treatment strategies. This review is specifically focused on the in vivo mouse osteomyelitis studies available in literature. Thus, a systematic search on Web of Science and PubMed was conducted using the query "(infection) AND (mice OR mouse OR murine) AND (model OR models) AND (arthroplasty OR fracture OR (internal fixator) OR (internal fixation OR prosthesis OR implant OR osteomyelitis)". After critical assessment of the studies according to the inclusion and exclusion criteria, 135 studies were included in the detailed analysis. Based on the model characteristics, the studies were classified into five subject groups: haematogenous osteomyelitis, post-traumatic osteomyelitis, bone-implant-related infection, peri-prosthetic joint infection, fracture-related infection. In addition, the characteristics of the mice used, such as inbred strain, age or gender, the characteristics of the pathogens used, the inoculation methods, the type of anaesthesia and analgesia used during surgery and the procedures for evaluating the pathogenicity of the infecting micro-organism were described. Overall, the mouse is an excellent first step in vivo model to study the pathogenesis, inflammation and healing process of osteomyelitis and to evaluate novel prophylaxis and treatment strategies.
Topics: Animals; Anti-Bacterial Agents; Disease Models, Animal; Humans; Inflammation; Mice; Osteomyelitis; Staphylococcal Infections
PubMed: 34672359
DOI: 10.22203/eCM.v042a22 -
Clinical Ophthalmology (Auckland, N.Z.) 2021This meta-analysis aims to summarize 12-month best-corrected visual acuity (BCVA) outcomes in response to anti-vascular endothelial growth factor (VEGF) therapy and... (Review)
Review
PURPOSE
This meta-analysis aims to summarize 12-month best-corrected visual acuity (BCVA) outcomes in response to anti-vascular endothelial growth factor (VEGF) therapy and dexamethasone implant for the treatment of diabetic macular edema (DME) and to identify factors affecting treatment response using evidence generated from meta-regression.
METHODS
A systematic review of electronic databases was conducted to identify randomized controlled trials (RCTs) and real-life/observational studies that reported 12-month changes in BCVA in patients with DME on anti-VEGF or dexamethasone implant treatment in monotherapy. Study factors that were analyzed are baseline patient characteristics, study type, drug employed, number of injections and 12-month change in BCVA. Data were pooled in a random-effects meta-analysis with BCVA change as the main outcome. Meta-regression was conducted to assess the impact of multiple covariates.
RESULTS
One-hundred-five heterogeneous study populations (45,032 eyes) were identified and included in the analysis. The use of anti-VEGFs and dexamethasone implant induced an overall increase of +8.13 ETDRS letters in BCVA at 12 months of follow-up. Meta-regression provided evidence that mean BCVA change using anti-VEGFs was not statistically higher for RCTs (p=0.35) compared to observational studies. Dexamethasone implant showed a trend for better results in observational studies over RCTs. Populations following a fixed aflibercept regimen performed better than those following a reactive treatment regimen. Mean BCVA gain was higher in younger populations (p<0.001), with lower baseline BCVA (p<0.0001) and longer diabetes duration (p<0.0001), receiving a higher number of injections (p<0.0001).
CONCLUSION
Intravitreal therapy with anti-VEGFs or dexamethasone implant produces a significant improvement in BCVA at 12 months in patients with DME. Meta-regression identified the modifiable covariates that can be targeted in order to maximize functional results.
PubMed: 33551641
DOI: 10.2147/OPTH.S236423 -
Journal of Clinical Medicine Apr 2024This systematic review aimed to evaluate the impact of antiresorptive drug therapy on osseointegrated dental implants and the association with medication-related... (Review)
Review
This systematic review aimed to evaluate the impact of antiresorptive drug therapy on osseointegrated dental implants and the association with medication-related osteonecrosis of the jaw (MRONJ). A systematic search, including a computer search of several databases with specific keywords, a reference search, and a manual search of four key maxillofacial journals were performed. Relevant articles were then evaluated and those that fulfilled the five predetermined criteria were chosen to enter the final review. A total of 445 implants in 135 subjects were included in the eight studies analyzed in the final review. The failure rate of dental implants after antiresorptive medication in the included studies was 23%, with 83% of failures attributed to MRONJ. The average time from antiresorptive drug initiation to MRONJ development was approximately 34 months, ranging from 3 months to 16 years. The majority of MRONJ cases were classified as stage 2, and all sites showed either complete healing or substantial mucosal coverage after treatment. This review highlights the significant impact of antiresorptive drugs on osseo- integrated implants, with MRONJ identified as a leading cause of implant failure. The potential role of peri-implantitis as a trigger for MRONJ is emphasized. Regular monitoring and maintaining good periodontal health, especially within the first three years of antiresorptive drug therapy initiation, are crucial for implant success. Physicians and dentists should provide comprehensive information to patients prescribed with antiresorptive drugs, emphasizing the need for an awareness of the risks of MRONJ in the context of osseointegrated implants. A longer term of follow-up is recommended to identify and manage MRONJ around dental implants in an early manner.
PubMed: 38610856
DOI: 10.3390/jcm13072091 -
Breast (Edinburgh, Scotland) Feb 2021The impact of neoadjuvant chemotherapy (NACT) on surgical outcomes following immediate breast reconstruction (IBR) remains unclear. While it is generally considered safe... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The impact of neoadjuvant chemotherapy (NACT) on surgical outcomes following immediate breast reconstruction (IBR) remains unclear. While it is generally considered safe practice to perform an IBR post NACT, reported complication rates in published data are highly variable with the majority of studies including fewer than 50 patients in the NACT and IBR arm. To evaluate this further, we conducted a systematic review and meta-analysis on the effect of NACT on autologous and implant based immediate breast reconstructions. We aimed to assess for differences in the post-operative course following IBR between patients who received NACT with those who did not.
METHODS
PubMed, EMBASE, and Cochrane Library were searched from 1995 to Sept 2, 2020 to identify articles that assessed the impact of NACT on IBR. All included studies assessed outcomes following IBR. Only studies comparing reconstructed patients receiving NACT to a control group of women who did not receive NACT were included. Unadjusted relative risk of outcomes between patients who received or did not receive NACT were synthesized using a fixed-effect meta-analysis. The evidence was assessed using the Newcastle Ottawa Scale scores and GRADE. Primary effect measures were risk ratios (RRs) with 95% confidence intervals.
RESULTS
A total 17 studies comprising 3249 patients were included in the meta-analyses. Overall, NACT did not increase the risk of complications after immediate breast reconstructions (risk ratio [RR]: 0.91, 95% CI 0.74 to 1.11, p = 0.34). There was a moderate, but not significant, increase in flap loss following NACT compared with controls (RR: 1.23, 95% CI 0.70 to 2.18, p = 0.47; I = 0%). Most notably, there was a statistically significant increase in implant/expander loss after NACT (RR: 1.54, 95% CI 1.04 to 2.29, p = 0.03; I = 34%). NACT was not shown to significantly increase the incidence of hematomas, seromas or wound complications, or result in a significant delay to commencing adjuvant therapy (RR: 1.59, 95% CI 0.66 to 3.87, p = 0.30).
CONCLUSION
Immediate breast reconstruction after NACT is a safe procedure with an acceptable post-operative complication profile. It may result in a slight increase in implant loss rates, but it does not delay commencing adjuvant therapy.
Topics: Breast Neoplasms; Chemotherapy, Adjuvant; Combined Modality Therapy; Female; Humans; Mammaplasty; Neoadjuvant Therapy; Postoperative Complications
PubMed: 33341706
DOI: 10.1016/j.breast.2020.11.023 -
Journal of Biomaterials Applications Feb 2020Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and...
BACKGROUND
Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and safety has been published.
OBJECTIVE
This systematic review intends to review and assess commercially available polydioxanone implants and their safety and performance in patients.
METHODS
We searched for approved polydioxanone implants in several Food and Drug Administration databases. Then, we performed a literature search for publications and clinical trials where polydioxanone devices were implanted in patients. This search was performed on MEDLINE, Embase, Scopus and other databases. Safety and performance of polydioxanone implants in patients were assessed and compared with the implantation of non-polydioxanone devices, when possible, based on scoring systems developed by the authors that analyse surgical site infection rates, inflammatory reaction rates, foreign body response, postoperative pain and fever.
RESULTS
Food and Drug Administration databases search revealed that 48 implants have been approved since 1981, with 1294 adverse reactions or product malfunction in the last decade and 16 recalls. A total of 49 clinical trials and 104 scientific publications were found. Polydioxanone sutures and meshes/plates had low rates of surgical site infection, inflammatory reaction, foreign body response and postoperative fever. Polydioxanone clips/staples reported high rates of surgical site infection, postoperative fever and pain, with sub-optimal clinical performance and poor safety rates. The remaining implants identified showed high levels of safety and performance. Safety scores of polydioxanone implants and non-polydioxanone alternatives are similar. Polydioxanone monofilament sutures perform better than non-polydioxanone alternatives but performance did not differ with remaining polydioxanone implant types.
CONCLUSIONS
Although polydioxanone clips/staples should be implanted with caution and monitored carefully, in general, safety and performance scores of other polydioxanone implants did not differ from non-polydioxanone alternatives. This review will be a useful reference for researchers and industries developing new polydioxanone medical devices.
Topics: Absorbable Implants; Biocompatible Materials; Device Approval; Humans; Inflammation; Medical Device Recalls; Polydioxanone
PubMed: 31771403
DOI: 10.1177/0885328219888841 -
International Journal of Antimicrobial... Jan 2024Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating prosthetic joint infection (PJI) or prosthetic valve endocarditis (PVE) due to staphylococci and streptococci.
METHODS
A systematic search was performed from inception to 13 June 2022 in Embase, MEDLINE, Cochrane and Web of Science to investigate the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating staphylococcal and streptococcal PJI or PVE. Randomised controlled trials (RCTs) and observational studies were included in the systematic review and meta-analysis.
RESULTS
Fourteen studies were included. A moderate quality of evidence was found in favour of rifampicin in patients with staphylococcal PJI who underwent a debridement, antibiotics and implant retention (DAIR) procedure [odds ratio = 2.49, 95% confidence interval (CI) 1.93-3.23]. Including the two RCTs only, adding rifampicin to the antibiotic regimen after DAIR was also in favour of rifampicin, but this was not statistically significant (risk ratio = 1.27, 95% CI 0.79-2.04; n = 126). Pooling data for patients with staphylococcal PJI who underwent a two-stage procedure showed that adding rifampicin was not associated with therapeutic success. Limited evidence was found for the use of rifampicin for PVE caused by staphylococci.
CONCLUSIONS
Adding rifampicin in the treatment of staphylococcal PJI treated by DAIR clearly increased the likelihood for therapeutic success. The clinical benefit of adjunctive rifampicin in the treatment of other staphylococci and streptococci implant-associated infections is still unclear.
Topics: Humans; Anti-Bacterial Agents; Arthritis, Infectious; Debridement; Prosthesis-Related Infections; Retrospective Studies; Rifampin; Staphylococcus; Streptococcus; Treatment Outcome
PubMed: 37875179
DOI: 10.1016/j.ijantimicag.2023.107015 -
Journal of Dentistry (Shiraz, Iran) Sep 2022Bone morphogenetic protein (BMP), a potential osteoinductive agent, was systematically reviewed for merits and demerits when used as a bone additive that was intervened...
STATEMENT OF THE PROBLEM
Bone morphogenetic protein (BMP), a potential osteoinductive agent, was systematically reviewed for merits and demerits when used as a bone additive that was intervened during the surgical phase of dental implant placement; and suitable drug carriers that could withstand the functional load and deliver BMP at its lowest concentration.
PURPOSE
To identify the carriers and concentration of BMP acceptable during surgical phase of implant placement and evaluate its efficacy in bone gain and osseointegration.
MATERIALS AND METHOD
The study design was systematic review. Literature search as per PICO format was carried out within a time range from 2000 to July 2021. The review fol-lowed PRISMA guidelines and registered with the PROSPERO (CRD42020171667). The focus question included the population with an intra-oral implant placed in both animal and human models that were intervened with BMP-2 as an external additive biomaterial during the surgical phase. 2631 articles selected from the initial search were systematically filtered and yielded 16 articles that were qualitatively analysed.
RESULTS
The inter-rater reliability and level of agreement were 93.71%, κ(Kappa)>0.81 re-spectively. Results revealed the collagen carrier was commonly used for BMP delivery but lacked the property to withstand functional load and sustained release. BMP concentration varied in the range of 0.215μg to 0.8mg and the study revealed significantly indifferent out-come with low dose compared to the highest dose. BMP supplement showed better osseointe-gration in comparison with non-supplemented sites during the early period (within 6 months).
CONCLUSION
BMP at lower concentrations and with appropriate carriers, collagen sponge, hydroxyapatite/tricalcium phosphate (HA/TCP) with a bio ceramic bulking agent, and poly (D, L-lactide-co-glycolic acid) (PLGA) reinforced with gelatin/HA/TCP accelerated bone growth during the initial stages of healing. Further long-term clinical trials for dental implant, analysing the sustained release of BMP with biodegradable and load-bearing carriers should be considered.
PubMed: 36588970
DOI: 10.30476/DENTJODS.2021.90931.1536 -
Laryngoscope Investigative... Jun 2024To establish audiological and other outcomes following cochlear implantation in humans and animals with eluting electrodes. (Review)
Review
OBJECTIVES
To establish audiological and other outcomes following cochlear implantation in humans and animals with eluting electrodes.
METHODS
Systematic review and narrative synthesis. Databases searched (April 2023): MEDLINE, EMBASE, CENTRAL, ClinicalTrials.gov, and Web of Science. Studies reporting outcomes in either humans or animals following cochlear implantation with a drug-eluting electrode were included. No limits were placed on language or year of publication. Risk of bias assessment was performed on all included studies using either the Brazzelli or Systematic Review Centre for Laboratory animal Experimentation (SYRCLE) assessment tools. The review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement.
RESULTS
Searches identified 146 abstracts and 108 full texts. Of these, 18 studies met the inclusion criteria, reporting outcomes in 523 animals (17 studies) and 24 humans (1 study). Eluting electrodes included dexamethasone (16 studies), aracytine (1 study), nicotinamide adenine dinucleotide (1 study), the growth factors insulin-like growth factor 1 (IGF1) and hepatocyte growth factor (HGF) (1 study), and neurotrophin-3 (1 study). All included studies compare outcomes following implantation with an eluting electrode with a control non-eluting electrode. In the majority of studies, audiological outcomes (e.g., auditory brainstem response threshold) were superior following implantation with an eluting electrode compared with a standard electrode. Most studies which investigated post-implantation impedance reported lower impedance following implantation with an eluting electrode. The influence of eluting electrodes on other reported outcomes (including post-implantation cochlear fibrosis and the survival of hair cells and spiral ganglion neurons) was more varied across the included studies.
CONCLUSIONS
Eluting electrodes have shown promise in animal studies in preserving residual hearing following cochlear implantation and in reducing impedance, though data from human studies remain lacking. Further in-human studies will be required to determine the clinical usefulness of drug-eluting cochlear implants as a future treatment for sensorineural hearing loss.
PubMed: 38855776
DOI: 10.1002/lio2.1263