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Endobronchial Valve Therapy in Patients with Homogeneous Emphysema: Results from the IMPACT Study
Abstract
Rationale
Endobronchial valves (EBVs) have been successfully used in patients with severe heterogeneous emphysema to improve lung physiology. Limited available data suggest that EBVs are also effective in homogeneous emphysema.
Objectives
To evaluate the efficacy and safety of EBVs in patients with homogeneous emphysema with absence of collateral ventilation assessed with the Chartis system.
Methods
Prospective, multicenter, 1:1 randomized controlled trial of EBV plus standard of care (SoC) or SoC alone. Primary outcome was the percentage change in FEV1 (liters) at 3 months relative to baseline in the EBV group versus the SoC group. Secondary outcomes included changes in FEV1, St. George’s Respiratory Questionnaire (SGRQ), 6-minute-walk distance (6MWD), and target lobe volume reduction.
Measurements and Main Results
Ninety-three subjects (age, 63.7 ± 6.1 yr [mean ± SD]; FEV1, % predicted, 29.3 ± 6.5; residual volume, % predicted, 275.4 ± 59.4) were allocated to either the EBV group (n = 43) or the SoC group (n = 50). In the intention-to-treat population, at 3 months postprocedure, improvement in FEV1 from baseline was 13.7 ± 28.2% in the EBV group and −3.2 ± 13.0% in the SoC group (mean between-group difference, 17.0%; P = 0.0002). Other variables demonstrated statistically and clinically significant changes from baseline to 3 months (EBV vs. SoC, respectively: SGRQ, −8.63 ± 11.25 vs. 1.01 ± 9.36; and 6MWD, 22.63 ± 66.63 m vs. −17.34 ± 52.8 m). Target lobe volume reduction at 3 months was −1,195 ± 683 ml (P < 0.0001). Of the EBV subjects, 97.2% achieved volume reduction in the target lobe (P < 0.0001). Procedure-related pneumothoraces occurred in 11 subjects (25.6%). Five subjects required removal/replacement of one or more valves. One subject experienced two valve migration events requiring removal/replacement of valves.
Conclusions
EBV in patients with homogeneous emphysema without collateral ventilation results in clinically meaningful benefits of improved lung function, exercise tolerance, and quality of life.
Journal Article
Phantom limbs and body integrity identity disorder : literary and psychoanalytic reflections
\"Phantom Limbs and Body Integrity Identity Disorder discusses the conditions of Phantom Limb Syndrome and Body Integrity Identity Disorder together for the first time, exploring examples from literature, film, and psychoanalysis to re-ground theories of the body in material experience\"-- Provided by publisher.
Book
Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial
In patients with non-valvular atrial fibrillation, embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. We assessed the efficacy and safety of percutaneous closure of the LAA for prevention of stroke compared with warfarin treatment in patients with atrial fibrillation.
Adult patients with non-valvular atrial fibrillation were eligible for inclusion in this multicentre, randomised non-inferiority trial if they had at least one of the following: previous stroke or transient ischaemic attack, congestive heart failure, diabetes, hypertension, or were 75 years or older. 707 eligible patients were randomly assigned in a 2:1 ratio by computer-generated randomisation sequence to percutaneous closure of the LAA and subsequent discontinuation of warfarin (intervention; n=463) or to warfarin treatment with a target international normalised ratio between 2·0 and 3·0 (control; n=244). Efficacy was assessed by a primary composite endpoint of stroke, cardiovascular death, and systemic embolism. We selected a one-sided probability criterion of non-inferiority for the intervention of at least 97·5%, by use of a two-fold non-inferiority margin. Serious adverse events that constituted the primary endpoint for safety included major bleeding, pericardial effusion, and device embolisation. Analysis was by intention to treat. This study is registered with
Clinicaltrials.gov, number
NCT00129545.
At 1065 patient-years of follow-up, the primary efficacy event rate was 3·0 per 100 patient-years (95% credible interval [CrI] 1·9–4·5) in the intervention group and 4·9 per 100 patient-years (2·8–7·1) in the control group (rate ratio [RR] 0·62, 95% CrI 0·35–1·25). The probability of non-inferiority of the intervention was more than 99·9%. Primary safety events were more frequent in the intervention group than in the control group (7·4 per 100 patient-years, 95% CrI 5·5–9·7,
vs 4·4 per 100 patient-years, 95% CrI 2·5–6·7; RR 1·69, 1·01–3·19).
The efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. Although there was a higher rate of adverse safety events in the intervention group than in the control group, events in the intervention group were mainly a result of periprocedural complications. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with non-valvular atrial fibrillation.
Atritech.
Journal Article
Replaceable you : adventures in human anatomy
\"The body is the most complex machine in the world, and the only one for which you cannot get a replacement part from the manufacturer. For centuries, medicine has reached for what's available--sculpting noses from brass, borrowing skin from frogs and hearts from pigs, crafting eye parts from jet canopies and breasts from petroleum by-products. Today we're attempting to grow body parts from scratch using stem cells and 3D printers. How are we doing? Are we there yet? In Replaceable You, Mary Roach explores the remarkable advances and difficult questions prompted by the human body's failings. When and how does a person decide they'd be better off with a prosthetic than their existing limb? Can a donated heart be made to beat forever? Can an intestine provide a workable substitute for a vagina? Roach dives in with her characteristic verve and infectious wit. Her travels take her to the OR at a legendary burn unit in Boston, a \"superclean\" xeno-pigsty in China, and a stem cell \"hair nursery\" in the San Diego tech hub. She talks with researchers and surgeons, amputees and ostomates, printers of kidneys and designers of wearable organs. She spends time in a working iron lung from the 1950s, stays up all night with recovery techs as they disassemble and reassemble a tissue donor, and travels across Mongolia with the cataract surgeons of Orbis International. Irrepressible and accessible, Replaceable You immerses readers in the wondrous, improbable, and surreal quest to build a new you\"-- Dust jacket flap.
BOOK
What are the essential features of a successful surgical registry? a systematic review
ObjectiveThe regulation of surgical implants is vital to patient safety, and there is an international drive to establish registries for all implants. Hearing loss is an area of unmet need, and industry is targeting this field with a growing range of surgically implanted hearing devices. Currently, there is no comprehensive UK registry capturing data on these devices; in its absence, it is difficult to monitor safety, practices and effectiveness. A solution is developing a national registry of all auditory implants. However, developing and maintaining a registry faces considerable challenges. In this systematic review, we aimed to identify the essential features of a successful surgical registry.MethodsA systematic literature review was performed adhering to Preferred Reporting Items for Systematic Review and Meta-Analysis recommendations. A comprehensive search of the Medline and Embase databases was conducted in November 2016 using the Ovid Portal. Inclusion criteria were: publications describing the design, development, critical analysis or current status of a national surgical registry. All registry names identified in the screening process were noted and searched in the grey literature. Available national registry reports were reviewed from registry websites. Data were extracted using a data extraction table developed by thematic analysis. Extracted data were synthesised into a structured narrative.ResultsSixty-nine publications were included. The fundamentals to successful registry development include: steering committee to lead and oversee the registry; clear registry objectives; planning for initial and long-term funding; strategic national collaborations among key stakeholders; dedicated registry management team; consensus meetings to agree registry dataset; established data processing systems; anticipating challenges; and implementing strategies to increase data completion. Patient involvement and awareness of legal factors should occur throughout the development process.ConclusionsThis systematic review provides robust knowledge that can be used to inform the successful development of any UK surgical registry. It also provides a methodological framework for international surgical registry development.
Journal Article
A Long-Term Follow-Up Investigation of Endobronchial Valves in Emphysema (the LIVE Study): Study Protocol and Six-Month Interim Analysis Results of a Prospective Five-Year Observational Study
Background: Randomized controlled trials indicate that significant lung volume reduction (ELVR) can be obtained with Zephyr® valves by occluding the target lobe in the absence of collateral ventilation, leading to relevant functional benefits in advanced emphysema patients. Objectives: To observe the long-term effects of endobronchial valve (EBV) implantation in emphysema patients screened by Chartis assessment in the context of daily pulmonology practice. Methods: The LIVE Study is a prospective, observational, open-label, single-arm, multicenter trial conducted in Germany. 498 patients included in this interim analysis were enrolled between July 2, 2012, and September 16, 2014. The 6-month follow-up visit data were recorded for 343 patients (safety population), and complete data sets were available for 321 treated patients (efficacy population) - 56.4% male, age: 64.5 years, forced expiratory volume in 1 s (FEV 1 ) % predicted: 31.3%, residual volume (RV) % predicted: 252%. Results: Efficacy results at 6 months: FEV 1 (l) increased by +100 ml (+11.9%), RV (l) decreased by -0.42 liter, and the COPD Assessment Test score decreased by -3.14 points (each p < 0.0001). Safety outcomes: A total of 66 adverse events (AEs; with 50 serious AEs - SAEs) were reported in 55 patients (16%) during the hospital stay for EBV placement - pneumothorax (35 cases), chronic obstructive pulmonary disease (COPD) exacerbation (5 cases), and pneumonia (4 cases). During the subsequent 6-month follow-up window, 170 SAEs were recorded in 125 patients (36.4%), predominantly COPD exacerbation (53% of the SAEs). Conclusion: The current results of this large-scale German observational study performed in the context of daily practice further demonstrates that ELVR with Zephyr® valves is an effective and well-tolerated treatment option in advanced emphysema.
Journal Article
The impact of implantation site on procedure success in patients with unresolved facial palsy treated with upper-eyelid gold weight loading
Loading of the upper eyelid is a well-established procedure for the correction of incomplete eyelid closure due to unresolved facial palsy. Some incurable complications are attributed to type IV hypersensivity reaction, but there is no confirmation of this hypothesis. The aim of the study was to show the impact of gold weights on eyelid tissues depending on the implantation site. Out of 94 total patients (aged 53 ± 17 years) treated from July 2009–2021, since 2014 thirty consecutive patients were randomised into one of 3 groups: the GLE group (gold weight fixed 2 mm above the eyelash line), the GUE group (gold weight fixed at the border of the tarsus and the levator aponeurosis), and the PUE group (platinum chain fixed in the same way as in the GUE group). In the cases of complications, the explanted weights were evaluated histopathologically. The outcomes were compared between groups. Incomplete eyelid closure was corrected in all patients. Serious complications were noted in 100% of patients in the GLE group and 20% in the GUE group (p < 0.0001). A slight lymphocytic reaction was observed in the GUE group. A moderate to significant lymphocytic reaction was observed in the GLE group (p < 0.001). Adverse reactions of the upper eyelid microenvironment resulting from gold weights seem to be dependent on mechanical damage to the eyelid structures, rather than on implants themselves. The site of placement of the weight in the upper eyelid may be critical for procedure success.
Journal Article
Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (The BeLieVeR-HIFi trial): study design and rationale
Although lung volume reduction surgery improves survival in selected patients with emphysema, there has been ongoing interest in developing and evaluating bronchoscopic approaches to try to reduce lung volumes with less morbidity and mortality. The placement of endobronchial valves is one such technique, and although some patients have had a significant improvement, responses have been inconsistent because collateral ventilation prevents lobar atelectasis. We describe the protocol of a trial (ISRCTN04761234) aimed to show that a responder phenotype, patients with heterogeneous emphysema and intact interlobar fissures on CT scanning, can be identified prospectively, leading to a consistent benefit in clinical practice.
Journal Article
Silver-coated megaprostheses in the proximal femur in patients with sarcoma
BackgroundProximal femur replacements in patients with sarcoma are associated with high rates of infection. This study is the largest one comparing infection rates with titanium versus silver-coated megaprostheses in sarcoma patients.MethodsInfection rates were assessed in 99 patients with proximal femur sarcoma who underwent placement of a titanium (n = 35) or silver-coated (n = 64) megaprosthesis. Treatments administered for infection were also analyzed.ResultsInfections occurred in 14.3% of patients in the titanium group, in comparison with 9.4% of those in the silver group, when the development of infection was the primary end point. The 5- and 10-year event-free survival rates for the prosthesis relative to the parameter of infection were 90% in the silver group and 83% in the titanium group. The overall infection rates were 10.9% in the silver group and 20% in the titanium group. Two patients each in the silver and titanium groups ultimately had to undergo amputation. The need for two-stage prosthesis exchanges (57.1% in the titanium group) declined to 14.3% in the silver group.ConclusionUsing a silver-coated proximal femoral replacement nearly halved the overall infection rate. When infections occurred, it was usually possible to avoid two-stage prosthesis exchanges in the silver group.
Journal Article