FAM210A and SOST Polymorphisms are Associated with Musculoskeletal Phenotypes in Healthy Young Adults

Recent research has suggested that genetic variants associated with bone mineral density (BMD) and fracture risk may also predict the rate of bone acquisition and peak bone mass. Genetic variants in the muscle-specific FAM210A (rs4796995) and the bone-specific SOST (rs4792909) have been shown to be associated with total BMD and fracture risk in adults. The purpose of this study is to explore the influence of these genetic variants on musculoskeletal phenotypes in three previously developed cohorts of children and young adults. Applied Biosystems Taqman allelic discrimination assays and the QuantStudio 7 Flex Real-Time PCR System were used to perform genotyping. Hardy-Weinberg equilibrium was assessed. Phenotypes were tested in sex-specific cohorts with an additive model using analysis of covariance (ANCOVA) methods. Where applicable, post hoc pair-wise comparisons were performed and the resulting p-values adjusted using the Sidak method. Statistically significant associations were found between variants of rs4796995 and dominant arm baseline bone volume (p=0.005) and baseline cortical bone volume (dominant p=0.004, non-dominant p=0.018) in Caucasian males from an exercise cohort. Associations were also found between rs4796995 variants and the left hand isometric grip strength (p=0.007) in African American women and VO2 max (p=0.037) in Caucasian males from a cohort assessing inherited markers of metabolic syndrome. We have demonstrated that variations in the FAM210A gene in healthy young adults are strongly associated with markers of musculoskeletal fitness. These findings suggest that individuals with the minor allele, particularly Caucasian males, may be at risk for developing lower peak bone mass and muscle strength at skeletal maturity. Early identification of genetic variants associated with BMD and fracture risk has the potential to aid the development of personalized medicine strategies designed to mitigate long term fracture risk by maximizing the use of appropriate fitness, nutrition, and other health maintenance strategies

A Review of Reported Adverse Events in MRI-Safe and MRI-Conditional Cochlear Implants

OBJECTIVES: This study looks to examine how the development of diametric magnet cochlear implant devices (CIDs) has affected observed magnetic resonance imaging (MRI)-related adverse events and MRI safety measures. METHODS: A search of the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was conducted using the product code MCM for Cochlear implants. Reports were included for analysis if they involved MRI in recipients of cochlear implantation. Included reports were stratified into two cohorts by year: 2010 to 2014 and 2015 to 2020, reflecting the FDA approval of diametric magnet cochlear implants in 2015. Extracted event variables included implant manufacturer, adherence to MRI protocol, patient injuries, and device malfunctions. RESULTS: The product code search query yielded a total of 27,305 reports, from which 584 reports were included for analysis. From 2010 to 2014, there were 109 adverse events and 30 pre-MRI explantations. Implant displacement was the most common device malfunction (n = 69, 87.3%), and pain was the most common patient injury (n = 16, 53.3%). From 2015 to 2020, there were 566 adverse events and 62 pre-MRI explantations. The most common device malfunction was implant displacement (n = 365, 94.6%) and pain was the most common patient injury (n = 114, 63.3%). Only 64/114 (56.1%) reports after 2015 reported adherence to the recommended MRI protocol. No adverse events occurred in patients with synchrony diametric-magnet CIDs. CONCLUSION: Despite the advent of FDA-approved MRI-safe diametric magnet devices, implanted patients are still experiencing injury, explantation, and device malfunction, and providers are reporting poor compliance with MRI safety protocols

Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: A MAUDE database review

© 2020 Elsevier Inc. Background: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. Objective: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration\u27s (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. Methods: A search of the FDA MAUDE database was conducted using the product code “MNQ” for “Inspire stimulator for sleep apnea.” Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. Results: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). Conclusion: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence

Adverse events associated with the Inspire implantable hypoglossal nerve stimulator: A MAUDE database review.

© 2020 Elsevier Inc. Background: Implantable hypoglossal nerve stimulation (HNS) has been found to be a safe and effective therapy for patients with obstructive sleep apnea, and patient adherence to treatment has been found to be as high as 86% after 12 months of therapy. Objective: The purpose of this study is to review the medical device reports (MDRs) submitted to the Food and Drug Administration\u27s (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events related to HNS therapy that could hinder compliance. Methods: A search of the FDA MAUDE database was conducted using the product code “MNQ” for “Inspire stimulator for sleep apnea.” Reports of adverse events associated with Inspire for sleep apnea from January 2000 to May 2020 were included for analysis. From these included reports, event variables were collected, including event setting, adverse event to patient, iatrogenic injury, device malfunction, interventions, and root causes. Results were compiled and reviewed. Results: The search query yielded 180 reports that met inclusion criteria, containing a total of 196 adverse events. The most commonly reported adverse events to patients were infection (n = 50, 34.2%), neuropraxia (n = 22, 15.1%) and hematoma/seroma (n = 17, 11.6%). A total of 83 adverse events (42.3%) required reoperation. The most common reoperations performed for adverse events to patients were explantation (n = 30, 46.2%) and device repositioning/lead revision (n = 24, 36.9%), while the most common reoperation performed for device malfunctions was device replacement (n = 10, 55.6%). Conclusion: In attempting to further improve patient compliance, understanding these device malfunctions and adverse events related to HNS implantation or usage is crucial for the identification of potential causes of patient non-adherence

Intraoral midline mandibulotomy to improve access for transoral robotic surgery (TORS) base of tongue resection in a retrognathic and microstomic patient.

A 74-year-old man was referred to a tertiary academic otolaryngology clinic for evaluation of a left-sided neck mass with unknown primary. Nuclear imaging modalities revealed a primary cancer located at the left tongue base. Further investigation revealed the tumour to be a p16 positive squamous cell cancer with metastatic spread to cervical lymph nodes of multiple levels. The patient was found on initial investigation to have microstomia and a retrognathic mandible, which are typically considered unsuitable for robotic surgery due to difficulties obtaining adequate exposure. The patient underwent bilateral neck dissection, followed by transoral robotic-assisted left base of tongue resection. A midline intraoral mandibulotomy was performed to improve robotic access. Following tumour resection, the mandible was repaired using open reduction with internal plate fixation. Postoperative occlusion was maintained, and the patient recovered well from mandibulotomy with none of the morbidity or cosmetic defects associated with a traditional lip-split approach

Operation time effect on rates of perioperative complications after operative treatment of distal radius fractures

© 2021 Professor P K Surendran Memorial Education Foundation Purpose: The purpose is to identify the impact of operation time length on complications for patients undergoing operative treatment of distal radius fracture. Methods: Patients who underwent operative treatments for distal radius fractures were identified in a national database. Data collected include patient demographic information, comorbidities, and complications. Results: Operation time was found to be an independent predictor for return to the operating room. Operation time was not found to be a predictor of other postoperative complications. Conclusion: Surgeons should work to shorten procedure duration whenever possible to minimize the risks that longer operative times can have on patient outcomes