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BMJ Open Apr 2018The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of... (Review)
Review
OBJECTIVES
The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches.
SETTINGS AND PARTICIPANTS
A systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries.
RESULTS
The following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis.
CONCLUSIONS
Registries provide a 'real-world' picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs' data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate.
Topics: Cardiac Resynchronization Therapy; Coronary Disease; Defibrillators, Implantable; Europe; Heart Diseases; Heart Valve Prosthesis Implantation; Humans; Pacemaker, Artificial; Prostheses and Implants; Registries; Stents; United States
PubMed: 29654008
DOI: 10.1136/bmjopen-2017-019039 -
The Cochrane Database of Systematic... Dec 2014Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Incontinence can have a devastating effect on the lives of sufferers with significant economic implications. Non-surgical treatments such as pelvic floor muscle training and the use of mechanical devices are usually the first line of management, particularly when a woman does not want surgery or when she is considered unfit for surgery. Mechanical devices are inexpensive and do not compromise future surgical treatment.
OBJECTIVES
To determine whether mechanical devices are useful in the management of adult female urinary incontinence.
SEARCH METHODS
For this second update we searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 21 August 2014), EMBASE (January 1947 to 2014 Week 34), CINAHL (January 1982 to 25 August 2014), and the reference lists of relevant articles.
SELECTION CRITERIA
All randomised or quasi-randomised controlled trials of mechanical devices in the management of adult female urinary incontinence determined by symptom, sign or urodynamic diagnosis.
DATA COLLECTION AND ANALYSIS
The reviewers assessed the identified studies for eligibility and risk of bias and independently extracted data from the included studies. Data analysis was performed using RevMan software (version 5.3).
MAIN RESULTS
One new trial was identified and included in this update bringing the total to eight trials involving 787 women. Three small trials compared a mechanical device with no treatment and although they suggested that use of a mechanical device might be better than no treatment, the evidence for this was inconclusive. Four trials compared one mechanical device with another. Quantitative synthesis of data from these trials was not possible because different mechanical devices were compared in each trial using different outcome measures. Data from the individual trials showed no clear difference between devices, but with wide confidence intervals. One trial compared three groups: a mechanical device alone, behavioural therapy (pelvic floor muscle training) alone and behavioural therapy combined with a mechanical device. While at three months there were more withdrawals from the device-only group, at 12 months differences between the groups were not sustained on any measure.
AUTHORS' CONCLUSIONS
The place of mechanical devices in the management of urinary incontinence remains in question. Currently there is little evidence from controlled trials on which to judge whether their use is better than no treatment and large well-conducted trials are required for clarification. There was also insufficient evidence in favour of one device over another and little evidence to compare mechanical devices with other forms of treatment.
Topics: Adult; Aged; Exercise Therapy; Female; Humans; Middle Aged; Muscle Contraction; Pelvic Floor; Pessaries; Prostheses and Implants; Randomized Controlled Trials as Topic; Tampons, Surgical; Urinary Incontinence; Urinary Sphincter, Artificial
PubMed: 25517397
DOI: 10.1002/14651858.CD001756.pub6 -
World Journal of Gastroenterology Mar 2017To analyze the anatomy of sacral venous plexus flow, the causes of injuries and the methods for controlling presacral hemorrhage during surgery for rectal cancer. (Review)
Review
AIM
To analyze the anatomy of sacral venous plexus flow, the causes of injuries and the methods for controlling presacral hemorrhage during surgery for rectal cancer.
METHODS
A review of the databases MEDLINE and Embase™ was conducted, and relevant scientific articles published between January 1960 and June 2016 were examined. The anatomy of the sacrum and its venous plexus, as well as the factors that influence bleeding, the causes of this complication, and its surgical management were defined.
RESULTS
This is a review of 58 published articles on presacral venous plexus injury during the mobilization of the rectum and on techniques used to treat presacral venous bleeding. Due to the lack of cases published in the literature, there is no consensus on which is the best technique to use if there is presacral bleeding during mobilization in surgery for rectal cancer. This review may provide a tool to help surgeons make decisions regarding how to resolve this serious complication.
CONCLUSION
A series of alternative treatments are described; however, a conventional systematic review in which optimal treatment is identified could not be performed because few cases were analyzed in most publications.
Topics: Blood Loss, Surgical; Decision Making; Electrocoagulation; Hemostasis; Hemostasis, Surgical; Humans; Hydrodynamics; Metals; Pelvis; Prostheses and Implants; Rectal Neoplasms; Rectum; Sacrum; Veins
PubMed: 28321171
DOI: 10.3748/wjg.v23.i9.1712 -
Journal of Investigative Surgery : the... Jun 2018To compare clinical outcomes of unipolar and bipolar radial head prosthesis in the treatment of patients with radial head fracture. (Comparative Study)
Comparative Study Meta-Analysis Review
PURPOSE
To compare clinical outcomes of unipolar and bipolar radial head prosthesis in the treatment of patients with radial head fracture.
MATERIALS AND METHODS
Medline, Cochrane, EMBASE, Google Scholar databases were searched until April 18, 2016 using the following search terms: radial head fracture, elbow fracture, radial head arthroplasty, implants, prosthesis, unipolar, bipolar, cemented, and press-fit. Randomized controlled trials, retrospective, and cohort studies were included.
RESULTS
The Mayo elbow performance score (MEPS), disabilities of the arm, shoulder, and hand (DASH) score, radiologic assessment, ROM, and grip strength following elbow replacement were similar between prosthetic devices. The pooled mean excellent/good ranking of MEPS was 0.78 for unipolar and 0.73 for bipolar radial head arthroplasty, and the pooled mean MEPS was 86.9 and 79.9, respectively. DASH scores for unipolar and bipolar prosthesis were 19.0 and 16.3, respectively. Range of motion outcomes were similar between groups, with both groups have comparable risk of flexion arc, flexion, extension deficit, rotation arc, pronation, and supination (p values <0.001 for both unipolar and bipolar prosthesis). However, bipolar radial head prosthesis was associated with an increased chance of heterotopic ossification and lucency (p values ≤0.049) while unipolar prosthesis was not (p values ≥0.088). Both groups had risk for development of capitellar osteopenia or erosion/wear (p values ≤0.039).
CONCLUSION
Unipolar and bipolar radial head prostheses were similar with respect to clinical outcomes. Additional comparative studies are necessary to further compare different radial head prostheses used to treat radial head fracture.
Topics: Bone Diseases, Metabolic; Elbow Joint; Elbow Prosthesis; Humans; Ossification, Heterotopic; Postoperative Complications; Prosthesis Design; Prosthesis Implantation; Radiography; Radius Fractures; Range of Motion, Articular; Treatment Outcome; Elbow Injuries
PubMed: 28901795
DOI: 10.1080/08941939.2017.1299262 -
The Journal of Hand Surgery... Oct 2023Literature investigating the long-term outcomes of prosthesis options for proximal interphalangeal (PIP) joint arthroplasty is scarce, with most reports combining... (Meta-Analysis)
Meta-Analysis
Literature investigating the long-term outcomes of prosthesis options for proximal interphalangeal (PIP) joint arthroplasty is scarce, with most reports combining indications and underlying pathologies in analyses. In this study, we aim to compare silicone, pyrocarbon and metal prostheses in PIP joint arthroplasty for primary degenerative osteoarthritis (OA). A review of scientific literature published between 1990 and 2021 was conducted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. Relevant studies were screened and the appropriate data was extracted. An evaluation of clinical outcomes (range of motion [ROM] and pain), complications (reoperation) and survival rates for each prosthesis was performed. Twelve studies were included for analysis with a total of 412 PIP joints. ROM was 66.6°, 55.8° and 46.4° for metal, silicone and pyrocarbon implants, respectively. Silicone implants had the best pain score on the visual analogue scale (1.2) followed by the pyrocarbon (2.6) and metal (3.9) groups. Complication rates were lowest in silicone implants (11.3%) compared to 18.5% in pyrocarbon and 22.4% in metal prostheses. Survival did not differ significantly amongst the three groups. Our findings suggest that for patients with primary degenerative OA, PIP joint arthroplasty using a silicone prosthesis can provide greater pain relief with lower complication rates compared to other implant options. Level III (Therapeutic).
Topics: Humans; Joint Prosthesis; Finger Joint; Arthroplasty, Replacement, Finger; Osteoarthritis; Arthroplasty; Silicones; Pain
PubMed: 37881822
DOI: 10.1142/S2424835523500571 -
Surgery Jun 2016Three-dimensional (3D) printing is becoming increasingly important in medicine and especially in surgery. The aim of the present work was to identify the advantages and... (Review)
Review
BACKGROUND
Three-dimensional (3D) printing is becoming increasingly important in medicine and especially in surgery. The aim of the present work was to identify the advantages and disadvantages of 3D printing applied in surgery.
METHODS
We conducted a systematic review of articles on 3D printing applications in surgery published between 2005 and 2015 and identified using a PubMed and EMBASE search. Studies dealing with bioprinting, dentistry, and limb prosthesis or those not conducted in a hospital setting were excluded.
RESULTS
A total of 158 studies met the inclusion criteria. Three-dimensional printing was used to produce anatomic models (n = 113, 71.5%), surgical guides and templates (n = 40, 25.3%), implants (n = 15, 9.5%) and molds (n = 10, 6.3%), and primarily in maxillofacial (n = 79, 50.0%) and orthopedic (n = 39, 24.7%) operations. The main advantages reported were the possibilities for preoperative planning (n = 77, 48.7%), the accuracy of the process used (n = 53, 33.5%), and the time saved in the operating room (n = 52, 32.9%); 34 studies (21.5%) stressed that the accuracy was not satisfactory. The time needed to prepare the object (n = 31, 19.6%) and the additional costs (n = 30, 19.0%) were also seen as important limitations for routine use of 3D printing.
CONCLUSION
The additional cost and the time needed to produce devices by current 3D technology still limit its widespread use in hospitals. The development of guidelines to improve the reporting of experience with 3D printing in surgery is highly desirable.
Topics: Humans; Models, Anatomic; Printing, Three-Dimensional; Prostheses and Implants; Surgical Procedures, Operative
PubMed: 26832986
DOI: 10.1016/j.surg.2015.12.017 -
Journal of Cataract and Refractive... Oct 2016The purpose of this review was to evaluate the postoperative results of cosmetic iris implants. A systematic review of studies reporting postoperative outcomes of... (Review)
Review
UNLABELLED
The purpose of this review was to evaluate the postoperative results of cosmetic iris implants. A systematic review of studies reporting postoperative outcomes of cosmetic iris implants identified 26 studies and 3 videos, comprising 128 eyes. In 88 (68.8%) of the eyes, the device required explantation due to complications. Secondary glaucoma occurred in 59 eyes, uveitis in 39 eyes, cataract in 22 eyes, and severe endothelial cell loss or corneal decompensation in 44 eyes. In 8 eyes, the final corrected distance visual acuity was counting fingers or worse. The review showed that cosmetic iris implants resulted in a substantial number of cases with severe complications. The finding strongly suggests that this cosmetic surgical technique should be avoided.
FINANCIAL DISCLOSURE
None of the authors has a financial or proprietary interest in any material or method mentioned.
Topics: Cosmetic Techniques; Device Removal; Glaucoma; Humans; Iris; Lens Implantation, Intraocular; Postoperative Complications; Prostheses and Implants; Retrospective Studies; Visual Acuity
PubMed: 27839608
DOI: 10.1016/j.jcrs.2016.08.013 -
Knee Surgery, Sports Traumatology,... Mar 2023Nitride-based ceramic coatings, such as titanium nitride (TiN) and titanium niobium nitride (TiNbN), have been introduced in total knee arthroplasty (TKA) to enhance the... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Nitride-based ceramic coatings, such as titanium nitride (TiN) and titanium niobium nitride (TiNbN), have been introduced in total knee arthroplasty (TKA) to enhance the mechanical properties and biocompatibility of knee components, harden the metal surface and reduce CoCrMo exposure and metal ion release. However, the theoretical advantages of these ceramic coatings in TKA have yet to be fully elucidated. This systematic review aimed to provide clinical evidence on mid-term outcomes of ceramic-coated knee prostheses in comparison with uncoated standard CoCrMo knee prostheses in primary TKA. The hypothesis was that ceramic-coated implants can be used in primary TKA with no inferior outcomes compared to uncoated CoCrMo implants.
METHODS
A systematic review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to find all clinical studies regarding primary TKA with ceramic-coated knee prostheses. MEDLINE (PubMed), Embase and Cochrane Library were searched from 1990 to October 2020 to identify relevant studies for the first qualitative analysis. Using PICOS eligibility criteria, a subgroup of the selected studies was used to perform a meta-analysis.
RESULTS
Fifteen studies were included in this systematic review, of which six were included in the meta-analysis: 3 randomized controlled trials, 2 retrospective comparative studies and 1 prospective cross-sectional study. Pooled data overall included 321 coated TKAs vs. 359 uncoated TKAs and a mean follow-up of 4.6 years (range, 2-10 years). No significant difference in the implant survival risk ratio with revision or reoperation due to any reason was found between coated and uncoated TKAs, even considering the RCT study subgroup with a risk ratio of 1.02 (P = 0.34). No significant differences were found for postoperative complications, clinical scores, or metal blood concentrations at 1 year.
CONCLUSION
The findings of this systematic review and meta-analysis support the statement that ceramic-coated TKAs are not inferior to uncoated TKAs, showing comparable survival rates, complication rates and clinical outcomes. There is strong evidence that ceramic-coated TKA does not improve the clinical results or survival rate in comparison with uncoated TKA.
LEVEL OF EVIDENCE
II, Therapeutic.
Topics: Humans; Arthroplasty, Replacement, Knee; Retrospective Studies; Prospective Studies; Cross-Sectional Studies; Knee Prosthesis; Ceramics; Treatment Outcome; Randomized Controlled Trials as Topic
PubMed: 34714355
DOI: 10.1007/s00167-021-06775-6 -
Journal of Prosthodontic Research Oct 2018This systematic review evaluates the clinical outcome of zirconia implant-associated survival and success rates, marginal bone loss, and implant-restoration complex... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
This systematic review evaluates the clinical outcome of zirconia implant-associated survival and success rates, marginal bone loss, and implant-restoration complex integrity.
STUDY SELECTION
Using the preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines, studies including ≥10 patients restored with zirconia implants supporting single crowns (SCs) or fixed dental prostheses (FDPs) prior to January 2017 were identified. Primary outcomes were survival rates and marginal bone loss around one and two-piece zirconia implants and the associated implant-restoration complex integrity.
RESULTS
1349 studies were selected; after duplicate removal and title screening, 36 remained for full-text screening. 17 studies met the inclusion criteria: 2 randomized controlled clinical studies, 11 prospective clinical studies and 4 retrospective studies. In total, 1704 implants from 1002 patients were evaluated, including 1521 one-piece and 183 two-piece zirconia implants with follow-up between 1 and 7 years. The mean survival rate was 95% (95% CI 91-97%). The overall mean marginal bone loss was 0.98mm (95% CI 0.79-1.18); the mean marginal bone loss after 1year was 0.89mm (95% CI 0.60-1.18). No meta-analysis regarding prosthetic outcomes was possible.
CONCLUSIONS
Survival and marginal bone loss values after one year for one-piece zirconia implants are acceptable, but long-term studies are required to support their clinical use. No particular restoration material can be recommended; this decision is apparently based on clinicians' preferences. Results from two-piece implants do not provide sufficient data to support their clinical use and no abutment or cementing materials for two-piece zirconia implants can be recommended.
Topics: Alveolar Bone Loss; Dental Implants; Dental Materials; Dental Restoration, Permanent; Humans; Prospective Studies; Prosthesis Failure; Prosthodontics; Retrospective Studies; Time Factors; Treatment Outcome; Zirconium
PubMed: 29983377
DOI: 10.1016/j.jpor.2018.04.007 -
The International Journal of Oral &... 2015To identify the influence of fixed prosthesis type on biologic and technical complication rates in the context of screw versus cement retention. Furthermore, a... (Review)
Review
PURPOSE
To identify the influence of fixed prosthesis type on biologic and technical complication rates in the context of screw versus cement retention. Furthermore, a multivariate analysis was conducted to determine which factors, when considered together, influence the complication and failure rates of fixed implant-supported prostheses.
MATERIALS AND METHODS
Electronic searches of MEDLINE (PubMed), EMBASE, and the Cochrane Library were conducted. Selected inclusion and exclusion criteria were used to limit the search. Data were analyzed statistically with simple and multivariate random-effects Poisson regressions.
RESULTS
Seventy-three articles qualified for inclusion in the study. Screw-retained prostheses showed a tendency toward and significantly more technical complications than cemented prostheses with single crowns and fixed partial prostheses, respectively. Resin chipping and ceramic veneer chipping had high mean event rates, at 10.04 and 8.95 per 100 years, respectively, for full-arch screwed prostheses. For "all fixed prostheses" (prosthesis type not reported or not known), significantly fewer biologic and technical complications were seen with screw retention. Multivariate analysis revealed a significantly greater incidence of technical complications with cemented prostheses. Full-arch prostheses, cantilevered prostheses, and "all fixed prostheses" had significantly higher complication rates than single crowns. A significantly greater incidence of technical and biologic complications was seen with cemented prostheses.
CONCLUSION
Screw-retained fixed partial prostheses demonstrated a significantly higher rate of technical complications and screw-retained full-arch prostheses demonstrated a notably high rate of veneer chipping. When "all fixed prostheses" were considered, significantly higher rates of technical and biologic complications were seen for cement-retained prostheses. Multivariate Poisson regression analysis failed to show a significant difference between screw- and cement-retained prostheses with respect to the incidence of failure but demonstrated a higher rate of technical and biologic complications for cement-retained prostheses. The incidence of technical complications was more dependent upon prosthesis and retention type than prosthesis or abutment material.
Topics: Bone Screws; Cementation; Dental Cements; Dental Prosthesis Design; Dental Prosthesis Retention; Dental Prosthesis, Implant-Supported; Dental Restoration Failure; Humans; Multivariate Analysis; Postoperative Complications; Prosthesis Retention; Regression Analysis
PubMed: 25615920
DOI: 10.11607/jomi.3607