Detección y manejo de implantación inadecuada de reservorio venoso central en arteria subclavia

We present a case of a female patient with ovarian cancer who had an inadvertent vascular access device implantation in the subclavian artery, being detected after 10 days. She was successfully treated with a covered stent without immediate complications.     

Percutaneous closure of patent foramen ovale: “Closed” door after the lastrandomized trials?简

Patent foramen ovale (PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials (CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them (PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one (CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure (1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed (1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reduce the risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.     

Mechanical thrombectomy with a novel stent retriever with multifunctional zones: Initial clinical experience with the NeVa™ thrombectomy device

Background and purposeThe NeVa™ (Vesalio, Nashville, Tennessee) thrombectomy device is a CE-approved novel hybrid-cell stent retriever with offset enlarged openings coupled with functional zones and a closed distal end. The device was designed to incorporate and trap resistant emboli. The purpose was to determine the safety and efficacy of the NeVa™ stent.MethodsProspective data was collected on the first thirty consecutive patients treated at four stroke centers with NeVa™ as first line treatment between December 2017 and May 2018. Clinical outcome measures included re-perfusion scores after each pass, complications (per-procedural complications, device related adverse events, all intracerebral hemorrhage (ICH) and symptomatic ICH (sICH) on follow up imaging), 24 hour NIHSS, mRS at discharge and 90 days. Baseline data as well as treatment parameters were documented.ResultsMean presenting NIHSS was 16. Sites of primary occlusion were 10 ICA, 16 M1-MCA, 3 M2-MCA and one basilar. There were five tandem occlusions. Reperfusion outcomes after each NeVa pass; TICI ≥ 2b after first pass 63%, after 1 or 2 passes 83%, after 1 to 3 passes 90%. TICI 2c-3 after first pass 47%, after 1-2 passes 57%, after 1–3 passes 60%. TICI ≥ 2b after final pass 93%; TICI 2c-3, 63%. There were no device related serious averse events and no sICH. Clot material was partially or completely incorporated into the device after 70% passes. The mean 24 hour NIHSS was 7 and the 90 day mRS was 0–2 in 53%.ConclusionsThe NeVa™ device demonstrated a high rate of first pass complete reperfusion effect, a good safety profile and favorable 90 day clinical outcomes in this initial clinical experience.     

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.

Acquisition and analysis of 3D mandibular movement using a device based on electromagnetic sensors and a neural network

In dental medicine, the study of mandibular movement has an important role in oral rehabilitation as it allows diagnosis of pathologies in the temporomandibular joint and the definition of adequate treatment plans. In this paper, a new device specially developed for the acquisition and analysis of 3D mandibular movement is presented. A facial arc is adopted as its main support structure and electromagnetic sensors are employed to acquire the mandibular movement. A neural network is used to transform the electrical signals output by the sensors into 3D Cartesian coordinates. A custom-made computer application is developed to display and analyse the movement acquired. The device is shown to be easy to use, comfortable for patients and capable of being produced at an affordable price.     

医疗设备检测管理系统关键技术研究

为适应全国医疗器械检验机构日渐复杂的工作流程,为使医疗器械检验工作更加科学化、规范化,同时做到可查、可追,我们设计了此软件。目前,在国家食品药品监督管理局沈阳医疗器械质量监督检验中心实施执行此软件,它改变了检验工作档案记录没有数字化图像的历史,对于现场检验,避免漏检、错检起到了决定性的改变,实现了实时资料审查,及时修正错误。     

NCAR-医疗器械不良事件监测信息交换的平台

通过介绍国际医疗器械法规协调组织发起的,在国际范围内交换医疗器械不良事件监测信息的国家医疗器械管理机构报告,旨在为我国开展医疗器械不良事件监测信息管理及参与国际信息交流提供借鉴。