| Coverage Policy Manual | |
| Policy #: | 2006030 |
| Category: | Surgery |
| Initiated: | September 2006 |
| Last Review: | March 2024 |
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| Balloon Ostial Dilation (Balloon Sinuplasty) | |
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| Description: |
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.
Recurrent acute rhinosinusitis (RARS) is defined as 4 or more episodes per year of acute bacterial rhinosinusitis without signs or symptoms of rhinosinusitis between episodes.
Most cases of CRS and RARS are treated with medical therapy (e.g., antihistamines, steroids, nasal lavage, and antibiotics) (Rosenfeld, 2015).
Functional endoscopic sinus surgery (FESS) involves the insertion of an endoscope into the nose for a direct visual examination of the openings into the sinuses. Using the endoscope and a combination of surgical tools (e.g., curettes, forceps, powered micro-debriders, powered shavers, and/or sinus balloon catheters), surgeons enlarge the patient’s sinus openings to clear passageways in order to restore normal sinus ventilation and drainage. The goal of surgery is to improve sinus ventilation and drainage by enlarging the openings of the sinuses, removing any polyps and correcting significant structural problems that may be hindering drainage.
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.
Approximately 350,000 FESS procedures are done each year in the United States for CRS.
A newer procedure, balloon ostial dilatation can be used as an alternative or as an adjunct to FESS for those with CRS or RARS. The goal of this technique, when used as an alternative to FESS, is to improve sinus drainage using a less invasive approach. 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. According to the manufacturer, the RELIEVA SPINPLUS® Balloon Sinuplasty System is intended to: provide a means to access the sinus space and illuminate within and transilluminate across nasal and sinus structures; dilate the sinus ostia and spaces associated with the paranasal sinus cavities for diagnostic and therapeutic procedures; and irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
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 in children. Subsequent devices developed by Acclarent have also been cleared by FDA through the 510(k) process. These include the Relieva Spin Sinus Dilation System® cleared in August 2011 and the Relieva Seeker Balloon Sinuplasty System® cleared in November 2012.
In June 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 by Entellus Medical, the ENTrigue® Sinus Dilation System, (ENTrigue Surgical, which has subsequently been acquired by ArthroCare, Corporation (Austin, TX), and the XprESS™ Multi-Sinus Dilation Tool, also received 510(k) clearance in August, 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 the 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 (ArthroCare, San Antonio, TX, a division of Smith and 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. Ventera™ Sinus Dilation System does not require a guide wire or an illumination system as it is intended for use as a tool in combination with endoscopic sinus surgery (Hathorn, 2015).
FDA product code: LRC
The following is a list of Balloon Ostial Dilation Devices Cleared by the U.S. Food and Drug Administration:
Coding
Beginning in 2011, there are specific category I CPT codes for these procedures (31295-31297). These codes may be used to describe balloon sinuplasty when no other surgical intervention has been performed on the same sinus site.
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Policy/ Coverage: |
Effective June 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Use of a catheter-based inflatable device (balloon ostial dilation) for the treatment of chronic rhinosinusitis in the sinus being considered for dilation meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness when the following criteria are present:
AND
AND
AND
NOTE:
BOD used in combination with Functional Endoscopic Sinus Surgery
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of balloon ostial dilation for the treatment of chronic rhinosinusitis for any indication not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of balloon ostial dilation for the treatment of chronic rhinosinusitis for any indication not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Repeat balloon ostial dilation in any sinus does not meet benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, repeat balloon ostial dilation (sinuplasty) in any sinus, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of balloon ostial dilation for the treatment of recurrent acute rhinosinusitis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the use of balloon ostial dilation for the treatment of recurrent acute rhinosinusitis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Office-based or outpatient hospital/ambulatory balloon sinus ostial dilation (balloon sinuplasty) for all other indications, including but not limited to those listed below, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, office-based or outpatient hospital/ambulatory balloon sinus ostial dilation (balloon sinuplasty) for all other indications, including but not limited to those listed below, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to June 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Use of a catheter-based inflatable device (balloon ostial dilation) for the treatment of chronic rhinosinusitis in the sinus being considered for dilation meets primary coverage criteria when the following criteria are present:
AND
AND
AND
NOTE:
BOD used in combination with Functional Endoscopic Sinus Surgery
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of balloon ostial dilation for the treatment of chronic rhinosinusitis for any indication not described above, does not meet primary coverage criteria that there be scientific evidence of safety and effectiveness.
For members with contracts without primary coverage criteria, the use of balloon ostial dilation for the treatment of chronic rhinosinusitis for any indication not described above, is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
The use of balloon ostial dilation for the treatment of recurrent acute rhinosinusitis does not meet primary coverage criteria that there be scientific evidence of safety and effectiveness.
For members with contracts without primary coverage criteria, the use of balloon ostial dilation for the treatment of recurrent acute rhinosinusitis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to January 1, 2021
The use of balloon sinuplasty as an adjunctive procedure during functional endoscopic sinus surgery in the same sinus cavity is considered integral to the primary procedure and not reimbursable separately.
The use of a balloon sinuplasty as a stand-alone procedure for treatment of sinusitis or the use of balloon sinuplasty in all other diagnoses and situations does not meet primary coverage criteria that there be scientific evidence of safety and effectiveness.
For contracts without primary coverage criteria, the use of a balloon sinuplasty as a stand-alone procedure for treatment of sinusitis or the use of balloon sinuplasty in all other diagnoses and situations is considered investigational and is not covered. Investigational services are exclusions in the member benefit contract.
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| Rationale: |
“Due to the detail of the rationale, the complete document is not online. If you would like a hardcopy print, please email: codespecificinquiry@arkbluecross.com”
2020 Update
A literature search was conducted through May 2020. The key identified literature is summarized below.
Levy et al conducted a systematic review and meta-analysis of BOD for CRS (Levy, 2016). Studies of balloon ostial dilation in combination with FESS were included if they reported data on subgroups of patients undergoing BOD as a standalone procedure. Reviewers included 17 studies; 11 of these provided data for meta-analysis. Two RCTs were included. The other studies were prospective or retrospective observational studies.
Change from baseline in quality of life, as measured by SNOT-20 scores was clinically and statistically significant in patients who received BOD. Secondary outcome measures of postoperative complications, debridements, and revision surgery were heterogeneously reported without the consistency or power needed to make statistically valid comparisons. The reviewers concluded that BOD for the treatment of CRS in the reported study population had positive impact on patient quality of life as assessed by a validated measurement. Improvements exceeded the threshold of 0.8 and could be considered clinically significant. The reviewers also concluded that additional information was needed to determine the role of BOD in specific patient populations such as those with moderate to advanced sinus disease, to compare the incidence of postoperative complications and debridements in patients who receive BOD compared with FESS, and additional study of patients outcomes following BOD in the operating room versus the office setting.
BOD as a standalone procedure for patients with CRS has been evaluated in 4 RCTs reported in 6 publications. Two studies were published after the systematic review conducted by Levy et al (Chandra, 2016; Minni, 2018).
The largest RCT is the REMODEL (randomized evaluation of maxillary antrostomy versus ostial dilation efficacy through long‐term follow‐up) trial. REMODEL results at 6, 12, and 24 months have been reported in 3 publications (Cutler, 2013; Bikhazi, 2014; Chandra, 2016). This was an industry-sponsored RCT that compared BOD as a stand-alone procedure with FESS. A total of 105 patients with CRS or RARS and failure of medical therapy were randomized to BOD or FESS. Patients with gross sinonasal polyposis were excluded. 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 BOD group. The primary outcomes were the change in SNOT-20 scores at 6-month follow-up and mean number of postoperative debridements. Secondary outcomes included recovery time, complication rates, and rates of revision surgery. Noninferiority analysis was performed for the primary outcome of change in symptom score and superiority analyses was performed on the debridement outcome.
Ninety-one patients who were enrolled in REMODEL were available at 6-month follow-up (Cutler, 2013). The improvement in the mean SNOT-20 score was 1.67 (1.10) in the balloon dilation group and 1.60 (0.96) in the FESS arm (P =.001) for noninferiority. Postoperative debridements were more likely in the FESS group with a mean of 1.2 (1.0) compared to a mean of 0.1(0.6) in the balloon dilation group ( P <.001) for superiority in the balloon arm). Patients in the BOD arm returned to normal daily activities faster (1.6 days vs 4.8 days, P =.002 for superiority) and required fewer days of prescription pain medications (0.9 days vs 2.8 days, P =.002 for superiority) with balloon dilation. There were no major complications in either group, and 1 patient in each group required revision surgery.
Bikhazi et al reported 1-year follow-up from the REMODEL trial (Bikhazi, 2014). Eighty-nine (96.7%) subjects were available at 1 year. Improvement in the mean SNOT-20 score was 1.64 in the balloon dilation arm and 1.65 in the FESS arm (P <.001 for noninferiority). During the year postprocedure, both groups had fewer self-reported rhinosinusitis episodes (mean reduction in episodes, 4.2 in the balloon arm vs 3.5 in the FESS arm; P <.001).
Final REMODEL results were reported in Chandra et al (Chandra, 2016). This publication included 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 reported total of 61 FESS patients and 74 BOD patients. 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 BOD group required 0.2 debridements per patient compared with 1.0 per patient in the FESS group (P <.001). Mean change in SNOT-20 score from baseline to 12-month follow-up was -1.59 (P <.001) and -1.60 (P <.001) for the BOD 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 REMODEL, three smaller RCTs provide evidence on the comparison of BOD to FESS in patients with CRS.
Minni et al published a prospective, randomized study comparing BOD and traditional endoscopic sinus surgery (ESS) for CRS of the frontal sinuses (Minni, 2018). At three Italian hospitals, 102 individuals (148 sinuses) were enrolled with mild involvement of the frontal sinus, the average post-procedure SNOT-20 scores for the BOD and ESS groups were 24.6 and 27.54 (P =.42), respectively; for patients with moderate/severe involvement, the scores were 23.47 and 30.71 (P <.05), respectively. Post-procedure Lund-Mackay scores were 0.58 (BOD) and 0.54 (ESS; P =.30) in the mild group and 0.53 (BOD) and 0.78 (ESS; P =.38) in the moderate/severe group.
Bizaki et al reported on results from a RCT that compared balloon ostial dilation with FESS among patients with symptomatic chronic or recurrent acute rhinosinusitis (Bizaki, 2014). Results were not reported separately for patients with CRS and RARS, and the study authors stated, "For this study, both CRS and RARS were considered to be one disease." The trial enrolled 46 subjects, 4 of whom withdrew; the analysis included 42 patients (n=21 in each group; statistical power calculations not reported). Both treatment 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.
Achar et al was an open-label pilot study of 24 patients with CRS who had failed medical therapy and were scheduled for surgery (Achar, 2012). Patients were randomized to BOD 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 <.03) Patients who received BOD were able to return to normal activities sooner than those who received FESS (2.2 days vs 5.0 days; P NR). Adverse events were not reported.
A retrospective cohort study used data from a large commercial insurance database to examine adverse events reported in patients who underwent balloon dilation (n=2851), FESS (n=11,955), or a hybrid procedure (n=1234) between 2011 and 2014. 13,The primary outcomes were surgical complication and revision rates within 6 months of the initial surgery. The overall complication rate was 7.35% with FESS and 5.26% with balloon dilation. The 6-month revision rates for balloon dilation, FESS, and hybrid surgeries were 7.89%, 16.85%, and 15.15%, respectively. Almost all revisions occurred with FESS regardless of primary procedure. However, differences in revision rates could have been due to differences in disease severity in patients who received FESS versus balloon dilation. Major complications included orbital complications, cerebrospinal fluid leak, severe epistaxis, and requirement for revision.
Two RCTs of BOD reported results separately for patients with RARS. A third RCT, reported by Bizaki et al compared BOD with FESS among patients with CRS or RARS, but results were not reported separately by diagnosis (Bizaki, 2014). The study authors stated, "For this study, both CRS and RARS were considered to be one disease." This trial is discussed in the previous section on BOD for CRS.
In the REMODEL trial, 32% (N=29) of the patients enrolled had a diagnosis of RARS. The CABERNET (Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients) trial compared BOD plus medical therapy to medical therapy alone in 59 patients with RARS. Both trials used the AAO-HNS diagnosis of RARS to select eligible patients: 4 or more episodes of acute rhinosinusitis in the past 12 months. In CABERNET, evidence of sinus or osteomeatal complex disease during an acute episode from a CT scan was also required for enrollment. In REMODEL, all patients met criteria for medically necessary FESS, but explicit CT requirements for patients with RARS were not specified.
Among the 29 patients diagnosed with RARS in the REMODEL trial, there was a signficiant improvement in quality of life for those who received either BOD or FESS, and the difference between treatment arms was not significant (P =.838). Bikhazi et al reported twelve-month results from REMODEL (Bikhazi, 2014). Data were not reported separately by diagnosis, but the publication states, "At 1 year, symptom improvement in each of the four subgroups [including based on diagnosis] remained statistically significant (P <.001) in both treatment arms and there was no difference (P = NS) in improvement between patients who underwent balloon dilation or FESS." REMODEL results were not reported separately by diagnosis for secondary outcomes, or for the primary outcome (SNOT-20) at 24 months.
In 2019, Sikand et al, the primary outcome was the difference between arms in change in Chronic Sinusitis Survey (CSS) score from baseline to 24 weeks (Sikand, 2019).The change in CSS was significantly greater in the BOD group compared to the control group (mean change 37.3 vs 21.8; P =.0424). The study authors did not specify whether this was considered clinically significant. Patients in the BOD group had a lower mean number of sinus infections through the 24-week followup period (0.2 vs 0.9; P =.0015). Durability of the outcome measure differences was demonstrated up to 48 weeks. After the 24-week followup period, 18 of 30 patients who were randomized to the control arm elected to receive BOD.Of those who crossed over at 24 weeks, 0 reported no change or worsening of symptoms, 3 reported improved symptoms but still used nasal sprays at high rates, 4 had improved symptoms to varying degrees but were not eliminated, and 1 reported a sinus infection just before their 24-week visit. There was one procedure-related serious adverse event in the BOD group (the patient sought treatment for a headache in the emergency department the evening after the procedure), two possibly procedure-related nonserious adverse events, and no device-related adverse events.
Practice Guidelines and Position Statements
American Academy of Otolaryngology – Head and Neck Surgery et al
In 2018, the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) published a clinical consensus statement on balloon dilation of the sinuses (Piccirillo, 2018). Participating subgroups included the Triologic Society, the American Rhinologic Society, the American Academy of Otolaryngic Allergy, and the American Academy of Allergy, Asthma & Immunology. The expert panel used Delphi method surveys to assess consensus on proposed statements. Statements achieving a mean score of 7.00 or higher and having no more than 1 outlier (2 or more LIkert points from the mean in either direction) met criteria for consensus. Strong consensus was defined as a mean Likert score of 8.00 or higher with no outliers. The following statements met consensus; statements reaching strong consensus are highlighted.
Patient Criteria:
Perioperative Considerations:
Outcome:
The AAO-HNS updated its statement on balloon ostial dilation, reaffirming its 2010 position statement: “Sinus ostial dilation … is a therapeutic option for selected patient with chronic rhinosinusitis…. This approach may be used alone... or in conjunction with other instruments….” (AAO-HNS, 2017).
In 2015, the Academy’s Foundation updated its 2007 clinical practice guidelines on adult sinusitis, which do not discuss surgical therapy or use of balloon sinuplasty.1,
National Institute for Health and Care Excellence
In 2008, a guidance on balloon catheter dilation of paranasal sinus ostia from the National Institute for Health and Care Excellence (NICE) stated:
In 2016,NICE published a recommendation on the use of the XprESS Multi-Sinus Dilation System for the treatment of chronic rhinosinusitis20,:
1.1 “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).
1.2 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.”
The recommendation was based on the results of the REMODEL study: the committee "considered that the evidence from REMODEL demonstrated that balloon dilation (with either XprESS or FinESS) is clinically non‑inferior to FESS in terms of alleviating symptoms in patients with uncomplicated chronic sinusitis." Single-arm observational studies were of lower quality but were consistent with the findings of the REMODEL study.
American Rhinologic Society
A position statement, revised in 2017, from the American Rhinologic Society, stated that sinus ostial dilation is “a therapeutic option for selected patients with chronic rhinosinusitis (CRS) … who have failed appropriate medical therapy (ARS, 2017).”
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
American Academy of Otolaryngology - Head and Neck Surgery.(2017) Position Statement: Dilation of sinuses, any method (e.g., balloon, etc.). 2017; http://www.entnet.org/content/position-statement-dilation-sinuses-any-method- eg-balloon-etc. Accessed January 21, 2020. American Rhinologic Society (ARS).(2017) 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 21, 2020. National Institute of Health and Care Excellence (NICE).(2008) Balloon catheter dilation of paranasal sinus ostia for chronic sinusitis [IPG273]. 2008; http://www.nice.org.uk/guidance/IPG273/chapter/1-Guidance. Accessed January 21, 2020. National Institute of Health and Care Excellence (NICE).(2016) XprESS multi sinus dilation system for treating chronic sinusitis [MTG30]. 2016; https://www.nice.org.uk/guidance/mtg30. Accessed January 21, 2020. Piccirillo JF, Payne SC, Rosenfeld RM et al.(2018) Clinical Consensus Statement: Balloon Dilation of the Sinuses. Otolaryngol Head Neck Surg. 2018 Feb;158(2). PMID 29389303 Sikand A, Ehmer DR, Stolovitzky JP et al.(2019) In-office balloon sinus dilation versus medical therapy for recurrent acute rhinosinusitis: a randomized, placebo-controlled study. Int Forum Allergy Rhinol. 2019 Feb;9(2). PMID 30452127 13. Chaaban MR, Rana N, Baillargeon J et al.(2018) Outcomes and Complications of Balloon and Conventional Functional Endoscopic Sinus Surgery. Am J Rhinol Allergy. 2018 Sep;32(5). PMID 29947260 6. Greguric T, Trkulja V, Baudoin T, et al.(2017) Association between computed tomography findings and clinical symptoms in chronic rhinosinusitis with and without nasal polyps . Eur Arch Otorhinolaryngol. May 2017; 274(5): 2165-2173. PMID 28154930 Achar P, Duvvi S, Kumar BN.(2012) Endoscopic dilatation sinus surgery (FEDS) versus functional endoscopic sinus surgery (FESS) for treatment of chronic rhinosinusitis: a pilot study. Acta Otorhinolaryngol Ital 2012; 32(5):314-9. Ahmed J, Pal S, Hopkins C et al.(2011) Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis. Cochrane Database Syst Rev 2011; (7):CD008515. Albritton FDt, Casiano RR, Sillers MJ.(2012) Feasibility of in-office endoscopic sinus surgery with balloon sinus dilation. Am J Rhinol Allergy. May-Jun 2012;26(3):243-248. PMID 22449614 American Academy of Otolaryngology-Head and Neck Surgery. Statement on Balloon Dilation. Adopted June 28, 2010. Available online at: http://www.entnet.org/Practice/Balloon-Dilation.cfm. Last accessed November 30, 2010. American Rhinologic Society (ARS). Revised Poisition Statement on Endoscopic Balloon Catheter Sinus Dilation Technology. Available online at: http://www.american-rhinologic.org/patientadvocacy.balloon.phtml. Last accessed November 30, 2010. Batra PS, Ryan MW, Sindwani R et al.(2010) Balloon catheter technology in rhinology: reviewing the evidence. Laryngoscope 2010. Batra PS, Ryan MW, Sindwani R, et al.(2011) Balloon catheter technology in rhinology: Reviewing the Evidence. Laryngoscope. Sep 7 2011;121(1):226-232. PMID 20824793 Bikhazi N, Light J, Truitt T, et al.(2014) 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 Bizaki AJ, Numminen J, Taulu R, et al.(2015) A controlled, randomized clinical study on the impact of treatment on antral mucociliary clearance: uncinectomy versus balloon sinuplasty. Ann Otol Rhinol Laryngol. Nov 26 (b) 2015. PMID 26611244 Bizaki AJ, Numminen J, Taulu R, et al.(2015) Decrease of nasal airway resistance and alleviations of symptoms after balloon sinuplasty in patients with isolated chronic rhinosinusitis. A prospective, randomized clinical study. Clin Otolaryngol. Nov 9 2015 (a). PMID 26548697 Bizaki AJ, Numminen J, Taulu R, et al.(2016) A controlled, randomized clinical study on the impact of treatment onantral mucociliary clearance: uncinectomy versus balloon sinuplasty. Ann Otol Rhinol Laryngol. May2016;125(5):408-414. PMID 26611244 Bizaki AJ, Taulu R, Numminen J, et al.(2014) Quality of life after endoscopic sinus surgery or balloon sinuplasty: a randomized clinical study. Rhinology. Dec 2014;52(4):300-305. PMID 25479206 Blue Cross and Blue Shield Association Technology Evaluation Center (TEC).(2012) Balloon Ostial Dilation for Treatment of Chronic Rhinosinusitis. TEC Assessments 2012; Volume 27, Tab 9. Bolger WE, Brown CL, et al.(2007) Safety and outcomes of balloon catheter sinusostomy: a multicenter 24-week analysis in 115 patients. Otolaryngol Head Neck Surg, 2007; 137L10-20. Bolger WE, Vaughan WC.(2006) Catheter-based dilation of the sinus ostia: initial safety and feasibility analysis in a cadaver model. Am J Rhinol 2006; 20:290-4. Bozdemir K, Kutluhan A, Cetin H et al.(2011) 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 2011; 25(3):198-200. Brodner D, Nachlas N, Mock P, et al.(2013) Safety and outcomes following hybrid balloon and balloononly procedures using a multifunction, multisinus balloon dilation tool. Int Forum Allergy Rhinol. Aug 2013;3(8):652-658. PMID 23424023 Brown CL, Bolger WE.(2006) Safety and feasibilityof balloon catheter dilation of paranasal sinus ostia: a preliminary investigation. Ann Otol Rhinol Laryngol 2006; 115:293-9. 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Cutler J, Truitt T, Atkins J et al.(2011) First clinic experience: patient selection and outcomes for ostial dilation for chronic rhinosinusitis. Int Forum Allergy Rhinol 2011; 1(6):460-5. FDA.(2006) Relieva Sinus Balloon Inflation Device. www.fda.gov/cdrh/pdf5/k052198; 2006. Friedman M, Schalch P, Lin HC et al.(2008) Functional endoscopic dilatation of the sinuses: patient satisfaction, postoperative pain, and cost. Am. J. Rhinol. 2008; 22(2):204-9. Gliklich RE, Metson R.(2015) Techniques for outcomes research in chronic sinusitis. Laryngoscope. 2015 Oct;125(10). PMID 26390386 Gould J, Alexander I, Tomkin E, et al.(2014) 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 Hathorn IF, Pace-Asciak P, Habib AR, et al.(2015) Randomized controlled trial: hybrid technique using balloon dilation of the frontal sinus drainage pathway. Int Forum Allergy Rhinol. 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