Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019.

OBJECTIVE: The US Food and Drug Administration (FDA) regulates the marketing of medical devices based on the premarket approval (PMA) or 510(k) pathway. We investigated the relationship among the regulatory pathway of otolaryngologic devices, the number of recalls, and the recall characteristics. STUDY DESIGN: Retrospective cross-sectional analysis. SETTING: Publicly available FDA databases. METHODS: The FDA Ear, Nose, and Throat Devices Panel database was queried for 510(k) clearances and PMA approvals from 1976 to 2019. Device recalls from 2003 to 2019 were reviewed. Devices were then categorized by subspecialty, type, supporting evidence, and PMA supplement type. Logistic regression characterized the odds of recall for each device type and subspeciality. RESULTS: A total of 1061 (57.8%) 510(k) and 778 (42.3%) PMA device applications and modifications were approved. There were 120 (11.3%) recall events associated with 42 unique otolaryngologic devices cleared via the 510(k) pathway, as compared with 25 (3.2%) recall events for 5 unique PMA devices. 510(k) device approvals were more likely to be recalled than PMA device approvals (odds ratio, 3.67; 95% CI, 2.38-5.88; P < .0001). 510(k) surgical devices (odds ratio, 2.1; 95% CI, 1.1-4.4; P = .03) were more likely to be recalled than diagnostic devices. Devices designated for laryngology (70.0%) and general otolaryngology (25.0%) composed the majority of recalls. CONCLUSION: Otolaryngologic devices approved by the FDA via the 510(k) pathway exhibit a higher number of recalls than the PMA pathway. Given the balance between regulation and facilitating innovation, postmarket surveillance and ongoing regulatory improvements are critical to ensure optimal safety of medical devices.

VE/VCO2 slope predicts RV dysfunction and mortality after left ventricular assist device: a fresh look at cardiopulmonary stress testing for prognostication.

Preoperative cardiopulmonary exercise testing (CPET) is well validated for prognostication before advanced surgical heart failure therapies, but its role in prognostication after LVAD surgery has never been studied. VE/VCO2 slope is an important component of CPET which has direct pathophysiologic links to right ventricular (RV) performance. We hypothesized that VE/VCO2 slope would prognosticate RV dysfunction after LVAD. All CPET studies from a single institution were collected between September 2009 and February 2019. Patients who ultimately underwent LVAD implantation were selectively analyzed. Peak VO2 and VE/VCO2 slope were measured for all patients. We evaluated their association with hemodynamic, echocardiographic and clinical markers of RV dysfunction as well mortality. Patients were stratified into those with a ventilatory class of III or greater. (VE/VCO2 slope of ≥ 36, n = 43) and those with a VE/VCO2 slope < 36 (n = 27). We compared the mortality between the 2 groups, as well as the hemodynamic, echocardiographic and clinical markers of RV dysfunction. 570 patients underwent CPET testing. 145 patients were ultimately referred to the advanced heart failure program and 70 patients later received LVAD implantation. Patients with VE/VCO2 slope of ≥ 36 had higher mortality (30.2% vs. 7.4%, p = 0.02) than patients with VE/VCO2 slope < 36 (n = 27). They also had a higher incidence of clinically important RVF (Acute severe 9.3% vs. 0%, Severe 32.6% vs 25.9%, p = 0.03). Patients with a VE/VCO2 slope ≥ 36 had a higher CVP than those with a lower VE/VCO2 slope (11.2 ± 6.1 vs. 6.0 ± 4.8 mmHg, p = 0.007), and were more likely to have a RA/PCWP ≥ 0.63 (65% vs. 19%, p = 0.008) and a PAPI ≤ 2 (57% vs. 13%, p = 0.008). In contrast, peak VO2 < 12 ml/kg/min was not associated with postoperative RV dysfunction or mortality. Elevated preoperative VE/VCO2 slope is a predictor of postoperative mortality, and is associated with postoperative clinical and hemodynamic markers of impaired RV performance.

Quantitative Analysis of Enhanced Selfies in a Young Adult Population.

The use of filters and editing tools for perfecting selfies is increasing. While some aesthetic experts have touted the ability of this technology to help patients convey their aesthetic goals, others have expressed concerns about the unrealistic expectations that may come from the ability for individuals to digitally alter their own photos in these so-called "super-selfies." The aim of the study is to determine the changes that individuals seek when enhancing selfies. Twenty subjects participated in this study between July 25 and September 24, 2019. Subjects had two sets of headshots taken (neutral and smile) and were provided an introduction on the use of the Facetune2 app. Subjects received a digital copy of their photographs and were asked to download the free mobile app. After 1 week of trialing the different tools for enhancing their appearance, subjects submitted their self-determined most attractive edited photographs. Changes in marginal reflex distance (MRD) 1 and 2, nose height and width, eyebrow height, facial width, skin smoothness, skin hue, and saturation as well as overall image brightness were recorded. Paired two-tailed t-test was used to evaluate pre- and post-facial measurements. There were no statistically significant changes identified in the analysis of the altered photos in neutral expression. Analysis of all smiling photographs revealed that subjects increased their smile angle (right: +2.92 mm, p = 0.04; left: +3.58 mm, p < 0.001). When smiling photographs were assessed by gender, females were found to significantly increase their MRD2 (right: +0.64 mm, p = 0.04; left: +0.74 mm, p = 0.05) and their smile angle (right: +1.90 mm, p = 0.03; left: +2.31 mm, p = 0.005) while also decreasing their nose height (-2.8 mm, p = 0.04). Males did not significantly alter any of the facial measurements assessed. This study identifies the types of changes that individuals seek when enhancing selfies and specifies the different aspects of image adjustment that may be sought based on a patient's gender.

Cinebot: Creation of Movies and Animated GIFs Directly from PACS-Efficiency in Presentation and Education.

The presentation of radiology exams can be enhanced through the use of dynamic images. Dynamic images differ from static images by the use of animation and are especially useful for depicting real-time activity such as the scrolling or the flow of contrast to enhance pathology. This is generally superior to a collection of static images as a representation of clinical workflow and provides a more robust appreciation of the case in question. Dynamic images can be shared electronically to facilitate teaching, case review, presentation, and sharing of interesting cases to be viewed in detail on a computer or mobile devices for education. The creation of movies or animated images from radiology data has traditionally been challenging based on technological limitations inherent in converting the Digital Imaging and Communications in Medicine (DICOM) standard to other formats or concerns related to the presence of protected health information (PHI). The solution presented here, named Cinebot, allows a simple "one-click" generation of anonymized dynamic movies or animated images within the picture archiving and communication system (PACS) workflow. This approach works across all imaging modalities, including stacked cross-sectional and multi-frame cine formats. Usage statistics over 2 years have shown this method to be well-received and useful throughout our enterprise.

Developing Deeper Radiology Exam Insight to Optimize MRI Workflow and Patient Experience.

Process variability during the acquisition of magnetic resonance imaging (MRI) can lengthen examination times and introduce unexpected exam differences which can negatively impact the cost and quality of care provided to patients. Digital Imaging and Communications in Medicine (DICOM) metadata can provide more accurate study data and granular series-level information that can be used to increase operational efficiency, optimize patient care, and reduce costs associated with MRI examinations. Systematic use of such data analysis could be used as a continuous operational optimization and quality control mechanism.

Microfluidic purification and concentration of malignant pleural effusions for improved molecular and cytomorphological diagnostics.

Evaluation of pleural fluids for metastatic cells is a key component of diagnostic cytopathology. However, a large background of smaller leukocytes and/or erythrocytes can make accurate diagnosis difficult and reduce specificity in identification of mutations of interest for targeted anti-cancer therapies. Here, we describe an automated microfluidic system (Centrifuge Chip) which employs microscale vortices for the size-based isolation and concentration of cancer cells and mesothelial cells from a background of blood cells. We are able to process non-diluted pleural fluids at 6 mL/min and enrich target cells significantly over the background; we achieved improved purity in all patient samples analyzed. The resulting isolated and viable cells are readily available for immunostaining, cytological analysis, and detection of gene mutations. To demonstrate the utility towards aiding companion diagnostics, we also show improved detection accuracy of KRAS gene mutations in lung cancer cells processed using the Centrifuge Chip, leading to an increase in the area under the curve (AUC) of the receiver operating characteristic from 0.90 to 0.99. The Centrifuge Chip allows for rapid concentration and processing of large volumes of bodily fluid samples for improved cytological diagnosis and purification of cells of interest for genetic testing, which will be helpful for enhancing diagnostic accuracy.