Medical Devices-Evidence and Research最新文献

Background: There is insufficient evidence to determine whether intra-articular injections may be effective for treatment of glenohumeral osteoarthritis. Euflexxa(®) (high molecular weight hyaluronate), a bioengineered high molecular weight hyaluronan, has been shown to be a safe and effective treatment for patients with knee osteoarthritis. There is also support for the use of hyaluronate injection for the treatment of chronic shoulder pain associated with osteoarthritis or rotator cuff damage. This small-scale exploratory study was conducted to evaluate the safety and efficacy of high molecular weight hyaluronate for the treatment of chronic shoulder pain associated with osteoarthritis.

Methods: Subjects with glenohumeral osteoarthritis and chronic pain (n = 27) received one injection per week for 3 weeks of high molecular weight hyaluronate and were assessed for changes in pain (100 mm visual analog scale [VAS]), range of motion, and the subject's and physician's global assessment over 26 weeks. Subjects were also assessed for pain, stiffness, and physical functioning using the Western Ontario and McMaster Universities Arthritis Index (WOMAC). Finally, responses were evaluated using modified Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT)-Osteoarthritis Research Society International (OARSI) Proposition D criteria. Safety was assessed by recording adverse events.

Results: High molecular weight hyaluronate significantly improved pain (VAS, WOMAC), range of motion, stiffness, and physical functioning scores; 77.8% of subjects were rated as having an OMERACT-OARSI Proposition D high response. There were no serious adverse events, and none were considered to be related to treatment.

Conclusion: Treatment with high molecular weight hyaluronate improves pain, stiffness, and range of motion, and may have an acceptable safety and tolerability profile. A randomized, double-blind, placebo-controlled clinical trial may be warranted to investigate further the efficacy and safety of intra-articular high molecular weight hyaluronate for treatment of chronic shoulder pain in patients with glenohumeral osteoarthritis.

From its introduction, the antibiotic tobramycin has been an important tool in the management of persons with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa lung infections. Initially an intravenous rescue treatment for pulmonary exacerbations, tobramycin delivered by inhalation has become a mainstay of chronic suppressive CF infection management. Platforms for tobramycin aerosol delivery have steadily improved, with increased lung deposition complimented by decreased device complexities, loaded tobramycin doses, delivery times, and treatment burdens. Most recently, a unique tobramycin inhalation powder (TIP) formulation with a portable delivery system, the TOBI(®) Podhaler(®) (Novartis AG, Basel, Switzerland) has been developed and approved in Europe, Canada, and Chile. Four capsules, each containing 28 mg of TIP are successively pierced and inhaled via the T-326 Dry Powder Inhaler Device (Novartis AG, Basel, Switzerland). No external power source is required to deliver an efficacious tobramycin dose in minutes. By comparison, tobramycin inhalation solution (TIS) (TOBI(®); Novartis), is delivered by LC(®) Plus (PARI Respiratory Equipment Inc, Midlothian, VA) jet nebulizer powered by an air compressor over 15-20 minutes. Comparative pharmacokinetics, safety, and efficacy studies of TIS and TIP in CF subjects with P. aeruginosa ≥ 6 years old demonstrate that: tobramycin lung deposition with 112 mg TIP is comparable to that attained with 300 mg TIS, TIP is more effective than placebo and not inferior to TIS with respect to pulmonary function benefit, and TIP has significantly faster treatment times and achieves higher patient satisfaction than TIS. TIP is associated with an increased frequency of mild to moderate local adverse events (cough, dysphonia, and dysgeusia) compared with TIS, however, these become less frequent as subjects gain TIP experience. These results suggest that the TOBI Podhaler may better meet the needs of many CF patients and families by reducing treatment time and complexity and improving patient satisfaction compared with TIS.

Purpose: The purpose of this study was to assess the preventive effect of cilostazol on in-stent restenosis in patients after superficial femoral artery (SFA) stent placement.

Materials and methods: Of 28 patients with peripheral arterial disease, who had successfully undergone stent implantation, 15 received cilostazol and 13 received ticlopidine. Primary patency rates were retrospectively analyzed by means of Kaplan-Meier survival curves, with differences between the two medication groups compared by log-rank test. A multivariate Cox proportional hazards model was applied to assess the effect of cilostazol versus ticlopidine on primary patency.

Results: The cilostazol group had significantly better primary patency rates than the ticlopidine group. Cumulative primary patency rates at 12 and 24 months after stent placement were, respectively, 100% and 75% in the cilostazol group versus 39% and 30% in the ticlopidine group (P = 0.0073, log-rank test). In a multivariate Cox proportional hazards model with adjustment for potentially confounding factors, including history of diabetes, cumulative stent length, and poor runoff, patients receiving cilostazol had significantly reduced risk of restenosis (hazard ratio 5.4; P = 0.042).

Conclusion: This retrospective study showed that cilostazol significantly reduces in-stent stenosis after SFA stent placement compared with ticlopidine.

Background and methods: A novel therapeutic system for the treatment of hypertension was developed on the basis of a slow-breath training mechanism, using a microbreathing pressure sensor device for the detection of human respiratory signals attached to the abdomen. The system utilizes a single-chip AT89C51 microcomputer as a core processor, programmed by Microsoft Visual C++6.0 to communicate with a PC via a full-speed PDIUSBD12 interface chip. The programming is based on a slow-breath guided algorithm in which the respiratory signal serves as a physiological feedback parameter. Inhalation and exhalation by the subject is guided by music signals.

Results and conclusion: Our study indicates that this microbreathing sensor system may assist in slow-breath training and may help to decrease blood pressure.

Purpose: Photoacoustic (PA) imaging is a recently developed breast cancer imaging technique. In order to enhance successful clinical implementation, we quantified the potential clinical value of different scenarios incorporating PA imaging by means of multi-criteria analysis. From this analysis, the most promising area of application for PA imaging in breast cancer diagnosis is determined, and recommendations are provided to optimize the design of PA imaging.

Methods: The added value of PA imaging was assessed in two areas of application in the diagnostic track. These areas include PA imaging as an alternative to x-ray mammography and ultrasonography in early stage diagnosis, and PA imaging as an alternative to Magnetic Resonance Imaging (MRI) in later stage diagnosis. The added value of PA imaging was assessed with respect to four main criteria (costs, diagnostic performance, patient comfort and risks). An expert panel composed of medical, technical and management experts was asked to assess the relative importance of the criteria in comparing the alternative diagnostic devices. The judgments of the experts were quantified based on the validated pairwise comparison technique of the Analytic Hierarchy Process, a technique for multi-criteria analysis. Sensitivity analysis was applied to account for the uncertainty of the outcomes.

Results: Among the considered alternatives, PA imaging is the preferred technique due to its non-invasiveness, low cost and low risks. However, the experts do not expect large differences in diagnostic performance. The outcomes suggest that design changes to improve the diagnostic performance of PA imaging should focus on the quality of the reconstruction algorithm, detector sensitivity, detector bandwidth and the number of wavelengths used.

Conclusion: The AHP method was useful in recommending the most promising area of application in the diagnostic track for which PA imaging can be implemented, this being early diagnosis, as a substitute for the combined use of x-ray mammography and ultrasonography.

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.

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.

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.

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.

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.