Abstract
Objective:
To determine the efficacy of balloon sinus dilation (BSD) compared to functional endoscopic sinus surgery (FESS) or medical management for chronic rhinosinusitis (CRS).
Methods:
A qualified medical librarian conducted a literature search for relevant publications that evaluate efficacy of BSD. Studies were assessed independently by 2 reviewers for inclusion in the systematic review and meta-analysis.
Results:
From 315 abstracts reviewed, 18 studies were included in qualitative review, and 7 were included in meta-analysis. Quantitative analysis included 4 randomized clinical trials (RCTs) and 3 cohort studies comparing baseline and post-operative Sinonasal Outcome Test (SNOT)-20 scores in BSD and FESS. A meta-analysis restricted to the studies reporting SD for changes from baseline (2 RCTs, 1 cohort) showed the pooled difference in means to be 0.435, less than a clinically meaningful difference of 0.8. A separate sensitivity analysis of the studies including 4 additional studies with imputed values of SD for changes from baseline showed the pooled difference of means to be 0.237 assuming the highest level of correlation (Corr 0.8) between the pre- and post-intervention scores.
Conclusions:
There is limited high-quality evidence that assesses the efficacy of BSD versus FESS in the management of CRS patients. To better inform CRS management, future studies should compare BSD with endoscopic sinus surgery, hybrid procedures, and/or medical management alone using validated objective and patient-reported outcome measures.
Keywords: balloon sinuplasty, sinus ostial dilation, endoscopic sinus surgery, chronic rhinosinusitis
INTRODUCTION
Balloon sinus ostial dilation (BSD) is increasingly used for chronic rhinosinusitis (CRS), however high-level evidence supporting its efficacy is lacking. BSD was approved by the United States Food and Drug Administration (FDA) in 2005 to “dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.”1–3 BSD is a less invasive alternative to functional endoscopic sinus surgery (FESS) to treat CRS and its use is growing nationally.2,4,5 An evaluation of Medicare data from 2011 to 2015 showed a five-fold increase in BSD use compared to a small 5.9% increase in non-balloon ESS procedures.6
The American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) assembled an expert panel to develop a clinical consensus statement (CCS) on the use of BSD in paranasal sinus pathology to ensure patient safety and proper utilization.7 A systematic literature review was performed to evaluate the evidence regarding indications, perioperative considerations, and clinical outcomes for BSD. There was consensus that BSD is an effective adjunct to FESS in patients with chronic sinusitis without nasal polyps, improves short term quality of life in patients with limited CRS without polyposis, has a role in recurrent acute sinusitis or persistent sinus disease after FESS, and can be effective in frontal sinusitis.7
In this study, we assess articles reviewed by the CCS panel on the efficacy of BSD in CRS. We present a systematic review and meta-analysis of studies comparing CRS outcomes after BSD versus traditional FESS.
METHODS
Systematic review and meta-analysis were conducted and reported in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) of Observational Studies in Epidemiology guidelines. The study protocol is provided as a supplement.
Eligibility criteria:
We performed a literature search for randomized or observational studies published in any language within last 10 years on adults (18+years) with chronic or recurrent sinusitis that reported BSD outcomes and had traditional FESS, no treatment, or medical therapy as the comparator. Studies on BSD in pediatrics and for non-CRS indications were excluded.
Search protocol and study selection:
A medical librarian created search strategies to identify published literature on BSD for CRS in adults. The search strategies were created using relevant standardized terms and key words, and were conducted in several databases including PubMed, Embase, Cochrane Database of Systematic Reviews, Clinicaltrials.gov, National Guideline Clearinghouse, NICE – NHS Evidence, Canadian Medical Association, Centre for Reviews and Dissemination Health Technology Assessments Database, and Technology Evaluation Center Assessment Program.7 Searches were completed for all articles published up to 2017.7 A repeat search was performed after the end of study search period for the CCS development panel to find relevant articles up to July 2021. Full search strategies are provided in the Supplemental Appendix. Articles were screened by two authors independently.
Data collection:
Data on publications, patients, indications, treatment, and outcomes were recorded in a spreadsheet. Study variables included author, publication year, single or multi-institution setting, country, study design, Oxford Centre for Evidence-Based Medicine (CEBM) 2011 Levels of Evidence, enrollment period, inclusion/exclusion criteria, funding, and information about conflicts of interest (COI). Patient variables included age, gender, history of previous surgery and previous polyps. Treatment details included preoperative imaging, intervention with BSD alone or hybrid, sinus surgery, medical therapy or observation, sinuses addressed, anesthesia type, and clinical setting of office versus operating room (OR). Data on follow-up, nasal endoscopy findings, Lund-Mackay scores, nasal QOL instrument such as Sino-Nasal Outcome test (SNOT), postoperative recovery, and complications were collected.
Data analysis:
A qualitative review of the included studies was performed. The principal quantitative summary measure was the difference in mean with 95% confidence interval (CI) for the SNOT-20 score between BSD and comparator intervention. We also calculated the standardized mean difference (SMD) and 95% CIs. Meta-analysis for these summary measures was performed with STATA 15.0/CMA statistical software. For multiple publications on the same patient cohort, studies with complete result reporting for the outcome(s) of interest and/or longer follow-up were included for quantitative analysis. A random effects model was used for pooled data to to account for clinical heterogeneity. To include RCTs and cohort studies with missing standard deviation (SD) for changes in mean from baseline in the meta-analysis, we imputed the missing SD when pre- and post-intervention SDs were known and performed sensitivity analyses using different value levels of correlation coefficient (Corr).8 For the sensitivity analyses, we further performed subgroup analyses for randomized versus cohort studies, and for BSD alone versus hybrid procedure. We analyzed the outcome both as the difference in means and the SDM, however, we report difference in means of SNOT-20 as the outcome due to its more meaningful interpretation. For studies reporting SNOT-22 (n=2, 1 RCT9 & 1 cohort10), we converted the scores as required to make it comparable to the SNOT-20 scoring. A difference of 0.8 in mean SNOT-20 score is considered clinically meaningful.11
Assessment of Quality, Heterogeneity, and Publication Bias:
The study quality was assessed by Cochrane Risk for Bias Tool for randomized controlled trials (RCT) and Newcastle-Ottawa Quality Assessment Scale (NOS) for cohort studies. Heterogeneity of effects was assessed clinically and by using the I2 statistic. I2 > 50% was considered evidence of significant heterogeneity. Funnel plots were used to assess for publication bias.
RESULTS
Study selection:
The systematic search for the CCS development panel identified 248 abstracts, of which 120 met eligibility criteria for full text screening and 105 were excluded.7 The main reasons for exclusion were mechanistic-based articles (n=51) and absence of a comparator group with standalone BSD studies (n=38). An updated search after CCS development identified 67 additional citations for review (Figure 1). Of these, 3 articles compared BSD with FESS,12,13 and 1 published longer follow-up results14 for a previously reported cohort study15. In sum, the search methods yielded 18 articles for qualitative review and 7 for quantitative meta-analysis.
FIGURE 1.
PRISMA selection of studies
Study and patient characteristics of the selected studies:
Study characteristics are presented in Table 1. Of 18 studies included in qualitative review, nine were RCTs9,12,16–22 and nine were cohort10,13,15,23–28 studies. When multiple articles reported on the same patient cohort, all studies were included in narrative review but only the study with the most complete result reporting was included in quantitative analysis.13,18,21, 26–28 The inclusion criterion in RCTs was most commonly refractory CRS defined per European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) or AAOHNS guidelines; the CRS criteria were well-defined only in two cohort15,26 studies. Three studies included revision cases.10,15,23 Change in SNOT-20 score was the most common primary outcome. BSD alone was the intervention in six RCTs9,12,17,18,21,22 and two cohort studies23,26, with hybrid interventions in the others including BSD with additional procedures such as septoplasty, turbinectomy, uncinectomy and polypectomy. The proportion of patients undergoing BSD alone vs hybrid intervention was reported only by two studies.10,19 BSD was performed in the OR under general anesthesia in all RCTs (settings not reported in one)19, while procedural settings and anesthesia were generally mixed or not reported in cohort studies.10,13,15,23–27 Patients with polyposis were included in five RCTs, but distribution of the polyps was reported only in one study in which all patients had polyps.16 Among the cohort studies, distribution of polyps was reported by three,10,24,28 of which one24 study included all patients with polyps, one had no polyps patients in BSD alone vs 80% in hybrid group (proportion in FESS not reported)10 and one had 21% in BSD vs 41% in FESS.28
TABLE 1.
Summary of patient criteria and perioperative considerations
| Author, year | No. of institution (country) | Inclusion criteria definition | Inclusion of revision cases | Inclusion of nasal polyps | Primary outcome | Secondary outcome(s) | Intervention (BSD/Hybrid) | Setting | Anesthesia | Dilated Sinus(es) |
|---|---|---|---|---|---|---|---|---|---|---|
| Plaza, 201116 | 3 (Spain) | Medical refractory CRS per EPOS CPGs | No | Yes (all had polyps) | VAS on CRS symptom, RSDI (Spanish) | Butanol test for olfaction; frontal recess endoscopy; revision sx | Hybrid | OR | General | Frontal |
| Achar, 201217 | 2 (UK) | Medical refractory CRS per EPOS CPGs | No | Yes (% NR) | SNOT-20, Saccharine clearance test | ‐ | BSD | OR | General | Frontal, Maxillary |
| Cutler, 201318 | 5 (USA) | Medical refractory CRS per AAOHNS CPGs | No | Yes (% NR) | SNOT-20, debridement | Change in no. of RS episodes, work productivity & activity; ostial patency; complications; revision sx | BSD | OR | General | Maxillary, ethmoid |
| Marzetti, 201419 | 1 (Italy) | Sinus headache per AAOHNS guidelines | No | No | Efficacy in SH; morbidity | SNOT22 | BSD (66%), hybrid (34%) | NR | NR | Frontal |
| Hathorn, 201520 | 1 (Canada) | Medical refractory CRS per Canadian CPGs | No | Yes (% NR) | Frontal sinus ostium patency | Operating time, blood loss, ostium size, Philpott-Javer endoscopic score | Hybrid | OR | General | Frontal |
| Bizaki, 20169 | 1 (Finland) | chronic or recurrent RS w/o adequate response to medical rx | No | No | SNOT22 | ‐ | BSD | OR | General | Maxillary |
| Chandra, 201621 a | 5 (USA) | Medical refractory CRS per AAOHNS CPGs | No | Yes (% NR) | SNOT-20, debridement | Change in no. of RS episodes, work productivity & activity; ostial patency; complications; revision sx | BSD | OR | General | Maxillary, ethmoid |
| Minni, 201822 | 3 (Italy) | Medical refractory CRS per EPOS CPGs | No | No | Zinreich modified LM, SNOT-20 | Frontal recess obstruction | BSD | OR | General | Frontal |
| Hanci, 202012 | 1 (Turkey) | Medical refractory CRS per EPOS CPGs | No | No | Sniffin sticks olfaction test | ‐ | BSD | OR | General | Frontal |
| Friedman, 200823 | 1 (USA) | LM scores ≤ 12; recurrent RS; abnormal CT after antibiotics x 4w | Yes (34%) in both groups | No | SNOT 20 | GPA, postop pain, cost | BSD | OR | Local, general | Maxillary, frontal, sphenoid |
| Bozdemir, 201124 | 1 (Turkey) | Candidates for sx for nasal polyposis | No | Yes (all with polyp) | Endoscopy and CT score | Complications, revision sx | Hybrid | OR | General | Maxillary, frontal, sphenoid, ethmoid |
| Di Girolamo, 201425 | 1 (Italy) | Hematologic illness with RS diagnosed per Rhinosinusitis Task Force criteria | No | Yes (% NR) | SNOT20 | GPA; nasal packing | Both (% NR) | NR | Local (32%), general | Maxillary, frontal, sphenoid |
| ElBadawey, 201410 | 1 (UK) | >16y old with medical refractory CT-confirmed frontal sinus pathology with facial pain or discomfort | Yes (% per Rx group NR) | Yes (none in BSD, 80% with polyps in hybid group) | SNOT22 | Glasgow Benefit Inventory QOL | Both (60% hybrid) | NR | NR | Frontal |
| Koskinen, 201726 | 2 (Finland) | CRS per EPOS CPGs | No | Yes (% NR)b | OR time, anesthesia type, complication, sick leave | ‐ | BSD | Office (33%), OR | Local (86%), general | Maxillary |
| Koskinen, 201627 b | 2 (Finland) | CRS per EPOS CPGs | No | Yes (% NR)c | long-term efficacy and satisfaction | ‐ | BSD | Office (39%), OR | Local (89%), general | Maxillary |
| Koskinen, 201228 b | 2 (Finland) | CRS per EPOS CPGs | No | Yes (21% in BSD, 41% in ESS)c | VAS on RS symptom; CRS exacerbation | ‐ | BSD | NR | NR | Maxillary |
| Koskinen, 202113 | 4 (Finland) | CRS per EPOS CPGs | No | No | Revision sx | Patient satisfaction | BSD | NR | Local (90%), general | Maxillary |
| Payne, 201615 | 24 (USA) | AAOHNS rhinosinusitis task force criteria for failed medical rx,SNOT20>0.6 | Yes (% NR) | Yes (% NR) | Chronic Sinusitis Survey score improvement | SNOT20, RSDI, missed work days; topical/oral steroids; abx usage; safety; revision procedures | Both (% NR) | Office (28%), OR | Local (72%), general | Maxillary, frontal, sphenoid |
BSD- Balloon sinus dilation, CRS- chronic rhinosinusitis, EPOS- European Position Paper on Rhinosinusitis & Nasal Polyps, CPG- clinical practice guidelines, Rx- therapy, OR- Operating room, VAS- visual analog scale, RSDI- Rhinosinusitis disability index, sx-surgery, NR- not reported, SNOT-Sinonasal outcomes test, AAO-HNS- American Academy of Otolaryngology & Head-Neck Surgery, RS- rhinosinusitis, SH- Sinus headache, LM- Lund-MacKay, GPA- Global Patient Assessment, QOL- Quality of life, ESS- Endoscopic sinus surgery, Rx- treatment
Included patients from Cutler study
Overlapping patient cohort;
History of previous nasal polyps but no intraoperative endoscopic signs of polyps
Summary of study findings:
The study outcomes are summarized in Table 2. Among the RCTs, pre- and post-intervention SNOT mean scores with SD were reported by three,9,19,22 the difference between the pre- and post-intervention mean scores with SD by two,17,18 only the mean change without SD by one,21 and none were reported by two studies.16,29 One RCT reported the number of sinuses but not the number of patients assigned to BSD versus FESS and therefore was excluded from meta-analysis.22 Pre- and post-operative scores were reported by four cohort studies,10,15,23,25 of which only two reported change in mean scores with SD.15,23 Among these cohort studies, FESS was the comparator group in all except one15 which had medical management as the comparator. Data required for meta-analysis to evaluate difference in means with 95% CIs between BSD and FESS groups was reported completely only by two RCTs17,18 and one cohort study.23
TABLE 2.
Summary of study outcomes
| Balloon sinus dilatation/Hybrid | Comparator | Conclusion | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Author, year | n | Additional procedure (n) | Pre-intervention score (SD) | Post-intervention score (SD) | Type | n | Pre-intervention score (SD) | Post-intervention score (SD) | |||||
| Mean (SD) | SNOT | LM | SNOT | LM | SNOT | LM | SNOT | LM | |||||
| RCT | |||||||||||||
| Plaza, 201116 | 17 | n NR | NR | 19.2 | NR | 3.6 | FESS | 16 | NR | 18.6 | NR | 4.2 | BD of the frontal recess is a relatively safe and effective tool in chronic frontal RS |
| Achar, 201217 | 12 | 2 | 3.18 (0.74) | 7.92 (4.4) | NR [diff: 2.19 (0.76)] | NR | FESS | 12 | 2.58 (0.89) | 8.25 (3.91) | NR [diff: 1.48 (0.62)] | NR | FEDS is as effective as FESS in treatment of CRS |
| Cutler, 201318 | 50 | 0 | 2.54 (0.91) | 3.2 (3.2) | NR [diff: 1.67 (1.1)] | NR | FESS | 42 | 2.54 (0.79) | 3.6 (3.5) | NR [diff: 1.6 (0.96)] | NR | BD is noninferior to FESS for symptom improvement & superior for postop debridements in max/ant ethmoid disease |
| Marzetti, 201419 | 35 | Septoplasty:20/35 BSD, 15/40 ESS had septo; all had IT reduction | 1.24 (0.04) | NR | 0.24 (0.01) | NR | FESS | 40 | 1.3 (0.05) | NR | 0.35 (0.03) | NR | Improvement in headache can be expected in patients treated with balloon catheter. |
| Hathorn, 201520 | 30* | 0 | NR | 1.4 (0.5) | NR | NR | FESS | 30 | NR | 1.3 (0.5) | NR | NR§ | Hybrid balloon successfully dilates FS drainage pathway with reduced blood loss |
| Bizaki, 20169 | 30 | 0 | 1.94 (0.8) | 3–4 score: 8/30 | 1.15 (0.95) | NR | Uncinectomy | 32 | 2.07 (0.85) | 3–4 score: 14/32 | 1.39 (0.8) | NR | Both BD & uncinectomy improved the QOL & decreased upper airway resistance of patients with mild, isolated chronic or recurrent RS. |
| Chandra, 201621 | 74 | 0 | NR | NR | change of 1.59 at 12 mo, 1.65 at 24 mo | NR | FESS | 61 | NR | NR | change of 1.65 at 12 mo, 1.45 at 24 mo | Change of 1.45 | Outcomes comparable at all time points from 6 to 24 mo. BD has faster recovery, less postoperative pain, & fewer debridements. |
| Minni, 201822, b | NR (69 sinuses) | 0 | Light: 3.05 (0.42) Severe: 3.24 (0.38) |
Light: 1.68 (0.47) Severe: 3.10 (0.53) |
Light: 1.23 (0.44) Severe: 1.17 (0.32) |
Light: 1.57 (0.50) Severe: 3.07 (0.27) |
FESS | NR (79 sinuses) | Light: 3.28 (1.00) Severe: 3.36 (0.67) |
Light: 1.57 (0.50) Severe: 3.07 (0.27) |
Light: 1.38 (0.37) Severe: 1.54 (0.51) |
Light: 0.54 (0.59) Severe: 0.78 (0.80) |
BCD and FESS outcomes comparable, post-op SNOT-20 significantly better in BCD for patients with severe CRS |
| Hanci, 202012 | 22 | 0 | NR | NR | NR | NR | FESS | 22 | NR | NR | NR | NR | Olfaction better in ESS than BSD at 1–12 mo postop |
| Cohort | |||||||||||||
| Friedman, 200823 | 35 | 0 | 2.8 (0.52) | NR | 0.78 (0.55)[diff: 1.99 (0.66)] | NR | FESS | 35 | 2.7 (0.85) | NR | 1.29 (0.87) [diff: 1.41 (0.98)] | NR | FEDS and FESS resulted in significant improvement in SNOT-20 scores for selected patients with mild disease |
| Bozdemir, 201124 | 10* | Polypectomy, n NR | NR | 10.2 (2.15) | NR | 6.2 (3.11) | FESS | 10 | NR | 10 (2.58) | NR | 6 (3.3) | At 1 year postsurgery, polypectomy plus BCD is as effective as FESS |
| Di Girolamo, 201425 | 25 | n NR | 2.9 (0.52) | NR | 0.88 (0.55) | NR | FESS | 85 | 2.8 (0.85) | NR | 0.98 (0.87) | NR | BD represents a potentially low aggressive treatment, safe & effective in onco-hematologic patients |
| ElBadawey, 201410 | 17 | NR | 2.57 (0.94) | NR by Rx | 1.59 (1.32) | NR | FRC, EMLP | 13 | 2.92 (0.8) | NR by Rx | 1.64 (1.36) | NR | Symptoms & QOL assessed by SNOT-22 significantly improved after all 3 procedures |
| Koskinen, 2021 | 77 | 0 | NR | 4.8 | NR | NR | FESS | 82 | NR | 7.2 | NR | NR | Higher revision sx rate in BSD than FESS |
| Koskinen, 201726 | 36 | 0 | NR | 6 (total) | NR | NR | FESS | 39 | NR | 7.5 (total) | NR | NR | No difference in operative time; sick leave & adhesions higher in ESS |
| Koskinen, 201627 | 28/36 | 0 | NR | NRa | NR | NR | FESS | 30/33 | NR | NRa | NR | NR | Symptom reduction similar; reduction in acute exacerbations, thick nasal discharge & blockage higher in ESS |
| Koskinen, 201228 | 24/40 | 0 | NR | 2 (R), 3 (L), median | NR | NR | FESS | 29/45 | NR | 4 (R), 4 (L), median | NR | NR | Similar VAS change; greater reduction with ESS |
| Payne, 201615 | 146 | ethmoidectomy, septoplasty, poylpectomy, turbinate reduction ( n NR) | BSD alone: 2.4 (1); BSD +/− adjunct: 2.5 (1) | 8.4 (5.1) | BSD alone 0.9 (0.8) [diff 1.6 (1.1)]; BSD +/− adjunct:0.8 (0.8) [diff 1.7 (1.1) |
NR | Medical Rx | 52 | 2.4 (0.9) | 8.7 (5.2) | 1.4 (1) [ difference 1 (1)] | NR | Patients with BD had significantly greater improvement in QOL vs MM;# polyposis, worse CT scores, depression did worse regardless of rx |
BD- balloon dilation, RS- rhinosinusitis, FEDS-functional endoscopic dilatation sinus surgery, FESS-functional endoscopic sinus surgery, IT- inferior turbinate, FS- frontal sinus, QOL- Quality of life, FRC- Frontal recess clearance, EMLP- Endoscopic modified Lothrop procedure, QOL- quality of life, Rx- therapy
Actual values not reported; median LM total on right significantly lower in BSD vs ESS, no difference on the left
SNOT-20 scores and SD scaled to be out of 5 for purposes of comparison.
comparator group included opposite sinus;
reported separately for groups with and without polyps but not overall
In an updated publication14 with follow-up of 12 months, greater improvements in self-reported QOL from baseline noted with BSD using the Chronic Sinusitis Survey Rhinosinusitis disability index measures and a trend toward improvement using the SNOT-20
A random effect model meta-analysis of these three studies (n=186 patients, 97 BSD, 89 FESS; Figure 2)17,18,23 showed the pooled difference in means to be 0.435 (0.054 to 0.817), a statistically significant difference favoring BSD over FESS, but less than the clinically meaningful difference of 0.8. Results from sensitivity analysis of seven studies (Supplementary Table) that included four additional studies with imputed SD10,19,25,30 (n=463 patients; 204 BSD, 259 FESS) for change in mean scores from baseline for 4 different correlations (using Corr of 0.1, 0.3, 0.5 and 0.8 (Figure 3)), showed the pooled estimate of difference in means (95% CI) of 0.221 (−0.001 to 0.443), 0.213 (0.00 to 0.426), 0.203 (0.002 to 0.403), and 0.175 (0.008 to 0.343) respectively.
FIGURE 2.
Meta-analysis for pooled difference in means (95% CI) for SNOT-20 scores in BSD vs FESS, where 0.8 is the clinically meaningful difference in scores (n=3 studies)
FIGURE 3.
Meta-analysis for pooled difference in means (95% CI) for SNOT-20 scores in BSD vs FESS including studies with imputed standard deviation, where 0.8 is the clinically meaningful difference in scores (n=7 studies)
Subgroup analyses were performed to delineate between randomized versus observational studies and BSD alone versus hybrid procedures. One subgroup analysis showed a further reduction in effect size for randomized studies compared to cohort studies (Supplementary Table). In a second subgroup analysis, the estimate for pooled difference in means was not clinically meaningful when FESS was compared to BSD alone nor when compared to hybrid interventions (Supplementary Table).
Post-operative data are summarized in Table 3. The shortest follow-up time was 6 months in RCTs and 3 months in cohort studies. No major complications were reported across all studies. Revision procedures were reported by 5 RCTs16,18–20 and 4 cohort15,23,24,27 studies. The overall rate of revision was low with comparable frequency between the two intervention groups.
TABLE 3.
Summary of post-BSD intervention course and follow-up
| Author, year | Complication types | Complications (n) | Post-recovery (days) BSD vs Sx | Post-BSD care | Revision procedures (n) | Minimum follow-up (mo) |
|---|---|---|---|---|---|---|
| RCT | ||||||
| Plaza, 201116 | Synechiae, minor bleeding in both groups | NR | NR | Oral abx + steroids x 1w, saline irrigation & topical steroid x 1m, debridement q.o.w x 8w as needed | 4 (1 in hybrid, 3 in ESS) | 12 (1 LTFU in each group) |
| Achar, 201217 | None | 0 | 2.2 vs 5 | saline spray x 6w, flixonase gtt x 4w followed by flixonase/nasone spray x 6w | NR | 6 |
| Cutler, 201318 | None | 0 | NR | 1 in each arm | 6 | |
| Marzetti, 201419 | None | 0 | NR | abx suspension x10d and acetaminophen as needed | 0 | 6 |
| Hathorn, 201520 | None | 0 | NR | oral steroid x1w, budesonide nasal rinses | 0 | 12 (73% at 12 mo, all until till 3 mo) |
| Bizaki, 20169 | Infection, crusting, synechiae, bleeding, anosmia | 9 in BD vs 16 in uncinectomy | NR | NR | NR | 6 (30/30 BSD, 30/32 uncinectomy) |
| Chandra, 201621 | None | 0 | 1.7 vs 5 | NR | 1/37 rev in BD, 2/29 in FESS @ 18 mo | 24 (130/135 at 12 mo, 66/135 at 18 mo, 25/135 at 24 mo) |
| Minni, 201822 | Frontal recess obstruction, synechiae | 9 | NR | Oral abx + steroids, nasal irrigation, topical steroids x 1 mo, weekly debridement as needed. | 9 | 12 |
| Hanci, 202012 | NR | NR | NR | NR | NR | NR |
| Cohort | ||||||
| Friedman, 200823 | turbinate lateralization and scarring | 8 in BSD vs 3 in FESS | NR | NR | 1 in BD vs 0 in FESS | 3 |
| Bozdemir, 201124 | None | 0 | NR | Cefuroxime x 5d, saline irrigations x 2w, topical mometasone spray x 10 mo | 0 | 12 |
| Di Girolamo, 201425 | None | 0 in BSD & ESS | NR | NR | NR | 3 mo (Death @ 3mo: 1 BSD, 5 in ESS)* |
| ElBadawey, 201410 | NR | NR | NR | NR | NR | 3 in prospective group (overall mean 12, range 6 to 24) |
| Koskinen, 202113 | NR | NR | NR | NR | 17 in BSD, 6 in ESS | Mean (min – max) FU in years: BSD: 5.3 (1–11) ESS: 9.8 (5–15) |
| Koskinen, 201726 | Postoperative adhesions not obstructing osteomeatal area | 0 (BSD), 8/38 (ESS) | median sick leave: 4 (2–14 d) in BD vs 14 (9–14) in ESS | debridement in ESS vs none in BSD | NR | Average FU: 52d in BSD (28/36), 33d in ESS (38/39) |
| Koskinen, 201627 | NR | NR | NR | debridement in ESS vs none in BSD | 4 (BSD), 0 (ESS) | 60; mean FU (y): BSD: 6.4 (5.6–7.3), ESS: 6 (4.9–6.9) |
| Koskinen, 201228 | NR | NR | NR | debridement in ESS vs none in BSD | NR | 18 |
| Payne, 201615 | 2 procedure-related events (TIA, dental crown), 1 postop sinus infection | 3 | 2 | care for BSD arm customized to disease process | 0 in BSD, 7/52 (13.5%) in MM had BSD | 6# |
LTFU= lost to follow-up, q.o.w- every other week, gtt-drops, TIA- transient ischemic attack, abx- antibiotics, Sx- surgery, MM-medical management, NR- not reported
cause of death unknown
Results were reported at longer follow-up of 12 months in an updated publication14
Assessment of quality:
Statistical heterogeneity was observed with I2 of 65%. The quality, risk of bias, and conflicts of interest across the RCTs and cohort studies are presented in Table 4 and 5, respectively. Among RCTs, there was a low risk for selection, attrition, and reporting bias and a high risk of performance bias and detection bias due to non-blinding of participants and personnel and outcome assessment (Table 4). Based on the NOS, lower scores were summated for the factors of comparability, independent outcome assessment, and follow-up criteria (Table 5). A funnel plot of studies with complete data was not valuable due to only 3 included studies, while the funnel plot for 7 studies with imputed SD did not show any obvious asymmetry concerning for publication bias (Supplementary Figure).
TABLE 4.
Quality, risk of bias, funding & COI assessment of RCTs
| Author, year | CEBM level | Random sequence allocation | Allocation concealment | Blinding participants/personnel | Blinding outcome assessment | Incomplete outcome | Selective reporting | Other sources | Funding | COI |
|---|---|---|---|---|---|---|---|---|---|---|
| Plaza, 201116 | 2 | −1 | 0 | −1 | −1 | −1 | 1 | 0 | Non-industry | unclear |
| Achar, 201217 | 2 | −1 | −1 | 1 | 1 | −1 | −1 | 0 | NR | unclear |
| Cutler, 201318 | 2 | −1 | −1 | 1 | −1 | −1 | −1 | 0 | Industry | Yes |
| Marzetti, 201419 | 2 | 1 | 1 | 1 | 0 | 0 | −1 | 0 | Non-industry | None |
| Hathorn, 201520 | 2 | −1 | −1 | 1 | −1 | 1 | −1 | 0 | Industry | No |
| Bizaki, 20169 | 2 | −1 | 1 | 1 | 1 | −1 | −1 | 0 | Non-industry | None |
| Chandra, 201621 | 2 | −1 | −1 | 1 | 0 | −1 | −1 | 0 | Industry | Yes |
| Minni, 201822 | 2 | 0 | 0 | 1 | 1 | −1 | 0 | 0 | NR | No |
| Hanci, 202012 | 2 | −1 | −1 | 1 | 1 | −1 | 1 | 0 | NR | No |
CEBM- Center of Evidence-Based Medicine, NR- not reported; High risk of bias = 1, unknown risk of bias = 0, low risk of bias = −1
TABLE 5.
Quality, risk of bias, funding & conflicts of interest (COI) assessment of cohort studies
| Author, year | CEBM level | Selection | Comparability | Outcome | Follow-up | Funding | COI | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Exposed cohort | Non-exposed cohort | Ascertainment of exposure | Outcome at start | Cohorts comparable | Assessment independent | Long enough | All accounted | ||||
| Friedman, 200823 | 3 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | Non-industry | None |
| Bozdemir, 201124 | 3 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | Non-industry | None |
| Di Girolamo, 201425 | 3 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | Not specified | None |
| ElBadawey, 201410 | 3 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | Non-industry | None |
| Koskinen, 202113 | 3 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | Non-industry | None |
| Koskinen, 201726 | 3 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | Non-industry | None |
| Koskinen, 201627 | 3 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | Non-industry | None |
| Koskinen, 201228 | 3 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 1 | Non-industry | None |
| Payne, 201615 | 3 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | Industry | Yes |
CEBM – Center of Evidence-Based Medicine
DISCUSSION
This systematic review and meta-analysis of the literature on BSD for chronic rhinosinusitis failed to identify a clinically meaningful difference in the patient-reported quality of life with the intervention of BSD vs FESS as measured by SNOT-20. This review also noted a small number of high-quality studies that investigated a difference in patient-reported quality of life as measured by the SNOT-20 items. A meta-analysis restricted to the studies reporting SD for changes from baseline showed the pooled difference in means to be 0.435 while a separate sensitivity analysis of the studies including the imputed values of SD for changes from baseline showed the pooled difference of means to be 0.237 assuming the highest level of correlation (Corr 0.8) between the pre- and post-intervention scores.
Our meta-analysis was limited by an incomplete reporting of the SD and mean difference between the pre- and post-intervention scores within each treatment group of BSD and FESS. We therefore, performed two analyses; one excluding the studies with incomplete reporting to reduce loss of precision and interpretation bias; and another sensitivity analysis where we used the available data to compute missing information. Both analyses failed to identify a clinically meaningful difference in the use of BSD versus FESS. Our results are similar to a previous meta-analysis by Levy et al who failed to note a significant difference in QOL improvement following intervention with BSD or FESS in their analysis of 2 RCTs.31 Cohort studies comparing the two interventions have not been analyzed by previous meta-analyses on BSD in CRS3,31 unlike our study where we included them for generalizability of the summary effect and also assessed them through subgroup analysis.
This narrative systematic review observed a significant heterogeneity in the eligibility criteria, type of intervention, sinuses treated during the intervention, operative settings, type of anesthesia, result reporting, post-intervention care, and follow-up duration. A paucity of studies with large sample size studies with robust follow-up was evident. Of all RCTs, Chandra et al21 reported results at 24 months but the study could not be included as no SD was given for the change of scores from baseline. Furthermore, among the 135 patients originally reported in the multicenter study (74 balloon dilation, 61 FESS),18 the follow-up data at 24 months was available for 25/135 (18.5%) patients.21
We also noted most of the studies utilized a hybrid approach that included other sinonasal procedures in addition to BSD. For instance, Plaza et al16 performed septoplasty and/or partial middle turbinectomy in addition to BSD to increase access to the frontal sinus outflow for all patients. Hybrid procedures were also performed for CRS with polyposis including polypectomy, uncinectomy, ethmoidectomy and wide maxillary antrostomy.10,16,19,24,25 However, subgroup analysis did not reveal a clinically meaningful difference in outcomes between FESS and BSD alone nor FESS and hybrid procedures. It was also difficult to assess comparability of patient cohort between the intervention groups particularly in cohort studies for factors such as baseline comorbidities and the presence of nasal polyps. Many studies included patients with polyposis, however, data was not reported for the proportion of such patients within each intervention group,15,17,18,20,21,25 and it was unclear in certain studies28 if patients with a previous history of polyps or with current polyps were included. This is important since the presence of polyposis alone regardless of the intervention type can have a significant impact on health-related QOL.32,33
Secondary outcomes, such as Lund-Mackay scores, postoperative sinus infections, operating time or cost, patient satisfaction, postoperative narcotics usage, or olfactory function were not consistently reported and therefore, could not be analyzed. Cost analysis was performed by Friedman et al23 who reported cost to be similar for primary procedures, however, the cost for revision surgery using BDS was less. The complications and revision surgery rates were low in both intervention groups. Common complications reported more frequently after BSD included synechiae, turbinate lateralization, and scarring.16,23,28
Our analysis reports on eight studies in which patients with nasal polyps were included. The effectiveness of balloon dilation of the sinuses in patients with nasal polyps is uncertain, especially if the polyps are not addressed in a hybrid fashion. At present, the CCS published by the AAO-HNS does not support the use of balloon dilation as sole or adjunct procedure in the management of nasal polyps. Many surgeons may find the balloon to be useful as a tool in these patients, in essence serving as a secondary “navigation” device or facilitating additional dissection. However, in the studies reported in our analysis, balloon technology was used as the primary procedure for the applicable sinus, with or without polypectomy performed at the same time. While it can be difficult to extrapolate the isolated benefit of balloons in this population, the results may at least indicate that there can be some role.
The strengths of this systematic review include the comprehensive search strategy, inclusion of articles assessed for CCS, independent quality and level of evidence assessment, rigorous analysis, and inclusion of the risk of bias assessment. In the presence of multiple publications, we selected to include the study with larger sample size, complete outcome reporting, and longer follow-up. Sensitivity analysis increased precision of our estimates and showed that the overall results remained robust to the use of imputed SD at different levels of the correlation coefficients. Some RCTs were judged to be high in risk of bias, particular concerns were lack of blinding of study personnel and patients, while some of the cohort studies were deemed low quality due to lack of comparable cohorts and short follow-up. Funding and COI data was also collected. Of the RCTs, three each were industry18,20,21 and non-industry9,16,19 funded while the funding was not clearly reported by three (TABLE 4).12,17,22
This systematic review is limited in drawing inferences about the effectiveness of BSD vs FESS or BSD vs medical management due to the small number of studies designed to provide such results and the significant heterogeneity among study variables. Heterogeneity was evidenced in a variety of ways, most importantly the type of intervention, sinuses approached, and duration of follow-up. In addition, the use of non-validated patient-reported outcome questionnaires prevented adequate analysis of the studies16,20,24,28 even though they were included in the narrative review. Using a non-validated questionnaire, Koskinen et al28 reported greater symptom reduction after FESS than after BSD when observing CRS patients with at least one comorbidity such as asthma, previous nasal polyps, or allergic rhinitis.
In conclusion, there is an absence of high-quality evidence that assesses the efficacy of BSD versus FESS in the management of CRS patients with or without polyposis. This meta-analysis suggests a statistically but not clinically significant greater increase in SNOT-20 scores after BSD compared to FESS. However, there was significant heterogeneity and inconsistency across studies in reporting eligibility criteria, baseline characteristics, follow-up, and outcomes. These limitations preclude definitive conclusions on how patient-related quality of life compares between the two approaches. To fully inform CRS patient management, further research should include well-defined eligibility criteria, comparative treatments with BSD alone versus endoscopic sinus surgery or hybrid procedures, medical management with nasal saline lavage with corticosteroids, appropriate control groups, inclusion of widely used and validated patient-reported outcome measures, and pre-specified subgroup analysis of patients with polyposis and germane comorbidity profiles. Future studies which report these data will inform BSD treatment practices.
Supplementary Material
SUPPLEMENTARY FIGURE. Funnel plot showing no publication bias in the analyzed studies (n=7) that reported SNOT-20 scores for BSD vs FESS interventions
Acknowledgements
The authors would like to acknowledge Lauren Yaeger, medical librarian who created the literature search strategies for this review.
Funding:
Research by Dr. Sinha and Dr. Tharakan reported in this publication was supported by the National Institute of Deafness and Other Communication Disorders within the National Institutes of Health, through the “Development of Clinician Researchers in Academic ENT” training grant, award number T32DC000022. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health.
Footnotes
Presentations: None.
Conflicts of Interest: None
REFERENCES
- 1.US Food, Drug Administration. Medical Devices. April 2005 Clearances. https://www.fda.gov/medical-devices/510k-clearances/search-releasable-510k-database (accessed 10 November 2020).
- 2.Laury AM, Bowe SN, Stramiello J, McMains KC. Balloon dilation of sinus ostia in the Department of Defense: Diagnoses, actual indications, and outcomes. Laryngoscope. 2017;127(3):544–549. [DOI] [PubMed] [Google Scholar]
- 3.Ahmed J, Pal S, Hopkins C, Jayaraj S. Functional endoscopic balloon dilation of sinus ostia for chronic rhinosinusitis. Clin Otolaryngol. 2012;37(3):221–221. [DOI] [PubMed] [Google Scholar]
- 4.Catalano PJ. Balloon dilation technology: Let the truth be told. Curr Allergy Asthma Rep. 2013;13(2):250–254. [DOI] [PubMed] [Google Scholar]
- 5.Chaaban MR, Baillargeon JG, Baillargeon G, Resto V, Kuo YF. Use of balloon sinuplasty in patients with chronic rhinosinusitis in the United States. Int Forum Allergy Rhinol. 2017;7(6):600–608. [DOI] [PubMed] [Google Scholar]
- 6.Svider PF, Darlin S, Bobian M, et al. Evolving trends in sinus surgery: What is the impact of balloon sinus dilation? Laryngoscope. 2018;128(6):1299–1303. [DOI] [PubMed] [Google Scholar]
- 7.Piccirillo JF, Payne SC, Rosenfeld RM, et al. Clinical Consensus Statement: Balloon Dilation of the Sinuses. Otolaryngol - Head Neck Surg (United States). 2018;158(2):203–214. [DOI] [PubMed] [Google Scholar]
- 8.Cochrane handbook for Systematic Reviews of Interventions https://handbook-5-1.cochrane.org/chapter_9/9_2_3_2_the_standardized_mean_difference.htm (Accessed 10 November 2020). Published online 2010.
- 9.Bizaki AJ, Numminen J, Taulu R, Rautiainen M. 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. 2016;41(6):673–680. [DOI] [PubMed] [Google Scholar]
- 10.ElBadawey MR, Alwaa A, ElTaher M, Carrie S. Quality of life benefit after endoscopic frontal sinus surgery. Am J Rhinol Allergy. 2014;28(5):428–432. [DOI] [PubMed] [Google Scholar]
- 11.Piccirillo JF, Merritt MG, 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. [DOI] [PubMed] [Google Scholar]
- 12.Hanci D, Gürpinar B, Üstün O, Kumral TL, Karaketir S, Uyar Y. Comparison of the Olfactory Functions in Conventional Endoscopic Sinus Surgery to the Balloon Sinuplasty in Frontal Sinus Surgery. J Craniofac Surg. 2020;31(6):1731–1733. [DOI] [PubMed] [Google Scholar]
- 13.Koskinen A, Lundberg M, Lilja M, et al. Long-Term Follow-Up After Maxillary Sinus Balloon Sinuplasty and ESS. Ear, Nose Throat J. 2021;31(6):014556132098603. [DOI] [PubMed] [Google Scholar]
- 14.Stolovitzky JP, Mehendale N, Matheny KE, et al. Medical Therapy Versus Balloon Sinus Dilation in Adults With Chronic Rhinosinusitis (MERLOT): 12-Month Follow-up. Am J Rhinol Allergy. 2018;32(4):294–302. [DOI] [PubMed] [Google Scholar]
- 15.Payne SC, Stolovitzky P, Mehendale N, et al. Medical therapy versus sinus surgery by using balloon sinus dilation technology: A prospective multicenter study. Am J Rhinol Allergy. 2016;30(4):279–286. [DOI] [PubMed] [Google Scholar]
- 16.Lefevre F, Rosenberg AB. Balloon dilation of the frontal recess: a randomized clinical trial. Ann Otol Rhinol Laryngol. 2012;121(10):511–518. [PubMed] [Google Scholar]
- 17.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. 2012;32(5):314–319. [PMC free article] [PubMed] [Google Scholar]
- 18.Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: A prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013;27(5):416–422. [DOI] [PubMed] [Google Scholar]
- 19.Marzetti A, Tedaldi M, Passali FM. The role of balloon sinuplasty in the treatment of sinus headache. Otolaryngol Pol. 2014;68(1):15–19. [DOI] [PubMed] [Google Scholar]
- 20.Hathorn IF, Pace-Asciak P, Habib ARR, Sunkaraneni V, Javer AR. Randomized controlled trial: Hybrid technique using balloon dilation of the frontal sinus drainage pathway. Int Forum Allergy Rhinol. 2015;5(2):167–173. [DOI] [PubMed] [Google Scholar]
- 21.Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016;126(1):44–50. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Minni A, Dragonetti A, Sciuto A, et al. Use of balloon catheter dilation and steroid-eluting stent in light and severe rhinosinusitis of frontal sinus: A multicenter retrospective randomized study. Eur Rev Med Pharmacol Sci. 2018;22(21):7482–7491. [DOI] [PubMed] [Google Scholar]
- 23.Friedman M, Schalch P, Lin HC, Mazloom N, Neidich M, Joseph NJ. Functional endoscopic dilatation of the sinuses: Patient satisfaction, postoperative pain, and cost. Am J Rhinol. 2008;22(2):204–209. [DOI] [PubMed] [Google Scholar]
- 24.Bozdemir K, Kutluhan A, Çetin H, Yalçiner G, Bilgen AS. 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. [DOI] [PubMed] [Google Scholar]
- 25.Di Girolamo S, Mazzone S, Di Mauro R, Giacomini P, Cantonetti M. Surgical management of rhinosinusitis in onco-hematological patients. Clin Exp Otorhinolaryngol. 2014;7(4):302–306. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26.Koskinen A, Mattila P, Myller J, et al. Comparison of intra-operative characteristics and early post-operative outcomes between endoscopic sinus surgery and balloon sinuplasty. Acta Otolaryngol. 2017;137(2):202–206. [DOI] [PubMed] [Google Scholar]
- 27.Koskinen A, Myller J, Mattila P, et al. Long-term follow-up after ESS and balloon sinuplasty: Comparison of symptom reduction and patient satisfaction. Acta Otolaryngol. 2016;136(5):532–536. [DOI] [PubMed] [Google Scholar]
- 28.Koskinen A, Penttilä M, Myller J, et al. Endoscopic sinus surgery might reduce exacerbations and symptoms more than balloon sinuplasty. Am J Rhinol Allergy. 2012;26(6):150–156. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 29.Hathorn I, Habib AR, Santos RD, Javer A. The safety and performance of a maxillary sinus ostium self-dilation device: A pilot study. Int Forum Allergy Rhinol. 2014;4(8):625–631. [DOI] [PubMed] [Google Scholar]
- 30.Bizaki AJ, Numminen J, Taulu R, Rautiainen M. A controlled, randomized clinical study on the impact of treatment on antral mucociliary clearance: Uncinectomy versus balloon sinuplasty. Ann Otol Rhinol Laryngol. 2016;125(5):408–414. [DOI] [PubMed] [Google Scholar]
- 31.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 (United States). 2016;154(1):33–40. [DOI] [PubMed] [Google Scholar]
- 32.Poetker DM, Mendolia-Loffredo SST. Outcomes of endoscopic sinus surgery for chronic rhinosinusitis associated with sinonasal polyposis. Am J Rhinol. 2007;21(1):84–88. [DOI] [PubMed] [Google Scholar]
- 33.Alobid I, Benítez P, Bernal-Sprekelsen M, et al. Nasal polyposis and its impact on quality of life: Comparison between the effects of medical and surgical treatments. Allergy Eur J Allergy Clin Immunol. 2005;60(4):452–458. [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
SUPPLEMENTARY FIGURE. Funnel plot showing no publication bias in the analyzed studies (n=7) that reported SNOT-20 scores for BSD vs FESS interventions