Nasal obstruction is defined clinically as a patient symptom that presents as a sensation of reduced or insufficient airflow through the nose. 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 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.
For individuals with symptomatic nasal obstruction due to internal nasal valve collapse who receive radiofrequency volumetric tissue reduction (RFVTR), the evidence includes systematic reviews and a randomized controlled trial (RCT) with 12-month and 24-month uncontrolled follow-up phases. Relevant outcomes are symptoms, change in disease status, treatment-related morbidity, functional outcomes, and quality of life. Systematic reviews have generally shown improvements in nasal obstruction scores. In the RCT, follow-up at 3 months revealed a statistically significant improvement in response with the RFVTR procedure compared to the sham group. However, these results are limited by the small study size, lack of diversity, short duration, and failure to control for confounding factors such as medication or nasal dilator use. Moreover, the trial's results may not fully represent the potential effect of RFVTR since treatment was limited to lateral nasal wall repair, not addressing soft tissues like septal swell bodies and inferior turbinates. A significant and durable effect on nasal obstruction post-RFVTR treatment was reported up to 24 months during the uncontrolled crossover phase of the trial. Additional RCTs with extended follow-up periods, larger and more diverse populations, and comparisons of RFVTR to other treatments (medications, nasal dilators, and rhinoplasty) are necessary to confirm the procedure's efficacy for nasal obstruction. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
Radiofrequency volumetric tissue reduction for nasal obstruction due to internal nasal valve collapse is considered investigational.
| CPT | 30469 | Repair of nasal valve collapse with low energy, temperature-controlled (ie, radiofrequency) subcutaneous/submucosal remodeling |
| ICD10-CM | J34.8200 | Internal nasal valve collapse, unspecified |
| J34.8201 | Internal nasal valve collapse, static | |
| J34.8202 | Internal nasal valve collapse, static |
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 on 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.1,2, 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.
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 a septal deviation. Prior nasal surgery, nasal trauma, and congenital anomaly are additional causes.
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. 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.[Lee DY, Won TB. Management of Nasal Valve Dysfunct.... 17(3): 189-197. PMID 39111772]
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):
Treatment of symptomatic nasal valve collapse includes the use of non-surgical 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 resulting 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 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.
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).4, 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.
The VivAer® Stylus is distinct from the RhinAer® device (Aerin Medical) currently reviewed in evidence review 7.01.168 (Cryoablation, Radiofrequency Ablation, and Laser Ablation for Treatment of Chronic Rhinitis) as it targets nasal tissue for remodeling to improve airflow as opposed to disrupting the posterior nasal nerve in rhinitis.
