CAM 701105

Balloon Sinuplasty for Treatment of Chronic Sinusitis

Category:Surgery   Last Reviewed:September 2019
Department(s):Medical Affairs   Next Review:September 2020
Original Date:September 2007    

Description:
Balloon ostial dilation (also known as balloon sinuplasty) is proposed as an alternative to traditional endoscopic sinus surgery for patients with chronic rhinosinusitis who fail medical management. The procedure involves placing a balloon in the sinus ostium and inflating the balloon to stretch the opening. It can be performed as a stand-alone procedure or as an adjunctive procedure to functional endoscopic sinus surgery (FESS).

For individuals with chronic rhinosinusitis who receive balloon ostial dilation as a stand-alone procedure, the evidence includes systematic reviews and randomized controlled trials (RCTs). Relevant outcomes are symptoms, change in disease status, quality of life, treatment-related morbidity. The available systematic reviews (including a Cochrane review and a TEC Assessment) have concluded that, although nonrandomized evidence has suggested balloon ostial dilation has similar outcomes to FESS, evidence from randomized trials is needed to demonstrate an improvement in outcomes for patients treated with balloon ostial dilation. Since publication of the systematic reviews, an additional RCT (REMODEL) has been published. It assessed 105 patients, reporting short-term improvement in symptoms similar to those seen with FESS and potential advantages for balloon ostial dilation on postoperative recovery time and pain medication use. Limitations of the REMODEL trial include its unblinded design, lack of blinded outcome assessment across the range of outcome measures, and differential dropout between groups. Other trials have provided limited additional evidence.

For individuals with chronic rhinosinusitis who receive balloon ostial dilation as an adjunct to FESS, the evidence includes 2 RCTs and single-arm series. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The 2 available RCTs did not report significant clinically meaningful benefits associated with the addition of balloon ostial dilation to FESS.

Background 
CHRONIC RHINOSINUSITIS
Chronic rhinosinusitis (CRS) is characterized by purulent nasal discharge, usually without fever, that persists for weeks to months. Symptoms of congestion often accompany the nasal discharge. There also may be mild pain and/or headache. Thickening of mucosa may restrict or close natural openings between sinus cavities and the nasal fossae, although symptoms vary considerably because of the location and shape of these sinus ostia.

Estimates have suggested approximately 30 million individuals in the United States suffer from CRS. Most cases are treated with medical therapy, but surgical drainage is an option for patients who fail to respond to medical therapy. Functional endoscopic sinus surgery (FESS) has become an important aspect for surgical management of chronic sinusitis, although evidence from randomized controlled trials (RCTs) is limited. For this procedure, a fiberoptic nasal endoscope is used to visualize the sinus ostia, and any obstruction found is corrected. This procedure restores patency and allows air and mucous transport through the natural ostium. Approximately 350,000 FESS procedures are done each year in the United States for CRS.

Treatment
A newer procedure, balloon ostial dilatation can be used as an alternative to FESS or as an adjunct to FESS for those with CRS. The goal of this technique, when used as an alternative to FESS, is to improve sinus drainage using a less invasive approach. When used as an adjunct to FESS, it is intended to facilitate and/or increase access to the sinuses. The procedure involves placing a guidewire in the sinus ostium, advancing a balloon over the guidewire, and then stretching the opening by inflating the balloon. The guidewire location is confirmed with fluoroscopy or with direct transillumination of the targeted sinus cavity. General anesthesia may be needed for this procedure to minimize patient movement.

The maxillary sinus creates a unique challenge. The maxillary ostia, located within the ethmoid infundibulum, often cannot be accessed transnasally without excising a portion of the uncinate process. An alternative approach to the maxillary ostia is through the sinus, via the canine fossa. A guidewire can be advanced from within the maxillary sinus to the nasal fossa. The dilating balloon can enlarge the ostia while deflecting the uncinate process.

Outcomes
To quantify the severity of CRS and to assess treatment response, various outcomes measures can be used, including patient-reported quality of life (QOL) measures, radiologic scores, and endoscopic grading.

The Lund-Mackay scoring system uses radiologist-rated information derived from computed tomography scans regarding opacification of the sinus cavities, generating a score from 0 to 12.1,2 

Several disease-specific patient-reported QOL scores have been used. Commonly used is the Sino-Nasal Outcome Test 20 (SNOT-20), which is a validated questionnaire for which patients complete 20 symptom questions on a categoric scale (0 [no bother] to 5 [worst symptoms can be]). Average rankings can be reported over all 20 symptoms, as well as by 4 subclassified symptom domains. The SNOT-22, avariation of the SNOT-20, includes 2 additional questions (“nasal obstruction” and “loss of smell and taste”). The minimal clinically important difference for the SNOT-22 has been estimated to be 8.9 points.3 

Additionally, QOL may be reported based on overall health-related QOL scores, such as the 36-Item Short-Form Health Survey-36 (SF-36). The SF-36 includes 8 scaled scores on various health domains, which are transformed into a 0-to-100 scale (100 corresponding to best health).

Regulatory Status
In 2008, the Relieva™ Sinus Balloon Catheter (Acclarent, Menlo Park, CA) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. FDA determined that this device was substantially equivalent to existing devices for use in dilating the sinus ostia and paranasal spaces in adults and maxillary sinus spaces inchildren. Subsequent devices developed by Acclarent have also been cleared by FDA through the 510(k) process. They include the Relieva Spin Sinus Dilation System® (cleared in 2011) and the Relieva Seeker Balloon Sinuplasty System® (cleared in 2012).

In 2008, the FinESS™ Sinus Treatment (Entellus Medical, Maple Grove, MN) was cleared for marketing by FDA through the 510(k) process. The indication noted is to access and treat the maxillary ostia/ethmoid infundibulum in adults using a transantral approach (FDA product code: EOB). The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. Two other balloon sinus ostial dilation devices, the ENTrigue® Sinus Dilation System (ENTrigue Surgical, acquired by more recently by Smith & Nephew), and the XprESS™ Multi-Sinus Dilation Tool, also received 510(k) clearance in 2012.

In 2013, a sinus dilation system (Medtronic Xomed, Jacksonville, FL), later named the NuVent™ EM Balloon Sinus Dilation System, was cleared for marketing by FDA through the 510(k) process for use in conjunction with a Medtronic computer-assisted surgery system when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone, or cartilaginous tissue surrounding the drainage pathways of the frontal, maxillary, or sphenoid sinuses.

Also in 2013, a sinus dilation system (Smith & Nephew), later named the Ventera™ Sinus Dilation System, was cleared for marketing through the 510(k) process to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a transnasal approach.

Table 1 summarizes the currently FDA cleared balloon sinus dilation devices.

FDA product code: LRC.

Table 1. Balloon Ostial Dilation Devices Cleared by the US Food and Drug Administration

Device

Manufacturer

510(k) No.

Date Cleared

Indication

MESIRE - Balloon Sinus Dilatation System

 Meril Life Sciences  

K172737

12/12/2017

Sinus Ostia Dilation

Relieva SpinPlus Nav Balloon Sinuplasty System

Acclarent Inc.

K171687

9/5/2017

Sinus Ostia Dilation

XprESS ENT Dilation System

Entellus Medical Inc.

K163509

4/5/2017

Sinus Ostia Dilation

Relieva UltirraNav Sinus Balloon Catheter

Acclarent Inc.

K161698

10/24/2016

Sinus Ostia Dilation

Vent-Os Sinus Dilation Family

Sinusys Corp.

K160770

6/29/2016

Sinus Ostia Dilation

Relieva Scout Multi-Sinus Dilation System

Acclarent Inc.

K153341

2/12/2016

Sinus Ostia Dilation

XprESS Multi-Sinus Dilation System

Entellus Medical Inc.

K152434

11/20/2015

Sinus Ostia Dilation

DSS Sinusplasty Balloon Catheter

Intuit Medical Products LLC

K143738

8/27/2015

Sinus Ostia Dilation

Relieva SpinPlus Balloon Sinuplasty System

Acclarent Inc.

K143541

4/22/2015

Sinus Ostia Dilation

XprESS Multi-Sinus Dilation Tool

Entellus Medical Inc.

K142252

10/17/2014

Sinus Ostia Dilation

Relieva Scout Multi-Sinus Dilation System

Acclarent Inc.

K140160

2/20/2014

Sinus Ostia Dilation

Policy: 
The use of balloon ostial dilation, e.g., Balloon Sinuplasty TM, for the treatment of chronic rhinosinusitis (CRS) may be considered medically necessary, only in the affected sinus(es) with demonstrated disease, only when all of the following criteria are met: 

  1. Medical record documentation of persistent, continuous inflammation of the paranasal sinuses (frontal, maxillary, and/or frontal) for 12 weeks or longer
  2. At least one of the following has persisted for 12 weeks or longer
    • Anterior or posterior mucopurulent nasal discharge
    • Nasal obstruction
    • Facial pain, pressure or fullness
  3. The individual has radiological evidence (computed tomography) of at least one of the following:
    • Air fluid levels
    • Mucosal thickening of > 2mm
    • Sinus opacification
  4. The individual has been tested for allergies and any contribution of allergies to persistent CRS has been comprehensively managed, including but not limited to, allergy immunotherapy.
  5. Medical record documentation of failed medical therapy and persistent symptoms  for 12 weeks or longer, including but not limited to, the following:
    • At least two full courses of antibiotic therapy guided by culture and sensitivity
    • Intra-nasal corticosteroids
    • Antihistamine spray and/or decongestants 

Balloon sinus ostial dilation used as an adjunct during functional endoscopic sinus surgery (FESS) is considered integral to the primary FESS procedure and is not additionally or separately reimbursed. 

Balloon sinuplasty is not medically necessary in the following circumstances

  • The treatment of ethmoid disease
  • The presence of sinonasal polyps
  • Extensive previous surgery with significant osteoneogenesis 

Policy Guidelines
There are specific category I CPT codes for these procedures (31295-31297). These codes may be used to describe balloon sinus ostial dilation when no other surgical intervention has been performed on the same sinus site.

This procedure might also be coded as an unlisted sinus procedure (31299). It could be submitted alone or with other nasal/sinus endoscopy codes. 

If balloon sinus ostial dilation is performed with cutting tools such as curettes and forceps, the procedure might use the CPT codes for nasal/sinus endoscopy with maxillary antrostomy (31256), nasal/sinus endoscopy with frontal sinus exploration (31276), or nasal/sinus endoscopy with sphenoidectomy (31287). Plans should be aware of these possibilities. In those instances, the balloon dilation would be considered inclusive/incidental to the procedure.

In the Medicare outpatient hospital setting, HCPCS code C1726 may be used for the device.   

Benefit Application:
BlueCard®/National Account Issues

State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale
Balloon sinus ostial dilation can be performed as a stand-alone procedure or as an adjunct to functional endoscopic sinus surgery (FESS). When performed in combination with FESS, it is sometimes referred to as a hybrid procedure because there are elements of both balloon sinus ostial dilation and FESS.

Controlled trials are essential in determining the efficacy of this procedure in relation to alternatives. The natural history of the disorder includes resolution with medical therapy or no therapy in a large proportion of patients. Medical therapy is effective at reducing symptoms for most patients, and because surgical treatment is an invasive procedure with its own set of risks, it is appropriate to seek demonstration of improved outcomes with surgical therapy in direct comparison with medical therapy controls. Therefore, this review has focused on randomized controlled trials (RCTs) and systematic reviews of RCTs or studies that report on long-term follow-up.

The primary outcome measures relevant for the treatment of chronic rhinosinusitis (CRS) are patientreported symptoms and quality of life (QOL). Studies should predefine responder criteria for whatever outcome measures are used and assess between-group differences in the proportion of patients considered responders. Examiner evaluation of the nasal and sinus appearance and polyp size may provide some information about treatment outcomes, but these evaluations are limited by the lack of universally accepted standards.

The literature consists of a few small RCTs, a small number of non-RCTs, and a larger number of singlearm case series, most of which are retrospective. This evidence is reviewed next, with emphasis on the available controlled trials, in 2 categories: (1) balloon ostial dilation as a stand-alone procedure and (2) balloon ostial dilation as an adjunct to FESS. The following is a summary of the key literature evidence to date. 

BALLOON OSTIAL DILATION AS A STAND-ALONE OR ADJUNCT PROCEDURE
Systematic Reviews
A 2012 TEC Assessment on balloon ostial dilation for treatment of CRS reviewed evidence from 1 RCT, 3 nonrandomized comparative studies, and 9 case series.4 The TEC Assessment concluded that the evidence was insufficient to determine the effect of the technology on health outcomes. One RCT comparing balloon sinus ostial dilation with FESS was inadequately powered and did not evaluate differences in outcomes between the 2 treatments. While most nonrandomized comparative studies of balloon sinus ostial dilation and FESS showed no difference in health outcomes between 2 treatments, confounding factors may have biased the comparisons. Several case series showed improvement in symptoms of rhinosinusitis over baseline measures, and such improvement appeared durable up to 2 years. Case series did not allow conclusions on the comparative efficacy of balloon sinus ostial dilation to FESS. 

A 2011 Cochrane review assessed the literature on balloon sinus ostial dilation for CRS.5 Reviewers concentrated on RCTs, and included the Plaza et al. (2011) RCT6 as the sole controlled trial that met selection criteria. Reviewers rated this study as having a low risk of bias for most parameters, but a high risk of bias in reporting outcomes. They noted that symptom scores were not presented systematically and that details of statistical testing were not reported. Reviewers’ overall conclusion was that there is no convincing evidence supporting the use of balloon sinus ostial dilation in CRS. 

In 2016, Levy et al. reported on a systematic review and meta-analysis of studies of paranasal balloon ostial dilation for CRS.7 Reviewers included 17 studies, with 3 RCTs (Achar et al. [2012],8 Bikhazi et al. [2014],9 Cutler et al. [2013]10). Two RCTs reported on change score differences for the Sino-Nasal Outcome Test 20 (SNOT-20) between patients treated with balloon ostial dilation and with FESS (n=110; standard mean difference, -0.42; 95% confidence interval [CI], -1.39 to 0.55; I2=76%). There were improvements in SNOT-20 scores and sinus opacification after balloon ostial dilation. 

In 2011, Batra et al. performed a comprehensive review of the literature on balloon catheter technology in rhinology.11 They included observational cohort studies that provided relatively less evidence about the efficacy of balloon ostial dilation. Reviewers concluded that prospective RCTs comparing FESS with balloon catheter technology were needed. 

BALLOON OSTIAL DILATION AS A STAND-ALONE PROCEDURE VS FESS ALONE
Randomized Controlled Trials
REMODEL Trial
The REMODEL study was an industry-sponsored RCT (Cutler et al., 2013) that compared balloon ostial dilation as a stand-alone procedure with FESS.10 A total of 105 patients with recurrent acute sinusitis or chronic sinusitis and failure of medical therapy were randomized to balloon ostial dilation or FESS.  

Balloon ostial dilation was performed with the Entellus device, which is labeled for a transantral approach.  FESS consisted of maxillary antrostomy and uncinectomy with or without anterior ethmoidectomy. Thirteen patients withdrew consent before treatment, 11 (21%) in the FESS group and 2 (4%) in the balloon ostial dilation group. The primary outcomes were the change in SNOT-20 scores at 6-month follow-up and mean number of débridements performed postoperatively. Secondary outcomes included recovery time, complication rates, and rates of revision surgery. Both superiority and noninferiority analyses were performed on these outcomes. 

Ninety-one patients were available at 6-month follow-up. The improvement in the SNOT-20 score (SD) was 1.67 in the balloon dilation group and 1.60 in the FESS arm (p=0.001 for noninferiority). Postoperative débridements were more common in the FESS group than in the balloon dilation group (1.2 in the FESS arm vs 0.1 in the balloon ostial dilation arm, p<0.001 for superiority in the FESS arm). Patients in the balloon dilation arm returned to normal daily activities faster (1.6 days vs 4.8 days, p=0.002 for superiority) and required fewer days of prescription pain medications (0.9 days vs 2.8 days,  p=0.002 for superiority). There were no major complications in either group, and 1 patient in each group required revision surgery. 

Bikhazi et al. (2014) reported 1-year follow-up from the REMODEL trial.9 Eighty-nine (96.7%) subjects were available at 1 year. Improvement in the SNOT-20 score was 1.64 in the balloon dilation arm and 1.65 in the FESS arm (p<0.001 for noninferiority). During the year postprocedure, both groups had fewer self-reported rhinosinusitis episodes (reduction in episodes, 4.2 in the balloon arm vs 3.5 in the FESS arm; p=NS).

In 2016, Chandra et al. reported results up to 2 years postprocedure for subjects in the REMODEL trial, along with an additional 30 subjects treated with FESS or in-office balloon sinus dilation, for a total of 61 FESS patients and 74 balloon sinus dilation patients.12 Follow-up data were available for 130, 66, and 25 patients at 12, 18, and 24 months, respectively. Details about group-specific treatment received and loss to follow-up were not reported for the additional 30 patients not included in the REMODEL trial. The balloon sinus dilation group required 0.2 débridements per patient compared with 1.0 per patient in the FESS group (p<0.001). Mean change in SNOT-20 score from baseline to 12-month follow-up was -1.59 (p<0.001) and -1.60 (p<0.001) for the balloon sinus dilation and FESS groups, respectively, which was considered clinically significant. These changes were maintained at 24 months. At 18 months, overall revision rates were 2.7% in the balloon dilation group and 6.9% in the FESS group. In addition to the longer term results of the REMODEL trial, this article included a meta-analysis of the REMODEL balloon dilationtreated patients and data from 5 manufacturer-sponsored trials, 3 of which had previously been reported in peer-reviewed form (BREATHE: Stankiewicz et al. [2010],13 Stankiewicz et al. [2012]14; RELIEF: Levine et al. [2013]15; XprESS Transnasal Maxillary Multi-Sinus: Gould et al. [2014]16). Across the 6 studies, 846 patients were treated with balloon sinus dilation, including 121 not described in prior publications. In a random-effects model, overall mean and subscale scores for the SNOT-20 improved compared with baseline at every follow-up time point.

Additional RCTs
Bizaki et al. (2014) reported results from an RCT that compared balloon ostial dilation to FESS among patients with symptomatic chronic or recurrent rhinosinusitis.17 The trial enrolled 46 subjects, 4 of whom withdrew; the analysis included 42 patients (n=21 in each group; statistical power calculations reported). Both groups demonstrated significant improvements in SNOT-22 scores from baseline to postprocedure. There were no differences in change in total SNOT-22 scores between groups at 3 months postprocedure. As a 2016 follow-up publication, trialists reported on nasal airway resistance and sinus symptoms between FESS- and balloon ostial dilation-treated groups.18 For this analysis, 62 patients were included (32 from the FESS group, 30 from the balloon dilation group). Patients in the balloon ostial dilation group had significant improvements in nasal volume from pre- to postoperative measurements, but there were no significant differences between groups pre- or postoperatively in nasal volume. 

Another RCT by Bizaki et al. (2016) compared balloon ostial dilation to FESS, with a focus on mucociliary clearance.19 It was conducted at the same institution as the previously reported Bizaki RCT; however, this RCT did not specify whether it was conducted in the same set of patients. This trial enrolled 36 patients who were randomized to balloon ostial dilation (n=17) or to FESS (n=19); 7 patients dropped out (3 in the FESS group, 4 in the balloon dilation group) and were not included in analyses. SNOT-22 scores improved in both groups from pre- to postoperative analyses. However, changes in total SNOT-22 scores did not differ significantly between groups. There was no significant change in mucociliary clearance before and after either treatment, nor was there a significant between-group difference in mucociliary clearance. 

Marzetti et al. (2014) reported results from a small RCT that compared balloon ostial dilation using an unspecified device (or devices) to FESS in the treatment of sinus headache.20 The trial included 83 patients with sinus headache, based on American Academy of Otolaryngology‒Head and Neck Surgery definitions, 44 randomized to conventional endoscopic sinus surgery (ESS) and 35 to balloon ostialdilation. In the balloon dilation group, 23 patients were “only frontal sinus balloon” patients, in which balloon catheters were the only tools used for frontal sinus sinusotomy, and 12 were “hybrid,” in which balloon catheters and traditional ESS were used concurrently. It was not specified how patients were selected for these groups. At 6-month follow-up, SNOT-22 scores improved from 28.6 (baseline) to 7.8 in the ESS group and from 27.3 (baseline) to 5.3 in the balloon dilation group; improvements in both groups were statistically significant (p<0.001).

An RCT from Turkey, published in 2011, reported on physiologic outcomes.21 Twenty patients were randomized to removal of the uncinate process via FESS or to balloon sinus ostial dilation as a stand-alone procedure. The main outcome measures were CO2 concentration in the sinuses and maximum sinus pressure, both intended as surrogate measures for sinus ventilation. The CO2 concentration decreased in both study arms to a similar degree. The maximum sinus pressure decreased in the FESS group but did not change in the balloon sinus ostial dilation group. 

Another RCT was published by Achar et al. in 2012.8 It enrolled 24 patients with CRS who had failed medical therapy and were scheduled for surgery. Patients were randomized to balloon dilation or to FESS and followed for 24 weeks. The primary outcome measures were changes in SNOT-20 scores and clearance time using the saccharin test. Both groups improved significantly on both measures. The degree of improvement was greater for the balloon dilatation group than for the FESS group on both the SNOT-20 score (43.8 vs 29.7, p<0.03) and on the saccharin test score (7.5 vs 3.5, p=0.03). Adverse events were not reported.

Bozdemir et al. (2011) published a small study of 10 patients with nasal polyposis, in which 1 nasal passage was treated with FESS and the other with balloon sinus ostial dilation.22 All procedures were performed by the same surgeon, and polypectomy was performed before FESS or balloon sinus ostial dilation in all patients. Outcome measures included sinus patency, as measured by computed tomography (CT) scan (Lund-Mackay classification) or repeat endoscopy (Mackay grading). At 10 days postprocedure, there were improvements in both groups on measures of patency, but no differences between groups. 

Nonrandomized Comparative Studies
A large number of nonrandomized comparative studies have evaluated balloon ostial dilation.23-27 Given the availability of RCT evidence, these studies do not provide significant additional evidence on the efficacy of balloon ostial dilation. 

Section Summary: Balloon Ostial Dilation as a Stand-Alone Procedure vs FESS Alone
A number of randomized trials have compared balloon ostial dilation as a stand-alone procedure to FESS. These trials have generally reported that short-term outcomes with balloon ostial dilation are similar to those with FESS. Only 1 RCT, the REMODEL trial (105 patients randomized), was likely to have adequate power to detect group differences. It reported the noninferiority for the change in SNOT-20 scores and the superiority for balloon ostial dilation on postoperative recovery and pain medication use. The trial had methodologic limitations, including lack of blinded outcome assessment and differential dropout rates. This evidence shows some support for balloon ostial dilation as an alternative to FESS in patients with CRS, but it is limited.

BALLOON OSTIAL DILATION AS AN ADJUNCT TO FESS VS FESS ALONE
Two RCTs identified have evaluated the incremental benefit of balloon ostial dilation to FESS compared with FESS alone.

Hathorn et al. (2015) reported results of a single-blinded, randomized trial of balloon dilation with the Ventera Sinus Dilation System as an adjunct to frontal sinusotomy (Draf IIA) in which each patient served is his or her own control.28 The Draf IIA procedure involves a more extensive drainage procedure with resection of the floor of the frontal sinus. Thirty patients with CRS were randomized to right or left balloon sinus dilation in conjunction with frontal sinusotomy. Both groups had high (30/30) rates of sinus ostia patency at 3 months postprocedure. Several procedure-related factors differed between groups: the hybrid (balloon sinuplasty) procedures were significantly shorter (655 seconds vs 898 seconds; 95% CI for difference, 30.9 to 454.4 seconds; p=0.03) and associated with less estimated blood loss (53 mL vs 91 mL; 95% CI for difference, 8.8 to 57.5 mL; p=0.008). 

A double-blinded RCT of balloon sinus ostial dilation as an adjunct to FESS versus FESS alone was published by Plaza et al. in 2011.6 This trial enrolled 34 patients with CRS who were refractory to intensive medical management. Patients were randomized to a “hybrid approach” that included balloon sinus ostialdilation of the affected frontal recess along with traditional FESS of other paranasal sinuses, or to traditional FESS with the Draf I procedure. In both groups, an anterior ethmoidectomy was performed. A posterior ethmoidectomy and/or sphenoidotomy were performed as required by intraoperative assessment in both groups. Outcome measures at 12-month follow-up included symptoms, the Rhinosinusitis Disability Index, CT results of sinus patency, and the permeability of the frontal recess, as assessed by office endoscopy. There was 1 dropout in each group, leaving 16 patients per group for analysis. For both groups, there were improvements in symptoms, standardized rhinosinusitis scoring indices, and CT patency, but no differences between groups. Rates for the 12-month outcome of endoscopic patency were 73% in balloon sinus ostial dilation patients and 63% in FESS patients. The published study contained contradictory statements on whether this difference was statistically significant. The lead author of this study clarified that the difference reported in the results for endoscopic patency was not statistically significant (G. Plaza, personal communication, April 2012). There were no major complications reported. 

Section Summary: Balloon Ostial Dilation as an Adjunct to FESS vs FESS Alone
Two RCTs evaluating balloon ostial dilation as an adjunct to FESS were identified. Both suggested that the addition of balloon ostial dilation to traditional procedures can be done without adverse effects. One trial reported improved procedure times and less blood loss with balloon ostial dilation, although it is not clear whether the procedure time and blood loss were evaluated by a blinded observer. Both trials reported no significant differences between the hybrid and standard approaches in terms of sinus ostia patency. 

BALLOON OSTIAL DILATION AS A STAND-ALONE OR ADJUNCT PROCEDURE
Single-Arm Studies
Some single-arm studies have reported follow-up beyond 2 years for balloon ostial dilation and are described here. Bolger and Vaughan (2007) reported on outcomes at 24 weeks from a prospective, multicenter study of balloon sinus ostial dilation.29 In this study, 115 patients, for whom FESS was recommended, received treatment with the balloon catheter. Sinusotomy was attempted in 358 sinuses, and cannulation was successful in 347. Ostia patency rates were assessed at weeks 1, 12, and 24; at 24 weeks, 304 (88%) of the 347 sinuses were evaluated. While only 5 were nonpatent, the status of 18% was reported as indeterminate. Patients’ symptoms as measured by SNOT-20 scores also improved posttreatment. The device malfunctioned in 12 (3.4%) of 358 cases, the balloon ruptured in 7 cases, and the catheter tip malfunctioned in 4 cases. The authors indicated that there were no serious adverse events.

Additional follow-up to 2 years has been reported for a subset of the 115 patients in the previous study.30,31 At the 1-year follow-up, 70 (61%) of the 115 patients remained in the study.30 Of the 66 patients who had follow-up nasal endoscopy, 85% of sinus ostia were patent; however, by adding results of CT scans showing improvement, 92% were judged to have functional patency. The report on clinical symptoms with 2-year follow-up involved a similar subset of patients (N=65).31 In this longer term study, in which 34 patients had only balloon treatment, 85% of patients had improved symptoms. Revision treatment was required in 3.6% of sinuses involving 6 (9%) of 65 patients. 

A second prospective multicenter, single-arm study of balloon sinus ostial dilation in refractory rhinosinusitis was published by Stankiewicz et al. in 2010.13 They reported 1-year follow-up data of the Balloon Remodeling Antrostomy Therapy (BREATHE I) study. In it, 30 patients received balloon dilation of the ethmoid infundibulum using the FinESS system, a transantral dilation approach via the canine fossa. The primary outcome measure was patient-reported QOL measured using the SNOT-20. Average overall symptom score at baseline was 2.9. At 3, 6, and 12 months postintervention, average overall symptom scores were 0.7, 0.8, and 0.8, respectively. 

Two-year results from the BREATHE study were reported in 2012.14 At that time, 59 patients were treated with balloon sinus ostial dilation, with a mean follow-up of 27 months. Mean SNOT-20 scores (SD) improved from 2.65 at baseline to 0.79 at the longest follow-up. This report also discussed measures of functional impairment using the Work Limitation Questionnaire (WLQ) and the Work Productivity and Activity Impairment Questionnaire (WPAI). Mean scores on the WLQ for overall productivity loss decreased from 8% at baseline to 2.5% at longest follow-up (estimates from graphical representation), and this pre- and postchange was statistically significant (p<0.001). Similar improvements were reported on other parameters of the WLQ and WPAI. 

Series with shorter follow-up have also been published. For example, Soler et al. (2016) reported results of a single-arm study evaluating stand-alone balloon sinus dilation for CRS in children ages 2 to 21 years.32 At 6-month follow-up, results of the Sinus and Nasal Quality of Life Survey were significantly improved compared with baseline (p<0.001). 

SUMMARY OF EVIDENCE
For individuals with chronic rhinosinusitis who receive balloon ostial dilation as a stand-alone procedure, the evidence includes systematic reviews and randomized controlled trials (RCTs). Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The available systematic reviews (including a Cochrane review and a TEC Assessment) have concluded that, although nonrandomized evidence has suggested balloon ostial dilation has similar outcomes to functional endoscopic sinus surgery (FESS), evidence from randomized trials is needed to demonstrate an improvement in outcomes for patients treated with balloon ostial dilation. Since publication of the systematic reviews, an additional RCT (REMODEL) has been published. It assessed 105 patients, reporting short-term improvement in symptoms similar to those seen with FESS and potential advantages for balloon ostial dilation on postoperative recovery time and pain medication use. Limitations of the REMODEL trial include its unblinded design, lack of blinded outcome assessment across the range of outcome measures, and differential dropout between groups. Other trials have provided limited additional evidence. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with chronic rhinosinusitis who receive balloon ostial dilation as an adjunct to FESS, the evidence includes 2 RCTs and single-arm series. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The 2 available RCTs did not report significant clinically meaningful benefits associated with the addition of balloon ostial dilation to FESS. The evidence is insufficient to determine the effects of the technology on health outcomes. 

INPUT FROM PHYSICIAN SPECIALTY SOCIETIES AND ACADEMIC MEDICAL CENTERS
While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2013 Input
In response to requests, input was received from 2 specialty societies and 6 academic medical centers while this policy was under review in 2013. The overall input was mixed on whether balloon ostial dilation should be medically necessary, either as a stand-alone procedure or as an adjunct to functional endoscopic sinus surgery (FESS). There was no consensus on subpopulations of patients with chronic rhinosinusitis who might benefit from balloon ostial dilation. There was consensus that randomized controlled trials should compare balloon ostial dilation with standard care in order to determine efficacy.

2011 Input
In response to requests, input was received from 2 physician specialty societies and 6 academic medical centers while this policy was under review in 2011. Input was mixed. A number of reviewers agreed that balloon ostial dilation was investigational. These reviewers commented about the need for additional trials to compare outcomes with standard approaches. Comments were made on the lack of selection criteria for use of the balloon catheter. Reviewers also noted that the current studies do not permit separating the results for use of the balloon ostial dilation from concurrent FESS, because most studies used both techniques.

2008 Input
In response to requests, input was received from 2 physician specialty societies and 2 academic medical centers while this policy was under review in 2008. Input from 1 specialty society did not specifically address the clinical aspects of balloon ostial dilation but made comments related to coding. Another specialty society noted concerns due to lack of controlled studies and also commented that the long-term objective follow-up (e.g., computed tomography scans) was on a limited number of patients. Input from 2 academic centers indicated this treatment was not investigational but should be viewed as another surgical tool for the treatment of chronic sinusitis.

PRACTICE GUIDELINES AND POSITION STATEMENTS
National Institute for Health and Care Excellence
A 2008 guidance on balloon catheter dilation of paranasal sinus ostia from the National Institute for Health and Care Excellence (NICE) has stated : “Current evidence on the short-term efficacy of balloon catheter dilation of paranasal sinus ostia for chronic sinusitis is adequate and raises no major safety concerns. Therefore, this procedure can be used provided that normal arrangements are in place for clinical governance, consent and audit.”33 In 2016, NICE published a recommendation on the use of the XprESS Multi-Sinus Dilation System for the treatment of chronic rhinosinusitis34:

  1. “The case for adopting the XprESS multi -sinus dilation system for treating uncomplicated chronic sinusitis after medical treatment has failed is supported by the evidence. Treatment with XprESS leads to a rapid and sustained improvement in chronic symptoms, fewer acute episodes and improved quality of life which is comparable to functional endoscopic sinus surgery (FESS).
  2. XprESS should be considered in patients with uncomplicated chronic sinusitis who do not have severe nasal polyposis. In these patients, XprESS works as well as FESS, is associated with faster recovery times, and can more often be done under local anaesthesia.”  

American Academy of OtolaryngologyHead and Neck Surgery 
In July 2016, the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) Foundation updated its statement on balloon ostial dilation, reaffirming its 2010 position statement: “Sinus ostial dilationis a therapeutic option for selected patient with chronic rhinosinusitis…. This approach may be used alone ... or in conjunction with other instruments.”35

In 2015, the AAO-HNS Foundation updated its 2007 clinical practice guidelines on adult sinusitis, which do not discuss surgical therapy or use of balloon sinuplasty.36 

American Rhinologic Society
A position statement, revised in 2015, from the American Rhinologic Society, stated that sinus ostial dilation is “an appropriate therapeutic option for selected patients with sinusitis.”37 

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
Not applicable. 

ONGOING AND UNPUBLISHED CLINICAL TRIALS
Some currently unpublished trials that might influence this review are listed in Table 1. 

Table 1. Summary of Key Trials

NCT No. Trial Name Planned Enrollment Completion Date
Ongoing

NCT01714687a

Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)

400 Apr 2016 (ongoing)
Unpublished

NCT01990820

Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty

48 Mar 2016 (unknown)

 NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.

References:       

  1. Hopkins C, Browne JP, Slack R, et al. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. Oct 2007;137(4):555-561. PMID 17903570
  2. Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg. Sep 1997;117(3 Pt 2):S35-40. PMID 9334786
  3. Hopkins C, Gillett S, Slack R, et al. Psychometric validity of the 22-item Sinonasal Outcome Test. Clin Otolaryngol. Oct 2009;34(5):447-454. PMID 19793277
  4. Blue Cross and Blue Shield Association Technology Evaluation Center Program. Balloon Ostial Dilation for Treatment of Chronic Rhinosinusitis. TEC Assessments 2012;27:Tab 9. PMID
  5. Ahmed J, Pal S, Hopkins C, et al. Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis. Cochrane Database Syst Rev. Jul 6 2011(7):CD008515. PMID 21735433
  6. Plaza G, Eisenberg G, Montojo J, et al. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. Aug 2011;120(8):511-518. PMID 21922974
  7. Levy JM, Marino MJ, McCoul ED. Paranasal sinus balloon catheter dilation for treatment of chronic rhinosinusitis: a systematic review and meta-analysis. Otolaryngol Head Neck Surg. Jan 2016;154(1):33-40. PMID 26519456
  8. Achar P, Duvvi S, Kumar BN. Endoscopic dilatation sinus surgery (FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of chronic rhinosinusitis: a pilot study. Acta Otorhinolaryngol Ital. Oct 2012;32(5):314-319. PMID 23326011
  9. Bikhazi N, Light J, Truitt T, et al. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. Jul 2014;28(4):323-329. PMID 24823902
  10. Cutler J, Bikhazi N, Light J, et al. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. Sep-Oct 2013;27(5):416-422. PMID 23920419
  11. Batra PS, Ryan MW, Sindwani R, et al. Balloon catheter technology in rhinology: reviewing the evidence. Laryngoscope. Sep 7 2011;121(1):226-232. PMID 20824793
  12. Chandra RK, Kern RC, Cutler JL, et al. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. Jan 2016;126(1):44-50. PMID 26228589
  13. Stankiewicz J, Truitt T, Atkins J, Jr. One-year results: Transantral balloon dilation of the ethmoid infundibulum. Ear Nose Throat J. Feb 2010;89(2):72-77. PMID 20155675
  14. Stankiewicz J, Truitt T, Atkins J, et al. Two-year results: transantral balloon dilation of the ethmoid infundibulum. Int Forum Allergy Rhinol. May-Jun 2012;2(3):199-206. PMID 22337530
  15. Levine SB, Truitt T, Schwartz M, et al. In-office stand-alone balloon dilation of maxillary sinus ostia and ethmoid infundibula in adults with chronic or recurrent acute rhinosinusitis: a prospective, multi-institutional study with-1-year follow-up. Ann Otol Rhinol Laryngol. Nov 2013;122(11):665-671. PMID 24358625
  16. Gould J, Alexander I, Tomkin E, et al. In-office, multisinus balloon dilation: 1-Year outcomes from a prospective, multicenter, open label trial. Am J Rhinol Allergy. Mar-Apr 2014;28(2):156-163. PMID 24598043
  17. Minni A, Dragonetti A, Sciuto A, et al. Use of balloon catheter dilation vs. traditional endoscopic sinus surgery in management of light and severe chronic rhinosinusitis of the frontal sinus: a multicenter prospective randomized study. Eur Rev Med Pharmacol Sci. Jan 2018;22(2):285-293. PMID 29424885
  18. Bizaki AJ, Taulu R, Numminen J, et al. Quality of life after endoscopic sinus surgery or balloon sinuplasty: a randomized clinical study. Rhinology. Dec 2014;52(4):300-305. PMID 25479206
  19. Bizaki AJ, Numminen J, Taulu R, et al. Decrease of nasal airway resistance and alleviations of symptoms after balloon sinuplasty in patients with isolated chronic rhinosinusitis: a prospective, randomised clinical study. Clin Otolaryngol. Dec 2016;41(6):673-680. PMID 26548697
  20. Bizaki AJ, Numminen J, Taulu R, et al. A controlled, randomized clinical study on the impact of treatment on antral mucociliary clearance: uncinectomy versus balloon sinuplasty. Ann Otol Rhinol Laryngol. May 2016;125(5):408-414. PMID 26611244
  21. Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngol Pol. Jan-Feb 2014;68(1):15-19. PMID 24484944
  22. Kutluhan A, Salviz M, Bozdemir K, et al. The effects of uncinectomy and natural ostial dilatation on maxillary sinus ventilation: a clinical experimental study. Eur Arch Otorhinolaryngol. Apr 2011;268(4):569-573. PMID 21110035
  23. Bozdemir K, Kutluhan A, Cetin H, et al. Comparison of outcomes of simple polypectomy plus balloon catheter dilatation versus functional endoscopic sinus surgery in nasal polyposis: a preliminary study. Am J Rhinol Allergy. May-Jun 2011;25(3):198-200. PMID 21679533
  24. Bolger WE, Brown CL, Church CA, et al. Safety and outcomes of balloon catheter sinusotomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg. Jul 2007;137(1):10-20. PMID 17599558
  25. Kuhn FA, Church CA, Goldberg AN, et al. Balloon catheter sinusotomy: one-year follow-up--outcomes and role in functional endoscopic sinus surgery. Otolaryngol Head Neck Surg. Sep 2008;139(3 Suppl 3):S27-37. PMID 18707992
  26. Weiss RL, Church CA, Kuhn FA, et al. Long-term outcome analysis of balloon catheter sinusotomy: two-year follow-up. Otolaryngol Head Neck Surg. Sep 2008;139(3 Suppl 3):S38-46. PMID 18707993
  27. Soler ZM, Rosenbloom JS, Skarada D, et al. Prospective, multicenter evaluation of balloon sinus dilation for treatment of pediatric chronic rhinosinusitis. Int Forum Allergy Rhinol. Mar 2017;7(3):221-229. PMID 27888649
  28. Hathorn IF, Pace-Asciak P, Habib AR, et al. Randomized controlled trial: hybrid technique using balloon dilation of the frontal sinus drainage pathway. Int Forum Allergy Rhinol. Feb 2015;5(2):167-173. PMID 25360863
  29. National Institute of Health and Care Excellence (NICE). Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis [IPG273]. 2008; http://www.nice.org.uk/guidance/IPG273/chapter/1-Guidance. Accessed January 23, 2019.
  30. National Institute of Health and Care Excellence (NICE). XprESS multi sinus dilation system for treating chronic sinusitis [MTG30]. 2016; https://www.nice.org.uk/guidance/mtg30. Accessed January 23, 2019.
  31. American Academy of Otolaryngology - Head and Neck Surgery. Position Statement: Dilation of sinuses, any method (e.g., balloon, etc.). 2017; https://www.entnet.org/?q=node/542. Accessed January 23, 2019.
  32. Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. Apr 2015;152(2 Suppl):S1-S39. PMID 25832968
  33. American Rhinologic Society (ARS). Ostial Balloon Dilation Position Statement. 2017; https://www.american-rhinologic.org/index.php?option=com_content&view=article&id=33:ostial-balloon-dilation-position-statement&catid=26:position-statements&Itemid=197. Accessed January 23, 2019.

 Coding Section

Codes Number Description
CPT 31299 Unlisted procedure, accessory sinuses
  31295 Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (e.g., balloon dilation), transnasal or via canine fossa
  31296 Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (e.g., balloon dilation)
  31297 Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (e.g., balloon dilation)
  31298 (effective 1/1/2018)  Nasal/sinus endoscopy, surgical; with dilation of frontal and sphenoid sinus ostia (eg, balloon dilation) 
ICD-9 Diagnosis 473.0-473.9 Chronic sinusitis code range
HCPCS C1726 Catheter, balloon dilatation, non-vascular
ICD-10-CM (effective 10/01/15)   Investigational for all relevant diagnoses
  J32.0-J32.9 Chronic sinusitis code range
ICD-10-PCS (effective 10/01/15)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.
Type of Service Surgery  
Place of Service Outpatient  

 Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

"Current Procedural Terminology© American Medical Association.  All Rights Reserved" 

History From 2014 Forward     

09/03/2019 

Annual review, no change to policy intent. Updating regulatory status and references. 

09/05/2018 

Annual review, no change to policy intent. 

01/25/2018 

Corrected formatting in Policy Section. No change to policy intent. 

01/18/2018 

Delayed annual review with major revision to policy statement and intent. Updating to have medical necessity criteria.Also updating background, description, rationale and references. 

12/05/2017

Updating policy with 2018 coding. No other changes. 

09/01/2016 

Annual review, no change to policy intent. Updating background, description, regulatory status, rationale and references. 

07/27/2015 

Annual review, no change to policy intent. Updated background, description, rationale and references. Added guidelines and coding. 

07/10/2014

Annual review. Updated description, background, rationale and references. No change to policy intent.


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