Medical Devices-Evidence and Research最新文献

{"title":"Everolimus-eluting stents: update on current clinical studies.","authors":"Dominic J Allocco, Anita A Joshi, Keith D Dawkins","doi":"10.2147/MDER.S22043","DOIUrl":"10.2147/MDER.S22043","url":null,"abstract":"<p><p>Everolimus-eluting stents (EES) have become the most commonly implanted coronary stents worldwide. This review describes and analyzes the clinical data supporting the use of EES, focusing primarily on published, randomized, controlled trials. Everolimus-eluting stents have been shown to have less restenosis, stent thrombosis, and periprocedural myocardial infarction compared with earlier generation paclitaxel-eluting stents (PES). Lower rates of adverse events for EES compared with PES were generally seen in all subgroups, with the notable exception of patients with diabetes mellitus. There have been fewer, randomized, clinical trials comparing EES with either sirolimus-eluting stents or zotarolimus-eluting stents, although very good results with EES have been observed in the trials that have been performed. Recent clinical trial data suggest that this excellent safety and efficacy profile is maintained in a next-generation EES designed to have improved mechanical properties and radiopacity.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"91-8"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3417879/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term effectiveness and safety of sirolimus drug-eluting stents.","authors":"Mahesh Bikkina,&nbsp;Jayanth Koneru","doi":"10.2147/MDER.S11749","DOIUrl":"https://doi.org/10.2147/MDER.S11749","url":null,"abstract":"<p><p>The root cause of coronary artery disease is atherosclerosis, ie, intraluminal narrowing (stenosis) of the arteries that supply blood to tissues of the heart. The introduction of the drug-eluting stent over the past decade has revolutionized the field of interventional cardiology. It is used extensively in clinical practice for the treatment of coronary artery disease. The first drug-eluting stent to receive US Food and Drug Administration approval was the sirolimus-eluting stent. Recently, two other stent analogs of sirolimus were approved, ie, the zotarolimus-eluting stent and the everolimus-eluting stent. However, concern has arisen in recent years about the long-term safety and efficacy of drug-eluting stents, due to the occurrence of late adverse clinical events, such as stent thrombosis. This review focuses on clinical studies that have been performed with the sirolimus-eluting stent or its analogs. We discuss the pharmacology, safety, and various therapeutic options that exist when choosing stents for coronary artery disease. Our aim is to provide a thorough review of the long-term efficacy and safety of sirolimus drug-eluting stents, and also to discuss currently approved and promising investigational drug-eluting stents, in an effort to provide insight into how these stents are currently evolving and generate further investigation in this area.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"117-24"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S11749","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Heart detection and diagnosis based on ECG and EPCG relationships.","authors":"W Phanphaisarn,&nbsp;A Roeksabutr,&nbsp;P Wardkein,&nbsp;J Koseeyaporn,&nbsp;Pp Yupapin","doi":"10.2147/MDER.S23324","DOIUrl":"https://doi.org/10.2147/MDER.S23324","url":null,"abstract":"<p><p>A new design of a system for preliminary detection of defective hearts is proposed which is composed of two subsystems, in which one is based on the relationship between the electrocardiogram (ECG) and phonocardiogram (PCG) signals. The relationship between both signals is determined as an impulse response (h(n)) of a system, where the decision is made based on the linear predictive coding coefficients of a heart's impulse response. The other subsystem uses a phase space approach, in which the mean squared error between the distance vectors of the phase space of the normal heart and abnormal heart is judged by the likelihood ratio test (Λ) value, on which the decision is made. The advantage of the proposed system is that a heart's diagnosis system based on the ECG and EPCG signals can lead to high performance heart diagnostics.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"133-44"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S23324","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Critical appraisal of cardiac implantable electronic devices: complications and management.","authors":"Luigi Padeletti,&nbsp;Giosuè Mascioli,&nbsp;Alessandro Paoletti Perini,&nbsp;Gino Grifoni,&nbsp;Laura Perrotta,&nbsp;Procolo Marchese,&nbsp;Luca Bontempi,&nbsp;Antonio Curnis","doi":"10.2147/MDER.S15059","DOIUrl":"https://doi.org/10.2147/MDER.S15059","url":null,"abstract":"<p><p>Population aging and broader indications for the implant of cardiac implantable electronic devices (CIEDs) are the main reasons for the continuous increase in the use of pacemakers (PMs), implantable cardioverter-defibrillators (ICDs) and devices for cardiac resynchronization therapy (CRT-P, CRT-D). The growing burden of comorbidities in CIED patients, the greater complexity of the devices, and the increased duration of procedures have led to an augmented risk of infections, which is out of proportion to the increase in implantation rate. CIED infections are an ominous condition, which often implies the necessity of hospitalization and carries an augmented risk of in-hospital death. Their clinical presentation may be either at pocket or at endocardial level, but they can also manifest themselves with lone bacteremia. The management of these infections requires the complete removal of the device and subsequent, specific, antibiotic therapy. CIED failures are monitored by competent public authorities, that require physicians to alert them to any failures, and that suggest the opportune strategies for their management. Although the replacement of all potentially affected devices is often suggested, common practice indicates the replacement of only a minority of devices, as close follow-up of the patients involved may be a safer strategy. Implantation of a PM or an ICD may cause problems in the patients' psychosocial adaptation and quality of life, and may contribute to the development of affective disorders. Clinicians are usually unaware of the psychosocial impact of implanted PMs and ICDs. The main difference between PM and ICD patients is the latter's dramatic experience of receiving a shock. Technological improvements and new clinical evidences may help reduce the total burden of shocks. A specific supporting team, providing psychosocial help, may contribute to improving patient quality of life.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"157-67"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S15059","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Updates on the use of ureteral stents: focus on the Resonance(®) stent.","authors":"Manoj V Rao,&nbsp;Anthony J Polcari,&nbsp;Thomas Mt Turk","doi":"10.2147/MDER.S11744","DOIUrl":"https://doi.org/10.2147/MDER.S11744","url":null,"abstract":"<p><p>The Resonance(®) metallic ureteral stent is one of the latest additions to the urologist's armamentarium in managing ureteral obstruction. One advantage of this stent over traditional polymer-based stents is resistance to encrustation with stone material, which allows longer dwell times and less frequent exchange procedures. Although exchanging a metallic stent is slightly more complicated than exchanging a polymer stent, the fluoroscopic techniques required are familiar to most urologists. The Resonance stent is also more resistant to compression by external forces, potentially allowing greater applicability in patients with metastatic cancer. Furthermore, the use of this stent in patients with benign ureteral obstruction is shown to be associated with significant cost reduction. Clinical studies on the use of this stent are accumulating and the results are mixed, although Level 1 evidence is lacking. In this article we present a comprehensive review of the available literature on the Resonance metallic ureteral stent.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"11-5"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S11744","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Deep sedation for endoscopic retrograde cholangiopancreatography: a comparison between clinical assessment and Narcotrend(TM) monitoring.","authors":"Somchai Amornyotin, Wiyada Chalayonnawin, Siriporn Kongphlay","doi":"10.2147/MDER.S17236","DOIUrl":"10.2147/MDER.S17236","url":null,"abstract":"<p><strong>Introduction: </strong>Moderate to deep sedation is generally used for endoscopic retrograde cholangiopancreatography (ERCP). The depth of sedation is usually judged by clinical assessment and electroencephalography-guided monitoring. The aim of this study was to compare the clinical efficacy of clinical assessment and Narcotrend(TM) monitoring during deep-sedated ERCP.</p><p><strong>Methods: </strong>One hundred patients who underwent ERCP in a single year were randomly assigned to either group C or group N. Patients in group C (52) were sedated using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. Patients in group N (48) were sedated using the Narcotrend(TM) system. The MOAA/S scale 1 or 2 and the Narcotrend(TM) index 47-56 to 57-64 were maintained during the procedure. The primary outcome variable of the study was the successful completion of the endoscopic procedure. The secondary outcome variables were the total dose of propofol used during the procedure, complications during and immediately after procedure, and recovery time.</p><p><strong>Results: </strong>All endoscopies were completed successfully. The mean total dose of propofol in group C was significantly lower than that in group N. However, the mean dose of propofol, expressed as dose/kg or dose/kg/h in both groups, was not significantly different (P = 0.497, 0.136). Recovery time, patient tolerance and satisfaction, and endoscopist satisfaction were comparable between the two groups. All sedation-related adverse events during and immediately after the procedure, such as hypotension, hypertension, tachycardia, bradycardia, transient hypoxia, and upper airway obstruction, in group C (62.2%) were significantly higher than in group N (37.5%) (P = 0.028).</p><p><strong>Conclusion: </strong>Clinical assessment and Narcotrend(TM)-guided sedation using propofol for deep sedation demonstrated comparable propofol dose and recovery time. Both monitoring systems were equally safe and effective. However, the Narcotrend(TM)-guided sedation showed lower hemodynamic changes and fewer complications compared with the clinical assessment-guided sedation.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"43-9"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3417873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"AxiaLIF system: minimally invasive device for presacral lumbar interbody spinal fusion.","authors":"Steven M Rapp,&nbsp;Larry E Miller,&nbsp;Jon E Block","doi":"10.2147/MDER.S23606","DOIUrl":"https://doi.org/10.2147/MDER.S23606","url":null,"abstract":"<p><p>Lumbar fusion is commonly performed to alleviate chronic low back and leg pain secondary to disc degeneration, spondylolisthesis with or without concomitant lumbar spinal stenosis, or chronic lumbar instability. However, the risk of iatrogenic injury during traditional anterior, posterior, and transforaminal open fusion surgery is significant. The axial lumbar interbody fusion (AxiaLIF) system is a minimally invasive fusion device that accesses the lumbar (L4-S1) intervertebral disc spaces via a reproducible presacral approach that avoids critical neurovascular and musculoligamentous structures. Since the AxiaLIF system received marketing clearance from the US Food and Drug Administration in 2004, clinical studies of this device have reported high fusion rates without implant subsidence, significant improvements in pain and function, and low complication rates. This paper describes the design and approach of this lumbar fusion system, details the indications for use, and summarizes the clinical experience with the AxiaLIF system to date.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"125-31"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S23606","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Soya oil-based shampoo superior to 0.5% permethrin lotion for head louse infestation.","authors":"Ian F Burgess,&nbsp;Katrina Kay,&nbsp;Nazma A Burgess,&nbsp;Elizabeth R Brunton","doi":"10.2147/MDER.S17551","DOIUrl":"https://doi.org/10.2147/MDER.S17551","url":null,"abstract":"<p><strong>Background: </strong>This was a randomized, assessor-blind, controlled comparison of a soya oil- based medical device shampoo with a medicinal permethrin lotion in an alcohol vehicle for treatment of head louse infestation to generate data suitable for a regulatory submission to achieve reimbursable status for the shampoo product.</p><p><strong>Methods: </strong>We treated 91 children and adults, divided between two sites, on two occasions 9 days apart. Participants washed their hair and towel-dried it before treatment. The shampoo was used twice for 30 minutes each time. The lotion was used for 30 minutes followed by rinsing. Assessments were made by dry detection combing on days 2, 9, 11, and 14 after the first treatment. According to present knowledge, this combing technique does not influence the overall head louse populations or outcome of treatment.</p><p><strong>Results: </strong>The soya oil shampoo was significantly (P < 0.01) more effective than the lotion for both intention to treat (62.2% versus 34.8% successful treatment) and per-protocol (74.3% versus 36.8% success) groups. Post-treatment assessments showed the necessity for repeat treatment, but that a 9-day interval was too long because if eggs hatched after the first treatment, the lice could grow old enough to lay eggs before the second treatment.</p><p><strong>Conclusion: </strong>The soya oil-based shampoo was more effective than the permethrin lotion, more cosmetically acceptable, and less irritant.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"35-42"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S17551","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853308","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparing the accuracy of ES-BC, EIS-GS, and ES Oxi on body composition, autonomic nervous system activity, and cardiac output to standardized assessments.","authors":"John E Lewis,&nbsp;Stacey L Tannenbaum,&nbsp;Jinrun Gao,&nbsp;Angelica B Melillo,&nbsp;Evan G Long,&nbsp;Yaima Alonso,&nbsp;Janet Konefal,&nbsp;Judi M Woolger,&nbsp;Susanna Leonard,&nbsp;Prabjot K Singh,&nbsp;Lawrence Chen,&nbsp;Eduard Tiozzo","doi":"10.2147/MDER.S24291","DOIUrl":"https://doi.org/10.2147/MDER.S24291","url":null,"abstract":"<p><strong>Background and purpose: </strong>THE ELECTRO SENSOR COMPLEX (ESC) IS SOFTWARE THAT COMBINES THREE DEVICES USING BIOELECTRICAL IMPEDANCE, GALVANIC SKIN RESPONSE, AND SPECTROPHOTOMETRY: (1) ES-BC (Electro Sensor-Body Composition; LD Technology, Miami, FL) to assess body composition, (2) EIS-GS (Electro Interstitial Scan-Galvanic Skin; LD Technology) to predict autonomic nervous system activity, and (3) ES Oxi (Electro Sensor Oxi; LD Technology) to assess cardiac output. The objective of this study was to compare each to a standardized assessment: ES-BC to dual-energy X-ray absorptiometry (DXA), EIS-GS to heart rate variability, and ES Oxi to BioZ Dx Diagnostic System (BioZ Dx; SonoSite Inc, Bothell, WA).</p><p><strong>Patients and methods: </strong>The study was conducted in two waves. Fifty subjects were assessed for body composition and autonomic nervous system activity. Fifty-one subjects were assessed for cardiac output.</p><p><strong>Results: </strong>We found adequate relative and absolute agreement between ES-BC and DXA for fat mass (r = 0.97, P < 0.001) with ES-BC overestimating fat mass by 0.1 kg and for body fat percentage (r = 0.92, P < 0.001) with overestimation of fat percentage by 0.4%. For autonomic nervous system activity, we found marginal relative agreement between EIS-GS and heart rate variability by using EIS-GS as the predictor in a linear regression equation (adjusted R(2) = 0.56, P = 0.03). For cardiac output, adequate relative and absolute agreement was found between ES Oxi and BioZ Dx at baseline (r = 0.60, P < 0.001), after the first exercise stage (r = 0.79, P < 0.001), and after the second exercise stage (r = 0.86, P < 0.001). Absolute agreement was found at baseline and after both bouts of exercise; ES Oxi overestimated baseline and stage 1 exercise cardiac output by 0.3 L/minute and 0.1 L/minute, respectively, but exactly estimated stage 2 exercise cardiac output.</p><p><strong>Conclusion: </strong>ES-BC and ES Oxi accurately assessed body composition and cardiac output compared to standardized instruments, whereas EIS-GS showed marginal predictive ability for autonomic nervous system activity. The ESC software managing the three devices would be useful to help detect complications related to metabolic syndrome, diabetes, and cardiovascular disease and to noninvasively and rapidly manage treatment follow-up.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"169-77"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/MDER.S24291","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ionically cross-linked hyaluronic acid: wetting, lubrication, and viscoelasticity of a modified adhesion barrier gel.","authors":"Katherine Vorvolakos, Irada S Isayeva, Hoan-My Do Luu, Dinesh V Patwardhan, Steven K Pollack","doi":"10.2147/MDER.S13962","DOIUrl":"10.2147/MDER.S13962","url":null,"abstract":"<p><p>Hyaluronic acid (HA), in linear or cross-linked form, is a common component of cosmetics, personal care products, combination medical products, and medical devices. In all cases, the ability of the HA solution or gel to wet surfaces and/or disrupt and lubricate interfaces is a limiting feature of its mechanism of action. We synthesized ferric ion-cross-linked networks of HA based on an adhesion barrier, varied the degree of cross-linking, and performed wetting goniometry, viscometry, and dynamic mechanical analysis. As cross-linking increases, so do contact angle, viscosity, storage modulus, and loss modulus; thus, wetting and lubrication are compromised. These findings have implications in medical device materials, such as adhesion barriers and mucosal drug delivery vehicles.</p>","PeriodicalId":47140,"journal":{"name":"Medical Devices-Evidence and Research","volume":" ","pages":"1-10"},"PeriodicalIF":1.3,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3417868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30853922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}