Adverse Events Associated With Tracheostomy: A MAUDE Database Analysis.

OBJECTIVE: Tracheotomy is one of the most common procedures. Although tracheostomy complications have been extensively studied, literature related to device complications is scarce. The objective of this study is to describe complications associated with tracheostomies utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. STUDY DESIGN: Retrospective cross-sectional study. SETTING: The US Food and Drug Administration's (FDA) MAUDE database (2015-2020). METHODS: The FDA's MAUDE database was queried for all reports on adverse events related to tracheostomy from January 1, 2015 to December 31, 2020. RESULTS: A total of 3086 adverse events related to open tracheostomy and 52 related to percutaneous tracheostomy were identified. For open tracheostomy, 2872 (93%), were related to device malfunction, and 214 (7%) consisted of patient-related factors. The most frequently reported device-related adverse event was cuff malfunction, with 1834 (59%) reported events, which includes cuff deflation, pilot balloon malfunction, and cuff inflation line malfunction. The most frequently reported patient-related adverse events were tracheostomy tube obstruction with 67 events (2%). For percutaneous tracheostomy, 38 (73%) events were related to device malfunction, and 14 (27%) were related to patient injury. The most frequently reported adverse events were cuff malfunction (29%), safety ridge malfunction (17%), and bleeding (10%). CONCLUSION: The MAUDE database is a useful tool that can be utilized to complement existing literature in identifying common and rare adverse events associated with tracheostomy device-related failures, which are mostly reliant on isolated, published case reports.

Invasive fungal sinusitis: A comparison of pediatric versus adult cases.

BACKGROUND: Invasive fungal sinusitis (IFS) is a rare infection with high mortality, mainly impacting immunocompromised patients. Given its significant mortality, timely recognition and treatment is crucial. This study aims to highlight the differences in presentation of IFS between pediatric and adult patients to aid in prompt diagnosis and treatment of this condition. METHODS: A comprehensive literature search of PubMed, EMBASE, Web of Science, Global Index Medicus, Global Health (EBSCO) and Cochrane Database of Systematic Reviews was conducted to identify articles relating to IFS. Patient demographics, comorbidities, presentation, disease characteristics, treatments and outcomes were extracted from the studies, and statistical analyses were conducted to compare these variables between pediatric and adult patients. RESULTS: 111 studies identified 22 pediatric and 132 adult patients worldwide. Children were more likely to have hematologic malignancies compared to adults (59.1 % vs. 15.2 %, p < 0.001). Facial symptoms such as pain, edema, and numbness were the most common symptoms for both age groups. In the pediatric population, fever and nasal or oral mucosal lesions were more common presenting symptoms (both p < 0.001). Pediatric patients were more likely to present without disease extension beyond the sinuses (p < 0.001). There was no significant difference in either medication treatment or mortality between the two cohorts. CONCLUSION: IFS often presents with non-specific symptoms and a unique presentation in pediatric and adult populations. Clinical awareness of the varying presentations in both populations is important to treat in a timely manner given the rapid progression and high mortality rates of IFS.

Lack of Consensus in Rehabilitation Protocols After Posterior Shoulder Stabilization.

Background: Posterior shoulder instability is being identified and treated more frequently by orthopaedic providers. After posterior shoulder stabilization, long-term outcomes in function and mobility are largely dependent on the postoperative rehabilitation period. Thus, it is important to assess the consistency between protocols at different institutions. Purpose/Hypothesis: The purpose of this study was to investigate the variability among rehabilitation protocols published by academic orthopaedic programs and their affiliates. It was hypothesized that there would be little consistency in the duration of immobilization, timing of functional milestones, and start dates of various exercises. Study Design: Cross-sectional study. Methods: Rehabilitation protocols after posterior shoulder stabilization that were published online from Accreditation Council for Graduate Medical Education (ACGME)-accredited orthopaedic surgery programs and their affiliates were evaluated for recommendations on immobilization, exercises, activities, range of motion (ROM), and return-to-sport goals. Results: Of the 204 ACGME-accredited orthopaedic surgery programs, 22 programs and 17 program affiliates had publicly available rehabilitation protocols that were included for review. There were 37 programs (94.9%) that recommended the use of sling immobilization for a mean of 4.7 ± 1.8 weeks postoperatively. Active ROM of the elbow, wrist, and hand was the most common early ROM exercise to be recommended (36 programs; 92.3%). The goal of 90° passive external rotation demonstrated the widest range of recommended start dates (0-12 weeks postoperatively). Late ROM exercises and start dates varied between protocols, with the largest standard deviation found in achieving full active ROM (13.5 ± 3.6 weeks). Resistance exercises showed a wide range of recommended start dates. Bench presses and push-ups began, on average, at 13.1 ± 3.4 and 15.3 ± 3.2 weeks, respectively. Return to sport was recommended at 21.7 ± 3.6 weeks. Conclusion: There was a high level of variability in postoperative rehabilitation protocols after posterior shoulder stabilization among orthopaedic programs and their affiliates, suggesting that a standard protocol for rehabilitation has yet to be established.

Decreased Case Volume for Orthopaedic Sports Medicine Fellows During the Early Stages of the Coronavirus Disease 2019 Pandemic.

Purpose: To compare the surgical case volume for orthopaedic sports medicine fellows in the most recent classes with one another and in years preceding the pandemic. Methods: The Accreditation Council for Graduate Medical Education case log reports of key procedures for orthopaedic sports medicine fellows during academic years 2018-2019, 2019-2020, and 2020-2021 were extracted. Comparisons between these years in adult, pediatric, and total case volumes were performed using a 2-sample t-test to detect significant changes in the average number of key procedures completed between consecutive years. Results: There was a significant decrease in the total number of cases completed by fellows during the 2020 academic year (P = .043) compared with 2019, immediately followed by a significant increase in case volume in 2021 (P < .001) (2019, 339 ± 123; 2020, 316.2 ± 108; 2021, 356.5 ± 117). There was a significant increase in adult case volume from 2020 to 2021 (2020, 295.7 ± 106; 2021, 332.9 ± 117; P < .001), whereas no trends were noted in pediatric case volume. Between the prepandemic year of 2019 and the first year of the pandemic, significant decreases were noted in case volume for several procedures, including multiligamentous knee injuries, knee instability and pediatric hip arthroscopy. From the first to the second years of the pandemic (2019-2020 to 2020-2021), significant increases were observed in case volume for rotator cuff, acromioclavicular instability, elbow instability, knee cartilage, and meniscal surgeries. Conclusions: Orthopaedic sports medicine fellows experienced significant decreases in volume for several key case categories between the year preceding the coronavirus disease 2019 pandemic and the first academic year during the pandemic. There were subsequent increases in cases between the first year of the pandemic and the second year, which may be associated with resuming elective surgical cases. Level of Evidence: IV, retrospective database analysis.