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Abstract

Importance

Idiopathic subglottic stenosis is a debilitating and recurrent disease, often requiring reintervention. Balloon dilation is a well-recognized, minimally invasive treatment to alleviate symptoms, and is typically performed in the operating room. In-office balloon dilation in the awake patient has rarely been reported, and may obviate the need for general anesthesia in this patient population.

Objective

This study aims to detail the safety and efficacy of in-office balloon dilation for mild to moderate subglottic stenosis.

Design

Mixed-methods study.

Setting

Single tertiary-care institution in Montreal, Canada.

Participants and Intervention

All adult patients with Cotton-Myer Grade I-II idiopathic subglottic stenosis undergoing in-office balloon dilation between June 1, 2022 and August 1, 2023 were prospectively recruited.

Main Outcome Measures

Pre- and post-procedure validated dyspnea and voice scales, airway diameter and spirometry values were obtained. Patient- and physician-reported adverse events were thoroughly documented.

Results

Eleven patients underwent in-office balloon dilation during the study period (F:M 10:1, mean age 55.8 years). The median Dyspnea Index and voice handicap index-10 scores both significantly decreased following the procedure. In-office balloon dilation improved airway patency, with an estimated median of 40% to 10% stenosis (median difference −25%, 95% CI (−45, −15), P = .003). The normalized peak expiratory flow percentage significantly increased from a median of 62% to 99% (median difference 27%, 95% CI (19, 40), P = .004). The median time to regular activities was one day. Six patients having previously undergone the procedure under general anesthesia indicated a preference for in-office dilation. There were no severe adverse events.

Conclusion and Relevance

In-office balloon dilation is a safe and effective option for the management of mild-moderate idiopathic subglottic stenosis, with demonstrated improvement in both patient-reported outcomes and objective measures.

Keywords

idiopathic subglottic stenosis balloon dilation in-office procedures local anesthesia

Graphical Abstract

Introduction

Subglottic stenosis is a rare yet debilitating disease, which presents a significant challenge to both patients and clinicians due to its profound impact on quality of life.¹ The condition may arise from various etiologies, including intubation-related injury, trauma, autoimmune diseases, or congenital anomalies.² However, in up to a third of patients there is no identifiable cause, and these cases are thus termed idiopathic.³ Idiopathic subglottic stenosis (iSGS) results from a fibroinflammatory process, typically affecting middle-aged women, with recurrent and progressive unprovoked upper airway narrowing at the level of the cricoid cartilage and upper trachea.^4,5

There are several management options for iSGS, ranging from endoscopic procedures (including laser, cold steel, balloon dilation, and submucosal infiltration of steroids or chemotherapeutic agents) to more invasive options such as cricotracheal reconstruction or a permanent tracheostomy.^1,5 Endoscopic techniques remain the favored approach given their improved safety and tolerability profile; however multiple treatments are often required due to the recurrent nature of the disease.¹ To mitigate the need for recurrent general anesthesia as well as expedite patient recovery and return to daily activities, some authors have advocated for outpatient or in-office management of subglottic stenosis for patients with mild to moderate disease.^6-8 Our institution has offered balloon dilation under topical anesthesia for patients with grade I or II iSGS (as assessed by the Cotton-Myer scale⁹) for the past 2 years.

We herein describe the safety and efficacy of office-based balloon dilation in a mixed-method study of patients with iSGS. The primary objective of this pilot study was to assess objective and subjective symptom improvement, safety, and tolerability of the procedure through pre- and post-procedural questionnaires with validated dyspnea indices, as well as objective changes in endoscopic findings and spirometry metrics.

Materials and Methods

Study Design, Setting, and Population

All adult patients with Cotton-Myer Grade I-II iSGS undergoing in-office balloon dilation at the Voice Laboratory of the Royal Victoria Hospital between June 1, 2022 and August 1, 2023 were prospectively recruited. Candidacy for in-office balloon dilation was assessed by the staff surgeon based on disease and patient characteristics. Patients with severe stenosis (Cotton-Myer Grade III-IV) and those with a confirmed systemic or traumatic etiology were excluded. Furthermore, patients with a comorbid chronic lung pathology with anticipated poor pulmonary reserve (eg, uncontrolled asthma and chronic obstructive pulmonary disease), recent acute respiratory tract infection (<4 weeks), neurologic or cognitive impairment precluding effective communication with the team, uncontrolled anxiety, and those preferring the procedure be performed under general anesthesia were excluded. This study was approved by the McGill University Health Center Research Ethics Board (ID: 2023-8979).

Procedure

All procedures were performed in the laryngology clinic of a quaternary care academic hospital. The surgical team consisted of a staff laryngologist (K.K. or J.Y.), a senior otolaryngology resident or fellow, and one nurse. The clinic is physically located across the emergency department, with access to emergency equipment and personnel. Two simple hand gestures were reviewed with patients both at the initial scheduling visit, and immediately prior to the procedure: a “thumbs-up” indicating readiness to hold their breath for balloon inflation, and an open hand (i.e. “stop” sign) indicating near maximal breath-holding capacity and the need to rapidly deflate the balloon. In addition, patients were instructed to practice both breath holding and the hand gestures at home between the initial visit and the planned procedure. All patients confirmed they understood these symbols and verbalized they felt comfortable and in control prior to starting the procedure.

Up to 1 cc of a solution of 3% lidocaine + 0.25% phenylephrine was first used to anesthetize and vasoconstrict both nasal cavities. Up to 10 ccs of 2% lidocaine in total were then instilled through the working channel of a flexible endoscope for a laryngeal gargle as previously described by Hogikyan.¹⁰ Some patients required additional trans-cricothyroid or trans-tracheal airway instillation of 1 cc of 2% lidocaine to achieve optimal topical anesthesia. The cumulative total dose of topical lidocaine if all three methods are used (nebulized, laryngeal gargle and transcervical instillation) is 250 mg, thus below the maximum reported safe dose of topical lidocaine for patients weighing over 55 kg (ie, 4.5 mg/kg, up to 300 mg). Doses used are often lower, and are further reduced for patients weighing less than 55 kg to stay within the recommended safe threshold.

A high-compliance balloon (Hercules^® 3 Stage Wire Guided Balloon, Cook Medical, Indiana, USA, size 10–12, 12–15, or 15–18 mm) was then inserted transnasally (either through the same or contralateral nostril depending on nasal patency), and advanced to the level of the subglottis under direct visualization (Figure 1). Maintaining the guide wire inside the balloon and gently curving the balloon wire allowed for easier passage through the nasopharynx as well as directing the balloon anteriorly toward the larynx. The balloon was inflated to a maximum of 6 atmospheres of pressure under visualization for up to 30 seconds or until the patient signaled to deflate (Figure 2). The procedure was performed under continuous oxygen saturation monitoring, and patients remained in the clinic for a 30-minute observation period post-procedure.

Figure 1.

In-office balloon dilation performed under continuous oxygen saturation after transnasal and laryngeal topicalization.

Figure 2.

Endoscopic images of the pre-dilation subglottic stenosis (A), balloon positioning (B), inflation (C), and post-dilation subglottic airway with near normal diameter (D).

A previous case report described balloon entrapment in the subglottis of a pediatric patient using the Acclarent Inspira AIR balloon dilation system, leading to a Class I Food and Drug Administration recall.¹¹ In an abundance of caution, our institutional protocol includes keeping an 18-gauge needle loaded on a large syringe on the table (both in-office and in the operating room), should it be required for urgent transcervical deflation. This emergency measure has thankfully never been required, either in the operating room or in the outpatient department.

Adjunct medical management included routine proton-pump inhibitor therapy, and consideration of intralesional triamcinolone in cases where early scarring/fibrosis was noted at the follow-up visit.

Outcomes

Pertinent data was retrieved from the electronic medical records by one author (C.R.), including patient demographics, comorbidities, and disease characteristics (date of diagnosis, severity of stenosis, presumed etiology based on prior investigations, and any prior operation room or in-office interventions).

Patients were asked to complete pre- and post-procedural questionnaires available in both national languages (English and French) when consented to the procedure and at the first in-clinic follow-up. These questionnaires (see Supplemental Material) included the following validated scales: the dyspnea index (DI), modified Medical Research Council (mMRC) dyspnea scale and the voice handicap index-10 (VHI-10). The post-procedural questionnaire additionally included a 10-point visual analog scale (VAS) of pain levels during the procedure and any side effects noted as a free response format. Finally, patients having previously undergone an endoscopic procedure under general anesthesia were asked to compare the average length of time to return to regular functions and indicate their preference between in-office dilation and procedures under general anesthesia.

The estimated degree of stenosis before and after each procedure was established through a review of the recorded flexible nasolaryngotracheoscopy, as graded by one of two senior laryngologists (K.K. or J.Y.). Pre- and post-procedure spirometry testing was requested for all included patients. Previous studies have shown the peak expiratory flow percentage (PEF%) may be used as a surrogate measure of disease severity and correlates with quality of life; it was therefore chosen as the index measure.¹²

Data Analysis

Descriptive statistics are presented as counts and percentages for categorical variables and as means and standard deviations (SD) for continuous variables when the values followed an approximately normal distribution; otherwise, the medians and interquartile ranges (IQR: 25th percentile; 75th percentile) were reported.

The DI and VHI-10 were treated as continuous variables, as they represent total scores from an aggregate of items graded on a Likert scale.¹³ Thus, changes in median values pre- and post-procedure for these variables, as well as for airway diameter and spirometry values (PEF%, FVC%, FEV1%, and FEV1/FVC) were investigated using the Wilcoxon signed-rank test.

The mMRC scale was considered a categorical ordinal variable since it is a Likert item with only five discrete values. Results were presented as the number of patients whose scores either increased, decreased, or remained stable from pre- to post-procedure.

All statistical tests of the hypothesis were two-sided and performed at a significance level of .05. Confidence intervals (CI) were computed suing bootstrap methods. Data analysis was performed using R statistical software.¹⁴

Results

Patients

Twelve patients presenting to the Voice Laboratory of the Royal Victoria Hospital were assessed for eligibility. One patient was deemed ineligible due to a complex tracheal stenosis secondary to an inhalational injury. A total of 11 patients were ultimately included (Table 1). Ten patients (90.1%) were female, and the mean age was 55.8 years (SD 12.9).

Table 1.

Patient Demographics and Disease Characteristics.

Patient demographics (N = 11)
Gender (F:M)	10:1
Age (years), mean (SD)	55.8 (12.9)
Comorbidities, n (%)
Hypertension	6 (54.5)
Hypothyroidism	4 (36.4)
Asthma	2 (18.2)
Gastroesophageal reflux disorder	2 (18.2)
Dyslipidemia	1 (9.1)
Depression	1 (9.1)
Disease characteristics
Length of time since initial diagnosis, median (IQR), months	48.9 (8;84)
Prior surgeries
Balloon dilation, laser, or	6 (54.5%)
Steroid injection under general	Range 1-6 procedures
Anesthesia
None	5 (45.5%)

Abbreviations: IQR, Interquartile range: 25th percentile; 75th percentile; SD, standard deviation.

Since there was no identified etiology in all cases despite biopsies and an exhaustive rheumatological workup, they were labeled as idiopathic. Six of the included patients had had prior iSGS treatments performed under general anesthesia. It bears mention one included patient had a previous attempt at dilation under general anesthesia at an outside institution which was aborted due to poor exposure.

All included patients underwent a successful in-office dilation. The number and duration of insufflations are reported in Table 2. One patient additionally received an in-office intralesional injection of 1 mL of triamcinolone 40 mg/mL upon noting an area of early scarring 6 weeks after the dilation. The time to first follow-up was a median of 35 days post-procedure (IQR 24.5; 48).

Table 2.

Number and Duration of Insufflation.

Balloon insufflations	First	Second	Third	Unknown
Patients	8	6	1	3
Duration (seconds; median, IQR)	17.5 (10; 20)	17.5 (14.3; 25.3)	8	—

All patients completed the pre- and post-procedure questionnaires and underwent a pre- and post-nasolaryngotracheoscopy for endoscopic assessment of airway caliber. Pre- and post-procedure spirometry data is available for nine patients, as two patients did not present to their spirometry appointment.

Validated Dyspnea and Voice Questionnaires

The DI scores were decreased post-procedure from a median score of 31 (IQR 26.5; 32) to 6 (IQR 4; 13), median difference of -23 [95% CI (−28, −8), P = .003; Figure 3A]. For reference, previous authors have described a 4-point change in DI scores as the minimally important difference in patients with laryngotracheal stenosis.¹⁵ Scores on the mMRC dyspnea scale decreased in 9/11 patients, remained stable from 1 to 1 in one patient, and increased from 0 to 1 in another patient (Figure 4). VHI-10 scores decreased from a median of 13 (IQR 6.5; 23) to 5 (IQR 1.5; 9.5), median difference of −7 [95% CI (−18, −4), P = .002; Figure 3B], the minimally important difference being previously reported as a decrease of 6 points.¹⁶

Figure 3.

Pre- and postoperative patient-reported dyspnea and voice-related questionnaires: (A) dyspnea index and (B) voice handicap index-10 (VHI-10), as well as the percentage of airway stenosis as estimated by tracheoscopy (C) and predicted peak expiratory flow (PEF%) (D).

Figure 4.

Distribution of pre- (light gray) and post-procedure (dark gray) scores on the mMRC dyspnea scale.

Estimated Airway Diameter and Spirometry

The estimated degree of stenosis as assessed by nasolaryngotracheoscopy decreased from a median of 40% (IQR 30; 55) to 10% (IQR 5; 17.5), median difference −25% [95% CI (−45, −15), P = .003] (Figure 3C). The normalized PEF% significantly increased from a median of 62% (IQR 54; 99) prior to procedure, to 99% (IQR 88.5; 109.5), median difference 27% [95% CI (19, 40), P = .004; Figure 3D]. There was no significant change in pre- and post-procedure FEV1%, FVC% and FEV1/FVC ratio (Table 3).

Table 3.

Pre- and Post-Procedural Spirometry Data.

Parameter	Pre-procedure (median, IQR)	Post-procedure (median, IQR)	Median difference (95% CI)	P-value
PEF%	62 (55; 98)	99 (94; 111)	27 (19, 40)	.004
FEV1%	99 (77; 102)	100 (87; 103)	2 (−6, 4)	.07
FVC%	104 (83; 112)	103 (99; 109)	2 (−3, 15)	1
FEV1/FVC	74 (70; 80)	77 (75; 83)	3 (−2, 9)	.19

Abbreviations: CI, confidence interval; FEV1%, percentage predicted of forced expiratory volume in 1 s; FVC%, percentage predicted of forced vital capacity; FEV1/FVC, forced expiratory volume in 1 s to forced vital capacity ratio; IQR, Interquartile range: 25th percentile; 75th percentile; PEF, peak expiratory flow.

Preference for Setting

All six included patients having previously undergone a subglottic airway procedure under general anesthesia (either laser, balloon dilation, and/or submucosal steroid injections) indicated a preference for the in-office setting on the post-procedural questionnaire. An open question inquiring on the reasoning behind this preference elicited the following responses: “quicker, still effective,” “no stress of staying or waiting in the hospital,” “more interactions with surgical and nursing team.”

Pain, Tolerability, and Reported Adverse Events

Included patients graded the pain threshold during the procedure on a 10-point VAS at a median of 3 (IQR 1.5; 5). Nine of 11 patients reported feeling in control during the procedure. The other two patients who answered “no” were patients having previously undergone a procedure under general anesthesia and nevertheless reported a preference for the in-office setting. One indicated being “nervous about the procedure” which she reported would likely be alleviated with a “tranquilizer and soothing music,” while the other quoted a “faster recuperation” as the main advantage. Two patients experienced minor subjective airway restriction following the procedure lasting two days. The only other reported adverse events included transient odynophagia in two patients and a mild cough in one patient.

Patients reported returning to their regular activities at a median of 1 day (IQR 1; 2.5) after the in-office procedure. In contrast, the six patients having previously undergone procedures under general anesthesia reported returning to regular activities at a median of 7 days (IQR 2.5; 7).

Time to Recurrent Surgical Procedure and Length of Follow-up

The median follow-up was 11.8 months (IQR 7.2; 13.0). Three patients developed symptomatic recurrence requiring a repeat dilation at 5.4, 7.1, and 10.6 months. All opted for repeat dilation under local anesthesia.

Discussion

Idiopathic subglottic stenosis is a life-altering diagnosis for many patients, who must often navigate through cycles of recurrent disease-related symptoms and treatment-related morbidity. In an online account, one patient with iSGS coined the term “stenosis sufferers” to denote the shared lived experience of patients afflicted with this rare and recurrent disease.¹⁷ While there is a growing body of data on the various surgical techniques, there is a paucity of literature regarding outpatient balloon dilation under local anesthesia,¹⁸ a technique which may both facilitate and accelerate the post-procedure recovery and return to regular activities. The protocol presented in this study has validated the procedure with significant improvement in both patient-reported outcomes and objective spirometry data, with minimal associated morbidity.

While in-office procedures remain largely unexplored, prior authors have reported endoscopic treatment of subglottic stenosis in the awake or lightly sedated patient in the operating room. Andrews et al retrospectively studied 18 patients having undergone tracheoplasty using combined laser and balloon dilation with a short-acting narcotic infusion and local anesthesia, with no complications.⁸ Similarly, Leventhal et al described successful endoscopic management with Nd:YAG laser ablation of subglottic stenosis in 16 patients using light sedation with midazolam and ketamine.² Hsu and Damrose further reported on the safety of same-day discharge following endoscopic airway dilation performed under general anesthesia, with no overnight complications in 21 inpatient and 93 outpatient procedures.⁷ As such, the authors postulate outpatient treatment is a safe and viable option, particularly in patients with iSGS who are, epidemiologically, typically middle-aged and healthy females.⁷

Two recent retrospective studies described in-office submucosal steroid injections for idiopathic subglottic stenosis, with a favorable tolerability and safety profile.^6,19 Hoffman et al. retrospectively studied 16 patients having undergone on average 3 office-based transnasal injections of triamcinolone acetonide 40 mg/mL with a statistically significant improvement in DI and mMRC scores, as well as degree of stenosis.⁶ Franco et al similarly reported improved airway caliber and predicted peak expiratory flow in six patients having undergone six to seven in-office subglottic steroid injections.¹⁹

Our study further expands this foundational work by describing in-office, outpatient balloon dilation with improved airway patency, patient-reported dyspnea measures, and PEF%. As was the case in the series by Hoffman et al,⁶ two of our patients experienced a minor subjective increased sensation of airway restriction lasting less than 48 hours after the procedure. While patients should be counseled that a stable and minor sensation of restriction may be expected, progressive or severe symptoms should prompt urgent medical attention.

Potential benefits to this in-office procedure when compared to general anesthesia included an earlier return to regular activities, described as resumption of work and light exercise. Patients used the free text box to describe an increased “self-sufficiency” and “less grogginess” after in-office dilations under local anesthesia when compared to general anesthesia. Ease of scheduling, decreased time spent in the hospital on the day of the procedure, and active patient participation in the procedure were additional quoted advantages. Finally, while not a primary consideration in the care of individual patients, the cost-effectiveness of in-office procedures is a well-established additional benefit in the laryngology literature, as described for laryngeal biopsies.²⁰

An important consideration in performing procedures under local anesthesia, particularly when working in the airway, is careful patient selection and preparation. Our protocol relies on clear, simple instructions, and teaching of hand gestures. Patients are frequently reminded they are completely in control of the timing of inflation and deflation. With appropriate counseling, teaching, and careful topicalization of the nasal cavities, oropharynx, laryngeal inlet, and subglottis, we found the procedure to be very well tolerated. This was supported by the finding that all patients having previously undergone a procedure under general anesthesia reported preferring the in-office setting.

The time to symptomatic recurrence requiring repeated intervention constitutes an important metric of procedural success in the iSGS literature. The largest study to date included 724 patients treated endoscopically, with or without adjuvant medical therapy, recruited through social media by close collaboration with patient advocates and referral from high-volume centers.¹ While perioperative complications were minimal, the authors report that 23.5% of patients treated endoscopically had disease recurrence within the 3-year study period.¹ Our study showed a comparable rate of recurrence, with 3 of 11 patients (27.3%) requiring repeat dilation, albeit with a shorter follow-up period. However, when recurrences do occur, the in-office setting allows for prompt and efficient treatment. This may be of particular importance in a context of scarce operation room resources, which is omnipresent in publicly funded healthcare systems.

In a recent systematic review highlighting the wide variety of reported endoscopic procedures, including cold steel, balloon or rigid dilation, laser (CO₂ or Nd:YAG), and corticosteroids or mitomycin C injections, there was no clearly superior technique.²¹ While combined techniques were associated with better outcomes, no included study reported on balloon dilation only.²¹ Our current protocol entails single-modality treatment with high-compliance balloons, with intralesional triamcinolone injection at the follow-up visit if early scarring or inflammation was noted (as was the case in one patient). Compared to treatments under general anesthesia, in-office balloon dilation in the awake patient is limited with regards to duration of inflation, and combination treatment with various endoscopic modalities may be challenging in a single sitting. Our results have thus far been satisfactory with a staged submucosal corticosteroid infiltration on an as needed basis, but ancillary prospective trials will be required to investigate patient tolerability and effect on time to recurrence with combined approaches.

Finally, this study is not without limitations. First, our study included a limited sample size due to the rarity of the disease. Second, the suitability/efficacy of this procedure in patients with subglottic stenosis from a known etiology remains uncertain. Procedure-specific parameters including optimal balloon size, maximal pressure, and duration of insufflation require future study. Additionally, length of follow-up was variable with some patients having only recently undergone a dilation, limiting our ability to establish a median time to recurrence. Lastly, the inclusion of a control group undergoing the procedure in the standard operating room setting was not possible due to the rarity of this disease. Patients having experienced both settings were thus asked to retrospectively detail treatments under general anesthesia and the associated recovery process, introducing a possible recall bias.

Conclusion

This pilot study supports in-office balloon dilation under local anesthesia as a feasible and effective option for the management of mild to moderate iSGS, expanding our therapeutic armamentarium for this debilitating condition. While careful patient selection and preparation is imperative for procedural success, our experience has shown that in-office balloon dilation improved patient-reported outcomes, degree of stenosis, and spirometry parameters with minimal associated morbidity in this patient population.

Supplemental Material

sj-docx-1-ohn-10.1177_19160216251314764 – Supplemental material for In-Office Balloon Dilation for Idiopathic Subglottic Stenosis: A Pilot Study

Supplemental material, sj-docx-1-ohn-10.1177_19160216251314764 for In-Office Balloon Dilation for Idiopathic Subglottic Stenosis: A Pilot Study by Catherine F. Roy, Antonia Lagos-Villaseca, José A. Correa, Jennifer A. Silver, Eli Layous, Anne V. Gonzalez, Jonathan Young and Karen M. Kost in Journal of Otolaryngology - Head & Neck Surgery

Footnotes

Acknowledgements

None

Authors Contributions

Catherine Roy: Design, data acquisition, analysis and interpretation of data, creation of figures and supplementary materials, preparation and review of manuscript. Antonia Lagos-Villaseca: Data acquisition, analysis and interpretation of data, preparation, and review of manuscript. José A. Correa: Analysis and interpretation of data, creation of figures and supplementary materials, preparation and review of manuscript. Jennifer A. Silver: Data acquisition, creation of figures and supplementary materials, review of manuscript. Eli Layous: Design, data acquisition, review of manuscript. Anne Valerie Gonzalez: Design, data acquisition, analysis and interpretation of data, review of manuscript. Jonathan Young: Data acquisition, review of manuscript. Karen M. Kost: Design, data acquisition, analysis and interpretation of data, preparation and review of manuscript.

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Catherine F. Roy

Jennifer A. Silver

Supplemental Material

Additional supporting information is available in the online version of the article.

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Supplementary Material

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