SURG.00079 Nasal Valve Repair

This document addresses the following procedures or products used to treat nasal obstruction.

Note: Please see the following related documents for additional information:

Nasal valve suspension as a surgical technique for the repair of nasal valve collapse is considered investigational and not medically necessary.

Low-dose radiofrequency intranasal tissue remodeling as a treatment of nasal airway obstruction is considered investigational and not medically necessary.

Use of an absorbable nasal implant to repair collapsed nasal wall tissue is considered investigational and not medically necessary.

Nasal obstruction has been defined as a sensation of insufficient airflow through the nose. Symptoms associated with chronic nasal obstruction may include nasal congestion, stuffiness, headache, fatigue, sleep disturbance, daytime sleepiness, snoring, and a decline in health-related quality of life (QoL). One of the most common causes of nasal obstruction is internal nasal valve dysfunction, wherein the angle between upper lateral cartilage and the septum becomes too narrow and results in increased airway resistance and nasal obstruction. It has been estimated that of the individuals with nasal obstruction and severe or extreme symptoms, 73% have nasal valve collapse (NVC) as a contributor. NVC leads to varying difficulty with nasal inspiration, diminished exercise tolerance, and significant decreases in quality of life. Etiologies include weakening of the cartilage that supports the nasal valve, natural anatomical differences, congenital abnormalities or developmental issues, prior rhinoplasty or other surgical procedures, trauma, and aging. Regardless of cause, NVC can result in significant patient distress (Samra, 2018; Schuman, 2019; Sharif-Askary, 2020; Sinkler, 2021).

According to American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS):

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 (AAO-HNS, 2023).

Nasal valve suspension is a surgical nasal valve repair that attaches nasal valve tissues to the orbital rim or lateral suture(s) suspension to perinasal structures.

The first report on nasal valve suspension as a simplified technique for nasal valve repair was published by Paniello (1996). This report, based on the experience with 12 individuals, concluded that nasal valve suspension was effective at providing symptomatic relief of airway obstruction. A more in-depth report (Friedman, 2003) discusses the experience of the procedure (with slight modifications) in over 100 individuals. The results indicate that the vast majority of individuals undergoing nasal valve suspension surgery had a self-reported improvement in airway symptoms. The study did, however, have several limitations. First, the follow-up for most individuals in the study was less than 1 year; long-term results are not available. Second, the basis for the improvement as reported by individuals is purely subjective and no objective measures were used to demonstrate effectiveness. Lastly, the authors indicated that the precise indicators for this procedure are unclear and require further study.

Friedman (2004) reported on 52 individuals thought to have nasal valve obstruction that were treated with a modified nasal valve suspension technique and had a mean follow-up of 12.6 months. Eighty-four percent showed improvement in a QoL outcome measure (Sino-Nasal Outcome Test) and 94.2% had postoperative increases in cross sectional area as measured by acoustic rhinometry. However, the QoL tool used did not include either nasal stuffiness or nasal obstruction as one of the questions but instead asked about such sensations as alertness, energy levels and general well-being. The authors acknowledge that many alternative surgical techniques are available to correct nasal valve obstruction, and that the long-term effectiveness of this suspension procedure remains to be evaluated. They conclude: “Long term studies are needed to assess the performance of this corrective technique” and “Follow up periods beyond 30 months will help determine the natural course of the suspended valve and the possibility of its release.” To date, no well-designed additional studies comparing nasal valve suspension with other surgical alternatives have been published. There are inadequate data to make determinations about whether nasal valve suspension results in improved outcomes in individuals with airway obstruction.

In June 2016, the Latera^™ Absorbable Nasal Implant (Spirox^™ Inc., Menlo Park, CA) was cleared by the FDA for “Supporting nasal upper and lower lateral cartilage.” This implantable device is proposed to assist in the surgical correction of collapsed nasal wall tissue, possibly improving nasal obstruction. The implant consists of copolymer materials and is designed to be absorbed by the body within approximately 18 months following implantation. The Latera system also includes a disposable delivery device that enables minimally invasive placement of the implant. The Latera implant and accessory delivery device have the same fundamental scientific technology and intended indications for use as the predicate device, the INEX Absorbable Nasal Implant and accessory delivery tool that received FDA 510(k) clearance on December 4, 2015 (K152958). Studies have been limited by small numbers of participants, lack of randomization, short term outcomes data and study design not robust enough to demonstrate the safety and efficacy of this implant for any indication (San Nicoló, 2017, 2018; Stolovitzky, 2018).

San Nicolo and colleagues (2017) evaluated the safety and effectiveness of an absorbable implant for lateral cartilage support in individuals with NVC with 12 months follow-up. A total of 30 participants with Nasal Obstruction Symptom Evaluation (NOSE) score of greater than or equal to 55 and isolated NVC were treated; 14 procedures were performed in an operating suite under general anesthesia, and 16 procedures were performed in a clinic-based setting under local anesthesia. Participants were followed-up through 12 months post-procedure; a total of 56 implants were placed in 30 participants. The mean pre-operative NOSE score was 76.7 ± 14.8, ranging from 55 to 100. At 12 months follow-up, the mean score was 35.2 ± 29.2, reflecting an average within-participant reduction of -40.9 ± 31.2 points. Most (76 %) of the participants were responders (defined as having at least 1 NOSE class improvement or a NOSE score reduction of at least 20 %). No adverse changes in cosmetic appearance were reported at 12 months post-procedure; 3 implants in 3 participants required retrieval within 30 days post-procedure and resulted in no clinical sequelae. The authors concluded that the findings of this study demonstrated the safety and effectiveness of an absorbable implant for lateral cartilage support in participants with NVC at 12 months post-procedure.

San Nicolo and colleagues (2018) reported the results of a follow-up study (San Nicolo et al, 2017) that assessed whether the safety and effectiveness of the nasal implant persisted in these participants for 24 months following the procedure. A total of 30 participants with NOSE score of greater than or equal to 55 and isolated NVC were treated. Participants were followed from 12 to 24 months post-procedure. A total of 56 implants were placed in 30 participants. The mean pre-operative NOSE score was 76.7 ± 14.8, ranging from 55 to 100. At 24 months follow-up, the mean score was 32.0 ± 29.3, reflecting an average within-participant reduction of -44.0 ± 31.1 points. No device-related adverse events were reported in the 12 to 24 months period. A total of 5 participants exited the study prior to the 24-month follow-up; 4 of the 5 participants who exited were elected for further intervention and 1 participant was lost to follow-up. The authors concluded that this study demonstrated the absorbable implant for lateral nasal wall support and symptom improvement was safe in some subjects with NVC at 24 months post-procedure. Furthermore, the researchers stated that additional studies with a larger sample size and additional concomitant procedures would be valuable and a trial that extended beyond 24 months would be useful in understanding the longer term benefits of the implant.

Stolovitzky and colleagues (2018) in a prospective, multi-center, non-randomized, single-blinded study, examined 6-month outcomes for treatment of lateral wall insufficiency (LWI) with a bio-absorbable implant. A total of 101 participants with severe-to-extreme class of NOSE scores were enrolled at 14 U.S. clinics (September 2016 to March 2017). Participants were treated with a bio-absorbable implant designed to support lateral wall, with or without concurrent septoplasty and/or turbinate reduction procedure(s); NOSE scores VAS were measured at baseline and month 1, 3, and 6 post-operatively. The LWI score was established by independent physicians observing the lateral wall motion video. A total of 43 participants were treated with the absorbable implant alone, whereas 58 had adjunctive procedures; 17 participants reported 19 adverse events, all of which resolved with no clinical sequelae. Patients demonstrated significant reduction in NOSE scores at 1, 3, and 6 months post-operatively (79.5 ± 13.5 pre-operatively, 34.6 ± 25.0 at 1 month, 32.0 ± 28.4 at 3 months, and 30.6 ± 25.8 at 6 months post-operatively; p < 0.01 for all). The participants also demonstrated significant reduction in VAS scores post-operatively (71.9 ± 18.8 pre-operatively, 32.7 ± 27.1 at 1 month, 30.1 ± 28.3 at 3 months, and 30.7 ± 29.6 at 6 months post-operatively; p < 0.01 for all). These results in participants treated with the implant alone were similar to those treated with the implant and adjunctive procedures. Consistent with participant-reported outcomes, post-operative LWI scores were significantly lower (1.83 ± 0.10 and 1.30 ± 0.11 pre- and post-operatively; p < 0.01). The researchers concluded that stabilization of the lateral nasal wall with the absorbable implant improved participants' nasal obstructive symptoms over 6 months. Limitations of this study included its single-arm study design and short‐term (6 months) follow‐up.

Stolovitzky and colleagues (2019) reported the results of a prospective, multi-center, single-blinded, randomized controlled trial (RCT) with sham control, to examine the safety and effectiveness of the Latera Absorbable Nasal Implant. The study included 137 participants from 10 clinics. Study participants were randomized into 2 arms: treatment arm (70 participants) and sham control arm (67 participants). Outcome measures were followed through 3 months post the procedure. The primary outcome was the responder rate (percentage of participants with reduction in clinical severity by greater than or equal to 1 category or greater than or equal to 20 % reduction in NOSE score). Prior to the procedure, there were no statistically significant differences in participant demographics and nasal obstruction symptom measures between the 2 arms. At 3 months post procedure, the responder rate was significantly higher for the treatment arm compared to the control (82.5 % versus 54.7 %, p = 0.001). Participants in the treatment arm also had a significantly greater decline in NOSE scores (-42.4 ± 23.4 versus -22.7 ± 27.9, p < 0.0001) and significantly lower VAS scores (-39.0 ± 29.7 versus -13.3 ± 30.0, p < 0.0001) than the sham control arm; 17 participants reported 19 procedure/implant-related adverse events, all of which resolved without clinical sequelae. The researchers concluded that this study demonstrated the safety and effectiveness of the bioabsorbable implant in reducing participants' nasal obstruction symptoms. Limitations of the study included the short‐term (no more than 3 months) follow‐up data, and the single‐blinded study design in which all participants were blinded but physicians were aware of the assignment, which may have introduced risk of bias.

Kim and colleagues (2020) conducted a systematic review and meta-analysis to assess the effectiveness of the bioabsorbable nasal implant for treating nasal obstruction caused by LWI. A total 2 researchers independently reviewed 5 databases (PubMed, SCOPUS, Embase, Web of Science, and the Cochrane Database), starting at the earliest time-point recorded in the database to September 2019. Studies that scored endoscopic lateral wall movement and nasal obstruction related to QOL post-operatively prior to and following bioabsorbable nasal implants and those that compared the outcomes of nasal implants (treatment group) with outcomes of sham surgery (control group) were included in the analysis. A total of 5 studies (396 participants) met the inclusion criteria. The researchers found the bioabsorbable nasal implant significantly reduced endoscopic lateral wall motion compared to pre-treatment values and improved QOL at 12 months post-operatively. The incidence of adverse events following the nasal implant procedure was 5% and consisted mostly of skin or mucosal reaction, infection, or implant retrieval. All adverse events were resolved without significant sequelae. The researchers reported that when compared with sham surgery, the bioabsorbable nasal implants significantly improved disease-specific QOL. Although the researchers concluded that bioabsorbable nasal implants may reduce nasal wall movement and improve subjective symptom scores compared to pre-operative status, the number of enrolled studies (and participants) and short follow-up periods limit the generalizability of these results. The researchers acknowledged that larger comparative studies or well-designed RCTs with longer follow-up periods are needed.

Sidle and colleagues (2020) conducted a prospective, non-randomized, multi-center study, to examine the 12-month outcomes for in-office treatment of dynamic NVC using a bioabsorbable implant. A total of 166 participants with severe-to-extreme class of NOSE scores were enrolled at 16 U.S. clinics (November 2016 to July 2017). In an office setting, participants were treated with a bioabsorbable implant (Latera) to support the lateral wall, with or without concurrent inferior turbinate reduction (ITR). NOSE scores and VAS were assessed at baseline and 1, 3, 6, and 12 months post-operatively. The LWI score was established by independent physicians observing the lateral wall motion video. A total of 105 participants were treated with implant alone, whereas 61 had implant in addition to ITR; 31 participants reported 41 adverse events, all of which resolved without clinical sequelae. Participants demonstrated a significant reduction in NOSE scores throughout 12 months post-operatively (77.4 ± 13.4 baseline versus 36.2 ± 22.7 at 1 month post-operatively, 33.0 ± 23.4 at 3 months, 32.1 ± 24.6 at 6 months, and 30.3 ± 24.3 at 12 months; p < 0.001). Participants also demonstrated a significant reduction in VAS scores post-operatively (69.7 ± 18.1 baseline versus 31.3 ± 27.1 at 12 months post-operatively, p < 0.001). These findings were similar in group treated with implant alone and those treated with the implant + ITR. Consistent with participant-reported outcomes, post-operative LWI scores were demonstrably lower (1.42 ± 0.09 and 0.93 ± 0.08 pre- and post-operatively, p < 0.001). The researchers concluded using a bioabsorbable implant for the treatment of dynamic NVC improved clinical evidence of LWI at 6 months and improved nasal obstructive symptoms in a majority of participants up to 12 months. The researchers acknowledged that longer follow‐up is needed to determine efficacy beyond 12 months.

Bikhazi and colleagues (2022) assessed the long-term safety and effectiveness of the treatment and cross-over arms of a RCT examining an absorbable nasal implant to address dynamic NVC. Participants were adults with severe/extreme nasal airway obstruction primarily secondary to nasal valve insufficiency who had implant placement. Follow-up visits were conducted at 3-, 6-, 12-, 18-, and 24-month post-implantation. Visits involved the collection of the following participant-reported outcome measures: NOSE score, VAS, and the Epworth Sleepiness Scale (ESS). Participants were evaluated for adverse events at each visit. A total of 111 participants with implants were followed. Of the 111, 90 completed the 12-month visit and 70 completed the 24-month visit. NOSE responder rates were greater than 80 % at all follow-up visits through 24 months. Mean reduction from baseline in NOSE scores was 30 points or greater and statistically significant (p < 0.001) at all time-points through 24 months. Decrease in the mean VAS score was 29.7 points or higher and statistically significant (p < 0.001) at all time-points. The subgroup of participants with baseline ESS values of greater than 10 experienced statistically significant (p < 0.001) and clinically meaningful reductions at all post-implant periods. No serious adverse events related to the device or procedure were reported. Implant migration/retrieval rate was 4.5 % (10/222) of total implants or 9 % of participants (10/111). The researchers concluded the absorbable nasal implant was a safe and effective treatment for dynamic NVC in individuals with severe/extreme nasal obstruction and provided durable symptom improvement 24 months following placement.

Limitations of this study include the lack of long-term follow-up of the control arm, significant loss of participants to follow-up at 18 and 24 months, and a lack of objective assessment of nasal valve collapse. The researchers noted that a more objective evaluation of NVC, such as computed calculation of change in area of the nasal valve through endoscopic video or photo could be considered in future studies. The researchers recognized that another limitation of this study was an uneven distribution of participants of varying race or ethnicity. Although the enrolled population of non-White subjects was low at 14 %, attempts were made in the study design to find a diverse population, such as the inclusion of 10 clinical sites across multiple geographies. While all attempts to find a diverse population were made, inherent bias toward White participants may exist. The researchers pointed out that previous studies have demonstrated racial differences in nasal anatomy that may contribute to under-representation of some ethnic groups. In addition to nasal anatomy variations, differences in cultural views toward surgery, or inequality in clinician attitude may have an impact on the ethnic subsets enrolled in studies such as in this.

Currently, the published peer-reviewed literature evaluating the use of an absorbable nasal implant as a treatment of LWI consists primarily of studies that lack of randomization, lack of control groups, lack long-term outcomes and include small study populations with limited diversity. Additional RCTs with larger and more diverse cohorts, longer periods of follow-up, and comparison of this modality to other treatments for LWI are needed to make determinations about the safety and effectiveness of this procedure as a treatment for nasal obstruction due to collapsed nasal wall tissue.

Low-dose Radiofrequency Intranasal Tissue Remodeling as a Treatment of Nasal Airway Obstruction

Functional rhinoplasty or septorhinoplasty is the most established approach to treating the NVC (Samra, 2018). Researchers have also been exploring the use of low-dose radiofrequency (RF) energy as a less invasive means to reshape nasal tissue to treat NVC.

The VivAer procedure is a non-invasive, office-based procedure that uses low-dose RF energy to alter the soft tissue of the nose.

In otorhinolaryngology (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. (FDA, 2017).

Brehmer and colleagues (2019) conducted a nonrandomized prospective study evaluating the safety and efficacy of low-dose RF remodeling treatment of narrowed nasal valves and to measure changes in the symptoms of snoring and nasal obstruction. The study included 31 participants presenting with symptoms of nasal obstruction and snoring. Researchers used the VivAer low energy RF system to remodel the nasal sidewall in order to improve airflow. Thirty days after treatment, participants completed two questionnaires measuring perceived nasal obstruction and snoring (NOSE, Snore Outcomes Survey [SOS]). The participants’ satisfaction with the RF ablative treatment was evaluated 90 days after the intervention using a 10-point Likert scale (1 = completely dissatisfied; 10 = very satisfied). All participants reported improvement in nasal breathing measured by NOSE score, sleep quality by SOS questionnaire, and quality of life as measured by EQ-5D and Sino-Nasal Outcome Test (SNOT-22). The authors concluded that the RF remodeling treatment provides a durable and well-tolerated non-invasive treatment for those individuals suffering with congestion due to narrowness or collapse of the internal nasal valve. This study’s findings are limited by the small size, lack of randomization, control group and comparator, and by the short follow-up period.

Jacobowitz and colleagues (2019) reported 6-month results of an industry-sponsored study using a bipolar, temperature-controlled RF device (TCRFD)to reshape the nasal valve as a treatment for NAO (NAO). The 50 participants in the study all had severe or extreme obstruction at baseline. None of the participants had previous surgery to the nasal valve in the preceding 12 months. Participants continued to use oral and topical treatments for nasal obstruction during the study. A positive response to the Cottle or modified Cottle maneuver showed that, for each participant, the nasal valve was the primary contributor to nasal obstruction. Symptoms self-reported using the average NOSE Scale score (Nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and inability to get enough air during exercise) decreased by 69% at the 6-month assessment. No procedure- or device-related serious adverse events occurred. Edema, soreness, and crusting resolved by 1 month and participants reported high satisfaction with the procedure. The authors assert that objective measures of airflow resistance do not correspond to self-reported airway obstruction. Lack of a randomized control group makes it impossible to evaluate how much of the subjectively reported outcomes could have been due to a placebo effect. The findings of this study are further limited by the small study size, lack of standardization and analysis of oral and topical medication use, and the short follow-up period.

Ephrat 2021 and another industry consultant conducted a prospective, nonrandomized, multicenter, extended follow-up study of the same participants who had participated in and completed the Jacobowitz et al (2019) trial (discussed above). In this study, the authors sought to determine whether the results achieved at 6 months would be sustained for 24 months and to assess the impact of the treatment on measures of individuals’ quality of life. Participants in this follow-up study provided self-administered evaluations of the NOSE and QoL measures at 12, 18, and 24 months post procedure. Participants were given the option to complete the follow-up assessments via in-person clinic visits, by telephone, or by mailed response. Forty-nine of the 50 participants in the original 6-month trial were eligible for this follow-up study. Thirty-nine individuals from 8 sites in the 6-month trial chose to enroll in the follow-up study. Three participants enrolled after the window for the 12-month visit was closed and were only evaluated for 18 months. All 39 participants had evaluations at 18 months and 36 of the 39 completed the 24-month follow-up. The researchers reported the clinically significant improvement from baseline in NOSE Scale score change demonstrated at 6 months (mean, 55.9; standard deviation [SD], 23.6; p<0.0001) was maintained through the 24-month follow-up period (mean, 53.5; SD, 24.6; p<0.0001). Respondents (≥ 15-point improvement) consisted of 92.3% of participants at 6 months and 97.2% at 24 months. Responses to the QoL questions also showed improvement in participant QoL. Other than the short duration, this trial shares the limitations of the Jacobowitz study cited above. In addition, it is limited by loss of 22% of the original cohort, raising the possibility of retention bias. Ephrat and colleagues acknowledged that in order to distinguish the relative true treatment effect from placebo effects, “it will be necessary to confirm the results of this study in additional participants as part of a planned randomized, controlled trial”.

Silvers and colleagues (2021) reported the results of an industry-sponsored prospective, multicenter, single-blinded, randomized controlled trial that assessed the safety and efficacy of a TCRFD for the treatment of NVC in participants with NAO. Participants were assigned to one of two arms: (A) bilateral temperature-controlled RF treatment (TCRFT) of the nasal valve (n=77) or (B) a sham procedure (n=41). For the sham treatment, the participant was prepared as for surgery, anesthetized, and the RF device was inserted into the nostrils, but no RF energy was transferred to the target tissue. The device was applied to the mucosa over the lower lateral cartilage of the lateral nasal wall. The main endpoint was responder rate at 3 months, defined as a 20% or greater reduction in NOSE scale score or ≥ 1 reduction in clinical severity category. At baseline, participants demonstrated 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 appreciably 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 demonstrated a significantly greater improvement 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 were considered at least possibly related to the device and/or procedure. In the active treatment arm, 1 participant experienced a vasovagal reaction, and another had intermittent nasal bleeding with mucus, both of which resolved. In the sham-control arm, 1 individual had intermittent headache, which also resolved. Results for this study of 118 individuals 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 blinded, perception of the presence or absence of local effects of RF treatment could have given participants an indication of their study group. The authors did not investigate whether participants were aware of their study group. This study does not show whether the proposed treatment effects last for longer than 3 months. The authors acknowledge that longer-term follow-up is needed to reveal the durability of the effect reported in this trial.

In 2021, Wu and colleagues conducted a prospective, non-randomized case series to better understand the mechanism of action of TCRF energy as a treatment of nasal valve obstruction. A total of 20 participants underwent the VivAer procedure under local anesthesia. All study participants had a history of chronic nasal obstruction for at least 1 year with a narrow nasal valve as a primary or significant contributor to their symptoms. Primary goal of this study was to assess subjective outcomes using NOSE, SNOT-22 and VAS scores. The secondary goal was to obtain objective data using peak nasal inspiratory flowrate (PNIF) measurement and computational fluid dynamics (CFD) techniques to identify factors contributing to participant’s outcomes. CFD models were created based on the pre and 90 days post-procedure computed tomography (CT) scans to identify prominent changes in nasal air flow parameters. Both the NOSE and VAS scores improved at 90 days post treatment: NOSE: pre-treatment 78.89±11.57; post-treatment 31.39±18.30, P = 5e-7 and VAS: pre-treatment 6.01±1.83; post-treatment 3.44±2.11, P=1e-4). Nasal airway volume in the treatment area improved 7% at 90 days post-treatment (pre-treatment 5.97±1.20, post-treatment 6.38±1.50cm³P=.018). However, there were no statistically significant differences in the measured PNIF, (pre-treatment: 60.16±34.49; post-treatment: 72.38 ± 43.66 ml/s; P=.13) and CFD computed nasal resistance (pre-treatment:0.096±0.065; post-treatment: 0.075 ± 0.026 Pa/(ml/s); P=.063). Among all the variables identified, only the peak mucosal cooling posterior to the nasal vestibule strongly correlated with the NOSE at baseline (r=−0.531, P=.023) and with 90 day post-treatment improvement (r=0.659, P=.003). No adverse events were reported. Of the 20 participants, one failed the pre-treatment screening, and one was lost during post-treatment follow up. Of the 18 participants that completed the study and were available at the 90 day follow-up, one individuals did not have an improved NOSE at 90 days post-treatment. The authors concluded that this study demonstrated that minimum remodeling of the nasal valve using RF can result in significant clinical outcome improvements, despite minimum nasal volume (7% increase) and minimum nasal resistances changes. Additionally, the authors found that the clinical relief of nasal obstruction may result from improvement in the perception of regional mucosal cooling during breathing beyond nasal resistance or peak flow rate. Limitations of the study include use a steady state computation to get a snapshot at peak inspiration, without realistically simulating full breathing cycles, which does not accurately represent the dynamic motion of the nasal valve anatomy. As the researchers pointed out, “nasal obstruction in the nasal valve is potentially dynamic, which is not computed in this study, which limits the interpretation of results and correlations with clinical scores. This was an industry funded study. however, the authors stated that the funders did not play a role in data collection and analysis, or the decision to publish the manuscript.

Han and colleagues (2022) published results of a prospective, multicenter, single-blinded, randomized clinical trial which reported safety and efficacy of TCRFD on NAO through 12 months of follow-up. Enrolment criteria included a baseline NOSE Scale score of 55 or greater with NVC as the primary or substantial contributor to the score. The primary endpoint was a 20% or greater reduction in NOSE Scale score or 1 or greater reduction in NOSE Scale clinical severity category. Eligible study participants were randomly assigned in a 2:1 fashion to TCRFD treatment of the nasal valve or a sham control procedure (with no RF energy). A total of 117 participants were randomized and included in the final analysis; 77 received active treatment and 40 were in the sham control arm. Following evaluation of the primary endpoint at 3 months, eligible participants in the sham control arm crossed over to active treatment (n=31; 76% 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, 73.6-79.1). 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%-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. Further investigation is warranted.

Jacobowitz and colleagues (2022) published outcomes of an extended 48-month follow-up study. The initial study (described in more detail above; Jacobowitz, 2019) was a prospective, single-arm multicenter study enrolling individuals with chronic severe nasal obstruction with NVC identified as the primary cause of obstruction. Bilateral treatment with a TCRFD was administered to all study participants. Of the 49 individuals in the initial study (Jacobowitz, 2019), 29 agreed to the current study with extended follow-up through 48 months. NOSE scores decreased from 81.0 (± 9.9) at baseline to 25.7 (± 19.1) after 48 months follow-up (68.3% change; p<0.001). A total of 96.4% (27 of 28) of participants were considered responders (defined as a ≥ 15-point improvement on the NOSE score scale). This study’s results are to be interpreted with caution due to the limitations described in the primary study: lack of randomized comparison group, use of subjective measures, no control of medication usage and the limited sample size which was further hampered by significant loss to follow-up at 48 months. Further investigation is warranted.

The efficacy the VivAer radiofrequency device to treat nasal obstruction was assessed through a systematic review and meta-analysis. Casale and colleagues (2023) reviewed literature published through December 2021. Prospective or retrospective studies on participants seeking treatment for nasal obstruction due to NVC with high NOSE scores (more than 55) were eligible for review. A total of four studies (218 participants 19-83 years of age) met the inclusion criteria and underwent TCRFT of the nasal valve regions bilaterally. Participants were ineligible for inclusion if they had undergone additional procedures such as septoplasty, turbinoplasty, rhinoplasty, and orthognathic surgery. Additionally, studies were not included in the analysis if they did not clearly report outcomes of interest with quantifiable data or if data could not be extracted or outcomes calculated from published results. The primary outcome consisted of NOSE questionnaire results, representing the disease-specific quality of life reported by the participants, comparing pre-treatment and post-treatment values during the follow-up period. Severity classification consisted of the following: mild (5–25 points), moderate (30–50 points), severe (55–75 points), or extreme (80–100 points). Comparisons were analyzed between pretreatment and post-treatment values, and/or between post-treatment and control (sham) outcomes during the 3 month follow-up period. The included studies reported minor adverse events subsequent to bilateral TCRFT. None of the studies reported changes in the external appearance of the nose. Three months post treatment, NOSE scores reduced significantly (pre-treatment: 76.16 ± 6.39; post-treatment: 31.20 ± 2.73; MD: 46.13; 95% confidence interval [CI] 43.27–48.99) with moderate heterogeneity (IF = 70.1%). In the only randomized controlled study, the active group demonstrated significantly better results than control group 3 months after treatment (active group from 76.7 ± 12.6 to 34.4 ± 24.8 vs control group from 78.8 ± 14.3 o 62.0 ± 29.04). The researchers acknowledged that “given the moderate heterogeneity of the results and the limited number of studies investigating small populations with short follow-up periods, the outcomes of this review must be considered with caution”. The authors also noted the risk of bias ranged from moderate to serious. The authors concluded the minimally invasive TCRFT using the VivAer device could be useful for treating NVC and significantly improved subjective breathing symptom scores, but additional large scale studies are needed to confirm these results.

Yao and colleagues (2023) reported the results of a follow up to three month outcomes published by Yao et al. in 2021. This prospective, single-arm, multicenter study evaluated the long-term symptom improvements in individuals with NAO secondary to NVC following minimally invasive TCRFT. Participants in the two year follow-up (n=91) were aged 18 years and above. Eligible participants (≥18 years of age) had NVC as a primary or significant contributor to their NAO. Baseline NOSE Scale scores were ≥60 and participants had a positive response to temporary nasal valve dilation, such as the modified Cottle maneuver. Individuals expected to require an adjunctive nasal procedure within 3 months of the study procedure were excluded from the trial. Study participants were treated in the nasal valve region with a TCRFD. The pre and post treatment NOSE scores served as primary outcomes. A total of 122 participants were treated and 91 were followed for 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 follow-up 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 attained 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 related to the study device and/or procedure were reported. The authors acknowledged limitations of this study included its unblinded, single-arm design. The fact that the study population was predominantly Caucasian limited the applicability of the observed outcomes to participants from non-Caucasian populations who may have meaningful differences in nasal anatomy. Additionally, although the TCRFD is indicated for treatment of soft tissues such as inferior turbinates and septal swell bodies, because treatment was limited to the internal nasal valve only, the results of this present study may not represent the total effect that that may be achievable using TCRF in a comprehensive NAO treatment protocol. The authors concluded that TCRFT 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 individuals with both static and dynamic NVC, turbinate enlargement, septal deviation, or prior nasal surgery. Further studies that incorporate more diverse populations and more liberal application of TCRF to address multiple NAO contributors are warranted to evaluate the full potential of TCRFTof NAO.

Han and colleagues (2024) conducted a systematic review and meta-analyses to compare treatment effect sizes after TCRFT of the internal nasal valve alone (i.e., not including turbinate treatment) and functional rhinoplasty surgery. Because functional rhinoplasty treatment of nasal valve dysfunction is frequently performed in combination with septoplasty, turbinate treatment, and techniques to address cosmesis, the researchers completed a series of analyses to compare TCRFT with (i) rhinoplasty surgery focused on the nasal valve, (ii) rhinoplasty surgery without a concomitant turbinate procedure, and (iii) all rhinoplasty surgery procedures. The treatment effect was ascertained from the NOSE scale scores at pre-procedural base line and at post-procedure 3, 6 and 12 months follow-up. An average pre-procedural NOSE score cutoff of 45 and higher was used to focus on participants with at least moderate NAO and objectively exclude participant populations focused on cosmetic outcomes alone. A NOSE score between 35 and 45 was defined as moderate NAO. Of 2529 initial articles, 5 studies identified as describing TCRFT and 63 studies describing functional rhinoplasty were included. Pooled effect sizes for TCRFT and functional rhinoplasty were comparable in all analyses. The researchers concluded that TCRFT of the internal nasal valve for NVD was associated with lasting effects comparable to functional rhinoplasty addressing the nasal valve only, rhinoplasty without concomitant turbinate treatment, and all rhinoplasties. Some limitations of the study include follow-up being limited to 12 months in order to maximize the quantity of evaluable data in each analysis group as studies with greater than12-month follow-up are substantially fewer. The authors also point out that it is possible that individual participants in a dataset had a NOSE score reflecting less than moderate NAO, however, the NOSE score cutoff of 45 maximized the potential that the majority of the participants in a dataset exhibited at least moderate NAO based on the NOSE score severity classification system. With regards to the quality of the studies included in the analysis, the researchers stated that while the traditional procedure studies were predominately of moderate to poor quality and demonstrated a high degree of heterogeneity, the large number of studies included in these meta-analyses are a broad representation of the functional rhinoplasty literature.

In a systematic review and meta-analysis, Kang and colleagues (2024) assessed the effectiveness of TCRFD in alleviating nasal obstruction by rectifying NVC. The researchers conducted a comprehensive review of studies retrieved from PubMed, SCOPUS, Embase, Web of Science, and Cochrane databases (up to December 2022). Studies included in the analysis examined the QOL and nasal obstruction scores prior to and post TCRFT; sham-controlled studies were also evaluated. A total of 451 participants across 8 studies were included in the analysis. Participants who underwent TCRF reported a significantly enhanced QOL 24 months following treatment compared to pre-treatment scores. The rates of clinically improved states and positive responses regarding QOL post treatment were 82 % and 91 %, respectively. Likewise, the disease-specific QOL, as indexed by the NOSE score, significantly improved. The investigators concluded that TCRF may help improve nasal obstruction symptoms but further randomized clinical studies with larger cohorts are needed to validate the effectiveness of TCRFT in enhancing nasal valve function.

In 2024, Silvers and colleagues reported the results of a prospective, multicenter, participant-blinded, randomized controlled trial that assessed the durability of TCRFTeffects and changes in medication and nasal dilator usage over a two year period. Key inclusion criteria were individuals between the ages of 18-85 years who were seeking treatment for NAO, a baseline Nasal Obstruction Symptom Evaluation (NOSE) score ≥55, NVC as the primary or significant contributor to the nasal obstruction, and a positive response to a temporary nasal dilation measure such as the modified Cottle maneuver. Instruments used to gauge the efficacy of outcome were the NOSE Scale and the ESS. The mean age of the 108 participants actively treated was 48.5 years, with 38.9 being male and 61.1% women. The mean NOSE score at baseline was 76.31 (95% CI, 73.6 to 79.1). At the two-year endpoint, the responder rate was 90.4%, [95% CI, 81.5% to 95.3%]) with a NOSE score treatment effect of -41.7, indicating a 54.7% improvement. Among participants using medications or nasal dilators at baseline, 78.9% had decreased or stopped all use in at least one class. No new adverse events related to the TCRFD/procedure were reported through the 2 year study period. The researchers concluded that TCRFD treatment of nasal valve dysfunction resulted in meaningful and sustained improvements in symptoms of NAO and led to a significant reduction in medication or nasal dilator use. The researchers pointed out that concurrent conditions like turbinate enlargement, septal deviation, or septal swell body did not significantly impact the odds of achieving a NOSE score of ≤25 at two years. The authors acknowledged the study had the following limitations: the long-term follow-up in this trial consisted of a single group, however, at inception, this trial was a RCT with a primary endpoint of 3 months. The researchers also pointed out that because the NOSE score is a patient-reported subjective measure, value would be added to future study results if objective measurement such as acoustic rhinometry or rhinomanometry were included. Lastly, the study population was comprised of predominantly Caucasian individuals, which limited the analysis of outcomes in non-Caucasian populations who might have meaningful differences in nasal anatomy.

Torabi and colleagues (2024) queried the FDA's Manufacturer and User Facility Device Experience (MAUDE) database and reported national adverse events (AEs) associated with the use of intranasal RF devices. A total of 24 device-related AEs were identified, 11 (45.8 %) for Celon (Olympus), 3 (12.5 %) for Vivaer (Aerin), 2 (8.3 %) for Neuromark (Neurent), and 8 (33.3 %) for Rhinaer (Aerin). Of these, 7 (63.6 %) of the Celon-related complications were related to tissue necrosis (predominately user error-related), but 1 (9.1 %) episode of pediatric ocular palsy was also reported. Complications associated with the VivAer device included synechiae formation, a case of mucosal perforation, and a case of empty nose syndrome. Of the posterior nasal nerve ablating devices, 9 of 10 AEs were epistaxes, of which 7 (77.8 %) required surgical intervention. The authors concluded that surgeons should practice vigilance and employ tissue-appropriate device settings when utilizing RF devices. Tissue necrosis and epistaxis may occur, as well as sporadic, but more devastating, complications.

Abello and colleagues (2024) reported on the temperature-mediated effect of RF energy on the relatively thin and fragile upper lateral cartilages as a result of treatment with the bipolar RF VivAer device. While previous studies have demonstrated that thermally mediated shape change of cartilage is thought to occur at a threshold of 60–75^oC, when fast infrared laser sources are used to generate heat, the bipolar RF device reaches a temperature of 60^oC, over an order of magnitude longer application time. The researchers proposed to measure surface temperature profiles, model the heating process using a finite element analysis (FEA), and then calculate tissue damage using rate process models in an effort to better understand the biophysical interactions between the RF device and porcine septal tissue. Composite porcine nasal septum was harvested and divided (1 mm and 2 mm). The RF device was used to heat the cartilage in composite porcine septum. An infrared camera (FLIR ExaminIR, Teledyne, Wilsonville, OR) was used to image temperature on the back surface of the sample. These data were incorporated into a heat transfer finite element model that also calculated tissue damage using Arrhenius rate process. Infrared temperature imaging exhibited peak back surface temperatures of 49.57° C and 42.21° C in 1- and 2-mm thick septum, respectively. Temperature maps were generated displaying the temporal and spatial evolution of temperature. A finite element model produced temperature profiles with respect to time and depth. Rate process models using Arrhenius coefficients revealed 30 % chondrocyte death at 1 mm depth after 18 s of RF treatment. The authors concluded that the use of the RF device creates a thermal profile that may result in thermal injury to cartilage. Computational modeling indicated chondrocyte death extending as deep as 1.4 mm below the treatment surface. These researchers concluded that further studies should be performed to improve dosimetry and optimize the heating process to reduce potential injury.

A 2021 ECRI reported the results of its clinical evidence-based assessment on the Vivaer Nasal Airway Remodeling Stylus as a treatment for NAO. The assessment consisted of their review of five studies described in eight journals and reporting on a total of 341 participants. The studies were comprised of one RCT (Silvers, 2021 discussed above) and four single-arm pretest/posttest studies. ECRI concluded there is “somewhat favororable” evidence for the use of the VivAer device and stated the following:

Evidence from one randomized, sham-controlled trial (RCT) and four single-arm, pre-post studies shows that the Vivaer stylus works well for reshaping the nasal airway and improving nasal breathing at three-month follow-up, but how it performs longer-term and how it compares with conventional or other surgical tools cannot be determined from available evidence.

Larger, multicenter RCTs comparing Vivaer with standard surgical tools and other devices and treatments for nasal valve collapse (e.g., functional rhinoplasty, nasal implant) and reporting longer term outcomes are needed to support stronger conclusions and guide provider choices. Five ongoing trials may provide limited evidence to address evidence gaps, but most are single arm and will report only three month outcomes (ECRI, 2021).

The 2023 position statement from the AAO-HNS provides an overview of nasal valve dysfunction as well as a discussion of the diagnosis and treatment of the condition. With regards to surgical repair of the nasal valve, the AAO-HNS states:

The treatment of nasal valve dysfunction may involve techniques that include cartilage grafting and open surgical repair, suture suspension techniques, and implants or radiofrequency treatment aimed at stabilizing the nasal valve… The nasal valve may be stabilized using office-based treatments, such as implants or radiofrequency treatment. For patients who require anatomic widening and definitive stabilization of the nasal valve, surgical treatment of nasal valve collapse, along with treatment of other possible causes of nasal airway obstruction, is required to optimize patient outcomes. Failure to perform nasal valve repair, when indicated, is a common cause of incomplete symptom resolution for patients with nasal obstruction and nasal valve dysfunction. (AAO-HNS, 2023).

At the time of this review, although the AAO-HNS has issued a position statement in support of the use of low energy RF intranasal remodeling treatment for the management of NVC, no clinical practice guidelines were identified that support this recommendation. The peer-reviewed literature evaluating the use of TCRFT of NAO as a result of NVC is predominately comprised of studies that have been limited by lack of randomization, lack of control groups, study populations with small numbers and limited diversity, short duration, and lack of control for confounding medication or nasal dilator use. Only one study (Silvers, 2024) was identified that compared low energy RF intranasal remodeling of the nasal valve to other forms of treatment for nasal obstruction due to NVC. In a similar manner, only one study (Jacobowitz, 2022) was identified that demonstrated the long-term efficacy of TCRFT for NVC for a period longer than 2 years. The published peer-reviewed literature suggests that TCRFT may help improve nasal obstruction symptoms that are a result of NVC, but further randomized clinical studies with larger and more diverse cohorts, longer periods of follow-up, and comparison of this modality to other treatments for NVC (medications, nasal dilators and rhinoplasty) are needed to validate the effectiveness of TCRFT in enhancing nasal valve function

NAO can impact an individual’s life by affecting routine daily activities such as breathing and sleeping. Treatment options for NAO are contingent upon the underlying cause of the symptoms.

NVC is a common cause of NAO. Nasal valve suspension refers to a surgical approach for nasal valve repair that involves suspension of the valve to the orbital rim. During the procedure, an anchored suture is first attached to the orbital rim and then a suture is passed through the collapsed valve. The suspension suture is then returned to the anchor site at the orbital rim and tied, resulting in a repaired nasal valve that presumably allows for less obstructed airflow. Modifications to this procedure or other types of suspensions, such as those using sutures tunneled within the facial soft tissue to an infraorbital incision on each side of the nose, have also been reported.

The Latera implant has been proposed as a method to support the lateral nasal cartilage in individuals with severe nasal obstruction. The device can be implanted unilaterally or bilaterally, using local anesthesia. After implantation, a fibrous capsule forms around the device and tissue continues to encapsulate the implant. Gradually, the implant degrades and is absorbed so that by 24 months following implantation, collagen replaces the implant.

Researchers are exploring the use of low-dose RF energy as a means to reshape nasal tissue to treat NVC. VivAer is intended to improve airflow for individuals with NVC. During this procedure, the clinician inserts the tip of the VivAer ARC Stylus into an individual’s nostril to deliver low RF energy to the target tissue of the nasal airway. The low-dose RF energy creates a coagulation lesion. As the lesion heals, the tissue shrinks and stiffens to diminish widen the airway, reduce airflow resistance, and improve the inhaled flow of air through the nose. The Aerin™ System automatically modifies the power output to maintain target temperature for therapeutic benefit while sparing the mucosa and surrounding tissue. The device consists of a console and two styluses, one for nasal airway obstruction and one for chronic rhinitis (FDA, 2017).

.Acoustic rhinometry: A technique that measures nasal patency; for example, the degree of openness of the nose.

Cottle maneuver: Manual lateral distraction of the cheek away from the airway; a procedure that is used to assist in the identification of the cause and location of NAO.

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Absorbable Nasal Implant
Latera
Nasal Airway Obstruction
Nasal Valve Collapse
Nasal Valve Suspension
Nasal Tissue Remodeling
Temperature-controlled Radiofrequency Treatment
VivAer

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

Subject: Nasal Valve Repair
Document #: SURG.00079	Publish Date: 10/01/2024
Status: Reviewed	Last Review Date: 08/08/2024

CPT
30468	Repair of nasal valve collapse with subcutaneous/submucosal lateral wall implant(s)
30469	Repair of nasal valve collapse with low energy, temperature-controlled (ie, radiofrequency) subcutaneous/submucosal remodeling
30999	Unlisted procedure, nose [when specified as nasal valve suspension by any method]

ICD-10 Diagnosis
	All diagnoses

Status	Date	Action
Reviewed	08/08/2024	Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale, Background/Overview, Definitions and References sections.
Reviewed	08/10/2023	MPTAC review. Updated Rationale and References sections.
	12/28/2022	Updated Coding section with 01/01/2023 CPT changes; added 30469 (30999 no longer applicable for radiofrequency tissue remodeling).
Revised	08/11/2022	MPTAC review. Title changed to “Nasal Valve Repair” Expanded scope of document to address an absorbable nasal implant and low-dose radiofrequency intranasal tissue remodeling for the treatment of nasal airway obstruction. Revised the Position Statement and updated the Description, Rationale, Background/Overview, References, Index and History sections. Content related to the absorbable nasal implant (Latera) moved from CG-SURG-87 to this document. Updated Coding section; added CPT code 30468 previously addressed in CG-SURG-87.
Reviewed	11/11/2021	MPTAC review. Updated review date and history sections.
Reviewed	11/05/2020	MPTAC review. Updated review date and history sections.
Reviewed	11/07/2019	MPTAC review. Updated review date and history sections.
Reviewed	01/24/2019	MPTAC review. Updated review date and History sections, Added note to the Description/Scope and History section referring the user to CG-SURG-87 Nasal Surgery for the Treatment of Obstructive Sleep Apnea and Snoring for information on the Latera nasal implant.
Reviewed	03/22/2018	MPTAC review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated review date, Definitions and History sections.
Reviewed	05/04/2017	MPTAC review. Updated review date and History section.
Reviewed	05/05/2016	MPTAC review. Updated review date, Definitions and History sections. Removed ICD-9 codes from Coding section.
Reviewed	05/07/2015	MPTAC review. Updated review date and History sections.
Reviewed	05/15/2014	MPTAC review. Updated review date, References and History sections.
Reviewed	05/09/2013	MPTAC review. Updated review date, References and History sections.
Reviewed	05/10/2012	MPTAC review. Updated review date, References and History sections.
Reviewed	05/19/2011	MPTAC review. Updated review date, References and History sections.
Reviewed	05/13/2010	MPTAC review. Updated review date, References and History sections.
Reviewed	05/21/2009	MPTAC review. No change to position statement.
Reviewed	05/15/2008	MPTAC review. No change to position statement. References were updated
	02/21/2008	The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
Reviewed	05/17/2007	MPTAC review. References updated.
Reviewed	06/08/2006	MPTAC review. Updated Description, Background and References.
Revised	09/22/2005	MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization.

Pre-Merger Organizations	Last Review Date	Document Number	Title
Anthem, Inc.			No document
WellPoint Health Networks, Inc.	09/23/2004	3.03.25	Nasal Valve Suspension