Economic impact analysis of a minimally invasive temperature-controlled radiofrequency device versus nasal surgery for the treatment of nasal airway obstruction in the United States.

OBJECTIVE: To determine the economic impact of a minimally invasive temperature-controlled radiofrequency (TCRF) device for treating nasal airway obstruction (NAO). METHODS: A budget impact model was developed for two scenarios: a reference scenario of functional rhinoplasty surgery with concomitant septoplasty and inferior turbinate reduction (ITR) performed in the hospital outpatient department where TCRF is not an available treatment option and a new scenario consisting of in-office TCRF treatment of the nasal valve and ITR. A payor perspective was adopted with a hypothetical population plan size of one million members. Costs were estimated over a time horizon of 4 years. The eligible population included patients with severe/extreme NAO and nasal valve collapse (NVC) as the primary cause or significant contributor. Data inputs were sourced from targeted literature reviews. Uncertainty within the model structure and input parameters was assessed using one-way sensitivity analysis. RESULTS: The introduction of a TCRF device resulted in population-level cost savings of $20,015,123 and per-responder average cost savings of $3531 through a 4-year time horizon due to lower procedure costs and complication rates of the device relative to the surgical comparator. Results were robust when varying parameter values in sensitivity analyses, with cost savings being most sensitive to the prevalence of NAO and estimated response rates to functional rhinoplasty and TCRF. CONCLUSIONS: In patients with severe/extreme NAO, with NVC as the primary or major contributor, introducing TCRF with ITR as a treatment option demonstrates the potential for significant cost savings over functional rhinoplasty with septoplasty and ITR.

Nasal valve dysfunction is a common cause of nasal airway obstruction (NAO) that has a significant impact on heath and quality of life for affected individuals. Previously, patients were offered temporary measures or a type of surgery called functional rhinoplasty which is a highly complex surgery that can be costly, requires recovery time, and in rare cases, not be successful. Recently, a new minimally invasive treatment alternative for NAO called temperature-controlled radiofrequency (TCRF) that may be performed in a surgery center or a doctor's office has become available. This paper provides the results of budget impact analysis performed to assess whether adding the TCRF procedure in place of surgery as a choice for patients with NAO will result in cost savings to an insurance payer with 1 million covered individuals in the United States over a period of 4 years. Results show that TCRF may result in an average of 9,416 fewer rhinoplasty surgeries, provide an average 4-year cost-savings of $3,531 for every patient that responds to TCRF treatment, and a savings of $20,015,123 over 4 years for the insurance provider. These potential cost savings over 4 years would likely be due to reduced procedure costs and complication rates compared to surgery.

Anatomic Relationship Between the Head of the Middle Turbinate and First Olfactory Filum: A Radiographic Assessment.

BACKGROUND: The endoscopic modified Lothrop procedure (EMLP) has become a frequently utilized procedure in rhinologic surgery. One of the most serious complications of the procedure is cerebrospinal fluid leak, which may occur due to lack of recognition of the anterior skull base in the region of the first olfactory filum (FOF), or direct injury to the FOF itself. OBJECTIVES: To evaluate the position of the head of the middle turbinate (MT) relative to the FOF, which is an important landmark in the EMLP. METHODS: A series of previously obtained patient computed tomography scans of the sinus were reviewed. A reproducible process was implemented to obtain the measurements. First, the FOF was identified on an axial series. Using a localization feature of the radiographic software, this anteroposterior (AP) position could be visualized in a coronal plane. Subsequently, the MT was viewed in a sagittal plane, where a measurement between the head of the MT and the AP position of the FOF could be performed. RESULTS: The AP distance between the head of the MT and the FOF was measured in 92 patients. The head of the MT was either at or anterior to the FOF in all measured subjects. The mean anterior distance of the head of the MT to FOF was 3.6 mm (±2.4 mm) on the right, and 3.8 mm (±2.2 mm) on the left. The range in AP distance was 0 to 12 mm. There was no significant difference in AP distance between the head of the MT and FOF based on gender (P = .413) or diagnosis (P = .254). CONCLUSIONS: In our study, the head of the MT was reliably at or anterior to the FOF in all subjects, suggesting its utility as a fixed landmark in endoscopic sinus surgery, particularly in the EMLP. LEVEL OF EVIDENCE: N/A.

Cost-effectiveness Analysis of Inferior Turbinate Reduction and Immunotherapy in Allergic Rhinitis.

BACKGROUND: Allergic rhinitis (AR) is a common condition that is frequently associated with atopic inferior turbinate hypertrophy (ITH) resulting in nasal obstruction. Current guidelines support the use of subcutaneous allergen immunotherapy (SCIT) when patients fail pharmacologic management. However, there is a lack of consensus regarding the role of inferior turbinate reduction (ITR), a treatment that we hypothesize is cost-effective compared with other available treatments. METHODS: We conducted a cost-effectiveness analysis comparing the following treatment combinations over a 5-year time horizon for AR patients presenting with atopic nasal obstruction who fail initial pharmacotherapy: (1) continued pharmacotherapy alone, (2) allergy testing and SCIT, (3) allergy testing and SCIT and then ITR for SCIT nonresponders, and (4) ITR and then allergy testing and SCIT for ITR nonresponders. Results were reported as incremental cost-effectiveness ratios (ICERs). RESULTS: For patients who fail initial pharmacotherapy, prioritizing ITR, either by microdebrider-assisting submucous resection or radiofrequency ablation, before SCIT was the most cost-effective strategy. Probabilistic sensitivity analysis demonstrated that prioritizing ITR before SCIT was the most cost-effective option in 95.4% of scenarios. ITR remained cost-effective even with the addition of concurrent septoplasty. CONCLUSION: For many AR patients who present with nasal obstruction secondary to atopic inferior turbinate hypertrophy that is persistent despite pharmacotherapy, ITR is a cost-effective treatment that should be considered prior to immunotherapy. LEVEL OF EVIDENCE: NA - Laryngoscope, 2023 Laryngoscope, 134:1572-1580, 2024.

Effects of nasal septum deviation and concha bullosa surgery on the frequency and financial burden of acute rhinosinusitis.

BACKGROUND: Nasal septum deviation/concha bullosa (DNS)/(CB) are known to be predisposing factors in the pathophysiology of acute rhinosinusitis (ARS). However, the effects of surgical treatment of these pathologies on ARS have not been adequately investigated. AIMS: To reveal the effects of the surgical treatment of DNS and CB on the frequency of the ARS, the use of antibiotics (ABs), and the direct cost incurred. METHODS: Medical records of the patients who had undergone successful surgery for DNS/CB and were diagnosed with ARS in the preoperative and postoperative 3-year period were retrospectively analyzed. The average annual number of ARS examinations of the patients, the number of ABs prescribed, and prescription, examination, and total health system costs were compared. RESULTS: Fifty-three patients (33 men (62%) and 20 women (38%)) were included in the study. There was a statistically significant decrease in the mean annual number of examinations for ARS, the number of ABs prescribed, prescription, examination, and total health system costs (p < 0.05) in the postoperative period compared with the preoperative period. CONCLUSIONS: The present study determined that successful surgeries performed in patients with DNS/CB resulted in a significant decrease in the average annual number of examinations performed for ARS, number of AB prescriptions, and prescription, examination, and total health system costs. With these results, it seems beneficial to direct patients to surgery within the framework of the health policies of countries to reduce the frequency and financial burden of ARS in DNS/CB patients.

Submucosal thulium laser turbinoplasty in children: assessment of efficacy and comparison with partial inferior turbinectomy.

This study aimed to assess efficacy of submucosal thulium laser turbinoplasty in children and to compare thulium laser turbinoplasty with partial inferior turbinectomy. This is a retrospective study over 10 years from 1 January 2009, conducted in a Pediatric Otorhinolaryngology Department in a university tertiary care center, including all the children who underwent thulium laser inferior turbinoplasty and partial inferior turbinectomy. The main outcome measures were the improvement in airflow using rhinomanometric cumulative flow at 150 Pa and then functional improvement using "OPERAS" score (nasal Obstruction, facial Pain, Epistaxis, Rhinorrhea, Anosmia, Sneezing). Eighty-six children underwent 47 submucosal thulium laser turbinoplasties and 48 partial turbinectomies. After submucosal thulium laser turbinoplasty, the cumulative flow at 150 Pa improved from 308.2 to 454.4 cm3 s-1 (p < 0.01) and the OPERAS score decrease was 1.5 point (p < 0.01). Daily use of intra nasal corticosteroid and antihistamine both decreased significantly. No local complications of this technique have been reported. Partial turbinectomies show a higher reduction of the OPERAS score and a better improvement of rhinomanometric parameters, but also a significantly higher complication rate. Submucosal thulium laser turbinoplasty is a good compromise between safety and efficacy, with substantial functional and rhinomanometric postoperative improvement.

Assessment of Biomarker Heterogeneity in Sinus Versus Inferior Turbinate Tissue in Patients Without Chronic Rhinosinusitis.

BACKGROUND: Currently, no consensus exists on the appropriate control specimen site to utilize in studies evaluating for biomarkers in chronic rhinosinusitis (CRS). Studies thus far have utilized tissue from various anatomic sites despite regional heterogeneity. OBJECTIVE: We set out to quantify the differences in biomarker levels present in inferior turbinate versus sphenoid sinus mucosa in paired healthy control patients. We hypothesize that statistically significant differences in cytokine/chemokine expression exist between these two distinct sites. METHODS: A 38-plex commercially available cytokine/chemokine Luminex Assay was performed on 54 specimens encompassing paired inferior turbinate and sphenoid sinus mucosa samples from 27 patients undergoing endoscopic anterior skull base surgery. Patients with a history of CRS were excluded. Paired sample t-tests and Fisher's exact tests were performed. RESULTS: Twenty-seven patients were included in the study, including 10 male and 17 female patients with an average age of 48 years. The following 8 biomarkers had statistically significant concentration differences between inferior turbinate mucosa and sphenoid mucosa sites: Flt-3L, Fractalkine, IL-12p40, IL-1Ra, IP-10, MCP-1, MIP-1ß, and VEGF, with all P-values <0.01. CONCLUSION: No consensus exists regarding the optimal choice of control specimen for CRS research. We present statistically significant quantitative differences in biomarker levels between paired inferior turbinate and sphenoid mucosa samples. This confirms the presence of heterogeneity between different subsites of sinonasal mucosa and highlights the need for standardization in future CRS research.

Use of Functional Rhinoplasty in the Aging Nose: Medicare Database Analysis.

Introduction: Nasal obstruction is a common clinical problem. It has become more recognized that the internal and external nasal valves are the areas of greatest resistance. There are changes with aging that can contribute to nasal valve compromise. This study sought to evaluate the utilization of functional rhinoplasty, septoplasty, and inferior turbinate reduction procedures in the Medicare population. Methods: The annual procedure data were obtained from the Part B National Summary Data File from 2000 to 2019. Functional rhinoplasty procedures using current procedural terminology (CPT) for rhinoplasty (30400, 30410, 30420, 30465), septoplasty (30520), and inferior turbinate reduction (30801, 30802, 30130, 30140, 30930) procedures were analyzed. Results: There was increased use of CPT codes 30465, 30410, and 30420 with a decrease in 30400. There was an overall increase in codes 30520 and 30140. When adjusting for the Medicare population per 100,000 enrollees, there was increased use of 30465 and 30140 and decrease in 30520. The charges and payment trends were similar to the overall use of CPT codes. Discussion: There is an overall increase in use of nasal airway procedures including functional rhinoplasty in the aging population.

Middle turbinate mucosal flap: Low-morbidity option in the management of skull base defects.

BACKGROUND: To describe the low morbidity of middle turbinate mucosal flap (MTMF) to repair anterior skull base defects. METHODS: Skull base endonasal endoscopic surgeries performed at a tertiary hospital between 2015 and 2018 were analyzed. Patients were divided into two groups according the existence or not of a significant intraoperative cerebrospinal fluid (CSF) leak. In Group 1 (n = 28), gasket seal and a pedicled endonasal flap were used to repair the defect: 13 nasoseptal flaps (NSF), 8 inferolateral wall flaps (ILF), and 7 MTMF. In Group 2 only an endonasal flap was used: 9 NSF, 4 ILF, and 18 MTMF. Surgical and recovery time were analyzed (Student's t test). Our favorite surgical technique is described. RESULTS: Fifty-nine patients were included. Average surgical time was 27.7, 41.6, and 11.3 min for NSF, ILF, and MTMF, respectively. MTMF showed a faster recovery. CONCLUSION: MTMF is a safe reconstructive option for anterior skull base defects.

Eustachian Tube Function Assessment after Radiofrequency Turbinate Reduction in Atopic and Non-Atopic Patients.

(1) Background: Inferior turbinates' hypertrophy is often associated with Eustachian tube dysfunction (ETD); radiofrequency turbinate reduction (RTR) may provide a long-term improvement of nasal obstruction and ETD-related symptoms. (2) Aim: The study aimed to compare ETD in atopic and non-atopic patients before and after RTR and to investigate the correlation between tympanometry and Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7). (3) Methods: Ninety-seven patients, ranging from 33 to 68 years old, were screened by skin tests and divided into atopic (G1) and non-atopic (G2). Eustachian tube function (ETF) was evaluated through tympanometry, William's test and ETDQ-7. (4) Results: A moderate to severe subjective ETDQ-7 was found in the 35.42% of G1 and in the 22.45% of G2 patients before RTR. William's test resulted normal in 141 ears (72.68%), partially impaired in 15 (7.73%), and grossly impaired in 38 (19.59%) before surgery. A grossly ETD was evidenced in the 19.59% of cases before surgery and decreased to 6.18% after surgery with a significant difference among atopic patients (p < 0.001). (5) Conclusion: RTR may be considered a treatment option in patients suffering from ETD and inferior turbinates' hypertrophy; RTR reduced the percentage of grossly impaired ET function (p < 0.001). ETDQ-7 and William's test may represent valuable tools to assess ET function before and after surgery.

Cost Benefit and Utility Decision Analysis of Turbinoplasty with Adenotonsillectomy for Pediatric Sleep-Disordered Breathing.

OBJECTIVES: Use decision analysis techniques to assess the potential utility gains/losses and costs of adding bilateral inferior turbinoplasty to tonsillectomy/adenoidectomy (T/A) for the treatment of obstructive sleep-disordered breathing (oSDB) in children. Use sensitivity analysis to explore the key variables in the scenario. STUDY DESIGN: Cost-utility decision analysis model. SETTING: Hypothetical cohort. SUBJECTS AND METHODS: Computer software (TreeAge Software, Williamstown, Massachusetts) was used to construct a decision analysis model. The model included the possibility of postoperative complications and persistent oSDB after surgery. Baseline clinical and quality-adjusted life year (QALY) parameters were estimated using published data. Cost data were estimated from Centers for Medicare and Medicaid 2018 databases ( www.cms.gov ). Sensitivity analyses were completed to assess for key model parameters. RESULTS: The utility analysis of the baseline model favored the addition of turbinoplasty (0.8890 vs 0.8875 overall utility) assuming turbinate hypertrophy was present. Sensitivity analysis indicated the treatment success increase (%) provided by concurrent turbinoplasty was the key parameter in the model. A treatment success increase of 3% of turbinoplasty was the threshold where concurrent turbinoplasty was favored over T/A alone. The incremental cost-effectiveness ratio (ICER) of $27,333/QALY for the baseline model was favorable to the willingness-to-pay threshold of $50,000 to $100,000/QALY for industrialized nations. CONCLUSIONS: The addition of turbinoplasty for children with turbinate hypertrophy to T/A for the treatment of pediatric oSDB is beneficial from both a utility and cost-benefit analysis standpoint even if the benefits of turbinoplasty are relatively modest.

Use of intranasal submucosal fillers as a transient implant to alter upper airway aerodynamics: implications for the assessment of empty nose syndrome.

BACKGROUND: Empty nose syndrome (ENS) is a debilitating condition associated with inferior turbinate tissue loss. Surgical augmentation of the inferior meatus has been proposed to treat ENS, although efficacy data with validated, disease-specific questionnaires is limited. Instead we evaluated submucosal injection of a transient, resorbable filler into the inferior meatus to favorably alter nasal aerodynamics in ENS patients. METHODS: Patients with a history of inferior turbinate reduction, diagnosed with ENS via Empty Nose Syndrome 6-Item Questionnaire (ENS6Q) and cotton testing, were enrolled and underwent submucosal injection of carboxymethylcellulose/glycerin gel (Prolaryn®) into the inferior meatuses between July 2014 and May 2018. This material likely resorbs over several months. Outcomes included comparisons of preinjection and postinjection symptoms at 1 week, 1 month, and 3 months using the ENS6Q, 22-item Sino-Nasal Outcome Test (SNOT-22), Generalized Anxiety Disorder 7-item scale (GAD-7), and Patient Health Questionnaire-9 (PHQ-9). RESULTS: Fourteen patients underwent injections. Mean ENS6Q scores significantly decreased from baseline at 1 week (20.8 vs 10.5; p < 0.0001), and remained reduced but upward-trending at 1 month (13.7, p = 0.002) and 3 months (15.5, p > 0.05) following injections. Mean SNOT-22 scores significantly decreased at 1 week (p = 0.01) and 1 month (p = 0.04), mean GAD-7 at 1 month (p = 0.02) and 3 months (p = 0.02), and mean PHQ-9 at 1 week (p = 0.01) and 1 month (p = 0.004) postinjection. CONCLUSION: Transient, focal airway bulking via submucosal filler injection at sites of inferior turbinate tissue loss markedly benefits ENS patients, suggesting that aberrant nasal aerodynamics from inferior turbinate tissue loss contributes to (potentially reversible) ENS symptoms.

Trends in inferior turbinate surgery: analysis of patients using the Medicare database.

BACKGROUND: The aim of this study was to characterize trends in turbinate reduction procedures from 2000 to 2015. METHODS: Annual procedure data were obtained for the period 2000-2015 and detailed Medicare provider and payment data were obtained for 2012-2015. Turbinate procedures analyzed included turbinate soft tissue mucosal ablation (TMA), turbinate soft tissue submucosal ablation (TSMA), turbinate excision (TE), and turbinate submucous resection (TSR). TMA and TSMA were grouped as turbinate soft tissue ablation (TA) for analysis. From 2012 to 2015, the type and location-facility (F) or nonfacility (NF)-of the providers performing the procedures were assessed. RESULTS: From 2000 to 2015, the total number of turbinate reduction procedures increased by an average of 3.8% annually. TSR had the highest annual increase at 5.4%. TE is the only procedure to show a decrease, by an average of -2.3% annually. From 2012 to 2015, the number of turbinate reduction procedures changed by -1.6% and 107.7% at F and NF locations, respectively. NF TSMA and TSR had the largest increases at 121.6% and 260.1%, respectively. Of the NF TA procedures, there was an average annual increase of 50% by non-otolaryngologists. For TA, the average F charge was 78.0% more than the NF charge, and the average NF otolaryngologist charge 11.5% more than the non-otolaryngologist charge. CONCLUSION: The number of turbinate reduction procedures increased steadily between 2000 and 2015, with the majority being TSRs. This is consistent with previous studies demonstrating that TSR leads to better outcomes. There has been a significant increase in turbinate reduction procedures performed in outpatient/ambulatory settings by otolaryngologists, non-otolaryngologists, and midlevel providers.

Time, Resident Involvement, and Supply Drive Cost Variability in Septoplasty with Turbinate Reduction.

Objective To determine factors that influence cost variability in septoplasty with inferior turbinate reduction. Study Design Case series with chart review. Setting Tertiary care hospital and affiliated ambulatory surgical center. Subjects and Methods Surgical costs were reviewed for adult patients undergoing septoplasty with inferior turbinate reduction between December 2014 and September 2017. Cases where additional procedures were performed were excluded. Operative supply costs, operative time, room time, and resident involvement were determined. Contribution of these factors to total costs and variability were analyzed. Results The study included 116 patients (mean age, 38 years) and 4 faculty surgeons. Total cost was primarily driven by operative time (74%), with a smaller portion of total cost arising from supplies (26%). Time cost ( P < .0001) and supply cost ( P = .006) varied significantly among surgeons. A resident was involved in 46.6% of cases. When subanalyzed by resident year, no-resident and senior resident (postgraduate years 4 and 5) cases had nearly identical mean times, while junior resident (postgraduate years 1-3) cases had mean times and operative time costs that were 39% greater ( P < .001). Conclusion For septoplasty with inferior turbinate reduction, the greatest driver of cost variation was operative time. Resident involvement correlated with increased time and cost. Supply costs had a much smaller impact. When subanalyzed by resident year, junior resident-involved cases were significantly longer than no-resident cases.

Assessment of nasal obstruction with rhinomanometry and subjective scales and outcomes of surgical and medical treatment. / Evaluación de la obstrucción nasal mediante rinomanometría y escalas subjetivas y medición del éxito terapéutico médico y quirúrgico.

INTRODUCTION: Prospective study of patients with nasal obstruction (NO) in order to measure therapeutic success by anterior active rhinomanometry (AAR), Nasal Obstruction Symptom Evaluation (NOSE) scale and Visual Analogue Scale (VAS) and to establish the correlation between these tests. METHODS: Patients with NO, on whom we performed an AAR, NOSE and VAS scales at baseline and after medical treatment (topical nasal steroid) or surgery (septoplasty, turbinoplasty or septoplasty and turbinoplasty). The nasal flow obtained by the AAR and the score of both subjective scales (NOSE and VAS) were compared and analyzed. RESULTS: A total of 102 patients were included in the study. Surgical treatment resulted in statistically significant differences with the AAR and the subjective scales. While in patients with medical treatment there was an increase in the AAR nasal flow but without statistical significance (P=.1363). The correlation between the AAR, the NOSE and VAS scales was measured finding a strong correlation between the NOSE and VAS scales only (r=.83327). CONCLUSIONS: The patients with NO treated surgically have better results when these are evaluated by AAR or with subjective scales. There is no significant correlation between AAR, NOSE and VAS scales, this is considered to be because the AAR and subjective scales are complementary and measure different aspects of NO. The AAR and subjective scales are useful tools to be used together for the follow up of patients with NO.