Inducing cavitation within hollow cylindrical radially polarized transducers for intravascular applications.

Thrombotic occlusions of large blood vessels are increasingly treated with catheter based mechanical approaches, one of the most prominent being to employ aspiration to extract clots through a hollow catheter lumen. A central technical challenge for aspiration catheters is to achieve sufficient suction force to overcome the resistance of clot material entering into the distal tip. In this study, we examine the feasibility of inducing cavitation within hollow cylindrical transducers with a view to ultimately using them to degrade the mechanical integrity of thrombus within the tip of an aspiration catheter. Hollow cylindrical radially polarized PZT transducers with 3.3/2.5 mm outer/inner diameters were assessed. Finite element simulations and hydrophone experiments were used to investigate the pressure field distribution as a function of element length and resonant mode (thickness, length). Operating in thickness mode (∼5 MHz) was found to be associated with the highest internal pressures, estimated to exceed 23 MPa. Cavitation was demonstrated to be achievable within the transducer under degassed water (10 %) conditions using hydrophone detection and high-frequency ultrasound imaging (40 MHz). Cavitation clouds occupied a substantial portion of the transducer lumen, in a manner that was dependent on the pulsing scheme employed (10 and 100 µs pulse lengths; 1.1, 11, and 110 ms pulse intervals). Collectively the results support the feasibility of achieving cavitation within a transducer compatible with mounting in the tip of an aspiration format catheter.

Postoperative Complications of True Dropless Cataract Surgery versus Standard Topical Drops.

Purpose Compare postoperative outcomes in cataract surgery between eyes with standard drop regimen versus dropless protocol by residents. Design Retrospective cohort study between April 1, 2018 and March 31, 2020. Methods The study was performed at Lyndon B. Johnson General Hospital in Houston, Harris County, Texas. A total of 547 eyes (234 dropless vs. 313 standard) with phacoemulsification cataract surgery and minimum of 1-month follow-up with best-corrected visual acuity (BCVA) were included. Dropless received 40 mg sub-Tenon's triamcinolone and intracameral moxifloxacin. Patients were followed at postoperative day 1 (POD1), week 1 (POW1), and month 1 (POM1). Postoperative rate of BCVA better than 20/40 (Good vision) and rate of complications were compared between groups. Results Good vision on POM1 in dropless (77.8%) was noninferior to standard (75.1%, p = 0.80). Complication rate in dropless (28.6%) was noninferior to standard (24.0%, p = 0.13). Intraocular pressure (IOP) elevation on POD1 ( p = 0.041) and anterior chamber (AC) cells on POW1 and POM1 ( p < 0.001) were more frequent in dropless. Mean spherical equivalent at POM1 was better in dropless (-0.37 D [±0.81 D]) compared with standard (-0.61D [±0.77 D], p = 0.001). Early posterior capsular opacification (early PCO) was more frequent in dropless ( p = 0.042). Conclusions Postoperative rate of BCVA better than 20/40 and rate of postoperative complications were noninferior, although dropless had higher rates of AC inflammation, IOP elevation, and early PCO.

Views on minimum unit pricing for alcohol before its introduction among people with alcohol dependence in Scotland: A qualitative interview study.

INTRODUCTION: Scotland implemented a minimum price per unit of alcohol (MUP) of £0.50 in May 2018 (1 UK unit = 10 mL/8 g ethanol). Some stakeholders expressed concerns about the policy having potential negative consequences for people with alcohol dependence. This study aimed to investigate anticipated impacts of MUP on people presenting to alcohol treatment services in Scotland before policy implementation. METHODS: Qualitative interviews were conducted with 21 people with alcohol dependence accessing alcohol treatment services in Scotland between November 2017 and April 2018. Interviews examined respondents' current and anticipated patterns of drinking and spending, effects on their personal life, and their views on potential policy impact. Interview data were thematically analysed using a constant comparison method. RESULTS: Three key themes were identified: (i) strategies used to manage the cost of alcohol and anticipated responses to MUP; (ii) broader effects of MUP; and (iii) awareness and preparedness for MUP. Respondents expected to be impacted by MUP, particularly those on low incomes and those with more severe dependence symptoms. They anticipated using familiar strategies including borrowing and reprioritising spending to keep alcohol affordable. Some respondents anticipated negative consequences. Respondents were sceptical about the short-term benefits of MUP for current drinkers but felt it might prevent harm for future generations. Respondents had concerns about the capacity of treatment services to meet support needs. DISCUSSION AND CONCLUSIONS: People with alcohol dependence identified immediate concerns alongside potential long-term benefits of MUP before its introduction. They also had concerns over the preparedness of service providers.

An optical and acoustic investigation of microbubble cavitation in small channels under therapeutic ultrasound conditions.

Therapeutic focused ultrasound in combination with encapsulated microbubbles is being widely investigated for its ability to elicit bioeffects in the microvasculature, such as transient permeabilization for drug delivery or at higher pressures to achieve 'antivascular' effects. While it is well established that the behaviors of microbubbles are altered when they are situated within sufficiently small vessels, there is a paucity of data examining how the bubble population dynamics and emissions change as a function of channel (vessel) diameter over a size range relevant to therapeutic ultrasound, particularly at pressures relevant to antivascular ultrasound. Here we use acoustic emissions detection and high-speed microscopy (10 kframes/s) to examine the behavior of a polydisperse clinically employed agent (Definity®) in wall-less channels as their diameters are scaled from 1200 to 15 µm. Pressures are varied from 0.1 to 3 MPa using either a 5 ms pulse or a sequence of 0.1 ms pulses spaced at 1 ms, both of which have been previously employed in an in vivo context. With increasing pressure, the 1200 µm channel - on the order of small arteries and veins - exhibited inertial cavitation, 1/2 subharmonics and 3/2 ultraharmonics, consistent with numerous previous reports. The 200 and 100 µm channels - in the size range of larger microvessels less affected by therapeutic focused ultrasound - exhibited a distinctly different behavior, having muted development of 1/2 subharmonics and 3/2 ultraharmonics and reduced persistence. These were associated with radiation forces displacing bubbles to the distal wall and inducing clusters that then rapidly dissipated along with emissions. As the diameter transitioned to 50 and then 15 µm - a size regime that is most relevant to therapeutic focused ultrasound - there was a higher threshold for the onset of inertial cavitation as well as subharmonics and ultraharmonics, which importantly had more complex orders that are not normally reported. Clusters also occurred in these channels (e.g. at 3 MPa, the mean lateral and axial sizes were 23 and 72 µm in the 15 µm channel; 50 and 90 µm in the 50 µm channel), however in this case they occupied the entire lumens and displaced the wall boundaries. Damage to the 15 µm channel was observed for both pulse types, but at a lower pressure for the long pulse. Experiments conducted with a 'nanobubble' (<0.45 µm) subpopulation of Definity followed broadly similar features to 'native' Definity, albeit at a higher pressure threshold for inertial cavitation. These results provide new insights into the behavior of microbubbles in small vessels at higher pressures and have implications for therapeutic focused ultrasound cavitation monitoring and control.

An Otolaryngologist's Guide to Understanding the H-index and How It Could Affect Your Future Career.

Objectives: The h-index is a measure of research output and contribution that shows strong correlation with academic promotion in medicine. The purpose of this article is to clearly explain how h-index scores are calculated and how otolaryngologists can effectively and advantageously use these scores for their career development. Data Sources: PubMed. Review Methods: We performed an up-to-date PubMed literature review describing the design of the h-index and how to use it effectively along with its role in academic medicine, including otolaryngology. Conclusions: H-index scores are used as a metric for scientific output that considers the number of publications and the number of times each is cited. Search engines can automatically calculate h-index scores for one's work. Studies also revealed significant positive correlations that the h-index has from fellowship involvement, which could be beneficial for career advancement in academic medicine. Implications for Practice: Aspiring academic otolaryngologists should create a research profile to link and calculate the h-index for publications, submit to well-read high-impact journals for increased viewership and citations, and expand on foundational and personal research topics. Future studies should evaluate faculty and resident awareness of h-indices in the otolaryngology department to see how we can further address any underlying barriers. Otolaryngologists with the knowledge and tools necessary to maximize h-index scores and produce high-quality research in modern-day medicine not only provide potential advantages in career development but also bring significant contribution to the field of otolaryngology and patient care.

Prognosticators of Visual Acuity After Indirect Traumatic Optic Neuropathy.

BACKGROUND: The purpose of this study is to determine whether there are radiographic and systemic clinical characteristics that can predict final visual outcomes in patients with indirect traumatic optic neuropathy (iTON). METHODS: This study is a retrospective, multicenter case series of adult patients with iTON treated initially at large, urban, and/or academic trauma centers with follow-up at an affiliated ophthalmology clinic. In addition to detailed cranial computed tomography characteristics, demographics, systemic comorbidities, coinjuries, blood products administered, and intracranial pressure, along with other factors, were gathered. LogMAR visual acuity (VA) at the initial presentation to the hospital and up to 12 months follow-up was collected. RESULTS: Twenty patients met inclusion criteria; 16 (80%) were men with a mean age of 40.9 years (±20.9). Mean initial VA was 1.61 logMAR (∼20/800, ± 0.95), and final VA was 1.31 logMAR (∼20/400, ± 1.06). Three patients (4 eyes) had no light perception (NLP) VA at presentation and remained NLP at final follow-up. Of the predictors analyzed, only the initial VA was found to be a significant predictor of visual outcome. The presence of orbital fractures, intraconal and/or extraconal hemorrhage, as well as systemic comorbidities, were not found to significantly affect visual outcome. CONCLUSIONS: After evaluating multiple factors, initial VA was the only factor associated with visual prognosis in iTON. This knowledge may better enable clinicians to predict visual prognosis and set reasonable expectations with patients and families at the time of injury.

A resonant cavity system for exposing cell cultures to intense pulsed RF fields.

The IEEE and ICNIRP had specified a maximum permissible exposure for instantaneous peak electric field of 100 kV/m. However, no rationale was given for this limit. A novel exposure system was designed through a detailed process of analytical analysis, numerical modelling and prototype testing. The system consists of a cylindrical re-entrant resonant cavity that can achieve an electric field strength of more than 100 kV/m with an input power of 200 W. The working of the system was evaluated in simulation and experiment in terms of scattering parameters, electric field distributions and specific absorption rate. The system was then used to carry out in-vitro exposures of a human lymphoid cell line (GG0257) to a 1195 MHz signal at 53 dBm peak power and a pulse width of 550 ns at a range of interpulse intervals to identify heating-induced changes in cell viability. The proposed system offers high Q value of 5920 in unloaded condition which was reduced to 57 when loaded with 12 ml of cell culture but still offering 67 kV/m of the field intensity. Using the system for the exposure of GG0257 cells lasting 18 min, interpulse intervals of 11 µs or less caused a reduction in the number of viable cells and a corresponding increase in necrotic cells. For a shorter exposure duration of 6 min, the reduction in cell viability was seen at interpulse intervals of 5.5 µs or less. The designed exposure system is well capable of handling high intensity electric fields. Temperature measurements with a fibre optic probe and temperature sensitive labels showed that changes in viability were associated with temperature increases above 46 °C. This novel exposure system is an efficient means to investigate the possible relationship between peak field intensity and biological effects to provide a rationale behind the maximum exposure limit of 100 kV/m.

Increasing frequency of gene copy number aberrations is associated with immunosuppression and predicts poor prognosis in gastric adenocarcinoma.

BACKGROUND: Patients with Epstein-Barr virus-positive gastric cancers or those with microsatellite instability appear to have a favourable prognosis. However, the prognostic value of the chromosomal status (chromosome-stable (CS) versus chromosomal instable (CIN)) remains unclear in gastric cancer. METHODS: Gene copy number aberrations (CNAs) were determined in 16 CIN-associated genes in a retrospective study including test and validation cohorts of patients with gastric cancer. Patients were stratified into CS (no CNA), CINlow (1-2 CNAs) or CINhigh (3 or more CNAs). The relationship between chromosomal status, clinicopathological variables, and overall survival (OS) was analysed. The relationship between chromosomal status, p53 expression, and tumour infiltrating immune cells was also assessed and validated externally. RESULTS: The test and validation cohorts included 206 and 748 patients, respectively. CINlow and CINhigh were seen in 35.0 and 15.0 per cent of patients, respectively, in the test cohort, and 48.5 and 20.7 per cent in the validation cohort. Patients with CINhigh gastric cancer had the poorest OS in the test and validation cohorts. In multivariable analysis, CINlow, CINhigh and pTNM stage III-IV (P < 0.001) were independently associated with poor OS. CIN was associated with high p53 expression and low immune cell infiltration. CONCLUSION: CIN may be a potential new prognostic biomarker independent of pTNM stage in gastric cancer. Patients with gastric cancer demonstrating CIN appear to be immunosuppressed, which might represent one of the underlying mechanisms explaining the poor survival and may help guide future therapeutic decisions.

Trends in Academic Achievement Within Otolaryngology: Does Fellowship Training Impact Research Productivity?

BACKGROUND: Scholarly productivity and research output vary among different subspecialties. The h-index was developed as a more wholesome metric that measures an author's contribution to literature. OBJECTIVE: Through a web-based cross-sectional analysis, we investigated the differences in scholarly impact and influence of both fellowship and nonfellowship-trained academic otolaryngologists in the United States. A secondary objective was to further understand the output among the larger fellowship fields. METHODS: A cross-sectional analysis was performed for active faculty otolaryngologists. A total of 1704 otolaryngologists were identified as faculty in residency training programs across the United States. Their h-index and publication data were gathered using the Scopus database. The data were obtained in August 2019 and analysis occurred in January 2020. RESULTS: Head and neck surgical faculty (25.5%) had the highest representation with fellowship experience. Among all faculty, there was no statistical difference in the overall average h-index scores when comparing faculty that had fellowship training with those who did not (12.6 and 12.1, respectively, P = .498). Rhinologists had the highest publication output per year at 3.90. Among fellowship-trained faculty, the highest average h-index and total publications were seen in head & neck surgery, while facial plastics had the lowest averages (P < .001). CONCLUSIONS: In this study, fellowship-trained faculty had a greater but not significant scholarly impact than nonfellowship faculty. Furthermore, there were significant variations in output among the various subspecialties of otolaryngology. Growing fields, as academic rhinology, are continuing to flourish in robust research productivity and output. This study further demonstrates the potential, growing influence of fellowship training on research involvement and academic advancement within the otolaryngology subspecialties.

Determining Risk Factors That Affect Progression in Patients with Nonproliferative Diabetic Retinopathy.

PURPOSE: To determine risk factors that affect nonproliferative diabetic retinopathy (NPDR) progression and establish a predictive model to estimate the probability of and time to progression in NPDR. Patients and Methods. Charts of diabetic patients who received an initial eye exam between 2010 and 2017 at our county hospital were included. Patients with proliferative diabetic retinopathy (PDR), fewer than 2 years of follow-up, or fewer than 3 clinic visits were excluded. Demographics and baseline systemic and ocular characteristics were recorded. Follow-up mean annual HbA1c and blood pressure, best-corrected visual acuity, and the number of antivascular endothelial growth factor treatments were recorded. Stage and date of progression were recorded. A 5-state nonhomogeneous continuous-time Markov chain with a backward elimination model was used to identify risk factors and estimate their effects on progression. RESULTS: Two hundred thirty patients were included. Initially, 65 eyes (28.3%) had no retinopathy; 73 (31.7%) mild NPDR; 60 (26.1%) moderate NPDR; and 32 (13.9%) severe NPDR. Patients were followed for a mean of 5.8 years (±2.0 years; range 2.1-9.4 years). 164 (71.3%) eyes progressed during the follow-up. Time-independent risk factors affecting progression rate were age (hazard ratio (HR) = 0.99, P=0.047), duration of diabetes (HR = 1.02, P=0.018), and Hispanic ethnicity (HR = 1.31, P=0.068). Mean sojourn times at mean age, duration of diabetes, and annual HbA1c for a non-Hispanic patient were estimated to be 3.03 (±0.97), 4.63 (±1.21), 6.18 (±1.45), and 4.85 (±1.25) years for no retinopathy, mild NPDR, moderate NPDR, and severe NPDR, respectively. Each 1% increase in HbA1c annually diminished sojourn times by 15%, 10%, 7%, and 10% for no retinopathy, mild NPDR, moderate NPDR, and severe NPDR, respectively. CONCLUSION: HbA1c level is a significant modifiable risk factor in controlling the progression of DR. The proposed model could be used to predict the time and rate of progression based on an individual's risk factors. A prospective multicenter study should be conducted to further validate our model.

Multi-site comparison of factors influencing progress of African insecticide testing facilities towards an international Quality Management System certification.

BACKGROUND: Insecticidal mosquito vector control products are vital components of malaria control programmes. Test facilities are key in assessing the effectiveness of vector control products against local mosquito populations, in environments where they will be used. Data from these test facilities must be of a high quality to be accepted by regulatory authorities, including the WHO Prequalification Team for vector control products. In 2013-4, seven insecticide testing facilities across sub-Saharan Africa, with technical and financial support from Innovative Vector Control Consortium (IVCC), began development and implementation of quality management system compliant with the principles of Good Laboratory Practice (GLP) to improve data quality and reliability. METHODS AND PRINCIPLE FINDINGS: We conducted semi-structured interviews, emails, and video-call interviews with individuals at five test facilities engaged in the IVCC-supported programme and working towards or having achieved GLP. We used framework analysis to identify and describe factors affeting progress towards GLP. We found that eight factors were instrumental in progress, and that test facilities had varying levels of control over these factors. They had high control over the training programme, project planning, and senior leadership support; medium control over infrastructure development, staff structure, and procurement; and low control over funding the availability and accessibility of relevant expertise. Collaboration with IVCC and other partners was key to overcoming the challenges associated with low and medium control factors. CONCLUSION: For partnership and consortia models of research capacity strengthening, test facilities can use their own internal resources to address identified high-control factors. Project plans should allow additional time for interaction with external agencies to address medium-control factors, and partners with access to expertise and funding should concentrate their efforts on supporting institutions to address low-control factors. In practice, this includes planning for financial sustainability at the outset, and acting to strengthen national and regional training capacity.

Wearable Activity Tracking Device Use in an Adolescent Weight Management Clinic: A Randomized Controlled Pilot Trial.

Background: The use of physical activity tracker devices has increased within the general population. However, there is limited medical literature studying the efficacy of such devices in adolescents with obesity. In this study, we explored the feasibility of using wearable activity tracking devices as an adjunct intervention on adolescents with obesity. Methods: Randomized controlled pilot trial evaluated the feasibility (attrition ≤50%) of an activity tracking intervention (ATI) and its effects on weight loss in adolescents with obesity enrolled in an adolescent weight management clinic (AWMC). Outcomes included feasibility (attrition rate) and absolute change in BMI. Differences between groups at 6, 12, and 18 weeks were examined. Results: Forty-eight participants were enrolled in the study. Eighteen subjects were randomly assigned to the ATI group and 30 to control. The average age was 14.5 years. Overall, the majority of participants were Hispanic (56%). Sexes were equally distributed. The average baseline BMI was 37.5 kg/m2. At the study conclusion, the overall attrition rate was 52.1%, 44.4% in the ATI group versus 56.6% in the control group, with a differential attrition of 12.2%. The ATI and control groups each showed an absolute decrease in BMI of -0.25 and -2.77, respectively, with no significant differences between the groups. Conclusion: The attrition rate in our study was >50%. Participation in the AWMC by the ATI and control groups resulted in maintenance of BMI and body weight for the study duration. However, the use of an activity tracking device was not associated with greater weight loss. This trial is registered with NCT03004378.

Evaluating the Role of Anesthesia on Intraoperative Blood Loss and Visibility during Endoscopic Sinus Surgery: A Meta-analysis.

BACKGROUND: Previous studies and meta analyses have led to incongruent and incomplete results respectively when total intravenous anesthesia (TIVA) and inhalational anesthesia (IA) are compared in endoscopic sinus surgeries in regards to intraoperative bleeding and visibility. OBJECTIVE: To perform a more comprehensive meta-analysis on randomized controlled trial (RCTs) comparing TIVA with IA in endoscopic sinus surgery to evaluate their effects on intraoperative bleeding and visibility. METHODS: A systematic review and meta-analysis of studies comparing TIVA and IA in endoscopic sinus surgery for chronic rhinosinusitis was completed in May 2020. Utilizing databases, articles were systematically screened for analysis and 19 studies met our inclusion criteria. The primary outcome included intraoperative visibility scores combining Boezaart, Wormald and Visual Analogue Scale (VAS). Secondary outcomes included rate of blood loss (mL/kg/min), estimated total blood loss (mL), Boezaart, Wormald scores, VAS, heart rate, and mean arterial pressure (MAP). RESULTS: 19 RCTs with 1,010 patients were analyzed. TIVA had a significantly lower intraoperative bleeding score indicating better endoscopic visibility (Boezaart, VAS, and Wormald) than IA (-0.514, p = 0.020). IA had a significantly higher average rate of blood loss than TIVA by 0.563 mL/kg/min (p = 0.016). Estimated total blood loss was significantly lower in TIVA than IA (-0.853 mL, p = 0.002). There were no significant differences between TIVA and IA in the mean heart rate (-0.225, p = 0.63) and MAP values (-0.126, p = 0.634). The subgroup analyses revealed no significant difference between TIVA and IA when remifentanil was not utilized and whenever desflurane was the IA agent. CONCLUSION: TIVA seemed to have superior intraoperative visibility scores and blood loss during endoscopic sinus surgery when compared to IA. However, the results are not consistent when stratifying the results based on the use of remifentanil and different inhaled anesthetics. Therefore, the conclusion cannot be made that one approach is superior to the other.

Meta-analysis Exploring Sinopulmonary Outcomes of Aspirin Desensitization in Aspirin-Exacerbated Respiratory Disease.

OBJECTIVE: The objective of this study is to explore the sinopulmonary outcomes of aspirin desensitization through a systematic review and meta-analysis. DATA SOURCES: Embase and OVID Medline databases. REVIEW METHODS: A systematic review of published articles on outcomes following aspirin desensitization in any language for relevant articles was performed in February 2019. Outcomes included sinonasal quality-of-life assessment, sense-of-smell scores, FEV-1 (forced expiratory volume in 1 second), and medication/steroid use. RESULTS: Thirteen studies met the inclusion criteria out of 6055 articles screened. Aspirin desensitization resulted in significant improvement in FEV-1 and reduction in asthma medication/steroid use (P < .05). There was no significant improvement in the sinonasal quality of life of patients who underwent aspirin desensitization (P = .098). CONCLUSION: Aspirin desensitization appears to be effective in improving pulmonary outcomes and should be considered in the treatment of patients with aspirin-exacerbated respiratory disease. However, good-quality studies are still needed to determine the ideal protocol tailored to individual patients.

Effects on phacoemulsification efficiency and chatter at variable longitudinal ultrasound settings when combined with constant torsional energy.

PURPOSE: To evaluate longitudinal power settings for optimally efficient lens fragment removal, using the Centurion machine. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, USA. DESIGN: Experimental study. METHODS: Porcine lens nuclei were cut into 2.0 mm cubes. Experiments were conducted at 100% torsional power; vacuum set at 500 mm Hg, aspiration 50 mL/min, and intraocular pressure 110 mm Hg. A 20-degree tip with a 30-degree bevel was used. Longitudinal power was tested between 20% and 100%. Efficiency (time for fragment removal) and chatter (the number of times the fragment bounced from the tip) were measured. RESULTS: A linear increase in efficiency was observed from 20% to 100% longitudinal power (R = 0.9281, slope = -0.0271). An efficiency slope change occurred at 60% power, with the largest incremental change in efficiency between 20% and 60% (R = 0.9756, slope = -0.0394) and a lesser change between 60% and 100% (R = 0.9827, slope = -0.0121). Chatter analysis showed minimal events at 20% to 60%, but a significant increase at >80% (P = .005). This increase appeared to be incremental (R = 0.8929). CONCLUSIONS: Increasing longitudinal power, with all other settings constant, increased efficiency. Greatest efficiency gains were observed between 20% and 60%. At 80% and 100%, chatter events increased significantly. With a goal of recommending optimally efficient settings while minimizing excess energy and chatter, adding 60% of longitudinal power to 100% torsional power was shown to be the best setting to increase efficiency and avoid repulsion in these vacuum and aspiration settings.

Exploring Balloon Sinuplasty Adverse Events With the Innovative OpenFDA Database.

BACKGROUND: Balloon sinuplasty (BSP) has become a common, minimally invasive treatment for chronic sinusitis. Like any surgical procedure, there are definite risks when using it as a stand-alone procedure or in conjunction with other revision procedures. OBJECTIVE: To explore the adverse events of BSP using the openFDA cloud with regard to malfunction and injury following surgery. METHODS: Between January 2015 and December 2018, the Food and Drug Administration's (FDA) openFDA database was queried for adverse event use. Reports were further categorized by procedure location, injury type, device malfunction, procedure (stand-alone BSP vs hybrid), and source of complication (anatomical or surgeon related). RESULTS: Seventy-eight events were reported to the FDA in the study period. Majority of cases consisted of device malfunctions (64.1%), while patient injuries consisted of 43.5%. Frontal sinus procedures had the greatest presence of adverse events (47.4%) with the majority reporting significant cerebrospinal fluid (CSF) leaks (P < .001) and device retention (P = .021). Orbital complications (P = .004) were found to be significantly associated with dilation of the maxillary sinus. Skull-based injuries were the only factor incident in which surgeon-reported anatomical complications were significant (P = .018). CONCLUSIONS: As balloon dilation procedure continues to rise in the United States, significant adverse events continue to occur. Frontal sinus BSP leads to the highest number of complications and a 4.75 reported CSF leaks yearly. Based on real data, surgeons performing the procedure should be acquainted with common BSP-related injuries so they can prepare for those circumstances and share informed consent with their patients.