1. Aetna considers radiofrequency volumetric tissue reduction (RFVTR, Somnoplasty) for treatment of chronic nasal obstruction due to mucosal hypertrophy of the inferior turbinates experimental and investigational because there is insufficient evidence in the peer-reviewed published medical literature directly comparing RFVTR to the established alternatives of electrocautery or submucosal surgical resection of the turbinates with scalpel or ablative laser.  In addition, there are no published clinical studies reporting on the long-term outcomes of individuals with mucosal hypertrophy that have been treated with RFVTR.

2. Aetna considers RFVTR of the turbinates for treatment of obstructive sleep apnea experimental and investigational. 

3. Aetna considers RFVTR of turbinates for snoring not medically necessary. See CPB 004 - Obstructive Sleep Apnea.

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 electrocautery 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."

Although recent studies suggest that radiofrequency tissue ablation may be effective in treating chronic nasal obstruction and refractory allergic rhinitis, these findings need to be validated by randomized, controlled studies with larger sample size and longer follow-up.

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 (i) radiofrequency tissue ablation, (ii) laser ablation, and (iii) 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 two main drawbacks of this study: (i) the 19 patients represented a long-term follow-up rate of 68 % (19/28), which may have introduced bias; and (ii) 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.