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Open Heart Oct 2020Determine whether an ultrathin biodegradable polymer sirolimus-eluting stent ('Orsiro'-BP-SES) has clinical benefits over second-generation durable polymer drug-eluting... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Determine whether an ultrathin biodegradable polymer sirolimus-eluting stent ('Orsiro'-BP-SES) has clinical benefits over second-generation durable polymer drug-eluting stents (DP-DES).
METHODS
We conducted a prospective systematic review and meta-analysis of randomised clinical trials comparing Orsiro BP-SES against DP-DES (PROSPERO Registration: CRD42019147136). The primary outcome was target lesion failure (TLF): composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically indicated target lesion revascularisation (TLR)) evaluated at the longest available follow-up.
RESULTS
Nine trials randomised 11 302 patients to either Orsiro BP-SES or DP-DES. At mean weighted follow-up of 2.8 years, the primary outcome (TLF) occurred in 501 of 6089 (8.2%) participants with BP-SES compared with 495 of 5213 (9.5%) participants with DP-DES. This equates to an absolute risk reduction of 1.3% in TLF in favour of Orsiro BP-SES (OR 0.82; 95% CI 0.69 to 0.98; p=0.03). This was driven by a reduction in TVMI (OR 0.80; 95% CI 0.65 to 0.98; p=0.03). There were no significant differences in other clinical endpoints: cardiac death, TLR and stent thrombosis.
CONCLUSION
The Orsiro BP-SES shows promising clinical outcomes in patients undergoing percutaneous coronary intervention compared with contemporary second-generation DES at a short to medium term follow-up. More research is warranted to evaluate performance over a longer follow-up period and in different clinical and lesion subsets.
Topics: Absorbable Implants; Aged; Coronary Artery Disease; Drug-Eluting Stents; Female; Humans; Male; Middle Aged; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Randomized Controlled Trials as Topic; Risk Assessment; Risk Factors; Time Factors; Treatment Outcome
PubMed: 33046595
DOI: 10.1136/openhrt-2020-001394 -
BMC Oral Health Apr 2020Bisphosphonate coating of dental implants is a promising tool for surface modification aiming to improve the osseointegration process and clinical outcome. The... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Bisphosphonate coating of dental implants is a promising tool for surface modification aiming to improve the osseointegration process and clinical outcome. The biological effects of bisphosphonates are thought to be mainly associated with osteoclasts inhibition, whereas their effects on osteoblast function are unclear. A potential of bisphosphonate coated surfaces to stimulate osteoblast differentiation was investigated by several in vitro studies with contradictory results. The purpose of this systematic review and meta-analysis was to evaluate the effect of bisphosphonate coated implant surfaces on alkaline phosphatase activity in osteoblasts.
METHODS
In vitro studies that assessed alkaline phosphatase activity in osteoblasts following cell culture on bisphosphonate coated titanium surfaces were searched in electronic databases PubMed/MEDLINE, Scopus and ISI Web of Science. Animal studies and clinical trials were excluded. The literature search was restricted to articles written in English and published up to August 2019. Publication bias was assessed by the construction of funnel plots.
RESULTS
Eleven studies met the inclusion criteria. Meta-analysis showed that coating of titanium surfaces with bisphosphonates increases alkaline phosphatase activity in osteoblasts after 3 days (n = 1), 7 (n = 7), 14 (n = 6) and 21 (n = 3) days. (7 days beta coefficient = 1.363, p-value = 0.001; 14 days beta coefficient = 1.325, p-value < 0.001; 21 days beta coefficient = 1.152, p-value = 0.159).
CONCLUSIONS
The meta-analysis suggests that bisphosphonate coatings of titanium implant surfaces may have beneficial effects on osteogenic behaviour of osteoblasts grown on titanium surfaces in vitro. Further studies are required to assess to which extent bisphosphonates coating might improve osseointegration in clinical situations.
Topics: Alkaline Phosphatase; Animals; Cell Differentiation; Cells, Cultured; Dental Implants; Diphosphonates; Osseointegration; Osteoblasts; Surface Properties; Titanium
PubMed: 32334598
DOI: 10.1186/s12903-020-01089-4 -
Urologia Internationalis 2022The aim of this study is to review the literature on the use of antifungal prophylaxis in penile prosthesis (PP) surgery and provide a summary on its efficacy as an...
OBJECTIVE
The aim of this study is to review the literature on the use of antifungal prophylaxis in penile prosthesis (PP) surgery and provide a summary on its efficacy as an adjunct to current prophylactic regimes in patients undergoing PP surgery.
MATERIALS AND METHODS
PubMed, Medline, and EMBASE databases were systematically searched up to May 2020. All included studies were analysed and the information extracted included author, title of study, year of publication, type of study, journal of publication, and main findings regarding post PP implantation fungal infections.
RESULTS
Nine relevant studies were included in this review, comprising retrospective single-centre studies and retrospective multicentre studies ranging from 2017 to 2020. Fungal infections were found responsible for 11.1% of all PP infections, with a greater risk in patients with diabetes, obesity, and from warmer climates. Current American Urological Association (AUA) and European Association of Urology (EAU) prophylaxis guidelines do not incorporate the use of antifungals. Trials of antifungal prophylaxis regimes combined with antibiotic prophylaxis have demonstrated a reduction in PP fungal infections.
CONCLUSIONS
Fungal infections represent a significant proportion of implant infections and therefore antifungal prophylaxis is warranted. Future studies comparing the efficacy of traditional antibiotic prophylaxis as set out by AUA/EAU with novel prophylaxis regimes including the addition of an antifungal may provide more definitive guidance on this issue. Until then antifungal prophylaxis in all patients undergoing PP procedures may provide a significant cost-effect benefit.
Topics: Antifungal Agents; Humans; Male; Mycoses; Penile Diseases; Penile Prosthesis; Retrospective Studies
PubMed: 35235938
DOI: 10.1159/000522173 -
Molecular Biology Reports Jun 2020Sensorineural hearing loss (SNHL) is the most common form of hearing loss that is routinely treated with hearing aids or cochlear implants. Advances in regenerative...
Sensorineural hearing loss (SNHL) is the most common form of hearing loss that is routinely treated with hearing aids or cochlear implants. Advances in regenerative medicine have now led to animal studies examining the possibility of restoring injured hair cells with mesenchymal stem/stromal cell (MSC) administration. We conducted a systematic review and meta-analysis to collate the existing preclinical literature evaluating MSCs as a treatment for SNHL and quantify the effect of MSCs on functional hearing. Our protocol was published online on CAMARADES. Searches were conducted in four medical databases by two independent investigators. Twelve studies met inclusion and were evaluated for risk of bias using SYRCLE. Rodent models were commonly used (n = 8, 66%), while auditory brainstem response (ABR) and distortion product otoacoustic emissions (DPOAE) were the most frequent measures assessing hearing loss. MSCs were derived from multiple tissue sources, including bone marrow, adipose tissue, and umbilical cord blood and the dose ranged from 4 × 10 to 1 × 10 cells. Treatment with MSCs resulted in an improvement in ABR and DPOAE (mean difference-15.22, + 9.10, respectively). Despite high heterogeneity and multiple "unclear" domains in the risk of bias, this review provides evidence that MSCs may have a beneficial effect in hearing function.
Topics: Animals; Disease Models, Animal; Evoked Potentials, Auditory, Brain Stem; Hearing Loss; Hearing Loss, Sensorineural; Mesenchymal Stem Cell Transplantation; Mesenchymal Stem Cells
PubMed: 32323262
DOI: 10.1007/s11033-020-05460-0 -
Journal of Orthopaedic Research :... Dec 2021Surgical site infection in the presence of orthopedic implants poses significant healthcare and socioeconomic burden. To assess the potential of various prevention... (Meta-Analysis)
Meta-Analysis
Surgical site infection in the presence of orthopedic implants poses significant healthcare and socioeconomic burden. To assess the potential of various prevention strategies against Staphylococcus-induced stainless steel-associated infections, a review of animal evidence was designed. The databases of PubMed, Embase, and CENTRAL were searched until March 10, 2020, for articles including animal models with stainless steel instrumentation and techniques to prevent Staphylococcus infection. We conducted a random-effects meta-analysis of standardized mean differences (SMD) with subgroup analysis linked to various protection strategies and we recorded complications. Quality was assessed with the SYRCLE's risk of bias tool. Twenty-five studies were included. Combined active coating (featuring organic antibacterial compound release) and degradable passive finishing (lipid- or polymer-based structure modification reducing bacterial adhesion) was favored over untreated controls (SMDs for methicillin-sensitive Staphylococcus aureus [MSSA] and methicillin-resistant Staphylococcus aureus [MRSA] were -3.46, 95% CI [-4.53 to -2.4], p < .001 [n = 4 head-to-head comparisons]; and -6.67, 95% CI [-10.53 to -3], p < .001 [n = 5 head-to-head comparisons], respectively). Systemic vitamin D supplementation and systemic antibiotic administration with or without local antibiotics demonstrated favorable outcomes against MSSA infection. On the contrary, no benefit was seen following vaccination. Of note, no side effects were documented. On the basis of data gathered from eight studies, which comprised 294 animals, a bioresorbable polymer- or lipid-based surface modification supplemented with organic coating yielded improved infection-related outcomes against MSSA and MRSA stainless steel infections, and therefore, this strategy could be further investigated in human research.
Topics: Animals; Anti-Bacterial Agents; Lipids; Methicillin-Resistant Staphylococcus aureus; Orthopedics; Polymers; Stainless Steel; Staphylococcal Infections; Staphylococcus aureus
PubMed: 33527485
DOI: 10.1002/jor.24999 -
The Cochrane Database of Systematic... Mar 2020Glaucoma is a leading cause of irreversible blindness. A number of minimally-invasive surgical techniques have been introduced as a treatment to prevent glaucoma from... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Glaucoma is a leading cause of irreversible blindness. A number of minimally-invasive surgical techniques have been introduced as a treatment to prevent glaucoma from progressing; ab interno trabecular bypass surgery with the Schlemm's canal Hydrus microstent is one of them.
OBJECTIVES
To evaluate the efficacy and safety of ab interno trabecular bypass surgery with the Hydrus microstent in treating people with open angle glaucoma (OAG).
SEARCH METHODS
On 7 May 2019, we searched CENTRAL (2019, Issue 5), which contains the Cochrane Eyes and Vision Trials Register; Ovid MEDLINE; Ovid Embase; the ISRCTN registry; ClinicalTrials.gov; and the WHO ICTRP.
SELECTION CRITERIA
We searched for randomised controlled trials (RCTs) of the Hydrus microstent, alone or with cataract surgery, compared to other surgical treatments (cataract surgery alone, other minimally-invasive glaucoma device techniques, trabeculectomy), laser treatment, or medical treatment.
DATA COLLECTION AND ANALYSIS
A minimum of three authors independently extracted data from reports of included studies, using a data collection form and analysed data, based on standard Cochrane methods.
MAIN RESULTS
We included three published studies, with 808 people randomised. Two studies had multiple international recruitment centres in the USA and other countries. The third study had several sites based in Europe. All three studies were sponsored by the Hydrus manufacturer Ivantis Inc. All studies included participants with mainly mild or moderate OAG (mean deviation between -3.6 dB (decibel) and -8.4 dB in all study arms), which was controlled with medication in many participants (mean medicated intraocular pressure (IOP) 17.9 mmHg to 19.1 mmHg). There were no concerns regarding allocation concealment bias, but masking of outcome assessors was high or unclear risk in all studies; masking of participants was achieved, and losses to follow-up were not a concern. Two studies compared the Hydrus microstent combined with cataract surgery to cataract surgery alone, in participants with visually significant cataracts and OAG. We found moderate-certainty evidence that adding the Hydrus microstent to cataract surgery increased the proportion of participants who were medication-free from about half to more than three quarters at 12-month, short-term follow-up (risk ratio (RR) 1.59, 95% confidence interval (CI) 1.39 to 1.83; 2 studies, 639 participants; I² = 0%; and 24-month, medium-term follow-up (RR 1.63, 95% CI 1.40 to 1.88; 2 studies, 619 participants; I² = 0%). The Hydrus microstent combined with cataract surgery reduced the medium-term mean change in unmedicated IOP (after washout) by 2 mmHg more compared to cataract surgery alone (mean difference (MD) -2.00, 95% CI -2.69 to -1.31; 2 studies, 619 participants; I² = 0%; moderate-certainty evidence), and the mean change in IOP-lowering drops (MD -0.41, 95% CI -0.56 to -0.27; 2 studies, 619 participants; I² = 0%; low-certainty evidence). We also found low-certainty evidence that adding a Hydrus microstent to cataract surgery reduced the need for secondary glaucoma surgery from about 2.5% to less than 1% (RR 0.17, 95% CI 0.03 to 0.86; 2 studies, 653 participants; I² = 27%; low-certainty evidence). Intraocular bleeding, loss of 2 or more visual acuity (VA) lines, and IOP spikes of 10 mmHg or more were rare in both groups; estimates were imprecise, and included both beneficial and harmful effects. There were no cases of endophthalmitis in either group. No data were available on the proportion of participants achieving IOP less than 21 mmHg, 17 mmHg, or 14 mmHg; health-related quality of life (HRQOL), or visual field progression. One study provided short-term data for the Hydrus microstent compared with the iStent trabecular micro-bypass stent (iStent: implantation of two devices in a single procedure) in 152 participants with OAG (148 in analyses). Use of the Hydrus increased the proportion of medication-free participants from about a quarter to about half compared to those who received iStent, but this estimate was imprecise (RR 1.94, 95% CI 1.21 to 3.11; low-certainty evidence). Use of the Hydrus microstent reduced unmedicated IOP (after washout) by about 3 mmHg more than the iStent (MD -3.10, 95% CI -4.17 to -2.03; moderate-certainty evidence), and the use of IOP-lowering medication (MD -0.60, 95% CI -0.99 to -0.21; low-certainty evidence). Both devices achieved a final IOP < 21 mmHg in most participants (Hydrus microstent: 91.8%; iStent: 84%; RR 1.09, 95% CI 0.97 to 1.23; low-certainty evidence). None of the participants who received the Hydrus microstent (N = 74) required additional glaucoma surgery; two participants who received the iStent (N = 76) did. Few adverse events were found in either group. No data were available on the proportion of participants achieving IOP less than 17 mmHg or 14 mmHg, or on HRQOL.
AUTHORS' CONCLUSIONS
In people with cataracts and generally mild to moderate OAG, there is moderate-certainty evidence that the Hydrus microstent with cataract surgery compared to cataract surgery alone, likely increases the proportion of participants who do not require IOP lowering medication, and may further reduce IOP at short- and medium-term follow-up. There is moderate-certainty evidence that the Hydrus microstent is probably more effective than the iStent in lowering IOP of people with OAG in the short-term. Few studies were available on the effects of the Hydrus microstent, therefore the results of this review may not be applicable to all people with OAG, particularly in selected people with medically uncontrolled glaucoma, since IOP was controlled with medication in many participants in the included studies. Complications may be rare using the Hydrus microstent, as well as the comparator iStent, but larger studies are needed to investigate its safety.
Topics: Cataract Extraction; Glaucoma Drainage Implants; Glaucoma, Open-Angle; Humans; Randomized Controlled Trials as Topic; Trabeculectomy
PubMed: 32147807
DOI: 10.1002/14651858.CD012740.pub2 -
Neurology India 2023Surgical site infection (SSI) rates (1-9%) remain high despite the widespread adoption of infection control bundles. Topical vancomycin has emerged as an effective... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Surgical site infection (SSI) rates (1-9%) remain high despite the widespread adoption of infection control bundles. Topical vancomycin has emerged as an effective strategy to reduce the rate of SSI in patients undergoing spinal surgery including instrumentation. However, its use and efficiency in cranial neurosurgery is not well established. The aim of this study is to study the efficacy of topical vancomycin in cranial neurosurgery.
METHODS
A systematic search was performed according to Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines. Data regarding type of surgery, use of implants, the dose of vancomycin, technique of administration in each study, outcomes, rate of SSI, and the interval between surgery and SSI; possible complications related to antibiotic use were collected.
RESULTS
A total of 12 studies were included in the qualitative analysis with 3,446 patients. SSI developed in 1.6% of the patients in the vancomycin group as compared to 5.28% in the control group. The pooled risk ratio was 0.24 with 95% CI: 0.12-0.51 (P-value: <0.00001). The difference between the subgroups was significant (P-value: < 0.00001). The number needed to treat (NNT) was 27.2. The studies showed low heterogeneity with an I of 24%. Meta-regression analysis showed that the number of patients in a study, duration of follow-up, and year of publication did not contribute significantly to effect size.
CONCLUSION
The limited systemic absorption of vancomycin and broad-spectrum led to its widespread applicability in the prevention of SSI in all types of cranial neurosurgery. Cases with implantable pulse generators, cranioplasty, and cerebrospinal fluid (CSF) diversion procedures have all demonstrated their unequivocal effectiveness.
Topics: Humans; Vancomycin; Surgical Wound Infection; Anti-Bacterial Agents; Neurosurgical Procedures
PubMed: 37929420
DOI: 10.4103/0028-3886.388107 -
Medicine Apr 2020The impact of dexamethasone on pain management for knee arthroscopy remains controversial. We conduct a systematic review and meta-analysis to explore the influence of... (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The impact of dexamethasone on pain management for knee arthroscopy remains controversial. We conduct a systematic review and meta-analysis to explore the influence of dexamethasone for knee arthroscopy.
METHODS
We search PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases through October 2018 for randomized controlled trials (RCTs) assessing the effect of dexamethasone on pain intensity for patients with dental implant. This meta-analysis is performed using the random-effect model.
RESULTS
Four RCTs involving 228 patients are included in the meta-analysis. Overall, compared with control group for knee arthroscopy, dexamethasone supplementation has no notable effect on pain scores at 4 to 6 hours (Std. MD = 0.99; 95% CI = -2.97 to 4.95; P = .62), but exerts significantly favorable promotion to pain scores at 12 hours (Std. MD = -1.06; 95% CI = -1.43 to -0.69; P < .00001), duration of block (Std. MD = 1.87; 95% CI = 0.65 to 3.10; P = .003), time to first analgesic requirement (Std. MD = 0.90; 95% CI = 0.51 to 1.29; P < .00001), analgesic consumption (Std. MD = -1.62; 95% CI = -2.31 to -0.93; P < .00001), and patient satisfaction (Std. MD = 1.15; 95% CI = 0.73 to 1.58; P < .00001).
CONCLUSIONS
Dexamethasone supplementation has importantly positive influence on pain control for knee arthroscopy.
Topics: Analgesics; Anti-Inflammatory Agents; Arthroscopy; Dexamethasone; Humans; Knee Joint; Nerve Block; Pain Management; Pain Measurement; Pain, Postoperative; Patient Satisfaction; Randomized Controlled Trials as Topic
PubMed: 32311920
DOI: 10.1097/MD.0000000000019417 -
Scientific Reports Feb 2021We conducted a meta-analysis of real-world studies on the 0.19 mg Fluocinolone Acetonide (FAc) intravitreal implant for chronic diabetic macular oedema (DMO), comparing... (Meta-Analysis)
Meta-Analysis
We conducted a meta-analysis of real-world studies on the 0.19 mg Fluocinolone Acetonide (FAc) intravitreal implant for chronic diabetic macular oedema (DMO), comparing these findings with the Fluocinolone Acetonide for Diabetic Macular Edema (FAME) study. The primary outcome was mean change of best corrected visual acuity (BCVA) at 24 months. Secondary outcomes were 36-month mean BCVA, mean central macular thickness (CMT) change, rates of eyes receiving supplementary intravitreal therapy, cataract surgery, intraocular pressure (IOP)-lowering drops and glaucoma surgery. Mean differences (MDs) with 95% confidence intervals (CIs) were calculated. Nine real-world studies were included. The FAc implant yielded a significantly improved BCVA at 24 and 36 months (24-month MD = 4.52; 95% CI 2.56-6.48; 36-month MD = 8.10; 95% CI 6.34-9.86). These findings were comparable with the FAME study. The FAc implant yielded significantly reduced 24- and 36-month CMT. Pooled proportions of cataract surgery, IOP-lowering drops and glaucoma surgery were 39%, 27% and 3%, respectively, all lower than the FAME study. Pooled estimate of supplementary intravitreal therapy was 39%, higher than the 15.2% of the FAME study. This meta-analysis of real-world studies confirms favorable visual and anatomical outcomes following FAc insert for chronic DMO. In real-life studies more than one third of patients received supplementary intravitreal therapy, an issue that needs to be further explored.
Topics: Anti-Inflammatory Agents; Diabetic Retinopathy; Drug Implants; Fluocinolone Acetonide; Glucocorticoids; Humans; Intraocular Pressure; Macular Edema
PubMed: 33637841
DOI: 10.1038/s41598-021-84362-y -
Cardiovascular Revascularization... Sep 2019The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating.
OBJECTIVES
The study estimated the health economic impact of a latest generation coronary stent with ultrathin struts and bioresorbable polymer coating.
BACKGROUND
The recent BIOFLOW V trial, an international FDA approval trial (ClinicalTrials.gov: NCT02389946), has shown that an ultrathin, bioresorbable polymer sirolimus-eluting stent had a significantly lower rate of target lesion failure and target vessel-related myocardial infarction than a thin, durable polymer everolimus-eluting stent at 12 months, driven by a lower rate of peri-procedural myocardial infarction (ppMI).
METHODS
We used a Markov model to project mortality and cost outcomes of that lower ppMI rate from a U.S. health system perspective over a 12-month horizon. Model parameters were derived from BIOFLOW V trial data, a systematic literature review and expert interviews.
RESULTS
Use of the bioresorbable polymer sirolimus-eluting stent compared to durable polymer everolimus-eluting stent is associated with net reductions in medical cost of $124 (Interquartile Range (IQR) $97-154) per patient in 2018 US$, of which $115 (IQR $76-124) accrues to the initial admission and $10 (IQR $7-72) to cost of follow-up. The lower rate of ppMI translates into a gain of 0.000017 (IQR 0.000011-0.000022) quality-adjusted life-years (QALY) per patient.
CONCLUSIONS
Lower ppMI rates of bioresorbable polymer sirolimus-eluting stent translate into reductions in direct medical cost, while improving patient outcomes. Most of the cost reduction is attributed to the initial admission with moderate savings up to 12 months post-discharge.
Topics: Absorbable Implants; Cardiovascular Agents; Clinical Trials as Topic; Computer Simulation; Coronary Artery Disease; Cost Savings; Cost-Benefit Analysis; Drug Costs; Drug-Eluting Stents; Everolimus; Health Care Costs; Humans; Markov Chains; Models, Economic; Myocardial Infarction; Percutaneous Coronary Intervention; Polymers; Prosthesis Design; Risk Assessment; Risk Factors; Sirolimus; Time Factors; Treatment Outcome
PubMed: 30638888
DOI: 10.1016/j.carrev.2018.11.006