Changes in Single-Specialty Postoperative Opioid Prescribing Patterns in Response to Legislation: Single-Institution Analysis Over Time

Objectives To determine changes in the prescriptions of postoperative opioids in response to Florida state legislation restricting the number of days for which these medications could be prescribed to 3 days in most circumstances or 7 days at provider discretion. Study Design A retrospective review was performed for all patients undergoing 7 common outpatient otolaryngology surgical procedures. Setting Single-institution academic center in Florida. Methods Query of the state’s online prescription drug monitoring program was used to compare prescription habits 3 months before and after the law and then again 1 year later. Results A total of 561 patients were identified meeting criteria. The number of days that opioids were prescribed decreased significantly, from 6.42 to 4.48 to 3.03 days. There was a significant decrease in the proportion of patients receiving any postoperative opioid prescription, from 0.80 to 0.52 to 0.32. The total morphine milligram equivalents prescribed decreased from 28.4 before the law to 18.4 at 1 year after. Conclusions Legislative restrictions on the length of opioid prescriptions were associated with significant decreases in the proportion of patients receiving any opioids, the number of days that opioids were prescribed, and the total morphine milligram equivalents 3 months after the law went into effect, with even more dramatic changes at the 1-year time point. We opine that these changes are due to providers learning that many procedures do not require postoperative opioids and therefore increasingly considering and utilizing nonopioid alternatives in this setting

Head and Neck Cancer Patients: Rates, Reasons, and Risk Factors for 30-Day Unplanned Readmission

Objective To analyze rates, risk factors, and complications for 30-day readmission among head and neck cancer (HNC) patients. Methods Retrospective review of administrative records from Vizient (Irving, Texas) Clinical Data Base/Resource Manager on HNC patients who underwent a head and neck surgical procedure from January 2013 through September 2015 at 176 academic and community medical centers. Results Of the 18,121 patients included in the study, 2502 patients were readmitted within 30 days (13.8%). Mean time to readmission was 11 ± 8.2 days. Cancer of the hypopharynx, oropharynx, pharynx, and larynx all had higher odds of readmission compared to oral cavity (odds ratio [OR], 1.8, 1.7, 1.6, and 1.5; 95% confidence interval [CI], 1.4-2.2, 1.4-1.9, 1.2-2.3, and 1.3-1.7, respectively). Consistent with this, flap procedures and laryngectomy had the highest odds of readmission (OR, 1.4 and 1.3; 95% CI, 1.3-1.6 and 1.0-1.5 vs glossectomy, respectively). The most common surgical causes for readmission were postoperative infection (17.6%) and surgical wound dehiscence (16.8%), which most commonly presented on postdischarge days 4 to 5. Acute cardiac events occurred in up to 15.4% of patients depending on complexity of surgery. Dysphagia and electrolyte disturbances were common (15.8% and 15.4%, respectively); patients with these complications typically presented earlier, between days 3 and 4. Discussion Patients with HNC are at high risk of readmission. The cancer subsite and procedure significantly influenced the risk, rate, and reason for readmission. Implications for Practice Findings from this study can help quality improvement and patient safety administrators develop interventions that uniquely target HNC populations

Drug Repurposing in the Treatment of Traumatic Brain Injury

Traumatic brain injury (TBI) is the most common cause of morbidity among trauma patients; however, an effective pharmacological treatment has not yet been approved. Individuals with TBI are at greater risk of developing neurological illnesses such as Alzheimer’s disease (AD) and Parkinson’s disease (PD). The approval process for treatments can be accelerated by repurposing known drugs to treat the growing number of patients with TBI. This review focuses on the repurposing of N-acetyl cysteine (NAC), a drug currently approved to treat hepatotoxic overdose of acetaminophen. NAC also has antioxidant and anti-inflammatory properties that may be suitable for use in therapeutic treatments for TBI. Minocycline (MINO), a tetracycline antibiotic, has been shown to be effective in combination with NAC in preventing oligodendrocyte damage. (−)-phenserine (PHEN), an anti-acetylcholinesterase agent with additional non-cholinergic neuroprotective/neurotrophic properties initially developed to treat AD, has demonstrated efficacy in treating TBI. Recent literature indicates that NAC, MINO, and PHEN may serve as worthwhile repositioned therapeutics in treating TBI

Complications Associated with PROPEL Mometasone Furoate Bioabsorbable Drug-eluting Sinus Stents From 2012 to 2020

Background: Till date, there have been no studies that have analyzed a database to examine postmarket adverse events associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Objective: To determine the postmarket complications associated with PROPEL mometasone furoate bioabsorbable drug-eluting sinus stents. Methods: The US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was searched for adverse events associated with PROPEL bioabsorbable drug-eluting sinus stents between January 1, 2012 and December 31, 2020. Data were extracted and analyzed from medical device reports (MDRs) that involved sinus stents. Results: After 47 MDRs were identified, 25 reports involving PROPEL bioabsorbable drug-eluting sinus stents were reviewed, from which 40 adverse events were recorded. Of these, there were 32 adverse events to patients and 8 device malfunctions. The most common adverse events to patients included infection (21.8%), oropharyngeal obstruction (15.6%), and headache/pain (12.5%). The most common device malfunction reported was migration and expulsion of the stent (87.5%). Conclusions: PROPEL sinus stents have been shown to be effective in preventing sinus outflow obstruction after functional endoscopic sinus surgery. Both adverse events to patients and device malfunctions are reported infrequently. A more comprehensive understanding of rare postmarket complications seen with PROPEL sinus stents may further aid informed decision-making regarding their usage

Pediatric bilateral vocal cord granulomas presenting as airway foreign body following prolonged intubation due to COVID-19 related multisystem inflammatory syndrome

Background: This report is a case of bilateral vocal cord granulomas (VCG) in a 9-year-old child presenting as an airway foreign body and stridor following prolonged intubation due to COVID-19 pneumonia complicated by multisystem inflammatory syndrome in children (MIS-C). Case presentation: This case reports a 9-year-old male who presented to the emergency department with acute stridor concerning for airway obstruction. X-ray findings suggested an airway foreign body; however, on rigid bronchoscopy, ball-valving bilateral VCG obstructing 90% of the glottic airway were identified. After excision of the VCGs, the patient's symptoms resolved with no postoperative complications. Conclusion: With suspected foreign body aspiration in a pediatric patient with a history of prolonged intubation, it is important to consider a broad differential diagnosis. VCGs are rare complications of prolonged intubation that could be in children with prior history of intubation following COVID-19 pneumonia

Multidisciplinary Post-Operative Care Pathway to Reduce Readmissions Following Endoscopic Transsphenoidal Pituitary Surgery

Background: Thirty-day unplanned readmission following endoscopic transsphenoidal pituitary surgery (ETPS) occurs in up to 14% of patients. Delayed hyponatremia is one of the most common causes, accounting for 30% of readmissions and often occurs within 1 week of surgery. The authors prior retrospective review identified endocrinology follow up as protective factor. Objectives: Implementation of a multidisciplinary post-operative care pathway (POC pathway): (a) to reduce 30-day hospital readmissions following ETSP; (b) improve inpatient and outpatient coordination of care with endocrinologist. Methods: Single institution temporal cohort study of patients prior to (control cohort) and after implementation of the POC pathway (intervention cohort). The POC pathway utilized post-discharge 1-1.5L/day fluid restriction, a post-operative day 5-7 serum sodium, and endocrinology follow up within 1 week of discharge to stratify patients into tiered hyponatremia regimens. Results: 542 patients were included in the study, 409 (75%) in the control cohort and 133 (25%) in the intervention cohort. All cause readmission was significantly reduced following implementation of the POC pathway (14% vs 6%, p=0.015). Coordination with endocrinologist significantly increased in the inpatient (96% vs. 83%, p <0.001)) and outpatient (77% vs. 68%, p=0.042) setting. Patients who were not in the POC pathway had the highest risk of readmission (OR: 2.5; 95% CI: 1.1-5.5). Conclusions: A multidisciplinary POC pathway incorporating endocrinologist in conjunction with post-discharge weight-based fluid restriction and post-operative serum sodium levels can safely be used to reduce 30-day readmissions following ETPS. </jats:p

30-Day Readmissions and Coordination of Care Following Endoscopic Transsphenoidal Pituitary Surgery: Experience with 409 Patients

Abstract Objective  The study aimed to (1) quantify readmission rates and common causes of readmission following endoscopic transsphenoidal pituitary surgery (ETPS); (2) identify risk factors that may predict readmission within 30 days; (3) assess postoperative care coordination with endocrinology follow-up; and (4) identify patients for whom targeted interventions may reduce 30-day readmissions. Methods  Retrospective quality improvement review of patients with pituitary adenoma who underwent ETPS from December 2010 to 2018 at a single tertiary care center. Results  A total of 409 patients were included in the study, of which 57 (13.9%) were readmitted within 30 days. Hyponatremia was the most common cause of readmission (4.2%) followed by pain/headache (3.9%), cerebrospinal fluid leak (3.4%), epistaxis (2.7%), hypernatremia (1.2%), and adrenal insufficiency (1.2%). Patients with hyponatremia were readmitted significantly earlier than other causes (4.3 ± 2.2 vs. 10.6 ± 10.9 days from discharge, p  = 0.032). Readmitted patients had significantly less frequent outpatient follow-up with an endocrinologist than the nonreadmitted cohort (56.1 vs. 70.5%, p  = 0.031). Patients who had outpatient follow-up with an endocrinologist were at lower risk of readmission compared with those without (odds ratio: 0.46; 95% confidence interval: 0.24–0.88). Conclusion  Delayed hyponatremia is one of the most common causes of 30-day readmission following ETPS. Postoperative follow-up with an endocrinologist may reduce risk of 30-day readmission following ETPS. Implications for Clinical Practice  A multidisciplinary team incorporating otolaryngologist, neurosurgeons, and endocrinologist may identify patients at risk of 30-day readmissions. Protocols checking serum sodium within 1 week of surgery in conjunction with endocrinologist to tailor fluid restriction may reduce readmissions from delayed hyponatremia

Rare presentation of angiomatosis in the paranasal sinuses mimicking juvenile nasopharyngeal angiofibroma in a 16 year old male

Rare presentation of pediatric angiomatosis of the paranasal sinus and skull base presenting mimicking juvenile nasopharyngeal angiofibroma (JNA). This is a 16-year-old male who presented to the emergency room with acutely worsening headaches, decreased visual acuity, subjective diplopia on lateral gaze, and a skull base mass centered in the sphenoid cavity. Endoscopic biopsy at an outside facility was aborted due to profuse bleeding. Upon transfer to a tertiary care center, contrast MR demonstrated a heterogeneously and avidly enhancing vascular mass centered around the sphenoid and skull base originating from the internal maxillary artery with significant bilateral extension into the adjacent paranasal sinuses, sella, and cavernous sinus. History of presentation and imaging was suggestive of JNA. Patient underwent preoperative embolization followed by endoscopic endonasal transphenoidal resection with a skull base trained otolaryngologist and neurosurgeon. Final pathology confirmed angiomatosis. This is only the second reported case of paranasal sinus angiomatosis in the literature. Angiomatosis has a high rate of recurrence and failure of timely diagnosis can lead to requirement of repeated surgical intervention. Re-operations are associated with increased costs, patient dissatisfaction, and poorer surgical/clinical outcomes. Because angiomatosis can mimic JNA, hemangiomas, or other vascular tumors, it is essential to maintain a broad differential diagnosis that includes angiomatosis when evaluating sinonasal tumors

GMP-grade human neural progenitors delivered subretinally protect vision in rat model of retinal degeneration and survive in minipigs

Abstract Background Stem cell products are increasingly entering early stage clinical trials for treating retinal degeneration. The field is learning from experience about comparability of cells proposed for preclinical and clinical use. Without this, preclinical data supporting translation to a clinical study might not adequately reflect the performance of subsequent clinical-grade cells in patients. Methods Research-grade human neural progenitor cells (hNPC) and clinical-grade hNPC (termed CNS10-NPC) were injected into the subretinal space of the Royal College of Surgeons (RCS) rat, a rodent model of retinal degeneration such as retinitis pigmentosa. An investigational new drug (IND)-enabling study with CNS10-NPC was performed in the same rodent model. Finally, surgical methodology for subretinal cell delivery in the clinic was optimized in a large animal model with Yucatan minipigs. Results Both research-grade hNPC and clinical-grade hNPC can survive and provide functional and morphological protection in a dose-dependent fashion in RCS rats and the optimal cell dose was defined and used in IND-enabling studies. Grafted CNS10-NPC migrated from the injection site without differentiation into retinal cell phenotypes. Additionally, CNS10-NPC showed long-term survival, safety and efficacy in a good laboratory practice (GLP) toxicity and tumorigenicity study, with no observed cell overgrowth even at the maximum deliverable dose. Finally, using a large animal model with the Yucatan minipig, which has an eye size comparable to the human, we optimized the surgical methodology for subretinal cell delivery in the clinic. Conclusions These extensive studies supported an approved IND and the translation of CNS10-NPC to an ongoing Phase 1/2a clinical trial (NCT04284293) for the treatment of retinitis pigmentosa. Graphical abstrac