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1.
Am J Otolaryngol ; 45(1): 104069, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-37862881

RESUMEN

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.


Asunto(s)
Epistaxis , Exsanguinación , Humanos , Estados Unidos , Epistaxis/etiología , Epistaxis/terapia , Bases de Datos Factuales
2.
Am J Otolaryngol ; 45(2): 104132, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38039912

RESUMEN

OBJECTIVE: Granulomatosis with polyangiitis is associated with otolaryngologic complaints in 70-95 % of cases, with the most common being serous otitis media. In rare cases, patients may experience facial nerve palsy in conjunction with otologic or nasal symptoms; and, often, initially present to an otolaryngologist. It is important for healthcare professionals to be able to recognize the nuisances of facial nerve palsy as a potential presentation of granulomatosis with polyangiitis. STUDY DESIGN: Systematic review. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol, PubMed and MED-LINE Databases were queried for articles published from January 2007 to December 2022 describing facial nerve palsy in the context of Granulomatosis with polyangiitis, formerly known as Wegener's Granulomatosis. The keywords included "facial nerve palsy", "facial palsy", "granulomatosis with polyangiitis", "Wegener's granulomatosis", "ANCA positive" in the title/abstract. All full-text articles available in English were screened, including single case presentations. Abstracts, commentaries, and publications deemed outside the scope of our study aims were excluded from review. After removal of duplicate articles, a total of 85 articles were screened. After applying inclusion and exclusion criteria, 14 articles were included in the review. RESULTS: There were a total of 28 reports of facial nerve palsy in the literature in patients who were eventually diagnosed with granulomatosis with polyangiitis. The patients' ages ranged from 14 to 68 years old. None of the patients had been previously diagnosed with GPA, and a majority of them presented initially with other otologic symptoms. Hearing loss was reported in 24 patients (86 %), otalgia was present in 11 patients (39 %), and otorrhea was present in 6 patients (21 %). Bilateral facial paralysis was reported in 10 patients in the literature (36 %). In total, 16 patients underwent surgery for facial paralysis: 6 tympanomastoidectomies, 4 mastoidectomies, 2 explorative tympanotomies. Surgery was generally considered ineffective in resolving facial weakness. All patients ended up receiving some combination of steroids and immunosuppressant, most commonly prednisolone and cyclophosphamide or rituximab, which was eventually transitioned to azathioprine for maintenance. Unlike auditory thresholds, which remained decreased in two patients, all patients recovered facial function following appropriate medical treatment of their vasculitis. CONCLUSIONS: Facial nerve paralysis in patients with granulomatosis with polyangiitis is a rare but treatable phenomenon. In patients with intractable otitis media, unresolving facial palsy, or a combination of otologic issues, it is important to consider GPA as a possible source. The prognosis for facial function appears to be excellent in patients who undergo appropriate treatment for vasculitis, but further studies are needed for confirmation.


Asunto(s)
Parálisis de Bell , Parálisis Facial , Granulomatosis con Poliangitis , Pérdida Auditiva , Humanos , Adolescente , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Parálisis Facial/diagnóstico , Parálisis Facial/etiología , Parálisis Facial/terapia , Granulomatosis con Poliangitis/complicaciones , Granulomatosis con Poliangitis/diagnóstico , Granulomatosis con Poliangitis/terapia , Nervio Facial , Pérdida Auditiva/complicaciones
3.
Am J Otolaryngol ; 45(4): 104297, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38692072

RESUMEN

IMPORTANCE: The symptoms of primary hyperparathyroidism are often subtle, such as fatigue, mood changes, and sleep disturbances. After parathyroidectomy, patients often report improvement in sleep and mood; however, objective data supporting these improvements is lacking. OBJECTIVE: This prospective study uses standard measures to objectively and subjectively assess sleep in patients with primary hyperparathyroidism before and after parathyroidectomy. DESIGN: A longitudinal prospective study was conducted over three one-week-long periods: pre-parathyroidectomy, 1-week post-parathyroidectomy, and three months post-parathyroidectomy. During each time point, patients wore an actigraphy device, recorded a sleep diary, and completed the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and Depression Anxiety Stress Scale (DASS). Statistical analysis was performed using repeated measures models to compare the average measures among the three time points and test for trends over time. SETTING: Single institution, tertiary care center. PARTICIPANTS: Patients with primary hyperparathyroidism from ages 18 to 89 years old. EXPOSURE: Parathyroidectomy between September 2020 and January 2024. MAIN OUTCOMES AND MEASURES: Actigraphy data, consensus sleep diary, Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Depression Anxiety Stress Scales - 21 Items (DASS). RESULTS: Thirty-six patients were enrolled, and 34 patients completed the study. Actigraphy data showed a significant negative trend in average sleep latency (p = 0.045) and average time in bed (p = 0.046). Sleep diary data showed additional differences in the number of awakenings (p = 0.002), wake after sleep onset (p < 0.001), sleep quality (p < 0.001), and sleep efficiency (p = 0.02) among the three time points and/or as a significant negative trend. PSQI and ISI scores were significantly different among the three time points (p = 0.002 and p < 0.001, respectively) and also declined significantly over time (p = 0.008 and p = 0.007, respectively). DASS depression, anxiety, and stress scores were significantly different among the three time points (p < 0.001, p = 0.01, and p < 0.001, respectively), and stress also declined significantly over time (p = 0.005). CONCLUSION AND RELEVANCE: This study represents the most extensive prospective study demonstrating objective and subjective sleep and mood improvement in patients with primary hyperparathyroidism after parathyroidectomy.


Asunto(s)
Actigrafía , Hiperparatiroidismo Primario , Paratiroidectomía , Humanos , Hiperparatiroidismo Primario/cirugía , Hiperparatiroidismo Primario/complicaciones , Hiperparatiroidismo Primario/psicología , Persona de Mediana Edad , Masculino , Femenino , Estudios Prospectivos , Anciano , Adulto , Estudios Longitudinales , Anciano de 80 o más Años , Calidad del Sueño , Adulto Joven , Adolescente , Depresión/etiología , Resultado del Tratamiento , Sueño/fisiología , Índice de Severidad de la Enfermedad , Trastornos del Inicio y del Mantenimiento del Sueño/etiología
4.
Am J Otolaryngol ; 44(4): 103896, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37068320

RESUMEN

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.


Asunto(s)
Enfermedades del Oído , Trompa Auditiva , Adulto , Humanos , Niño , Dilatación , Estudios Retrospectivos , Endoscopía , Cateterismo , Enfermedades del Oído/terapia
5.
Am J Otolaryngol ; 44(5): 103961, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37343508

RESUMEN

OBJECTIVE: To review and summarize reported adverse events related to the use of porcine small intestine submucosal grafts (Biodesign™) in otologic procedures. STUDY DESIGN: Retrospective cross-sectional analysis. SETTING: Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. MATERIAL AND METHODS: The MAUDE database was queried for all medical device reports (MDR) related to otologic use of Biodesign™ (Cook Medical, Bloomington, IN) from January 2016 to November 2022. Adverse events (AEs) were identified by reviewing all reports with the basic search term "Biodesign" and "Biodesign, Otologic". Reports were individually reviewed and categorized with special attention to AEs. RESULTS: A total of 500 reports were reviewed. Since FDA approval of Biodesign™ in 2016, there have been 5 adverse events reported for use of Biodesign™ during otologic surgery (tympanoplasty, n = 3; stapes surgery, n = 2). All reported events described patient injury, and all cases required at least one revision surgery. Four cases described significant foreign body inflammatory reactions. Complications included hearing loss (n = 3), severe otalgia (n = 2), persistent perforation (n = 2), vertigo (n = 2), and facial paralysis (n = 1). CONCLUSION: The use of porcine small intestinal submucosal graft has been thought to be a safe and effective option for otologic surgery, with the advantage of availability without graft harvest in minimally invasive endoscopic surgery. However, foreign body or granulomatous reactions have been documented and should be considered prior to its use in otologic surgery.


Asunto(s)
Cuerpos Extraños , Procedimientos Quirúrgicos Otológicos , Humanos , Porcinos , Animales , Estados Unidos , Estudios Retrospectivos , Estudios Transversales , Procedimientos Quirúrgicos Otológicos/efectos adversos , Endoscopía , Bases de Datos Factuales
6.
Am J Otolaryngol ; 43(5): 103553, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35988364

RESUMEN

OBJECTIVE: Cochlear implant (CI) migration due to head trauma is a rare complication, and there is limited data summarizing this topic. This review seeks to provide a more comprehensive understanding of risk factors, clinical presentations, diagnosis, and intervention strategies for traumatic CI displacement. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Protocol was followed using the PubMed and MED-LINE databases from 2000 to 2021, with manual cross-checks of reference lists of identified articles for additional relevant studies. The keywords used for database searches included "cochlear implant", "migration", "displacement", "extrusion" and "head trauma". All full-text articles available in English were screened, including single case presentations. Abstracts, commentaries, and publications deemed outside the scope of our study aims were excluded from review. RESULTS: After the removal of duplicate articles, a total of 152 articles were screened. After applying inclusion and exclusion criteria, 11 articles were included in the review. Due to heterogeneity of the available literature, a qualitative synthesis was employed to integrate results by identifying common themes among the relevant studies. CONCLUSIONS: The incidence of traumatic CI migration is extremely low and can be due to receiver-stimulator displacement, magnet displacement, or electrode extrusion. Migration occurred anywhere from 3 months to 26 years after implantation, suggesting that risk of migration from head trauma does not depend solely on time from implantation. There are several methods for repairing migrated CI, but there is limited data comparing operative techniques, specifically in the prevention of traumatic CI migration.


Asunto(s)
Implantación Coclear , Implantes Cocleares , Traumatismos Craneocerebrales , Implantación Coclear/efectos adversos , Implantes Cocleares/efectos adversos , Traumatismos Craneocerebrales/etiología , Humanos
7.
J Craniofac Surg ; 33(6): 1754-1761, 2022 Sep 01.
Artículo en Inglés | MEDLINE | ID: mdl-35949018

RESUMEN

INTRODUCTION: Advances in operative management, minimally invasive procedures, and physical therapy have allowed for dramatic improvements in functional and cosmetic outcomes in patients with facial paralysis. Our goal was to evaluate the current trends and practice patterns in the diagnosis and management of facial paralysis by provider demographics. MATERIALS AND METHODS: An electronic questionnaire was distributed to members of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS). Practice patterns in the diagnosis and treatment were compared by level of training (fellowship-trained facial plastic and reconstructive surgeon versus non-fellowship trained), practice type (academic and private), practice length, patient volume, and presence of a dedicated facial nerve clinic. The bivariate associations of the outcome variables and the stratification factors were analyzed using 2-way contingency tables and Fisher's exact tests. RESULTS: The survey was sent to 1129 members of the AAFPRS. The response rate was 11.7% (n=132). Most respondents were fellowship-trained surgeons (79%) in the academic setting (55%), and most have been in practice for more than 10 years (53%). Practice setting and patient volume were the factors most associated with significant variations in management, including the use of facial paralysis grading scales, photography/videography, patient-reported outcome metrics, as well as differences in both noninvasive and surgical management. CONCLUSION: Based on the present study, several physician demographic factors may play a role in choosing which diagnostic and treatment options are employed for facial paralysis, with practice setting and patient volume appearing to be the 2 variables associated with the most significant differences.


Asunto(s)
Parálisis Facial , Cirujanos , Cirugía Plástica , Parálisis Facial/diagnóstico , Parálisis Facial/cirugía , Becas , Humanos , Pautas de la Práctica en Medicina , Cirugía Plástica/educación , Encuestas y Cuestionarios , Estados Unidos
8.
ORL J Otorhinolaryngol Relat Spec ; 83(4): 219-226, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33853078

RESUMEN

INTRODUCTION: The precise etiology of Ménière's disease (MD) remains unknown; however, given the association of MD with serum antibodies and human leukocyte antigen (HLA) complex, several studies have proposed a relationship between MD and thyroid disorders. Similarly, multiple hypotheses exist regarding the metabolic disturbances of fluctuating thyroid hormone as a potential contributing agent in the development of MD. METHODS: A total of 171 abstracts were identified and screened by 2 independent reviewers. Based on inclusion and exclusion criteria, 8 studies were selected for final analysis. Due to heterogeneity of clinical data, meta-analysis was not feasible. RESULTS: The prevalence of autoimmune thyroid disease and hypothyroidism in MD varied significantly from 1 to 38%. Notable bias was introduced given the lack of standardization of diagnostic criteria across studies. Articles that described autoimmune thyroid-specific antibodies and HLA types also presented inconclusive results. Multiple studies noted a potential etiologic role of hypothyroidism in MD, which was often confounded by thyroxine supplementation. CONCLUSIONS: Despite a potential correlation in the medical literature between thyroid disorders and MD, there is currently no definitive causal relationship. Although most of the present medical literature focuses on autoimmunity, dysregulated thyroid hormone levels may also be implicated in the association of MD with thyroid disorders.


Asunto(s)
Enfermedad de Meniere , Enfermedades de la Tiroides , Humanos , Enfermedad de Meniere/complicaciones , Enfermedad de Meniere/epidemiología , Prevalencia , Enfermedades de la Tiroides/complicaciones , Enfermedades de la Tiroides/epidemiología
9.
Ann Plast Surg ; 85(2S Suppl 2): S166-S170, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32541542

RESUMEN

BACKGROUND: The global COVID-19 pandemic has had a profound impact on facial plastic and reconstructive surgery. Our review serves as a safety resource based on the current literature and is aimed at providing best-practice recommendations. Specifically, this article is focused on considerations in the management of craniomaxillofacial trauma as well as reconstructive procedures after head and neck oncologic resection. METHODS: Relevant clinical data were obtained from peer-reviewed journal articles, task force recommendations, and published guidelines from multiple medical organizations utilizing data sources including PubMed, Google Scholar, MEDLINE, and Google search queries. Relevant publications were utilized to develop practice guidelines and recommendations. CONCLUSIONS: The global COVID-19 pandemic has placed a significant strain on health care resources with resultant impacts on patient care. Surgeons operating in the head and neck are particularly at risk of occupational COVID-19 exposure during diagnostic and therapeutic procedures and must therefore be cognizant of protocols in place to mitigate exposure risk and optimize patient care.


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/prevención & control , Traumatismos Craneocerebrales/cirugía , Cara/cirugía , Neoplasias de Cabeza y Cuello/cirugía , Pandemias/prevención & control , Atención Perioperativa/métodos , Procedimientos de Cirugía Plástica/métodos , Neumonía Viral/prevención & control , COVID-19 , Protocolos Clínicos , Asignación de Recursos para la Atención de Salud , Humanos , Control de Infecciones/métodos , Atención Perioperativa/normas , Procedimientos de Cirugía Plástica/normas , SARS-CoV-2
10.
Facial Plast Surg ; 36(5): 628-634, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-32791532

RESUMEN

The aim of the study is to: (1) evaluate national trends in care of facial paralysis, namely Bell's palsy, patients to identify the types of treatments patients are receiving and treatment gaps and (2) identify if newer, more complex surgical therapies published in the literature are being employed. Data were collected from the MarketScan Commercial Claims and Encounters Database by Truven Health. From the database, all inpatient and outpatient claims with International Classification of Diseases, 9th Revision, Clinical Modification diagnosis codes for facial paralysis/dysfunction between 2005 and 2013 were extracted. Trends in medical and surgical management were evaluated specifically cataloging the use of steroids, antivirals, botulinum toxin, surgical and rehabilitation service current procedural terminology codes. A total of 42,866 of patients with a formal diagnosis of Bell's palsy were identified with 39,292 (92%) adults and 3,754 (8%) children (< 18 years old), respectively. Steroids were provided to 50.1% of children and 59.8% of adults and antivirals were prescribed to 26.2 and 39.4% of the children and adults, respectively. Within the first 2 years after diagnosis, 0.5% of children and 0.9% of adults received surgery, 0.1% of children and 0.8% of adults received botulinum toxin treatments, and 10.9% of children and 21.5% of adults received rehabilitation services. Despite the limitations of a claims database study, results showing trends in care of facial paralysis are still nonsurgical with many patients receiving no treatment at all. Although limited literature has shown an increase in the use of pharmacotherapy as well as techniques including physiotherapy, chemodenervation, and various surgical therapies, these interventions may be underutilized.


Asunto(s)
Antivirales , Parálisis de Bell , Parálisis Facial , Adolescente , Adulto , Antivirales/uso terapéutico , Parálisis de Bell/diagnóstico , Parálisis de Bell/tratamiento farmacológico , Niño , Quimioterapia Combinada , Parálisis Facial/terapia , Humanos , Esteroides/uso terapéutico
11.
Ann Plast Surg ; 83(2): 190-194, 2019 08.
Artículo en Inglés | MEDLINE | ID: mdl-31232802

RESUMEN

INTRODUCTION: Facial paralysis (FP) has many functional consequences with a large impact on daily life. Although an association with FP and depression has been observed and described in the literature, there are currently no large-scale studies to further validate this correlation. Our goal was to determine whether patients with FP become depressed at a higher rate compared with matched controls. METHODS: We performed a retrospective cohort study using MarketScan Commercial Claims and Encounters Database by Truven Health. From the database, all inpatient and outpatient claims with International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes for FP and depression between 2005 and 2013 were extracted. Patients younger than 18 years were categorized as children and those 18 years or older as adults. Patients were subcategorized as having a history of depression if a diagnosis of depression preceding a diagnosis of FP was noted. We matched each patient to a control in the MarketScan database based on age, sex, and state of residence. We compared rates of depression between these patients and matched controls using conditional logistic regression. The method of Kaplan and Meier was used to estimate cumulative incidence curves of depression by each group. RESULTS: Approximately 57,941 patients were identified with International Classification of Diseases, Ninth Revision, codes for FP. Among children and adult patients without a diagnosis of depression before the index date for FP, 6.4% (285) and 9.7% (4733), respectively, had a diagnosis of depression within 2 years of the diagnosis of FP. Matched controls showed depression rates within 2 years of 3.9% for children (P < 0.001) and 6.1% for adults (P < 0.001). CONCLUSIONS: The present study adds to the current body of knowledge on FP and depression given its large sample size and analysis of adult and pediatric populations over 2 years. Indeed, we found that depression rates were significantly increased in both adults and children as compared with matched controls. Our results suggest a need for long-term depression screening in patients with FP.


Asunto(s)
Depresión/epidemiología , Parálisis Facial/psicología , Adolescente , Adulto , Niño , Bases de Datos Factuales , Femenino , Humanos , Incidencia , Masculino , Estudios Retrospectivos , Estados Unidos/epidemiología
14.
Neurochirurgie ; 70(5): 101570, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-38810538

RESUMEN

OBJECTIVE: Auditory Brainstem Implants (ABI) are used to restore hearing in patients lacking appropriate cochlear anatomy and/or cochlear nerve. The objective of this study was to examine the Manufacture and User Facility Device Experience (MAUDE) database to analyze adverse events. STUDY DESIGN: This is a study of a multi-institutional database maintained by the US FDA. SETTING: A database analysis was performed via collaboration of multiple clinicians at tertiary referral centers. METHODS: The MAUDE database was queried for Medical Device Reports (MDRs) relating to ABIs. MDRs were identified using the advanced search term "Implant, Auditory Brainstem" and reviewing all reports with the basic search term "Brainstem Implant". All collected reports were individually reviewed. RESULTS: A total of 265 individual patient reports were reviewed, of which 55 reports met inclusion criteria. Reports regarding audiologic outcome included failure to provide hearing benefit (n = 27), implant failure/device malfunction (n = 10), and device non-use (n = 6). Postoperative complications included local skin infection (n = 3), CSF leak (n = 3), elevated ICP (n = 1), surgical site dehiscence (n = 1), swelling (n = 1), seroma formation requiring drainage (n = 1), and meningitis (n = 2). Two patients had dislodged magnets during 1.5 Tesla MRI acquisition. There were 35 instances of full explantation of the device and 1 partial removal; 13 patients had a new device implanted following explantation. CONCLUSIONS: Poor hearing results, device failure, and non-use were commonly reported causes for explanation in this analysis. This information can aid physicians in counseling patients and family members and managing device expectations.


Asunto(s)
Implantes Auditivos de Tronco Encefálico , Bases de Datos Factuales , Complicaciones Posoperatorias , Humanos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Masculino , Femenino , Adulto , Persona de Mediana Edad , Implantación Auditiva en el Tronco Encefálico/métodos , Implantación Auditiva en el Tronco Encefálico/efectos adversos , Niño , Adolescente , Anciano , Estados Unidos , Preescolar
15.
Am J Rhinol Allergy ; 37(6): 686-691, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37635415

RESUMEN

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.


Asunto(s)
Trompa Auditiva , Humanos , Dilatación/efectos adversos , Cateterismo/métodos , Bases de Datos Factuales
16.
Ear Nose Throat J ; : 1455613231158795, 2023 Feb 23.
Artículo en Inglés | MEDLINE | ID: mdl-36820503

RESUMEN

OBJECTIVE: To characterize the association between scholarly activity, academic rank, practice setting, and malpractice claims among otolaryngologists over the past decade. METHODS: Data was extracted from the two legal databases, WestLaw and LexisNexis. The records were obtained from January 2010 to January 2020. Scopus and PubMed databases were used to identify bibliometric data. RESULTS: Of the 102 malpractice cases identified, 77.5% (N = 79) were ruled in favor of the defendant, 13.7% (N = 14) in favor of the plaintiff, and 8.8% (N = 9) were settled outside of the court. A total amount of $46,533,346.82 was rewarded to plaintiffs in 14 cases. Endoscopic sinus surgery was the procedure associated with the most malpractice claims (N = 16). Alleged improper performance (N = 51) was the most common underlying reason for litigation. Of the 102 defendant surgeons, 82 (80.4%) were in community/private settings. Among the 14 cases in that a surgeon was found at fault, 13 (92.8%) were in the community/private setting. Among the surgeons with at least one publication, the mean Hirsch Index (h-index) was 8.2. There was a statistically significant correlation between the mean h-index and litigation outcome (95% CI: -8.9 to -0.9, P = .017). CONCLUSION: Our analysis showed that most malpractice litigations were among otolaryngologists practicing in community/private settings. We also found that higher scholarly activity measured by the h-index was associated with verdicts in favor of the defendant/surgeon. This study was limited by not all-inclusive aspects of the legal databases that were used, the small sample size, and the lack of multivariable analysis.

17.
Craniomaxillofac Trauma Reconstr ; 16(1): 62-69, 2023 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36824183

RESUMEN

Study Design: Systematic review of the literature. Objective: The goal of this study is to review the current literature on the trends in management of laryngeal fractures following trauma. Methods: Independent searches of the PubMed and MEDLINE databases were performed. Articles from the period of 1963 to 2020 were collected. All studies which described laryngeal fractures using the Boolean method and relevant search term combinations, including "Laryngeal", "Fracture", "Operative", and "Management" were collected. Results: A total of 588 relevant unique articles were identified for analysis. Of these, 24 articles were deemed appropriate for inclusion in the literature review. Due to variability in study design and outcome measures, formal synthesis of data in the form of a meta-analysis was not possible. Conclusions: Laryngeal fractures are rare traumatic injuries that require early identification and evaluation with complex management options. This comprehensive review aims to highlight the breadth of the topic with regard to presentation and clinical management. Though there remains no clear best practice for laryngeal fracture management, we review trends in clinical practice throughout the literature.

18.
Ann Otol Rhinol Laryngol ; 132(9): 1050-1058, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36226335

RESUMEN

OBJECTIVE: Identify risk factors and perioperative morbidity for pediatric patients undergoing septoplasty. METHODS: The American College of Surgeons National Surgical Quality Improvement Program Pediatric (NSQIP-P) database was retrospectively queried to identify patients who underwent septoplasty (CPT 30520) for a diagnosis of deviated nasal septum (ICD J34.2) from 2018 to 2019. Outcomes analyzed include patient demographics, medical comorbidities, surgical setting, operative characteristics, length of stay, and postoperative outcomes. RESULTS: A total of 729 children were identified. Median age at time of surgery was 15.8 years, with most patients (82.8%) >12 years of age; no significant association was identified between age at time of surgery and adverse surgical outcomes. Overall, postoperative complications were uncommon (0.6%), including readmission (0.4%), septic shock (0.1%), and surgical site infection (0.1%). A history of asthma was found to be a significant risk factor for postoperative complications (P = .035) as well as BMI (P = .028). CONCLUSION: The 30-day postoperative complications following pediatric septoplasty in children reported in the NSQIP-P database are infrequent. Special considerations regarding young age, complex sinonasal anatomy, and surgical technique remain important features in considering corrective surgery for the pediatric nose and certainly warrant further investigation in subsequent studies.


Asunto(s)
Procedimientos Neuroquirúrgicos , Infección de la Herida Quirúrgica , Niño , Humanos , Adolescente , Estudios Retrospectivos , Procedimientos Neuroquirúrgicos/métodos , Factores de Riesgo , Morbilidad , Mejoramiento de la Calidad , Bases de Datos Factuales , Complicaciones Posoperatorias/diagnóstico
19.
Ear Nose Throat J ; 101(8): NP358-NP361, 2022 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-33155853

RESUMEN

OBJECTIVE: Congenital anomalies of the external ear may present a reconstructive challenge, particularly when normal chondrocutaneous components of the auricle fail to develop. Our goal was to develop a novel technique for lobule reconstruction of a congenitally absent earlobe with photographic documentation of the technique. METHODS: Informed consent for perioperative photography and publication of case details was obtained. A postauricular, turnover flap with ipsilateral conchal cartilage grafting was performed to reconstruct the lobule, and a superiorly based, postauricular, rotation advancement flap was used to close the donor site defect. RESULTS: Perioperative photographs are included demonstrating technique and cosmetic results. CONCLUSIONS: Malformations rarely involve the lobule or lower third of the ear primarily. Literature regarding lobule reconstruction for congenital malformations is scarce. We present a novel technique for lobule reconstruction of a congenitally absent earlobe performed in a single stage that avoids a visible neck scar and allows for simultaneous conchal cartilage harvest. The technique demonstrated satisfactory cosmesis regarding contour and overall appearance and these results remained stable at 1-year follow up.


Asunto(s)
Pabellón Auricular , Procedimientos de Cirugía Plástica , Cartílago/trasplante , Cicatriz/cirugía , Pabellón Auricular/cirugía , Oído Externo/cirugía , Humanos , Procedimientos de Cirugía Plástica/métodos , Colgajos Quirúrgicos
20.
Facial Plast Surg Aesthet Med ; 24(3): 202-206, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-33617355

RESUMEN

Objective: To evaluate the safety profile, including adverse drug reactions and operative complications, of liposomal bupivacaine (LB) use for local anesthesia during functional septorhinoplasty. Study Design: Retrospective review. Subject and Methods: A database query was conducted for patients >18 years of age who underwent septorhinoplasty from January 1, 2019, to August 1, 2020. Adverse drug reactions and postoperative outcomes were compared between patients who received locally administered LB and patients who received standard local anesthetic at the completion of the surgery. Results: A total of 95 cases were included in our data analysis. No significant differences were found in adverse reactions overall (6.3% vs. 3.1%, p = 0.51) or complications, including rate of infection (3.2% vs. 3.1%, p = 1), cartilage warping (1.6% vs. 0%, p = 1), graft resorption (0% vs. 0%, p = 1), septal hematoma (0% vs. 0%, p = 1), and need for revision surgery (4.8% vs. 3.1%, p = 1) between LB and control groups. Conclusion: LB demonstrated an acceptable safety profile when compared with standard local anesthetics during septorhinoplasty, with no significant difference in systemic or local adverse drug reactions or postoperative complications.


Asunto(s)
Bupivacaína , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Adulto , Anestésicos Locales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/complicaciones , Humanos , Dimensión del Dolor/efectos adversos , Dolor Postoperatorio
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