Single-use flexible bronchoscopy with the Boston Scientific^® EXALT™ Model B—an academic quaternary centre experience

Introduction

Single-use flexible bronchoscopes (SUFBs) have become increasingly popular in recent years owing to their portability, accessibility, lack of requirement for cleaning and potential to reduce infection transmission. Fourteen commercially available devices were identified in a recent narrative review published in April 2024 which reviewed the cost effectiveness, cross contamination and environmental impact of each (1).

While the initial intended users for SUFBs were the anaesthetist in the intensive care unit or operating theatre for assistance with intubation, tracheostomy placement, airway management, or bronchoalveolar lavage (BAL) (2-4), the target market has now shifted towards bronchoscopy units. The incidence and increased awareness of bronchoscopy-associated infection further supports a switch to SUFBs (5-7). The coronavirus disease 2019 (COVID-19) pandemic also reaffirmed the potential sterility benefit and absence of post-procedure cleaning requirement of SUFBs (8-10).

The Boston Scientific^® EXALT^TM Model B range (Marlborough, MA, USA) became available in 2021. There are three sizes available—slim, regular and large—with a corresponding working channel diameter of 1.2, 2.2 and 2.8 mm, respectively. All scope sizes have an articulation angle of 180 degrees up and down. It is attached to a 12.3” high resolution portable monitor with a 6.6” live screen with Endoscopy Report Writer integration allowing instant image capture which can be attached to bronchoscopy reports. In a recent bench-top comparison of five different SUFBs, the Boston Scientific^® EXALT^TM Model B performed well, most notably with a dramatically better suction capability which was up to double that of other similar sized SUFB scopes (11). Similar suction capability was also identified in another pre-clinical study (12). A pilot clinical evaluation of this scope recorded a high level of user satisfaction and commented only on one technical limitation (that being an inability to pass a forceps to the anterior segment of the right upper lobe) though the cohort number was small with 24 patients included (13).

To evaluate the performance of the Boston Scientific^® EXALT^TM Model B bronchoscope, we prospectively collected data on its usage in a quaternary referral centre in patients undergoing basic and advanced bronchoscopic procedures. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-840/rc).

Methods

We collected data prospectively from 2021 to 2024 on consecutive patients undergoing bronchoscopy using the Boston Scientific^® EXALT^TM Model B bronchoscope which was connected to our own in suite monitor (national medical standards certification achieved for medical devices prior to use) (Figure 1). The study was carried out in an academic centre with an interventional pulmonology service. Bronchoscopy in our endoscopy unit is performed under conscious sedation using titrated doses of fentanyl and midazolam. There were three endoscopists included in the study and the option to use the Boston Scientific^® EXALT^TM Model B scope was at the discretion of the bronchoscopist for each case with a reusable scope available immediately if required. Data was collected by the performing endoscopist at the time of the procedure (see Appendix 1). All patients included were over 18 years of age.

Figure 1 Boston Scientific^® EXALT™ Model B single use bronchoscope assessment. (A,B) Boston Scientific^® EXALT™ Model B with EXALT ™ monitor. (C) Endoscopic biopsy of endobronchial lesion.

Data collected included patient demographics and COVID-19 status, procedure details (indication, location, SUFB size, procedure performed, complications), and user satisfaction and demographics (see Appendix 1 for sample questionnaire). User satisfaction was visualized using a Likert scale of one to five in ascending order of satisfaction. Incidence of technical limitations relating to scope handle, suction connector, suction quality, image failure, or inability to sample lobes was also recorded along with any relevant comments/feedback. Incidence of patient-related complications was also recorded.

Recorded data were compiled and simple statistics applied.

Statistical analysis

User satisfaction was visualized using a Likert scale of one to five in ascending order of satisfaction. Mean user satisfaction was calculated from these results.

Ethical statement

This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Clinical Research Ethics Committee of University College Cork (ECM 4 (d) 1/6/2021). All patients had provided informed consent for the procedure and evaluation of the Boston Scientific^® EXALT Model B bronchoscope.

Results

From 2021 to 2024, there were 108 procedures performed with the EXALT™ bronchoscope.

User demographics

Three faculty bronchoscopists were included with all in excess of 5 years’ experience, qualification through standardised respiratory/pulmonology fellowship training in Ireland and/or the USA and over 200 prior procedures with or without trainer. Two were right-handed (see Table 1).

Patient demographics

There were 51 (47.2%) female patients and 57 (52.8%) male patients among this cohort. One patient tested COVID positive.

Procedure details

The procedures were carried out in three different locations: endoscopy (n=100, 92.6%), ICU (n=2, 1.9%), and theatre (n=6, 5.6%). The larger 2.8 model was used in 84 (77.8%) cases while the 2.2 model was used in 26 (24.1%). In two cases both sizes were used due to failure of the larger scope to achieve the required tip angulation to the target upper lobe airway.

Indications in order of frequency were as follows (see Figure 2): malignancy (n=45), infection (n=26), shortness of breath or cough (n=7), asthma (n=5), haemoptysis (n=5), benign stenosis (n=5), bronchiectasis (n=4), chronic obstructive pulmonary disease (n=4), mucus clearance (n=2), lobar collapse (n=2), bronchitis (n=1), interstitial lung disease (n=1) and sarcoidosis (n=1).

Figure 2 Distribution of procedural indications for bronchoscopy performed with the Boston Scientific^® EXALT™ Model B single-use bronchoscope. COPD, chronic obstructive pulmonary disease; ILD, interstitial lung disease; SOB, shortness of breath.

Procedures performed included airway inspection (n=108), BAL (n=75), endobronchial biopsy (n=23) (Figure 1C), brushings (n=13), argon plasma coagulation (n=10), bronchial washings (n=8), electrocautery (n=5), transbronchial biopsy (n=4), cryobiopsy (n=2), transbronchial needle aspiration (n=1) (see Figure 3).

Figure 3 Procedures performed with the Boston Scientific^® EXALT™ Model B bronchoscope. APC, argon plasma coagulation; BAL, bronchoalveolar lavage; EBBX, endobronchial biopsy; TBBx, transbronchial biopsy; TBNA, transbronchial needle aspiration.

Rigid bronchoscopy was used in four cases, with the SUFB passed through the rigid scope. These cases were all performed in theatre.

User satisfaction/complications

The average user satisfaction rating (using a Likert scale of 1–5 in ascending order) was 4.7 (see Figure 4) with the maximum score being given in 88 cases (81.5%). There were 20 cases (18.5%) with less than maximum satisfaction scores. Reasons for user dissatisfaction are outlined in Table 2. The most common reason for user dissatisfaction was difficulty passing tools through the working channel (n=7, see Table 2). Other reasons for lower satisfaction ratings included: image failure/quality (n=5), suction problems (n=3), angulation issues (n=2), and stiffness (n=1). Two cases did not comment on the reason for suboptimal satisfaction.

Figure 4 User satisfaction ratings for the Boston Scientific^® EXALT™ Model B single-use bronchoscope. Satisfaction was evaluated using a 5-point Likert scale. Numbers in parentheses indicate the number of procedures.

Another reason for reduced user satisfaction was limitation in scope angulation. The endoscopist was unable to sample the desired upper lobe airway target in one case. In another fluoroscopy-guided case, the initial 2.8 model was unable to achieve the required angle to sample a lesion and so a 2.2 model was then successfully used. One endoscopist noted an inability to flex to the right upper lobe while another commented on limited flexibility in getting to the anteroposterior segment of the left upper lobe. There were two cases where endoscopists commented on the scope being stiff (one was a general comment, the other was noted while trying to access the left upper lobe with tools in the working channel).

In three procedures, difficulty with suction was reported. In the first the suction button was jammed, in the second the suction was not functioning properly, while in the third the suction was too high and the sample was lost from the trap into the disposable suction cannister. Image failure was noted in two cases requiring a switch to a second bronchoscope. In three cases it was noted that the image quality was substandard.

No case required conversion from single use to reusable scope. There were no patient-related complications.

Discussion

Feedback regarding the use of Boston Scientific^® EXALT™ Model B performed was positive in our quaternary care academic centre with an interventional pulmonology program. Connecting the scope to our monitors was straightforward. It demonstrated a high level of user satisfaction and versatile applications. There were no patient-related complications and technical limitations did not require conversion to a reusable scope in any case. While the autonomy of the individual endoscopists to choose an SUFB for each case may contribute to a selection bias towards lower risk procedures, the results of our study are reassuring in that conversion to a reusable bronchoscope was not required despite malignancy in 41.7% cases which in itself can be associated with higher risk. The majority of reasons for user dissatisfaction were related to image, stiffness of scope or suction. As stated regarding image, most cases included satisfactory image. Introducing a new monitor and processor will lead to a change in image and it can take time for bronchoscopists to adapt. Interpretation of image thus is subjective and thus only assessable by comparative studies. The most common reason for user dissatisfaction was difficulty in passing tools through the working channel (seven cases, 6.5%). One of these procedures was rectified by conversion to the smaller Boston Scientific^® EXALT™ Model B 2.2 scope. One reason for this is the amount of thumb force required to flex and extend the scope tip. In our bench top testing, in comparison to four other SUFB scopes, the EXALT™ Model B required the most thumb force for tip movement (11). In comparison to the other scopes it was mid-range in tip angulation capabilities. Another reason for inability to biopsy a difficult to reach lesion is loss of tip angulation with instrumentation. Indeed, our centre has previously reported loss of tip angulation of reusable bronchoscopes with tools in situ (14). However, in our bench top testing in comparison to four other scope types, the EXALT™ Model B had the least amount of reduction in angulation related to instrumentation. Finally, our subsequent experience has identified that the passing of instruments with the EXALT™ Model B under maximum flexion is difficult. Thus, our approach to attempt to overcome the inability to biopsy with scope tip maximum flexion is to allow the tip back into neutral position, pass the instrument to the tip of the scope and then flex the scope tip and biopsy.

However, during this evaluation and in our subsequent experience, the main advantage of the EXALT™ Model B is suction. In both our bench top analysis and another similar study (11,12), the EXALT™ Model B dramatically and significantly outperformed other SUFBs with similar channel size and even reusable scopes with larger channel 3.2 mm size. The reason for this is due to the clam-shell shape of the suction channel and no obstruction through the scope of suction from tip to suction port due to scope design. In our bench top analysis in comparison to similar channel size single use scopes and a larger 3.2 mm channel reusable scope, the EXALT™ Model B was the only scope capable of suctioning a pseudo-mucus liquid (1% guar gum solution) around an instrument in situ. Indeed, a technical complication highlighted in one patient was the loss of sample into the disposable suction cannister through the BAL trap due to excessive suction power. It is now our practice to either turn down suction or “piggy back” a second BAL trap between scope and disposable suction cannister to prevent loss of sample. The superior suction capabilities of the EXALT™ Model B has made it the scope of choice in our institution for hemoptysis, potential thick secretions such as our cystic fibrosis cohort and flexible bronchoscopy through the rigid bronchoscope (with the added advantage of no risk of damage to a reusable scope due to trauma and during rigid bronchoscopy training).

Prior reviews and studies have highlighted the importance of recognition of scope related infection and the hypothesis that transitioning to SUFB may reduce this risk (1-6,8-10,15-20). One retrospective database analysis study (only published in abstract version) of 14,228 procedures suggested that the rate of readmission doubled after bronchoscopy using a reusable scope as opposed to an SUFB (21). However, the abstract does not clarify the cause of readmission and potential bias related to confounders.

Other factors that need to be considered are cost and environmental impact. Regarding cost, studies have varied depending on the variables analysed and the inclusion of cost related to infection. A frequently cited systematic review in 2019 analysed reports of cross contamination with reusable bronchoscopes and the resultant cost per patient and performed a cost effectiveness analysis from 16 studies identified. From a micro cost analysis the total cost per use of a reusable scope was £249 versus £220 in favour of single use bronchoscopy, however £511 versus £220 in patients with scope related infection (predicted in 2.8% patients) (16). Thus SUFBs compare favourably in terms of cost with the general consensus being that SUFBs are cost effective in institutions with a high annual volume of procedures with one study quoting a threshold of >200 procedures per year (17-20,22,23).

Another factor to consider is the environmental impact of these instruments. There are few studies which assess the environmental footprint of disposable scopes. One study compared carbon dioxide-equivalent emissions and resource consumption from an SUFB versus a reusable scope using a life cycle assessment (24). They showed that the materials and personal protective equipment used in the cleaning process play a key role in the assessment and so given the wide variability in practice a robust conclusion could not be made. An audit in 2021 of 278 endoscopies determined that a full transition to SUFBs would increase net waste by up to 40% (25). A more favourable environmental impact from multi-use instruments over disposable counterparts was also iterated in a systematic review this year which assessed various types of scopes (26).

An overriding question in the consideration of transitioning to SUFBs is how they compare to reusable scopes in terms of performance and yet to date we have identified only one study which directly compares the two in the endoscopy suite (27). This prospective study included 45 patients with a central lung cancer who underwent bronchoscopic routine examination, BAL, and biopsy. A reusable scope was used in 30 cases and an SUFB (Vathin^® H-SteriScope™) in the remaining 15 cases. They concluded that SUFBs were non-inferior to reusable scopes in each procedure and the operators were satisfied with the SUFBs. The experience with SUFBs in our institution thus far has also been favourable (11,13,28,29)

Regarding national or international society guidelines, thus far the only body that has commented on the utility of SUFB is the Respiratory Branch of the Chinese Medical Association (30). They addressed nine key issues concerning SUFBs: definition, construction, benefits, application scenarios, pre-operative preparation, sedation, anaesthesia requirements, disinfection processes and training. Twelve consensus statements were highlighting advantages of SUFB including portability and accessibility. They also highlighted the requirement of standardised and systematic training.

Conclusions

In conclusion, our analysis of the Boston Scientific^® EXALT™ Model B bronchoscope identified a range of benefits, including a high level of user satisfaction, a low rate of technical difficulties, and a wide array of procedural applications with no patient-related complications or requirement to convert to a reusable scope. This study augments the ever-growing data supporting the use of SUFBs in the setting of the bronchoscopy suite, though further comparative studies are desirable in order for endoscopists to make a fully informed and centre-appropriate decision about switching from reusable bronchoscopes.

Acknowledgments

We would like to thank all the Endoscopy staff in Cork University Hospital for their assistance with this project. This project was presented as an oral presentation at the World Congress for Bronchology and Interventional Pulmonology 2024.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-840/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-840/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-840/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2025-840/coif). M.P.K. received consulting fees and speaker fees from The Surgical Company and Boston Scientific, and has been on the advisory board of both companies. He has served as a key opinion leader for The Surgical Company, who have also previously granted Cork University Hospital single use bronchoscopes and monitor as training material. He has received speaker fees from Pentax Medical. He is the President of the Irish Thoracic Society and Irish Regent of the World Association of Bronchoscopy and Interventional Pulmonology. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Clinical Research Ethics Committee of University College Cork (ECM 4 (d) 1/ 6/2021). All patients had provided informed consent for the procedure and evaluation of the Boston Scientific^® EXALT Model B bronchoscope.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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