Evaluating post-rhinoplasty nasal obstruction treatment: The efficacy of VivAer radiofrequency ablation.

PURPOSE: Nasal obstruction is a prevalent issue affecting up to one-third of adults, often requiring surgical intervention. Low-temperature radiofrequency (RF) treatment, specifically VivAer, has emerged as a promising alternative, especially for the treatment of nasal valve collapse (NVC). However, its efficacy in patients with a history of rhinoplasty or nasal valve repair remains unexplored. METHODS: A single-center retrospective chart review was conducted on 37 patients with a history of rhinoplasty or nasal valve repair who underwent VivAer RF treatment. Treatment outcomes were assessed using the Nasal Obstruction Symptom Evaluation (NOSE) scale. The primary outcome was defined as a decrease in NOSE score by at least one severity category or a 20 % reduction in total NOSE score. RESULTS: The study found a statistically significant average reduction in NOSE score of 22.4 points or 36.6 %. Among patients with a positive treatment response (21 patients or 56.8 %), the average NOSE score reduction was 34.7 points or 55.6 %. Repeat RF treatment in non-responders resulted in a 50 % response rate. No significant difference was observed in treatment outcomes based on the type of prior rhinoplasty or NVC. CONCLUSIONS: Temperature-controlled RF treatment with VivAer can effectively alleviate nasal obstruction in patients with a history of rhinoplasty or nasal valve repair, offering a viable alternative to revision surgery. The study also highlights the potential benefit of repeat RF treatment in non-responders. Further research, including randomized controlled trials, is needed to validate these promising results and expand the treatment options for this complex patient population.

Temperature Profile Measurement From Radiofrequency Nasal Airway Reshaping Device.

OBJECTIVE: Nasal airway obstruction (NAO) is caused by various disorders including nasal valve collapse (NVC). A bipolar radiofrequency (RF) device (VivAer®, Aerin Medical, Sunnyvale, CA) has been used to treat NAO through RF heat generation to the upper lateral cartilage (ULC). The purpose of this study is to measure temperature elevations in nasal tissue, using infrared (IR) radiometry to map the spatial and temporal evolution of temperature. STUDY DESIGN: Experimental and computational. METHODS: Composite porcine nasal septum was harvested and sectioned (1 mm and 2 mm). The device was used to heat the cartilage in composite porcine septum. An IR camera (FLIR® ExaminIR, Teledyne, Wilsonville, OR) was used to image temperature on the back surface of the specimen. These data were incorporated into a heat transfer finite element model that also calculated tissue damage using Arrhenius rate process. RESULTS: IR temperature imaging showed peak back surface temperatures of 49.57°C and 42.21°C in 1 and 2 mm thick septums respectively. Temperature maps were generated demonstrating the temporal and spatial evolution of temperature. A finite element model generated temperature profiles with respect to time and depth. Rate process models using Arrhenius coefficients showed 30% chondrocyte death at 1 mm depth after 18 s of RF treatment. CONCLUSION: The use of this device creates a thermal profile that may result in thermal injury to cartilage. Computational modeling suggests chondrocyte death extending as deep as 1.4 mm below the treatment surface. Further studies should be performed to improve dosimetry and optimize the heating process to reduce potential injury. Laryngoscope, 134:1063-1070, 2024.

Prevalence and Identification of Nasal Airway Obstruction in Patients Presenting to Otolaryngology Clinics: Results From a Large Descriptive Practice Survey.

Objective: Determine the prevalence of nasal airway obstruction (NAO) in patients presenting to general otolaryngology clinics using the Nasal Obstruction Symptom Evaluation Scale (NOSE) score as a screening tool. Study Design: The clinic staff at 149 otolaryngology specialty clinics geographically distributed in the United States administered the NOSE Scale assessment to 3533 patients presenting to the clinics over a period of 1 week, regardless of the reason for the visit. All patients completed the NOSE Scale score, and additional data were collected, including the primary reason for the visit. Demographic and patient characteristics were summarized using frequencies and percentages for categorical variables. Results: The overall mean NOSE Scale score for the 3533 patients surveyed was 37.6 (SD 31.5). A total of 37.4% (1320/3533) of surveyed patients, regardless of visit reason, had severe/extreme NAO symptoms. Overall, the most common visit reason category was "Other" (61.2%, 2162/3533), followed by "NAO" (22.6%, 798/3533) and "Sinus" (16.2%, 573/3533). The mean NOSE scores for patients in each of the visit categories were 23.4 (SD 25.9), 64.7 (SD 23.3), and 53.3 (SD 28.1); for "Other," "NAO," and "Sinus," respectively. Among the patients coming in with "NAO" or "Sinus" as a primary complaint, 76.2% (608/798) and 57.2.% (328/573) had severe or extreme NOSE scores. A total of 17.8% (384/2162) of patients coming in for "Other" reasons had NOSE scores indicating severe/extreme NAO symptoms. Conclusions: The findings of this large, descriptive otolaryngology practice survey found a high prevalence of moderate to severe/extreme NAO among patients presenting to otolaryngology practices. Incorporating assessments, such as the NOSE Scale score and other diagnostic practices into the patient intake workflow and assessments, could help identify symptomatic NAO patients that might otherwise be overlooked.

Two-year outcomes of temperature-controlled radiofrequency device treatment of the nasal valve for patients with nasal airway obstruction.

Background: The objective of this study was to evaluate long-term symptom improvements in patients with nasal airway obstruction (NAO) secondary to nasal valve collapse (NVC) following minimally invasive temperature-controlled radiofrequency (TCRF) treatment. Methods: A prospective, single-arm, multicenter study in patients >18 years with NAO due to NVC. Inclusion criteria were response to nasal valve dilation (e.g., modified Cottle maneuver) and baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥60. Patients were treated in the nasal valve region with a TCRF device and followed through 2 years. A responder was ≥20% reduction NOSE Scale score or ≥1 reduction in severity class. Results: A total of 122 patients were treated and 91 reached 2 years. The mean baseline NOSE Scale score was 80.3 (95% CI, 78.1-82.6). The adjusted mean change in score at 2 years was -45.8 (95% CI, -53.5 to -38.1), p < 0.001; a 57.0% improvement. The 2-year responder rate was 90.1% (95% CI, 82.3%-94.7%). Significant and sustained symptom improvement was achieved in subpopulations based on sex, age, body mass index, baseline NAO severity, nasal surgery history, NVC mechanism, septal deviation, and other anatomic contributors of NAO. No serious adverse events with a relationship to the study device and/or procedure were reported. Conclusions: Minimally invasive TCRF device treatment of the internal nasal valve for NAO is well tolerated and leads to significant and sustained improvement in NAO symptom severity through 2 years, including in patients with both static and dynamic NVC, septal deviation, turbinate enlargement, or prior nasal surgery. Level of Evidence: 2b.

Could the use of a new novel bipolar radiofrequency device (Aerin) improve nasal valve collapse? A systematic review and meta-analysis.

BACKGROUND: Surgical treatment for nasal obstruction caused by nasal valve collapse requires a significant recovery period and risks of complications, while nasal dilators are uncomfortable. Recently, radiofrequency treatment of lateral walls has been used under local anesthesia as an office base surgery. This work aims to assess the efficacy of a new radiofrequency device, the Vivaer™ System (Aerin Medical, Sunnyvale, CA), to treat nasal obstruction through a systematic review and meta-analysis. METHODS: Two researchers independently reviewed the literature up to December 2021. Studies on patients seeking treatment for nasal obstruction due to nasal valve collapse were included in the analysis. RESULTS: Four studies (218 patients) met the inclusion criteria and treated the nasal valve regions bilaterally with the Aerin Medical Vivaer™ System. After the treatment, the NOSE score was reduced at three months postoperatively. Minor adverse events were reported in the included studies, and two showed no complications. None of the studies reported changes in the external appearance of the nose. CONCLUSION: The radiofrequency treatment using the Vivaer device can be useful for treating nasal valve collapse, improving significantly subjective breathing symptom scores. Further studies on a large scale are needed to confirm these results.

Evaluation and Management of the Nasal Airway.

Nasal airway obstruction is a very common phenomenon that can significantly decrease patients' quality of life. This review article summarizes in an evidence-based fashion the diagnosis and treatment of nasal airway obstruction. The nasal airway may be obstructed at the level of the nasal valve, septum, nasal turbinates, sinonasal mucosa, or nasopharynx. Nasal valve obstruction and septal deviations are usually treated surgically depending on the level of valve obstruction. Isolated turbinate hypertrophy is usually managed medically as part of the treatment of rhinitis, with surgery reserved for cases refractory to medical care. Sinonasal and nasopharyngeal conditions are treated according to the diagnosis.

Temperature-controlled radiofrequency device treatment of the nasal valve for nasal airway obstruction: A randomized controlled trial.

BACKGROUND: Nasal valve collapse is one of several causes of nasal obstruction. The safety and efficacy of a temperature-controlled radiofrequency (RF) device for the treatment of the nasal valve for nasal airway obstruction (NAO) has been established in single-arm studies. The objective of this trial was to compare active device treatment against a sham procedure (control). METHODS: In a prospective, multicenter, single-blinded, randomized controlled trial (RCT), patients were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area. The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall. The primary endpoint was responder rate at 3 months, defined as a ≥20% reduction in Nasal Obstruction Symptom Evaluation (NOSE)-scale score or ≥1 reduction in clinical severity category. RESULTS: At baseline, patients had a mean NOSE-scale score of 76.7 (95% confidence interval [CI], 73.8 to 79.5) and 78.8 (95% CI, 74.2 to 83.3) (p = 0.424) in the active treatment and sham-control arms, respectively. At 3 months, the responder rate was significantly higher in the active treatment arm (88.3% [95% CI, 79.2%-93.7%] vs 42.5% [95% CI, 28.5%-57.8%]; p < 0.001). The active treatment arm had a significantly greater decrease in NOSE-scale score (mean, -42.3 [95% CI, -47.6 to -37.1] vs -16.8 [95% CI, -26.3 to -7.2]; p < 0.001). Three adverse events at least possibly related to the device and/or procedure were reported, and all resolved. CONCLUSION: This RCT shows temperature-controlled RF treatment of the nasal valve is safe and effective in reducing symptoms of NAO in short-term follow-up.

Treating Nasal Valve Collapse in Facial Paralysis: What I Do Differently.

Patients with facial paralysis require a systematic zonal assessment. One frequently overlooked region is the effect of facial paralysis on nasal airflow. Patients with flaccid paralysis experience increased weight of the cheek and loss of muscle tone in the ala and sidewall; this significantly contributes to nasal valve narrowing and collapse. These specific findings are often not adequately corrected with traditional functional rhinoplasty-grafting techniques. Flaccid paralysis typically results in inferomedial displacement of the alar base, which must be restored with suspension techniques to fully treat the nasal obstruction. Multiple surgical options exist and are discussed in this article.

A comparison of an absorbable nasal implant versus functional rhinoplasty for nasal obstruction.

PURPOSE: An absorbable nasal implant for the treatment lateral nasal wall collapse was approved for use in patients with nasal obstruction. It remains to be seen whether this treatment is equivalent to open techniques for the treatment of nasal valve incompetence from collapsibility. MATERIALS AND METHODS: Two groups were analyzed for the study. One group had surgery which included the implant, septoplasty, and inferior turbinate submucous reduction and the other group had a variety of functional rhinoplasty techniques for lateral wall insufficiency in addition to septoplasty and inferior turbinate submucous reduction. NOSE and SNOT-22 were used to demonstrate pre and post-operative changes. RESULTS: Ninety total patients were identified. Fifty patients underwent insertion of an absorbable nasal implant and 40 underwent a traditional open technique to stabilize the LNW. For the implant group the mean NOSE score was 63.4 (SD 24) and post-operative was 22.9 (SD 19.9), in addition, the SNOT-22 score was 38.8 (SD 19.8) and post-operative was 18.5 (SD 15.2). For the open rhinoplasty group, the mean NOSE score was 57.9 (SD 23.2) and post-operative was 17.6 (SD 16.4). The SNOT-22 score was 33.6 (SD 14.9) and post-operative score was 11.5 (SD 15.2) The delta between pre and post-operative NOSE and SNOT-22 test were not different at an average of 3.95 months post-operatively between the groups (NOSE, P = 0.94 and SNOT-22, p = 0.53). CONCLUSION: In patients with multiple structural causes of nasal obstruction, including lateral wall insufficiency, insertion of an absorbable nasal implant, to support the LNW, seems to be equally effective as functional rhinoplasty techniques over a 4 month timeframe.

Nasal Airflow Changes With Bioabsorbable Implant, Butterfly, and Spreader Grafts.

OBJECTIVES/HYPOTHESIS: Internal nasal valve compromise is a major cause of nasal obstruction, with a growing number of ways to treat this condition. In this study, we compared the effects of butterfly graft, spreader graft, and the bioabsorbable nasal implant on nasal airflow resistance. STUDY DESIGN: Cadaver study. METHODS: Computational fluid dynamics (CFD) simulations were completed from nine preoperative and postoperative cadaveric subjects. Each cadaveric head underwent placement of a bioabsorbable nasal implant (BNI) (Spirox Latera; Stryker ENT, Plymouth, MN), butterfly graft, or spreader graft. Pre- and postoperative computed tomography (CT) scans were used to generate three-dimensional models of the nasal airway used in steady-state CFD simulations of airflow and heat transfer during inspiration. RESULTS: Butterfly graft placement resulted in a mean improvement in nasal airway resistance of 24.9% (±7.3), whereas BNI placement resulted in a 6.7% (±1.2) improvement, and spreader graft placement also resulted in a consistent improvement of 2.6% (±13.5). Pressure within the main nasal cavity was consistently lower following butterfly graft placement versus a spreader graft or BNI. Butterfly and spreader graft placement also resulted in modest improvements in airflow allocation, whereas BNI demonstrated more variation (-1% to 12%). Heat flux was not significantly different; however, a small improvement in total heat flux was seen with all three interventions. CONCLUSIONS: The results of this study demonstrate reduction in nasal airway resistance in all three surgical interventions, with the butterfly graft demonstrating superiority to the other two techniques. However, these data only reflect a static environment and not dynamic changes in airflow seen during respiration. LEVEL OF EVIDENCE: NA Laryngoscope, 130:E817-E823, 2020.

Diagnosis and management of septal deviation and nasal valve collapse - a survey of Canadian otolaryngologists.

BACKGROUND: Management of nasal valve collapse (NVC) in patients with a septal deviation can be challenging. Our objective was to determine the opinions of Canadian Otolaryngologists regarding the diagnosis and management of nasal obstruction in patients with septal deviation and NVC. METHODS: A twenty-question survey was developed for the purpose of our study. Questions were divided into the following areas: diagnosis, management and prognosis. We included all otolaryngologists who were members of the Canadian Society of Otolaryngology. RESULTS: The response rate to our survey was 18%. The most commonly identified cause of a failed septoplasty was incomplete septoplasty (41.9%), followed by nasal valve collapse (25.6%). The Cottle manoeuvre (62.8%) and visual inspection (39.5%) were noted to be the most important diagnostic tools for external and internal NVC respectively. However, physicians often rely on a variable number of different examinations when making a diagnosis of nasal valve collapse. When evaluating which patients with a septal deviation also required nasal valve surgery, 27.9% of responders believed the current physical examination methods provided a high accuracy, while 55.8% indicated moderate accuracy and 16.3% indicated low accuracy. Compared to other subspecialties in Otolaryngology, Facial Plastic and Reconstruction Surgeons noted higher septoplasty failure rates in patients with co-morbid NVC. CONCLUSIONS: NVC is an important concern for otolaryngologists performing septoplasty. Although most physicians believe that the physical exam provides a moderate effectiveness when predicting who requires a functional rhinoplasty, diagnostic methods used for NVC is varied and inconsistent.

Evolution of the butterfly graft technique: 15-year review of 500 cases with expanding indications.

OBJECTIVES/HYPOTHESIS: To describe the evolution of the butterfly graft technique for the treatment of nasal valve compromise, with specific attention to technical developments allowing for expanded indications. To review the impact on patient-reported outcomes of nasal airway function and nasal aesthetics. STUDY DESIGN: Retrospective chart review. METHODS: A review of a single surgeon's patients at a private practice and tertiary care center undergoing surgical correction for nasal valve compromise using the butterfly graft technique between July 2002 and April 2017. Data collected included etiology of nasal valve compromise, additional procedures performed, complications, and functional and aesthetic patient-reported outcomes. RESULTS: Over the study period, 512 patients underwent surgery to correct nasal valve compromise utilizing the butterfly graft technique. The overall patient-reported relief of nasal obstructive symptoms was complete in 87%, improved but not completely relieved in 10%, and not improved in 4%. No patients reported a worsening in their nasal obstructive symptoms. The overall patient-reported change in nasal appearance was improved 53%, the same 32%, worse in 15%. The patients in the latter half of the study tended to report better aesthetic results. CONCLUSIONS: The results of this study suggest that the surgical technique for the butterfly graft evolved over time and allowed for improved aesthetic outcomes, without reduction in the efficacy in correction of nasal valve compromise. The evolution in technique allowed for expansion of the indications for the butterfly graft while maintaining the favorable patient-reported aesthetic and functional results. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:S1-S10, 2019.

Management of Long-Standing Flaccid Facial Palsy: Static Approaches to the Brow, Midface, and Lower Lip.

Chronic flaccid facial paralysis (FFP>2 years) may be approached with static and dynamic techniques. A horizontal zonal assessment evaluates the upper, middle, and lower thirds of the face. Surgery is tailored to an individual's deficits, goals, and health status. While dynamic reanimation is the gold standard for rehabilitation, there are cases in which static approaches are more appropriate or may be used as an adjunct to dynamic techniques. This article focuses on the surgical management of FFP primarily using static approaches to the individual zones of the face to create resting symmetry.

A prospective cohort study assessing the clinical utility of the Cottle maneuver in nasal septal surgery.

BACKGROUND: A nasal septal deviation can have a significant detrimental effect on a patient's quality of life. Nasal valve collapse (NVC) often co-exists with a septal deviation. The Cottle maneuver is one of the most common methods to diagnose NVC; however, no study has assessed the efficacy of this physical exam finding. This study tests the hypothesis that patients with nasal obstruction due to a septal deviation with a negative pre-operative Cottle maneuver will demonstrate a greater improvement in their Nasal Obstruction Symptom Evaluation (NOSE) score, compared to patients who demonstrate a positive pre-operative Cottle maneuver, when assessed at 12 months following a septoplasty with turbinate diathermy. METHODS: This was a prospective Cohort Study. The population was 141 patients with nasal obstruction due to a septal deviation with or without nasal valve collapse, excluding patients with bilateral complete nasal valve collapse. Patients were placed in cohorts according to the results of the Cottle maneuver (positive or negative). A NOSE questionnaire was administered at baseline and 12-months after a septoplasty with turbinate diathermy. Non-adjusted NOSE scores were used (score out of 20). An ANOVA was used to compare if there was a difference in outcomes between patient cohorts. RESULTS: One hundred and forty-one patients completed 12-month follow-up with 71.5% of patients demonstrating a positive Cottle maneuver at baseline. The mean (95% C.I.) difference in NOSE score at 12 months between patients with a positive Cottle versus a negative Cottle was 0.18 (- 1.6 to 1.92; p = 0.38). CONCLUSION: In a univariate, single surgeon study, a positive Cottle Maneuver does not appear to influence outcomes in the described patient population compared to those with a negative Cottle Maneuver when undergoing a septoplasty.

Surgical Management of Nasal Valve Collapse.

Nasal valve collapse has multiple causes, including congenital, traumatic, and, unfortunately, iatrogenic. Recognition of the causes of nasal valve collapse and the methodology for treatment is paramount not only for the otolaryngologist but also for any physician managing the nasal airway. This article focuses on the cause and surgical management of internal and external nasal valve collapse.

Anatomy and Physiology of Nasal Obstruction.

Nasal obstruction is a common presenting symptom to clinicians and affects up to one-third of the population. There are several factors that cause nasal obstruction, including anatomic, physiologic, and pathophysiologic factors. The anatomy and physiology of nasal obstruction is complicated and is influenced by patency of nasal passages, mucociliary function, airflow receptors, autonomic function, and degree of mucosal inflammation. Common anatomic causes include internal nasal valve stenosis/collapse, septal deviation, and turbinate hypertrophy. Common physiologic causes include sinonasal inflammatory disorders and iatrogenic causes.

Nasal Valve Reconstruction Using a Titanium Implant: An Outcomes Study.

Septoplasty alone is not always sufficient to correct nasal obstruction. Various techniques have been employed to repair nasal valve collapse and improve airflow. This article aimed to evaluate outcomes and quality of life following nasal valve reconstruction using a titanium implant in patients with nasal valve collapse. This is a single-center retrospective study that consisted of a telephone questionnaire of 37 quality-of-life measures and questions related to the surgical procedure and recovery process to evaluate postsurgical outcomes. Fifteen patients completed the survey. There was a significant improvement in nasal blockage/obstruction, breathing through the nose, sleeping, breathing through nose during exercise, the need to blow nose, sneezing, facial pain/pressure, fatigue, productivity, and restlessness/irritability after surgery. Overall, 100% of patients were satisfied with the results and would recommend this procedure. The most common postoperative complaints were pain (33%) and difficulty breathing (33%). Patients noticed no increase (20%) or a slight increase (73%) in the size of their nose. Sixty percent of patients cannot see the implant and 13% report the implant is barely noticeable. Nasal valve repair with a titanium implant was successful at improving symptoms of nasal obstruction and other quality-of-life issues. Satisfaction was high among all patients. The implants are palpable, thought to be visible by some patients, yet accepted by the majority of patients. This approach may be especially important in patients with prior nasal surgery but continue to experience refractory symptoms.

In Vitro and In Vivo Studies of Alar-Nasal Cartilage Using Autologous Micro-Grafts: The Use of the Rigenera® Protocol in the Treatment of an Osteochondral Lesion of the Nose.

Cartilage defects represent a serious problem due to the poor regenerative properties of this tissue. Regarding the nose, nasal valve collapse is associated with nasal blockage and persistent airway obstruction associated with a significant drop in the quality of life for patients. In addition to surgical techniques, several cell-based tissue-engineering strategies are studied to improve cartilage support in the nasal wall, that is, to ameliorate wall insufficiency. Nevertheless, there are no congruent data available on the benefit for patients during the follow-up time. In this manuscript, we propose an innovative approach in the treatment of cartilage defects in the nose (nasal valve collapse) based on autologous micro-grafts obtained by mechanical disaggregation of a small portion of cartilage tissue (Rigenera® protocol). In particular, we first analyzed in vitro murine and human cartilage micro-grafts; secondly, we analyzed the clinical results of a patient with pinched nose deformity treated with autologous micro-grafts of chondrocytes obtained by Rigenera® protocol. The use of autologous micro-graft produced promising results in surgery treatment of cartilage injuries and could be safely and easily administrated to patients with cartilage tissue defects.

The External Nasal Valve.

The external nasal valve is a complex entity comprised of multiple structures and tissue types. As such, there is no single operation that can address all problems of the external valve. This article reviews the relevant anatomy, pathologic conditions, and treatments for external nasal valve dysfunction, including a detailed review of the nasal muscles and their contribution to external nasal valve patency. Surgical and nonsurgical options for treatment and the evidence supporting the importance of proper external nasal valve function on quality-of-life measures are discussed.