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.     

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.     

Key Principles of Clinical Validation,Device Approval,and Insurance Coverage Decisions of Artificial Intelligence

Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.     

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.     

Impact of Pump Replacement on Outcome in Advanced Heart Failure Patients With Left Ventricular Assist System

Pump thrombosis is one of the major adverse events associated with the use of a left ventricular assist system (LVAS) in patients with advanced heart failure. We investigated the clinical implication of pump replacement because of thrombus formation. This study included 87 patients who underwent implantation of a Nipro (Toyobo) pulsatile extracorporeal LVAS intended as a bridge to transplantation and were alive more than 3 months after implantation. The pump of this device is translucent, and daily evaluation for signs of thrombus formation was performed. Pump replacement was performed for significant thrombus formation that became visible. Data collection including demographics as well as hematologic values were performed 1 day before (baseline) and 3 months after implantation, and all patients were followed for 2 years or until death. At 3 months after LVAS implantation, 41 patients (47.1%) had undergone pump replacement because of pump thrombus. Baseline body surface area <1.63 m² was a significant predictor of pump replacement (hazard ratio [HR] 2.15, P = 0.04). At 3 months after implantation, there was a significantly higher incidence of stroke (P < 0.05) as well as a significantly greater decrease in body weight (F = 4.92, P = 0.03) in patients who underwent pump replacement as compared to those without. The 2‐year mortality after implantation was 26.4%. Multivariate Cox regression analysis showed that pump replacement within 3 months after implantation was an independent predictor of mortality (HR 2.50, P = 0.03). In conclusion, pump replacement for thrombus formation may have a strong association with worse outcome. Our results reconfirm the clinical importance of device thrombus in the management of LVAS.     

全腹腔镜辅助下透壁锥形滤器取出的临床分析

背景与目的:锥形滤器是近些年较为常用的可取出下腔静脉滤器,但其容易发生倾斜及回收钩嵌入或穿透下腔静脉壁,导致常规腔内介入方法无法取出,甚至发生严重并发症。因此,本研究探讨全腹腔镜辅助下回收钩穿透下腔静脉壁的锥形滤器取出的安全性与效果,为临床提供有效的处理策略与方法。方法:回顾性分析2016年12月—2019年11月收治15例下腔静脉锥形滤器植入患者的临床资料。其中男12例,女3例;平均年龄(47.7±13.3)岁。置入Celect滤器12例,Denali滤器2例,Option滤器1例。所有滤器经颈静脉介入无法取出,术前CT提示滤器回收钩穿透下腔静脉壁,所有患者在全麻下采用全腹腔镜辅助下滤器取出术。结果:手术方式为经腹腔途径9例(60.0%),经腹膜外途径6例(40.0%)。全腹腔镜辅助下滤器成功取出14例(93.3%),其中1例为Option滤器,2例为Denali滤器,11例为Celect滤器。1例(6.7%)Celect滤器腹腔镜手术未能分离回收钩,中转开腹手术成功取出。腹腔镜取出率为93.3%。患者滤器置入时间为(103.9±70.3)d,围手术期1例(6.7%)术中失血给予输血治疗,1例(6.7%)切口皮肤感染,术后平均住院(7.4±2.8)d。结论:全腹腔镜辅助下取出回收钩穿透下腔静脉壁的锥形滤器是安全有效的,能避免滤器长期植入导致的并发症,术前CT评估能提高手术成功率。