Vagus nerve stimulation: analysis of device parameters in 154 patients during the long-term XE5 study

PURPOSE: To determine the effect of changes in device settings and duty cycle (on and off times) on the efficacy of vagus nerve stimulation (VNS) for refractory epilepsy. In the long-term XE5 study of VNS for intractable epilepsy, the median reduction in seizure frequency improved significantly after 1 year of follow-up. A central question is whether device changes improve efficacy. We analyzed the effects of device parameter changes on seizure frequency in 154 subjects who completed the study and who had complete data for analysis. METHODS: Retrospective analysis of device changes during the XE5 long-term study of VNS. During the XE5 long-term follow-up study, the subject's device settings were modified within a Food and Drug Administration (FDA)-approved range of output current, pulse duration, frequency, on time, and off time. Significant changes in device settings occurred after 3 months. We investigated the relationship between percentage reduction in seizures and changes in device parameters between the 3- and 12-month visits. Within-group comparisons were performed for those who continued on standard on/off cycle of 30 s on and 5 min off, and those with the most common off times of 3, 1.8, and < 1.1 min. RESULTS: Output current, pulse duration, frequency, and off time changed significantly between the 3- and 12-month long-term follow-ups. For the group as a whole, changes in device settings were not correlated with an improvement in efficacy. However, a significant improvement in efficacy occurred in a subgroup whose off time was reduced to < or = 1.1 min. In this group, the median reduction in seizures improved from 21% before the change in off time, to 39% after the change in off time (Wilcoxon Signed-Rank, p = 0.011). The responder rate (> 50% reduction in seizures) also significantly improved from 19 to 35% (McNemar's test, p = 0.046). CONCLUSIONS: The data from this retrospective analysis indicate that device changes were not the primary determinant of increased efficacy at 12 months of long-term follow-up. In general, patients who remained on the original settings of 30 s on and 5 min off continued to respond or improve in their response over the 1-year period. However, some patients may benefit from reductions in off time (increases in duty cycle). In a subgroup initially resistant to VNS, a change in off time to < or = 1.1 min off did result in significant improvements in efficacy.     

如何做好医疗器械的管理

现代化的医疗设备为提高医疗水平、保障人民的身体健康作出了巨大的贡献。现在的医疗设备科技含量很高,所以要求有与之相适应的管理水平,建立完善的管理制度,提高医疗设备使用、提高管理人员的的技术水平。如何做好医疗器械的管理工作,是需要国家、企业、医院等各机构共同努力完成的。     

The Rise of the Neophallus: A Systematic Review of Penile Prosthetic Outcomes and Complications in Gender-Affirming Surgery

Background

Penile prostheses are commonly used to achieve erectile rigidity after phalloplasty in trans masculine patients. Implantation poses significant challenges because of the delicate nature of the neophallus and lack of native erectile tissue. Many groups have developed novel phalloplasty and prosthesis insertion techniques, but none have proven superior.

挥发油动力学模型测定装置

目的 :设计一种中药材挥发油提取过程中动力学模型的测定装置。方法 :以共水蒸馏法测定。结果 :该装置可非常精确地测出任意时刻挥发油提取量 ,并求出其精确的动力学方程。结论 :该装置可用于挥发油的动模测定。     

Fast three-dimensional numerical hemolysis approximation

The in vivo implantation of a mechanical device contributes to hemodynamic disturbances, which are responsible for damage to the membranes of red blood cells that in turn can lead to their rupture (hemolysis). It is important to ascertain at the design stage of such mechanical devices that they are innocuous to blood. Because there is no in vivo hemolysis index, we concentrated our efforts on the in vitro hemolysis index of the American Society for Testing and Material (ASTM) standard. We present in this work a framework for minimizing medical device-induced hemolysis by the development of a numerical method for predicting hemolysis similar to that used in in vitro experiments. The method is based on a novel interpretation of the Giersiepen-Wurzinger blood damage correlation that replaces the computation of blood damage along the streamline by a volume integration of a damage function over the computational domain. We assess the behavior and accuracy of this methodology with 3D examples.     

Copper accumulation in actinomyces druses during endometritis after long-term use of an intrauterine contraceptive device

A 32-year-old woman carried a copper intrauterine contraceptive device (IUCD) or intrauterine pessar (IAP) for more than 5 years. She had acyclic menstrual bleedings and underwent a corpus abrasio after explantation of IUCD. The histological study of paraffin sections showed an actinomycotic endometritis with brown to black deposits in or around typical actinomyces druses, but there was no carcinoma. The electron microscopic study of these accumulations by electron energy loss spectroscopy (EELS) in TEM demonstrated copper deposits in the shell and matrix of these druses as well as inside the bacteria. With scanning electron microscopy (SEM) and Energy Dispersive X-Ray Analysis (EDX), the electron-dense accumulations revealed high signals for copper and sulfur, but also of phosphorus and oxygen in a lower extent. This copper accumulation is discussed as an active uptake and concentration by these actinomyces bacteria.     

舌下含服米索前列醇在剖宫产术后放置宫内节育器中的应用

目的:探讨舌下含化米索前列醇在剖宫产术后放置宫内节育器中的作用。方法:选择剖宫产术后满6个月、自愿要求放置宫内节育器而无禁忌症、初孕初产妇女500例分为研究组240例,术前1小时舌下含化米索前列醇400μg;对照组260例,术前不用药。两组年龄、是否哺乳期无统计学差异(P>0.05)。结果:研究组手术成功率为100%,疼痛Ⅰ级为98.75%,疼痛Ⅱ级为1.25%疼痛Ⅲ级为0,子宫穿孔发生率为0,宫颈损伤发生率0.42%,心脑反应发生率为0;阴道流血量多为3.33%,与对照组(78.85%、35.00%、53.46%、11.54%、5.77%、16.52%、11.15%、23.46%)相比,差异有统计学意义(P<0.01)。结论:舌下含化米索前列醇用于剖宫产术后放置宫内节育器,给药方便、副作用少,手术安全性好、无痛苦、并发症少、成功率高,是一种值得推广的方法。     

中美医疗器械生产企业监督管理之比较与借鉴

比较中美两国对医疗器械生产企业监督管理的一般规定、生产的质量体系检查、生产企业的市场准入要求和上市后的监测等方面的差异。     

论植入性医疗器械临床流通规范化全过程管理

如何对植入性医疗器械临床流通过程进行规范管理一直是困绕医院管理者的话题。我院通过开展全过程医疗质量实时监控,规范了植入性医疗器械从购销、使用、随访整个临床流通过程的管理,充分保障了患者用械安全。     

Left Ventricular Assist Device Support as a Bridge to Recovery in Young Children

Objective. Left ventricular assist device (LVAD) experience and follow‐up data in children are limited. We report the deployment and successful weaning from LVAD in young children with severe heart failure (HF). Design. From 2004–2009, 13 children suffering from HF were placed on LVAD. All presented with a dilated left ventricle (LV) with severely reduced contractility, secondary to myocarditis, atrial arrhythmia or idiopathic HF. This study reports their outcomes and longitudinal follow‐up. Results. Of 13 young children with HF (ages 1 month–6 years; mean 19.2 months) placed on LVAD: eight weaned to recovery and successful hospital discharge, one was transplanted and four died. Echo follow‐up in the weaned patients (mean age 22.1 months) revealed significant improvements from pre‐LVAD measurements: LV end‐diastolic dimension (LVED) mean z‐score decreased from +4.8 to +0.95 (P < .001); fractional shortening (FS %) improved from a mean of 9.3% to 33% (P < .001); and the degree of mitral regurgitation (MR) significantly improved (P < .05). Time to LVAD deployment from HF diagnosis was more likely to be less than 30 days in the successfully weaned patients (100%) than patients who died or were transplanted (20%); P= .007. Conclusions. LVAD support can be utilized as a bridge to recovery in young children with HF. Following LVAD weaning, children sustain improvements in LV size, function and degree of MR. LVAD deployment less than 30 days from HF diagnosis improves the likelihood of successful weaning and illustrates that children with acute etiologies of HF are more likely to achieve recovery.