Clinical Spotlight

Introduction: Balloon dilation, either alone or in combination with other adjunctive techniques, is the most common treatment modality for subglottic and tracheal stenosis primarily because of ease of use and the ability to deploy the device endoscopically. Although it is widely used, it is by no means a perfect treatment modality. One of its shortcomings is that the use of an airway dilation balloon typically necessitates momentary (but complete) occlusion of the airway by the balloon during dilation. Patients with poor pulmonary reserve may only tolerate a few seconds of apnea, thus limiting the duration of dilation and potentially causing significant oxygen desaturation. A new non-occlusive airway dilation balloon recently became available in the United States that circumvents this problem in an innovative way. Rather than using a single cylindrical balloon, the Trachealator (DISA Medinotec, Johannesburg, South Africa) uses a ring of 6-8 much smaller individual semi-rigid cylindrical balloons thus forming a hollow dilation device through which the patient can be ventilated during the dilation procedure (Figure 1). In addition, we recently extended the use of this novel device to an area that only a small number of centers in the world have attempted - to perform airway dilation in an awake patient without the need for general anesthesia. After the dilation balloon is inflated, the device allows the patient to breathe through it while the dilation is being performed. Two cases are illustrated herein describing our early experience with this novel device.  

Case 1: A 60-year-old morbidly obese woman with severe asthma and chronic obstructive pulmonary disease developed a roughly 60 percent tracheal stenosis after being intubated for a routine abdominal surgery. Given her comorbidities, we anticipated poor pulmonary reserve. In the brief time taken to expose the larynx and initiate supraglottic jet ventilation, she had desaturated to 85 percent and a small endotracheal tube was placed to provide positive pressure ventilation. Once oxygenation improved, the stenosis was addressed with CO2 laser scar lysis, steroid injection, and balloon dilation through an operative laryngoscope. With the balloon dilator fully inflated, jet ventilation proceeded uninterrupted while the dilator remained deployed for 2 minutes.  There were no additional desaturations.  At a recent 2 month follow up, there was no recurrence of stenosis.  

Case 2: A 63-year-old woman with post-intubation subglottic stenosis after a prolonged intubation in 2008 required dilation every 1-2 years. In 2021, she requested office-based treatment for her condition due to high out-of-pocket insurance costs for procedures under general anesthesia. She underwent several office-based steroid injections with incomplete relief. Based on our positive experience using the Trachealator under general anesthesia with jet ventilation, she was offered balloon dilation with the Trachealator under only mild sedation and topical anesthetic. After application of anesthetic to the nasal and pharyngeal mucosa, a flexible endoscope was passed below the level of the glottis and a guidewire placed. The guidewire was then used to place the device across the stenosis under endoscopic guidance. The device was then fully inflated, and the patient was allowed to breathe normally during the dilation. After the procedure the patient reported that she felt only mild discomfort associated with the dilation and, most importantly, no restriction of breathing during the procedure.

Discussion: Balloon airway dilation is a technology that has been widely used for decades with very little modification or innovation. The Trachealator represents a promising new technology in the endoscopic management of airway stenosis that overcomes a significant disadvantage of this treatment modality – the need for complete occlusion of the airway during the procedure. Given that this device has only recently gained FDA approval in the US, the only available published studies investigating this device are from Europe. In 2022, Hofmeyr et al published the first human trial of the device whereby the dilation was conducted endoscopically through a Laryngeal Mask Airway in 20 patients and ventilation was successfully maintained during the entire procedure (1). Also in 2022, Wijermars et al published a series of seven patients who underwent endoscopic dilation using the device with CO2 laser scar lysis and steroid injection similar to the technique used in Case 1 with excellent results (2). Other centers are currently performing the procedure in awake patients both with and without sedation with publications forthcoming.

Conclusions: As illustrated by the two cases presented here, this innovative new device has the potential to allow a safer and possibly more effective endoscopic dilation in medically complex patients who have poor pulmonary reserve or who may be at significant risk under general anesthesia. The Division of Laryngology at Augusta University is currently investigating outcomes, clinical usefulness, safety, and cost effectiveness of this exciting new technology and hope to bring this device into more widespread use in the office setting in the future thus avoiding the cost, risks and inconvenience associated with procedures conducted in the operating room.

References:

1. Hofmeyr R, McGuire J, Park K, et al. Prospective Observational Trial of a Nonocclusive Dilatation Balloon in the Management of Tracheal Stenosis. JCardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):3008-3014.

2. Wijermars LGM, Hoekstra CEL, Nguyen TTT, et al. New Treatment Strategyfor Subglottic Stenosis Using the Trachealator, a Novel Non-occlusive Balloon.Laryngoscope. 2022 Nov;132(11):2202-2205.