| Coverage Policy Manual | |
| Policy #: | 2018028 |
| Category: | Surgery |
| Initiated: | November 2018 |
| Last Review: | March 2025 |
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| Minimally Invasive Treatment of Nasal Obstruction | |
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| Description: |
Nasal Valve Collapse
Nasal valve collapse (NVC) is a readily identifiable cause of nasal obstruction. Specifically, the internal nasal valve represents the narrowest portion of the nasal airway with the upper lateral nasal cartilages present as supporting structures. The external nasal valve is an area of potential dynamic collapse that is supported by the lower lateral cartilages. Damaged or weakened cartilage will further decrease airway capacity and increase airflow resistance and may be associated with symptoms of obstruction. Patients with NVC may be treated with nonsurgical interventions in an attempt to increase the airway capacity but severe symptoms and anatomic distortion are treated with surgical cartilage graft procedures. The placement of an absorbable implant to support the lateral nasal cartilages has been proposed as an alternative to more invasive grafting procedures in patients with severe nasal obstruction. The concept is that the implant may provide support to the lateral nasal wall prior to resorption and then stiffen the wall with scarring as it is resorbed. The application of radiofrequency volumetric tissue reduction for nasal obstruction has been proposed as a less invasive means to treat nasal obstruction due to internal NVC. By utilizing RF energy, the treatment aims to provide relief with reduced recovery times and fewer complications compared to traditional surgical methods
Nasal obstruction is defined clinically as a patient symptom that presents as a sensation of reduced or insufficient airflow through the nose. Commonly, patients will feel that they have nasal congestion or stuffiness. In adults, clinicians focus the evaluation of important features of the history provided by the patient such as whether symptoms are unilateral or bilateral. Unilateral symptoms are more suggestive of structural causes of nasal obstruction. A history of trauma or previous nasal surgery, especially septoplasty or rhinoplasty, is also important. Diurnal or seasonal variation in symptoms is associated with allergic conditions.
Nasal valve collapse (NVC) is a is a readily identifiable cause of nasal obstruction (Lee, 2024; Wang, 2019). The internal nasal valve is the narrowest part of the nasal passage and is supported by the upper lateral nasal cartilages (see pathophysiology below). On the other hand, the external nasal valve, also known as the nasal entrance, is prone to dynamic collapse and is supported by the lower lateral cartilages. When cartilage is damaged or weakened, it can reduce airway capacity, increase airflow resistance, and lead to symptoms of obstruction. While nonsurgical treatments aim to enhance airway capacity in patients with NVC, severe symptoms and significant anatomical distortion typically require surgical cartilage graft procedures.
Etiology
Nasal obstruction associated with the external nasal valve is commonly associated with post-rhinoplasty or traumatic sequelae and may require functional rhinoplasty procedures. A common cause of internal nasal valve collapse is septal deviation. Prior nasal surgery, nasal trauma, and congenital anomaly are additional causes.
Pathophysiology
The internal nasal valve, bordered by the collapsible soft tissue between the upper and lower lateral cartilages, the anterior end of the inferior turbinate, and the nasal septum, forms the narrowest part of the nasal airway. During inspiration, the lateral wall cartilage is dynamic and draws inward toward the septum and the internal nasal valve narrows providing protection to the upper airways. The angle at the junction between the septum and upper lateral cartilage is normally 10° to 15° in white populations. Given that the internal nasal valve accounts for at least half of the nasal airway resistance; even minor further narrowing of this area can lead to symptomatic obstruction for a patient. Damaged or weakened lateral nasal cartilage will further decrease airway capacity of the internal nasal valve area, increasing airflow resistance and symptoms of congestion (Howard, 2002).
Physical Examination
A thorough physical examination of the nose, nasal cavity, and nasopharynx is generally sufficient to identify the most likely etiology for the nasal obstruction. Both the external and internal nasal valve areas should be examined. The external nasal valve is at the level of the internal nostril. It is formed by the caudal portion of the lower lateral cartilage, surrounding soft tissue, and the membranous septum.
The Cottle maneuver is an examination in which the cheek on the symptomatic side is gently pulled laterally with 1 to 2 fingers. If the patient is less symptomatic with inspiration during the maneuver, the assumption is that the nasal valve has been widened from a collapsed state or dynamic nasal valve collapse. An individual can perform the maneuver on oneself, and it is subjective. A clinician performs the modified Cottle maneuver. A cotton swab or curette is inserted into the nasal cavity to support the nasal cartilage and the patient reports whether there is an improvement in the symptoms with inspiration. In both instances, a change in the external contour of the lateral nose may be apparent to both the patient and the examiner.
According to American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS, 2023):
"The diagnosis of symptomatic nasal valve dysfunction is a clinical diagnosis, made by patient history and physical exam. These diagnoses are made by a qualified Otolaryngologist as a part of a thorough physical examination of the nose...Subjective improvement in nasal breathing with the Cottle or modified Cottle maneuver confirms the diagnosis of nasal valve collapse."
Treatment
Treatment of symptomatic nasal valve collapse includes the use of nonsurgical interventions such as the adhesive strips applied externally across the nose or use of nasal dilators, cones, or other devices that support the lateral nasal wall internally applying the principle of the modified Cottle maneuver. Severe cases of obstruction result from nasal valve deformities are treated with surgical grafting to widen and/or strengthen the valve. Common materials include cartilaginous autografts and allografts, as well as permanent synthetic grafts. Cartilage grafts are most commonly harvested from the patient’s nasal septum or ear.
The placement of an absorbable implant to support the lateral nasal cartilages has been proposed as an alternative to more invasive grafting procedures in patients with severe nasal obstruction.
Radiofrequency Volumetric Tissue Reduction
The application of low-dose radiofrequency (RF) energy has been proposed as an alternative technique for reshaping nasal tissue to address NVC. This method has been suggested as a viable alternative to more invasive grafting procedures, particularly for patients experiencing severe nasal obstruction. By utilizing RF energy, the treatment aims to provide relief with reduced recovery times and fewer complications compared to traditional surgical methods.
Nasal Swell
The nasal septal swell body (NSB), also known as the nasal septal turbinate, is a conserved region of the septum located anterior to the middle turbinate and superior to the inferior turbinate approximately 2.5 cm above the nasal floor (Costa, 2010). The swell body is not well understood, but observation has suggested that it may influence nasal airflow. Additional research is needed to determine the contribution of nasal swell body (NSB) presence to persistent nasal obstruction, and the effects of treatment.
Regulatory Status
In May 2016, LATERA (Spirox) was cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process (Food and Drug Administration product code: NHB) (Rhee, 2010). LATERA is the only commercially available absorbable nasal implant for treatment of nasal valve collapse. It is a class II device. LATERA absorbable implant (K161191), manufactured by Spirox (part of Stryker), is indicated for supporting nasal upper and lower lateral cartilage. Product Code NHB.
In April 2020, the VivAer Stylus (Aerin Medical) was cleared for use in otorhinolaryngology (ENT) surgery by the FDA through the 510(k) process as a tool to treat nasal obstruction (K200300) (FDA, 2020). Clearance was based on equivalence in design and intended use of a predicate device, the Vivaer ARC Stylus (K172529). The VivAer Stylus is functionally unchanged from the predicate in design and intended use to generate and deliver bipolar RF energy to treat tissue in otorhinolaryngology (ENT) procedures. As per the FDA 510K summary, the VivAer Stylus is indicated for use in ENT surgery for the coagulation of soft tissue in the nasal airway, to treat nasal airway obstruction by shrinking submucosal tissue, including cartilage in the internal nasal valve area.
Coding
Previously there was no specific code for absorbable nasal implants. However, effective April 1, 2018, there is HCPCS C9749, which describes this device. Some facilities may still use the unlisted code C1889 (Implantable/insertable device for device intensive procedure, not otherwise classified). Physician work for the nasal implant placement would be billed with the unlisted CPT code 30999 (Unlisted procedure, nose). Some providers may use CPT 30465 (Repair of nasal vestibular stenosis [e.g., spreader grafting, lateral nasal wall reconstruction]) for this service; however, the unlisted code is appropriate.
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Policy/ Coverage: |
Effective July 2025
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The insertion of an absorbable lateral nasal implant for the treatment of symptomatic nasal valve collapse does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the insertion of an absorbable lateral nasal implant for the treatment of symptomatic nasal valve collapse is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency volumetric tissue reduction for nasal obstruction due to internal nasal valve collapse does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency volumetric tissue reduction for nasal obstruction due to internal nasal valve collapse is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
All other ablative techniques (e.g., radiofrequency ablation) that create submucosal lesions in the nostril and/or lateral nasal wall for the treatment of symptomatic nasal valve collapse do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, all other ablative techniques (e.g., radiofrequency ablation) that create submucosal lesions in the nostril and/or lateral nasal wall for the treatment of symptomatic nasal valve collapse are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
All other minimally invasive techniques, including those that do not involve cartilage grafting and/or complex suture techniques (e.g., lateral crural turn in flap), for the treatment of symptomatic nasal valve collapse do not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, all other minimally invasive techniques, including those that do not involve cartilage grafting and/or complex suture techniques (e.g,. lateral crural turn in flap), for the treatment of symptomatic nasal valve collapse are considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Nasal septal swell body destruction, ablation, or coblation for the treatment of sinonasal disease, including but not limited to nasal obstruction, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, nasal septal swell body destruction, ablation, or coblation for the treatment of sinonasal disease, including but not limited to nasal obstruction, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective prior to July 2025
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The insertion of an absorbable lateral nasal implant for the treatment of symptomatic nasal valve collapse does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the insertion of an absorbable lateral nasal implant for the treatment of symptomatic nasal valve collapse is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.
Absorbable Lateral Nasal Valve Implant
Clinical Context and Therapy Purpose
The purpose of insertion of an absorbable nasal valve implant in patients who have symptomatic nasal valve obstruction due to nasal valve collapse is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The question addressed in this evidence review is: Does the use of an absorbable nasal valve implant in patients who have symptomatic nasal valve obstruction due to nasal valve collapse improve the net health outcome?
The following PICOTS were used to select literature to inform this review.
Patients
The relevant population of interest is adults who have severe symptomatic nasal obstruction symptoms due to internal nasal valve (also known as zone 1) collapse (NVC). NVC is one of the recognized structural causes of obstructed breathing and congestion, and the diagnosis is primarily clinical. NVC may be unilateral or bilateral and is typically constant with each inspiration. The condition may occur in association with prior trauma or rhinonasal surgery. The evaluation consists of clinical history to elicit alternative causes or co-occurring conditions such as obstructive sleep apnea or medication use. In addition to examination of the head and neck, the Cottle maneuver or modified Cottle maneuver (previously described) is used to rule in NVC. Anterior rhinoscopy and nasal endoscopy are used and rule out structural abnormalities such as septal deviation or mucosal conditions such as enlarged turbinates. Radiographic studies are not generally indicated (Fraser, 2009).
Interventions
The therapy being considered is unilateral or bilateral insertion of an absorbable nasal implant into the lateral nasal wall. The product is predominantly cylindrical in shape with a diameter of 1 mm and an overall length of 24 mm with a forked distal end for anchoring into the maxillary periosteum. It is composed of poly(L-lactide-co-D-L-lactide) 70:30 copolymer, which is absorbed in the body over approximately 18 months. It is packaged with a 16-gauge insertion device. The available product information describes the integrity of the implant to be maintained for 12 months after implantation while a fibrous capsule forms around the device. A remodeling phase where collagen replaces the implant within the capsule persists through 24 months and is the purported mechanism of support for the lateral nasal wall support (Spriox, 2017).
Comparators
The following therapies and practices are currently being used to treat NVC: nonsurgical treatments include the use of externally applied adhesive strips or intranasal insertion of nasal cones. The basic mechanism of action of these treatments is to widen the nasal valve and permit increased airflow. Surgical grafting using either autologous cartilage (typically from the nasal septum, ear, or homologous irradiated rib cartilage) or a permanent synthetic implant may be performed to provide structural support to the lateral wall support defect.
Outcomes
The general outcomes of interest are change in symptoms and disease status, treatment-related morbidity, functional status, and change in quality of life. The Nasal Obstruction Symptom Evaluation (NOSE) score is an accepted symptom questionnaire for research purposes. The score can also be stratified to indicate the degree of severity of the nasal obstruction symptoms. The insertion of the absorbable implant is performed under local anesthesia and the adverse event profile includes mild pain, irritation, bruising and inflammation, awareness of the presence of the implant, infection, and the need for device retrieval prior to complete absorption.
Timing
The duration of follow-up to assess early procedural outcomes is 1 month and at least 24 months would be required to evaluate the durability of symptom improvement as well as to confirm the association with the purported device mechanism of action.
Setting
Insertion of an absorbable nasal implant is performed in the outpatient setting by an otolaryngologist or plastic surgeon.
Study Selection Criteria
No randomized comparative studies were identified to evaluate the absorbable nasal implant. The best available evidence consists of 2 nonrandomized prospective industry-sponsored studies of the commercially available absorbable nasal implant.
Nonrandomized Studies
Stolovitzky (2018) reported on 6-month outcomes for 101 patients with severe-to-extreme class of NOSE scores were enrolled at 14 U.S. clinics between September 2016 and March 2017. In the total cohort, 40.6% had a history of allergic rhinitis and 32.7% had a history of sinus disease. The types and rates of prior rhinologic surgeries were septoplasty (26.7%), turbinate reduction (29.7%), endoscopic sinus surgery (22.8%), and rhinoplasty (10.9%). The rate of prior septoplasty was 53.5% in the group that received the absorbable implant alone and 87.9% in the group that received implant plus adjunctive surgery. Overall, fifty-eight (57%) patients had adjunctive procedures (not expressly reported) in addition to the implant placement. In addition to the NOSE score, patients were assessed pre- and postoperatively with the Lateral Wall Insufficiency score, which is based on a review of a lateral wall motion video. Patients reported visual analog scale scores for nasal congestion at each follow-up visit.
Summary of Evidence
For individuals with symptomatic nasal obstruction due to internal nasal valve collapse who receive an absorbable lateral nasal valve implant, the evidence includes 2 nonrandomized prospective, single-cohort industry-sponsored studies. Relevant outcomes are symptoms, change in disease status, treatment-related morbidity, functional outcomes, and quality of life. Both studies are limited by the heterogeneity of the populations evaluated. Specifically, the types and rates of prior nasal procedures were not well described, nor was the clinical rationale for alternative or adjunctive procedural interventions. Overall, improvements in the Nasal Obstruction Symptom Evaluation score have been demonstrated in the study reports. However, a clinically significant difference may not be consistently apparent in small study populations. Some patients meeting the positive responder criteria still reported severe symptoms, and many patients reported some loss of improvement at 1 year. Data elements are missing or difficult to determine for important outcomes. As reported, adverse events appeared to be mild in severity and self-limiting, but still appeared common. Device retrievals are incompletely characterized. They occurred in 10% of patients in the primary cohort study, and it is not known, eg, whether a device retrieval occurred in a patient who had only a unilateral nasal implant. The need for device retrievals appears to occur early in the course of follow-up (1 month); suggesting technical experience limitations on the part of the operator or inappropriate patient selection. The duration of outcomes reporting is less than the duration of absorption of the device (18 months) and the purported completion of tissue remodeling phase (24 months). Randomized controlled trials with a sham control are feasible and should be performed. The evidence is insufficient to determine the effects of the technology on health outcomes.
Supplemental Information Practice Guidelines and Position Statements
American Academy of Otolaryngology
- Head Neck Surgery
The American Academy of Otolaryngology - Head Neck Surgery released a clinical consensus statement on the diagnosis and management of nasal valve compromise (Rhee, 2010). The statement also iAndicated that nasal endoscopy and nasal photography were both deemed useful but not routinely required.
U.S. Preventive Services Task Force Recommendations
Not applicable.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in September 2018 identified an ongoing trial that might influence this review. Summary of the trial is listed below.
NCT03400787 Latera Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse
Planned Enrollment: 150 Completion Date: Feb 2020
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A sham-controlled randomized trial with a three month follow-up by Stolovitzky et al randomized 137 patients with severe to extreme NOSE scores to an office-based nasal implant or sham control procedure (Stolovitzky, 2019). Followup at three months showed a significant improvement in responder rate, change in NOSE score, and visual analog scale compared to the sham group, although over half of the control group also were considered responders. Six patients (8.6% of 70), had the implant removed by 3 months and analysis was not intent-to-treat or last observation carried forward. Other adverse events included pain (n=4), foreign body sensation (n=3), localized swelling (n=2), inflammation (n=1), skin puncture (n=1), and vasovagal response (n=2). The follow-up of the implant group will continue through 24 months.
Sidle et al reported 12-month outcomes for 160 patients with severe-to-extreme NOSE scores who were enrolled at 14 U.S. clinics between September 2016 and July 2017 (Sidle, 2019). Insertion of a Latera implant alone was reported for 105 patients and insertion of the implant plus adjunctive procedure was reported for 61 patients. San Nicoló et al reported 24-month outcomes for 30 patients who were treated at 3 clinical sites in Germany (San Nicolo, 2017; San Nicolo, 2018). In the larger study by Sidle et al, 5.3% of patients had the implant removed. In the study by San Nicoló et al, 13.3% of patients had the implant removed (Sidle, 2019. The improvement in symptoms was consistent for the studies, with a mean change of over 40 points from baseline on the NOSE score. Results were reported for patients who retained the implant, and neither study used the last observation carried forward. The 24-month outcomes from the smaller study by San Nicoló et al are the most relevant, as resorption and remodeling are expected to occur within that time frame (San Nicolo, 2017; San Nicolo, 2018). At enrollment, 30 patients were classified as severe to the extreme on the NOSE scale. At the 24 month follow-up, 4 patients had an additional procedure, 8 were classified as severe to extreme, and 17 had improved to mild to moderate. Follow-up beyond 18 months in a larger number of patients is needed.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Sidle, Stolovitzky, and colleagues reported outcomes from 2 post-marketing studies that enrolled a total of 277 patients with severe-to-extreme NOSE scores at 19 U.S. clinics between September 2016 and July 2017 (Stolovitzky, 2018; Sidle, 2020; Sidle, 2021). One of the trials (NCT02964312) was conducted in an office setting and enrolled 166 participants. The second study (NCT02952313) implanted the device in the operating room and included 113 participants. Concomitant procedures (septoplasty and/or inferior turbinate reduction) were at the discretion of the investigators.
The most recent publication from these studies included data from 177 patients who were followed for 24 months under a protocol extension (Sidle, 2021). NOSE scores through 24 months were reported separately for patients who received an implant alone (n = 69, NOSE = 30.4 [24.6 standard deviation {sd}), implant plus inferior turbinate reduction (n=39, NOSE = 27.6 [23.1 sd]), or an implant combined with septoplasty and inferior turbinate reduction (n=69, NOSE = 16.0 [20.7 sd]). The data presented by Sidle et al is described further (Sidle, 2021). The mean change from baseline for the 177 patients with 24-month data was -53.6 (95% confidence interval [CI], -57.0 to -50.1), with a responder rate of around 90%. Loss to follow-up in these cohorts was high, with 100 of 277 participants discontinuing the study before 24 months (44 were lost to follow-up, 17 withdrew due to lack of response, 38 withdrew or did not consent to the extension study, and 2 died). Sensitivity analysis, performed with a worst-case scenario with all missing 24-month data assigned no change from baseline, showed a mean change from baseline in the NOSE score of -34.2 (95% CI, -38.1 to -30.2), representing an improvement of 1 class.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Bikhazi et al reported results from a 24-month uncontrolled follow-up phase of the RCT (Bikhazi, 2021). Participants randomized to the control group were given the option to crossover to the treatment group following the 3-month randomized phase. There were a total of 137 participants in the randomized cohort. 71 received treatment and 66 were sham participants. 111 participants enrolled in the long-term follow-up phase. (71 received treatment and 40 were sham participants). After 12 months, 90 participants remained, 75 at the 18-month visit, and 70 at the 24-month visit. The Key RCT results at 24 months are as follows:
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
In 2023, the American Academy of Otolaryngology-Head Neck Surgery (AAO-HNS) issued a position statement on nasal valve repair stating that treatment options of nasal valve dysfunction may include implants aimed at stabilizing the nasal valve (AAO-HNS, 2023). No specific recommendations were made for nasal implants. The AAO-HNS recognizes surgical repair of the nasal valve as a distinct surgical procedure that can alleviate nasal obstruction symptoms for patients who have nasal valve collapse and are suitable candidates for this intervention.
2025 Update
The evidence review for Radiofrequency Volumetric Tissue Reduction for Nasal Obstruction
was created in March 2025 with a search of the PubMed database. The most recent literature update was performed through December 10, 2024.
The efficacy of radiofrequency volumetric tissue reduction (RFVTR) to treat nasal obstruction has been assessed through several systematic reviews (Casale, 2023; Han, 2024; Kang, 2024).
Casale et al performed a systematic review and meta-analysis to evaluate the effectiveness of VivAer for treating nasal obstruction (Casale, 2023). The review included prospective and retrospective studies involving participants with nasal obstruction due to NVC and high NOSE scores (greater than 55). Five studies (N=297 participants), published through December 2021, met the criteria and involved bilateral treatment of the nasal valve regions. Participants were excluded if they had undergone additional procedures such as septoplasty, turbinoplasty, rhinoplasty, or orthognathic surgery. Studies that did not report quantifiable outcomes or lacked extractable data were also excluded. The primary outcome measured was the NOSE questionnaire scores, which reflect the disease-specific quality of life. Comparisons were made between pre-treatment and post-treatment values, and between post-treatment and control (sham) outcomes over a 3-month follow-up period. Minor adverse events were reported, but none of the studies mentioned changes in the external appearance of the nose. Three months post-treatment, NOSE scores significantly decreased (pre-treatment: 76.16 ± 6.39; post-treatment: 31.20 ± 2.73; Mean Difference (MD): 46.13; 95% confidence interval [CI] 43.28 to 48.99), with moderate heterogeneity (I2 =70%, p less than 0.01). In the only RCT by Silvers et al, the active group showed significantly better results than the sham-control group 3 months after treatment. The review authors cautioned that due to moderate heterogeneity and the limited number of small population studies with short follow-up periods, these results should be interpreted with caution. They also noted a risk of bias ranging from moderate to serious. The authors concluded that VivAer could be effective for treating NVC and substantially improved subjective breathing symptom scores. However, they emphasized that additional large-scale studies are necessary to confirm these findings.
Han et al conducted a systematic review and meta-analysis to compare the treatment effect sizes of RFVTR using VivAer on the internal nasal valve alone, against functional rhinoplasty surgery (Han, 2024). Given that functional rhinoplasty for nasal valve dysfunction is often accompanied by septoplasty, turbinate treatment, and cosmetic techniques, they performed analyses to compare RFVTR with (i) rhinoplasty focused solely on the nasal valve, (ii) rhinoplasty excluding turbinate procedures, and (iii) all types of rhinoplasty surgery. The treatment effect was measured using NOSE scale scores at pre-procedural baseline and at 3-, 6-, and 12-months post-procedure. A pre-procedural NOSE score cutoff of 45 or higher was used to include participants with moderate to severe nasal airway obstruction and to exclude those focused solely on cosmetic outcomes. Five studies on RFVTR and 63 studies on functional rhinoplasty, published through December 2022, were included in the analysis. Pooled effect sizes for RFVTR and all forms of rhinoplasty were comparable. At 12 months, weighted mean difference (WMD) was -48.8 (95%CI, -56.9 to -40.7), I2 =68% for RFVTR treatment and WMD, -47.7 (95%CI, -51.1 to -44.4), I2 =90.0% for functional rhinoplasty. The study concluded that RFVTR of the internal nasal valve has lasting effects comparable to functional rhinoplasty, whether focused on the nasal valve alone or not including turbinate treatment, as well as all rhinoplasty procedures. The study had some limitations, including a follow-up period limited to 12 months to increase the quantity of evaluable data, as studies with longer follow-ups were fewer. It was noted that some datasets might include participants with less than moderate NAO, but the cutoff of 45 ensured most participants had at least moderate nasal airway obstruction. The quality of the included studies varied, with many traditional procedure studies being of moderate to poor quality and showing high heterogeneity.
In a systematic review and meta-analysis, Kang et al examined the efficacy of RFVTR in mitigating nasal obstruction by addressing NVC (Kang, 2024). The analysis included studies that assessed QOL and NOSE scores before and after RFVTR with VivAer, and also evaluated sham-controlled studies. Eight studies (N=451 participants) met the inclusion criteria. Participants who underwent RFVTR reported a significantly improved QOL 24 months post-treatment compared to pre-treatment scores. The rates of clinically improved states and positive responses regarding QOL post-treatment were 82% and 91%, respectively. Furthermore, the disease-specific QOL, as measured by the NOSE score, showed significant improvement: At 24 months, MD, 56.35 (95% CI, 50.29 to 62.41, I2 =0.0%). The authors concluded that RFVTR may be beneficial in alleviating nasal obstruction symptoms; however, further RCTs with larger sample sizes are necessary to confirm the effectiveness of RFVTR in enhancing nasal valve function.
A sham-controlled randomized trial with a 3-month follow-up was identified, and its 12-month and 24-month outcomes have been published (Silvers, 2021; Han, 2022: Silvers, 2024).
Silvers et al presented findings from a prospective, multicenter, single-blinded, industry-funded RCT, which evaluated the safety and efficacy of RFVTR with VivAer for NVC in patients with nasal obstruction [The Vivaer Procedure for Treatment of Nasal Airway Obstruction: A ProspecTive, Multicenter Randomized Controlled TriAl Comparing Vivaer to Sham Control (VATRAC)] (Silvers, 2021). Participants were divided into two groups: (A) received bilateral RFVTR of the nasal valve (n=77), and (B) underwent a sham procedure (n=40). During the sham treatment, participants were prepped for surgery, anesthetized, and VivAer was inserted into their nostrils without transferring RF energy to the target tissue. The device was applied to the mucosa over the lower lateral cartilage of the lateral nasal wall. The primary endpoint was the responder rate at 3 months, defined as a 20% or greater reduction in the NOSE scale score or at least a 1-point reduction in clinical severity category. At baseline, participants exhibited a mean NOSE-scale score of 76.7 (95% CI, 73.8 to 79.5) in the active treatment group and 78.8 (95% CI, 74.2 to 83.3) (p=.424) in the sham-control group. After 3 months, the responder rate was significantly higher in the active treatment group. Moreover, the active treatment group showed a significantly greater improvement in the NOSE-scale score. Three adverse events were considered at least possibly related to the device and/or procedure. In the active treatment group, one participant experienced a vasovagal reaction and another had intermittent nasal bleeding with mucus, both of which resolved. In the sham-control group, one individual experienced intermittent headache, which also resolved. It is important to note that the results of this study may not be generalizable to broader populations. This trial did not control for or analyze possible differences in oral or topical medication use during the trial. Although the study was blinded, the perception of the presence or absence of local effects of RFVTR could have provided participants with an indication of their study group. The authors did not investigate whether participants were aware of their study group.
Studies by Han et al and Slivers et al have reported on the 12-month and 24-month results of the VATRAC trial, respectively. After the 3-month visit, which served as the primary endpoint, participants in the VATRAC trial were unblinded. Patients in the index sham-control group who remained eligible and consented to continue in the trial were given crossover treatment. For the follow-up period extending from 3 to 24 months, all participants who received active treatment, including both initial active treatment patients and those who crossed over from the sham-control arm, were combined into a single analysis cohort.
Han et al published results of the VATRAC trial through 12 months of follow-up (Han, 2022). Following evaluation of the primary endpoint at 3 months, eligible participants in the sham control arm crossed over to active treatment (n=31; 77% of the sham control cohort). The mean baseline NOSE Scale score of the combined group of participants who received treatment (N=108) was 76.3 (95% CI, 73.6 to 79.1). At 12 months (81% of those treated were available for analysis; n=88), the rate of participants who were defined as ‘responders’ by meeting the primary endpoint was 89.8% (95% CI, 81.7% to 94.5%) and the median NOSE Scale score improved from baseline (mean change, -44.9, 95% CI, -52.1 to -37.7). No device nor procedure-related serious adverse events were reported. The high attrition rate and cross-over at 3 months render conclusions regarding this study’s outcomes subject to serious bias.
Silvers et al. presented the two-year results of the VATRAC trial, which aimed to evaluate the long-term effects of RFVTR and changes in the usage of medication and nasal dilators over the study period (Silvers, 2024). At the 24-month mark, the responder rate was 90% (N=108 participants), with a NOSE score treatment effect of -41.7, indicating a 55% improvement. Among participants who used medications or nasal dilators at the beginning of the study, 79% had reduced or stopped use in at least one class. No new adverse events related to the RFVTR procedure were reported during the study period. The authors concluded that RFVTR treatment for nasal valve dysfunction led to significant and sustained improvements in nasal airway obstruction symptoms and a notable reduction in the use of medications or nasal dilators. They also noted that conditions such as turbinate enlargement, septal deviation, or septal swell body did not significantly affect the likelihood of achieving a NOSE score of less than or equal to 25 at two years. However, there were several study limitations: the long-term follow-up consisted of a single group, despite the trial originally being an RCT with a primary endpoint at three months. Additionally, because the NOSE score is a subjective, patient-reported measure, future studies could benefit from including objective measures such as acoustic rhinometry or rhinomanometry. Furthermore, the study population was predominantly Caucasian, limiting the analysis of outcomes in non-Caucasian populations who might have meaningful differences in nasal anatomy.
In 2023, the American Academy of Otolaryngology-Head Neck Surgery (AAO-HNS) issued a position statement on nasal valve repair stating that treatment options of nasal valve dysfunction may include implants aimed at stabilizing the nasal valve. With regards to surgical repair of the nasal valve, the AAO-HNS states (AAO-HNS; 2023):
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed below.
Summary of Key Trials
The evidence review for Nasal Swell was created in March 2025 with a search of the PubMed database.
Ibrahim et al reported on a retrospective review that included 25 patients (48 sides) who had nasal vestibular body (NVB) reduction by radiofrequency ablation between 2013 and 2019 (Ibrahim, 2020). Posttreatment healing and complications were reviewed at early (less than 1 month) and late (mean, 7.3 months) time points after radiofrequency ablation. A subset of the NSB-treated individuals (18 of 25 patients) was compared with 10 NVB-control patients for pre- and post- treatment outcomes using 22-item Sino-Nasal Outcome Test (SNOT-22) and subdomain scoring. NVBs were reduced in all cases (48 of 48 sides) at both the early and late time points. Local crusting (22 of 23, 95.6%) and bone exposure (4 of 23, 17.3%) resolved by the late time-point. Significant reductions in the SNOT-22 scores (−24,
p = 0.001) and individual subdomain (−2,
p = 002) scores were seen in the NVB-treatment group compared to the reductions control group (−8 and
−1, respectively, both
p greater than 0.001).
Kim et al presented the results of a retrospective, case-series study of Coblation nasal septal swell body (NSB) reduction for the treatment of nasal obstruction in patients with abnormally thickened NSB. The study was conducted at a single tertiary medical center. 8 patients underwent Coblation NSB reduction. Pre-operative and post-operative nasal functions were evaluated by acoustic rhinometry and subjective symptom scales. These researchers also analyzed pre-operative CT scan images and nasal endoscopic findings. The mean maximal NSB width was 16.4 ± 2.2 mm on pre-operative coronal CT scan images. The mean VAS score for nasal obstruction was decreased from pre-operative 7.63 ± 0.99 points to 3.88 ± 0.92 points (post-operative 3 months), 4.16 ± 0.78 points (post-operative 6 months), and 4.63 ± 0.69 points (post-operative 1 year); 6 of the 8 patients were satisfied with the clinical outcome at 1 year after the procedure. The authors stated that, to the best of their knowledge, Coblation NSB reduction has not yet been reported in the medical literature; these findings showed that it can be an effective treatment modality for nasal valve narrowing in patients with abnormally thickened NSB.
Research regarding nasal swell is limited. Current evidence is insufficient that the technology results in an improvement in the net health outcome. Further well-designed studies are needed to validate the effectiveness of treatment for nasal swell.
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Bikhazi N, Ow RA, O'Malley EM, et al.(2021) Long-Term Follow-up from the Treatment and Crossover Arms of a Randomized Controlled Trial of an Absorbable Nasal Implant for Dynamic Nasal Valve Collapse. Facial Plast Surg. Dec 29 2021. PMID 34965603 Fraser L, Kelly G.(2009) An evidence-based approach to the management of the adult with nasal obstruction. Clin Otolaryngol. Apr 2009;34(2):151-155. PMID 19413614 Howard BK, Rohrich RJ.(2002) Understanding the nasal airway: principles and practice. Plast Reconstr Surg. Mar 2002;109(3):1128-1146; quiz 1145-1146. PMID 11884847 Howard BK, Rohrich RJ.(2002) Understanding the nasal airway: principles and practice. Plast Reconstr Surg. Mar 2002;109(3):1128-1146; quiz 1145-1146. PMID 11884847 Lipan MJ, Most SP.(2013) Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. Sep-Oct 2013;15(5):358-361. PMID 23846399 Rhee JS, Weaver EM, Park SS, et al.(2010) Clinical consensus statement: Diagnosis and management of nasal valve compromise. Otolaryngol Head Neck Surg. Jul 2010;143(1):48-59. PMID 20620619 San Nicoló M, Stelter K, Sadick H, et al.(2017) Absorbable implant to treat nasal valve collapse. Facial Plast Surg. Apr 2017;33(2):233-240. PMID 28388804 Sidle DM, Stolovitzky P, O'Malley EM, et al.(2021) Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures. Facial Plast Surg. Oct 2021; 37(5): 673-680. PMID 33853139 Sidle DM, Stolovitzky P, Ow RA et al.(2019) Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope, 2019 Jun 30. PMID 31254279 Spirox.(2017) Latera. 2017; http://www.spiroxmed.com/latera. Accessed September 10, 2018. Stewart MG, Witsell DL, Smith TL, et al.(2004) Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. Feb 2004;130(2):157-163. PMID 14990910 Stolovitzky P, Senior B, Ow RA et al.(2019) Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol, 2019 Jun 22;9(8). PMID 31226238 Stolovitzky P, Sidle DM, Ow RA, et al.(2018) A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. Laryngoscope. May 14 2018. PMID 29756407 |
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