Radiofrequency Thermotherapy vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency A Randomized Clinical Trial

Research Original Investigation Radiofrequency Thermotherapy vs Bone-Anchored Suspension for Treatment of Lateral Nasal Wall Insufficiency A Randomized Clinical Trial Joshua D. Weissman, MD; Sam P. Most, MD IMPORTANCE Lateral nasal wall insufficiency is a common problem with little consensus on optimal treatment. OBJECTIVE To assess the efficacy of radiofrequency () thermotherapy for the treatment of lateral nasal wall collapse. DESIGN, SETTING, AND PARTICIPANTS A prospective randomized trial comparing thermotherapy with bone-anchored suspension technique () for lateral nasal wall collapse in 13 patients was conducted, with recruitment occurring between March 1, 2010, and February 28, 2012, and follow-up of 1 year. The setting was a tertiary care facial plastic and reconstructive surgery clinic at an academic hospital. Eligible patients had lateral nasal wall insufficiency and met study inclusion criteria. Editorial page 80 Journal Club Slides and Supplemental content at jamafacialplasticsurgery.com CME Quiz at jamanetworkcme.com and CME Questions page 160 INTERVENTIONS Participants were randomized to receive either of the lateral nasal wall or thermotherapy to the lateral nasal wall. MAIN OUTCOMES AND MEASURES Outcomes were assessed 1, 3, 6, and 12 months after surgery using 2 subjective patient outcomes surveys (the Nasal Obstructive Symptom Evaluation and a visual analog scale) and a physician-derived assessment of lateral wall collapse. RESULTS Significant improvements in symptom scores were seen postoperatively for both treatment arms, though more consistently in the radiofrequency group. One month postoperatively, the mean (SD) drop in NOSE scores was 52.5 ± 22.2 and 51.7 ± 26 (P =.96) for the and groups, respectively. Similar results were noted at 6 and 12 months postoperatively (56.7 ± 38.2 vs 50 ± 14.7 [P =.76] and 53.3 ± 20.2 vs 56.7 ± 18.9 [P =.84] at 6 and 12 months, respectively). No statistical difference in change in NOSE scores occurred between the 2 groups at 1, 6, or 12 months postoperatively. Likewise, the drop in VAS scores between the 2 treatment groups was similar at each time point. One month postoperatively, the mean (SD) drop in VAS scores was 5.1 ± 2.8 and 4.8 ± 2.6 (P =.90). Similar results were noted at 6 and 12 months postoperatively (5.8 ± 3.4vs4.9± 3.1 [P =.72] and 5.5 ± 3.1vs5.4± 1.3 [P =.96] at 6 and 12 months, respectively). Using a physician-derived score, significant improvement was seen in patients in the group at 1 month (P =.005), 6 months (P =.002), and 12 months (P =.03). For the group, significant improvement was noted only at the 1-month postoperative visit (P =.007). Comparison of vs revealed significant improvement in the group over the group at 12 months (P =.04). The other periods revealed no significant differences between the two. CONCLUSIONS AND RELEVANCE Radiofrequency thermotherapy is a viable alternative option for lateral nasal wall collapse, both in terms of improvements in symptoms and physical examination, with suggested evidence for efficacy at least as good as that for bone-anchored suspension. LEVEL OF EVIDENCE 1. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN14219489 JAMA Facial Plast Surg. 2015;17(2):84-89. doi:10.1001/jamafacial.2014.1384 Published online January 29, 2015. Author Affiliations: Division of Facial Plastic and Reconstructive Surgery, Stanford University School of Medicine, Stanford, California (Weissman, Most); associate editor, JAMA Facial Plastic Surgery (Most). Corresponding Author: Sam P. Most, MD, Division of Facial Plastic and Reconstructive Surgery, Stanford University School of Medicine, 801 Welch Rd, Stanford, CA 94305 (smost@ohns.stanford.edu). 84 (Reprinted) jamafacialplasticsurgery.com

Thermotherapy vs Bone-Anchored Suspension Original Investigation Research Nasal obstruction due to lateral wall insufficiency (LWI) is a common finding in patients evaluated in otolaryngology and facial plastic surgery clinics, and treatment has been a challenge to the facial plastic surgeon. Many techniques have been described 1-6 to address this type of nasal obstruction, but none has emerged as a clear favorite. More recently, a small case series 7 described the use of radiofrequency () energy as a treatment for LWI. In theory, the scar and tissue retraction induced by low-energy delivery would decrease the tendency toward dynamic collapse of the lateral nasal wall and perhaps also contribute to a more patent static angle of the internal nasal valve. Although a novel use of the technology, the study was limited in that it was a case series, and LWI was not measured using a validated scale. We sought to more critically evaluate the usefulness of this technique compared with one of our preferred methods of treatment of lateral nasal wall collapse: bone-anchored suspension technique (). To accomplish this evaluation, we designed a single-center randomized clinical trial using both validated clinical measures of LWI and a disease-specific, validated outcome scale. Figure 1. CONSORT Flow Diagram 25 Patients assessed for eligibility 13 Randomized 12 Excluded (all refused to participate) 6 Randomized to 7 Randomized to 1 Lost to 1-mo follow-up 3 Lost to 6-mo follow-up 4 Lost to 12-mo follow-up (reasons varied) 5 Included in 1-mo follow-up 3 Included in 6-mo follow-up 2 Included in 12-mo follow-up 0 Excluded from analysis 1 Lost to 1-mo follow-up 3 Lost to 6-mo follow-up 4 Lost to 12-mo follow-up (reasons varied) 6 Included in 1-mo follow-up 4 Included in 6-mo follow-up 3 Included in 12-mo follow-up 0 Excluded from analysis indicates bone-anchored suspension technique;, radiofrequency. Methods Study Design Institutional review board approval was obtained from Stanford University School of Medicine for the study protocol, and all patients provided written informed consent. No financial compensation was provided. The project was approved through the institutional review board process in 2010, and the Stanford Institutional Review Board did not require registration at that time. At the request of the journal, the trial has been registered. The full study protocol can be found in the trial protocol in the Supplement. This study was a prospective randomized trial comparing thermotherapy with for lateral nasal wall collapse. Physician review of the videos for grading of the lateral nasal wall collapse was done in a blinded, nonsequential manner. Recruitment was done through a tertiary facial plastic surgery clinic, with all participants enrolled between March 1, 2010, and February 28, 2012. All eligible patients were offered the opportunity for enrollment in the trial with the caveat that the method of treatment for LWI would be determined in randomized fashion once they agreed to participate. Patients Eligible patients were adults with nasal obstruction for at least 1 year due to LWI as seen on examination, with or without septal deviation, turbinate hypertrophy, or internal nasal valve narrowing. The patients must have not responded to medical management with topical corticosteroids and have had no nasal trauma or surgery within the past year. Excluded were all individuals with an active smoking history, immunocompromise, previous rhinoplasty, history of radiotherapy to the head and neck, septal perforation, and granulomatous disease (Figure 1). Many patients with LWI have concomitant issues with the septum and turbinates. Consequently, participants with septal deviation, inferior turbinate hypertrophy, and chronic rhinosinusitis were included in the study, reasoning that their treating surgical procedures would be randomly distributed between the 2 treatment arms. Interventions Bone-anchored suspension technique was performed in the manner described by Roofe and Most 8 on patients who were randomized into this treatment group. Radiofrequency thermotherapy of the lateral nasal wall was performed using a bipolar -induced thermotherapy device (Celon ProBreath; Olympus) in a manner similar to that described by Seren. 7 For application, a mucosal packet was created heading from the intermediate crus toward the piriform aperture (Figure 2). The probe was placed in the dissection plane, and 3 separate deliveries of 12 W were applied in 3 adjacent foci separated by approximately 2 mm. The tip of the probe was placed atop the piriform aperture to avoid infraorbital nerve damage. At these settings, the elliptical area of energy delivery extends from the tip of the probe back 11 mm, with a radius of 2.1 mm. Outcomes Three sets of outcome measures were assessed at the initial preoperative visit and as well at postoperative follow-up times of 1, 3, 6, and 12 months after treatment. For reporting purposes, time points with fewer than 3 patients were excluded. Developed in 2004, 9 the Nasal Obstructive Symptom Evaluation (NOSE) scale, a validated quality-of-life symptom survey, is more applicable to the realm of functional rhinoplasty with its assessment of nasal congestion. The NOSE scale has been used as a quality-of-life measure in studies on jamafacialplasticsurgery.com (Reprinted) JAMA Facial Plastic Surgery March/April 2015 Volume 17, Number 2 85

Research Original Investigation Thermotherapy vs Bone-Anchored Suspension Figure 2. Radiofrequency Device Application Sites septoplasty, 10 nasal valve correction, 11 functional rhinoplasty, 12 thermotherapy treatment of turbinates, 13 and lateral nasal suspension. 8 The scale is composed of 5 questions that are assigned 4 points each. The score is multiplied by 5 to convert it to a 100-point scale, with higher scores representing more significant symptoms. A visual analog scale (VAS) was used to assess overall nasal congestion. The scale is a 10-cm horizontal line anchored by word descriptors. It is scored by measuring the distance in millimeters from the left of where the patient s mark was placed. A higher number indicates more severe symptoms. Endoscopic evaluation of lateral nasal wall collapse was performed using a system 14 that grades the degree of lateral nasal wall movement with inspiration. The endoscopic examinations performed preoperatively and postoperatively were recorded, digitally reviewed, and measured in a randomized nonsequential manner at the conclusion of the study by the senior author (S.P.M.) to gauge response in a blinded fashion. In contrast to the previous 2 outcome assessments, endoscopic evaluation of lateral nasal wall collapse allowed for a somewhat less subjective, physician-derived assessment of the degree of lateral wall collapse. This measure has been validated regarding interrater and intrarater reliability. 15 Statistical Analysis Statistical analysis was conducted by performing paired and unpaired 2-tailed t tests comparing NOSE, VAS, and endoscopic evaluation scores within and between the 2 treatment arms. Each side of the nose was independently evaluated for the LWI score; thus, each ala/sidewall was counted individually. Results Entry point End point Green dots indicate the intranasal entry point for device; red dots approximate the end point of the device. Seven of the participants who were initially enrolled and randomized to the thermotherapy treatment group underwent this surgery. Six individuals were enrolled and underwent surgery to include the. Data collection postoperatively was highest at earlier times in the study, with most patients returning for their 1-month postoperative visit and then fewer for subsequent visits. Data were collected on all patients at their follow-up visits using the NOSE and VAS surveys along with a videographic recording of their nasal endoscopy examination. One patient in the group did not complete the VAS survey properly at his 6-month postoperative visit. In addition to the stated experimental intervention, 5 of the 6 patients (83%) and 6 of the 7 thermotherapy patients (86%) also underwent septoplasty, and 5 of the 6 recipients (83%) and all 7 thermotherapy recipients (100%) received inferior turbinate reduction. One patient in each group underwent concomitant endoscopic sinus surgery. All patients in the group underwent an external rhinoplasty approach, whereas 3 of the patients receiving thermotherapy (43%) had external rhinoplasty approaches performed, 1 of which was for cosmetic tip work and the other 2 for septal reconstruction. An unpaired t test was performed comparing preoperative NOSE scores and VAS scores. This evaluation revealed a significant baseline asymmetry in the mean (SD) preoperative NOSE scores for the and thermotherapy groups (P =.04). Differences in the VAS scores for the and thermotherapy groups were also significant (P =.046) (Table 1). Thus, to compare the efficacy of the 2 treatments, the changes in NOSE and VAS scores were calculated for each participant at each postoperative visit. In all cases, the NOSE and VAS scores decreased postoperatively. In addition, the decrease in the NOSE scores between the 2 treatment groups was similar at each time point (Table 2). One month postoperatively, the mean drop in NOSE scores was 52.5 (22.2) and 51.7 (26.0). Similar results were noted at 6 and 12 months postoperatively (56.7 [38.2] vs 50.0 [14.7] and 53.3 [20.2] vs 56.7 [18.9], respectively) (Table 2). No statistically significant change in NOSE scores occurred between the 2 groups at 1, 6, or 12 months postoperatively. Likewise, the drop in VAS scores between the 2 treatment groups was similar at each time point (Table 2). One month postoperatively, the mean drop in VAS scores was 5.1 (3.8) and 4.8 (2.6), respectively, for the and groups. Similar results were noted at 6 and 12 months postoperatively (5.8 [3.4] vs 4.9 [3.1] and 5.5 [3.1] vs 5.4 [1.3] at 6 and 12 months, respectively [Table 2]). No statistically significant difference in change in NOSE scores occurred between the 2 groups at 1, 6, or 12 months postoperatively. Comparing the preoperative physician-derived lateral nasal wall grading scores using an unpaired t test, no significant differences were noted between the preoperative mean thermotherapy and scores (2.1 vs 1.7; P =.23); thus, direct comparisons between the groups were made with this outcome assessment. For the thermotherapy group, paired t test comparison of the baseline scores to each postoperative assessment yielded significant improvement at 1 month (P =.005), 6 months (P =.002), and 12 months (P =.03), as reported in Table 3. For the group, the same comparisons 86 JAMA Facial Plastic Surgery March/April 2015 Volume 17, Number 2 (Reprinted) jamafacialplasticsurgery.com

Thermotherapy vs Bone-Anchored Suspension Original Investigation Research Table 1. NOSE and VAS Scores for Patients Undergoing and to the Lateral Nasal Wall Postoperative, mo Treatment Preoperative 1 6 12 NOSE Scores Mean (SD) [P value] a 85.8 (10.7) 33.8 (25.0) [.002] 26.7 (28.9) [.002] 30.0 (18.0) [<.001] No. 6 4 3 3 Mean (SD) [P value] a 69.3 (14.0) 18.3 (15.4) [<.001] 22.5 (11.9) [<.001] 16.7 (7.6) [<.001] No. 7 6 4 3 P value.04.26.80.30 VAS Scores Mean (SD) [P value] a 8.6 (1.0) 4.2 (3.6) [.02] 3.4 (3.9) [.01] 3.7 (3.8) [.02] No. 6 5 3 3 Mean (SD) [P value] a 7.0 (1.4) 2.1 (2.1) [<.001] 2.6 (2.6) [.005] 2.2 (0.8) [<.001] No. 7 6 4 3 P value.046.25.76.53 Abbreviations:, bone-anchored suspension technique; NOSE, Nasal Obstructive Symptom Evaluation;, radiofrequency; VAS, visual analog scale. a Row P values represent comparison with the preoperative score. Table 2. Comparison of Decrease in NOSE and VAS Scores With and Decrease in Postoperative Score, mo Treatment Group 1 6 12 NOSE Scores Mean (SD) 52.5 (22.2) 56.7 (38.2) 53.3 (20.2) No. 4 3 3 Mean (SD) 51.7 (26.0) 50.0 (14.7) 56.7 (18.9) No. 6 4 3 P value.96.76.84 VAS Scores Mean (SD) 5.1 (3.8) 5.8 (3.4) 5.5 (3.1) No. 4 3 3 Mean (SD) 4.8 (2.6) 4.9 (3.1) 5.4 (1.3) No. 6 4 3 P value.90.72.96 Abbreviations:, bone-anchored suspension technique; NOSE, Nasal Obstructive Symptom Evaluation;, radiofrequency; VAS, visual analog scale. Table 3. Comparison of Preoperative and Postoperative LWI Scores With and Postoperative Treatment Group Preoperative 1 mo 6 mo 12 mo Mean (SD) [P value] a 1.7 (0.8) 0.8 (0.5) [.007] 0.8 (1.0) [.24] 1 (0) [.09] No.of alae 12 8 4 4 Mean (SD) [P value] a 2.1 (0.9) 0.8 (1.1) [.005] 0.8 (0.7) [.002] 0.3 (0.5) [.03] No. of alae 18 13 8 6 P value.84 >.99.04 Abbreviations:, bone-anchored suspension technique; LWI, lateral wall insufficiency;, radiofrequency. a Row P values represent comparison with the preoperative score. yielded significant improvement only at the 1-month postoperative visit (P =.007), whereas the remainder of the follow-up data points were not significant. Because there were no significant baseline differences using this measure, evaluating each temporal postoperative visit of one group against the other revealed significant improvement in the thermo- jamafacialplasticsurgery.com (Reprinted) JAMA Facial Plastic Surgery March/April 2015 Volume 17, Number 2 87

Research Original Investigation Thermotherapy vs Bone-Anchored Suspension therapy group over the group at 12 months (P =.04). The other time periods revealed no significant differences between the groups (Table 3). One patient in the group experienced a small, selfresolving hematoma over the nasal sidewall within 24 hours after the operation. One patient in the thermotherapy group, who also underwent unilateral left endoscopic maxillary antrostomy with anterior ethmoidectomy, developed left-sided infraorbital nerve hypoesthesias involving the anterior and middle superior alveolar nerve distributions. This complication resolved within 6 months. All patients also developed mild edema over the sidewall where the energy had been delivered, although this always resolved within 1 to 2 weeks. There was no blanching or skin necrosis. Discussion The passage of air through the nasal airway involves a complex interaction among multiple potential fixed, anatomic components, such as septal deviation, along with reversible factors, such as mucosal edema or the nasal cycle. In addition to fixed obstructions, dynamic collapse of the nasal wall has been described by several authors. 1-3,7,14,15 The Bernoulli principle explains the fundamentals of the dynamic collapse seen with inspired air and subsequent negative intranasal pressure. The pressure decrease results in folding of weaker, more susceptible structures. The internal nasal valve is best described as the point of maximal narrowing in the anterior nasal airway between the septum, upper lateral cartilage, and anterior inferior turbinate. Lateral wall insufficiency can be thought of as occurring in 2 distinct regions: zones 1 and 2. 14 Zone 1 LWI occurs more cephalad as the upper lateral cartilage complex moves inward during inspiration with subsequently more significant collapse of the upper lateral wall. Externally, this may be seen as medial collapse in the supra-alar region, although it is possible that it can only been seen intranasally. Zone 2 LWI more approximates the classically described external nasal valve collapse because its location is more caudal, primarily involves the ala, and can reliably be seen externally. 14,16 The causes of LWI vary by site. Zone 1 LWI is more frequently idiopathic and is seen in the aging population; other causes include trauma, genetics, or prior surgery. 14 Zone 2 LWI also may be a consequence of surgical alterations in anatomic support, postfacial paralysis, or aging or may occur in patients with variant anatomy that predisposes such abnormality, including narrow nostrils, projected tip, and thin alae. 1,14 The causes of LWI may be related to weakening of softtissue attachments from the upper lateral cartilage to the piriform aperture. Dense fascial attachment was described 17 extending from the periosteum of the piriform aperture to lateral cartilages. Just as supports this ligamentous attachment, thermotherapy may also strengthen it. Means of treatment of LWI have varied and evolved alongside the field of facial plastic surgery, and treatment has centered on either structurally supporting the lateral nasal wall or repositioning the upper lateral cartilages. Alar batten grafts, lateral crural struts, flaring sutures, and suture suspension are a few of the techniques used to address lateral nasal wall collapse. 1-4 Paniello 6 introduced nasal valve suspension as a treatment for internal nasal valve collapse. This method allowed for passage of a retention suture from an endonasal approach to a fixation point on the inferior orbital rim as accessed through a transconjunctival incision. This approach was modified by Friedmanetal, 18,19 who used a 3-mm external incision in an infraorbital skin crease to access the rim along with burial of the suture beneath the nasal mucosa to avoid granuloma formation. Shortly after their original study, 18 Friedman et al 19 reported on a larger series of patients who had undergone treatment with the investigators modified with outcomes measured by the 20-Item Sino-Nasal Outcome Test (SNOT-20) 20 and acoustic rhinometry, with mean follow-up of just over 1 year. They noted significant quality-of-life improvement in more than 84% of patients who received treatment exclusively for valve correction, although the SNOT-20 was designed primarily for evaluation of rhinosinusitis. The follow-up ranged from 6 to 60 months. A series by Roofe and Most 8 reported no complications and significant improvement with as seen on the NOSE scale, with mean follow-up of approximately 4 to 5 months. Radiofrequency treatment of the lateral nasal wall was proposed by Seren 7 more recently. He theorized that the low-level energy delivered to the soft tissues of the lateral nasal wall would induce similar changes used in thermotherapy ablation of turbinates: controlled necrosis followed by development of scar and tissue retraction. In his study, a turbinate probe was used to treat the lateral nasal wall. Outcomes were judged as significantly improved according to VAS scores during 16 weeks of follow-up. Our study was set up as a noninferiority assessment of thermotherapy to the lateral nasal wall compared with the older. Recruitment proceeded slower than expected, likely owing to the mandatory acceptance of a randomized treatment method. As such, the numbers were small, with 6 participants undergoing and 7 undergoing thermotherapy. The small sample size probably led to significant baseline differences between the 2 patient-derived subjective outcomes measures (NOSE and VAS), with less-symptomatic baseline scores seen on both measures for the thermotherapy group. According to a new severity classification scheme based on NOSE scores, 21 the thermotherapy group would be categorized as severe and the group would be categorized as extreme. We were able to compare postoperative outcomes with baseline scores within each group, with more robust and consistent significant improvements seen for the thermotherapy group as measured by the NOSE and VAS and significant but fewer improvements seen in the arm. However, the baseline differences prevent direct comparison using these outcomes measures. The physician-derived grading of LWI, which was performed in a blinded nonsequential manner, revealed no baseline asymmetries and showed consistent significant improvement in the thermotherapy arm at all intervals. The group demonstrated significant improvement only at 1 month. 88 JAMA Facial Plastic Surgery March/April 2015 Volume 17, Number 2 (Reprinted) jamafacialplasticsurgery.com

Thermotherapy vs Bone-Anchored Suspension Original Investigation Research Although the subjective outcomes measures indicated the thermotherapy group to have overall fewer symptoms preoperatively, the physician-assessed measure indicated greater amounts of collapse in this group. Direct comparison of both groups revealed significant improvement of the thermotherapy group over the group at 12 months postoperatively. It may be argued that direct comparison between the groups should not be undertaken given the baseline asymmetries on the subjective scores; however, we think it merits reporting. Strengths of the study include the randomized design and the use of validated outcomes measurements for both LWI and subjective measures of nasal obstruction. Shortcomings of this study largely stem from the small sample size and loss of participants to follow-up. All patients underwent other nasal surgical interventions, such as septoplasty, in addition to the thermotherapy and interventions. Ideally, this study would have involved only the experimental and control interventions in isolation to allow for comparison; however, such a study is not feasible since most patients have causes of obstruction other than the lateral nasal wall that can be addressed during the same procedure. Conclusions Radiofrequency thermotherapy is a viable alternative for the treatment of LWI independently as well as an alternative to. Although the consequences of a small sample size limit our ability to make broad conclusions, the data support thermotherapy of the lateral nasal wall as an effective, lessinvasive means of treatment for LWI. Significant improvements were seen and continued at 1 year following surgery. Based on the physician-derived assessment of lateral nasal wall collapse, there is even a suggestion that thermotherapy may be better than at addressing physical evidence of lateral nasal wall collapse. Larger studies are necessary to confirm and validate the results of this study. ARTICLE INFORMATION Accepted for Publication: October 24, 2014. Published Online: January 29, 2015. doi:10.1001/jamafacial.2014.1384. Author Contributions: Dr Weissman had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: All authors. Acquisition, analysis, or interpretation of data: All authors. Drafting of the manuscript: All authors. Critical revision of the manuscript for important intellectual content: All authors. Statistical analysis: All authors. Obtained funding: Weissman. Administrative, technical, or material support: All authors. Study supervision: Most. Conflict of Interest Disclosures: After completion of the analysis but before submission of the manuscript for publication, Dr Most has become a consultant for Aerin Medical Corp. No other disclosures were reported. 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A simplified technique for airway correction at the nasal valve area. Otolaryngol Head Neck Surg. 2004;131(4):519-524. 20. Piccirillo JF, Merritt MG Jr, Richards ML. Psychometric and clinimetric validity of the 20-Item Sino-Nasal Outcome Test (SNOT-20). Otolaryngol Head Neck Surg. 2002;126(1):41-47. 21. Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013;15(5): 358-361. jamafacialplasticsurgery.com (Reprinted) JAMA Facial Plastic Surgery March/April 2015 Volume 17, Number 2 89