Nasal Epistaxis Balloons: A Comprehensive MAUDE Database Analysis.

BACKGROUND: While nasal epistaxis balloons are generally seen as safe and routinely utilized by both surgical and nonsurgical providers, the complication profile related to this type of device has not been well defined. OBJECTIVE: The objective of this study was to utilize the FDA MAUDE (Manufacturer and User Facility Device Experience) database to better assess adverse events (AE) related to use of nasal epistaxis balloons. Reports were individually tabulated and events were categorized with special attention to AEs. METHODS: The FDA MAUDE database was queried for all medical device reports (MDR) related to nasal epistaxis balloon devices from January 2012 to November 2022. RESULTS: 19 MDRs met inclusion criteria. 5 MDRs were classified as device related (26.3 %); two events were reported for balloon leak and deflation, two events were reported for device breakage, and one device related event was unknown. 14 MDRs (73.7 %) were classified as patient related. Two documented MDRs were patient deaths due to exsanguination. Additional serious AEs included balloon ingestion and subsequent small bowel perforation (n = 1), cerebrospinal fluid leak (n = 1), skull base violation and intracranial placement of the device (n = 1), and respiratory distress (n = 3). CONCLUSION: Though epistaxis control with nasal balloons is generally seen as a safe procedure, there have been several concerning AEs reported. While two reports of death due to exsanguination were the most severe AEs, multiple other life-threatening AEs were also documented. Increased awareness of associated complications can be used to better counsel patients during the informed consent process as well as providers in their clinical decision making.

Virtual surgical planning for mandibular reconstruction in an abbreviated admission pathway.

OBJECTIVES: Virtual Surgical Planning (VSP) creates individualized surgical plans for free flap reconstruction of mandibular defects. Prior studies indicate that VSP can offer cost benefits due to reduced operative time and length of stay (LOS). We assessed the impact of VSP in the context of a validated postoperative abbreviated LOS clinical pathway. METHODS: This study assessed patients undergoing VSP vs conventional fibular free flap reconstruction for mandibular defects (12/2015-10/2020) and their operative time, ischemia time, and LOS were evaluated. RESULTS: Forty-four patients underwent VSP reconstruction, while 52 patients underwent conventional reconstruction for mandibular defects. VSP was associated with significantly lower total operative time (6 h and 57 mins vs 7 h and 54 mins, p = 0.011), but not length of stay or ischemia time. Total OR time was significantly increased with increasing number of segments needed in both the VSP group (p = 0.002) and the conventional group (p = 0.015). CONCLUSION: Shorter operative times and LOS have been attributed to the use of VSP in free tissue transfers. It is argued that these reductions offset the added cost of VSP. Our study indicates that there is no cost benefit for VSP utilization due to a significantly reduced operative time with no impact on length of admission in an abbreviated admission clinical pathway following free tissue transfer.

Sinus culture differences in patients with radiographic evidence of odontogenic disease.

PURPOSE: Odontogenic sinusitis is a well-known entity with a different pathogenesis than chronic rhinosinusitis. Nonspecific symptoms can make diagnosis difficult. This study aims to compare culture results between patients with and without computed tomography findings indicative of possible odontogenic disease. MATERIALS AND METHODS: This was a retrospective cohort study in which patients undergoing endoscopic sinus surgery for chronic sinusitis over a three-year period at a single institution were reviewed. CT imaging was reviewed for evidence of dental disease, specifically periapical lucency, dehiscence of the floor of the maxillary sinus, oroantral fistula, or foreign body. Culture results were then assessed and compared between groups with CT evidence of a possible odontogenic source to those without. RESULTS: Overall, 231 patients were evaluated. 92 patients (39.8 %) were found to have evidence of a likely odontogenic source on CT. Cultures were available for 118 of 231 patients (51.1 %). Patients with CT signs of odontogenic disease were significantly more likely to grow Proteus mirabilis (p = 0.018) and Klebsiella pneumoniae (p = 0.037) on culture. Patients without CT signs of odontogenic sources were significantly more likely to grow Pseudomonas aeruginosa (p = 0.009). Of note, patients with CT findings concerning for an odontogenic source were also more likely to grow fungi other than Aspergillus and Mucor species on culture (p = 0.004). CONCLUSION: Patients with CT findings concerning for an odontogenic source of sinus disease showed differences in culture results that could be important in differentiating pathogenesis of sinus disease.

Is there a role for Eustachian tube balloon dilation in pediatric patients with refractory Eustachian tube dysfunction?

BACKGROUND: Eustachian tube dysfunction (ETD) is common in children. Over the past decade, eustachian tube balloon dilation (ETBD) has become a more widespread treatment for this condition. Data has been encouraging in the adult population, but data among the pediatric population has been sparser. This comprehensive review aims to assess current evidence for ETBD in pediatric patients. REVIEW: Studies relevant to ETBD in the pediatric population were identified by utilizing the PubMed MEDLINE database. While multiple retrospective studies were found, this search yielded two systematic reviews focused on the pediatric population as the highest level of evidence assessing ETBD in children. There was overlap of included studies, but each review contained a unique set of studies. These reviews found that ETBD was safe in children. BEST PRACTICE SUMMARY: Overall, ETBD appears safe and efficacious in children with refractory ETD. Future prospective trials confirming this conclusion are warranted. At this time, there appears to be a role for ETBD with or without ventilation tube placement in children with refractory ETD.

Sequential targeted delivery of paclitaxel and camptothecin using a cross-linked "nanosponge" network for lung cancer chemotherapy.

The applicability of a HVGGSSV peptide targeted "nanosponge" drug delivery system for sequential administration of a microtubule inhibitor (paclitaxel) and topoisomerase I inhibitor (camptothecin) was investigated in a lung cancer model. Schedule-dependent combination treatment with nanoparticle paclitaxel (NP PTX) and camptothecin (NP CPT) was studied in vitro using flow cytometry and confocal imaging to analyze changes in cell cycle, microtubule morphology, apoptosis, and cell proliferation. Results showed significant G2/M phase cell cycle arrest, changes in microtubule dynamics that produced increased apoptotic cell death and decreased proliferation with initial exposure to NP PTX, followed by NP CPT in lung cancer cells. In vivo molecular imaging and TEM studies validated HVGGSSV-NP tumor binding at 24 h and confirmed the presence of Nanogold labeled HVGGSSV-NPs in tumor microvascular endothelial cells. Therapeutic efficacy studies conducted with sequential HVGGSSV targeted NP PTX and NP CPT showed 2-fold greater tumor growth delay in combination versus monotherapy treated groups, and 4-fold greater delay compared to untargeted and systemic drug controls. Analytical HPLC/MS methods were used to quantify drug content in tumor tissues at various time points, with significant paclitaxel and camptothecin levels in tumors 2 days postinjection and continued presence of both drugs up to 23 days postinjection. The efficacy of the NP delivery system in sequential treatments was corroborated in both in vitro and in vivo lung cancer models showing increased G2/M phase arrest and microtubule disruption, resulting in enhanced apoptotic cell death, decreased cell proliferation and vascular density.

Complications of Mandibular Fracture Repair.

Mandible fracture management has evolved dramatically. Therefore, the variety of surgical complications associated with mandibular fractures, and their incidences, have continued to change as well. This article aims to assess the most common and most concerning complications that can occur secondary to management of mandibular fractures by examining categories of complication types. This article also explores factors and techniques associated with reduced rates of complications as well as the management of complications.

Eustachian Tube Balloon Dilation: A Comprehensive Analysis of Adverse Events.

BACKGROUND: Eustachian tube balloon dilation (ETBD) has been Food and Drug Administration (FDA) approved for refractory Eustachian tube dysfunction since 2016. While ETBD is generally seen as safe, the complication profile has not been well defined. OBJECTIVE: The objective of this study was to utilize the FDA manufacturer and user facility device experience (MAUDE) database to better assess adverse events (AE) related to ETBD. METHODS: This is a study of a multiinstitutional database maintained by the U.S. FDA. A database analysis was performed via the collaboration of multiple clinicians at tertiary referral centers. The FDA MAUDE database was queried for all medical device reports (MDR) related to ETBD devices from January 2012 to November 2022. Eighty-eight unique MDR were identified, 16 of which met inclusion criteria. RESULTS: Three MDRs were classified as device-related (18.8%); none resulted in an AE. Thirteen MDRs (81.3%) were patient-related; all were classified as AEs. The most common AE was postoperative subcutaneous emphysema (n = 6, 46.2%). Of the patients with subcutaneous emphysema, there was a wide range of severity. The most severe AE (n = 1, 6.3%) was postoperative stroke secondary to carotid artery dissection. CONCLUSION: Though ETBD is generally seen as a safe procedure, there have been several concerning AEs reported to date. Increased awareness of ETBD complications can serve as a primer for improved patient education and counseling during the informed consent process and aid surgeons in clinical decision-making. Future studies with standardized reporting protocols are warranted to create a central registry for ETBD.

Managing Chronic Rhinosinusitis with Nasal Polyps in the Elderly: Challenges and Solutions.

The proportion of the population over 65 years old continues to grow. Chronic rhinosinusitis is common in this population and causes a reduction in quality of life and an increase in health care utilization. Diagnosis of chronic rhinosinusitis with nasal polyps follows the same principles for elderly patients as in the general population, but the elderly population presents some diagnostic challenges worth considering. Presbynasalis, the anatomic and functional changes of the nose and paranasal sinuses associated with aging must be accounted for when caring for these patients. In addition, polypharmacy and other medical issues that can cause similar symptoms must be considered. Medical therapy is generally similar to the general population but with additional concerns given the propensity for geriatric patients to be on multiple medications and to suffer from multiple medical issues. Sinus surgery should be considered following the same indications as in the general population. While some authors have found higher complication rates in endoscopic sinus surgery, others have found higher rates of success. As always, the risks of surgery must be considered with the possible benefits on a patient-to-patient basis.

Clinical Significance of Screening Electrocardiograms for the Administration of Propranolol for Problematic Infantile Hemangiomas.

OBJECTIVE: Low-dose nonselective ß blockade is an effective treatment for problematic infantile hemangioma (PIH). Screening electrocardiograms (ECG) are performed prior to the initiation of propranolol to minimize the risk of exacerbating undiagnosed heart block. How ECG results affect subsequent propranolol usage and patient management remains unclear. We examined the value of ECG prior to propranolol therapy in a quaternary pediatric hospital. METHODS: A retrospective chart review was performed on all infants who received propranolol (2 mg/kg/day divided three times daily) to treat PIH at Arkansas Children's Hospital from Sept. 2008 to Sept. 2015. All available demographic, historical, and clinical data were obtained. ECGs and echocardiographic data were reviewed and summarized. A pediatric cardiologist read all ECGs. RESULTS: A total of 333 patients (75% female) received propranolol therapy. ECG information was available for 317 (95%). Abnormal findings were present on 44/317 (13.9%) of study ECGs. The most common abnormal finding was "voltage criteria for ventricular hypertrophy" (n = 35, 76.1%). Two patients had abnormal rhythms; one had first-degree atrioventricular (AV) block, and one had occasional premature atrial contractions. Of the 31 patients who underwent echocardiograms, 20 (35%) were abnormal. 2.9% of infants with PIH treated with propranolol required a follow-up with a cardiologist. No patient was precluded from taking propranolol due to the findings on screening ECG. CONCLUSIONS: Screening ECGs prior to propranolol therapy are abnormal in nearly 14% of patients with PIH but are unlikely to preclude therapy. In the absence of prior cardiac history, this cohort offers further evidence suggesting that screening ECGs may be of limited value in determining the safety of propranolol in otherwise healthy infants with PIH.

Opioid reduction in ambulatory thyroid and parathyroid surgery after implementing enhanced recovery after surgery protocol.

BACKGROUND: Opioid abuse is widespread in the United States and the risk for chronic use is increased in surgical patients, including patients with thyroid and parathyroid. METHODS: Records for 171 patients prior to and 67 patients following implementation of an enhanced recovery after surgery (ERAS) protocol for ambulatory thyroid/parathyroid surgeries were reviewed. The ERAS included superficial cervical plexus block, multimodal premedication, and postoperative reliance on acetaminophen and ibuprofen with judicious prescribing of opioids. RESULTS: Post-ERAS patients were prescribed a mean 72 morphine milligram equivalents (MME); pre-ERAS patients were prescribed a mean 163 MME (p < 0.001). 97.1% of pre-ERAS patients were prescribed opioids with 91.1% filled; 68.7% of post-ERAS study patients were prescribed opioids with 84.8% filled. CONCLUSION: Implementation of ERAS and focus on prescribing practices decreased the MME prescribed and used for ambulatory thyroid and parathyroid surgery. Future steps include increased patient education and tracking pain scores and medication utilization out of hospital.

Risk Factors for Posttracheostomy Tracheal Stenosis.

Objective To determine the incidence of posttracheostomy tracheal stenosis and to investigate variables related to the patient, hospitalization, or operation that may affect stenosis rates. Study Design A combined retrospective cohort and case-control study. Setting Tertiary care academic medical center. Subjects and Methods A total of 1656 patients who underwent tracheostomy at a tertiary care medical center from January 2011 to November 2016 were reviewed for evidence of subsequent tracheal stenosis on airway endoscopy or computed tomography. Forty-three confirmed cases of posttracheostomy tracheal stenosis (PTTS) were compared with a subgroup of 319 controls. Factors including medical comorbidity, type and setting of tracheostomy, and hospitalization details were analyzed. Results Five-year incidence of PTTS was 2.6%. Obesity was the sole demographic factor associated with stenosis. Hospitalization-related variables associated with stenosis included tracheostomy after 10 days of orotracheal intubation and endotracheal tube cuff pressure ≥30 mm H2O. The surgical variables associated with higher rates of stenosis included percutaneous technique and insertion of an initial tracheostomy tube size >6. Bjork flap creation was negatively associated with stenosis. In multivariable analysis, obesity and insertion of tracheostomy tube size >6 were identified as risk factors. Conclusion Greater than 10 days of orotracheal intubation prior to tracheostomy and endotracheal tube cuff pressure ≥30 mm H2O were associated with greater rates of subsequent tracheal stenosis. The only patient-related factor associated with tracheal stenosis was obesity. Surgical variables associated with increased rates of subsequent stenosis included placement of a tracheostomy tube size >6, use of percutaneous technique, and failure to create a Bjork flap.

Impact of functional status and medical comorbidities on tracheostomy decannulation in pediatric patients.

PURPOSE: To determine if medical or functional factors influence the ability of a pediatric patient with a tracheostomy to tolerate decannulation. Retrospective evaluation of patients at a tertiary Children's Hospital undergoing evaluation with capped tracheostomy polysomnogram (cPSG) for possible tracheostomy decannulation. Charts were reviewed for demographic information, functional status, cPSG characteristics, and success or failure of decannulation. Statistical analysis was performed to determine which patient factors were predictive of successful decannulation. A total of 139 sleep studies were analyzed in 104 unique children followed for at least 1 year after a cPSG was performed to determine readiness for decannulation. At 1 year after most recent PSG, 79.8% of children were decannulated. There was no significant association between any single comorbid condition and the ability to decannulate. There was no association between individual or total functional status score and successful decannulation. Patients with at least 3 comorbid conditions investigated and a total functional score less than 7 were less likely to be decannulated successfully than other patients (71% vs. 93%, p= 0.04). Functional status and comorbid conditions do not independently predict successful decannulation. Regular multi-disciplinary team reevaluation is indicated in patients with lower functional status, as removal of tracheostomy tube may be successfully accomplished.

The effect of perioperative dexamethasone dosing on post-tonsillectomy hemorrhage risk.

OBJECTIVES: Dexamethasone is currently recommended for routine prophylaxis against postoperative nausea and vomiting after tonsillectomy procedures. However, some studies have raised concern that dexamethasone use may lead to higher rates of post-tonsillectomy hemorrhage. Our objective was to determine whether higher doses of dexamethasone administered perioperatively during tonsillectomy procedures are associated with an increased risk of secondary post-tonsillectomy hemorrhage. METHODS: We conducted a retrospective review of 9843 patients who underwent tonsillectomy and received dexamethasone at our institution from January 2010 to October 2014. We compared the dose of dexamethasone administered to patients who did and did not develop secondary post-tonsillectomy hemorrhage using Mann Whitney U tests. Multivariable logistic regression models were used to evaluate the association between dexamethasone dose and post-tonsillectomy hemorrhage after adjustment for demographic and clinical characteristics. RESULTS: A total of 280 (2.8%) patients developed secondary post-tonsillectomy hemorrhage. Patients who developed hemorrhage tended to be older (median (interquartile range) 7 (4-11) vs. 5 (3-8) years), p < 0.001) and had undergone tonsillectomy more often for chronic tonsillitis but less often for tonsillar or adenotonsillar hypertrophy or sleep disturbances. Dexamethasone dose was significantly lower on average in patients who experienced secondary post-tonsillectomy hemorrhage (median (interquartile range) 0.19 (0.14, 0.23) mg/kg vs. 0.21 (0.17, 0.30), p < 0.001). Multivariable modeling demonstrated that the dose of dexamethasone was not significantly associated with post-tonsillectomy hemorrhage after adjustment for age. CONCLUSIONS: There does not appear to be a dose-related increase in the risk of post-tonsillectomy hemorrhage for patients receiving dexamethasone during tonsillectomy procedures.