CRS indicates chronic rhinosinusitis; SBCD, sinus balloon catheter dilation.
Wang F, Song Y, Zhang X, Tan G. Sinus Balloon Catheter Dilation in Pediatric Chronic Rhinosinusitis Resistant to Medical Therapy. JAMA Otolaryngol Head Neck Surg. 2015;141(6):526-531. doi:10.1001/jamaoto.2015.0397
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Sinus balloon catheter dilation (SBCD) has been used for chronic rhinosinusitis (CRS). It is necessary to evaluate its effect on children with CRS.
To evaluate the efficacy of SBCD on pediatric CRS in China.
Design, Setting, and Participants
A prospective case-control study was conducted from October 1, 2012, to May 31, 2013, in an academic tertiary referral hospital. Participants included a total of 79 patients, aged 7 to 12 years, with CRS resistant to medical therapy.
Medical or SBCD treatment of pediatric CRS.
Main Outcomes and Measures
Age, sex, and results of computed tomographic scan, SBCD (case group) or conservative treatment (control group), sinonasal-5 questionnaire (SN-5), and visual analog scale (VAS) were analyzed and compared.
Data from 79 of 96 patients who had complete follow-up documents were statistically analyzed (42 boys; 37 girls; mean [SD] age, 9.3 [1.7] years). Compared with the preoperative scores, the SN-5 and VAS scores in children with CRS who underwent SBCD with or without adenoidectomy were significantly lower at 3 months (2.5 vs 4.3 for SN-5; P < .001; 3.1 vs 5.2 for VAS; P < .001) and at 1 year (2.9 vs 4.3 for SN-5; P = .001; 3.1 vs 5.2 for VAS; P < .001). Both SN-5 and VAS scores in the control group were significantly decreased at 3 months (3.1 vs 4.2 for SN-5; P = .001; 3.9 vs 5.1 for VAS; P < .001) but not significantly changed at 12 months (3.8 vs 4.2 for SN-5; P = .01; 4.9 vs 5.1 for VAS; P = .54). The SN-5 and VAS scores in the SBCD group were significantly lower than those for controls at 3 months (2.5 vs 3.1 for SN-5; P = .003; 3.1 vs 3.9 for VAS; P = .01) and at 1 year after surgery (2.9 vs 3.8 for SN-5; P < .001; 3.1 vs 4.9 for VAS; P < .001). By the 12-month SN-5 score evaluation, the rates of marked, moderate, and mild improvement were significantly better in the SBCD group (52% [22 of 42], 26% [11 of 42], and 14% [6 of 42], respectively) than in the control group (14% [5 of 37], 19% [7 of 37], and 11% [4 of 37], respectively) (P < .05 for all comparisons).
Conclusions and Relevance
The SBCD procedure is a safe and effective technique for pediatric CRS resistant to medical therapy.
Chronic rhinosinusitis (CRS) in children is very commonly seen in clinic and negatively affects the child’s quality of life and learning ability. Multiple factors contribute to the disease, including bacteriologic and inflammatory factors. The adenoids are a prominent contributor to this entity in the pediatric age group. The mainstay of treatment for CRS has been antibiotic therapy coupled with topical or systemic corticosteroid therapy and saline irrigation.1 Symptoms or outcomes of CRS in children were improved in half of patients or more after adenoidectomy.2 Some patients, however, have persistent symptoms despite maximum medical management and adenoidectomy, and further surgical intervention may be indicated.
Sinus balloon catheter dilation (SBCD) of the maxillary, frontal, and sphenoid sinuses to treat CRS was introduced in 2006 and has been shown to be safe and effective in recent multiple-center studies in adults.3 It has also been used for CRS in children4 and has increased the effectiveness of surgery from 50% with adenoidectomy alone to 80% when balloon dilation was performed.5 Herein, we report a case-control study of Chinese children with CRS who underwent SBCD (case) or conservative therapy (control).
A total of 96 children with CRS, diagnosed according to the criteria described in the European Position Paper on Rhinosinusitis and Nasal Polyps 2012,6 were enrolled this study from October 1, 2012, through May 31, 2013. The patients’ ages ranged from 7 to 12 years. This study was approved by the institutional ethics committee of the Third Xiangya Hospital, Central South University, Changsha, China, and patient written informed consent was obtained from all patients’ parents or guardians.
All patients were dissatisfied with previous repeated medical therapy they had undergone for at least 2 years, which included nasal steroid spray, oral and sometimes intravenous antibiotics, decongestants, and saline irrigation, and their symptoms significantly degraded their quality of life (QOL). The guardians of all these patients consulted physicians to learn whether surgical treatment might be beneficial for their children. Computed tomographic (CT) scans were performed, and Lund-Mackay scores were recorded for all patients. The children’s guardians also completed a sinonasal-5 questionnaire (SN-5)7 and visual analog scale (VAS)7 in the clinic to evaluate the child’s QOL of the last month. All patients underwent a skin-prick test of allergens, an immunoglobulin deficiency workup, and a sweat chloride test, if indicated. Patients were excluded if they had cystic fibrosis, syndromic diseases, rhinitis and/or asthma, or a history of prenasal surgery.
Ninety-six eligible patients were divided into 2 treatment groups as follows: first, the physicians explained the 2 therapeutic methods in detail to the patients’ guardians: SBCD (case group) and conservative treatment (control group) (including oral antibiotics, local nasal steroid spray, and nasal saline irrigation). Second, the patient’s guardians selected 1 of the 2 treatments. Of the 96 patients, 53 chose SBCD, and 43 chose conservative treatment (Figure). Follow-up ended on May 31, 2014, and at that time a total of 79 patients had been enrolled in the study for longer than 1 year: 42 SBCD patients and 37 control patients. Thirteen patients were lost to follow-up because of changes in telephone numbers and residences. Four control patients were excluded because they underwent SBCD after 6 months of conservative therapy. The patient characteristics are summarized in Table 1. No significant differences were noted in sex, age, or medical history between the 2 groups.
The SBCD procedure was performed as described elsewhere.3- 5 Briefly, all patients were placed under general anesthesia in the supine position on the operating table with the head slightly lowered. The nose was appropriately decongested with epinephrine pledgets. The procedure was conducted using guided imaging through a wide-angle endoscope (0°, 4 mm) and proceeded from maxillary sinus followed by frontal sinus. The uncinate process and ethmoid bulla were first identified, and polyps removed if present on the uncinate process.
The sinus guide catheter was inserted posteriorly and inferiorly within the middle meatus between the uncinate process and ethmoid bulla, and the tip of sinus guide was kept in line with the natural maxillary ostium. The lighted guide wire was then passed through the catheter into the sinus. Transillumination of the lateral and inferior maxilla confirmed that the guide wire was within the maxillary sinus. Once the guide wire was in place, the sinus balloon catheter was passed over the guide wire into the sinus and placed across the ostium. After positioning was confirmed, the balloon was inflated to 10 Pascal for 10 seconds. Inflation was repeated 3 times; dilation of the ostium was verified; and then the sinus was irrigated through the catheter with 100 mL of saline containing 0.1 mg/mL of dexamethasone and 1.6 mg/mL of gentamicin.
For SBCD of the frontal sinus, the tip of the sinus guide was insinuated between the uncinate process and the face of ethmoid bulla in the para-sagittal plane. Once the lighted wire was confirmed to be inside the frontal sinus, balloon advancement and dilation were performed and repeated more proximally or distally within the frontal sinus outflow tract. Sinus irrigation of the frontal sinus was carried out as with the maxillary sinus.
All SBCD patients were treated with oral antibiotics (amoxicillin-clavulanate, 750 mg, twice a day) for 2 weeks, and a steroid nasal spray (mometasone furoate, 50 µg/nostril) and saline rinse for 3 months after the operation.
Endoscopic adenoidectomy was also carried out through a 70 endoscope via the mouth approach in patients with CRS if the following criteria were satisfied: adenoids occupied more than 1/3 of the posterior choana as visualized by endoscopy; presence of snoring; and repeated episodes of otitis media.
The control patients were treated with antibiotics for 2 weeks (amoxicillin-clavulanate, 750 mg, twice a day) and a combination of a steroidal nasal spray (mometasone furoate, 50 µg/nostril) and saline rinse for 3 months.
All the patients were asked to return to the clinic for examination at 3 months, 6 months, and 1 year after undergoing the initial treatment. To improve patient follow-up rates, specialty nurses regularly conducted telephone interviews with all the patients. During each clinical follow-up, in addition to undergoing conventional examination of the nasal cavity, each patient was required to complete the SN-5 and VAS to evaluate his or her QOL of the last month as a result of nose and sinus problems.7 The use of antibiotics and steroids was recorded.
The overall effects were measured by comparing the 12-month SN-5 score with the preoperative SN-5 score. As originally described by Kay and Rosenfeld,7 a decrease of 0.5 to 1.0 in SN-5 score is a mild improvement; 1.0 to 1.5 is a moderate improvement; and a greater than 1.5 decrease is a marked improvement. Any case with SN-5 scores that decreased less than 0.5 were considered treatment failures.7 All follow-up data were obtained by a technician who was blinded to study group.
A postoperative CT scan was not performed because this represented added radiation exposure, and previous reports have shown that SN-5 scores correlate with CT scores.8
Data were analyzed using the SPSS statistical package, version 13.0 (SPSS Inc). One-way analysis of variance and the Mann-Whitney test were used for comparative analysis of the QOL scores and the overall efficacy of treatments. Statistical significance was set at P < .05.
A total of 96 children with CRS were enrolled in this study: 53 patients in SBCD group and 43 patients in the control group. The mean (SD) sinus CT scores were 13.3 (3.3) in SBCD group and 12.8 (3.5) among controls. A total of 104 maxillary sinuses in 53 patients and 69 frontal sinuses in 41 patients were targeted for balloon dilation after evaluation of the sinus CT scans in the SBCD group. Technique success rates for frontal and maxillary sinuses were 99% (68 of 69) and 99% (103 of 104), respectively. One planned bilateral frontal and maxillary sinus dilation could not be completed in the right side because severe septum deviation prevented access to the right side ostia planned for treatment.
A total of 79 of 96 patients completed 12 months of follow-up and the SN-5 and VAS questionnaires at each of the visits at 3 months, 6 months, and 1 year (42 boys; 37 girls; mean [SD] age, 9.3 [1.7] years). Table 2 summarizes the dynamic changes of SN-5 and VAS scores in patients in the 2 SBCD and control groups. Compared with the preoperative scores, the SN-5 and VAS scores in children with CRS were significantly lower at 3 months, 6 months, and 1 year after undergoing SBCD with or without adenoidectomy (P < .05 for all comparisons; see Table 2). Both SN-5 and VAS scores in the control group were significantly decreased at 3 months and 6 months (P < .05 for all comparisons; see Table 2), but not significantly changed at 12 months of follow-up (P > .05; see Table 2).
The SN-5 and VAS scores at 3 months, 6 months, and 1 year after surgery in the SBCD group were significantly lower than those for the control group (P < .05 for all comparisons; see Table 2). This finding indicated that SBCD with or without adenoidectomy could significantly improve the symptoms and QOL for children with CRS.
Dynamic observation of QOL demonstrated that both SN-5 and VAS scores slightly increased in the SBCD group (P > .05 for all comparisons; see Table 2) and significantly increased in the control group (P < .05 for all comparisons; see Table 2) at 1-year follow-up compared with the 3-month scores. This finding indicates that SBCD with or without adenoidectomy has a longer-term efficacy for children with CRS; whereas treatment with medications has a shorter-term efficacy for these patients.
The overall treatment efficacy was evaluated by comparing the 12-month SN-5 score with the pretreatment SN-5 score according to the criteria established by Kay and Rosenfeld.7 The rates of marked, moderate, and mild improvement were 52% (22 of 42), 26% (11 of 42), and 14% (6 of 42), respectively, in the SBCD group, and 14% (5 of 37), 19% (7 of 37), and 11% (4 of 37), respectively, in the control group. The Mann-Whitney test was used for comparison analysis. The results demonstrated that the efficacy of SBCD with or without adenoidectomy was significantly better than that of conservative treatment (P < .05 for all comparisons; see Table 3).
In a separate analysis of CRS with adenoid hypertrophy, 8 patients undergoing SBCD with adenoidectomy had an improvement rate of 100% (8 of 8) 12 months after the operation, whereas 6 patients treated with medication had an improvement rate of only 33% (2 of 6).
One of 53 patients (2%) who underwent SBCD experienced periorbital swelling without hematoma, and it was resolved within 1 week with no special treatment.
A stepwise approach has been conventionally used for management of pediatric CRS, and it includes medication, adenoidectomy, and functional endoscopic sinus surgery (FESS). Medical treatment is usually a first choice for this disease. Long-term appropriate antibiotic therapy is necessary and effective.9 However, for chronic disease, long-term antibiotic therapy has been limited by the China Health Administration because of the potential for developing bacterial drug resistance in China. Intranasal corticosteroid is a mainstay of treatment in China, and it has a good curative effect on pediatric CRS.6 Antibiotics can be used at the acute stage of chronic sinusitis.10 In addition, some patients have a good response to long-term treatment with nasal saline lavage. Treatment of comorbid conditions, such as asthma and allergic rhinitis, can greatly improve the symptoms in some children. Our current study shows that SN-5 score is also improved by a series of medical treatments including steroid nasal spray, oral antibiotics, and nasal saline irrigation in about 44% of children with treatment-resistant CRS. Therefore, it is necessary to consider conservative medical treatments for pediatric CRS; only a minority of children will have continued symptoms and need surgical intervention.
Adenoidectomy is a first-line surgical therapy for pediatric CRS with adenoid hypertrophy, and has been reported to be effective in more than 50% of children with CRS.11 It serves to eradicate the reservoir of pathogenic microorganisms in adenoids and reduces the bacteria in the middle meatus: a high correlation has been shown between the bacteria present within the adenoids and the middle meatus in children with CRS.12 However, minorities of children who have persistent CRS after adenoidectomy are often treated with FESS. Balloon catheter dilation has been reported to be effective in some refractory cases of chronic sinusitis and has a similar success rate to that of FESS.4,5 A multicenter randomized study comparing balloon dilation with FESS showed similar symptom relief between groups in patients with adult CRS and disease limited to the maxillary and anterior ethmoid sinuses.13 In the present study, our data demonstrate that both SN-5 and VAS scores are significantly decreased in patients with treatment-resistant pediatric CRS 12 months after SBCD, and symptoms are significantly improved. It indicates that SBCD is an appropriate therapy for CRS in children.
Sinus balloon catheter dilation has been shown to be safe and effective in children.4 Ramadan et al14 found the improvement rate of symptoms to be 81% to 92% in pediatric CRS, and the SN-5 improvement rates to be 50% marked, 29% moderate, and 8% mild. In the present study, the overall efficacy of SBCD shows that the rates of marked, moderate, and mild improvement are 52%, 26%, and 14%, respectively, and significantly better than controls. We found outcomes similar to those previously reported.
Balloon dilation alone is considered to be ineffective for children with a hypoplastic sinus or older children with significant ethmoid disease.15 However, it is effective for maxillary atelectasis16 and was performed in the ethmoidal air cell area by Kutluhan et al.17 Our results show that balloon dilation of the frontal and maxillary sinuses, combined with medical therapy, is effective for children with pan-rhinosinusitis associated with mucosal thickening in the frontal, ethmoid, maxillary, and sphenoid sinuses seen on preoperative CT scan. Dilation of the drainage pathway around the ostiomeatal complex is beneficial to control the inflammation of pan-sinusitis by a series of intraoperative and postoperative medical therapy regimens. Therefore, we suggest that balloon dilation of the frontal and maxillary sinuses is sufficient treatment for pediatric CRS, even though the ethmoid and sphenoid sinuses might also be invaded by inflammation.
There are data showing that irrigation added to adenoidectomy increases the success rate from 60% with adenoidectomy alone to 88% when maxillary sinus wash in added in children with CRS that previously failed to respond to medical therapy.18 Our data demonstrate that the overall improvement rate (marked, moderate, and mild) as measured by the SN-5 is 93% in children with CRS resistant to medical management after SBCD with sinus irrigation of dexamethasone and gentamicin. Therefore, irrigation alone, and not necessarily balloon dilation, might account for the positive results reported herein. Furthermore, an anti-inflammatory agent was used for irrigation in our patients, which might have enhanced the effect. The role of the SBCD procedure may be only to provide a good channel for sinus irrigation and improve sinus drainage.
The SBCD is quite safe for treating CRS, and complications are very rare. Sillers and Melroy19 recently reviewed complications of SBCD from 7 clinical studies and found only 3 adverse events reported. In the present study, only 1 patient experienced periorbital swelling, and that resolved without any sequelae within 7 days after the procedure. Our findings indicate that SBCD is a safe procedure for children with CRS.
The limitation of this study is that we did not carry out the randomization as initially designed because it was quite difficult to obtain informed consent from patients’ guardians for such a randomization. However, the technician responsible for obtaining the follow-up data was blinded to study group.
Our findings indicate that SBCD is a safe and effective method for treating pediatric CRS proven resistant to medical treatments. Dilation of the maxillary ostium and nasal frontal duct is sufficient to treat pan-rhinosinusitis in children.
Submitted for Publication: October 21, 2014; final revision received February 2, 2015; accepted February 19, 2015.
Corresponding Author: Guolin Tan, MD, Department of Otolaryngology–Head Neck Surgery, Third Xiangya Hospital, Central South University, 138 Tongzipo St, Changsha 410013, China (firstname.lastname@example.org).
Published Online: April 2, 2015. doi:10.1001/jamaoto.2015.0397.
Author Contributions: Dr Tan had full access to all of 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: Tan.
Acquisition, analysis, or interpretation of data: Wang, Song, Zhang, Tan.
Drafting of the manuscript: Wang, Song, Tan.
Critical revision of the manuscript for important intellectual content: Zhang, Tan.
Statistical analysis: Wang, Song.
Obtained funding: Tan.
Administrative, technical, or material support: Zhang, Tan.
Study supervision: Tan.
Conflict of Interest Disclosures: None reported.
Funding/Support: This study was supported by grant 12JJ2053 from the Nature Science Foundation of Hunan Province.
Role of the Funder/Sponsor: The Nature Science Foundation had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We wish to acknowledge Li Rong, MS, for assistance in obtaining the follow-up data.