Feasibility of Awake In-Office Transnasal Double Balloon Dilation of the Pharyngoesophageal Segment

Abstract

Objectives:

To review experience with and describe the feasibility of unsedated in-office transnasal double balloon dilations of the pharyngoesophageal segment (PES).

Methods:

Adults who underwent office-based transnasal double balloon dilations of the PES at a single academic institution over a three-year period were retrospectively studied. Clinicodemographic data, prior PES dilation history, procedural indications, pre-procedure anxiolytic usage, procedural data including the number of office-based double balloon dilation procedures performed and dilation diameter, complications, and subjective outcomes at two-weeks post-dilation were recorded.

Results:

Nineteen office-based double balloon dilations to 24 millimeters (12+12-millimeter balloons) were performed in seven patients (mean age: 65.3 years, 57.1% female). Indications for dilation were varied. Two (28.6%) patients had a history of oropharyngeal cancer treated with radiation therapy. No patients were post-laryngectomy. The majority (85.7%) of patients underwent at least one prior in-office transnasal single balloon dilation. Two (28.6%) patients required a pre-procedure anxiolytic. One complication occurred involving post-procedure epistaxis that resolved with topical oxymetazoline application. No esophageal lacerations or perforations were encountered. No procedures required early termination due to poor patient tolerance. The majority (71.4%) of patients reported subjective improvement in dysphagia symptoms at two-week follow-up.

Conclusion:

Double balloon dilation of the PES is feasible in unsedated patients in the office setting.

INTRODUCTION:

Balloon dilation of the esophagus emerged as an alternative to the traditional bougienage method in 1981 and was historically performed under general anesthesia (GA) or sedation.¹ The subsequent advent of ultrathin distal-chip transnasal esophagoscopes prompted a shift towards office-based esophageal procedures in unsedated patients. Transnasal dilation of the esophagus using a single radial expansion balloon in the office setting was first described by Rees in 2007.² Additional studies have confirmed its safety and tolerability.^3–5

The pharyngoesophageal segment (PES) encompasses the 3 to 5 cm high-pressure zone situated between the hypopharynx and the cervical esophagus. Although the term is often used interchangeably with the upper esophageal sphincter, the latter more precisely denotes the intraluminal high-pressure zone identified on manometric evaluation, whereas the PES refers to the anatomic structures that comprise it. It consists of the inferior pharyngeal constrictor, the cricopharyngeus muscle, and the proximal cervical circular esophageal muscle. In contrast to the esophagus, which has a circular shape, prior work has demonstrated that the cross-sectional area of the distended PES is kidney-shaped as opposed to round.^6,7 This distinct morphology of the PES is predicated by its rigid anterior boundary that consists of the posterior body of the cricoid cartilage that provides a rigid structure responsible for the preservation of this configuration during distension as well as its mobile muscular components.^8,9

The conventional approach to balloon dilation of the PES entailed the use of cylindrical bougienage or single radial expansion balloons, though these dilation methods facilitate a circular dilation that may be suboptimal due to the tendency of the dilator to deviate to the more patent side of the PES.⁷ Consequently, the simultaneous use of two cylindrical balloons has been proposed to afford a physiology-based dilation and facilitate optimal expansion.

Belafsky et al. found that the double balloon technique was feasible, safe, and effective when performed under intravenous sedation.^10,11 However, access to procedural sedation suites may be limited. Although single balloon dilations have been previously described in the office setting,^2–5 double balloon dilations may serve as a viable alternative, allowing for improved approximation of the PES.

To the best of our knowledge, office-based double balloon PES dilations have not been described in the literature. Accordingly, we review our technique as well as the feasibility of unsedated transnasal double balloon dilation of the PES performed in the office setting.

MATERIALS AND METHODS:

This study was approved by the Institutional Review Board at Weill Cornell Medicine. Adults who underwent in-office unsedated transnasal double balloon dilation of the PES for any indication between September of 2021 and November of 2023 by the senior author at our single tertiary academic institution were identified via Current Procedural Terminology (CPT) code 43220 (flexible esophagoscopy with transendoscopic balloon dilation of less than 30 millimeters in diameter). Those who received single balloon or OR-based dilations were excluded. Clinicodemographic data, pre-dilation 10-item Eating Assessment Tool (EAT-10) scores,¹² prior PES dilation history, procedural indications, pre-procedure anxiolytic usage, procedural data including the number of office-based double balloon dilation procedures performed and balloon dilation diameter, complications, and subjective outcomes at 2-weeks post-dilation were retrospectively reviewed and recorded. Self-limited gagging, eructation, or discomfort for which termination of the procedure was not required were not considered to be complications. The mean time interval between office-based transnasal double balloon dilation procedures was also approximated for those patients who underwent more than one procedure.

Prior to pursuing dilation, the options of sedated versus awake, in-office treatment were reviewed in detail with patients. The advantages and disadvantages of each were discussed and shared decision-making guided the approach utilized.¹³ Patients who had previously demonstrated intolerance to in-office procedures such as flexible laryngoscopy, Flexible Endoscopic Evaluation of Swallowing (FEES) assessments, and/or transnasal esophagoscopy were instead offered dilations under sedation. Among those who pursued the in-office approach, dilations occurred at a standalone outpatient laryngology clinic with no sedation. Patients were instructed to remain nil per os (NPO) for four hours prior to the procedure. No patients in the current cohort were receiving glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy. Although consensus guidelines for NPO duration in patients taking GLP-1 RAs undergoing this procedure are lacking, extended NPO intervals should be considered in this population. In a select subset of patients who expressed concerns regarding significant procedural anxiety, diazepam (2-8 mg orally) was prescribed, and patients were instructed to take this 30-60 minutes prior to the procedure. Topical anesthesia consisted of administration of a 1:1 mixture of Neosynephrine and 4% Lidocaine spray followed by placement of wide pledgets soaked in 4% Lidocaine in the nasal cavity. The pledgets remained in place for five to ten minutes prior to removal, and the patient was asked to gargle with and swallow one to two tablespoons of 4% Lidocaine. A standard transnasal esophagoscopy (TNE) was then performed through the more patent naris using a Pentax VE-1530 transnasal esophagoscope with a 2-milimeter working channel (Pentax Precision Medical Co, KayPentax, Lincoln Park, New Jersey). If TNE was not tolerated, dilation was not pursued. If the patient tolerated TNE, we proceeded to dilation of the PES using two Hercules^® 100 transnasal esophageal balloons and two Cook Sphere^® inflation devices (Cook Medical, Bloomington, IN). With the esophagoscope in the stomach, two soft flexible guidewires were passed through the endoscope’s working channel. The endoscope was subsequently withdrawn over the guidewires as the guidewires were advanced. Immediately upon endoscope removal, the guidewires were clamped at the entrance to the naris and held at the floor of the nasal cavity by an assistant. The endoscope was then passed preferentially through the contralateral naris and positioned in the pharynx to permit a view of the post-cricoid region. In cases where the endoscope is unable to be passed via the contralateral naris, a flexible laryngoscope can be utilized instead of a transnasal esophagoscope. The endoscope tip size of 5.1 millimeters (mm) was used to gauge the starting point for dilation, and the appropriately sized balloon dilators were passed over the guidewires and positioned to span the area of the PES to be dilated (Figure 1). At this point, patients were instructed that dilation would be commencing and to refrain from swallowing. Two assistants facilitated sequential dilations. First, it was determined which inflation device corresponded to each balloon prior to commencing dilation. Once confirmed, the first balloon was slowly inflated with saline to the target diameter (Figure 2), and this was subsequently repeated with the second balloon (Figure 3). Dilation was conducted to 12 + 12 mm for a period of 30 seconds. Following dilation, the site was carefully inspected for any bleeding to suggest laceration or perforation. Patients were observed in the clinic for 20 minutes and instructed to remain NPO for an additional two hours, after which they typically resumed their baseline diet. Follow-up was conducted via telephone call at two weeks post-procedure. Post-procedure swallow evaluations were only pursued if patients’ swallow status declined or changed appreciably after dilation.

Figure 1.

Positioning of each balloon to span the pharyngoesophageal segment

Figure 2.

Inflation of first balloon

Figure 3.

Inflation of both balloons

RESULTS:

Nineteen unsedated office-based transnasal double balloon dilations of the PES were performed in seven patients with a mean age of 65.3 years (range: 42-80 years). Patient case summaries, single and double balloon dilation histories, and subjective outcomes at two-week follow-up telephone visits following office-based double balloon dilations are detailed in Table 1. The average pre-intervention EAT-10 score was 28.7. Indications for dilation were varied. Three patients (42.9%) had a history of oropharyngeal carcinoma. Two (28.6%) were treated with radiation therapy, and one (14.3%) was managed surgically. No patients were post-laryngectomy. The majority of patients (85.7%) had undergone at least one prior awake in-office transnasal single balloon dilations of the PES. Two patients (28.6%) who each underwent more than one dilation required a pre-procedure anxiolytic. Among nineteen dilations, one minor complication occurred and involved epistaxis following the procedure that resolved with Afrin. No esophageal lacerations or perforations occurred. No procedures required early termination secondary to poor patient tolerance.

Table 1.

Patient case summaries

Case Number	Relevant History	Single Balloon Dilation History	Number and Dilation Diameters of Office-Based Double Balloon Dilations (OBDBD)	Approximate Mean Time Interval Between OBDBD	Subjective Outcomes at Follow-Up Visits 2-Weeks Post-OBDBD
1	74F with right tonsil cancer status-post chemoradiation with severe posterior pharyngeal wall radiation fibrosis	9 dilations (20-mm) in OR and office	11 dilations (12+12-mm)	~2 months	Improvement, but short-lived
2	67M with base of tongue cancer status-post radiation therapy with cricopharyngeal (CP) web	1 dilation (19-mm) in office	1 dilation (12+12-mm)	-	Improvement
3	42F with profound oropharyngeal swallowing dysfunction status-post posterior cranial fossa surgery complicated by cerebrovascular accident and multiple cranial nerve palsies	1 dilation (20-mm) in office	2 dilations (12+12-mm)	~8 months	Minimal improvement
4	80F with CP bar	1 dilation (20-mm) in office	1 dilation (12+12-mm)	-	Improvement
5	61F with oculopharyngeal muscular dystrophy (OPMD) and CP bar	1 dilation (20-mm) in office	2 dilations (12+12-mm)	~2 months	Improvement with first, no change with second
6	75M with OPMD and CP bar	2 dilations (20-mm) in office	1 dilation (12+12-mm)	-	Improvement
7	58M with p16+ left tonsil cancer status-post transoral robotic-assisted left radical tonsillectomy, right tonsillectomy, left selective neck dissection	-	1 dilation (12+12-mm)	-	Minimal improvement

DISCUSSION:

The continued evolution of the United States healthcare system and advancements in office-based equipment and technologies have resulted in a paradigm shift from management in the OR to the office setting. This change is particularly evident when considering the emergence of TNE and subsequent progression to interventional procedures including dilations, which have previously only been described in the context of single balloons. Recent work in an ovine model and sedated patients has suggested that the use of two cylindrical balloons may facilitate optimal approximation and dilation of the PES.^6,10–11 We demonstrate that in-office transnasal double balloon dilations of the PES can be practicably performed in the office.

Office-based dilations may confer several distinct advantages to those performed in the OR. Scheduling is often more facile in the office setting, and the recovery time is more favorable.³ Procedural costs are also significantly reduced. A prior cost analysis compared itemized billing records among similar patients who underwent office- versus OR-based dilations. Average total hospital charges were nearly $19,000 for traditional OR dilations and roughly $3,400 for those performed in the office with an average cost reduction of $15,389 per episode of care.⁴

Potential acute procedural complications include epistaxis, coughing, gagging, laryngospasm, aspiration of gastric contents, blood-tinged secretions, and mucosal lacerations. Refractory coughing or gagging, laryngospasm, and aspiration of gastric contents should prompt early termination of the procedure. Epistaxis may also warrant procedural abortion if it is of a refractory nature and/or impedes visualization. In cases of superficial mucosal lacerations, patients should be assessed for the presence of subcutaneous emphysema and can generally be managed conservatively with cautious diet resumption and consideration for acid suppression. Patients should be assessed for the presence of subcutaneous emphysema. Within our series of nineteen dilations, only one minor complication of post-procedure epistaxis occurred, and no major complications were encountered. All dilations were able to be completed. These findings are in accordance with prior work suggesting that in-office unsedated single balloon dilations can be feasibly performed with minimal complications. The seminal description by Rees in 2007 involved an anecdotal report of over 40 dilations with no adverse outcomes. Shortly thereafter, procedure safety and tolerability were formally retrospectively assessed for 20 office-based single balloon dilations. No clinically significant complications were encountered, though two procedures were ultimately aborted secondary to self-limited laryngospasm or gagging. Other series have described minor complications, including three focal superficial lacerations, two incidences of self-limited epistaxis,⁴ and one dilation site infection that was managed medically in the outpatient setting with no long-term sequelae.⁵ Prior studies involving sedated double balloon dilations suggest a similar safety profile. No complications occurred in a cohort of ten patients who underwent dilation with the simultaneous median use of two 15-mm balloon dilators for varied indications.¹⁰ Mucosal lacerations occurred in a subsequent series but were not discretely recorded; however, it was noted that this did not result in any deep neck space infections or other sequelae.¹¹ Although our findings largely align with prior reports, they should not be interpreted as definitive evidence of procedural safety. Larger prospective series incorporating systematic hemodynamic monitoring are needed to more rigorously assess safety.

Two patients (28.6%) in our series underwent prior radiation therapy for oropharyngeal carcinoma and were successfully dilated with the two-balloon technique in the office setting without complications. One of these patients (Case 1 in Table 1) has undergone a total of eleven office-based double balloon dilations at roughly two-month intervals. This patient’s PES dysfunction stems from thick radiation fibrosis at her posterior pharyngeal wall for which dilations have provided benefit, albeit short-lived. Several prior series have demonstrated that single balloon dilations can be safely performed at regular intervals in radiated patients.^3–5 Our findings suggest that the in-office double balloon technique can also be considered as a management option for patients with radiation histories.

The double balloon technique has been posited to afford physiology-based dilations that mimic the natural kidney shape of the distended PES.^6–8 This may allow for improved treatment response compared to single balloon dilations for which treatment failure has been reported to occur in over 15% and nearly 60% of patients require multiple dilations.^14–15

The majority of patients in our series reported improvement in dysphagia symptoms at two-week follow-up, though longitudinal outcomes were not assessed in the present study. Prior work has demonstrated favorable treatment outcomes for double balloon dilations performed under sedation. Randall et al. retrospectively studied in 17 patients with cricopharyngeus muscle dysfunction who underwent a serial “series of three” balloon dilations to 20 mm, 15 + 15 mm, and 18 + 18 mm separated by 4–6 weeks. Improvements were observed for both patient-reported dysphagia symptom scores and objective fluoroscopic swallowing parameters including increased mean PES opening and pharyngeal constriction ratio.¹¹ Within their cohort, the lateral fluoroscopic PES opening improved to 0.76 cm, exceeding the 0.62 cm that has been reported for single balloon dilation.¹⁶ Within the past two years, the novel Infinity Dilation System has become commercially available (Hope Medical, Cincinnati, OH). These dilators are specifically designed to conform to the anatomical structure of the PES and are available in three sizes to enable staged dilation procedures. A retrospective study comparing single, double, and Infinity balloon PES dilations performed under sedation showed that double and Infinity balloon dilations afforded greater average maximal PES dilation dimensions (32 and 33 mm, respectively) as compared to the single balloon (18 mm) technique. To the best of our knowledge, use of the Infinity Dilation System has not specifically been described in the awake patient in the office setting.¹⁷ Further comparative work is needed to assess clinical outcomes for single versus double balloon dilations.

The dilation duration at maximal balloon distension was 60 seconds in both of the aforementioned series in which double balloon dilation of the PES was performed under sedation.^11,17 In contrast, the present cohort underwent dilation for only 30 seconds. This discrepancy reflects concerns regarding the tolerability of longer dilation intervals in awake, unsedated patients. To our knowledge, the impact of extended dilation durations on PES tissue compliance has not been systematically investigated; however, it is reasonable to assume that longer intervals may facilitate greater tissue compliance and, consequently, more favorable clinical outcomes. Due to presumed challenges in patient tolerability, a similar disparity in maximal dilation caliber exists between our awake, unsedated cohort and prior series in which double balloon dilation of the PES was performed under sedation. Patients within our cohort underwent dilation to 24 mm, whereas dilations performed under sedation were performed up to 36 mm.^11,17 These considerations underscore potential limitations of performing dilations in awake patients and highlight the need for further research directly comparing the efficacy for sedated versus unsedated dilations.

A recent prospective series by Young et al. assessed patient tolerability, safety, and perceptions of PES dilations. A total of 46 dilations were performed among 41 patients in either a surgical endoscopy suite under procedural sedation in the presence of a registered nurse with experience in administering sedation (30.4%) or under monitored anesthesia care with sedation in the operating room by an anesthesia provider (69.6%). Roughly 70% of their cohort underwent a double balloon approach. Patients reported favorable overall experiences, with the majority indicating that they would undergo the same procedure in the future. Although clinical outcomes for the single versus double balloon approaches were not directly compared, no differences were observed in patient-reported levels of pain during dilation, overall pain, current pain level, overall experience, or preference for general anesthesia.¹⁸ Because the procedures within their cohort were performed under sedation, it remains unclear whether comparable results would be encountered in awake patients.

Our findings demonstrate feasibility within the office setting, obviating the need for sedation. Three out of our seven patients underwent more than one dilation, suggesting reasonable tolerability; however, formalized tolerance metrics were not employed, which is a limitation and represents an area for future work. This approach avoids the use of anesthesia personnel and endoscopy suite or operating room resources, thereby reducing cost, improving patient access, and streamlining care. This is a particularly important consideration in resource-limited healthcare systems such as the National Health Service in which the demand for laryngology care is significant but access to the operating room has become constrained.¹⁹

This study is subject to several limitations. Data were collected retrospectively, and our sample size is small. Although no procedures had to be aborted due to poor tolerability and no major complications occurred, formal safety and tolerability metrics were not directly assessed. This represents an important area for future study. Additionally, we have not systematically obtained patient-reported outcome metrics or performed swallowing evaluations post-procedure. Thus, longitudinal outcomes are lacking in the present cohort, and this represents an area for future prospective research. Additionally, the CPT code “43220” (flexible esophagoscopy with transendoscopic balloon dilation of less than 30 millimeters in diameter) was utilized to identify patients for inclusion. While this code is primarily intended for esophagoscopy performed via transoral means and its applicability to TNE is not universally accepted, no dedicated CPT code currently exists for TNE with balloon dilation.

CONCLUSION:

Double balloon dilations of the PES can be practicably employed in the office setting. They represent an additional useful tool in the armamentarium for dysphagia management, particularly in light of the ongoing paradigm shift from OR to office-based care in laryngology. This approach may offer particular benefit in resource-constrained settings.