Incidence and risk factors of in-hospital prosthesis-related complications following total shoulder arthroplasty.

BACKGROUND: The occurrence of prosthesis-related complications after total shoulder arthroplasty is devastating and costly. The purpose was to determine the incidence and risk of in-hospital prosthesis-related complications after total shoulder arthroplasty utilizing a large-scale sample database. METHODS: A retrospective database analysis was performed based on Nationwide Inpatient Sample from 2010 to 2014. Patients who underwent total shoulder arthroplasty were included. Patient demographics, hospital characteristics, length of stay, economic indicators, in-hospital mortality, comorbidities, and peri-operative complications were evaluated. RESULTS: A total of 34,198 cases were capture from the Nationwide Inpatient Sample database. There were 343 cases of in-hospital prosthesis-related complications after total shoulder arthroplasty and the overall incidence was 1%, with a more than 2.5-fold decrease from 2010 to 2014. Dislocation was the most common category among prosthesis-related complications (0.1%). The occurrence of in-hospital prosthesis-related complications was associated with significantly more total charges and slightly longer length of stay while less usage of Medicare. Risk factors of prosthesis-related complications were identified including younger age (<64 years), female, the native American, hospital in the South, alcohol abuse, depression, uncomplicated diabetes, diabetes with chronic complications, fluid and electrolyte disorders, metastatic cancer, neurological disorders, and renal failure. Interestingly, advanced age (≥65 years) and proprietary hospital were found as protective factors. Furthermore, prosthesis-related complications were associated with aseptic necrosis, rheumatoid arthritis, rotator cuff tear arthropathy, Parkinson's disease, prior shoulder arthroscopy, and blood transfusion. CONCLUSIONS: It is of benefit to study risk factors of prosthesis-related complications following total shoulder arthroplasty to ensure the appropriate management and optimize consequences although a relatively low incidence was identified.

Assessment of the Role and Timing of Glaucoma Surgery in Boston Keratoprosthesis Type 1 Patients.

PURPOSE: To determine the role and optimal timing of glaucoma surgery in relation to Boston keratoprosthesis type 1 (KPro) implantation. DESIGN: Retrospective, comparative, nonrandomized clinical study. METHODS: Single-center study of a total of 100 eyes (100 patients) implanted with a KPro between 2008 and 2017, and diagnosed with glaucoma before or after KPro. Patients were separated into 2 groups: those with preexisting glaucoma and those who developed de novo glaucoma after KPro. Groups were then divided based on whether patients were medically or surgically managed. Glaucoma surgery included glaucoma drainage device (GDD) implantation, trabeculectomy, and cyclophotocoagulation (CPC). Primary outcomes included best-corrected visual acuity (BCVA), glaucoma progression, and complications. Differences in outcomes were compared using parametric and nonparametric tests, as well as log-rank test to compare time-to-outcome events. RESULTS: Among 72 eyes with preexisting glaucoma, 27 (38%) had glaucoma surgery before KPro (18 GDD), whereas 45 (62%) were medically managed only. Among the latter, 19 (42%) needed glaucoma surgery post-KPro (16 GDD). Among 28 eyes with de novo glaucoma, 12 (43%) had glaucoma surgery post-KPro (9 GDD). For eyes with preexisting glaucoma, glaucoma progression was greater with glaucoma surgery performed post-KPro (100%) compared with pre-KPro (74%, P = .016) and to medical management (54%, P = .002). No increase in complications were observed with glaucoma surgery compared to medications only (P > .05), whereas fewer eyes maintained a BCVA of 20/200 or better over time with medical management (P = .013). Eyes with de novo glaucoma had similar progression, BCVA, and complications between medical and surgical care (P > .05). CONCLUSIONS: Glaucoma surgery should be performed before or at the same time as KPro implantation in eyes with preexisting glaucoma. Complication rates are not increased when glaucoma surgery is performed in KPro eyes with either preexisting or de novo glaucoma. To ensure optimal glaucoma control, glaucoma surgery should be performed as early as possible in KPro eyes with good visual potential.

Use of Nasal Implants and Dorsal Modification When Treating the East Asian Nose.

Dorsal augmentation and tip surgery are essential procedures for East Asians seeking rhinoplasty, because they generally have thicker skin and poorly developed nasal dorsum and tip. For dorsal augmentation, many Asian surgeons prefer using alloplastic material, like silicone, Gore-Tex, and filler injection, for cost-effectiveness, easy handling, and short operation times. Compared with autologous implant materials, the use of synthetic implant is suggested to be associated with many complications, such as infection, extrusion, and deviation. However, even with the use of the autologous material, problems such as reabsorption after grafting, donor site complications can take place.

First assessment of the performance of an implantable continuous glucose monitoring system through 180 days in a primarily adolescent population with type 1 diabetes.

AIM: To investigate the performance of the Eversense XL implantable continuous glucose monitoring (CGM) system through 180 days in a primarily adolescent population with type 1 diabetes (T1D). MATERIALS AND METHODS: This prospective, single-centre, single-arm, 180-day study evaluated the effectiveness and safety of the implantable CGM system in Canadian adolescent and adult subjects with T1D. Accuracy measures included mean absolute relative difference (MARD), 15/15% agreement between CGM glucose and blood glucose measured by Yellow Springs Instruments and surveillance error grid analysis. Adolescent subjects received one sensor in the upper arm and adult subjects received one sensor in each upper arm. In-clinic CGM system accuracy studies were performed every 30 days. The safety assessment included the incidence of adverse events related to either device or the insertion/removal procedure through 180 days. RESULTS: Thirty-six subjects (30 adolescent/6 adult, 13 female/23 male, mean age 17 ± 9.2 years, mean body mass index 22 ± 4 kg/m2 ) received the CGM system. Overall MARD was 9.4% (95% CI: 8.6%-10.5%). CGM system agreement at 15/15% (N = 7163) through 60, 120 and 180 days was 82.9% (95% CI: 78.4%-86.1%), 83.6% (95% CI: 80.4%-85.7%) and 83.4% (95% CI: 79.7%-85.5%), respectively. Surveillance error grid analysis showed 98.4% of paired values in clinically acceptable error zones A and B. No insertion/removal or device-related serious adverse events were reported. CONCLUSION: The Eversense XL CGM system is safe and accurate through 180 days in a primarily adolescent population of subjects with T1D.

The changing regulatory landscape for biomedical implants and its relationship to withdrawal of some vaginal mesh products.

PURPOSE OF REVIEW: Advancements in biomedical engineering and advanced therapies including tissue engineering products necessitate revisions to the regulation and governance of their production and use to ensure patient safety. In this review, the current regulations and recent improvements on the governance of biomedical devices are reviewed. RECENT FINDINGS: Current regulations on approval of biomedical devices failed to address some important aspects related to the definition of biocompatibility of medical implants. The main issue was that the failure to establish design requirements for a specific application - in this case, the pelvic floor. Another issue was the lack of knowledge on disease mechanisms leading to an inability to define clear targets for surgical treatment. A clear example of this is the recent vaginal mesh scandal. SUMMARY: Surgical innovations are inherently challenging. It is no surprise that the regulatory landscape lags behind advancements in biomedical technologies. Very recent modifications to the available regulations particularly in Europe aim to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices, which ensures patient safety while supporting innovation.

Avoiding MRI-Related Accidents: A Practical Approach to Implementing MR Safety.

MRI is a ubiquitous medical imaging technology typically using superconductivity to generate a strong, homogeneous, and generally ceaseless magnetic field. MRI and its magnetic field pose many safety hazards, including magnetic forces on metals, tissue heating and burns, nerve stimulation, bioeffects, acoustic noise, and contrast agent complications. The primary concern is that a wide variety of patients, staff members, technologists, and physicians can approach the incessant magnetic field, creating great potential for accidents that could occur if metals from the environment, adornments, implants, and other unintended sources are also present in or near the field. Many accidents have occurred and are occasionally reported in the United States and countries all over the world. Through carefully structured oversight and the establishment of strict guidelines regarding access, responsibilities, and training, these risks can be mitigated, and accidents can be prevented. Fortunately, there is currently a wide variety of resources available to facilitate the successful implementation of an effective MRI safety program. This article presents a general overview of and the authors' experience with an MRI safety program in terms of risk management and training. The MR safety program requirements and regulations in the United States devised by The Joint Commission and the ACR are also discussed. With these resources and a carefully selected team, the risk for MRI-related accidents can be vastly reduced if not completely eliminated.

Paraprosthetic Complications After Endoprosthesis Replacement of Pelvis Joint with Implants.

PURPOSE: The purpose of the paper is shaping of ideas about possible ways of decreasing complications of the analyzed types of operations and identification of opportunities of the impact on the socio-economic environment among the Afro-American population of USA. The paper demonstrates that the issue of coxofemoral prosthesis is not only a purely medical but also a social problem. In particular, availability of timely aid, as well as insurance in the form of surgery, refer to relevance of the range of problems. METHODOLOGY: The experimental method was used in the study. Patients were implanted different types of endoprostheses. 90 patients were implanted customized endoprostheses, 27 patients were implanted foreign module endoprostheses. The research subject is prediction of complications after endoprosthesis replacement surgeries depending on methods, types and forms. RESULTS: As a result, we can see that available health insurance is more acceptable understanding of the need for endoprosthesis replacement. Post-operative care issues fall into the range of social policy problems. A comparative aspect of a country with general insurance and differentiated coverage among the Afro-America population appears innovative. CONCLUSIONS: In the context of the current situation it can be concluded that surgery is the last stage for already established support system of the population. For this reason, it's worth mentioning that state bodies of the U.S. should put a greater emphasis on the health care of the Afro-American population.

Assessment of Glaucomatous Damage After Boston Keratoprosthesis Implantation Based on Digital Planimetric Quantification of Visual Fields and Optic Nerve Head Imaging.

PURPOSE: To investigate glaucomatous damage in Boston keratoprosthesis type I (KPro) patients through structural analysis of the optic nerve head and digital planimetric quantification of Goldmann visual fields, a novel method of monitoring perimetric changes in KPro patients. METHODS: Records of patients undergoing KPro implantation from 2007 to 2015 at a single institution were reviewed. Parameters related to glaucoma status and KPro outcomes were analyzed. RESULTS: Twenty-two eyes from 21 patients met inclusion criteria, with mean follow-up of 49.4 months (range 15-90). Mean results for the following parameters before KPro implantation and at last follow-up were (pre-KPro; at last follow-up): best-corrected visual acuity (2.07; 0.70 logMAR), number of glaucoma medications (1.14; 1.05), intraocular pressure (IOP) (18.4; 18.4 mm Hg), vertical cup-to-disc ratio (C/D) (0.48; 0.50), and horizontal C/D (0.52; 0.52). IOP-lowering procedures were performed pre-KPro (5/22), concurrently with KPro (10/22), post-KPro (6/22), or never (6/22). An increase in C/D ≥0.1 and loss of V4e isopter area >30% occurred in 22.7% and 12.5%, respectively. Development of post-KPro glaucoma, progression of preexisting or post-KPro glaucoma, and no glaucoma development as evidenced by an objective assessment of structural and functional parameters were seen in 2/22 (9.1%), 7/22 (31.8%), and 6/22 (27.3%) eyes, respectively. CONCLUSIONS: Clinicians should strive to vigilantly monitor for glaucoma despite the inherent difficulties in tonometry, optic nerve visualization and imaging, and visual field testing in KPro patients. Meticulous glaucoma surveillance with structural and functional testing combined with earlier IOP-lowering surgical intervention may result in decreased rates of glaucomatous vision loss in KPro patients.

Impact of left atrial appendage morphology on thrombus formation after successful left atrial appendage occlusion: Assessment with cardiac-computed-tomography.

A standardized imaging algorithm by cardiac computed tomography angiography (cCTA) (LOVE-view) was used in 30 patients to evaluate the influence of different left atrial appendage (LAA) morphologies on development of thrombosis in the LAA 6 months after implantation of an occlusion device (Watchman or Amplatzer-Cardiac-Plug) in patients with non-valvular atrial fibrillation, CHA2DS2-VASc-Score >1 and a contraindication for oral anticoagulation. The distribution of different LAA morphologies was 40% windsock, 17% broccoli and 43% chicken wing type. There was no significant difference in the level of thrombosis regarding LAA morphology or the type of chosen occlusion device. The rates of complete LAA thrombosis was 40% in broccoli type, 33% in windsock and 15% in chicken wing type. Independently of LAA type, 13% had none and 60% incomplete thrombosis. The ratio of density (LA/LAA) was 0.14 in patients with complete thrombosis and 0.67 in those with none or incomplete thrombosis. cCTA and the LOVE-view-imaging-algorithm were shown to be a valuable method for standardized imaging in clinical routine in a greater set of patients. Surprisingly thrombosis of the occluded LAA was still in progress in most cases at 6 months, whereas further studies are needed defining its clinical consequences, especially for the selection of the optimal post-procedural antithrombotic treatment strategy.

Assessment of corrosion in retrieved spine implants.

Recently the use of dissimilar metals in spine instrumentation has increased, especially in the case of adult deformities, where rods made from Cobalt Chrome alloys (CoCr) are used with Titanium (Ti) screws. The use of dissimilar metals increases the risk of galvanic corrosion and patients have required revision spine surgery due to severe metallosis that may have been caused by corrosion. We aimed to assess the presence of corrosion in spine implant retrievals from constructs with two types of material combinations: similar (Ti/Ti) and dissimilar (CoCr/Ti). First, we devised a grading score for corrosion of the rod-fixture junctions. Then, we applied this score to a collection of retrieved spine implants. Our proposed corrosion grading score was proven reliable (kappa > 0.7). We found no significant difference in the scores between 4 CoCr and 11 Ti rods (p = 0.0642). There was no indication that time of implantation had an effect on the corrosion score (p = 0.9361). We recommend surgeons avoid using implants designs with dissimilar metals to reduce the risk of corrosion whilst a larger scale study of retrieved spine implants is conducted. Future studies can now use our scoring system for spine implant corrosion. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 632-638, 2018.

Functional outcome and economic burden of operative management of patellar fractures: the pivotal role of onerous implants.

OBJECTIVES: The complication rate following operative treatment of patellar fractures remains high and is associated with a poor functional outcome. The primary goal of this study was to evaluate our functional outcome of patellar fracture osteosynthesis and define strategies to improve the outcome. The healthcare costs and utilization were calculated. METHODS: All demographic, clinical, radiographic variables and hospital-related costs of 111 patients with 113 surgically treated patellar fractures between January 2005 and December 2014 were analyzed. Fractures were grouped as either simple or complex. Functional outcome was assessed using Knee Injury and Osteoarthritis Outcome Score (KOOS). RESULTS: There were 67 simple fractures (59.3%) and 46 complex fractures (40.7%). The overall complication rate was 48.7%, including 19.5% implant-related complications. In 69 patients (61.1%), implants were removed. The outcome was rather poor, with considerable impairment in all KOOS subscales with the knee-related quality of life rated worst (median 62.5, IQR 37.5-81.25). Poor outcome correlated significantly with complex patellar fractures and extensive tension-band constructs. CONCLUSIONS: The operative treatment of patellar fractures was associated with a high complication rate, functional impairment and reduced quality of life. Complex patellar fractures and extensive tension-band constructs were identified as the main determinants of poor outcome and increased economic burden due to higher reinterventions rates. Strategies to reduce complications and improve outcome should focus on less onerous implants.

Assessment of degradation and biocompatibility of electrodeposited chitosan and chitosan-carbon nanotube tubular implants.

Designing three-dimensional tubular materials made of chitosan is still a challenging task. Availability of such forms is highly desired by tissue engineering, especially peripheral nerve tissue engineering. Aiming at this problem, we use an electrodeposition phenomenon in order to obtain chitosan and chitosan-carbon nanotube hydrogel tubular implants. The in vitro biocompatibility of the fabricated structures is assessed using a mouse hippocampal cell line (mHippoE-18). As both implants do not induce significant cytotoxicity, they are next subjected to in vitro degradation studies in the environment simulating in vivo conditions for specified periods of time: 7, 14, and 28 days. The mass loss of implants indicates their stability at the tested time period; therefore, the materials are subcutaneously implanted in Sprague Dawley rats. The explants are collected after 7, 14, and 28 days. The assessment of composition and changes in tissues surrounding the implanted materials is made in respect to surrounding tissue thickness as well as the number of blood vessels, macrophages, lymphocytes, and neutrophils. No symptoms of acute inflammation are noticed at any point in time. The observed regular healing process allows concluding that both chitosan and chitosan-carbon hydrogel tubular implants are biocompatible with high application potential in tissue engineering. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 104A: 2701-2711, 2016.

In Vivo Assessment of Phage and Linezolid Based Implant Coatings for Treatment of Methicillin Resistant S. aureus (MRSA) Mediated Orthopaedic Device Related Infections.

Staphylococcus comprises up to two-thirds of all pathogens in orthopaedic implant infections with two species respectively Staphylococcus aureus and Staphylococcus epidermidis, being the predominate etiological agents isolated. Further, with the emergence of methicillin-resistant S. aureus (MRSA), treatment of S. aureus implant infections has become more difficult, thus representing a devastating complication. Use of local delivery system consisting of S.aureus specific phage along with linezolid (incorporated in biopolymer) allowing gradual release of the two agents at the implant site represents a new, still unexplored treatment option (against orthopaedic implant infections) that has been studied in an animal model of prosthetic joint infection. Naked wire, hydroxypropyl methylcellulose (HPMC) coated wire and phage and /or linezolid coated K-wire were surgically implanted into the intra-medullary canal of mouse femur bone of respective groups followed by inoculation of S.aureus ATCC 43300(MRSA). Mice implanted with K-wire coated with both the agents i.e phage as well as linezolid (dual coated wires) showed maximum reduction in bacterial adherence, associated inflammation of the joint as well as faster resumption of locomotion and motor function of the limb. Also, all the coating treatments showed no emergence of resistant mutants. Use of dual coated implants incorporating lytic phage (capable of self-multiplication) as well as linezolid presents an attractive and aggressive early approach in preventing as well as treating implant associated infections caused by methicillin resistant S. aureus strains as assessed in a murine model of experimental joint infection.

A UK medical devices regulator's perspective on registries.

Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer's individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator - the Medicines and Healthcare Products Regulatory Agency (MHRA) - of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.

Why Good Healing Is A Good Business.

Wound infections can dramatically lengthen treatment times and cost the NHS large sums of money, which is why funding for preventative measures is so important, writes Claire Read.