Intranasal Radiofrequency Ablation

Number: 0592

Table Of Contents

Policy
Applicable CPT / HCPCS / ICD-10 Codes
Background
References

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Policy

Scope of Policy

This Clinical Policy Bulletin addresses intranasal radiofrequency ablation.

1. Medical Necessity

   Aetna considers radiofrequency volumetric tissue reduction (RFVTR, Somnoplasty) medically necessary for treatment of chronic nasal obstruction due to mucosal hypertrophy of the inferior turbinates.

   Aetna considers RFVTR of turbinates for snoring not medically necessary.

2. Experimental and Investigational

   Aetna considers the following interventions experimental and investigational because the effectiveness and safety of these approaches has not been established:

   1. RFVTR of the turbinates for treatment of obstructive sleep apnea
   2. Coblation non-thermal volumetric tissue reduction for treatment of hypertrophy of nasal turbinates
   3. Coblation-assisted turbinoplasty for the treatment of allergic rhinitis
   4. The RhinAer procedure for the treatment of chronic rhinitis
   5. Temperature-controlled radiofrequency neurolysis for the treatment of chronic rhinitis
   6. The NEUROMARK System (a multi-point radiofrequency ablation device) for the treatment of chronic rhinitis.

3. Related Policies

   • CPB 0004 - Obstructive Sleep Apnea in Adults
   • CPB 0475 - Coblation

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Table:

CPT Codes / HCPCS Codes / ICD-10 Codes

Code	Code Description
CPT codes covered if selection criteria are met:
30801	Ablation, soft tissue of inferior turbinates, unilateral or bilateral, any method (eg, electrocautery, radiofrequency ablation, or tissue volume reduction); superficial [RFVTR or somnoplasty]
30802	intramural [RFVTR or somnoplasty]
Other HCPCS codes related to the CPB:
C1886	Catheter, extravascular tissue ablation, any modality (insertable)
ICD-10 codes covered if selection criteria are met:
J34.0 - J34.1 J34.81 - J34.9	Other specified disorders of nose and nasal sinuses [chronic nasal obstruction]
J34.3	Hypertrophy of nasal turbinates [mucosal] [inferior]
ICD-10 codes not covered for indications listed in the CPB:
G47.33	Obstructive sleep apnea (adult) (pediatric)
J30.1 - J30.9	Allergic rhinitis
R06.83	Snoring
RhinAer:
CPT codes not covered for indications listed in the CPB:
30117	Excision or destruction (eg, laser), intranasal lesion; internal approach
ICD-10 codes not covered for indications listed in the CPB:
J31.0	Chronic rhinitis
Temperature-controlled radiofrequency neurolysis:
CPT codes not covered for indications listed in the CPB:
Temperature-controlled radiofrequency neurolysis -no specific code
ICD-10 codes not covered for indications listed in the CPB:
J31.0	Chronic rhinitis
The NEUROMARK System (a multi-point radiofrequency ablation device):
CPT codes not covered for indications listed in the CPB:
The NEUROMARK System (a multi-point radiofrequency ablation device) -no specific code
ICD-10 codes not covered for indications listed in the CPB:
J31.0	Chronic rhinitis

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Background

There are many potential causes for nasal obstruction.  Some of the most common causes are nasal allergies, deviation of the nasal septum (the partition in the middle of the nose on the inside), or sinus or nasal infection.

The nasal passages can also be obstructed by enlarged turbinates.  Enlarged turbinates can impair normal breathing, causing patients to breathe through the mouth.  Enlarged turbinates may be treated with intranasal sprays and medications.  If turbinate hypertrophy is chronic, surgical interventions may be considered.

The Somnoplasty device (Somnus Medical Technologies, Sunnyvale, CA) employs radiofrequency energy to ablate hypertrophied nasal turbinates.  The radiofrequency catheter is inserted into the submucosa of the hypertrophied inferior turbinate.  The submucosal tissue around the catheter is heated and the tissue coagulates.  As the coagulative lesions heals, the submucosal tissue shrinks.

The advantage of radiofrequency volumetric tissue reduction (RFVTR) over electro-cautery for turbinate hypertrophy is that the former can be performed as an office procedure with local anesthesia, whereas the latter is done in an outpatient surgical center under general anesthesia.

The evidence supporting RFVTR for inferior turbinate reduction consists of prospective case series.  However, there are no studies directly comparing RFVTR to electrocautery or cold knife surgery (which are the established alternative methods of inferior turbinate reduction).  In addition, there are no reports of the long-term durability of inferior turbinate reduction with RFVTR.  In a review of the literature on radiofrequency ablation for sleep disordered breathing, Massod and Phillips (2001) concluded that "[a]pplication of RFVTR to the tongue and turbinates has not been studied thoroughly enough to assess its efficacy at present."

Recent studies suggest that radiofrequency tissue ablation may be effective in treating chronic nasal obstruction and refractory allergic rhinitis.  In a prospective, randomized, double-blind, placebo-controlled clinical pilot study, Powell et al (2001) estimated the treatment effect of temperature-controlled radiofrequency (TCRF) reduction of turbinate hypertrophy in patients with sleep-disordered breathing (SDB) treated with nasal continuous positive airway pressure (CPAP).  A total of 22 CPAP-treated patients with SDB with turbinate hypertrophy were randomly assigned to either TCRF turbinate treatment (n = 17) or placebo control (n = 5).  Changes in nasal obstruction were assessed between pre-treatment and 4 weeks post-treatment.  The primary outcome evaluated changes in the blinded examiners' findings of nasal obstruction on a visual analogue scale (VAS).  Secondary outcomes included blinded patients' and unblinded examiner assessments of nasal obstruction VAS, nightly CPAP use, adherence, and tolerance, along with sleepiness and general health status scales.  The treatment group findings were subtracted from the changes in the placebo group to yield treatment effect.  The authors concluded that TCRF turbinate treatment appears to benefit nasal obstruction and CPAP treatment for SDB.  Placebo control and double blinding are critical for establishing the true treatment effect.  A future definitive trial is feasible to establish statistical significance of these findings.

In a prospective, non-randomized study, Black et al (2002) evaluated the effectiveness and morbidity of bipolar radiofrequency thermal ablation of the inferior turbinates in patients with nasal obstruction caused by turbinate hypertrophy (n = 20).  The authors concluded that the bipolar radiofrequency thermal ablation of inferior turbinates is a promising option, for inferior turbinate hypertrophy.

In a prospective, randomized clinical trial, Sapci et al (2003) compared nasal functions of patients with chronic nasal obstruction following treatment by

1. radiofrequency tissue ablation,
2. laser ablation, and
3. partial turbinectomy. 

The study was carried out on 45 adult volunteer patients with symptoms and signs of nasal obstruction and stuffiness related to enlarged turbinates (n = 15 in each group).  These investigators found that that radiofrequency tissue ablation to the turbinate was effective in improving nasal obstruction objectively and in preserving nasal mucociliary function.  Laser ablation of the turbinate was effective in improving the nasal obstruction; however, it significantly disturbed the mucociliary function.  Partial turbinectomy resulted in similar improvements as obtained with radiofrequency tissue ablation.  These findings were based on a small sample size and a relatively short follow-up (12 weeks).  Thus, further follow-up studies with a larger sample size is needed to evaluate the long-term improvement of symptoms and maintenance of nasal functions.

In a prospective, non-randomized study, Lin et al (2003) assessed the effectiveness of turbinate surgery with radiofrequency for the treatment of allergic rhinitis that is unresponsive to medical therapy (n = 108).  These researchers concluded that radiofrequency appears to be an effective and safe tool for treating allergic rhinitis with poor response to medical therapy.  If further long-term studies confirm these findings, radiofrequency has the potential to be one of the most popular surgical modalities for the treatment of allergic rhinitis refractory to medical therapy.

An assessment of RFVTR of the turbinates conducted by the National Institute for Clinical Excellence (NICE, 2004) concluded that "[c]urrent evidence on the safety and efficacy of radiofrequency volumetric tissue reduction for turbinate hypertrophy does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research .... The Advisory Committee noted that there was insufficient evidence to assess efficacy, given that patient numbers were so small in the studies reviewed".

In a randomized controlled trial (n = 32), Nease and Krempl (2004) assessed the short-term (8 weeks and 6 months) effectiveness of RFVTR in treating nasal obstruction in subjects with inferior turbinate hypertrophy.  These investigators concluded that RFVTR is an effective alternative for the treatment of patients with nasal obstruction due to inferior turbinate hypertrophy.  However, this is the first randomized study that demonstrates that RFVTR is significantly better than placebo in treating nasal obstruction due to inferior turbinate hypertrophy.  Its findings need to be validated by future studies with larger sample size and longer follow-up.

Porter et al (2006) reported the long-term effectiveness of RFVTR and compared this approach with other accepted surgical treatments of inferior turbinate hypertrophy.  This study was a prospective, 2-year follow-up of 19 patients originally enrolled in a prospective, randomized, single-blinded, placebo-controlled trial for treatment of inferior turbinate hypertrophy with RFVTR.  Patients assessed their severity of obstruction, frequency of obstruction, and overall ability to breathe by way of a 10-cm VAS.  Radiofrequency volumetric tissue reduction for inferior turbinate hypertrophy showed continued benefit at 2 years post-treatment, with no indication of increasing symptomatology.  The benefit showed in frequency of obstruction, severity of obstruction, and overall ability to breathe (p < 0.05) was maintained at 2 years.  No complications occurred.  These investigators concluded that RFVTR is effective in treating inferior turbinate hypertrophy with sustained benefit at 2 years follow-up while resulting in fewer complications than other surgical methods.  They noted that RFVTR is a relatively new procedure, and therefore there are few long-term evaluations of its effectiveness; this is the first prospective study to document successful outcomes at 2 years follow-up.

There are 2 main drawbacks of this study:

1. the 19 patients represented a long-term follow-up rate of 68 % (19/28), which may have introduced bias; and
2. there was no other treatment arm included in this study. 

These results need to be verified in future large, prospective, randomized, controlled trials comparing RFVTR with submucosal resection of the inferior turbinate.

Coblation

In a prospective, open-label, non-randomized trial, Di Rienzo Businco and colleagues (2010) evaluated the effectiveness of adding Coblation-assisted inferior turbinoplasty to a medical treatment regimen for symptoms associated with hypertrophic inferior turbinates.  Patients were assigned to treatment groups in order of enrollment into the study.  From June 2007 to June 2008, 220 patients with allergic rhinitis and hypertrophic inferior turbinates were enrolled and assigned into 2 groups:

1. the surgical group who received radiofrequency thermal ablation inferior turbinoplasty and medical therapy, and
2. the medical group who received medical therapy only. 

Groups were further divided into 2 allergen types based on antigen sensitivity:

1. perennial and
2. seasonal. 

Subjective complaints (itching, nasal obstruction, rhinorrhea, sneezing), clinical rhinoendoscopy and rhinomanometry tests results were recorded at the start of the study and 2 months post-treatment.  Effect sizes for the mean improvements after treatment were tabulated for all groups.  All study outcomes improved within all groups.  Comparison between medical and surgical groups showed higher improvement in both perennial and seasonal, respectively, in nasal obstruction, sneezing, rhinomanometry, and rhinomanometry after NPT.  Itching improved only in perennial allergen type.  Rhinoendoscopy clinical score showed improvement in surgical group over medical group in both allergen types.  The authors concluded that Coblation-assisted turbinate reduction is a promising adjunct to medical therapy in patients with persistent symptoms associated with allergic rhinitis.  Patients undergoing this surgery had greater reduction of symptoms than patients receiving medical therapy alone, where patients with perennial allergies appeared to benefit most.

In a prospective study, Simeon et al (2010) evaluated the effectiveness of Coblation turbinate reduction in children presenting with obstructive allergic rhinitis after failure of medical management (n = 9).  Coblation was performed after assessment of rhinitis.  Obstruction was assessed on rhinomanometry and VAS; other rhinologic functional signs were assessed on interview, and functional impact was assessed on the PRQLQ quality of life questionnaire.  After the procedure, all 9 children showed reduced nasal obstruction and improved rhinologic function signs, confirmed by the favorable evolution of PRQLQ scores.  The authors concluded that these findings demonstrated the interest of Coblation in controlling nasal obstruction in children with allergic rhinitis refractory to medical treatment, with conserved nasal function.  They stated that larger-scale studies with longer follow-up are needed to confirm these results.

Leong and associates (2010) evaluated the evidence for inferior turbinate surgery in children suffering with chronic nasal congestion.  A structured review of the PubMed, EMBASE and the Cochrane Collaboration databases (Cochrane Central Register of Controlled Trials, Cochrane Database of Systemic Reviews) was undertaken, using the MeSH terms: nasal obstruction, turbinates, surgery and children.  Only articles focusing on turbinate surgery with an exclusively paediatric cohort were included.  A total of 11 studies fulfilled the inclusion criteria.  The ages of the children ranged from 1 to 17 years at the time of surgery and were followed-up for a period of 3 months to 14 years.  Surgical indication for all studies was chronic nasal congestion, resistant to a trial of medical treatment for 2 to 3 months preceding surgery.  Of the 730 cases reviewed, 79.1 % had turbinate surgery as the standalone procedure.  The remaining 21.9 % had other concurrent procedures performed, the most common being adeno-tonsillectomy.  Although all studies generally supported the effectiveness of turbinate reduction surgery for inferior turbinate hypertrophy, the outcome measures used were varied and did not allow comparison across studies.  The authors concluded that there is currently little evidence to support turbinate reduction surgery in children.  The role of surgery, if any, has not been properly examined.  Furthermore, the long-term effects on nasal airflow dynamics, nasal physiology and long-term complications remain to be studied.

The evidence supporting the use of Coblation in the treatment of hypertrophied nasal turbinates consists of small scale studies, the largest of which had a sample size of 60 patients, of whom 30 underwent Coblation.  The overall analysis of the current literature illustrated conflicting results regarding the efficacy of Coblation relative to other currently available treatment options.

Coblation is a non-heat driven process which ablates hypertrophied tissues through use of radiofrequency energy in a conductive medium such as saline.  Lee et al (2006) compared the long-term effectiveness of coblation- and microdebrider-assisted partial turbinoplasty.  Thirty patients were treated with microdebrider and 30 with Coblation.  Patients were followed for 12 months post-operatively.  Nasal obstruction was improved significantly in both groups after 12 months, but symptom improvement was statistically significant only in the microdebrider group.  Lee et al (2006) concluded that "microdebrider-assisted partial turbinoplasty is more effective and satisfactory in long-term relief of nasal obstruction and reduction in mucosal volume of anterior head of inferior turbinate."

Gindros et al (2010) aimed to evaluate the effectiveness and safety of ultrasound treatment of the hypertrophied inferior turbinates in comparison to radiofrequency cold Coblation turbinate reduction and traditional submucosal monopolar inferior turbinate cauterization.  They prospectively studied 60 patients with chronic hypertrophic rhinitis of nonallergic etiology.  Thirty patients received inferior turbinate volume reduction using ultrasound procedure on the left side and monopolar diathermy on the right and the remaining 30 patients received radiofrequency Coblation on the left side and ultrasound turbinate reduction on the right.  Patients were followed post-operatively for six months.  Gindros et al (2010) found the best results in terms of decreasing subjective symptoms and nasal obstruction were obtained with the ultrasound procedure, and second with the radiofrequency technique.  A limitation of this study in the evaluation of Coblation is that only 30 patients received Coblation, and those patients received Coblation only on one side.

Leong et al (2010) followed a cohort of 18 patients who had undergone Coblation inferior turbinate reduction surgery (CITR), of whom 13 patients were available for follow-up at 32 months.  The mean baseline nasal conductance improved significantly (p = 0.033), but the mean VAS scores, although improved, did not achieve statistical significance.  This study was a pilot study of the long-term outcomes of CITR, and the sample size adversely affects the strength of the findings.

Roje et al (2011) performed Coblation in 52 patients with inferior turbinate hypertrophy who were refractory to medical therapy.  Nasal breathing was significantly improved in all patients, with total nasal resistance decreased from 0.44 Pa +/- 0.50 to 0.24 Pa +/- 0.11 (p < 0.001).  Improvement was statistically significant for hyposmia (p = 0.005), nasal draining (p = 0.003), and post-nasal drip (p < 0.001).  However, it should also be noted that there was no comparison group in this study.

In a prospective, single-blinded study, Shah et al (2015) compared intramural bipolar electro-cautery and RF coblation in the treatment of inferior turbinate hypertrophy with regards to objective and subjective improvement in nasal obstruction, rate and type of complications, experience during the procedure, and rate of recovery. A total of 41 adult patients with inferior turbinate hypertrophy refractory to medical management were treated with RF coblation in 1 nostril and intramural bipolar cautery in the other.  Subjective and objective data, including use of a VAS for subjective outcomes, acoustic rhinometry, and nasal endoscopy, were then obtained from each patient comparing the 2 techniques.  Radiofrequency coblation was significantly less painful than intramural bipolar cautery during the procedure (p = 0.03) and during the early post-operative period (p < 0.02) and produced less crusting at 3 weeks (p = 0.009).  Both interventions were similar in subjective and objective improvements in nasal obstruction as measured by acoustic rhinometry and subjective VAS outcomes.  The authors concluded that RF coblation appeared to offer an equivalent alternative to bipolar electro-cautery for the treatment of inferior turbinate hypertrophy with less discomfort during the procedure and early post-operative period.

Ye and Zhou (2015) noted that there are numerous surgical managements of hypertrophic inferior turbinate. Controversy still exists involving the optimal surgical technique for hypertrophic inferior turbinate.  These investigators discussed the most commonly used techniques for turbinate surgery and highlighted their recently published clinical outcomes.  Microdebrider-assisted turbinoplasty, along with total removal of inferior turbinate mucosa, turned out to have no negative impact on healing time and no adverse post-operative events.  The majority of recently published studies were focused on surgical outcomes of radiofrequency ablation (RFA).  It appeared that RFA could improve nasal resistance, sense of smell, and nasal mucociliary function.  A 1470-nm diode laser was found superior to a conventional 940-nm diode laser in reducing scar formation.  Ultrasonic bone aspirator was used to manage hypertrophic inferior turbinate caused by bone enlargement.  Few recent literatures reported turbinectomy.  The authors concluded that inferior turbinate surgery offered benefit and improved nasal obstruction in patients with hypertrophic inferior turbinate refractory to medical treatment.  Moreover, they stated that rigorously designed study including subjective and objective measurements, control or comparison group, and long-term follow-up should be carried out in the future.

Obstructive Sleep Apnea

An UpToDate review on "Management of obstructive sleep apnea in adults" (Kryger and Malhotra, 2015) states that "A systematic review reported that most of the evidence related to surgical treatments for OSA is from case series.  Meta-analyses of data extracted from these series suggest that UPPP, laser-assisted uvulopalatoplasty, radiofrequency ablation, and maxillo-mandibular advancement (MMA) decrease the AHI.  MMA is most consistently associated with a decreased AHI, although the morbidity of MMA has not been determined.  These meta-analyses were limited by a serious risk for bias and inconsistency among the series …. Radiofrequency ablation – RFA targeted to the turbinates, soft palate or tongue can be considered as a treatment option in patients with mild to moderate OSA who cannot tolerate or adhere to positive airway pressure, or in whom oral devices have been considered and found to be ineffective or undesirable.  The data supporting this technique are very limited, however, and the procedure is seldom used".

Snoring

Casale et al (2014) noted that simple snoring represents a social problem, not only because it could affect the patient's married life, but it often goes along with sleep-disordered breathing.  Chronic nasal obstruction has many sequel including snoring and the inferior turbinate hypertrophy (ITH) is its most common cause.  In a prospective study, these researchers evaluated the effectiveness of video-assisted endoscopic RFVTR to reduce snoring in patients affected by chronic nasal obstruction due to ITH.  This study was conducted over 48 habitual snoring persons with persistent nasal obstruction due to bilateral ITH refractory to medical management; they received one time RFVTR.  Nasal symptoms were assessed both subjectively, by VAS and Nasal Obstruction and Septoplasty Effectiveness (NOSE) Scale, and objectively by video-rhinohygrometer.  Snoring was measured by Snoring severity rated by the bed partner, in a longitudinal fashion, using VAS.  All patients were evaluated pre-operatively, and after 45th day (range of 35 to 50 days) post-operatively.  A total of 32 subjects completed study.  All patients had significant symptomatic improvement in nasal breathing (5.53 ± 2.88 versus 1.87 ± 1.75; p < 0.05), confirmed by video-rhinohygrometer values (p < 0.05).  All patients had significant improvement of snoring (5.62 ± 2.80 versus 1.86 ± 1.43, p < 0.001) with a mean snoring VAS improvement of 77.4 %.  The authors concluded that based on the findings of this study and literature review, it seems that RFVTR represents a safe, minimally invasive, easily performed, and time- and cost-effective surgery, which may decrease symptoms of snoring in patients with ITH, at least, in short-term follow-up.  This was a small study (n = 32) with short-term follow-up (mean of 45 days); these findings need to be validated by well-designed studies with larger sample size and longer follow-up.

In a pilot study, Woodson and colleagues (2017) examined the effect of RFA of the lateral palatal fat pad in patients with socially-disruptive snoring.  Snoring outcomes and complications were compared between a group of patients who were treated with RFA ablation of the lateral soft palate fat pad with or without inferior turbinate reduction (8 patients) and another group undergoing inferior turbinate reduction alone (12 patients).  Snoring loudness and bothersomeness improved in the palate but not inferior turbinate group.  Pain was mild and no major complications were observed.  The authors concluded that although further data on the  effectiveness of snoring reduction, duration of effect, and appropriate patient selection is needed, the findings of this pilot study supported RFA ablation of the lateral palatal space as a potential low morbidity procedure for snoring. 

Allergic Rhinitis

Tani and associates (2008) noted that laser-assisted inferior turbinoplasty has become accepted as a common treatment for patients displaying allergic rhinitis with severe nasal obstruction.  Coblation-assisted inferior turbinoplasty has recently been reported.  These researchers evaluated the effectiveness of Coblation-assisted inferior turbinoplasty, compared with laser surgery.  Between November 2004 and May 2007, a total of 29 patients were treated with Coblation-assisted inferior turbinoplasty.  These researchers evaluated symptom scores at 1 month, 1 year and 2 years after surgery, compared with the results of Nd: YAG laser surgery.  At 1 month after surgery, improvement rates of symptom scores were good and similar between Coblation- and laser-assisted surgery.  At 1 year after surgery, improvement rates of laser surgery had significantly decreased.  However, improvement rates of Coblation surgery had not changed at 1 and 2 years (sneeze, 64 %; nasal discharge, 71 %; nasal obstruction, 79 %) after surgery.  The authors concluded that Coblation-assisted inferior turbinoplasty appeared effective for the treatment of patients with allergic rhinitis and nasal obstruction.  This was a small (n = 29) study.

In a prospective, open-label, non-randomized trial, Di Rienzo Businco and colleagues (2010) evaluated the effectiveness of adding Coblation-assisted inferior turbinoplasty to a medical treatment regimen for symptoms associated with hypertrophic inferior turbinates.  Patients were assigned to treatment groups in order of enrollment into the study.  From June 2007 to June 2008, 220 patients with allergic rhinitis and hypertrophic inferior turbinates were enrolled and assigned into 2 groups: the surgical group who received radiofrequency thermal ablation inferior turbinoplasty and medical therapy, and the medical group who received medical therapy only. Groups were further divided into 2 allergen types based on antigen sensitivity: perennial and seasonal. Subjective complaints (itching, nasal obstruction, rhinorrhea, sneezing), clinical rhino-endoscopy and rhino-manometry tests results were recorded at the start of the study and 2 months post-treatment.  Effect sizes for the mean improvements after treatment were tabulated for all groups.  All study outcomes improved within all groups.  Comparison between medical and surgical groups showed higher improvement in both perennial and seasonal, respectively, in nasal obstruction, sneezing, rhino-manometry, and rhino-manometry after NPT.  Itching improved only in perennial allergen type.  Rhino-endoscopy clinical score showed improvement in surgical group over medical group in both allergen types.  The authors concluded that Coblation-assisted turbinate reduction is a promising adjunct to medical therapy in patients with persistent symptoms associated with allergic rhinitis.  Patients undergoing this surgery had greater reduction of symptoms than patients receiving medical therapy alone, where patients with perennial allergies appeared to benefit most.

In a prospective study, Simeon et al (2010) evaluated the effectiveness of Coblation turbinate reduction in children presenting with obstructive allergic rhinitis after failure of medical management (n = 9).  Coblation was performed after assessment of rhinitis.  Obstruction was assessed on rhino-manometry and VAS; other rhinologic functional signs were assessed on interview, and functional impact was assessed on the PRQLQ quality of life questionnaire.  After the procedure, all 9 children showed reduced nasal obstruction and improved rhinologic function signs, confirmed by the favorable evolution of PRQLQ scores.  The authors concluded that these findings demonstrated the interest of Coblation in controlling nasal obstruction in children with allergic rhinitis refractory to medical treatment, with conserved nasal function.  They stated that larger-scale studies with longer follow-up are needed to confirm these results.

Li et al (2013) evaluated the therapeutic effect of nasal Coblation plasma surgery for the treatment of persistent allergic rhinitis (PAR).  A total of 100 patients with mite-sensitized moderate-to-severe PAR who underwent nasal Coblation plasma surgery (inferior turbinoplasty plus nasal agger ablation) were enrolled in this study.  There were 68 male and 32 female patients aged 16 to 62 years (mean of 36.3 years).  The visual analog scale (VAS) for global rhinitis symptoms, nasal provocation test (NPT), anterior rhino-manometry, and T&T olfactometry were used to assess the short-term outcomes, pre-operatively and post-operatively at the end of 3 months after surgical procedure; SPSS19.0 software was applied for statistical analysis.  At 3 months after treatment, the total nasal symptom VAS scores significantly decreased from 7.0 ± 2.0 to 2.5 ± 1.5 (X(-) ± s; t = 18.00, p = 0.0001).  All patients were allergic to house dust mites with positive NPT before treatment.  At 3 months from the Coblation intervention, 88.0 % of the patients changed from positive NPT to negative, while 12.0 % remained as positive. There was a significant reduction in total nasal resistance, which diminished from 0.772 ± 0.224 to 0.221 ± 0.112 kPa·s·L(-1) after treatment (t = 22.00, p = 0.0001).  Pre-operative olfactory tests showed hyposmia in 31.0 % of the patients, with 22 cases for slight and 9 cases for moderate disorder.  Three months after treatment, 13.0 % were diagnosed as hyposmia, with 7 cases for slight and 6 cases for moderate disorder (χ(2) = 10.44, p = 0.005).  The authors concluded that nasal Coblation plasma surgery provided favorable short-term outcomes in terms of remarkable improvement in nasal symptoms, hyper-reactivity of nasal mucosa, nasal flow and olfactory function in patients with moderate-to-severe PAR, however, long-term effect needed further observation.

In an observational, cohort study, Bitar et al (2014) examined the safety and effectiveness of Coblation in relieving inferior turbinate hypertrophy in children.  The severity of allergic rhinitis and the severity and degree of nasal obstruction were assessed using subjective and clinical symptom grading tools, a VAS, and endoscopy.  Any post-operative complications were noted at 1 week, and at 1, 3, 6 and 12 months post-operatively.  Data from extended follow-up periods were included when available.  The statistical significance of changes in parameter values was assessed using the Wilcoxon signed-rank test.  A total of 32 patients were recruited (mean age of 11.28 years; range of 6 to 17 years).  Significant post-operative improvement (p < 0.001) was noted in the severity and degree of nasal obstruction.  This improvement was maintained after a mean follow-up period of 10.5 months (range of 1 month to 4 years).  No mucosal ulceration or adhesion was encountered.  Minimal crusting was noted in 8.57 % of patients at 1-week follow up.  Allergic rhinitis symptoms improved significantly.  The authors concluded that inferior turbinate reduction by Coblation was an effective and safe procedure in children aged 6 years and older.  The positive outcomes appeared to be long-lasting.  This was a small (n = 32) study.

In a prospective, single-blinded study, Shah et al (2015) compared intramural bipolar electrocautery and radiofrequency Coblation in the treatment of inferior turbinate hypertrophy with regards to objective and subjective improvement in nasal obstruction, rate and type of complications, experience during the procedure, and rate of recovery.  A total of 41 adult patients with inferior turbinate hypertrophy refractory to medical management were treated with radiofrequency Coblation in one nostril and intramural bipolar cautery in the other.  Subjective and objective data, including use of a VAS for subjective outcomes, acoustic rhinometry, and nasal endoscopy, were then obtained from each patient comparing the 2 techniques.  Radiofrequency Coblation was significantly less painful than intramural bipolar cautery during the procedure (p = 0.03) and during the early post-operative period (p < 0.02) and produced less crusting at 3 weeks (p = 0.009).  Both interventions were similar in subjective and objective improvements in nasal obstruction as measured by acoustic rhinometry and subjective VAS outcomes.  The authors concluded that radiofrequency Coblation appeared to offer an equivalent alternative to bipolar electrocautery for the treatment of inferior turbinate hypertrophy with less discomfort during the procedure and early post-operative period.  Moreover, these researchers stated that future studies should evaluate long-term outcomes with comparison of both subjective and objective measures.

The authors stated that the drawbacks of this study included a small cohort of patients in each group with poor patient follow-up.  Only 60 % of the patients completed the 6-week post-operative VAS score for nasal obstruction.  While the study only reported outcomes to 6 weeks, long-term follow-up is needed to determine the duration of the results and if further treatment is needed.  They stated that future studies could utilize this model for comparison of turbinate reduction procedures in the individual patient and provide for long-term follow-up.

In a prospective, randomized, controlled trial (RCT), Kang and colleagues (2019) examined the effects of inferior turbinate RFA, performed after septoplasty, on patients with allergic rhinitis (AR) symptoms.  This study entailed 60 patients with both a deviated nasal septum (DNS) and AR.  Those who underwent septoplasty/sham surgery constituted the Septo-Sham group and those who underwent septoplasty/RFA formed the Septo-RFA group.  Demographic factors, pre- and post-operative symptom scores for allergic rhinitis (SFARs), and NOSE Scale scores were calculated.  These researchers subdivided the total SFAR (tSFAR) scores into scores for nasal obstruction (SFAR-NO) and scores for symptoms other than nasal obstruction (SFAR-SONO); the latter included rhinorrhea, itching, and sneezing.  The baseline characteristics were similar between the groups.  The 2 types of surgery improved both the NOSE and SFAR scores.  In subgroup analysis according to the type of symptoms, both types of surgery showed improvement in SFAR-NO and SFAR-SONO scores.  However, the extent of improvement did not differ between the groups, regardless of the type of symptoms.  The authors concluded that for patients with both DNS and AR, both types of surgery afforded post-operative symptomatic improvement.  Both types of surgery yielded improvement in both nasal obstruction and symptoms other than nasal obstruction.  However, performing RFA after septoplasty did not afford further short-term symptomatic improvements.  Therefore, septoplasty without RFA may be optimal for patients with both DNS and AR.

Furthermore, an UpToDate review on "Complementary and alternative therapies for allergic rhinitis and conjunctivitis" (Bielory, 2019) does not mention Coblation-assisted turbinoplasty /radiofrequency Coblation as a therapeutic option.

The RhinAer Procedure for the Treatment of Chronic Rhinitis

The RhinAer Procedure, with the use of bi-polar RF energy, is a non-invasive therapeutic option for individuals who suffer from moderate-to-severe chronic rhinitis.  It disrupts posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate [IT]) that triggers rhinitis.  This procedure is incisionless and can be performed under local anesthesia.

Tosun et al (2005) examined the effectiveness of submucosal application of RF to the inferior turbinate for the treatment of vasomotor rhinitis.  A total of 20 patients with vasomotor rhinitis (9 men, 11 women; mean age of 29.2 years; range of 20 to 40 years) were treated with RF applied to the inferior turbinate.  Symptoms such as nasal obstruction, sneezing, and watery nasal discharge were graded with the use of a VAS before, and on days 1, 3, 7, 30, 60, 90, and 180 after the treatment.  The severity of symptoms began to decrease following the 1st week after the application.  Maximum relief was achieved between 30 to 60 days after the intervention.  The highest rate of improvement (85.4 %) was reported in sneezing, followed by nasal obstruction (76.4 %) and nasal discharge (67.7 %).  The mean VAS scores showed a significant improvement in all symptoms between 7 to 180 days after the procedure (p < 0.05).  The rate of patient satisfaction was 90 % for the relief of nasal obstruction and sneezing, and 80 % for nasal discharge.  Complaints about vasomotor rhinitis increased up to a severity near the pre-treatment level in 8 patients on the 180th post-operative day and the procedure was repeated.  The authors concluded that these findings indicated that RF may be used as an alternative therapeutic option in patients with vasomotor rhinitis.

Hytonen et al (2009) noted that RFA is a relatively new method for the reduction of submucosal tissue.  The method has gained increasing popularity in the treatment of snoring, tonsillar hypertrophy, tongue base hypertrophy, and nasal obstruction secondary to non-allergic or allergic rhinitis.  These researchers carried out a systematic literature review on the effectiveness, and complications of nasal RFA in the treatment of nasal obstruction.  They performed a computerized literature search using several databases to select articles dealing with RFA treatment in the field of otorhinolaryngology.  Selected articles were independently appraised by at least 2 of the authors.  A total of 35 articles met the inclusion criteria; 26 articles were reports on uncontrolled patient series.  Of the 9 included RCTs, only 1 reported a double-blind comparison.  Most of the studies reported an improvement in subjective symptoms after treatment and the number of serious side effects was small; however, the only placebo-controlled trial did not show effectiveness.  The authors concluded that nasal-RFA appeared to be a safe operative procedure and may reduce inferior turbinate submucosal tissue volume in patients having chronic nasal obstruction and who failed to respond to medical treatment.  Based on current knowledge, RFA altered the nasal mucosa only slightly and caused only minor discomfort and risk of side effects for the patient; however, most of the published studies on nasal-RFA were observational and had a relatively short follow-up.  These researchers stated that there is an urgent need for well-designed, randomized, double-blind, placebo-controlled trials on nasal-RFA treatment.

Assanasen et al (2014) noted that RFVTR of hypertrophic IT is an effective way to treat patients with intractable nasal mucosal obstruction.  These researchers examined the effectiveness of combined RFVTR and lateral out-fracture (LOF) of hypertrophic IT in chronic rhinitis (CR) patients on reduction of nasal obstruction, rhinorrhea, and nasal pruritus both short- and long-term.  A total of 73 patients with CR who failed medical treatment were recruited to undergo combined RFVTR and LOF of hypertrophic IT.  Nasal congestion scores were recorded before the operation, and immediately, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, and 3 years after the operation.  Rhinorrhea and pruritic score as well as total nasal airway resistance (TNAR) and total nasal airflow (TNAF) (measured by active anterior rhinomanometry) were recorded before the operation, and 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, and 3 years after the operation.  A total of 45 patients completed the follow-up period of 3 years.  Subjects consisted of 25 men and 20 women, with an average age of 31 years.  Nasal congestion scores were significantly improved immediately after the operation.  Nasal congestion scores and TNAR values were significantly decreased whereas TNAF values were significantly increased at every time-point post-operatively.  Rhinorrhea and pruritic scores were also significantly improved at every time-point 2 weeks post-operatively.  The authors concluded that combined RFVTR and LOF of hypertrophic IT was an effective treatment for nasal obstruction, rhinorrhea, and nasal pruritus in CR and the result lasted up to 3 years post-operatively.  These findings were confounded by the combined use of RF volumetric tissue reduction and lateral out-fracture.

In a prospective, randomized, non-inferiority study, Banhiran et al (2015) compared outcomes of temperature-controlled RF (TCRF) and bipolar RF (BRF) for IT reduction in patients with CR.  This trial enrolled 84 adult patients with CR refractory to medication; they were randomized into 2 intervention groups: TCRF (n = 42) or BRF (n = 42).  Primary outcomes consisted of patient-orientated VAS (0 to 10) of nasal obstruction at 4th post-operative week.  Secondary subjective outcomes included VAS of nasal discharge, sneezing, hyposmia, and post-nasal drip.  Objective outcomes included crusting, muco-ciliary transportation time, minimal cross-sectional area (CSA), total nasal volume, and nasal airway resistance performed by blind assessors before and at 4th post-operative week and 1-year follow-up.  Baseline and peri-operative data showed no statistically significant difference between the 2 groups, except for longer operative time in TCRF (481.5 ± 36.2 versus 37.1 ± 3.0 s, p < 0.001) and slightly more crusts in BRF group (p = 0.04).  Both intention-to-treat (ITT) and per-protocol analyses, TCRF (n = 39) versus BRF (n = 41), revealed no significant difference among subjective and objective outcomes between the 2 groups at 4th post-operative week.  The 95 % confidence intervals (CIs) of mean differences of VAS scores of all subjective symptoms were within defined margin (-1.5 to 1.5), except for nasal discharge.  At 1-year follow-up, there was still no significant difference in the outcomes.  Minimal pain and minor bleeding without serious adverse effects from both interventions were reported.  Both BRF and TCRF resulted in similar short-term outcomes, while less operative time was found in BRF group.  These researchers stated that further studies, especially, on cost-effectiveness should be conducted for better treatment selection.

In a prospective, randomized, single-blinded, placebo-controlled study, Harju et al (2018) compared RFA, diode laser, and microdebrider-assisted inferior turbinoplasty techniques in the treatment of chronic nasal obstruction caused by inferior turbinate enlargement; and compared these techniques with a placebo procedure.  A total of 98 consecutive patients with enlarged ITs due to persistent year-round rhinitis were randomized into a placebo, RFA, diode laser, and microdebrider-assisted inferior turbinoplasty groups in a ratio of 1:2:2:2.  All the procedures were performed under local anesthesia with the patients' eyes covered.  Assessments were conducted prior to surgery and 3 months after the surgery.  The severity of nasal obstruction measured by VAS score decreased statistically significantly in all the groups, including placebo; RFA (p = 0.03), diode laser (p = 0.02), and microdebrider-assisted inferior turbinoplasty (p = 0.04) all decreased the symptom score of the severity of nasal obstruction statistically significantly more compared to the placebo procedure.  The authors concluded that the placebo effect had a large role in the overall improvement of the severity of nasal obstruction after the inferior turbinate surgery; however, all 3 techniques provided a statistically significant (not sure whether this is clinically significant) additional reduction of the severity of nasal obstruction compared to the placebo procedure.

UpToDate reviews on “Chronic nonallergic rhinitis” (Lieberman, 2021) and “Chronic rhinosinusitis: Management” (Hamilos and Holbrook, 2021) do not mention radiofrequency as a management / therapeutic option.

Furthermore, there is a clinical trial on “RhinAer Procedure for Treatment of Chronic Rhinitis Study (RHINTRAC)” that is active, but not recruiting (Last updated January 22, 2021); and estimated study completion date is April 1, 2023.

Lee et al (2022) noted that TCRF neurolysis of the posterior nasal nerve (PNN; RhinAer) is a minimally invasive therapeutic option for patients with chronic rhinitis.  In a prospective, single-arm trial, these researchers examined clinical outcomes and QOL following TCRF neurolysis of the PNN.  This study enrolled 129 patients with chronic rhinitis at 16 medical centers in the U.S. and Germany.  The mean 24-hour rTNSS improved from 7.8 (95 % CI: 7.5 to 8.1) at baseline to 3.6 (95 % CI: 3.2 to 4.0) at 3 months and continued to improve to 2.9 (95 % CI: 2.5 to 3.3) at 6 months (p < 0.001 comparing follow-up to baseline and p = 0.002 comparing 3 and 6 months).  This represented 53.8 % improvement over baseline at 3 months and 62.8 % improvement at 6 months.  Rhinorrhea, congestion, sneezing, and itching sub-scores and post-nasal drip and cough scores were all significantly improved over baseline at both timepoints.  At 3 months, 76.2 % (95 % CI: 68.1 % to 82.8 %) of patients achieved a minimal clinically important difference of 30 % or more improvement in rTNSS over baseline and the percentage was higher at 6 months (83.5 % [95 % CI: 75.8 % to 89.0 %]).  At 3 months, 80.3 % (95 % CI: 72.6 % to 86.3 %) reported a minimal clinically important difference of 0.4-point or more improvement in the mini rhinoconjunctivitis quality of life questionnaire (mini RQLQ) score, and the percentage was higher at 6 months; 87.7 % (95 % CI: 80.7 % to 92.4 %).  There were no serious AES (SAEs) with a relationship to the device/procedure reported through 6 months.  The authors concluded that in this multi-center study, TCRF neurolysis of the PNN was safe and resulted in a significant reduction in rhinitis symptom burden at 3 months that was sustained/improved through 6 months.  The majority of patients reported a clinically relevant improvement in QOL at 3- and 6-month post-procedure.  Moreover, these researchers stated that continued follow-up will confirm that treatment effects are consistent with previously published long-term evidence.

The authors stated that the drawbacks of this study were the lack of a control arm and the limited follow-up to-date.  The effect sizes of the primary and secondary effectiveness endpoints were large; although unlikely, it was possible that placebo effects may have contributed to the overall observed effect.  Medication use was not limited by the protocol; however, the study was pragmatically designed to collect real-world outcomes.

Takashima et al (2023) stated that TCRF neurolysis of the PNN area for the treatment of chronic rhinitis was previously reported as superior to a sham-control procedure at 3 months post-procedure in a RCT.  The primary endpoint was a responder rate of 30 % or more improvement (decrease) for 24-hour rTNSS compared with baseline.  In a prospective, multi-center, patient-blinded RCT, these investigators presented 12-month outcomes after active treatment.  Subjects in the index active treatment arm were unblinded at 3 months and followed through 12 months.  At 3 months, eligible patients from the sham-control arm of the study were invited to cross-over to active treatment.  Eligibility criteria included rTNSS of 6 or higher, with moderate-severe rhinorrhea and mild-severe congestion.  The TCRF stylus was applied bilaterally to non-overlapping areas in the region of the PNN.  Patients in the index active treatment arm (n = 77) had a mean baseline rTNSS of 8.3 (95 % CI: 7.9 to 8.7).  At 12 months, the responder rate was 80.6 % (n = 67) (95 % CI: 69.1 % to 89.2 %).  At 12 months, the mean change in rTNSS was -4.8 (95 % CI: -5.5 to -4.1; p < 0.001), a 57.8 % improvement.  The available initial rTNSS-based outcomes in the cross-over, active treatment arm (n = 27) followed the same course as the index treatment arm.  No SAEs and 8 AEs related to the device/procedure were reported in the trial to-date.  The authors concluded that TCRF neurolysis of the PNN area was safe and the symptom burden improvement that was superior to a sham procedure at 3 months was sustained through 12 months.  Moreover, these researchers stated that the combined active treatment group will be followed through 2 years in this trial to demonstrate the durability of this effect.

The authors stated that this study had 2 main drawbacks.  First, the investigators were not blinded in the initial stages of the trial; however, the rTNSS used in endpoint evaluation is a patient‐reported outcome, mitigating the risk of bias.  Second, medication use was not controlled and could potentially have had some confounding effect on symptom relief, as measured by the rTNSS; however, analysis of the results when assigning all patients in the index active treatment arm who reported an increase in medication use to non-responders did not substantially affect the responder rate over time.

Posterior Nasal Nerve Neurectomy for the Treatment of Chronic Rhinitis

Qi et al (2021) examined the effectiveness of endoscopic selective vidian neurectomy in the treatment of severe persistent AR combined with chronic rhinosinusitis (CRS) with nasal polyps (ARwCRSwNP).  A total of 130 patients with moderate-to-severe persistent ARwCRSwNP were enrolled at Xuanwu Hospital, Capital Medical University, from September 2015 to September 2017.  Patients were divided into 2 groups; 61 patients (the control group) underwent conventional surgical treatment for CRS with nasal polyps and received conservative treatment for AR; 69 patients (the experimental group) received conventional surgical treatment for CRS with nasal polyps plus endoscopic selective vidian neurectomy with amputation of the posterior nasal nerve and pharyngeal branch of the vidian nerve.  Clinical parameters, including VAS score, Lund-Kennedy endoscopic mucosal morphology score, and Lund-Mackay sinus computed tomography (CT) scan lesion range score, were used to analyze and evaluate the pre-operative and post-operative data.  Comparisons were based on patient scores, and pre-operative and post-operative scores obtained at 6, 12, and 24 months were analyzed.  The experimental group had higher effectiveness in nasal obstruction, nasal itching, rhinorrhea, sneezing, and general symptoms than the control group (p < 0.05).  No complications such as tear-secretion disorder or atrophic rhinitis occurred in the experimental group, and no significant difference in complications incidence was observed between the 2 groups (p > 0.05).  The authors concluded that endoscopic selective vidian neurectomy was a safe and effective technique for the management of moderate-to-severe persistent ARwCRSwNP.  Moreover, these researchers stated that they look forward to expanding the patient sample in future studies, while continuing to examine this therapeutic option in depth.

The authors stated that although these findings are encouraging, there are still some limitations that will need to be addressed in future studies.  First, it was hard to achieve randomization or blinding of cases within the study.  Second, because of unavoidable factors, the follow-up time for some patients was less than 3 years, making for less-than-ideal observation intervals.  Third, this analysis would be more robust if the patient quality of life (QOL) were also examined. 

Furthermore, an UpToDate review on “Chronic nonallergic rhinitis” (Lieberman, 2022) states that “A number of other surgical procedures have been tried in the past, including vidian nerve resection, electrocoagulation of anterior ethmoidal nerve, sphenopalatine ganglion block, and others.  None of these techniques have been shown to have long-term benefits, and the potential risks (e.g., persistent pain) have to be considered carefully, since they may outweigh any possible benefits”.

Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis

In a prospective, single-blinded, multi-center RCT, Stolovitzky et al (2021) examined the safety and effectiveness of temperature-controlled RF neurolysis of the posterior nasal nerve (PNN) area for the treatment of chronic rhinitis.  Patients with 24-hour reflective Total Nasal Symptom Score (rTNSS) of greater than or equal to 6, including moderate-to-severe rhinorrhea and mild-to-severe congestion, were randomized 2:1 to active treatment of the PNN area with a temperature-controlled RF device (treatment group) or a sham procedure, with no RF energy delivery (control group).  The stylus was employed bilaterally to non-overlapping areas of the posterior middle meatus and posterior inferior turbinate in each nostril in the region of the PNN.  The primary endpoint was responder rate at 3 months, where a response was defined as greater than or equal to 30 % improvement (decrease) in rTNSS from baseline.  Patients had a mean baseline rTNSS of 8.3 (95 % CI: 7.9 to 8.7) and 8.2 (95 % CI: 7.6 to 8.8) (p = 0.797) in the active treatment (n = 77) and sham control (n = 39) arms, respectively.  At 3 months, responder rate was significantly higher in the active treatment arm: 67.5 % (95 % CI: 55.9 % to 77.8 %) versus 41.0 % (95 % CI: 25.6 % to 57.9 %) (p = 0.009).  The active treatment arm had a significantly greater decrease in rTNSS (mean of -3.6 [95 % CI: -4.2 to -3.0] versus -2.2 [95 % CI: -3.2 to -1.3]) (p = .013); 3 adverse events (AEs) related to the device/procedure were reported, and all resolved.  The authors concluded that this RCT showed temperature-controlled neurolysis of the PNN area was free from significant AEs and superior to a sham procedure in decreasing the symptom burden of chronic rhinitis.  Moreover, these researchers stated that long-term follow-up studies are needed to demonstrate the durability of the treatment effect.

The authors stated that this study had several drawbacks.  First, the findings reported to-date were through 3 months; thus, longer-term follow-up evaluation is needed to examine the durability of the effect.  Second, patients with a predisposition to poor wound healing (in the opinion of the investigator) were excluded from this trial; thus, the results may not be applicable to this patient population.  Third, researchers were not blinded; however, the rTNSS used in endpoint evaluation was reported by the blinded patient, mitigating the risk of bias; and the pain VAS was completed by the blinded patients.  Fourth, allergy testing was not required, so the relative effectiveness by rhinitis subtype could not be compared.  Fifth, medication use was not controlled and could potentially have had some confounding effect on symptom relief as measured by the rTNSS.  However, analysis of the results when assigning all patients in the active treatment arm who reported an increase in medication use to non-responders did not change the superiority of active treatment over sham control.

Silvers et al (2021) stated that nasal valve collapse is one of several causes of nasal obstruction.  In a prospective, single-blinded, multi-center RCT, these researchers compared active device treatment against a sham procedure (control) for the treatment of nasal airway obstruction (NAO).  Subjects were assigned to bilateral temperature-controlled RF treatment of the nasal valve (n = 77) or a sham procedure (n = 41), in which no RF energy was transferred to the device/treatment area.  The device was applied to the mucosa over the lower lateral cartilage on the lateral nasal wall.  The primary endpoint was responder rate at 3 months, defined as a greater than or equal to 20 % reduction in NOSE-scale score or greater than or equal to 1 reduction in clinical severity category.  At baseline, patients had a mean NOSE-scale score of 76.7 (95 % CI: 73.8 to 79.5) and 78.8 (95 % CI: 74.2 to 83.3) (p = 0.424) in the active treatment and sham-control arms, respectively.  At 3 months, the responder rate was significantly higher in the active treatment arm (88.3 % [95 % CI: 79.2 % to 93.7 %] versus 42.5 % [95 % CI: 28.5 % to 57.8 %]; p < 0.001).  The active treatment arm had a significantly greater decrease in NOSE-scale score (mean of -42.3 [95 % CI: -47.6 to -37.1] versus -16.8 [95 % CI: -26.3 to -7.2]; p < 0.001); 3 AEs at least possibly related to the device and/or procedure were reported, and all resolved.  The authors concluded that this RCT showed temperature-controlled RF treatment of the nasal valve was safe and effective in reducing symptoms of NAO in short-term follow-up.

The authors stated that this study had several drawbacks.  Among them were those common to randomized sham-controlled studies for medical devices and procedures.  Physicians were not blinded to treatment-arm assignment, which may have been a source of bias, but this was mitigated by patient blinding and use of patient-reported outcome measures (i.e., NOSE scale, ease-of-breathing VAS, pain VAS).  Unlike a placebo in pharmaceutical trials, which could appear identical to the active compound to patient, sham devices and procedures may differ enough from treatment that the patients guessed their arm allocation.  However, these investigators believed that the sham device and procedure in this trial closely replicated the treatment experience.  Medication use was not dictated by the protocol and could potentially have had some confounding effect on symptom relief.  However, primary endpoint analysis after converting responders to non-responders if they increased medication/mechanical nasal aid use did not change the superiority of active treatment over sham control.  Finally, the results reported were through 3 months and longer-term follow-up will reveal the durability of the effect observed in this trial to-date.

The studies by Stolovitzky et al (2021) and Silvers et al (2021) appeared to be the same study.

Ephrat et al (2021) noted that insufficiency of the nasal valve is increasingly being recognized as a cause of NAO.  The condition is associated with many symptoms, including nasal congestion, sleep disturbance, snoring, and an overall decline in QOL.  An in-office, minimally invasive RF treatment of the nasal valve has been associated with improved symptoms of nasal obstruction and patients' QOL for a 6-month period in a non-controlled, prospective, single-arm study.  These researchers examined if the results achieved with RF treatment at 6 months would be sustained through 24 months.  A total of 39 adult patients from an original cohort of 49 patients with severe-to-extreme NOSE Scale scores and dynamic or static internal nasal valve obstruction as the primary or significant contributor to obstruction were studied.  Patients received intra-nasal bilateral RF treatment in a clinical study with a follow-up to 6 months, and were prospectively evaluated at 12, 18, and 24 months at 8 community-based otolaryngology practices.  The patient-reported NOSE Scale score and 21 QOL questions were assessed.  Clinically significant improvement from baseline in NOSE Scale score change demonstrated at 6 months (mean of 55.9; standard deviation [SD], 23.6; p < 0.0001) was maintained through 24 months (mean of 53.5; SD, 24.6; p < 0.0001).  Responders (greater than or equal to 15-point improvement) consisted of 92.3 % of subjects at 6 months and 97.2 % at 24 months.  Responses to the QOL questions also showed improvement in patients' QOL.  The authors concluded that treatment of the nasal valve with an in-office, trans-nasal temperature-controlled RF procedure was associated with stable and lasting improvement in symptoms of nasal obstruction and QOL through 24 months in this non-controlled, single-arm study.  Moreover, these researchers stated that it will be necessary to confirm the findings of this study with additional patients as part of a planned RCT that may help determine the relative true treatment effect versus potential placebo effects.

The authors stated that the major drawbacks of this study were the single‐arm, non-randomized design and lack of a control group.  Based on the study design employed, the observed association of treatment and NOSE score could be due to a placebo effect.  Future studies will utilize a single‐blinded, randomized, sham‐controlled approach and larger sample sizes.  Another drawback was the lack of objective measures of nasal obstruction and nasal airflow; however, there were numerous studies in the literature that showed a poor correlation between objective measures of nasal resistance and airflow and the symptoms of nasal obstruction.  The NOSE Scale is a validated survey that measures the reduced QOL attributed to nasal obstruction; thus, the NOSE Scale score is generally used as a primary outcome in studies of therapy for nasal obstruction.  Another drawback was that the extended follow‐up study enrolled 39 of the 50 original subjects in the original 6‐month clinical study (49 were eligible for enrollment).  Comparison of demographic characteristics of original study subjects who chose to enroll with those who did not enroll did not reveal any signs of symptomatic bias.  All of the original sites were represented in this study.  An initial concern that subjects with less improvement or satisfaction with the procedure would choose not to enroll did not appear to take place.  Baseline and 26‐week NOSE Scale scores for those enrolled in the follow‐up study were slightly worse than for those that did not enroll, and all 3 of the non-responders at the 6‐month endpoint of the original study enrolled in this follow‐up study, indicating that bias toward enrollment of the most improved study participants was unlikely.  However, for consideration of worst case, if the 10 unenrolled participants from the original study and the 3 lost to follow‐up in this study were all considered non-responders, then the overall 24‐month responder percent was 71.4 %.

Ehmer et al (2022) stated that chronic rhinitis is a prevalent condition with a significant impact on QOL.  Posterior nasal nerve and vidian neurectomy are surgical options for treating the symptoms of chronic rhinitis but are invasive procedures.  In a prospective, single-arm, multi-center study with follow-up through 52 weeks, these researchers examined the outcomes of patients diagnosed with refractory chronic rhinitis and treated with temperature-controlled RF neurolysis of the posterior nasal nerve area in a minimally invasive procedure.  Subjects were adult patients who had chronic rhinitis symptoms of at least 6 months duration with inadequate response to at least 4 weeks usage of intra-nasal steroids and an overall 12-hour rTNSS greater than or equal to 6 with sub-scores 2 to 3 for rhinorrhea, 1 to 3 for nasal congestion, and 0 to 3 for each of nasal itching and sneezing.  Temperature-controlled RF energy was delivered to the nasal cavity mucosa overlying the posterior nasal nerve region with a novel single-use, disposable, hand-held device.  A total of 50 patients were treated (42.0 % men; mean age of 57.9 ± 11.9 years), and 47 completed the study through 52 weeks.  Mean rTNSS significantly improved from 8.5 (95 % CI: 8.0 to 9.0) at baseline to 3.6 (95 % CI: 3.0 to 4.3) at 52 weeks (p < 0.001), a 57.6 % improvement.  Similar trends in improvement were noted for rTNSS sub-scores (rhinorrhea, nasal congestion, itching, sneezing), post-nasal drip scores, and chronic cough scores.  Subgroup analysis demonstrated the treatment was effective regardless of rhinitis classification (allergic or non-allergic).  No serious AEs with a relationship to the device/procedure occurred.  The authors concluded that temperature-controlled RF neurolysis of the posterior nasal nerve area for the treatment of chronic rhinitis was safe and resulted in a durable improvement in the symptoms of chronic rhinitis through a 52-week follow-up.  Data suggested that this novel device could be considered a minimally invasive option in the otolaryngologist's armamentarium for the treatment of chronic rhinitis.  Moreover, these researchers stated that larger, controlled studies are needed to demonstrate the effectiveness of the device.

The authors stated that drawbacks of the study included the fact that the study was not controlled nor blinded.  While the effect sizes of the primary endpoint were sufficiently large as to demonstrate intra-patient baseline-to-follow-up changes, placebo effects may have contributed to the reported outcomes.  Furthermore, autonomic testing before inclusion would have characterized more thoroughly autonomic dysfunction and prospective allergy testing would have resulted in a more robust assignment of the rhinitis types.  Lastly, control of medication use would have reduced any confounding effects of medication changes.

The NEUROMARK System (Multi-Point Radiofrequency Ablation Device) for the Treatment of Chronic Rhinitis

In a prospective, single-arm, multi-center study, Reh et al (2023) examine the safety and effectiveness of the NEUROMARK System, a multi-point RFA device, for the treatment of patients with chronic rhinitis.  This trial was carried out on adults with chronic rhinitis who underwent RFA to the posterior nasal nerves.  Primary endpoints were device-related SAEs at 1 month and change from baseline in VAS nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months.  Total nasal symptom score (rTNSS) and mini RQLQ score were also evaluated.  A total of 36 subjects were enrolled and completed follow-up at 1 and 3 months.  Mean VAS NSS scores for rhinorrhea and nasal congestion showed significant improvement at 3 months (both p < 0.0001).  The mean percent changes from baseline in VAS rhinorrhea and nasal congestion were 53 % and 55 %, respectively.  Total scores and all individual rTNSS items significantly improved (all p < 0.001) over the measured interval.  Percent responder rate (30 % or more reduction from baseline in total rTNSS) at 3 months was 78 %.  The total mean mini RQLQ scores, as well as all subdomains, improved significantly (all p < 0.0001).  At 3 months, 89 % of participants reported a minimal clinically important difference of 0.4 point or more improvement in the mini RQLQ score.  No SAEs occurred during the study.  The authors concluded that the NEUROMARK System is a novel RFA device that provided safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis.  Study participants experienced statistically significant and clinically meaningful improvement in symptoms and QOL assessments at 3 months post-procedure.  Moreover, these researchers stated that further investigations of real‐world evidence in a large group of subjects would add to the evidence for this novel device.  Level of Evidence = IV.

These researchers stated that although this multi-center trial employed validated rhinitis and QOL tools, it was limited by the lack of a concurrent control.  These investigators attempted to mitigate this by using each subject as their own control, as they compared pre- to post‐procedure measures.  However, previous randomized sham‐controlled studies have shown that cryoablation and RFA procedures performed significantly better than sham‐controls; thus, validating posterior nasal nerve procedures for rhinitis symptoms.  Furthermore, while the authors presented only short‐term results, longer‐term follow‐up will be reported for this study cohort.  Subgroup comparison was limited by the sample size.

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References